The World Health Organization may of caused thousands of unnecessary TB deaths

Public Release: 23-Jun-2016

WHO’S TB care advice violated standards, researchers say

Poor countries told to follow cheaper, untested treatments

Duke University

DURHAM, N.C. — The World Health Organization (WHO) violated sound standards of medical care and human rights by nudging poorer countries to follow less expensive, untested and largely ineffective treatment protocols for tuberculosis patients, a new paper by researchers at Duke, Brandeis and Harvard universities argues.

The authors say the WHO violated its own constitution and international law from 1993 to 2002 by recommending and supporting a double standard of care for multidrug-resistant tuberculosis (MDR-TB), an airborne infectious disease.

Tuberculosis is the leading infectious killer of adults in the world, claiming roughly 4,000 lives every day. Multidrug-resistant strains of the disease are particularly difficult to diagnose, treat and prevent.

The authors describe the role the WHO played in Peru as the country worked to defeat MDR-TB in the late 1990s. WHO recommendations steered Peruvian health practitioners away from implementing a known, effective, yet more costly treatment, resulting in thousands of avoidable deaths, the authors argue. The authors also note the similar experiences of other low- and middle-income countries including India, Russia and Belarus.

WHO asserted that treating MDR-TB patients according to protocols proven successful in U.S. patients would be prohibitively expensive, and therefore advised focusing on preventing the emergence of new cases of MDR-TB. In addition to steering countries toward easier cases, WHO recommended less expensive but untested regimens for patients failing first-line treatments.

WHO based its advice on erroneous and anecdotal cost estimates of wealthy countries from the earliest years of the MDR-TB epidemic, rather than more rigorous cost estimates for care in both wealthy and poorer nations, the authors say.

The paper, “Double Standards in Global Health: Medicine, Human Rights Law and Multidrug-Resistant TB Treatment Policy,” by Thomas Nicholson, Catherine Admay, Aaron Shakow and Dr. Salmaan Keshavjee, was published online June 21 in the Health and Human Rights Journal.

“It is simply impossible to stop the spread of MDR-TB in families and communities without using medicines that can kill the resistant strains,” said Keshavjee, an associate professor of global health at Harvard. “This scientific fact was ignored for poor and middle-income countries because of concerns about cost. The result was the enshrinement of bad biomedicine into global policy.”

Without effective treatment, most people who are sick with any form of TB will infect people in their families and communities, and will eventually die from the disease.

The authors also argue that because the WHO acts as technical adviser for providers of foreign aid — funds that poorer countries need for their TB programs — the countries had little choice but to adopt the faulty protocol.

“With half a million MDR-TB cases occurring each year, and most of these cases not detected or receiving treatment, this issue is still extremely important,” said Nicholson, the paper’s lead author and an associate in research at the Duke Center for International Development.

“Unscientific recommendations for any disease, be it TB, Ebola or Zika, are unacceptable and dangerous. We hope the authors of global policy recommendations will focus less on whether to extend the highest standard of care to poor countries, and more on how to achieve it,” Nicholson said.

The impact of the double standard of care extends worldwide, said co-author Shakow, a lecturer in history at Brandeis.

“The irony is that in a global society, advocating different standards of treatment for poor countries and rich ones actually makes a public health problem much worse,” Shakow said. “By failing to live up to its own constitution, the WHO put everybody at risk.”

In 2002, second-line drugs became available for treatment of MDR-TB in mid- and low- income settings through a “Green Light Committee” co-sponsored by the WHO. However, the WHO guidelines on treatment of MDR-TB patients were not rewritten until 2006. Keshavjee served on the committee that rewrote the guidelines and chaired the Green Light Committee from 2007 to 2010.

“We hope WHO will keep sound medical care and human rights accountability front and center going forward,” said co-author Admay, a lecturer in Duke’s Sanford School of Public Policy. “When it’s institutionalized and systemic, when you don’t see the patient dying in front of you and the suffering is either invisible or normalized, accountability is elusive.”

Pharma Firms may of got caught manipulating data, resulting in agony and profit ?

“misleading marketing caused some lung-cancer patients “to die earlier and faster, with more pain.”

 “This settlement, however, allows the company to avoid the burden, disruption, cost and distraction of protracted civil litigation and to focus instead on our business of developing medicines that extend and improve human lives.”

Pharma Firms Reach $67M Deal With Feds

By DON DEBENEDICTIS

SAN FRANCISCO (CN) — Drugmaker Genentech and another pharmaceutical company will pay $67 million to settle a federal lawsuit accusing them of overstating the effectiveness of cancer drug Tarceva, the Justice Department said.
Federal prosecutors claim that from 2006 through 2011, Genentech and co-defendant OSI Pharmaceuticals made misleading statements to doctors about how well the drug worked for patients with non-small cell lung cancer.
In fact, the government claims, there was “little evidence” that Tarceva worked effectively for lung cancer patients — except for those who had never smoked or who had a mutation in a certain cell protein.
As a result of the exaggerated marketing to doctors, Genentech and OSI “knowingly caused false or fraudulent claims” to be submitted to Medicare and other federal and state health care programs for purchases of Tarceva for cancer patients who were smokers or lacked the mutation, according to the settlement agreement released late Monday.
The case appears to be the first settlement under the federal False Claims Act alleging a drug company exaggerated the survival data for a cancer drug, according to the law firm for the Genentech whistleblower who launched the lawsuit.
Earlier cases dealt with marketing drugs for unapproved uses.
“However, in this case, the manufacturers allegedly marketed their lung cancer drug with knowingly inflated survival data,” Nolan Auerbach & White partner Marcella Auerbach said in her firm’s release. “As alleged in the … complaint, the end result was a substantial boost in sales.”
The firm’s 2011 lawsuit on behalf of former Genentech employee Brian Shields claimed that the companies’ misleading marketing caused some lung-cancer patients “to die earlier and faster, with more pain.”
Federal prosecutors agreed to take over the case early on and reached Monday’s settlement with the drug companies.
“Drug manufacturers that make misleading claims about their product’s effectiveness can jeopardize the health of patients — in this case, cancer patients,” Health and Human Services official Steven J. Ryan said in a statement announcing the settlement. “Our agency will continue to protect both patients and taxpayers by holding those who engage in such practices accountable for their actions.”
“Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs,” Benjamin C. Mizer, chief of the Justice Department’s Civil Division, said in the statement. “The Department of Justice will hold those companies accountable that mislead the public about the efficacy of their products.”
The companies said the settlement allows them to put the five-year-old litigation behind them.
“We believe our Tarceva promotional communications and practices were and are entirely proper and in compliance with the law,” Genentech spokesman Andrew Villani said in an emailed statement. “This settlement, however, allows the company to avoid the burden, disruption, cost and distraction of protracted civil litigation and to focus instead on our business of developing medicines that extend and improve human lives.”
Villani also noted the settlement does not require the companies to submit to a detailed “corporate integrity agreement” with the Health and Human Services Department.
Under the settlement agreement, Genentech and OSI will pay $62.6 million to the federal government and $4.4 million to Medicaid programs in several states. South San Francisco-based Genentech is owned by Swiss drug company Roche, while OSI is owned by Astellas Pharma of Japan.
Shields will receive about $10 million of the total settlement out of the federal government’s share, according to the agreement.
Brian Stretch, the U.S. attorney in San Francisco who announced the deal Monday, said it “demonstrates the government’s unwavering commitment to pursue violations of the False Claims Act and recover taxpayer dollars spent as a result of misleading marketing campaigns.”

http://www.courthousenews.com/2016/06/07/pharma-firms-reach-67m-deal-with-feds.htm

FDA approved devices were not effective in clinical trials

Public Release: 20-May-2016

Flawed data behind regulation of high-risk women’s health devices

Some FDA approved devices were not effective in clinical trials

Northwestern University

CHICAGO — Some high-risk medical devices used in obstetrics and gynecology were approved by the FDA based on flawed data, according to a recent study from Northwestern Medicine.

The investigators assessed the regulation of women’s health devices approved by the FDA in the last 15 years. The authors suggest that their results, published in the journal Obstetrics and Gynecology, indicate that the agency’s approvals should be based on clinical studies more rigorous than currently required, both before and after the devices go to market.

“Devices are a huge part of the medical care that we provide women on a daily basis,” said study first author Dr. Jessica Walter, a resident in obstetrics and gynecology at Northwestern University Feinberg School of Medicine. “We found that there’s an opportunity to increase the burden of proof required for a device to be approved for public use.”

The team identified 18 high-risk devices approved by the FDA from 2000 to 2015, most of them for endometrial ablation (reducing menstrual flow), contraception and fetal monitoring. Four of the devices — 22 percent — were approved even though they failed to demonstrate efficacy in clinical trials. Six of the devices — 33 percent — were not required to undergo post-market studies to survey ongoing safety.

Three devices were eventually withdrawn from the market after approval. Of those three, two were not reviewed by physician experts on the FDA’s obstetrics and gynecology advisory committee. The other was reviewed but not recommended for approval by the committee.

“We looked at the class of devices with the highest potential risk to patients — the devices that had to go through the most rigorous pre-market approval process,” said senior author Dr. Steve Xu a resident in dermatology. “Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”

The authors point to controversial medical devices like a permanent contraceptive device approved by the FDA in 2002 that is now being evaluated after numerous reports of adverse events including pain, organ damage and unintended pregnancy. The device, meant to last a lifetime, was approved based on short-term evidence and insufficient post-market follow-up, explain the study authors.

“There are no explicit requirements about conducting randomized-controlled trials or post-market surveillance for medical devices. Requirements are decided on a case-by-case basis,” Xu said. “There are much higher standards for the approval of new drugs, whether oral, injectable or even topical. The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”

The authors note in the paper that the 21st Century Cures Act — healthcare legislation passed in the House of Representatives in May 2015 — currently contains provisions that would reduce medical device regulation. The bill is being considered by the Senate.

“There are provisions that would broaden the definition of the ‘valid scientific evidence’ manufacturers need in order to prove medical benefit. Our concern is that this would lead to more devices getting approved with even less clinical evidence that they are both safe and effective,” said Walter.

She and Xu said they believe that clinicians – in all specialties that use medical devices, not just obstetrics and gynecology – have a responsibility to understand how FDA regulation works and to take a more active role collecting and reporting data about the complications and unintended outcomes that result from devices. They also recommend that the FDA seek more input from expert advisory committees and rely on higher quality studies.

“I think some stakeholders believe that increasing regulation means stifling innovation, and that if we make it harder for these devices to be approved potentially life-changing devices will have a higher barrier to actually getting to market,” Walter said. “But that hasn’t necessarily been shown in the literature.”

###

The study’s co-authors are Dr. Emily Hayman and Shelun Tsai, both of Northwestern, and Dr. Comeron Ghobadi, of the University of Chicago.

Physicians Lack knowledge about FDA approval standards for ‘breakthrough therapy’

73 percent incorrectly believed FDA approval meant comparable effectiveness to other approved drugs; 70 percent incorrectly believed approval required both a statistically significant and clinically important effect. Among the 3 breakthrough knowledge questions, 52 percent incorrectly believed that strong evidence (randomized trials) is needed to earn the breakthrough designation.

Public Release: 12-Apr-2016

 

The JAMA Network Journals

In a study appearing in the April 12 issue of JAMA, Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women’s Hospital, Boston, and colleagues surveyed internists and specialists to examine their knowledge about Food and Drug Administration (FDA) approval standards and perceptions of the “breakthrough therapy” designation.

Since 2012, the FDA can designate a drug as a “breakthrough therapy” if preliminary clinical evidence–such as an improvement in a pharmacodynamic biomarker–suggests an advantage over existing options. The term is routinely used in press releases and prescribing resources. Although the term breakthrough leads consumers to overly optimistic beliefs about drug effectiveness, it is not known how physicians understand this term, or more generally, what FDA approval means.

Of 1,148 physicians contacted, 692 physicians (60 percent) responded. Participants were asked 3 questions about FDA approval and 5 about breakthrough therapies. Respondents showed limited knowledge of FDA approval: 73 percent incorrectly believed FDA approval meant comparable effectiveness to other approved drugs; 70 percent incorrectly believed approval required both a statistically significant and clinically important effect. Among the 3 breakthrough knowledge questions, 52 percent incorrectly believed that strong evidence (randomized trials) is needed to earn the breakthrough designation.

“The misconceptions identified may lead physicians to overprescribe newly approved drugs–particularly breakthrough therapies– and inadequately communicate how well these drugs work to the patients who will use them,” the authors write.

(doi:10.1001/jama.2015.16984; this study is available pre-embargo at the For The Media website.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

The 8 Assertions of Scientific Misconduct by the Joint Committee on Vaccination and Immunisation – Full 45 Page (FOIA) Document from the University of British Colombia’s Lucija Tomljenovic, PhD

Editor’s Note (Ralph Turchiano) Requested Repost from March 2011

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The vaccination policy and the Code of Practice of the Joint Committee on Vaccination and Immunisation (JCVI): are they at odds?

Lucija Tomljenovic, PhD

Neural Dynamics Research Group, Dept. of Ophthalmology and Visual Sciences, University of British Columbia, 828 W. 10th Ave, Vancouver, BC, V5Z 1L8, lucijat77@gmail.com

Introduction

No pharmaceutical drug is devoid of risks from adverse reactions and vaccines are no exception. According to the world’s leading drug regulatory authority, the US Food and Drug Administration (FDA), vaccines represent a special category of drugs in that they are generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. This, according to the FDA, places extra emphasis on vaccine safety. Universally, regulatory authorities are responsible for ensuring that new vaccines go through proper scientific evaluation before they are approved. An equal responsibility rests on the medical profession to promote vaccinations but only with those vaccines whose safety and efficacy has been demonstrated to be statistically significant. Furthermore, vaccination is a medical intervention and as such, it should be carried out with the full consent of those who are being subjected to it. This necessitates an objective disclosure of the known or foreseeable risks and benefits and, where applicable, a description of alternative courses of treatment. In cases where children and infants are involved, full consent with regards to vaccination should be given by the parents.

Deliberately concealing information from the parents for the sole purpose of getting them to comply with an “official” vaccination schedule could thus be considered as a form of ethical violation or misconduct. Official documents obtained from the UK Department of Health (DH) and the Joint Committee on Vaccination and Immunisation (JCVI) reveal that the British health authorities have been engaging in such practice for the last 30 years, apparently for the sole purpose of protecting the national vaccination program.

Here I present the documentation which appears to show that the JCVI made continuous efforts to withhold critical data on severe adverse reactions and contraindications to vaccinations to both parents and health practitioners in order to reach overall vaccination rates which they deemed were necessary for “herd immunity”, a concept which with regards to vaccination, and contrary to prevalent beliefs, does not rest on solid scientific evidence as will be explained. As a result of such vaccination policy promoted by the JCVI and the DH, many children have been vaccinated without their parents being disclosed the critical information about demonstrated risks of serious adverse reactions, one that the JCVI appeared to have been fully aware of. It would also appear that, by withholding this information, the JCVI/DH neglected the right of individuals to make an informed consent concerning vaccination. By doing so, the JCVI/DH may have violated not only International Guidelines for Medical Ethics (i.e., Helsinki Declaration and the International Code of Medical Ethics) [2] but also, their own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/ dh_digitalassets/@dh/@ab/documents/digitalasset/dh_115363.pdf).

The transcripts of the JCVI meetings also show that some of the Committee members had extensive ties to pharmaceutical companies and that the JCVI frequently co-operated with vaccine manufacturers on strategies aimed at boosting vaccine uptake. Some of the meetings at which such controversial items were discussed were not intended to be publicly available, as the transcripts were only released later, through the Freedom of Information Act (FOI). These particular meetings are denoted in the transcripts as “commercial in confidence”, and reveal a clear and disturbing lack of transparency, as some of the information was removed from the text (i.e., the names of the participants) prior to transcript release under the FOI section at the JCVI website (for example, JCVI CSM/DH (Committee on the Safety of Medicines/Department of Health) Joint Committee on Adverse Reactions Minutes 1986-1992; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306).

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Assertions

In summary, the transcripts of the JCVI/DH meetings from the period from 1983 to 2010 appear to show that:

1) Instead of reacting appropriately by re-examining existing vaccination policies when safety concerns over specific vaccines were identified by their own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines;

2) Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues;

3) On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with JCVI’s official advices on immunisations;

4) Persistently relied on methodologically dubious studies, while dismissing independent research, to promote vaccine policies;

5) Persistently and categorically downplayed safety concerns while over-inflating vaccine benefits;

6) Promoted and elaborated a plan for introducing new vaccines of questionable efficacy and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted;

7) Actively discouraged research on vaccine safety issues;

8) Deliberately took advantage of parents’ trust and lack of relevant knowledge on vaccinations in order to promote a scientifically unsupported immunisation program which could put certain children at risk of severe long-term neurological damage;

Notably, all of these actions appear to violate the JCVI’s own Code of Practice (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_115363.pdf).

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Evidence

I here provide the evidence in support of each of the above assertions. (Note: emphasis added throughout the text as underlined are by the author unless otherwise indicated)

1) Instead of reacting appropriately by re-examining existing vaccination policies when safety concerns over specific vaccines were identified by their own investigations, the JCVI either a) took no action, b) skewed or selectively removed unfavourable safety data from public reports and/or c) made intensive efforts to reassure both the public and the authorities in the safety of respective vaccines.

As early as 1981, the JCVI had substantial documentation which associated the measles

vaccine with serious adverse reactions including death and long-term adverse neurological 9th

outcomes. At the JCVI meeting held on April 1981 (http://www.dh.gov.uk/ab/ DH_095169), in discussing a paper that summarised all the reports of adverse reactions to the CSM, the following was noted:

(5.b.) Adverse Reactions to measles vaccine

“All reports since 1970 of encephalitis, encephalopathy or sudden death shortly after vaccination had been reviewed; 60 patients were involved of whom 8 had died, 36 had made an apparent complete recovery and 16 were left with permanent sequelae. The high proportion of deaths and patients with sequelae was surprising in comparison with the findings of the NCES [National Childhood Encephalopathy Study].”(5.b. Adverse Reactions to measles vaccine)

By 1983, the JCVI appeared to have had more evidence that the measles vaccine could cause encephalitis associated with “severe handicap” in a subset of vulnerable children. At the JCVI meeting on 17th of June 1983 (http://www.dh.gov.uk/ab/JCVI/DH_120115), the Committee on Safety of Medicines (CSM) received 66 reports of suspected adverse reactions to measles vaccines over the period January 1982 to April 1983. According to the transcript of the meeting:

(7. Suspected adverse reactions to measles vaccine: recent reports to the CSM) “These included three cases of encephalitis; on follow-up, two of these patients were left one year later with severe handicap and the third patient, after a year, appeared to be developmentally normal.”

By the end of 1981 serious safety concerns have also been raised with regards to another 3rd

routine paediatric vaccine, the whooping cough vaccine. At the meeting held on November 1981 (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough:

(5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event.”

Furthermore:

“The Chairman concluded that much was not known about the natural history of brain damage in the young.”

In spite of this, three years later, at the meeting on 25th of April 1986 (http:// www.dh.gov.uk/ab/DH_095169), the JCVI concluded their discussion on suspected adverse

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reactions for the period 19th September 1985 to 15th of January 1986 with the following statement:

(11.4) “The Committee agreed to a suggestion from the Chairman that in future it would accept reports on adverse reactions as “for information” only.” [their emphasis added-quotation marks]

It is somewhat perplexing why the JCVI adopted what appears to be a rather passive approach to vaccine safety, in light of the severe adverse reactions that were reported at that meeting. These included cot deaths, convulsions and anaphylaxis (11.4).

The JCVI appeared to have had other solutions for dealing with vaccine safety concerns. In a

“commercial in confidence” CSM/JCVI/Joint Sub-Committee on Adverse Reactions to Vaccination 7th

and Immunisation (ARVI) meeting on February 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), in a discussion about a surveillance study on adverse reactions to two measles vaccines, the members noted that:

“…results showed that 70 per cent of children were well after receiving Attenuvax and 61 per cent after receiving Rimevax. If children with mild general reactions were added to those who were apparently well then the numbers associated with Attenuvax were 85 per cent and those with Rimevax 80 per cent.” (7.1 PHLS [Public Health Laboratory Service] surveillance of adverse reactions to two measles vaccine (Rimevax and Attenuvax))

In other words, even skewing the data by adding cases of mild reactions to those who were “apparently” well, did far from producing a reassuring statistic in favour of the safety of the measles vaccines, as it still implied a rate of 15-20% of vaccine-associated serious adverse reactions (as opposed to 30-39% of mild-to-serious adverse reactions in total). After further discussion on this topic:

“…it was agreed there was now enough information to stop the study.”

While at the same time, there appeared to be no incentive to reconsider the current immunisation policy, in fact, it seemed more reasonable to conclude that some of the suspected adverse reactions to measles vaccine:

“…were unlikely to be associated with the use of measles vaccine and were more likely to be temper tantrums.” (7.2 Suspected adverse reactions to measles vaccine: a summary of recent reports to the CS, June 1983 to September 1985)

The summary of suspected adverse reactions to DTP vaccine administered alone or with oral polio

(OPV) during the period 19th September 1985 to 15th January 1986, presented at the same 7th

“confidential” meeting (CSM/JCVI/Joint Sub-Committee ARVI, February 1986) were more difficult to ascribe to “temper tantrums”:

(9.(1))

“Ninety such adverse reactions have been registered. These included six patients with convulsions, one a patient with abnormal fever following vaccination and one patient with apparent cerebral irritability; in addition two cot deaths were reported. (i) Case No. 154043 A three-month old boy who after his first dose of Trivax AD and OPV on 17 September 1985 was found dead 18 hours after immunisation….(ii) Case No. 154080 A three-month old girl who received her first dose of Trivax and OPV on the 19 September 1985 and was found dead on the night of 21/22 September 1985. No initial adverse reaction to vaccination was reported and the cause of death was stated as SIDS.” [sudden infant death syndrome]

By mid to the late 1980s, the JCVI had become increasingly concerned about publicly associating the terms “death” and/or “brain damage” with the word “vaccine”, because of the negative

BSEM March 2011 The Health Hazards of Disease Prevention

repercussions they perceived this would have on vaccination policy (CSM/JCVI/Joint Sub-Committee 7th3rd

ARVI meetings on February 1986; October 1986; http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306). Such concerns were also exacerbated by the increasing burden of litigations about pertussis vaccine-suspected injuries (JCVI meeting on 22nd April 1988; 20th October 1988; http:// www.dh.gov.uk/ab/DH_095169), and the possibility that vaccination could be linked to some cases of SIDS, as evident from the Reports on Yellow Cards quoted above.

At the meeting on 22nd April 1988 (http://www.dh.gov.uk/ab/DH_095169), in an ongoing discussion about the Loveday v Renton litigation, the Chairman:

“…reminded members that they had asked for a list of documents disclosed. JCVI (88)1 provided such a list, but it should not be made public. Dr Salisbury said that the Department’s solicitors had advised that a part of the section on whooping cough in the revised Memorandum was in conflict with the judgement in the above-mentioned case. They had recommended that any statement on the risk of neurological reaction should avoid any estimate of the size of the risk of death or permanent brain damage. Dr Salisbury said that paragraph 3.4.1c of the section on whooping cough in the Memorandum had been modified accordingly and this modification was tabled. Professor Miller observed that the conclusion to be reached from the judgment of the Court and from the assessment of the scientific evidence of risk of neurological reactions and their consequences, were not necessarily the same. The legal judgement was that there is insufficient evidence, on the balance of probabilities that the vaccine causes permanent damage to allow any claim for damages to succeed. The JCVI was concerned with the implications of scientific assessment of the evidence for vaccine policy purposes. On this basis he was content to quote the figure for attributable risk of serious neurological illness without giving a figure for the risk of permanent damage, which was consistent with the conclusion of the NCES quoted in the Whooping Cough Report 1981.”(Item 5, page 4 – Loveday v Renton)

The extent of the JCVI’s concerns with the implications of scientific assessment of vaccine safety on vaccine policy explains why they were opposed to any long-term surveillance for severe neurological disorders following vaccination. In fact, as it will be shown below in greater detail, the CSM/JCVI/ARVI

considered such studies “unreasonable” and paradoxically, ARVI even “deprecated the use of the term ‘brain damage’” (CSM/JCVI/Joint Sub-Committee ARVI meeting held on 7th February 1986;

http://www.dh.go v.uk/en/Fr eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306).

In 1989, 10 years prior to the “controversial” Lancet report by Wakefield et al. [3], the JCVI appeared to have been fully aware of the outcomes of the investigation carried out by the National Institute for Biological Standards and Control (NIBSC), which unequivocally established a link between the mumps component of the MMR vaccine (the Urabe-9 strain) and cases of vaccine- induced meningitis/encephalitis. In response to this, the JCVI appeared to have actively engaged in skewing and censoring data available to the public, continued to use the Urabe-9 containing MMR vaccines and made intensive efforts to reassure both the public and the authorities of the safety of all MMR vaccines.

According to the transcript of the JCVI meeting on 3rd November 1989 (http://www.dh.gov.uk/ab/ DH_095169), the causal agent of vaccine-induced meningitis/encephalitis was unequivocally identified:

(9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25) “Prof Collee expressed gratitude to the NIBSC for the progress it achieved in developing techniques to identify wild and vaccine virus strains. Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result. Professor Collee added that no mumps vaccine could be said to be void of risk. Dr Schild said NIBSC would be happy to continue analysing samples.”

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In the following meeting on 17th September 1990, the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions (http://www.dh.gov.uk/ab/JCVI/DH_095294), on reviewing the adverse reactions to the MMR vaccine reported on Yellow Cards, applied the following criteria to the assessments:

(6.3.1.)

“Definite=Virus isolated from CSF [cerebrospinal fluid], time course of 14-28 days;

Possible/probable=Cells isolated from CSF, no virus in CSF, acceptable time course” [their emphasis added-underlined]

The transcript then states:

“It was noted that there were 10 definite cases of meningitis/encephalitis.”

Both definite and probable cases were then discussed in some detail:

(6.3.4.)

“It was noted that the mumps viruses obtained from two out of three cases from Nottingham were sequenced and shown to be vaccine related. The patients had all been vaccinated from different batches and did not live close to each other.”

At the 17th September 1990 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095294), the JCVI CSM/DH Joint Sub-Committee on Adverse Reactions did recognize the need to do a follow- up analyses for long-term neurological outcomes in all cases of meningitis/encephalitis associated with the MMR vaccine. It was also recognized that the current avenues for adverse reactions reporting (via the Yellow Card, the British Paediatric Surveillance Unit (BPSU) scheme, directly to Communicable Disease Surveillance Centre (CDSC) and through Laboratory reports) were inadequate for detailed epidemiological evaluations. The JCVI CSM/DH Joint Sub-Committee then stated that:

(6.4) “In order to further validate vaccine related illnesses, fuller studies would be required.”

Despite these unresolved safety issues, the conclusion reached at the meeting was that:

(6.7) “There should be no change in the present recommendations or supply of MMR vaccine on the evidence available to us at the present time.”

Thus, instead of re-evaluating the vaccination policy, at least until safety concerns were fully evaluated, the JCVI choose to support the existing policy based on incomplete evidence that was available at that time.

Furthermore, at the 17th September 1990 meeting (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI appeared to have been fully aware of increasing numbers of cases of mumps vaccine-associated aseptic meningitis occurring in Japan, since at the time of the meeting, they had been presented with a draft of a study by Sugiura et al. [4]. The Japanese study found that among 630,157 recipients of the MMR vaccine containing the Urabe-9 mumps vaccine, there were at least 311 meningitis cases suspected to be vaccine- related. In 96 of these 311 cases, mumps virus related to the vaccine was isolated from the CSF. Sugiura et al. [4] noted that this was an unusually high incidence of vaccine-related adverse outcomes, which they had attributed in part to “adverse media publicity”. Nonetheless, the fact that in almost one third of the cases, the vaccine strain had been isolated from the CSF of children, suggests that safety concerns over the MMR were warranted. Indeed, in 1993 the Japanese suspended the use of the MMR vaccines containing the Urabe strain due to it causing a high incidence of aseptic meningitis, and reverted to the use of monovalent measles, mumps and rubella vaccines. According to Japanese Health Authorities, the withdrawal of the MMR had not caused an increase in deaths from wild

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measles infection. Noteworthy, in a BBC news report (http://news.bbc.co.uk/2/hi/asiapacific/ 1808316.stm), a spokesperson for the Japan’s Health Ministry stated that:

“…more children had died from the disease during the period when MMR was being used.”

In reference to the Japanese study, the JCVI transcript specifically states:

(6.6) “The paper confirmed information from Japan previously disclosed to ARVI.”

This suggests that the JCVI knew for some time that the Urabe-9 vaccine was causing problems and yet, did not consider the possibility to temporarily suspend its use.

Furthermore, four months prior to the 17th September 1990 meeting, at the JCVI 4th May 1990 meeting (http://www.dh.gov.uk/ab/DH_095169), ARVI expressed concerns regarding the reports from Japan. The major reason for these concerns was not that the JCVI/ARVI were in favour of using the Urabe-9 vaccine which was now associated with increased risk of meningitis/encephalitis in children, but rather:

(9.1.)

“Professor Banatvala was concerned about the possibility of the Japanese experience being published widely in the UK, and urged the gathering of information on the various episodes from all MMR manufacturers.”

ARVI also reached a rather surprising conclusion that:

“The Japanese experience may be due to different reporting/investigating criteria or other local factors.”

However, if this were the case, “the Japanese experience” would have been an isolated event. That this was not the case can be clearly seen from further readings of the JCVI 4th May 1990 meeting transcript (http://www.dh.gov.uk/ab/DH_095169):

(9.3.a.)

“Dr Thores spoke to the letter, JCVI/90/10, from Dr McIntyre. He highlighted SHHD [Scottish Home and Health Department] concern about the Canadian decision not to use Urabe strain vaccine, the cases of neurological complications in Japan, the seeming bias of the UK adverse reactions towards Scotland, and the continued use of vaccine distribution figures as the denominator when calculating adverse reaction rates.”

In spite of this, instead of re-evaluating or suspending the existing MMR vaccination policy due to safety concerns, the JCVI called for a specific and concentrated effort aimed at counteracting the growing public and health authorities’ concern over the safety of the Urabe-9 MMR vaccines.

(9.3.c.)

“Professor Peckham told the Committee that she was aware of three districts changing from use of Urabe to Jeryl Lynn vaccine, and therefore the Committee needed to reassure authorities of the safety of all MMR vaccines.”

Hence, it appears that the JCVI’s solution to the growing problem regarding the MMR vaccine safety issues was to provide as little information as possible to health practitioners, in order to preserve the JCVI’s vaccination policy. If this assumption is correct, does it suggest that the JCVI was more concerned about boosting vaccine uptake than child safety?

(9.3.e.)

“The Chairman asked the Committee if it thought necessary to draw up a statement about MMR.”

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(9.3.g.)

“Professor Hull suggested a simple sheet with ARVI’s evaluation of the vaccines. This would let doctors know that an expert committee had looked at the situation and perhaps reassure them.”

What appears to be a rather inadequate handling of the MMR safety concerns on behalf of the JCVI did not make the problem go away. Only a year later, at 1st November 1991 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), unable to resolve the continuing MMR safety issues the JCVI turned to vaccine manufacturers for help:

(7.1 Report on MMR) “On adverse reactions to the vaccine, the most worrying reports had been studies which showed problems with the Urabe vaccine, particularly Mumps Meningitis. Reports had also come from overseas countries, Canada being the most helpful….of 67 reported cases between October 1988 and August 1990, 38 children had definite or probable Aseptic Meningitis and one Encephalitis. Ten of these were definitely caused by the vaccine, and a further 29 were probably caused by the vaccine. Of these 39 children, 37 were followed up at 12 months. 33 (or 89%) were neuro-developmentally normal. Of the remaining four, two had neuro-developmental problems before being given MMR, one had behaviour problems and one had a cerebral astrocytoma. There had been eight reports of nerve deafness although one was pre-MMR; six needed further investigation. The over-all picture was that there were 3.7 cases per 100,000 doses of Urabe vaccine and no cases reported with the Jeryl Lynn vaccine. However, the MSD [Merck Sharp and Dohme] vaccine was generally not well accepted because of pain at the injection site. Urabe is the most reactogenic vaccine but some data suggested that it may also be the most immunogenic. It was impossible to make a firm decision about this until all information had been collected.”

(Note: it ought to be asked why the UK health authorities thought it was appropriate to vaccinate children with neurodevelopmental problems and cerebral astrocytoma with a vaccine that had caused substantial worries to them over its association with adverse reactions affecting the brain).

(7.2 Discussions with Manufacturers) “Dr Salisbury reported on his recent meetings with Merieux, MSD and SKB [Smithkline Beecham]. Information was shared and details of adverse events discussed. The manufacturers felt that the Department’s line-that is, surveying adverse events and checking immunogenicity-was correct.”

Again, the JCVI appeared to have adopted a passive approach to the problem and made no apparent efforts to identify specific sub-groups of children who may have been more prone to adverse reactions to the MMR. At the meeting that followed on 1st May 1992 (http:// www.dh.gov.uk/ab/JCVI/DH_095050), the same conclusions were reiterated in light of the continuing MMR crisis, with an additional concern that the actual number of vaccine- associated aseptic meningitis cases might have been higher, due to suspected underreporting:

(7.4 Report of North Herts Immunogenicity Study (Dr Elizabeth Miller)) “The report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases; a meeting had been held to discuss the Nottingham situation and the national data….In Nottingham all children with febrile convulsions were lumbar punctured, unlike some other areas from where reports had been received (Preston and Ashford) .The Committee agreed that no conclusion could be reached until the full immunogenicity results were available as well as the full analysis of the Nottingham and other data.”

In the meantime, no changes were made to the immunisation policies. Would a seemingly passive approach to child health and safety, suggest that the JCVI in essence agreed to the fact that during the surveillance for the purposes of “for information only”, some cases of

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suspected vaccine-induced convulsions, meningitis/encephalitis and deaths in children would just have to be tolerated?

Note also that for using the same technique of lumbar puncture, 18 years later, Dr Andrew Wakefield who investigated a consecutive series of children with chronic enterocolitis and regressive developmental disorder which appeared to have been linked to MMR vaccination, was charged and found unfit to practice medicine by the UK General Medical Council (GMC). According to the GMC hearing, lumbar puncture in children with MMR-suspected adverse neurological outcome was apparently ”not clinically indicated” (http://www.gmc-uk.org/static/documents/content/ Wakefield__Smith_Murch.pdf).

In July 1992, the data from Nottingham became available, nonetheless, it took another two months before the JCVI and the DH finally decided to take action, apparently not so much because of safety concerns but more so because of the legal advice given to the manufacturers by their lawyers in response to which the manufacturers decided to stop producing the Urabe-9 containing MMR vaccines. According to the transcript of the JCVI meeting on 6th November 1992 (http:// www.dh.gov.uk/ab/JCVI/DH_095050):

(8.1 Report to Sub-Committee on SEAR/CSM: Dr David Salisbury) “In August, Department of Health officials met with MCA [Medicines Control Agency] and the manufacturers. At the end of August SKB, acting on the advice of their lawyers, decided to stop producing vaccine and advise licensing authorities world wide accordingly; the Department had, therefore, to act quickly.”

Thus, only when the alarm was sounded by the manufacturers’ lawyers did the DH sense that the matters regarding the safety of the MMR vaccine required some urgency. In addition, it appears that the principal preoccupation of the European Authorities was how to preserve global vaccine policies in face of the Urabe-9 scandal.

“On the 3 and 4 September the Chief Medical Officers of European Community countries were advised in confidence of the situation at a routine meeting. ARGOS/SEAR [Sub- Committee on Safety, Efficiency (SEAR) and the Adverse Reaction Group of SEAR (ARGOS)] agreed on 4 September that no action would be taken to revoke the manufacturer’s license as a change of purchasing policy was to be made by the Department; revoking the license would have caused a world-wide vaccine crisis.”

The actual rate of aseptic meningitis after the MMR vaccination was discussed later on the JCVI 6th November 1992 meeting agenda (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(8.7 Risk of aseptic meningitis after MMR vaccination in UK children: Dr Elizabeth Miller) “The overall risk of this complication in the UK was 1 per 10,000 immunised children but, in Nottingham, this had increased to 1 in 4,000. Tests in Canada in 1989 had associated the Urabe vaccine with meningitis. The linking of laboratory records of CSE samples with district computer databases on immunisation had been very effective. The Committee was told that all the countries which had had a choice had switched from the Urabe to Jeryl Lynn;”

What is rather astonishing is that the four-year old Canadian concerns over the safety profile of the MMR vaccine (which had been confirmed in 1989), were apparently ignored by the JCVI or at least, not given much credence. While the Canadian Health Authorities suspended the use of the Urabe-9 MMR in 1988, the UK introduced it along with a vigorous promotional campaign. In a confidential meeting of the JCVI Working Party on the introduction of measles, mumps, rubella (MMR) vaccine on 11th February 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297):

(5. MMR vaccination in Canada) “Members read a report of cases of mumps encephalitis which had been associated with MMR vaccine containing the URABE strain of the mumps virus. The Canadian authorities had suspended the licences of MMR vaccines containing the URABE strain, but Dr Salisbury considered that the data on which the decision had been based was slender.”

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The JCVI also had a specific plan to combat any adverse publicity in case any of this “confidential” information was to reach the public:

“A statement would be prepared in anticipation of any adverse publicity which might arise.”

(7. Publicity) “A paper prepared by the MMR Publicity Group was presented, by Mr Flaherty and Mr Reid, for the Group to discuss and to approve the general approach it contained. Dr Ross considered that the priority was to get the message across to doctors, health visitors and nurses.”

Finally, the JCVI also had a number of funding strategies in place to promote the introduction of the MMR:

(9. Funding situation) “£800,000 had been set aside for publicity and £1.4 million had been set aside to cover the period October 1988 -March 1989 to assist health authorities with increased vaccine costs, the education of professionals and for the re-programming of child computers. Members noted that the Statement of Fees and Allowances would need altering to include item of service payment for MMR.”

This latter strategy was further refined on the JCVI Working Party on the introduction of MMR vaccine following meeting, on 17th May 1988 (http://www.dh.gov.uk/ab/JCVI/DH_095297):

(3. Matters Arising) “Dr McGuiness suggested that instead of an item of service payment GPs might be paid according to their immunization rates.”

In spite of carefully elaborated advertising and substantial investments, the JCVI did not entirely 6th

succeed in countering public concerns over vaccine safety, as on October 1989 (http:// www.dh.gov.uk/ab/JCVI/DH_095294):

(5.2.6) “The meeting’s further sadness was expressed over the press reports, which could have harmful implications and unnecessarily damage public confidence in vaccines.”

Regrettably, similar sadness was apparently not expressed by the JCVI members over a report of a vaccine-suspected death of a 16 month old child, which was discussed at the same meeting. Rather:

(5.2.4) “This was a fiscal case and as such was highly confidential. Doubts were expressed about the cause of death, and while it was not possible to give clear judgement, it was felt that there was unlikely to have been a causal relationship with the vaccine and that this was an unusual case.”

Science should be based on facts and experimental evidence, not feelings.

As for the alleged “slender” Canadian data on safety hazards of the SKF (Smith Kline and French)

Urabe MMR vaccine, in a confidential JCVI CSM/DH Joint Sub-committee on Adverse Reactions 7th

meeting on March 1990 (http://www.dh.gov.uk/ab/JCVI/DH_095294) the following was disclosed:

(6. Adverse reactions to MMR vaccine) “In Canada, the MSD vaccine had been used exclusively [Jeryl Lynn strain-containing MMR]. Following the introduction of SKF product, the cases of meningoencephalitis had been

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reported. When distribution of the SKF vaccine was halted, no further cases of meningoencephalitis were reported.”

Yet, from this clear evidence, the JCVI derived a conclusion that somewhat seems to defy logic:

“It was suggested that, due to different reaction criteria and methods of data collection, reporting in different countries should not be compared.”

In summary, the JCVI endorsed and promoted a policy of vaccinating every child in the UK with the Urabe-9 MMR vaccine, in spite of the evidence that this would have caused a greater risk of encephalitis in children, when compared to the alternative Jeryl Lynn version of the MMR. It was only under pressure from a potential legal action that the JCVI and DH decided that it was due time “to act quickly” and withdraw the Urabe MMR from use in routine vaccinations.

2) Significantly restricted contraindication to vaccination criteria in order to increase vaccination rates despite outstanding and unresolved safety issues.

Already in the early 1980s, the public confidence in the safety of the whooping cough (pertussis) vaccine has been eroded and since the uptake of the vaccine was relatively low, the JCVI sought ways to improve immunisation rates. According to Sir Charles Stuart-Harris,

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at the JCVI meeting on November 1981 (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough:

(5.c. Whooping Cough Vaccination Campaign) “…a 40% uptake of the vaccine ensured continuance of the disease; the uptake rate had to be improved.”

The transcripts of the JCVI meetings from 1981 to 1986 indicate that the Committee did not know what was the risk/benefit balance of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes. In spite of this, the JCVI went on with restricting contraindication criteria so that more children could be vaccinated. The JCVI also seemed to have been more preoccupied with protecting the “reputation of the vaccine” rather than protecting potentially vulnerable individuals, as the former served a basis for defining certain contraindication criteria.

In 1981, a Working Group on Contra-indications to Whooping Cough Vaccination had been set up because ARVI, which had been asked by the JCVI to consider contraindication to whooping cough vaccine, had not been able to reach an appropriate agreement on this

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issue. At a beginning of the meeting of this Working Group on May 1981 (http:// www.dh.gov.uk/ab/JCVI/DH_120115), it was noted that:

“It was extremely important that the present meeting should reach an agreed conclusion because the reports on whooping cough were to be published on the 12 May, and it was desirable for any new contra-indications to be ready as soon as possible after this date.”

and:

“When considering the question of contraindications, the general principle to be borne in mind was that the right balance had to be struck between the need to keep acceptance rates for vaccination as high as possible and the need to protect groups of children who had an increased risk of adverse reaction to vaccination.”

Assuming that the whooping cough vaccine is effective in preventing whooping cough, this principle indeed appears to be sound. Curiously however, one of the first items to be discussed under this agenda was that of respiratory illnesses and whether these should be regarded as a contraindication to whooping cough vaccination. Some members thought that respiratory illnesses ought to be deleted from the list of contraindications. Others however:

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“…thought that the reference to respiratory disease was not really a contra-indication; rather it was a move to protect the reputation of whooping cough vaccination by avoiding an association between vaccination and SIDS.”

Since apparently:

“Respiratory illness was often associated with SIDS, and therefore the reference to respiratory disease was a wise precaution to prevent SIDS and whooping cough vaccination being associated.”

Next:

“Professor Miller stressed the need to maintain public confidence in the vaccine and said there was a need to prevent children with epilepsy being vaccinated in order to avoid an apparent association between vaccination and fits.”

In addition:

“The Chairman asked members to consider “History of seizures, convulsions, or cerebral irritation in the neonatal period”. Professor Hull said that this contra-indication would include children with disguised brain damage; this was good for the reputation of the vaccine in that it prevented an apparent association between vaccination and the discovery of brain damage.”

It is somewhat perplexing why in discussing contraindication to whooping cough vaccination, the Working Group members entrusted with an “extremely important” task to reach a prompt agreement on this issue, appeared to have been more concerned about the reputation of the whooping cough vaccine, rather than the risk/benefit balance of whooping cough vaccination in children who were potentially more at risk of vaccine associated-adverse outcomes, especially since:

“It was agreed that the risk/benefit balance in this group of children was not known.”

Nonetheless, Dr Griffiths in referring to a paper from the US, in which children with a history of convulsions were immunised against whooping cough and then followed up noted that:

“…this data did show a slightly increased risk of convulsions following vaccination in children with a previous history of convulsions.”

In the ensuing discussion, members also considered whether a family history of epilepsy or other diseases of the central nervous system should be regarded as a contraindication to whooping cough vaccination and:

“There was general agreement that including other diseases of the central nervous system was unnecessarily restrictive, and that this particular contra-indication should be deleted.”

Whether such contraindications were indeed “unnecessarily restrictive” and whether the need to rush an agreement on this issue was justified in the light of the data available at that time, remains questionable following the observations made by Professor Gilliatt at

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the subsequent meeting held on November 1981 (http://www.dh.gov.uk/ab/ DH_095169):

(5.d. Comments on Professor Stewart’s letter) “In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

On 30th January 1986 at the Joint Working Party of the British Paediatric Association (BPA) and the JCVI Liaison group meeting (http://www.dh.gov.uk/ab/JCVI/DH_120115), concerns

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were expressed over the low rates of whooping cough vaccination due to contraindications which may have exempted children who had a family history of seizures. In discussing cases in whom whooping cough vaccination is not absolutely contraindicated but who require special consideration as to its advisability (item 4.8):

“Professor Gillliatt said that there had been a paper published recently in America, History of convulsions and the use of pertussis vaccine. Harrison C Stetler et al. Journal of Pediatrics 1985; vol 107; pages 175-179

which indicated that there was a quite high incidence of a family history of convulsions among the first degree relatives of children who had febrile convulsions. Members observed that changing this recommendation might decrease the number of children available for vaccination against whooping cough.”

By November 1986, the JCVI had a quite remarkable solution to deal with the “problem” of reduced uptake of the pertussis vaccine: the suggestion was to alter the advice on contraindication criteria.

According to the transcript of the 7th November 1986 JCVI meeting (section 3.5.2a; http:// www.dh.gov.uk/ab/DH_095169), the groups of children in whom the advisability of Whooping Cough vaccination required special consideration included:

i) Children with a documented history of cerebral damage in the neonatal period.

ii) Children with a personal history of convulsions.

iii) Children whose parents or siblings have a history of idiopathic epilepsy.

iv) Children with developmental delay thought to be due to a neurological defect.

v) Children with neurological disease.

It is further noted in the same transcript that:

“There was considerable discussion on 3.5.2(a)”

the details of which had not been given but:

“it was finally agreed that for (iii), it should be stressed that the risk was very slight and that (iv) and (v) should be combined under “children with neurological conditions which are stable” and “not a contraindication”, ie in 3.5.4.” [their emphasis added-underlined]

Based on no apparent scientific evidence the JCVI claimed that neurodevelopmental delays or neurological disorders were in fact stable conditions and as such, unlikely to be exacerbated by vaccinations. It would appear that the sole purpose of this potentially misleading claim was to reassure parents, who otherwise might have been deterred from vaccinating their child against pertussis, of the safety of pertussis vaccination. The same would apply to the JCVI statement regarding the alleged “very slight” risk of adverse reactions in children with family history of idiopathic epilepsy.

One has to wonder whether the notes of the “commercial in confidence” CSM/JCVI/Joint Sub- Committee ARVI meeting on 3rd October 1986, later obtained through FOI (which discussed among other “not be disclosed” items, suspected adverse reactions to DTP vaccines given alone or with OPV; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), would have had the same “reassuring” effect on parents had they been made publicly available at that time, or promoted with the same vigour as the vaccination campaigns:

“During the current period [13th May 1986 to the 11th September 1986] 95 suspected adverse reactions were reported. These included:

i)Death 151828. A 16 month old girl who two days after her first dose of DTP in mid-July 1985 was found to have a fever and a possible respiratory tract infection. Two days later

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she had a major fit and was admitted to hospital where further convulsions occurred. Further fits occurred at the end of July 1985 and she died on the 1st of August probably from pneumococcal septicaemia. This patient had a family history of idiopathic epilepsy.“ This case has been reported to previous meetings of ARVI.

ii)There were 8 reports of convulsions following vaccination including 165236, a patient who was in status epilepticus within hours of receiving her third dose of triple vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, a.)

It should be noted that the adverse reactions from OPV alone were no less severe and in fact more easily specifically attributed to the polio vaccine:

“A six month old girl who developed recipient vaccine-associated poliomyelitis 30 days after receiving her first dose of oral polio vaccine.” (7. Summary of Suspected Adverse Reactions to Vaccines, c.)

At the same meeting, the CSM/JCVI/Joint Sub-Committee ARVI discussed the results of a National Childhood Encephalopathy Study (NCES) as these were the subject of court proceedings on pertussis vaccine-related injury that were ongoing at that time:

(5.1.1.)

“The working party had established that the final number of cases in the NCES was 1,167. 39 cases had received triple vaccine in the week prior to the onset of their neurological illness (9 with infantile spasms, 18 with convulsions, and 12 with encephalopathies). These vaccine-associated cases included 5 patients (4 with convulsions and 1 with infantile spasms) who had a history of neurological events before immunisation which indicates possible prior abnormality.”

Again, one has to wonder whether these five patients also fitted in the JCVI’s criteria of “stable” neurological conditions. The apparently lenient attitude with regards to vaccine safety on behalf of the JCVI is perplexing, particularly in light of their admission which followed the brief discussion about the significance of the NCES findings the CSM/JCVI/Joint Sub-Committee ARVI:

(5.1.3.c.)

“From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.”

Is this supposed to be a reassuring statement for all those children with prior family history of epilepsy or those suffering from “stable” neurological disorders, who as a result of the JCVI’s decision to shrink the contraindication criteria, no longer had a choice to opt out from pertussis vaccination? In further “reassurance”, the following was noted in the transcript of the CSM/JCVI/

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Joint Sub-Committee ARVI meeting on October 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(5.1.5.)

“Queries had been raised with regard to long-term sequelae after vaccine-associated encephalopathy…Among 12 children with encephalopathy there were 2 deaths, and 5 children with impairment of varying severity at 1 year. The relative risk for an acute vaccine-associated illness (convulsions or encephalopathy) was 3.3, and was similar irrespective of degree of impairment.”

Thus, according to the JCVI’s own admission, not only was the risk of DTP-associated neurological complications a real one, it also appeared to be a relatively high risk.

A somewhat lenient approach to contraindication criteria was also used with vaccines other than DTP in order to boost vaccination rates.

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“In the matter of alleged egg allergy and measles vaccine, it was noted that although it was possible to amend the advice contained in the Memorandum ‘Immunisation against Infectious Disease’, it was also desirable to encourage manufacturers to change the advice in their data sheets.” (Meeting on 25 April 1986; http://www.dh.gov.uk/ab/DH_095169)

In other words, the JCVI appeared to be rather unwilling to change their own advice in the Memorandum and instead suggested that manufacturers should be “encouraged” to do so. The following Section (3) indicates that the JCVI elaborated a very simple solution for boosting vaccine uptake in face of impediments posed by contraindication criteria: restrict the contraindication criteria, rewrite information in the Memorandum and ask the pharmaceutical companies to change their data sheets as to “avoid confusion” and possible legal action.

3) On multiple occasions requested from vaccine manufacturers to make specific amendments to their data sheets, when these were in conflict with the JCVI’s official advice on immunisations.

That boosting vaccine uptake appeared to be the major force driving the JCVI’s decision process, can be inferred from their request to the manufacturer of the MMR vaccine Merieux to modify the data sheet information related to contraindication to adverse effects, at the 1st May 1987 meeting (http://www.dh.gov.uk/ab/DH_095169). Apparently, it was not sufficient to amend existing information on immunisation in their Memorandum to Infectious Diseases, it was also necessary to make that information concordant with the advices stated on manufacturer’s data sheets:

(7.2 Report of the meeting of the Working Party held on 25 February 1987) “It was also noted that the data sheet for the Merieux MMR vaccine contra-indicated the use of the vaccine in children with a past or family history of convulsions. Medicines Division would be asked to approach Merieux to ascertain whether they would be willing to adopt appropriate modification to this data sheet.”

At a later meeting on 23rd October 1987 (http://www.dh.gov.uk/ab/DH_095169), the JCVI also pressed for a change in the pertussis vaccine licensing details from the manufacturers, in spite of a pertussis vaccine-suspected injury litigation that was ongoing at that time. The Chairman of the JCVI approached the Association of British Pharmaceutical Industries to resolve this issue. The notes on this meeting state that:

(15.2) “The meeting considered revised contra-indications to pertussis vaccine in parallel with those at present published; ARVI was aware of the potential difficulties in relaxing the contra-indications to pertussis vaccine and suggested that the papers be sent to the CSM and also to the manufacturers. The latter, in a written response, replied that it was not possible at present to change the product license details whilst litigation was in progress.”

The “potential difficulties” that ARVI was concerned about were related to the ongoing pertussis litigation (this becomes more evident from the notes of a confidential meeting on 6th July 1987 cited further below). Unable to get the manufacturers to comply with their request, the JCVI turned to the Solicitors Branch in the Department of Health and Social Security (DHSS), to seek advice over:

“…the difficulty of reconciling revised contra-indications to pertussis vaccine with advice issued by the manufacturers.”(18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries; JCVI meeting 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169)

The advice from the Solicitors was that:

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“…such a discrepancy was not a problem for the JCVI whose function was to give advice to medical profession in the light of the best available knowledge.”(19. Memorandum “Immunisation Against Infectious Disease; JCVI meeting 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169)

Notably, the “difficulty of reconciling revised contra-indications to pertussis vaccine” had been previously discussed by the CSM/JCVI/Joint Sub-Committee ARVI, on 6th July 1987, in yet another meeting that was noted as “commercial” and “in confidence”.

According to this transcript which has been obtained through FOI (http://www.dh.gov.uk/ en/FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

“The Chairman reminded members that the proceedings, papers, and information before them were confidential and should not be disclosed.”

The same transcript also reveals the reason why the JCVI made great efforts to obtain the manufacturers’ compliance to their request to amend the data sheets on the pertussis vaccine and why, failing that, they sought help from the DHSS Solicitors. It was not necessarily because their policy was ethically and scientifically sound, but possibly because they were anxious about potential legal repercussions.

(Note that the names of the participants have been redacted from the transcript prior to its release under the FOI section at the JCVI website, so that the comments made are unattributable to particular members):

(6.4 JCVI’s revised contra-indications to pertussis vaccine) “The Chairman stated that JCVI had produced more permissive guidance on contra- indications to pertussis immunisation and that the revised contra-indications, shortly to appear in the next version of the Memorandum ‘Immunisation against Infectious Disease’ would not conform with the manufacturers data sheet. This might lead to confusion for general practitioners and other vaccinators and there might be legal problems. ________ commented that both the JCVI and the JCVI/BPA Working Party had tried to improve guidelines to give specific contra-indications but an attempt should be made to reconcile these with data sheets and product licenses. Delay in the new Memorandum might be worthwhile in order to obtain manufacturers agreement to changes in data sheets and also to give the BNF [British National Formulary] the opportunity to change its advice. _________ agreed with _______ and welcomed the clearer advice from JCVI on pertussis contraindications which he endorsed.”

The discussion that followed seems to indicate that ARVI was indeed nervous about potential legal implications, as apparently, they tried to evade having any responsibility on this matter:

“________ commented there was no need for JCVI advice to change but there should be awareness of the implications of change. _________ suggested a meeting with the manufacturers to discuss the changes in an attempt to seek common ground. __________ commented that it was not ARVI’s responsibility to dismantle other groups instructions. ________ noted that ARVI had responsibilities to both JCVI and CSM and asked that pertussis section of the revised Memorandum should be submitted to the CSM for endorsement and then to the Licensing Authority to discuss with manufacturers so that the data sheets and the Memorandum would be compatible. __________ suggested that advice should be followed and that members should submit their comments in writing to the Chairman. _________ hoped that there could be informal discussion with the manufacturers of areas of agreement or debate and __________ noted that the new pertussis guidelines would be produced at a time of a continuing pertussis litigation._________ asked if there was likely to be a change in pertussis vaccine in the near future as this might promote difficulties if the contra-indications were also to change._______ agreed that the pertussis section should be sent to CSM….”

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The following “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting 2nd

held on October 1987 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), reveals how the CSM dealt with the burden of responsibility over the revised pertussis contraindications issue:

(6.4 JCVI’s Revised Contra-indications to Pertussis Vaccine) “_________reported that the discrepancy between JCVI recommendations and manufacturers product licenses had been discussed at CSM who had upheld JCVI’s right to issue advice to the profession.”

“_________reported that a meeting was shortly to be held with the Pharmaceutical Industry to find common ground on issues such as this. _________stated that DHSS Solicitors views of this discrepancy had been sought and had been advised that there was no obligation on JCVI’s views to conform with the manufacturers product licenses when those views represented the advice of expert medical opinion.”

We see here that unlike the manufacturers, the CSM had endorsed the proposed revisions of contraindications to pertussis vaccine and their view was held by the DHSS Solicitors as superior to that of the vaccine Licensing Authority. This indeed is the case, since in the UK licensing process when applying for a licence, the pharmaceutical company will first submit a file to the Medicines and Healthcare products Regulatory Agency (MHRA) and the CSM within the MHRA will then review the application and produce an independent assessment. Following that, the CSM will issue a recommendation to the Licensing Authority that a licence is granted (http://www.ukmi.nhs.uk/ Med_info/licensing_process.pdf).

The CSM’s competence as a body of medical experts and the reliability of their advice can

be assessed from the notes of the preceding “commercial in confidence” CSM/JCVI/Joint 6th

Sub-Committee ARVI meeting, held on July 1987 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(6.1 Whooping cough) “In conjunction with Tabled Paper 1 and an unnumbered agenda paper the Secretary summarised the present position regarding the Loveday litigation for the benefit of new members. He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided. However, by the time ___________ could report a revised statement to CSM (see minutes of February 1987 meeting) it was already clear that nothing could be done to avoid ‘discovery’. Subsequently, the Chairman of CSM asked ARVI to keep a watching brief on the situation, and to let the Main Committee know if at any time it was thought possible to modify further the statement.”

The contents of the controversial statement that the CSM appeared to be eager to modify, in order to avoid potential legal consequences, have been disclosed to the JCVI/Joint Sub- Committee ARVI members on “commercial in confidence” meeting on 6th February 1987 obtained through FOI (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

The notes of that meeting in the section “7.1 Whooping cough vaccine –CSM advice” read:

“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.”

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Thus, the “best available knowledge” on which the CSM “upheld the JCVI’s right to issue advice to the profession on restricting contraindication to pertussis vaccination can be summarized as follows:

Both the CSM and the JCVI/Joint Sub-Committee ARVI seemed to have been fully aware of the fact that the pertussis vaccine could cause convulsions and adverse serious neurological outcomes in a sub-set of children. Apparently, the CSM and the JCVI/Joint Sub-Committee ARVI have then attempted to avoid “‘discovery’ of all the relevant JCVI, CSM and ARVI documentation”. Does this suggest that the top UK authorities responsible for sound vaccination policies were not as much concerned about putting certain children at risk of serious vaccine-induced neurological harm, as they were of legal repercussions that might have followed in the event that any of the “relevant” documents were to reach the public?

Finally, rather than being in line with public health interests, those responsible for the safety of medicines and sound vaccination practices appeared to have been more aligned with the interests of vaccine manufacturers. This is implied by the following discussion from the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI

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meeting held on June 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), at which members of the US Centers for Disease Control (CDC) were also present. In discussing the significance of the NCES report on pertussis vaccine injury it was noted:

(6. Litigation and pertussis vaccination) “6.1_______ referred to the June issue of the American Journal of Diseases of Childhood. He said that between 18 and 22 million doses of DPT were manufactured annually in the United States prior to the difficulties concerning whooping cough vaccine and litigation… Since 1985, the price of the vaccine has risen from 40 cents per dose to $ [unreadable] per dose in 1986 and it is expected to rise to $11 per dose. Litigation claims per year have risen from virtually nil in 1978/79 to over 219 in 1985, claiming [unreadable] billion US dollars, and litigation suits follow a similar pattern. The total amount claimed has likewise increased greatly.”

“6.2_______said that out of court settlements had not been included in these figures. It was difficult to protect manufacturers against such heavy compensation claims. The situation had been aggravated by an organisation called ‘Dissatisfied Parents Together’. The Hawkins Congressional Commission suggested that claimants might go into a system with a Panel and if accepted would be given an award of $1 million or alternatively accept court settlement. There was also a Bill before the American Government which suggested that punitive damage be done away with and that damages for pain and suffering only be awarded.”

Over the subsequent years the trend of restricting contraindications criteria by the JCVI in order to increase vaccination rates continued. On 20th October 1988 (http:// www.dh.gov.uk/ab/DH_095169):

(6.2 Health Education Authority (HEA) publications on MMR) “Members pointed out that the Data Sheet for MMR vaccine suggested that it should not be given before the age of 15 months and also that the vaccine should be given subcutaneously (and not by deep subcutaneous or intramuscular injection as suggested in the Memorandum). The difficulties of changing the Data Sheets to agree with the advice in the Memorandum “Immunisation Against Infectious Disease” were discussed.”

What also continued is the JCVI’s confidential meetings with vaccine manufacturers, which appeared to be focused on vaccine policy and business rather than child health and safety. In reference to the meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, the transcript of the JCVI meeting on 23rd October 1987 (http:// www.dh.gov.uk/ab/DH_095169) states:

“Also discussed was the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health

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service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries)

It ought to be asked why the Chairman of the JCVI deemed as appropriate for members of health services to be financially supported by the vaccine manufacturers.

On further relations between the JCVI and vaccine manufacturers, the transcript of the JCVI meeting on 4th May 1990 (http://www.dh.gov.uk/ab/DH_095169) reveals that:

(2. iv.) “The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans. Agreement was sought from the committee on the appropriateness of a summary of such discussions, cleared by the Chairman, being provided to manufacturers. The Committee agreed to this. In connection with this Professor Hull brought to the Committee’s attention a recent letter he had received from a GP, the contents of which indicated, and the Chairman and committee agreed, a continuing communication problem on the relationship between JCVI advice and manufacturer’s data sheets. Dr Salisbury said he was aware of this particular correspondence.”

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Incidentally, this is the same Professor Hull who, 8 years later, on July 1998, was prompted to write to Professor Zuckerman at the Royal Free Hospital in London, to express his concern about the work of Dr Andrew Wakefield, who investigated the histories of 12 children with regressive autism and gastrointestinal symptoms that appeared to be linked to the MMR vaccine (http://www.circare.org/autism/hull_zuckerman_19980706.pdf).

In summary, by making persistent efforts in restricting vaccination contraindication criteria, so that more children could be vaccinated, the JCVI appeared to have prioritized vaccination policy over vaccine safety. In doing so, both the JCVI and the CSM (which actively supported the JCVI’s amendments) may have shown a disregard for the safety of children. Furthermore, together with ARVI and the CSM, the JCVI attempted to avoid “’discovery’ of all the relevant documentation” and thus perhaps evade potential legal repercussions. By seemingly siding with vaccine manufacturers rather than public health interests, the CSM/JCVI appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety and thus possibly shown incompetence in their role in the public health service.

4) Persistently relied on methodologically dubious studies, while dismissing independent research, to promote vaccine policies.

Over the years, the JCVI has consistently promoted the MMR vaccine as safe, based on studies that have proven to be either irrelevant, inconclusive, or methodologically questionable. There was also a marked tendency by the JCVI to rely on epidemiological work to support the MMR policy. For example, in a discussion of a population-based study by Fombonne and Chakrabarti [5], which found no link between the MMR vaccine and autism, at the JCVI meeting on 2nd November 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044):

(7.1) “The Committee agreed that this data from Dr Fombonne was persuasive and indicated that the frequency of regressive autism appeared not to have increased.”

The problem with epidemiological studies is that they only test for “association” and not “causation”, thus providing unreliable estimates of true risks. Regarding the alleged safety of the MMR vaccine, the most comprehensive independent evaluation done on this subject, by the Cochrane Review (October 2005, http://www2.cochrane.org/reviews/en/ab004407.html), is hardly reassuring.

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Although the Cochrane Review found no significant evidence of an involvement of the MMR with either autism or Crohn’s disease, none of the 31 studies included in the review met the Cochrane Collaboration’s methodological criteria.

In fact, one of the major conclusions from the Cochrane’s 2005 MMR review was:

“The design and reporting of safety outcomes in MMR vaccine studies, both pre-and post- marketing, are largely inadequate.”

More specifically, referring to the 2001 Fombonne and Chakrabarti study which the JCVI regarded as “persuasive” in disproving the link between the MMR vaccine and autism, the Cochrane review made the following remark:

“The number and possible impact of biases in this study was so high that interpretation of the results is impossible.”

While historically, the JCVI tended to be quick in accepting those studies which dismissed safety concerns over the MMR or other vaccines, it was inert in accepting those which indicated that concerns were warranted. At the JCVI meeting on 1st November 2002 (http://www.dh.gov.uk/ab/ JCVI/DH_095044), the members discussed recent scientific research on the MMR where:

“The Committee was provided with recent research published on the safety of MMR, in particular the link with inflammatory bowel disease and autism. The following papers had undergone review by experts:

1. “Neuro-immunopathogenesis in Autism” V Singh. New Foundation of Biology 2001, 447-458. 2. Abnormal measles-mumps-rubella antibodies and CNS auto-immunity in children with autism. V Singh et al. Biomedical Science 2002; 9; 359-364 3. Small intestinal enteropathy with epithelial IgG and complement deposition in children with regressive autism. Torrente et al. Molecular Psychiatry 2002; 7(4);375-382 4. Development of an “allelic discrimination” type assay to differentiate between the strain origin of measles virus detected in intestinal tissue of children with ileocolonic lymphonodular hyperplasia and concomitant development disorder. O Sheils et al. Abstract presented at the Pathological Society of Great Britain and Ireland in July 2002. 5. Review article: the concept of entero-colonic encephalopathy, autism and opioid receptor ligand. A Wakefield et al. Alimentary Pharmacology and Theraputics 2002; 16: 663-674.” (10.2 Recent scientific research) The conclusions were:

“that this new evidence did not alter the CSM view: there was no evidence to support a causal link between MMR vaccine and autism and bowel disease. JCVI found the papers helpful and expressed its strong support for the conclusion reached by the CSM.”

As it will be evident from Section 8), the JCVI attitude towards vaccine safety, particularly the MMR, has not changed and to this day, the Committee still regards it as safe. On the other hand, independent research is accumulating to suggest otherwise. Only a year after the 1st November 2002 JCVI meeting, Singh and Jensen found more evidence to support an aetiological role of the measles virus component of the MMR vaccine in autism [6]. Using enzyme-linked immunosorbent assay, Singh and Jensen found that children with autism, unlike their siblings or normal children, had significantly elevated levels of measles antibodies in their sera. Antibodies against rubella and mumps did not significantly differ between these groups of children, however, immunoblotting screen against measles vaccine virus (source Merck&Co) showed that 43 out of 52 (83%) autistic children, but none of the 30 normal children or 15 siblings of autistic children, had antibodies against the measles vaccine virus. Since none of the children in Singh and Jensen study had any prior history of measles rash or wild type measles infection, but they all have had their immunisation with the MMR, the authors concluded [6]:

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“This vaccine in a small population of genetically predisposed children may perhaps manifest an atypical measles infection that does not yield a clinical rash but produces neurologic symptoms similar to those seen in children with autism.”

and

“Although more research is necessary to uncover the etiology of autism, the hyperimmune response to measles virus might indicate virus reactivation that triggers a misguided humoral immune response in children with the disorder.”

Finally, far from being “discredited” and “flawed” as suggested in latest editorials published in the BMJ [7], the “Wakefield’s hypothesis”, which indicates that there is “a pattern of colitis and ileallymphoidnodular hyperplasia in children with developmental disorders” [3], is now supported by more independent research [8-12]. Notably, several respectable publications suggest that the principal findings of the Wakefield’s 1998 Lancet study should not be discarded nor ignored. For example:

Quigley and Hurley [13]:

“Wakefield et al. are to be congratulated on opening yet another window onto the ever- broadening spectrum of gut/brain interactions. Their findings raise many challenging questions that should provoke further much-needed research in this area, research that may provide true grounds for optimism for affected patients and their families.”

Most recently, at the meeting on 2nd February 2011 (http://www.dh.gov.uk/ab/JCVI/DH_123529), the JCVI dismissed the relevance of a paper by world-renowned autoimmunologists Professor Yehuda Shoenfeld and Nancy Agmon-Levin [14], which raised serious concerns about the role of vaccine adjuvants in vaccine-related autoimmune conditions.

(XII. Papers for information and any other business, 61.) 3

“The committee discussed a review paper by Shoenfeld and Agmon-Levin (2010) on autoimmune/inflammatory syndrome induced by adjuvants, in particular on the role of adjuvants in the pathogenesis of four conditions: siliconosis, the Gulf war syndrome (GWS), the macrophagic myofasciitis syndrome (MMF) and post-vaccination phenomena. The committee considered that the paper did not provide convincing data on the role of adjuvants in these four ‘enigmatic’ medical conditions and that the review did not raise safety concerns about the use of adjuvants.”

5) Persistently and categorically downplayed safety concerns while overinflating vaccine benefits.

The sharp increase in litigation claims over pertussis vaccine injury between 1978/79-1985, presented an additional challenge for the CSM/JCVI/Joint Sub-Committee ARVI, as increased efforts were now needed to reassure the public in the safety of the pertussis vaccine.

In the transcript of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI 7th

meeting held on February 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), ARVI made the following comments on a confidential paper:

(Item 5.1 ARVI’s comments on ________ paper “Whooping cough disease, vaccination, vaccine damage”)

“________ deprecated the use of the term ‘brain damage’ which the public might consider as a permanent entity. The public may not also understand the significance of febrile convulsions.”

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Are we to assume that ARVI had not been aware of a certain controversial statement made by the CSM in the 1981 in a report on Whooping Cough about a possible link between DTP immunisation and serious neurological illness?:

“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist.” (JCVI/Joint Sub- Committee ARVI “commercial in confidence” meeting on 6th February 1987, section “7.1 Whooping cough vaccine –CSM advice”; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306)

Perhaps the reason why ARVI “deprecated the use of brain damage” is because of their firm belief that vaccines could not be associated with such events. Apparently, the possibility that vaccination could cause permanent brain damage must have been considered as an outrageous assertion, so much so that it did not even deserve scientific scrutiny. In fact, following a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis

7th

vaccine on February 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306), CSM/JCVI/Joint Sub- Committee ARVI jointly concluded that:

(6.5.1) “It was considered unreasonable to ask paediatricians to report for a period of six years.”

Under the same agenda, the CSM/JCVI/Joint Sub-Committee ARVI also decided that:

(6.5.1) “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

Obviously without such a standard, it would have been quite impossible to assess whether vaccination against pertussis caused more severe brain damage than natural pertussis infection. If concerns about pertussis vaccination were indeed unsupported and only a product of an inexpert “perception of the public” as ARVI’s statements would led us to believe, then surely such a study would have just reinforced the notion that vaccines are safe. However, it appears that according to the CSM/JCVI/Joint Sub-Committee ARVI’s problem-solving rationale, instead of encouraging further research, it seemed more acceptable to downplay safety concerns over possible vaccine-injury, which then justified their decision to take no further investigation into the matter. Unwillingness to carry out this specific research is perplexing indeed, in light of what was noted at the 3rd November 1981 meeting (http://www.dh.gov.uk/ab/DH_095169) in section 5 on Whooping Cough:

(5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

Are we meant to believe that “cessation of development” following episodes of vaccine-associated fits does not fit into the category of “permanent entity” and/or “brain damage”?

As for the public’s alleged misunderstanding on the significance of febrile convulsions, the

transcript notes of the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI 6th

meeting held on June 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306) are particularly enlightening:

In discussing the significance of the NCES report on pertussis vaccine injury:

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“The report used the NCES estimation of relative risk of 3:1, it was estimated that one third of such cases have permanent handicap one year from their onset (as derived from the NCES).”

(5.3 Complex Febrile Convulsions) “These were defined as being of more than 10 minutes in duration, or repetitive over 24 hours…Vaccine could cause such seizures and it was believed that 10 per cent of such complex seizures could result in permanent handicap…”

Perhaps the public would have been better acquainted with the significance of febrile convulsions and the fact that pertussis vaccine could cause them, had not:

“The Chairman reminded members that the proceedings, papers and information before them [were] confidential and should not be disclosed.”

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Paradoxically, at the prior meeting on February 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), at which ARVI stated it “deprecated the use of the term brain damage”, the CSM/ JCVI/Joint Sub-Committee ARVI acknowledged:

(6.5.1) “that the NCES may have missed cases of severe neurological disease which progressed to handicap among children who were not admitted to hospital.”

6th

Going back to the meeting that followed, on June 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306):

(5.7) “In the general discussion which followed, some members of the Committee felt that the report [referring to the American Medical Association (AMA) panel report on Pertussis Vaccine Injury, published in JAMA 1985; vol 254, pages 3083-3084] not only accepted the fact that vaccine damage was a real phenomenon but implied (by the way it was written) that it was commoner than was believed to be the case in the UK.”

Notably, according to the notes of the “commercial in confidence” CSM/JCVI/Joint Sub3rd

Committee ARVI meeting on October 1986 (http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306), the AMA panel report had been prepared:

(5.2) “…with the particular intention of providing information for legislators as to what type of vaccine-associated event might require compensation, if Federal compensation for presumed vaccine injury were to be introduced.”

Perhaps it is because of this that the CSM/JCVI/Joint Sub-Committee ARVI:

(5.2) “…agreed that the document contained a number of assertions which could not be accepted.”

One has to wonder whether such assertions unacceptable to the CSM/JCVI/Joint Sub- Committee ARVI include:

“…the fact that vaccine damage was real a phenomenon” and “commoner than was believed to be the case in the UK.” (CSM/JCVI/Joint Sub-Committee ARVI meeting on 6th June 1986; item 5.7; http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306)

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Other than perceiving health hazards associated with certain vaccines as a danger to overall routine immunisations, the JCVI felt that certain health professionals were also negatively affecting the vaccination policy by exercising more caution with regards to contraindication criteria than the JCVI deemed appropriate (for a remainder of the JCVI’s position with regards to contraindication criteria refer back to Sections 2) and 3)). In a Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority, at the Joint Working Party of the BPA and the JCVI Liaison group meeting on 30th September 1986 (FOI release, 86/3rd meeting; http:// www.dh.go v.uk/en/FreedomOfInf ormation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4140335), the member whose name was erased from the transcript commented that:

(7.)

“…the paper described a position which was still bedevilled by false contra-indications to measles vaccination.”

Apparently,

“________ commented that often parents wanted the vaccine given but were dissuaded by health service staff. ________ stressed the need for training of health professionals and the Chairman considered that the ‘responsible person’ in each district (quoted in previous circulars) should organise such a training.” (7. Measles vaccination: Summary Report on an investigation of failure to reach a measles immunisation uptake in the Maidstone Health Authority)

In a later meeting (JCVI 7th November 1986; http://www.dh.gov.uk/ab/DH_095169):

(9. BPA/JCVI Working Group) “Members agreed that the most disturbing feature was that a minority of health professionals could exert a disproportionally bad effect on a campaign.”

What the JCVI’s perception of a “responsible person” might be, is perhaps best understood in the light of their bewildering leniency towards vaccine safety and a seeming tendency to align with the manufacturers’ interests more than those of public health.

By 18th November, the JCVI had an elaborate strategy to improve measles vaccine uptake 1st

(as documented in the transcript of the JCVI meeting on May 1987; http:// www.dh.gov.uk/ab/DH_095169), which included:

(discussion about a PHLS meeting on 18th November on the uptake of measles vaccine)

“GP clinics where immunisations were given should be more attractive and use every opportunity of attendance at clinics to offer immunisation; this is especially important for deprived families.”

It was also recommended that:

“Regional and District Health Authorities (DHAs) should be accountable for their vaccination performance.”

Since:

“All the members agreed that accountability with regard to immunisation was most important. The Chairman is summing up said that immunisation was a most important NHS Policy and that recommendation before them, after editing, should be put to the NHS Management Board and then promulgated to the NHS with a separate copy to the nominated persons in the districts.”

That “immunisation was a most important NHS Policy” is also implied in a discussion on whooping cough at the JCVI meeting on 3rd November 1981 (http://www.dh.gov.uk/ab/ DH_095169):

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(5.d. Comments on Professor Stewart’s letter) “The meeting then considered Professor Stewart’s paper on deaths from whooping cough in Great Britain (JCVI(81)12). Dr Williams, referring to page 5 of the paper, said that deaths from whooping cough tended to be under-notified…On the other hand, at times of outbreaks of whooping cough the disease tended to be over-notified; this had the effect of lowering fatality ratio.”

In the ensuing discussion:

“The Chairman concluded that it would probably not be wise for the Committee to make a formal reply to this paper. (Members also thought that controversial replies to correspondence to the medical journals might not add support to the whooping cough vaccination campaign.)”

In the following years, the members of ARVI continued to “express anxieties” over eroding

confidence of the public in pertussis and other vaccines. In a Joint Sub-Committee ARVI 8th

meeting on March 1988, the members recommended that a monitoring system for vaccine reactions should be set up, which would cope with any vaccine related “adverse publicity” (item 7, Adverse Reactions Surveillance; http://www.dh.gov.uk/en/ FreedomOfInformation/Freedomofinformationpublicationschemefeedback/FOIreleases/ DH_4135306; note that this meeting was incorrectly noted as March 1998 rather than March 1988).

While the public appeared to have lost the confidence in the safety of the pertussis vaccine by the mid 80s, in 1989, the JCVI was still debating on whether or not the pertussis vaccine caused permanent brain damage. Referring to the NCES report it was generally accepted by the JCVI that if the vaccine led to severe neurological outcomes, it did so very rarely (JCVI

3rd

meeting on November 1989; http://www.dh.gov.uk/ab/DH_095169). Finally, it was agreed that the statistical data of attributable risk should be removed from the Memorandum since, according to Dr Salisbury:

“If the public was given a risk ratio — any ratio — they would still see it as a scientifically proven risk. It was therefore preferable not to use insecure figures if possible but to stress the benefits from vaccination.” (12.1 Whooping cough – article by Dr A H Griffith in Vaccine etc JCVI (89)32)

Regarding the alleged overall “benefits from vaccination”, it is worth mentioning that in a discussion about Diphtheria outbreaks in immunised populations on 22nd April 1988 (http:// www.dh.gov.uk/ab/DH_095169), the JCVI acknowledged that these do in fact:

(16.1) “occur in well-immunised populations…”

In addition, the decision to include mumps in the routine vaccination schedule with the introduction of the MMR in 1988 goes against JCVI’s own past advice, as evidenced by a discussion about the usefulness of the mumps vaccine in the JCVI meeting on 11th December 1974 (http:// www.dh.gov.uk/ab/JCVI/DH_095052):

(10.)

“The Committee agreed that there was no need to introduce routine vaccination against mumps.”

because

“complications from the disease were rare.”

Granted, opinions can change with time as new scientific evidence becomes available. Even so, the arguments are against routine mumps vaccination. Mumps in adults but not in children can cause mumps orchitis, a serious condition which may result in male sterility. Mumps outbreaks in older

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individuals increased in frequency since the introduction of the MMR into the routine schedule, most likely because of the poor effectiveness of the mumps component of the vaccine.

In a comprehensive assessment on mumps orchitis in the post-vaccine era, which included epidemiologic, clinical, therapeutic, and follow-up studies and outcomes of 609 patients, Ternavasio-de la Vega et al. [15] reported:

“Mumps orchitis is the most common complication of mumps infection in young postpubertal males. Testicular compromise is characterized by an abrupt onset of unilateral or bilateral marked scrotal swelling and pain, accompanied by constitutional symptoms and fever. Immunization programs against mumps have reduced the number of reported cases and influenced their age distribution. Since the introduction of mumps vaccine in 1967 (the year the first mumps vaccine was licensed in the United States), a shift in the age of peak incidence of mumps from children aged 5-9 years, in the prevaccine era, to children and young adults aged 10-24 years has been observed. Serious complications have appeared as a consequence because of the higher rate of sequelae among the older age-group. The principal complication of acute mumps orchitis is the atrophy of germinal epithelium with spermatogenesis arrest, which in turns leads to male sterility.”

The evidence for the poor effectiveness of the mumps vaccine has recently been reported by Castilla et al. [16]:

“This study adds to the literature showing moderate effectiveness of the mumps vaccine containing the Jeryl Lynn strain, which seems to be related with early and progressive waning immunity. This effect, seen in children vaccinated with both one and two doses, makes it difficult to control the disease even when high vaccination coverage is achieved, and leaves open the possibility that outbreaks will occur when the infection is reintroduced.”

“Our results indicate that this effect of waning immunity begins early, as seen in the fact that 3 or more years after the second dose of MMR vaccine, the risk of mumps was 10 times higher. This increased risk does not appear to be linear, but rather is accentuated over time.”

Hence, routine mumps vaccination has shifted a childhood disease to adolescents and young adults, groups with a higher incidence of adverse long-term complications and sequelae. By contrast, the benefits of naturally acquired immunity against mumps in early childhood are life-long protection against mumps and its serious complications later in life.

Curiously, at the meeting held on 17th September 1990 (http://www.dh.gov.uk/ab/JCVI/ DH_095294), the JCVI also acknowledged the consequences of shifting mumps infections to older age groups:

(6.5) “It was noted that the introduction of mumps immunisation could in theory shift the age specific infection rates to the older age groups in whom the complications were greater;”

However, the Committee concluded:

“…nevertheless, the gains from the progressive reduction in mumps illnesses outweigh such concerns.”

It would appear that in following the JCVI’s line of reasoning, one must conclude that the alleged benefit of eradicating mumps in young males where the illness is mild and “complications are rare”, outweighs the risk of male sterility.

Similar to mumps, the complications from rubella early in childhood are minimal, hence it may be argued that vaccination against both rubella and mumps are of little clinical benefit to a child. Serious complications from rubella may occur in a developing foetus of a pregnant woman who has contracted rubella during her first trimester. In such cases a child may be born with congenital rubella syndrome (CRS), involving multiple congenital abnormalities. The risk of CRS can be reduced either by making sure all women have caught rubella as children or by vaccinating those

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who have not prior to puberty. Hence, the current JCVI’s policy of vaccinating every child, male and female, against rubella does not appear to be justified.

Finally, apart from “no need to introduce routine vaccination against mumps” , the decision to introduce the MMR into a routine schedule was in conflict with the JCVI’s past concerns about risks associated with simultaneous administration of multiple live vaccines. Curiously, the MMR vaccine developed by MSD was first licensed in the UK in 1972, but not marketed until 1988. An indication as to why it took 16 years to introduce it in to a schedule may be found in the same meeting which discussed the usefulness of the mumps vaccine (JCVI meeting, 11th December 1974; http:// www.dh.gov.uk/ab/JCVI/DH_095052):

(11 Simultaneous administration of live vaccines (CHCS(VI)14))

“The Chairman refereed to the 3 vaccines which had been licensed for Merck Sharp and Dohme and asked for comments on the company’s claim that these could be administered simultaneously with live poliovirus vaccine. This use of the vaccine appeared to conflict with the Committee’s published advice and they had to consider (a) whether this advice should be changed and (b) if the vaccine concerned viz MMR, Biavax and Measles and Rubella virus vaccine and live MSD could be given with live poliovirus vaccine. Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”

Perhaps unknown to most lay people as well as medical professionals is the issue of vaccine contaminants which is somewhat inherent to the vaccine production process. In this regard, one particular item discussed under the section 3.4. Ruminant and Human Materials used in Vaccine Manufacture, at the JCVI meeting on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), deserves special emphasis:

(3.4.1) “This report was provided for information. The Committee asked by which date the vaccines already distributed would no longer include any whose production process may have involved the use of potentially BSE [Bovine spongiform encephalopathy] infected Category 1 or 2 material. The Committee was told that Category 1 material was only used at the master seed/working seed stage of the manufacture of a very few vaccines, not in routine vaccine production itself. Many vaccines are produced from master seeds which were manufactured many years ago…Master seed material often antedated the BSE epidemic in the UK, and was diluted many fold to the extent that any exposure to infected material, if ever present, would be remote.”

How many people would feel comfortable with taking medicinal products derived from potentially BSE-contaminated material? As to why such vaccines continued to be used:

(3.4.1) “There is reluctance to establish new master seeds for vaccines which have long history of use because such a change could possibly change the vaccine characteristics which may adversely impact safety and efficacy.”

Indeed, removing sources of possible BSE contamination from vaccine manufacture would have no doubt “impacted safety”; it would have made vaccines safer.

Curiously, when asked by the JCVI:

(3.4.3) “…to consider whether it would be possible to put the information it had summarised on vaccine manufacturing and excipients in vaccines into the public domain; the MCA would consult their lawyers on this point.”

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If there was no risk of contracting BSE from a vaccine, then why did the MCA have to consult their lawyers “on this point”?

At the same meeting, on 4th May 2001 (http://www.dh.gov.uk/ab/JCVI/DH_095044), the Committee discussed:

(4.5.1) “… suspected adverse reactions categorised as serious to DTP/Hib, polio, BCG, hepatitis A and B vaccines over the last three years. The data was based on Yellow Card reports received by the MCA.”

and it showed the following:

“i. DTP/Hib -the overall pattern and type of suspected reactions in 2000 were similar to previous years, with the exception of an increase in the number of respiratory reactions. Most of the increase appeared to be due to an increase in number of SIDS (5) and apnoea type reactions (14) being reported.

ii. Polio -The types of suspected reactions reported in 2000 were on the whole similar to previous years. The only differences appeared to be an increase in the number of cardiovascular, eye and respiratory reactions reported. iii. BCG -Overall the types of suspected reactions reported were similar with the exception of an increase in number of cardiovascular reactions in 1999 and musculo-skeletal reactions in 2000. iv. Hepatitis B -The types of suspected reactions reported on the whole had been similar, with a notable decrease in the number of serious cardiovascular, eye, immune system, musculo-skeletal and neurological reactions being reported. v. Hepatitis A -The types of suspected reactions being reported were on the whole fairly similar. However, there were three notable differences: a significant increase in the number of cardiovascular and musculo-skeletal reactions reported in 2000, and a significant increase in the number of immune system disorder reactions reported in 1999. All these type of reactions were recognised side effects of this vaccine.” (4.5.2) “Overall, there were no new safety issues identified.”

Perhaps these were not new issues, just old persisting ones. Nonetheless, in all but one case (Hepatitis B), the number of serious adverse reactions appeared to have increased and in some cases this was not only significant but also a “recognised side effect of this vaccine” (Hepatitis A). In spite of this:

(4.5.2) “The Committee was not persuaded given all the inherent uncertainties of spontaneous reporting that there were significant problems developing.”

If anything, the Committee previously appeared to have acknowledged that there were problems with underreporting of adverse reactions to vaccines. In a Report of North Herts Immunogenicity Study on the 1st May 1992 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), it was noted that “the report of a cluster of CSF mumps virus positive cases in Nottingham had caused concern that national surveillance may have been underreporting the incidence of cases…”

As noted in the following Section (6), the Yellow Cards are a passive surveillance system, not routinely used by the GPs and hence, data on adverse reactions obtained through Yellow Card reports are likely to be an underestimate of the true rate of these events.

Finally, since the principal rationale for shaping vaccine recommendations and policies according to the JCVI was to keep vaccination rates as high as possible so that presumably, “herd immunity”

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would be achieved, it would seem fair at this point to question exactly how well has this concept been established? The theory behind vaccine-mediated “herd immunity” appears sound, it maintains that vaccination of a significant portion of a population (herd), will provide a measure of protection for individuals who have not developed immunity. Obviously, transmission of a disease to the point where it would reach an epidemic is expected to be countered in a population where most individuals are thought to be immune. However, the concept of vaccine-mediated “herd immunity” is based on the assumption that vaccines are effective in conferring immunity to the individual. If this were so, then how does one explain outbreaks of infectious diseases in populations where over 95% of individuals have been vaccinated?

Gustafson et al. [17] “An outbreak of measles occurred among adolescents in Corpus Christi, Texas, in the spring of 1985, even though vaccination requirements for school attendance had been thoroughly enforced. Serum samples from 1806 students at two secondary schools were obtained eight days after the onset of the first case. Only 4.1 % of these students (74 of 1806) lacked detectable antibody to measles according to enzyme- linked immunosorbent assay, and more than 99 % had records of vaccination with live measles vaccine…After the survey, none of the 1732 seropositive students contracted measles. Fourteen of 74 seronegative students, all of whom had been vaccinated, contracted measles. In addition, three seronegative students seroconverted without experiencing any symptoms. We conclude that outbreaks of measles can occur in secondary schools, even when more than 99 percent of the students have been vaccinated and more than 95 percent are immune”

(Note that if the measles vaccine was effective in providing herd-protection, then the <5% of children in this study who did not seroconvert would still have had protection from contracting measles. The whole premise on achieving high vaccination rates rest on the assumption that the herd will protect those vulnerable individuals who have not been vaccinated, or do not seroconvert.)

Hersh et al. [18] “In early 1988 an outbreak of 84 measles cases occurred at a college in Colorado in which over 98 percent of students had documentation of adequate measles immunity (physician diagnosed measles, receipt of live measles vaccine on or after the first birthday, or serologic evidence of immunity) due to an immunization requirement effect since 1986.”

Tugwell et al. [19] “A chickenpox outbreak occurred in a school in which 97% of students without a prior history of chickenpox were vaccinated. Students vaccinated >5 years before the outbreak were at risk for breakthrough disease.”

It would thus appear that these vaccines only provide waning immunity, not herd immunity, as already well established in the case of the mumps vaccine by Castilla et al. [16] This often has the effect of shifting a relatively mild childhood disease to older age groups of children or young adults, in whom complications and sequelae from the disease are much more severe [15].

6) Promoted and elaborated a plan for introducing new vaccines of questionable efficacy and safety into the routine paediatric schedule, on the assumption that the licenses would eventually be granted.

On 7th May1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050), the JCVI met to discuss the use of the new conjugate Group C meningococcal vaccines. At the beginning of the meeting, Professor Hull, the Chairman:

“…reminded members that the minutes and proceedings of the JCVI were confidential. Politically and clinically sensitive material was dealt with by the Committee…”

It was further emphasised:

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“This was the main agenda item for the meeting. Much information had been made available and important decisions were required of the Committee, particularly about the introduction of meningococcal Group C conjugate vaccine, of which three brands would soon become available. Any decision would be dependent on the granting of product licenses and the wording of those licenses and, during the discussion, the Committee had to act on the assumption that licenses would be granted. The MCA was responsible for the safety, efficacy and quality of vaccines. The question for consideration by the Committee was how it would recommend that the vaccine should be introduced.”

The Committee members were also once again:

“…reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained.”

The Chairman had then asked for any declarations of interest:

“Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.”

In spite of these substantial conflicts of interests:

“There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.”

We are only left to speculate as to what such “common interest” might have been, between the JCVI and the pharmaceutical industry, bearing in mind several past instances where the Chairman of the JCVI met with the Association of British Pharmaceutical Industries to discuss:

“…the availability of scarce vaccines and the introduction of new vaccines into more regular use. The question of financial support for training members of the health service in immunisation was also discussed.” (18. Meeting of the Chairman of the JCVI and the Association of British Pharmaceutical Industries, JCVI meeting on 23rd October 1987; http:// www.dh.gov.uk/ab/DH_095169)

or where:

“The Chairman said that Departmental officials had recently met vaccine manufacturers who were keen to be informed, in confidence, of the outcome of JCVI discussions which might affect their own plans.” (2.iv. JCVI meeting on 4th May 1990 (http://www.dh.gov.uk/ ab/DH_095169)

The apparent close ties between the pharmaceutical industry, JCVI and the DH perhaps explain why the DH funded studies were not adequately designed to detect long-term vaccine-related adverse outcomes. In discussing 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ ab/JCVI/DH_095050), Dr Elizabeth Miller reported:

(i.)

“Papers providing data on the new vaccines’ safety and efficacy and data from the Department of Health funded studies were looked at; no other country had conducted similar studies. The Medicines Control Agency had also gathered lots of information and NIBSC was evaluating the vaccines. The data provided to the Committee related to the Wyeth product, which would be the first to become available. All available ADR [adverse reactions] data was included; the follow-up of ADRs had been up to the end of 4 to 6 weeks.”

It should be obvious that long-term adverse reactions cannot be identified if a study is not designed to detect them (and quite predictably there were none, since the DH funded

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studies showed that the MCC vaccines were well tolerated, section 8.4.1. vii., 7th May1999 JCVI meeting; http://www.dh.gov.uk/ab/JCVI/DH_095050). The reason for such omissions in study design are bewildering, given the past safety issues with the measles vaccine, where several children “were left one year later with severe handicap.” (7. Suspected adverse reactions to measles vaccine: recent reports to the CSM, JCVI meeting on 17th of June 1983; http://www.dh.gov.uk/ab/JCVI/DH_120115)

Not only did the safety of the new, soon-to-be introduced MCC vaccine remain questionable, but also:

(ii.)

“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.”

In the ensuing discussion we are told that the JCVI:

(iii.)

“…felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”

In other words, the JCVI and the DH were actively working on a plan to introduce a vaccine with no demonstrable safety or efficacy into a routine paediatric schedule. Apparently, those responsible for sound safe and effective immunisation policies concluded that it was “very difficult” to conduct the necessary trials and they felt that this would unnecessarily delay the introduction of the MCC vaccine into a routine immunisation schedule.

What should have been considered by the JCVI is that vaccines represent a special category of drugs, generally given to healthy individuals and often to prevent a disease to which an individual may never be exposed [1]. Because of this, according to the US FDA, significant emphasis should be placed on vaccine safety [1]. Thus, If there are uncertain benefits from a vaccine, only a small level of risk of adverse effects may be acceptable. If the benefits are certain, then a greater risk of side effects may be tolerated. However, neither of these two points would have applied in the case of the MCC introduction programme, since there is absolutely no clinical benefit to a child from a vaccine that has neither been proven to be safe nor effective. The only “benefit” from such a programme would have been more in line with certain “common interests” rather than public health.

What followed at the 7th May 1999 meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050), was a discussion on priority groups to whom the MCC vaccine should be offered, in which Dr Smithson made a following remark:

(ix.)

“…there was very little to chose between the priority age groups but suggested that infants were easier to target.”

Finally, the Committee concluded that:

(x.)

“…if sufficient vaccine was available, all children should have it…”

In the following meeting, held on 21st January 2000 (http://www.dh.gov.uk/ab/JCVI/ DH_095050), in section 6.4 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, Dr Elizabeth Miller reported that several safety studies indicated that the new vaccine was not a cause for concern. Although,

(6.4.4) BSEM March 2011 The Health Hazards of Disease Prevention

“… headache, particularly if it was associated with muscle stiffness inevitably raised fears of actual meningitis, although the vaccine could not cause this.”

Furthermore:

(6.4.6) “The Committee noted that this information would not have been available without the cooperation of the manufacturers. This had given everyone much more confidence in the vaccine programme and was a unique co-operation.”

9th

In the following meeting, on October 2000 (http://www.dh.gov.uk/ab/JCVI/ DH_095050), the Committee was given an update on the safety profile of the MCC vaccine:

(7.6.2) “The Working Party had received data available and had concluded that an association between MenC vaccine and seizures had not been proven. There had been 14 deaths reported. (2 further deaths had since been reported: 7 of the deaths were SIDS, 2 were meningitis B, 3 were in children with underlying conditions 1 was pneumococcal septicaemia, 1 was infantile encephalitis, 1 bronchiolitis and 1 child collapsed one month after immunisation with no cause of death being found).The Working Party believed that the deaths were all explained by other causes and that the vaccine was most unlikely to be implicated. By 21 September 2000, there had been 8.300 reports of 17,000 ADRs (1 ADR per 2,000 doses). The profiles were the same for each brand of vaccine.”

Note that the Working Party “believed” that the vaccine was not implicated. An even firmer belief in MCC vaccine safety was held by the JCVI:

(7.6.3) “The Committee did feel that the MCA statement that there was “no evidence that the vaccine caused meningitis” was far too light: the vaccine categorically did not cause meningitis. The MCA Meningitis Working Party would consider this issue further…”

How the JCVI could claim with such definite certainty that the newly introduced and poorly tested MCC vaccine could not cause meningitis is not clear from the transcript. Amongst those who did not share similar views with regards to vaccine safety are Alexander Harris Injury and Accident Solicitors and their clients, families whose children appear to have suffered severe long-term health problems following MCC vaccination. From their website (http:// www.alexanderharris.co.uk/OurWork/ProductLiability/MeningitisCVaccine/Pages/default.aspx), we learn that safety concerns about MCC vaccine were first raised by the media (and not the UK health authorities) and that:

“Some 16,527 adverse reactions from 7,742 patients had been reported by GPs to the Medicines Control Agency through the Yellow Card reporting system. As well as reactions at the site of the injection such as swelling and soreness were other long-term reports which included seizures and 12 deaths.”

This appears to be consistent with the data reported at the JCVI 9th October 2000 meeting. Further, the Solicitors made an important observation:

“The Yellow card reporting system is not routinely used by most GPs and healthcare professionals and as such the figures for adverse reactions are likely to be an underestimate. Despite the known under-reporting, the number of adverse reactions reported for Meningitis C vaccine is the highest for any vaccine within the UK immunisation programme.”

7)

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8) Actively discouraged research on vaccine safety issues.

On 14th October 1985 a letter was issued to Dr Derek Zutshi (DHSS), from a member affiliated with the London School of Hygiene and Tropical Medicine at the University of London, whose name was erased from the copy of the letter prior its FOI release (http://www.dh.gov.uk/prod_consum_dh/ groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4140359.pdf):

“Dear Derek

Enclosed are comments on the estimates of vaccination-associated SIDS as presented at the recent ARVI meeting. I hope they prove helpful.

Let me add that this is a complicated problem, but one that I would be interested to pursue in the future.”

In three pages, the author of the letter made several comments on “Tabled Paper 1, (Appendix to ARVI/85/34)”, titled “Note on the estimation of sudden infant deaths expected to occur by chance after immunization”, authored by Paul EM Fine from the London School of Hygiene and Tropical Medicine. A balanced critical overview was given on three key points relevant to Paul EM Fine’s estimation of SIDS: “method used”, “data used” and “assumptions made”, outlining both strengths and limitations. In a final note, the author concluded:

“These brief comments indicate a number of problems which arise in estimating the number of SIDS deaths expected to arise by chance, within 24 hours of vaccination, if there were no causal association between them. Some of these problems favour overestimation and others favour underestimation by the methods used in the DHSS note. Given the nature and direction of the biases, it is probable that the estimates presented in the DHSS note are of the correct order of magnitude. On the other hand, given the importance of the subject, a more thorough examination of the subject seems appropriate.”

Copies of this letter appear to have been forwarded to Dr M Graveney (DHSS) and Professor RW Gilliatt (JCVI).

Two months later, on 13th December 1985, on the University of Nottingham, Department of Child Health’s letterhead, a member whose name was erased from the copy of the letter released under FOI (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_4140362.pdf), also wrote to Dr Derek Zutshi, to express his grave concerns about potential further investigations into the relation between vaccination and SIDS:

“Dear Derek

I showed the Tabled Paper 1, (Appendix to ARVI/85/34) to Richard Madeley [Department of Community Medicine and Epidemiology, University of Nottingham Medical School] and he kindly prepared the enclosed observations. I agree with everything that he has said. As you know, at the meeting I had grave misgivings about the exercise and of the assumptions that were made.”

In the following section, “Re: Note on the estimation of sudden infant deaths expected to occur by chance after immunisation”, apparently from the author of the “enclosed observations”, Richard Madeley, several reasons are given for his own misgivings “about the exercise”, some of which appear to be sound, such as:

(3. The hypothesis that immunisation may cause SIDS) “c. Most deaths from SIDS occur before the age of four months2, when first immunisation takes place.”

(note, this still does not exclude the possibility that some cases of SIDS may be vaccine-related)

while others appear not as sound:

“d. There is no foolproof method of discrediting the hypothesis by statistical or epidemiological methods. On the contrary, there is a danger of getting drawn into a lengthy

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argument about numbers which neither side could win, thus giving more credibility to the hypothesis than it deserves.”

(it ought to be noted that in the realm of science, a hypothesis can only be proven or disproven by experimental evidence and not by personal opinions)

In his “Final Comments and Conclusions” the author stated:

“For those reasons, I think it would be extremely unwise for the DHSS to get involved in any type of epidemiological work on this hypothesis. The hypothesis seems most unlikely on grounds of basic scientific reasoning, and such evidence as already exists points in the opposite direction.”

“To go ahead in these circumstances would endow upon the hypothesis a respectability which it does not deserve. It is impossible to disprove through numbers. To try to do so, using flawed assumptions, as in the memorandum of the DHSS Statistics Division, weakens the position.”

Indeed, epidemiological work would not be the most appropriate way to address the possibility that SIDS could be causally related to vaccination given that epidemiological studies only test for “association” and not “causation”. However, case control studies as well as post-mortem lab analysis should have been considered as viable alternatives to further research. Such as:

Ottaviani et al. [20] “Herein we report the case of a 3-month-old female infant dying suddenly and unexpectedly shortly after being given a hexavalent vaccination. Examination of the brainstem on serial sections revealed bilateral hypoplasia of the arcuate nucleus. The cardiac conduction system presented persistent fetal dispersion and resorptive degeneration. This case offers a unique insight into the possible role of hexavalent vaccine in triggering a lethal outcome in a vulnerable baby. Any case of sudden unexpected death occurring perinatally and in infancy, especially soon after a vaccination, should always undergo a full necropsy study according to our guidelines.”

“The identification of a possible pathological basis of reflexogenic mechanisms in sudden, unexpected infant death necessarily requires examination of the brainstem nuclei and of the cardiac conduction system on serial sections.”

The senior author of this study, Professor Luigi Matturri is a member of the European Medicines Agency (EMEA) Pathologists Panel for evaluation of SUD (sudden unexpected death) cases reported for hexavalent vaccines. In a review by EMEA cited in the Introduction of the study, of five reports of unexplained deaths in children which occurred within 24 hours of vaccination with a hexavalent vaccine, panels of experts (including pathologists with the experience in the field of vaccines and SIDS), investigated whether there might have been a link between the vaccines and the deaths observed:

“The EMEA’s conclusions were that the causes of death remained unexplained. SIDS, viral infection, metabolic disorders, allergic reactions or airway obstruction were plausible but were not definitely proven to have been the cause of death [4]. However, to the best of our knowledge, during the mentioned post-mortem investigations, little, if any, attention was paid to examination of the brainstem and the cardiacconduction systems on serial sections, nor was the possibility of a triggering role of the vaccine in the lethal outcome considered.”

In addition, in responding to numerous criticisms of their study Unexplained cases of sudden infant death shortly after hexavalent vaccination [21] Zinka et al. noted [22]:

“(ad 6) The main problem is that vaccination specialists have failed for decades to establish any tests or other criteria to find out if adverse events are linked to vaccinations or not. To our knowledge they did not even try hard—why?!”

“(1) A precise description of the mechanism leading to serious adverse events after hexavalent vaccination is not the task of forensic pathology. This would be the job of vaccination specialists, and actually this job should have been done before phase 1 and phase 2 studies in order to get valid data on the drug safety.”

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In summary, it may be inferred from here that the real reason why causality is rarely (if ever) established by scientific investigations into vaccine-related serious adverse outcomes is because it is assumed that: a) they don’t happen and b) the study is not designed to detect them. This may further suggest that vaccines are not proven to be safe but are only assumed to be safe. Indeed, according to the US FDA “Historically, the non-clinical safety assessment for preventive vaccines has often not included toxicity studies in animal models. This is because vaccines have not been viewed as inherently toxic” [1].

9) Deliberately took advantage of parent’s trust and lack of relevant knowledge on vaccinations in order to promote a scientifically unsupported immunisation program which could put certain children at risk of severe long-term neurological damage.

Recently the DH announced that there would be a significant change in the current UK immunisation schedule, following the October 2010 meeting at which the JCVI recommended that children be vaccinated against six diseases at the same time. This would be through receiving three vaccines (Hib/MenC, MMR and pneumococcal) in one visit rather than getting the first vaccine at 12 months of age and the second two at 13 months of age. According to a letter sent by the Chief Medical Officer Professor Dame Sally Davies to local GPs (http://www.dh.gov.uk/en/ Publicationsandstatistics/Lettersandcirculars/Professionalletters/Chiefmedicalofficerletters/ DH_121748), this new “simplified” immunisation policy is to be implemented “as soon as practicable”. Furthermore, according to a BBC news report on 22nd November 2010 (http:// www.bbc.co.uk/news/health-11809967), the purpose for vaccinating against 6 diseases at one single appointment is “to boost vaccine uptake”, which has apparently been low ever since safety concerns regarding the MMR vaccine had been raised in public following the study of Wakefield et al. in 1998 [3]. Despite continued public concerns on the overall safety of the MMR and its possible link to autistic regression and other severe neurological outcomes, the DH spokesperson stated (http://www.dh.gov.uk/en/MediaCentre/Statements/DH_122026):

“Independent scientific research has shown that providing these vaccines at the same time is safe, effective and more convenient for parents.”

I have requested from the UK DH to show me these independent data. The request was granted, and much more than that. First to the independent data: they are not independent.

The study by Miller et al. [23], referenced by the DH states in the acknowledgments:

“This is an independent report funded by the Policy Research Programme in the Department of Health, UK, grant 039/031.”

As for the safety assessment:

“For safety, proportions of children with erythema, swelling or tenderness at site of injection, or fever or other systemic symptoms for 7 days after immunization were compared between regimens. No adverse consequences for either safety or immunogenicity were demonstrated when MCC/Hib was given concomitantly with

PCV and MMR at 12 months of age or separately at 12 and 13 months of age.”

Thus the vaccine was “demonstrated safe” based on a 7 day follow-up and monitoring for largely local reactions. Not only is this an appalling example of a vaccine safety study, it is the only study quoted by the DH and JCVI in support of their decision to implement a new vaccine schedule. This is evident from a Possible simplification of the childhood vaccination schedule report (http:// www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/ dh_121799.pdf), issued by the JCVI Secretariat in October 2010, which states:

(4.)

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“In June 2009, JCVI considered a pre-publication clinical trial paper from Miller et. al. that showed that co-administration did not adversely affect the immune response elicited by the vaccines. In addition, no safety concerns around co-administration were identified.”

The JCVI report further states:

(Annex A, Background)

“In June 2009 the Joint Committee on Vaccination and Immunisation concluded that there is no scientific reason to keep the combined Hib and Meningitis C vaccine (currently given at 12 months) and the MMR and pneumococcal vaccines (given at 13 months) separate.”

The “no scientific reason” is grossly misleading. Once again, it should be obvious that safety concerns cannot be identified if the study is not designed to detect them. Autistic regression is known to occur gradually over periods of weeks to many months. In spite of this, the vast majority of studies which are presumed to provide conclusive evidence on the safety of vaccines, have short follow ups and focus almost exclusively upon acute near-immediate events [23-29].

In addition, the fact that in 2008 The US federal Advisory Committee on Immunization Practices (ACIP) voted to withdraw their initial recommendation for the use of measles, mumps, rubella, and varicella vaccine (MMRV, marketed by Merck & Co., Inc. as ProQuad) as the vaccine of choice for vaccination of infants, because it was associated with double the risk of febrile seizures when compared to the MMR, shows that there is indeed solid reason for concern over simultaneous administration of multiple vaccines. Proquad contains only four vaccines in combination, not six. The research from The Vaccine Safety Datalink (VSD), considered by the ACIP, evaluated the incidence of febrile seizures in 43,000 children between the ages of 12 and 23 months who had been vaccinated with ProQuad and 315,000 who had received two separate MMR and varicella vaccines. Within 7 to 10 days after vaccination, those given ProQuad suffered twice as many seizures (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5710a3.htm):

“The preliminary results indicated a rate of febrile seizure of nine per 10,000 vaccinations among MMRV vaccine recipients compared with four per 10,000 vaccinations among MMR vaccine and varicella vaccine recipients.”

The multivalent vaccine Hexavac was also recently withdrawn following a recommendation from the EMEA (http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/12/ WC500017695.pdf) “as a precautionary measure“, due to its poor effectiveness. Safety concerns have also been raised over administration of hexavalent vaccines by Ottaviani et al. [20] and Zinka et al. [21] the latter, following five cases of infant deaths in Germany in 2005 (all occurring within 48 hrs of vaccination). The post-mortem analysis of six children aged 4-17 months (5 of whom were vaccinated with Hexavac and one with another hexavalent vaccine, Infanrix Hexa) reported by Zinka et al. [21], revealed abnormal pathologic findings particularly affecting the nervous system. Although there is no conclusive proof that these deaths were directly caused by vaccination, the authors felt it was:

“…important to inform vaccinating physicians and pediatricians as well as parents about such possibly fatal complications after application of hexavalent vaccines.”

In spite of these relevant findings, no mention of these two studies is found in the DH and the JCVI reports regarding the introduction of the new “simplified” and “improved” schedule.

Other than the paper by Miller et al. [23], the DH also provided me with the official report on their research on parents’ attitudes to the possibility of administering the Hib/MenC, PCV and MMR vaccines on a single occasion. Following their initial consideration of the draft paper by Miller et al., in 2009, the JCVI did recognize the need to seek parent’s opinion on the proposed “6 in 1” program before making any changes to the current schedule. In February 2010, the DH initiated this research and subsequently published it in a document Childhood immunisation programme: Attitudinal research into combining 12 and 13 month immunisations which is now available on the DH website at:

http://www.dh.gov.uk/en/Publichealth/Immunisation/Marketresearch/index.htm

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http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/ digitalasset/dh_122329.pdf

What the Attitudinal research found was that parent’s knowledge on childhood’s current immunisation timetable, particularly around 12 and 13 months, was generally low and apparently, the DH and the JCVI are content with keeping it that way, in order to preserve the national vaccination program. The DH and the JCVI concluded that informing parents of the changes would be “unwise” because it would create unnecessary panic. In order to prevent this, the health officials need to be instructed on how to “reassure” parents in the safety of vaccines, especially the MMR.

According to the Attitudinal research report, parents generally trusted the schedule and the NHS, however, some had reservations about the MMR, particularly if it was to be combined with other vaccines. Specifically, the Research Management Summary on Behalf of the DH from a Possible simplification of the childhood vaccination schedule report (http://www.dh.gov.uk/ prod_consum_dh/groups/dh_digitalassets/@dh/@ab/documents/digitalasset/dh_121799.pdf), issued by the JCVI Secretariat, states that:

“While the principle of combining vaccinations and/or giving more than one at the same time appeared largely to be accepted, if one of these is MMR, views can change.” (Conclusions and Recommendations: 2.)

In light of this explicit concern, the DH report noted:

“The combined schedule at 12 and 13 months was regarded with mixed feelings; if it is introduced, the way in which it is communicated will have a significant impact on how it is received. Given low awareness of the immunisation schedule, parents are unlikely to notice the change until informed about it.” [their emphasis added-italicised] (Conclusions and Recommendations: 3.)

They further elaborated on this particular finding:

“When the combined schedule was presented to parents first (before seeing the current schedule), very few identified the appointment at a year of age as different or worthy of comment. Parents’ problems and worries only came to the surface when the combined option was explicitly presented as a change to the schedule. Those in areas where the combined schedule is apparently already being given accepted it without question. When parents were told that the new schedule involves giving MMR and PCV at the same time as another vaccine, some changed their views, including some of those who were otherwise accepting of MMR.” (Conclusions and Recommendations: 4.)

On the basis of the above observations the DH concluded that it is best to keep parents ignorant of the proposed changes, in order to avoid what they deemed as “unwarranted anxiety”, as this would most likely lead to reduced immunisation rates:

“Offering parents a choice between the two schedules could generate more questions than answers, and seems unwise. It might also risk compromising current understanding of the vaccination schedule as ‘just what happens’, and reframing it as optional, which could reduce vaccine uptake.” (Conclusions and Recommendations: 5.)

Consistent with their past legacy that apparently puts priority on the preservation of the vaccination program rather than the safety of an individual, the British Health Authorities consider it “unwise” that parents should have a choice as to how immunisations are to be carried out. So much so that special action is needed to assure that their efforts in promoting vaccination are not hampered. In particular, to the DH it “seems sensible” to, somehow, camouflage the change in the vaccination schedule in order to prevent what they deem as “unwarranted anxiety”.

“It is also clear that offering parents detailed information, and flagging up changes, can generate anxiety where it is not warranted. In light of this, it seems sensible to introduce the combined schedule as far as possible without announcing it explicitly as a change.” (Conclusions and Recommendations: 6.)

BSEM March 2011 The Health Hazards of Disease Prevention

Indeed, the DH offers an elaborate strategy for addressing parental concerns about the “improved” and “simplified” vaccination program:

“If the combined immunisation is introduced, some parents will have questions about it, and health professionals, especially health visitors and practice nurses, will be their first port of call for information. Health professionals will have an important part to play in informing and reassuring parents, and they will need to provide consistent answers; any variation between what they say is likely to create a sense of unease among parents.” (Conclusions and Recommendations: 7.)

In revealing further details on how the health staff should approach those parents who may have concerns over the safety of the MMR vaccine, the DH advises:

“Health professionals will need to be ready to reassure parents that…

• combining vaccinations into one appointment and giving three at a time is entirely safe • the fact that MMR is one of these makes no difference, because MMR is safe • there is a good reason for the change: though the current system is effective and safe, changing it will be an improvement • there are significant benefits to baby and parent in having one fewer appointment and reduced distress” It should be obvious that any a priori exclusion of possible adverse effects from vaccines which is not based on valid scientific evidence but rather, a belief system is not by definition scientific. Rather, it reflects a disturbing trend to view anything associated with vaccines and vaccine policy as sacred and beyond scientific scrutiny. The need to protect the UK government-mandated vaccination program against any reasonable doubt, in the absence of any truly independent scientific evidence and despite a) CSM/JCVI/ARVI’s own records discussed under Sections 1)-3) & 5) which show that vaccines, including measles and the MMR are not “entirely safe” and b) the government’s own concession that the MMR can in fact cause permanent brain damage (in the case of Robert Fletcher who in August 2010 received £90,000 payout for epilepsy and severe mental retardation that he suffered following the MMR jab; http://www.bbc.co.uk/news/uk-englandmerseyside– 11125343), is even more disturbing.

If vaccines are indeed entirely safe as the DH and the JCVI claim, why do they feel they need to hide information from parents and health professionals?

Perhaps “combining vaccinations into one appointment and giving three at a time is” not “entirely safe”

As a reminder (JCVI meeting, 11th December 1974; http://www.dh.gov.uk/ab/JCVI/DH_095052):

(11 Simultaneous administration of live vaccines (CHCS(VI)14))

“Professor Dick and Dr Warin pointed out that an interval in the administration of live vaccines had been advocated in view of the probability of adverse reactions and because of the recent publicity surrounding adverse reactions. The Committee agreed that it would be inopportune to change the guidance that an interval of at least 3 weeks should be allowed to elapse between the administration of any 2 live vaccines whichever came first.”

The above would explain the need to censor certain information as well as why the JCVI went to great lengths in devising a special strategy with which such a task would be achieved:

“Given continued sensitivity about MMR, any negative news coverage will have a significant impact. Health professionals will be the front line in combating this, and will need to be

kept fully informed on the latest information from JCVI and DH to prevent any contradictions or confusion, and to ensure that they are equipped to reassure parents.” (Conclusions and Recommendations: 9.)

BSEM March 2011 The Health Hazards of Disease Prevention

The choice of words is rather peculiar here, it appears as if the DH and the JCVI are preparing for war. Their choice of weapons includes “educating” health professionals with what appears to be highly censored information, since numerous truly independent studies which raised safety concerns in the scientific community (particularly about the MMR vaccine), were simply dismissed by the JCVI (see Section 4). Both the JCVI and the DH opted instead for the methodologically dubious study by Miller et al. [23] as their only evidence to promote the new “improved” and “simplified” immunisation program. This obvious information bias is to be promulgated by the JCVI/ DH to the health profession.

Furthermore, according to the DH, it is not only important to censor information given to both parents and health professionals, the way in which this information is to be communicated is also very important.

“It is important that the information given by health professionals is pitched at the right level. The JCVI information prompted questions among many respondents, but was useful for reassuring some, particularly those with a more pragmatic view of immunisation. Information at this level needs to be carefully tailored by health professionals according to the attitudes of individual parents.”

The corresponding section from the Attitudinal research report (http://www.dh.gov.uk/ prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_122329.pdf) adds:

“If in doubt, we would suggest keeping it simple, as outlined above.” (D Conclusions; 3. Dealing with questions about the change to a combined schedule)

Since some disclosure to the parents on adverse events associated with the combined schedule is necessary, it is further regarded that in spite of some:

“…diverging views on when the sheet should be given to parents; on balance it seems wise to hand it out immediately before vaccination, so that parents feel they have been given advance warning, but do not dwell on the content to the extent that they begin to worry.” (D Conclusions; 4. The tear-off sheet on side effects)

The idea of “keeping it simple” was also welcomed by the health professionals. Indeed, as already discussed in Section 5), the public may not understand correctly the significance of febrile convulsions. Nor would anyone want the public to dwell extensively on associations between the words “vaccine” and “death” or “permanent brain damage”.

One has to wonder whether parents who to this day continue to trust the British Health Authorities on matters of immunisation, would still have the same opinion if crucial facts on vaccine-associated adverse events discussed in “commercial” and “in confidence” CSM/JCVI/Joint Sub-Committee ARVI meetings were fully disclosed to them:

From the Attitudinal research report (pg 22):

“To my eyes these things have all been tried and tested, the medical people studied for years, they tried all of this stuff. They obviously know getting these things correctly so my trust is in their hands really at the end of the day.”

From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( http://www.dh.go v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.5.1) “It was considered unreasonable to ask paediatricians to report for a period of six years.”

“No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

From Miller et al. [23]

BSEM March 2011 The Health Hazards of Disease Prevention

“For safety, proportions of children with erythema, swelling or tenderness at site of

injection, or fever or other systemic symptoms for 7 days after immunization were

compared between regimens.”

From the JCVI meeting held on 3rd November 1981 (http://www.dh.gov.uk/ab/DH_095169):

(5.d. Comments on Professor Stewart’s letter) “Professor Gilliatt observed that in the Meade Panel Study one-third of children with brain damage were not admitted to hospital. In both the Meade and Dudgeon studies there were examples of children who had a fit soon after vaccination which was followed by a fit at a later time and then followed by cessation of development. It was very difficult to assess this as a random event…The Chairman concluded that much was not known about the natural history of brain damage in the young.”

From the Attitudinal research report (pg 22):

“…the diseases must be serious and pose a risk – ‘the NHS wouldn’t put children through it [so young] if it wasn’t necessary.”

From the JCVI meeting on 11th December 1974 (http://www.dh.gov.uk/ab/JCVI/DH_095052):

(10.)

“…mumps vaccine was unnecessary because complications from the disease were rare.

The Committee agreed that there was no need to introduce routine vaccination against

mumps.”

From a discussion on a proposal for the surveillance of severe neurological disorders in infancy and their relationship to pertussis vaccine, 7th February 1986, CSM/JCVI/Joint Sub-Committee ARVI ( http://www.dh.go v.uk/en/F r eedo mO f Inf o r matio n/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.5.1) “No attempt would be made to study serious neurological disease arising from pertussis and other infectious diseases.”

From the Attitudinal research report (pg 23):

“They’re in the book and they say you should do them, I think if I don’t do them then that’s wrong. They know what they’re doing.”

From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held on 5th October 1984 (http://www.dh.gov.uk/ab/JCVI/DH_095294):

(9.)

“Fetal damage after accidental polio vaccination of an immune mother. Barton AE et al.

Journal of the RCGP 1984: 34: p. 390-394 Dr Smith observed that the termination of the pregnancy at 20 weeks in this case report was not related to the administration of oral poliovaccine (OPV).”

Note: how such conclusion could be reached remains unclear since:

“However, the foetus was reported to have signs of infection with poliovirus in the nervous system although no similar event had been previously seen after vaccination.” From the Attitudinal research report (pg 23):

“I don’t think they would put something into a child that is not good for them.”

BSEM March 2011 The Health Hazards of Disease Prevention

“I put my hands in the medical profession and they do a good enough job for me and I trust them.”

“Surely they wouldn’t give these injections if they felt they would harm?”

“I do think it’s a good thing. You want to try and protect your children so if that’s what they’re suggesting they have to have done you should trust your health professionals.”

“Because they’re recommended you kind of trust the doctors to guide you.”

From the “commercial in confidence” CSM/JCVI/Joint Sub-Committee ARVI meeting, held 6th

on July 1987 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(6.1 Whooping cough) “He explained that in February the CSM had called for ARVI’s advice about updating the statement made in the 1981 report on Whooping Cough (HMSO) about a possible link between DTP immunisation and serious neurological illness. It had been hoped that by this means ‘discovery’ of all the relevant JCVI, CSM and ARVI documentation on whooping cough vaccine could be avoided.”

6th

From the JCVI/Joint Sub-Committee ARVI “commercial in confidence” meeting on February 1987,

section “7.1 Whooping cough vaccine –CSM advice” (contents of the statement that CSM

wished to modify; http://www.dh.gov.uk/en/FreedomOfInformation/

Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

“No scientifically unassailable link has been established between DTP immunisation and serious neurological illness but we have come to conclusion, on the basis of all present evidence, that there is a prima facie case that such a link may exist. We would also agree that the evidence suggests that the vaccine causes convulsions in some children.”

From the CSM/JCVI/Joint Sub-Committee ARVI “commercial in confidence meeting on 3rd October 1986 (http://www.dh.gov.uk/en/FreedomOfInformation/ Freedomofinformationpublicationschemefeedback/FOIreleases/DH_4135306):

(5.1.3.c.)

“From the above there is reason to believe that the increased relative risk of prolonged convulsions after DTP was a real one.”

From the JCVI meeting on 3rd November 1989 (http://www.dh.gov.uk/ab/DH_095169):

(9. ARVI Committee – Minutes of meeting 6 October 1989 (JCVI (89)25) “Dr Schild reported that NIBSC was now able to distinguish clearly the wild strains from each of the two vaccines, and isolates from CSF clearly showed Urabe in all three cases believed to be associated with vaccine-although it should not be assumed that Jeryl-Lynn is not capable of the same result.”

From the JCVI meeting on 7th May 1999 (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(8. Meningococcal meningitis, i.) “Committee members were reminded that this issue, and the papers presented, was extremely sensitive, commercially and politically. It was requested that confidentiality be maintained. The Chairman asked for any declarations of interest. Professor Cartwright was involved in manufacturers’ studies on the vaccines, including health trials. Dr Goldblatt was

BSEM March 2011 The Health Hazards of Disease Prevention

involved in one company-sponsored study and had provided a clinical expert report to the MCA for one manufacturer. Dr Jones was involved in trials for two of the companies involved. Dr Schild said that NIBSC was evaluating the vaccines.

“There were no objections to these members continuing to take part in the meeting and it was agreed that they would be able to provide a valuable input to the discussion in common interest.”

From a discussion of the 8.4.1 Meningococcal C Conjugate (MCC) Vaccine Evaluation Programme, at the 7th May1999 JCVI meeting (http://www.dh.gov.uk/ab/JCVI/DH_095050):

(ii.)

“There was no good evidence for the efficacy of the meningococcal Group C conjugate vaccine, only the surrogate of antibodies compared with those known to be protective against invasive disease. To actually test the efficacy on the conjugate vaccine it would be necessary to introduce the vaccine and then conduct a Phase III or Phase IV study to test efficacy; this would be very difficult to do and would delay introduction by 3-5 years.”

(iii.)

“It was felt that it was important to plan the programme now and confirmation that the vaccines were equally effective could follow.”

Standards of Conduct

Finally, a reader may wish to assess the presented data on JCVI vaccination policies against the JCVI’s own Code of Practice (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/ @dh/@ab/documents/digitalasset/dh_115363.pdf) which states:

(Responsibilities of Committee and Sub-committee members):

(30)“All members of the Committee and its Sub-committees (‘members’) must demonstrate high standards of conduct.”

(31)“In exercising their duties, members must observe the ‘Seven Principles of Public Life’ set out by the Committee on Standards in Public Life (the Nolan Committee):

Selflessness: Holders of public office should take decisions solely in terms of the public interest. They should not do so in order to gain financial or other material benefits for themselves, their family, or their friends

Integrity: Holders of public office should not place themselves under any financial or other

obligation to outside individuals or organisations that might influence them in the performance of their official duties. Objectivity: In carrying out public business, including making public appointments,

awarding contracts, or recommending individuals for rewards and benefits, holders of public office should make choices on merit.

Accountability: Holders of public office are accountable for their decisions and actions to the public and must submit themselves to whatever scrutiny is appropriate to their office.

Openness: Holders of public office should be as open as possible about all the decisions and actions that they take. They should give reasons for their decisions and restrict information only when the wider public interest clearly demands.

BSEM March 2011 The Health Hazards of Disease Prevention

Honesty: Holders of public office have a duty to declare any private interests relating to their public duties and to take steps to resolve any conflicts arising in a way that protects the public interest.

Leadership: Holders of public office should promote and support these principles by leadership and example.”

(Conflicts of Interests)

(39) Personal pecuniary8 interest “If a member has in the last 12 months received, or plans to receive a financial payment or other benefit from a business or representative body relating to vaccines or any other product or service that could be under consideration by JCVI or a Sub-committee including:

• holding a directorship, or other paid position • carrying out consultancy or fee paid work • having shareholdings or other beneficial interests • receiving expenses (e.g. travel to, or registration for, conferences) and hospitality the member must declare this interest.

If this interest is specific to an agenda item and the payment or other benefit is connected specifically with the product under consideration, the member will be required to absent him/herself from the discussion and any subsequent vote.”

Summary

In conclusion, by apparently prioritizing vaccination policy over vaccine safety, the JCVI, the DH and the Committee on Safety of Medicines (CSM) may have shown a disregard for the safety of children. Through selective data reporting, the JCVI in conjunction with the DH, has promulgated information relating to vaccine safety that may be inaccurate and potentially misleading, thereby making it impossible for the parents to make a fully informed consent regarding vaccination. Furthermore, by 1) apparently misleading patients about the true risks of adverse reactions as to gain their consent for the administration of the treatment and 2) seemingly siding with vaccine manufacturers rather than public health interests, the JCVI and the CSM appear to have signally failed their fiduciary duty to protect individuals from vaccines of questionable safety. If these provisional conclusions are indeed correct, then the information presented here may help us in understanding the UK government’s and the JCVI’s official position on vaccine damage, that is, one of persistent denial.

BSEM March 2011 The Health Hazards of Disease Prevention

References

[1] Food and Drug Administration (FDA). Workshop on Non-clinical Safety Evaluation of Preventative Vaccines: Recent Advances and Regulatory Considerations. 2002. http://www.fda.gov/downloads/ biologicsbloodvaccines/newsevents/workshopsmeetingsconferences/transcriptsminutes/ ucm054459.pdf, last accessed May 30 2011. [2] World Medical Association (WMA). WMA Declaration of Helsinki -Ethical Principles for Medical Research Involving Human Subjects. 2011. http://www.wma.net/en/30publications/10policies/b3/, last accessed June 4 2011. [3] Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351 (9103): 637-41. [4] Sugiura A, Yamada A. Aseptic meningitis as a complication of mumps vaccination. Pediatr Infect Dis J 1991; 10(3): 209-13. [5] Fombonne E, Chakrabarti S. No evidence for a new variant of measles-mumps-rubella-induced autism. Pediatrics 2001; 108(4): E58. [6] Singh VK, Jensen RL. Elevated levels of measles antibodies in children with autism. Pediatr Neurol 2003; 28(4): 292-4. [7] Godlee F, Smith J, Marcovitch H. Wakefield’s article linking MMR vaccine and autism was fraudulent. BMJ 2011; 342: c7452. [8] Balzola F, Barbon V, Repici A, Rizzetto M, Clauser D, Gandione M, et al. Panenteric IBD-like disease in a patient with regressive autism shown for the first time by the wireless capsule enteroscopy: another piece in the jigsaw of this gut-brain syndrome? Am J Gastroenterol 2005; 100(4): 979-81. [9] Balzola F., et al. Beneficial behavioural effects of IBD therapy and gluten/casein-free diet in an Italian cohort of patients with autistic enterocolitis followed over one year. Gastroenterology 2006; 130 (Suppl. 2): S1364 A-21. [10] Balzola F., et al. Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients. Gastroenterology 2005; 128 (suppl.2): A-303. [11] Chen B, Girgis S, El-Matary W. Childhood autism and eosinophilic colitis. Digestion 2010; 81(2): 127-9. [12] Krigsman A, Boris M, Goldblatt A, Stott C. Clinical Presentation and Histologic Findings at Ileocolonoscopy in Children with Autistic Spectrum Disorder and Chronic Gastrointestinal Symptoms. Autism Insights 2010; 2: 1-11. [13] Quigley EM, Hurley D. Autism and the gastrointestinal tract. Am J Gastroenterol 2000; 95(9): 2154-6. [14] Shoenfeld Y, Agmon-Levin N. ‘ASIA’ -Autoimmune/inflammatory syndrome induced by adjuvants. J Autoimmun. 2011; 36(1): 4-8. [15] Ternavasio-de la Vega HG, Boronat M, Ojeda A, Garcia-Delgado Y, Angel-Moreno A, Carranza-Rodriguez C, et al. Mumps orchitis in the post-vaccine era (1967-2009): a single-center series of 67 patients and review of clinical outcome and trends. Medicine (Baltimore) 2010; 89(2): 96-116. [16] Castilla J, Garcia Cenoz M, Arriazu M, Fernandez-Alonso M, Martinez-Artola V, Etxeberria J, et al. Effectiveness of Jeryl Lynn-containing vaccine in Spanish children. Vaccine 2009; 27(15): 2089-93. [17] Gustafson TL, Lievens AW, Brunell PA, Moellenberg RG, Buttery CM, Sehulster LM. Measles outbreak in a fully immunized secondary-school population. N Engl J Med 1987; 316(13): 771-4. [18] Hersh BS, Markowitz LE, Hoffman RE, Hoff DR, Doran MJ, Fleishman JC, et al. A Measles Outbreak at a College with a Prematriculation Immunization Requirement. American Joumal of Public Health 1991; 81 (3): 360-4. [19] Tugwell BD, Lee LE, Gillette H, Lorber EM, Hedberg K, Cieslak PR. Chickenpox outbreak in a highly vaccinated school population. Pediatrics 2004; 113(3 Pt 1): 455-9. [20] Ottaviani G, Lavezzi AM, Matturri L. Sudden infant death syndrome (SIDS) shortly after hexavalent vaccination: another pathology in suspected SIDS? Virchows Arch 2006; 448(1): 100-4. [21] Zinka B, Rauch E, Buettner A, Rueff F, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Vaccine 2006; 24(31-32): 5779-80. BSEM March 2011 The Health Hazards of Disease Prevention

[22] Zinka B, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Letter to Editor. Response to the comment by H.J. Schmitt et al. Vaccine 2006; 24: 5785–6. [23] Miller E, Andrews N, Waight P, Findlow H, Ashton L, England A, et al. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps and rubella vaccine at 12 months of age. Clin Vaccine Immunol 2011; 18(3): 367–72. [24] Kaplan SL, Lauer BA, Ward MA, Wiedermann BL, Boyer KM, Dukes CM, et al. Immunogenicity and safety of Haemophilus influenzae type b-tetanus protein conjugate vaccine alone or mixed with diphtheriatetanus- pertussis vaccine in infants. J Pediatr 1994; 124(2): 323-7. [25] Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, et al. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine 2011; 29(8): 1569-75. [26] Li G, Zhang H, Zhou W, Ye Q, Li F, Wang H, et al. Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization. Vaccine 2010; 28(25): 4215-23. [27] Marchant CD, Miller JM, Marshall GS, Blatter M, Aris E, Friedland LR, et al. Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants. Pediatr Infect Dis J 2009; 29(1): 48-52. [28] Kanra G, Viviani S, Yurdakok K, Ozmert E, Yalcin S, Baldini A, et al. Safety, tolerability and immunogenicity of a Haemophilus influenzae type b vaccine containing aluminum phosphate adjuvant administered at 2, 3 and 4 months of age. Turk J Pediatr 1999; 41(4): 421-7. [29] Kim KH, Lee H, Chung EH, Kang JH, Kim JH, Kim JS, et al. Immunogenicity and safety of two different Haemophilus influenzae type b conjugate vaccines in Korean infants. J Korean Med Sci 2008; 23(6): 929-36.

China police arrest 37 over vaccine scandal

 

Source: Xinhua   2016-03-23 02:12:33

JINAN, March 23 (Xinhua) — Police in east China’s Shandong Province have detained 37 suspects implicated in a vaccine scandal that has shocked the nation and raised questions over vaccine safety.

Shandong police announced last month that they had arrested a mother and daughter alleged to have illegally sold improperly stored or expired vaccines worth more than 570 million yuan (88 million U.S. dollars) across 20 provincial-level regions since 2011.

Three pharmaceutical companies are being investigated by police, according to the work group handling the case.

Of the three, Shandong Zhaoxin Bio-tech Co. has had its good supply practice (GSP) certificate for pharmaceutical products revoked and ordered to halt operations.

The investigation involves 12 vaccines, 2 immune globulin and one therapeutic product.

Meanwhile, the group has ordered a sweeping check-up of local vaccine makers, wholesalers and buyers.

China’s drug regulator has identified nine vaccine wholesalers from six provinces suspected of filing fraudulent reports of buyers’ identities.

The China Food and Drug Administration said Tuesday that it had given local authorities until Friday to find out who bought the vaccines.

China’s top drug regulator, health authorities and police on Monday issued a circular ordering drug and health departments to trace the manufacturing source and to remove any of the substandard vaccines off the market as soon as possible.

It also called for efforts to identify and apprehend the suspects still at large, and a thorough investigation into the supply and sales chain of these inferior products.

Although produced by licensed manufacturers, the quality of the vaccines are questionable as they were not transported or stored properly.

http://news.xinhuanet.com/english/2016-03/23/c_135213644.htm

Doctor raises serious questions about medical awards system

Public Release: 2-Feb-2016

 

‘Club culture’ in British medicine must be replaced, argues senior heart doctor

BMJ

The system that awards national and academic honors to doctors is called into question by a senior doctor writing in The BMJ this week.

Consultant cardiologist, Peter Wilmshurst, tells the story of Anjan Kumar Banerjee, a surgeon who spent the years 2002 to 2008 erased from the medical register for serious professional misconduct related to research fraud, financial misconduct, and substandard care.

Yet in 2014 he was awarded an MBE “for services to patient safety.”

The MBE was forfeited two months later, but he remains a fellow of three medical colleges, explains Wilmshurst. The University of London has also ignored repeated requests to withdraw his Master of Surgery (MS) degree during the 15 years since it was confirmed to be based on fraudulent data.

“We need to get rid of the existing ‘club culture’ in British medicine and replace it with a culture that values integrity and transparency,” he argues. And he warns that the inappropriate award of honours and medical qualifications to Banerjee “is not an isolated case.”

British medicine has opaque procedures that can be manipulated to gain honours, advancement, and money (for example, clinical excellence awards), he writes. When errors occur, “the establishment would usually rather close ranks and silence whistleblowers than correct the error.”

He says he is aware of other cases in which serious misconduct has been concealed and the culprits have received honours and awards, and calls for action to tackle a “systemic problem” in British medicine.

Peter Wilmshurst’s story raises serious questions about the integrity of medical and scientific institutions, writes Richard Smith, in an accompanying editorial. Smith is former editor of The BMJ and now London-based Chair of the Board of Trustees for the international research institution icddr,b.

He argues that Britain has never taken the problem of scientific fraud seriously, and that “we have no way of knowing how many cases are successfully covered up.”

“We need to move to a world where universities recognise the rightness of investigating allegations of misconduct and commit to punishing those found guilty and to publishing the results of their investigations, correcting the research record, and retracting fraudulent research,” he writes.

And he says it’s “shameful that the colleges do not retract Banerjee’s fellowships, and their failure to do so raises questions about their competence and integrity.”

“Something is rotten in the state of British medicine and has been for a long time. Statutory regulation is needed,” he concludes.

Experts: High drug price trend has ‘infected’ generics

“as companies value profit at the expense of long-term utility to society”

Public Release: 27-Jan-2016

 

Authors highlight concern that pharmaceutical companies use strategies to delay patient access to affordable generic drugs

American Society of Hematology

(WASHINGTON, January 27, 2016) – An article published online today in Blood, the Journal of the American Society of Hematology (ASH), suggests that pharmaceutical companies use several strategies to keep affordable generic drugs from the market, illustrating an emerging trend that authors say is becoming as harmful to consumers as high-cost brand-name drugs.

The market price of pharmaceuticals, some costing patients more than $100,000 per year, increases public health spending and sometimes forces patients to make life-or-death decisions when they cannot afford their medications. The authors write that approximately one in five Americans admit they do not fill their prescriptions because of cost. From an economic standpoint, in 2013 the United States spent nearly 40 percent more per capita on pharmaceuticals than the second highest spender, Canada.

Generic drugs, which by law may enter the market once the patent on a brand-name drug expires, are intended to offer an affordable option for patients without sacrificing the efficacy and safety of the original formula. From 2004-2013, generic drugs saved the U.S. health system nearly $1.5 trillion, according to the authors. However, for many patients generic drugs are inaccessible.

“The timely availability of affordable generic drugs is the difference between life or death for patients with cancer and other diseases who cannot afford brand-name pharmaceuticals, the majority of which are priced at monopoly levels and protected by 20-year patents,” said lead author Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center. “Unfortunately, these sorely needed generics are increasingly out of reach. As we sought to understand what keeps these affordable drugs from the market, we identified several specific strategies that pharmaceutical companies use to extend their patents and eliminate competition.”

In this Blood Forum article, a feature of the journal designed to present well-documented opinions on issues important to the science and practice of hematology, Dr. Kantarjian and colleagues assert that pharmaceutical companies use a variety of strategies to delay, prevent, and suppress the timely availability of affordable generic drugs. Among them, the authors detail “pay-for-delay,” in which the company that owns the patent pays a generic company to delay entry into the market. The Federal Trade Commission estimates that the pay-for-delay settlements cost taxpayers, insurance companies, and consumers approximately $3.5 billion per year. In other cases detailed in the article, the patent-holder deters competition by creating its own version of drugs at generic prices. While this practice may reduce costs for consumers by 4-8 percent in the short-term, the authors suggest that companies often use the authorized generics as a bargaining chip in “pay-for-delay” deals, pledging not to release their own drugs in return for the true generic company promising to delay market entry.

Other strategies the authors discuss include investing heavily in advertising the brand-name drug (often spending more on marketing than on research and development) and lobbying for laws that prevent patients from importing cheaper generics from other countries, which the authors write can cost as little as 20-50 percent of U.S. prices. The authors also highlight some drug companies that they allege buy out competitors and then increase the price of a newly acquired generic drug by several fold overnight.

In addition, the authors also describe a strategy they call “product hopping,” which involves switching the market for a drug to a reformulated “new and improved” version with a slightly different tablet or capsule dose that offers no therapeutic advantage over the original but has a later-expiring patent. The company then heavily advertises the new brand-name drug in an effort to convince patients and physicians to switch. As a result, when the generic version of the original becomes available, pharmacists cannot substitute it for the new branded version because state laws allow substitution only if certain characteristics, such as dosing, remain the same.

In recognition of the harm and expense that the authors suggest these strategies impart on both patients and the economy, they propose several solutions that would support timely access to affordable generic drugs, including allowing Medicare to negotiate drug prices, monitoring and penalizing pay-for-delay deals, allowing transportation of pharmaceuticals across borders for individual use, and challenging weak patents.

“Each day in my clinic I see leukemia patients who are harmed because they cannot afford their treatment, some risking death because they cannot pay for the medicine keeping them alive,” said Dr. Kantarjian. “Overall, these strategies demonstrate that the trend of high brand-name drug prices has recently infected generic drugs, as companies value profit at the expense of long-term utility to society. We must be vigilant in recognizing these strategies and advocating for solutions that will allow companies to accomplish their dual mission: make reasonable profits and help save and/or improve patients’ lives.”

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Blood, the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online and has been serving the hematology community for 70 years. Blood is the official journal of the American Society of Hematology (ASH) (http://www.hematology.org), the world’s largest professional society concerned with the causes and treatment of blood disorders.

ASH’s mission is to further the understanding, diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems by promoting research, clinical care, education, training, and advocacy in hematology.

blood® is a registered trademark of the American Society of Hematology. Follow @BloodJournal on Twitter.

Allegations of Scientific Misconduct by GACVS/WHO/CDC Representatives et al

An open-letter of complaint to the Director-General of the World Health Organization, Dr. Margaret Chan chanm@who.int

Cc:        The Ministry of Health, Labour and Welfare, Japan, www-admin@nhlw.go.jp

             Minister of Health, Labour and Welfare, Japan, shiozaki@y-shiozaki.or.jp 

            Thomas Frieden, Director CDC, tomfrieden@cdc.gov 

Vice-Chancellor, Professor Stuart McCutcheon, The University of Auckland, s.mccutcheon@auckland,ac.nz

 

From: Sin Hang Lee, MD shlee01@snet.net

 

Date: January 14, 2016

 

Dear Dr. Chan:

 

As a medical doctor and scientist, I write to present grave concerns regarding the conduct of certain members of the Global Advisory Committee on Vaccine Safety (GACVS), the World Health Organization, the CDC and other scientific/health professionals during the time shortly before the public hearing on HPV Vaccine Safety which was held in Tokyo, Japan on February 26, 2014.  I have come into possession of documentation which leads me to believe multiple individuals and organizations deliberately set out to mislead Japanese authorities regarding the safety of the human papillomavirus (HPV) vaccines, Gardasil® and Cervarix®, which were being promoted at that time. 

 

I am sure you are well aware of the controversy currently surrounding these vaccines on a global level.  I am also sure you are aware of the fact that public confidence in national and international health authorities is at an all time low throughout the world.

 

Should the information in this letter prove to be accurate, nothing short of an immediate independent investigation resulting in appropriate disciplinary actions for those involved will be able to restore the public trust. Therefore, I implore you to act quickly and decisively regarding this critical public health issue.

FOI Request and Significant Related Communications

A series of emails recently uncovered via a Freedom of Information request submitted in New Zealand revealed evidence that Dr. Robert Pless, the chairperson of the Global Advisory Committee on Vaccine Safety (GACVS), Dr. Nabae Koji of the Ministry of Health of Japan, Dr. Melinda Wharton of the CDC, Dr. Helen Petousis-Harris of Auckland University, New Zealand, and others (including WHO officials) may have been actively involved in a scheme to deliberately mislead the Japanese Expert Inquiry on human papillomavirus (HPV) vaccine safety before, during and after the February 26, 2014 public hearing in Tokyo. I believe the information supplied by this group led directly to the issuance of the GAVCS statement on the continued safety of HPV vaccination on March 12, 2014 which contains the following paragraph:

 

“Several papers have also been published pertaining to the finding of HPV L1 gene DNA fragments in clinical specimens following HPV vaccination [13, 14]. These papers claimed an association with clinical events of an inflammatory nature, including cerebral vasculitis. While the GACVS has not formally reviewed this work, both the finding of DNA fragments in the HPV vaccine and their postulated relationship to clinical symptoms, have been reviewed by panels of experts. First, the presence of HPV DNA fragments has been addressed by vaccine regulatory authorities who have clearly outlined it as an expected finding given the manufacturing process, and not a safety concern [15]. Second, the case reports [13] of adverse events hypothesized to represent a causal association between the HPV L1 gene DNA fragments and death were flawed in both clinical and laboratory methodology [16]. The paper described 2 fatal cases of sudden death in young women following HPV vaccine, one after 10 days and one after 6 months, with no autopsy findings to support death as result of cerebral vasculitis or an inflammatory syndrome. Thus the hypotheses raised in these papers are not supported by what is understood about the residual DNA fragments left over following vaccine production [17]: given the extremely small quantities of residual HPV DNA in the vaccine, and no evidence of inflammation on autopsy, ascribing a diagnosis of cerebral vasculitis and suggesting it may have caused death is unfounded.” (the references 13-17 quoted were those listed in the GACVS Statement)

 

I believe this paragraph to be deceitful based on the following analysis:

The first sentence, “Several papers have also been published pertaining to the finding of HPV L1 gene DNA fragments in clinical specimens following HPV vaccination [13, 14]” was apparently constructed for dissembling and designed to mislead. The study in reference 13 [Tomljenovic L, Shaw CA. Death after Quadrivalent Human Papillomavirus (HPV) Vaccination: Causal or Coincidental? Pharmaceut Reg Affairs 2012, S12:001] was about HPV L1 VLPs. The authors of reference 13 never mentioned HPV L1 gene DNA fragments at all. Dr. Pless knew the difference between HPV L1 VLPs and HPV L1 gene DNA fragments because in his February 18, 2014 email addressed to Dr. Helen Petousis-Harris and the others involved in this scheme, Dr. Pless specifically asked Dr. Petousis-Harris to address her

statement regarding the alleged role of aluminum binding to DNA fragments and subsequent effects.” (see copy of February 18, 2014 email attached- It was not about HPV L1 VLPs). One cannot help but conclude that Dr. Pless intentionally put these two unrelated articles together and claimed that both articles studied HPV L1 gene DNA fragments in order to mislead the non-scientific readers and vaccination policy makers.

The second sentence, “These papers claimed an association with clinical events of an inflammatory nature, including cerebral vasculitis” is not true because the author in reference 14 (Lee, SH. Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination—A case report. Advances in Bioscience and Biotechnology, 2012, 3, 1214-1224) never claimed clinical events of an inflammatory nature, including cerebral vasculitis. Dr. Pless in fact misstates the author’s words in this document apparently to create a target to attack. 

When the facts don’t fit – simply change them?

The purpose of Dr. Pless intentionally combining two unrelated studies and two unrelated chemicals shows up in the following sentence: “the finding of DNA fragments in the HPV vaccine and their postulated relationship to clinical symptoms, have been reviewed by panels of experts”.  Who were these panels of experts? Dr. Pless presented none of their names. 

The sentence “Second, the case reports [13] of adverse events hypothesized to represent a causal association between the HPV L1 gene DNA fragments and death were flawed in both clinical and laboratory methodology [16],” is a blatant misrepresentation of the facts. The authors quoted in  Reference #13 never presented any data on HPV L1 gene DNA fragments. Reference #16 never reviewed the potential harm of HPV L1 gene DNA fragments in the HPV vaccines when injected into humans. 

A plea for help – and anyone will do?

The fact that Dr. Pless could not find any scientific reviews on the HPV L1 gene DNA fragments in HPV vaccines was illustrated in the email he sent to Dr. Helen Petousis-Harris on February 18, 2014 with the following plea for help: 

“We are seeking your advice on someone who may be able to address the more detailed questions around HPV DNA – specifically the hypotheses you have address in your statement regarding the alleged role of aluminum binding to DNA fragments and subsequent effects.  While the issue of whether the fragments constitute “contamination” has been dealt with, your statement was the only one to address the more obscure alleged consequences of the presence of those fragments.  The GACVS has not yet had a chance to delve into the DNA question.”

The FDA declaration confirming HPV DNA fragments in Gardasil® as an expected finding (Ref. 15), but providing no safety data on these HPV DNA fragments after being injected into animals or humans, obviously does not represent a review by panels of experts because it does not refer to any animal or human experimental data on “aluminum binding to DNA fragments and subsequent effects,” which was supposed to be Dr. Pless’ major concern.  

It is worth noting Dr. Helen Petousis-Harris demonstrated to Dr. Pless that she had experience using similar tactics in her February 18, 2014 email which stated: 

“To the best of my knowledge the rebuttal on our website is the only attempt to address this particular issue which Shaw and Lee presented at a coronal enquiry here. Placing the rebuttal in the public domain was the only means of providing the information to the crown representatives involved in that process at the 11th hour.”

Apparently under pressure to issue a statement within a week or two after the public hearing, Dr. Pless needed to find a panel of experts to declare the safety of aluminum bound to DNA fragments after injection into humans. The only publication remotely related to the subject he could use was Reference #16, a Clinical Immunization Safety Assessment (CISA) Network Technical Report titled “Review of a published report of cerebral vasculitis after vaccination with the Human Papillomavirus (HPV) Vaccine” dated November 9, 2012. 

However, in this CDC technical report, the unnamed author(s) of the document only questioned the data on HPV-16 L1 particles, never HPV L1 gene DNA fragments because the Lee paper reporting the finding of HPV L1 gene DNA fragments (Lee, SH. Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination—A case report. Advances in Bioscience and Biotechnology, 2012, 3, 1214-1224) was not published until December 27, 2012, one and a half months after the CISA Network Technical Report was issued. 

For the record, the quoted CISA report (Reference #16) began with the following paragraph:

“Recently there was discussion on a federally-sponsored vaccine safety listserv of a report in the literature of cerebral vasculitis after vaccination with the Human Papillomavirus Vaccine (HPV) (Tomljenovic L, Shaw CA. Death after Quadrivalent

Human Papillomavirus (HPV) Vaccination: Causal or Coincidental?  Pharmaceutical Regulatory Affairs: Open Access 2012,S12:001).  To address questions about the findings and conclusions reported in this manuscript, CDC convened a CDC-Clinical Immunization Safety Assessment (CISA) working group. Researchers from Vanderbilt

Medical Center, Johns Hopkins University, Columbia University, Duke Clinical Research Institute (Duke University), CDC and FDA participated in the call.”  

Lack of Peer-Review Credibility

According to: http://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/publications.html, this is the ONLY Technical Report issued in the last 12 years of records that has never been published in peer- reviewed journals. The Disclaimer at the end of this report states: 

“The information and conclusions in this report are those of the work group participants addressing this issue and do not necessarily represent the official position of CDC.” 

In other words, the CDC’s “Technical Report” (Ref #16 of the GACVS Statement) was written by  unnamed ghost writer(s) based on phone conversations.

Apparently Dr. Pless had no choice but to misbrand two unrelated articles and two unrelated chemicals in the vaccine Gardasil® so that he could use the CISA Network Technical Report on HPV-16 L1 particles to support his declaration on safety of HPV L1 gene DNA fragments after injection into humans. But first, he had to make policy makers believe “HPV-16 L1 particles” were synonymous to “HPV L1 gene DNA fragments” in chemistry. Once that was done, he apparently thought he could use the opinion on HPV-16 L1 particles to uphold the safety of HPV L1 gene DNA fragments bound to aluminum adjuvant. 

Unable to find a scientific report published in a peer reviewed journal on this issue of concern, Dr. Pless had to knowingly misquote the CISA report on HPV-16 L1 particles as evidence to support Dr. Helen Petousis-Harris’ blog published in the social media as he wrote in the GACVS statement: 

“Thus the hypotheses raised in these papers are not supported by what is understood about the residual DNA fragments left over following vaccine production [17]”. 

Acknowledgement of Residual HPV DNA in Gardasil®

Dr. Helen Petousis-Harris, the author of Ref. 17, was the only writer brave enough to publicly claim “extremely small quantities of residual HPV DNA in the vaccine” to be harmless without any supportive data. 

Who is Dr. Helen Petousis-Harris? Her qualification was disclosed in Dr. Pless’ email dated February 18, 2014 as he wrote:

“A meeting has recently been organized in Tokyo for February 26th, where Dr. Lee will present his findings…

…We are seeking your advice on someone who may be able to address the more detailed questions around HPV DNA – specifically the hypotheses you have address in your statement regarding the alleged role of aluminum binding to DNA fragments and subsequent effects.  While the issue of whether the fragments constitute

“contamination” has been dealt with,

 

your statement was the only one to address the

 

 

more obscure alleged consequences of the presence of those fragments.

  The GACVS

has not yet had a chance to delve into the DNA question.”  

Accepting the assignment, Dr. Helen Petousis-Harris wrote back immediately on February 18, 2014 as follows:

From: Helen Petousis-Harris [mailto:h.petousis-harris@auckland.ac.nz]  Sent:

Tuesday, February 18, 2014 5:19 AM To: ‘Robert Pless’ Cc: Robert Pless

(Robert.Pless@phac-aspc.gc.ca); 難波江 功二(nabae-koji); ZUBER, Patrick Louis F.;

Wharton, Melinda (CDC/OID/NCIRD) Subject: RE: URGENT: Regarding the posted commentary on the coronial inquiry expert witness testimony  

Dear Rob    Oh dear! I am so saddened to hear how extensive the impact of Lee, Shaw and Tomljenovic’s activities has become. I will certainly do anything I can to assist.  To the best of my knowledge the rebuttal on our website is the only attempt to address this particular issue which Shaw and Lee presented at a coronal enquiry here. Placing the rebuttal in the public domain was the only means of providing the information to the crown representatives involved in that process at the 11th hour. Prof David Gorsky has written prolifically on some of the experiments in his science blog over the past few years so I assume he has also given the material some thought. 

I do not know if I am expert on this but certainly have some experience in considering aluminium in vaccines and its role in inflammatory responses and local AEFI  as part

of my PhD some years ago. I assume you are referring to the VLP tightly bound to the

 

adjuvant

 and the Shaw and Tomljenovic ‘hypothesis’ that it somehow finds its way to the brain carried by macrophage?” 

 

Lack of Qualification/Credibility of Expert Witness Dr. Helen Petousis-Harris

Based on the above correspondence, Dr. Helen Petousis-Harris had no clue what Dr. Pless wanted her to address at the February 26, 2014 public hearing. She mistakenly assumed she was being asked to comment on “the VLP tightly bound to the adjuvant.” She did not even know that VLP is a protein, and cannot be tightly bound to the aluminum adjuvant as the DNA molecules can.  

Evidently, her only qualification was she had written a social media blog much like Professor David Gorski, a well-known online character assassin masquerading as a science defender whom she also recommended to the group saying: 

“Prof David Gorsky has written prolifically on some of the experiments in his science blog over the past few years so I assume he has also given the material some thought.”

I find it incredible that the WHO GACVS had to depend on online science blog writings as evidence to dismiss the potential risk of HPV DNA fragments in Gardasil®. As evidenced in the email above, on February 18, 2014, Dr. Pless knew very well that the CISA Network Technical Report dated November 2012 did not address the presence of HPV L1 gene DNA fragments in the vaccine Gardasil® because he wrote to Dr. Helen Petousis-Harris: 

“…We are seeking your advice on someone who  may be able to address the more detailed questions around HPV DNA – specifically the hypotheses you have address in your statement regarding the alleged role of aluminum binding to DNA fragments and subsequent effects.  While the issue of whether the fragments constitute

“contamination” has been dealt with,

 

your statement was the only one to address the

 

more obscure alleged consequences of the presence of those fragments.

  …”  

So, as of February 18, 2014 Dr. Pless and those whose names are listed on his email knew Dr. Helen

Petousis-Harris and Professor David Gorski were the only two writers who had addressed the issue of HPV L1 gene DNA fragments in the HPV vaccine, but in social media blogs only, and not in peerreviewed scientific journals. Dr. Pless needed to find someone to put a veneer of science over these online blogs. He found Dr. Helen Petousis-Harris for that. 

Government Counter-Actions to Evidence of Harmful Effects of HPV Vaccination

The following emails showed the actions taken by the bureaucrats of the Ministry of Health, Labour and Welfare of Japan, the chair of the public hearing session, Dr. Pless and Dr. Melinda Wharton of the CDC to counter the plausible consequences of the presence of the HPV DNA fragments in the Gardasil® vaccines.

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Based on the emails copied above, Dr Pless and those listed in these emails already drafted a GACVS statement before the public hearing. However, after having discussed to his boss, Dr. Nabae Koji wrote to the group on February 23, 2014 the following email: 

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In plain language, it appears that Dr. Nabae was instructing the WHO GACVS not to present any information formally in order to avoid cross-examination and scrutiny at the February 26, 2014 Public Hearing. Information provided after the public inquiry would provide a means for decision makers to be duly influenced by informal and cherry-picked ‘expert’ opinions. 

I believe this maneuver was orchestrated by the Chairperson of the WHO GACVS and others as nothing more than a very cunning means of avoiding having to supply scientific evidence to decision makers. Actions like this corrupt the entire concept of science-based medicine.

Dr. Helen Petousis-Harris was finally selected as spokesperson for the February 26, 2014 Tokyo public hearing. But according to the emails uncovered, Dr. Petousis-Harris’ Powerpoint slides had to be reviewed by the group before presentation at the public hearing to ensure she put forth the proper message. 

I found it astonishing to read the February 25, 2014 email sent by Dr.Nabae Koji to Dr. Helen PetousisHarris, their designated spokesperson. Dr. Nabae was concerned about Dr. Helen Petousis-Harris’ Powerpoint slide which stated “immune activation on uptake of HPV vaccine does not include an increase in inflammatory factors (incl TNF) even in vaccinees with large injection site reactions at time of local inflammation” because such claim contradicted the data presented by another expert at their previous meeting which in fact confirmed that cytokines following vaccines increased particularly at injection site after Cervarix® compared  to other vaccines (including tumor necrosis factor- TNF).  

It is of interest to note that Dr. Nabae Koji also deleted some questionable “Japanese Wildcard” data from Dr. Helen Petousis-Harris’ Powerpoint slides to be presented at the February 26, 2014 public hearing because he, Dr. Nabae, could not “explain it well”. 

GACVS Suppresses Vital Information and Manipulates Data to Support Claim of Vaccine Safety in the Face of Valid Contradictory Evidence

I find this to be yet another blatant example of suppression of information this group found to be potentially contradictory to and/or not totally compatible with their pre-determined GACVS “party line” statement on continued safety of HPV vaccination. Dr. Pless and the WHO officials seemed to have simply written a script for Dr. Helen Petousis-Harris to regurgitate at the public hearing and then proceeded to put forth the same presentation as an independent research reference to support their pre-determined GACVS statement. What an insult to the intelligence of the citizens of the world! 

The Powerpoint slides Dr. Helen Petousis-Harris presented at the public hearing claimed Dr Lee’s case report had no controls to prove that unvaccinated New Zealand teenage girls do not have HPV DNA in non-B conformations in their blood, therefore the findings are not scientifically valid. She said, “There are no controls used (unvaccinated). This is a vital part of the scientific process.” [original emphasis.]

Dr. Helen Petousis-Harris evidently does not understand the difference between a case report and a clinical trial; nor does she seem to know how hard it is for pathologists to find any HPV DNA in blood samples of patients, even those known to have HPV infections, let alone HPV DNA in non-B conformations. This shows how little, if any, experience she has in laboratory medicine.

I find Dr Petousis-Harris blog[1] which was quoted as Ref. 17 by Dr Pless in the GACVS statement in support of the declaration of HPV vaccination safety, to be more concerned with character assassination than in disputing the science of HPV L1 gene DNA fragments in Gardasil® or in postmortem materials.  

The very important email exchange between Dr. Nabae and Dr. Helen Petousis-Harris on February 25, 2014, one day before the Tokyo public hearing, is copied in this correspondence so you can judge for yourself whether these people manipulated the scientific data and process in order to mislead the Japanese Expert Inquiry, and vaccination policy makers worldwide.

First, please note Dr. Dr. Nabae’s concern about Dr. Helen Petousis-Harris’ claim of no cytokine increases in HPV vaccinees, as expressed in the email dated February 25, 2014 shown below, which was apparently written after he had an opportunity to review her proposed powerpoint presentation.

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Later in the morning apparently after a video conference Dr. Helen Petoussis Harris replied, asserting her scientific authority to comment as follows:

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So Dr. Helen Petousis-Harris used her PhD thesis[2] as authoritative research to support her theory of “No elevation of any cytokine associated with reactogenicity”?  

In fact, her PhD thesis has not been published in a peer-reviewed scientific journal because not only the experimental design and methodology used were highly questionable, as demonstrated in over 500 pages of Official Information documents and emails, but also in section 8.2 on limitations of this thesis, where Dr. Petousis-Harris states: 

“Timing and lack of baseline cytokine measures: Only a single blood sample was taken. The absence of a baseline measure precludes any within-individual changes. It cannot be determined if there were any changes in cytokine levels as a result of the administration of the vaccine or if these were base-line levels. In addition, blood samples were taken on day two, the day following vaccine administration, as it was thought local reactions would peak on this day. Injection site reactogenicity is not reported in a way that clarifies the peak time of reactions therefore this was an educated guess. Reactions actually peaked on the day of vaccination. It is possible that any elevations in cytokine levels may have waned by day two. Also, as many cytokines have localised activity it is possible that increased activity is not captured systemically. The fact that atopic score was associated with a range of cytokines supported that the assays were conducted successfully.” 

In Dr Helen Petousis-Harris’ own words, “as many cytokines have localised activity it is possible that increased activity is not captured systemically.” Nevertheless, Dr. Helen Petousis-Harris managed to satisfy Dr. Nabae that she only measured the cytokines in the serum and found no increase of cytokines after HPV vaccination  and her data did not really contradict the findings presented by their expert which confirmed increases in cytokines at the site of HPV vaccine injection. So both Dr. Nabae and Dr. Petousis-Harris decided to use “no increase in serum” as evidence for “No elevation of any cytokine associated with reactogenicity” as illustrated in the following email exchange.

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In my opinion these emails clearly demonstrate that this group of WHO officials and government employees charged with the responsibility to advise the expert committee of the Japanese government on HPV vaccination safety knew before the February 26, 2014 Tokyo public hearing that one of their own experts showed scientific evidence that HPV vaccination does increase cytokines, including tumor necrosis factor (TNF), particularly at the injection site compared to other vaccines. Yet, they chose to suppress this information at the public hearing. Of course, this piece of scientific data which was known to all members of the group, including Dr Robert Pless, the chairperson of GACVS, is also missing from the GACVS Statement on the continued safety of HPV vaccination issued on March 12, 2014.  

So why does HPV vaccination increase the level of cytokines, including TNF, at the site of injection compared to other vaccines? 

The answer is: HPV vaccines contain HPV L1 gene DNA fragments, the viral DNA fragments, bound to aluminum adjuvants in the vaccines. To understand this, the members of the GACVS should keep up with the recent research and scientific publications on aluminum adjuvants. A brief summary on this subject with 22 key peer-reviewed references is presented as follows.

Use of Aluminum Adjuvant

Aluminum salts have been used as adjuvants in vaccination empirically to boost immune responses of the host to the protein antigens for many decades. However, the mechanism of the adjuvant effects of aluminum salts has only been recently investigated at the molecular level.  It is now generally agreed in the scientific community that aluminum salts used as adjuvants are toxic and always damage the cells of the host at the site of injection, causing a localized inflammation at the vaccination site. This initial cell damage by the aluminum salt is an essential and necessary step to initiate its adjuvant effects because the free host DNA molecules released from the aluminum salt-damaged host cells act as mediators to trigger augmented immune responses of the host [1, 2]. The free DNA molecules of the dying host cells, also referred to as damage-associated molecular patterns (DAMPs) [3] bind the aluminum salt adjuvant at the site of injection, and the resulting DNA/aluminum complexes are phagocytized by the antigen-presenting cells (APCs) and macrophages. It was known as early as 2003, that when bound to aluminum salts as nanoparticles, free DNA molecules undergo dramatic conformational changes and can be introduced into mammalian cells as a means of gene transfection [4]. In vaccination with aluminum adjuvants, the transfected host DNA activates the pathways that would increase their ability to interact productively with antigen-specific CD4 T cells to boost host immune responses [1, 2]. 

In plain language, free DNA derived from the dying host cells is needed to be carried by aluminum adjuvants into the APCs or macrophages to function as mediators for boosting immune responses in vaccination.

However, the presence of recombinant HPV L1-specific DNA fragments in the vaccine Gardasil® has disrupted this expected normal immunity response platform in vaccination. The HPV DNA molecules, being of a viral origin, are “non-self” microbial products, also referred to as pathogen-associated molecular patterns (PAMPs). The human body’s defense system can distinguish the PAMPs from the DAMPs in order to mount an appropriate immune response to either the presence of a pathogen or a tissue damage [3].

The amorphous aluminum hydroxyphosphate sulfate (AAHS) nanoparticles which are expected to bind the free host DNA at the site of vaccine injection can also bind the fragments of HPV L1 gene DNA present in the vaccine Gardasil® [5] through a ligand exchange process between the phosphate groups of the DNA molecule and the hydroxyl groups on the aluminum adjuvant surface, similar to a reaction between phospholipids and AAHS in the recombinant hepatitis B vaccine [6]. 

In other words, Gardasil® has been furnished with a set of ready-made instant DNA immune “mediators” already in the adjuvant, in the form of a viral DNA/aluminum chemical compound, specifically an HPV L1 gene DNA/AAHS complex. The downstream events after transfection into the human macrophages of these viral DNA fragments which are rarely found in the human genome [7] are quite different from those after the DNA of the dying host cells is introduced into the macrophages. Despite similarities between DNA molecules, mammalian cells have the remarkable ability to distinguish viral DNA from their own DNA. The human macrophages are able to recognize the HPV L1 gene DNA as a ‘stranger’ and a ‘danger’ signal, and in response produce many antiviral immune molecules, collectively referred to as type I interferons and pro-inflammatory cytokines [8-10]. 

Massive systemic production of these type I interferons and pro-inflammatory cytokines induces an antiviral state and protects the host, but it also can contribute to endotoxin lethality and autoimmune diseases [9]. Many of these cytokines are myocardial depressants. The two cytokines that show the greatest cardiovascular effects in animals and humans are tumor necrosis factor (TNF)-α and IL-1β [11].

Administration of recombinant TNF-α in animal models is known to cause hemodynamic changes and even death [11]. 

Injection of Gardasil® into animals has been shown to induce unusually early strong innate immune responses with quick releases of a variety of cytokines from the macrophages [12]. Injection of HPV DNA/AAHS complexes into the host is also known to induce a strong immune reaction and a strong

CD8 T cell response [13].  Based on experiments with other viral DNA molecules, the recombinant HPV L1 gene DNA fragments transfected into human macrophages would also be recognized as “stranger” and “danger” signal, and invariably activate the macrophages to release numerous antiviral cytokines. Many of these cytokines, including TNF-α and IL-1β, are recognized myocardial depressants [14-18]. Hypotensive shock induced by TNF-α has been well documented among animals [19, 20] and humans

[21, 22].  

This brief review shows that there is a known molecular mechanism to explain why serious adverse reactions occur more often in people injected with HPV vaccines than with other vaccines, and why certain predisposed vaccinees may suffer a sudden unexpected death as the result of Gardasil® vaccination. 

It is my opinion that Dr Pless, those whose names appeared in the emails attached to this complaint, and all who blindly dismiss the potential toxicity of the newly created HPV L1 gene DNA/AAHS compound in order to continue to promote HPV vaccinations should be held accountable for their actions. There is no excuse for intentionally ignoring the scientific evidence. There is no excuse for misleading global vaccination policy makers at the expense of public interest. 

It is my contention these people have not only violated the Terms of Reference of the WHO Global Advisory Committee on Vaccine Safety (GACVS); they have violated the public trust. Immediate, independent and thorough investigations into their actions with appropriate disciplinary action is the only option available that might restore the public’s confidence in worldwide health authorities.

Thank you for your attention to this matter. 

Sincerely,

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Sin Hang Lee, MD, F.R.C.P. (C), FCAP 

Director

Milford Molecular Diagnostics Laboratory

2044 Bridgeport Avenue, Milford, CT 06460 USA

Email shlee01@snet.net

 

Attachments:

GACVS Terms of Reference

GACVS Statement on the continued safety of HPV vaccination on March 12, 2014

WHO GACVS emails from February 18, 2014 to February 27, 2014 in chronologic order Original FOIA -Attachment obtained in New Zealand

 

References

1.       Marichal T, Ohata K, Bedoret D, Mesnil C, Sabatel C, Kobiyama K, Lekeux P, Coban C, Akira S, Ishii KJ, Bureau F, Desmet CJ. DNA released from dying host cells mediates aluminum adjuvant activity. Nature Medicine   2011; 17: 996-1002. 

2.       McKee AS, Burchill MA, Munks MW, Jin L, Kappler JW, Friedman RS, Jacobelli J, Marrack P. Host DNA released in response to aluminum adjuvant enhances MHC class II-mediated antigen presentation and prolongs CD4 T-cell interactions with dendritic cells. Proc Natl Acad Sci U S A. 2013; 110:E1122-31. 

3.       Paludan SR, Bowie AG. Immune sensing of DNA. Immunity. 2013; 38:870-80.

4.       Matsuzawa Y, Emi N, Kanbe T. Calcium Phosphate and Aluminum Hydroxide as Non-Virus Gene Carrier: The Morphology of DNA-salt Complex and the Effects It on DNA Transfection   KAGAKU KOGAKU RONBUNSHU 2003; 29:.680-4.

5.       Lee SH. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®. J Inorg Biochem 2012; 117:85–92.

6.       Egan, P.M.; Belfast, M.T.; Giménez, J.A.; Sitrin, R.D.; Mancinelli, R.J. Relationship between tightness of binding and immunogenicity in an aluminum- containing adjuvant-adsorbed hepatitis B vaccine. Vaccine 2009; 27: 3175-80.

7.       Sparwasser T, Miethke T, Lipford G, Erdmann A, Häcker H, Heeg K, Wagner H. Macrophages sense pathogens via DNA motifs: induction of tumor necrosis factor‐alpha‐mediated shock. Eur J Immunol. 1997; 27:1671‐79.

8.       Orzalli MH, Knipe DM. Cellular sensing of viral DNA and viral evasion mechanisms.  Annu Rev Microbiol. 2014; 68:47792. 

9.       Yarilina A, Ivashkiv LB. Type I interferon: a new player in TNF signaling. Curr Dir Autoimmun. 2010; 11:94-104. 

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13.    Caulfield MJ, Shi L, Wang S, Wang B, Tobery TW, Mach H, Ahl PL, Cannon JL, Cook JC, Heinrichs JH, Sitrin RD. Effect of alternative aluminum adjuvants on the absorption and immunogenicity of HPV16 L1 VLPs in mice. Hum Vaccin. 2007; 3:139-45.

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15.    Kumar A, Paladugu B, Mensing J, Kumar A, Parrillo JE. Nitric oxide-dependent and -independent mechanisms are involved in TNF-alpha -induced depression of cardiac myocyte contractility. Am J Physiol Regul Integr Comp Physiol. 2007; 292:R1900-6. 

16.    Cauwels A, Van Molle W, Janssen B, Everaerdt B, Huang P, Fiers W, Brouckaert P. Protection against TNF-induced lethal shock by soluble guanylate cyclase inhibition requires functional inducible nitric oxide synthase.Immunity. 2000; 13:223-31.

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Clinical pharmacology of recombinant human tumor necrosis factor in patients with advanced cancer. J Clin Oncol. 1987; 5:1942-51.

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Parents accused of shaking their baby to death by ‘medic who branded herself TV’s Dr House’ clear their name and now file lawsuit against hospital for ‘series of fatal blunders’

  • Sara and Padraig Keenan claim daughter Lana died after ‘medical errors’
  • Couple were then wrongly accused of child abuse leading to her death
  • Doctor branded herself as TV’s Dr House claimed they’d shaken infant
  • Parents were barred from seeing daughter as she lay dying in hospital
  • Social workers also took their two sons away from the grieving couple
  • Keenans who were cleared of wrongdoing say they’re target of witch hunt
  • Suing hospital and ambulance responsible for alleged medical blunders

By HANNAH PARRY FOR DAILYMAIL.COM

PUBLISHED: 13:58 EST, 17 January 2016 | UPDATED: 18:39 EST, 17 January 2016

A family whose baby died after a series of ‘medical errors’ were then falsely accused by a doctor of causing the tragic death through child abuse, a lawsuit claims.

Sara and Padraig Keenan are suing over claims that blunders by ambulance staff and medics at a New York hospital led to the death of their three-month-old daughter Lana, the New York Post reports.

The couple had called 911 on January 3, 2014, after Mr Keenan discovered his daughter choking on her own vomit in her crib.

Sara and Padraig Keenan claim daughter Lana (pictured) died after 'medical errors' and they were then wrongly accused of child abuse leading to her death

 

Sara and Padraig Keenan claim daughter Lana (pictured) died after ‘medical errors’ and they were then wrongly accused of child abuse leading to her death

The Keenans are now suing over claims that blunders by ambulance staff and medics at a New York hospital led to the death of their three-month-old daughter

 

The Keenans are now suing over claims that blunders by ambulance staff and medics at a New York hospital led to the death of their three-month-old daughter

The lawsuit says that as their daughter lay dying, Mr and Mrs Keenan (pictured) were barred from being near her while social workers took custody of their sons, six and three

 

The lawsuit says that as their daughter lay dying, Mr and Mrs Keenan (pictured) were barred from being near her while social workers took custody of their sons, six and three

A friend was able to revive her but when EMTs from Exchange Ambulances arrived, they failed to intubate the young girl, give her oxygen or protect her from the cold as they carried her down the street to the ambulance, the lawsuit, seen by the Post, claims.

The emergency crews then took the infant to Bay Shore’s Southside Hospital, despite pediatric intensive care units being available at nearby Good Samaritan and Stony Brook hospitals.

Three-month-old Lana was given a cocktail of drugs including the same sedative linked to Michael Jackson’s death – Propofol – which led to her brain being starved of oxygen for an hour, court documents allege.

The grieving couple say that Dr. Jamie Hoffman-Rosenfeld allegedly introduced herself as the TV diagnostician Dr House

The grieving couple say that Dr. Jamie Hoffman-Rosenfeld allegedly introduced herself as the TV diagnostician Dr House

When staff tried to raise the baby’s blood pressure to get oxygen pumping to the brain again, the IV was incorrectly inserted.

The youngster was then transported more than an hour away to Cohen Children’s Medical Center in Queens, a sister hospital to Southside also run by Northwell Health.

It was the hospital where Lana would pass away just a few weeks later in February 2014.

But the grieving parents’ tragedy was far from over.

When their baby arrived at the Cohen they met Dr. Jamie Hoffman-Rosenfeld, who allegedly introduced herself to them as TV’s talented diagnostician Dr House.

She decided that Lana was suffering from shaken-baby syndrome as a result of child abuse from the parents and began a ‘bogus, illegitimate, and wholly contrived witch hunt falsely accusing both of harming their child and causing the injury which ultimately led to her death’, the court suit says.

The distraught parents were banned from being near their little girl as she lay dying after Hoffman-Rosenfeld and Suffolk County social workers secured orders of protection against Mr and Mrs Keenan.

Social workers then took custody of their young sons, aged six and three.

Police and the attorney’s office investigated the doctor’s claims but found no evidence of child abuse. Two separate autopsies also confirmed that no physical abuse had caused the infant’s death.

Sara and Padraig Keenan are seeking unspecified damages from Dr Hoffman-Rosenfeld, Northwell Health - which runs Southside Hospital (pictured), Suffolk County, the ambulance company and more

 

Sara and Padraig Keenan are seeking unspecified damages from Dr Hoffman-Rosenfeld, Northwell Health – which runs Southside Hospital (pictured), Suffolk County, the ambulance company and more

Yet social workers continued to pursue the custody case for their other children until the family were finally cleared of any abuse this month.

Mr and Mrs Keenan believe they were hounded by the case to try and force them to clear the hospital, and medical staff of any wrongdoing.

After being cleared of abuse, the couple have filed the federal lawsuit seeking unspecified damages from Dr Hoffman-Rosenfeld, Northwell Health, Suffolk County and Exchange Ambulances.

The Keenans have since given birth to another little girl, in August last year.

A spokesman for Northwell Health told DailyMail.com: ‘The loss of a child obviously is a tragedy and we have extended our sympathies to the family.

‘Because this is a matter of litigation, we are unable to comment on the specifics of the case.

‘However, it’s important to emphasize that New York State law requires health care providers to report any unexplained injuries involving children to Child Protective Services.’

A GoFundMe account has been set up for Lana’s family.

Or https://www.gofundme.com/lana2013

Read more: http://www.dailymail.co.uk/news/article-3403751/Parents-accused-child-abuse-witch-hunt-silence-family-baby-following-series-medical-errors-New-York-hospital-file-lawsuit.html#ixzz3xY7m73p7
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Blood products and vaccine manufacturer maker Kaketsuken covered up irregularities for 40 years

 

NATIONAL JAN. 09, 2016 – 02:51PM JST

TOKYO —

Blood products and vaccine manufacturer Kaketsuken on Friday was ordered by the state to suspend business for 110 days, the longest penalty ever handed down under Japan’s pharmaceutical law, as the company was found to have been adding unauthorized ingredients to its products and falsifying records for four decades.

While Kaketsuken, formally known as the Chemo-Sero-Therapeutic Research Institute, will be forced to halt business from Jan 18 to May 6, the health ministry has decided that in order to avoid impacts on patients it will exclude from the order some blood products and vaccines that do not have substitutes.

In December, a third party investigation panel released a report concluding the Kumamoto-based institute began straying from authorized processes for producing its blood products from 1974, or possibly earlier, and started using additives that prevents blood from clotting. The panel also accused the institute of forging data to cover it up from at least 1995 onwards.

Founded in 1945, Kaketsuken holds roughly 30% of the domestic influenza vaccine market and also produces vaccines for hepatitis A and B and Japanese encephalitis among others.

© KYODO

http://www.japantoday.com/category/national/view/blood-products-maker-kaketsuken-covered-up-irregularities-for-40-years

Vaccine and blood product maker Kaketsuken raided over decades of alleged faked records, illegal additives

 

“the panel said that the institute added substances not authorized by the government to flu vaccines and blood products for hemophilia patients”

KYODO

  • DEC 3, 2015

The health ministry inspected the premises of a major manufacturer of blood products and vaccines Thursday, a day after an investigative panel accused it of using unauthorized additives and of falsifying records.

The ministry’s action suggests that Chemo-Sero-Therapeutic Research Institute, or Kaketsuken, may yet be subject to punitive measures by the government.

The third-party panel, set up by the institute after allegations of misconduct surfaced in May, found the use of unauthorized additives and data manipulation stretching back over roughly 40 years.

An anonymous whistleblower got in touch with authorities, tipping them off about what was going on.

In a report that was submitted to the Health, Labor and Welfare Ministry on Wednesday, the panel said that the institute added substances not authorized by the government to flu vaccines and blood products for hemophilia patients and tweaked the proportions of ingredients without permission.

Furthermore, with regard to blood products, Kaketsuken lied to government officials during biennial inspections, the report alleged.

Calling such acts “aberrant” and representing “arrogance” by researchers, the panel accused the firm of violating the Pharmaceuticals and Medical Devices Law.

The panel pointed out that senior Kaketsuken officials, including director Seiji Miyamoto, failed to halt the malpractice despite knowing about it.

In a bid to cover up what was going on, Kaketsuken officials allegedly falsified records, making it look as though the products were manufactured correctly.

When they could not produce the needed historical documents, they artificially aged the faked papers by exposing them to ultraviolet radiation.

On Wednesday, Kaketsuken announced Miyamoto’s resignation.

Each member of the board of directors either resigned or was demoted.

The panel alleged that the institute conducted malpractice in a bid to get its products to market quickly and to ensure stable supplies. In all, it said, Kaketsuken falsified data on 31 manufacturing processes.

None of the products has caused serious side effects so far, but the scandal has outraged some patients, especially hemophiliacs, who were victimized in a separate scandal involving blood products infected with HIV.

Kaketsuken was one of the defendants involved in group lawsuits filed in 1989 by hemophiliacs who contracted HIV through blood products.

More than 1,400 hemophiliacs contracted HIV from blood products administered in the late 1970s and early 1980s. About 500 of them have since died.

“They simply lack the ethics and governance standards a pharmaceutical company is expected to have,” said Jugo Hanai, 53, leader of a nationwide association supporting victims of drug-induced diseases. “Such a malpractice wouldn’t last this long if the whole company hadn’t been involved in it.”

The civil case was settled in 1996, but Kaketsuken was heavily criticized for putting its interests before those of the patients.

“It seems they have drawn no lessons from the case,” said Hanai, who was among the plaintiffs in the HIV case.

He added: “The government, failing to detect their misconduct, is also responsible.”

Meanwhile, the panel failed to determine whether Kaketsuken fabricated data on its vaccines, the shipment of which was temporarily suspended in September after it was found that unauthorized methods were used in their production.

http://www.japantimes.co.jp/news/2015/12/03/national/science-health/drugmaker-kaketsuken-raided-decades-alleged-faked-records-illegal-additives/#.VmujF0orKUm

Concern over drug industry involvement at India’s ‘health camps’

Public Release: 2-Dec-2015

 

Unchecked screening and conflict of interests have experts worried, says report

BMJ

Pharmaceutical sales representatives are screening people in India in return for prescriptions for their products, finds a special report published by The BMJ today.

Free ‘health camps’ for poor people in India have grown popular, writes author Frederik Joelving, a journalist based in Denmark.

Local residents are invited to the camps that may include medical testing done by drug representatives or technicians, he explains. Some camps take place at temples or schools near slum areas and tend to attract hundreds of visitors, while smaller ‘patient camps’ can be at a hospital or in the waiting room of a doctor’s office.

The BMJ has evidence that unlicensed employees from several Indian drug firms and from the Indian arms of Abbott, Bayer, GlaxoSmithKline, Roche, and Sanofi have tested patients at health camps.

The Medical Council of India says the practice is unauthorised and that only a registered medical practitioner can perform screening and diagnostic tests.

Likewise, for doctors to prescribe specific products in return for testing services from a drug company is not only ‘totally unethical,’ said K L Sharma, joint secretary at the Ministry of Health and Family Welfare; it also violates MCI regulations.

Cipla acknowledged that its employees test patients, reports Joelving. A Roche spokesperson said that Roche Diabetes Care India donates testing supplies to diabetes education camps but added that “people with diabetes who attend the camp test on their own, after having signed a written consent.”

Ransom D’Souza, a GlaxoSmithKline India spokesperson, said: “Our sales representatives are not permitted to perform tests on patients in India” and added that GSK “at no point in time” has “sought prescriptions from [healthcare professionals] in reciprocation and that last year the company removed individual sales targets for its representatives.”

But Pinaki Dutt, a GSK sales rep from Bankura, West Bengal, told Joelving in 2013 that he and his colleagues were required by ‘company policy’ to do blood sugar tests at regular health camps.

“This kind of behavior can actually lead to harm to patients — overdiagnosis, misclassification [of healthy people as sick], iatrogenic harm of drugs,” Glyn Elwyn, a primary care clinician-researcher at The Dartmouth Center for Health Care Delivery Science in Hanover, New Hampshire, USA, told The BMJ.

The Indian subsidiaries of Abbott Laboratories have been particularly active in the push for screening, says Joelving, with each of the company’s business divisions organizing health camps.

In 2011 alone, the company says it screened more than 240,000 people for thyroid disorders. Meanwhile, sales of its flagship product Thyronorm (thyroxine) raced ahead of cheaper competitors in India.

“I would call it market penetration with a label of corporate social responsibility,” said Hans Hogerzeil, a professor of global health at Groningen University in the Netherlands and until 2011 director for essential medicines and pharmaceutical policies at the World Health Organization.

Abbott told The BMJ: “Health camps must not be supported in exchange for an explicit or implicit understanding to purchase, order, recommend, prescribe or provide favourable treatment to any Abbott products.”

But an Abbott rep who does screening at diabetes camps said that his services are an investment in the doctor and have nothing to do with charity. “The only objective is the business transaction,” said the rep, who spoke on condition of anonymity from fear of losing his job.

Finally, Leena Menghaney, a lawyer and India manager of Médecins Sans Frontières’ Access Campaign, said: “This is nothing but selling privatised health care, whether it’s medicines or diagnostics,” adding that she discourages her family from going to the camps.

Skin cancer drugs increase an average of 1,240% in price over 6 years

Public Release: 25-Nov-2015

Changes in retail prices for prescription dermatologic drugs from 2009-2015

The JAMA Network Journals

Prices among 19 brand-name prescription dermatologic drugs increased rapidly between 2009 and 2015, with prices for topical antineoplastic drugs to prevent the spread of cancer cells increasing an average of 1,240 percent, according to an article published online by JAMA Dermatology.

Landmark health reform in the United States has done little to curb the rising price of prescription drugs. Patients across the United States have little protection from health plans excluding coverage for expensive prescription drugs.

Steven P. Rosenberg, M.D., of the Miller School of Medicine at the University of Miami, and Miranda E. Rosenberg, B.A., of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, surveyed prescription drug prices at four national chain pharmacies in the West Palm Beach, Fla., area (Costco, CVS, Sam’s Club and Walgreens) in 2009, 2011, 2014 and 2015.

A total of 19 name-brand drugs with data available from all four surveys were selected for final analysis and grouped by treatment indication: acne and rosacea; psoriasis; topical corticosteroids; antiinfectives; and antineoplastics. The antineoplastic class did not include systemic medications for metastatic melanoma or basal cell carcinoma because such medications were not available in 2009.

The authors found that between 2009 and 2015:

  • Prices of all surveyed classes of brand-name drugs increased; the average increase was 401 percent.
  • Prices of topical antineoplastic drugs had the greatest average absolute and percentage increase of nearly $10,927 and 1,240 percent.
  • Prices of drugs in the antiinfective class had the smallest average absolute increase of almost $334.
  • Prices of psoriasis medications had the smallest average percentage increase of 180 percent.
  • The retail prices of seven drugs more than quadrupled during the study period, with the vast majority of price increases occurring after 2011.

“Percent increases for multiple, frequently prescribed medications greatly outpaced inflation, national health expenditure growth, and increases in reimbursement for physician services,” the study concludes.

###

(JAMA Dermatology. Published online November 25, 2015. doi:10.1001/jamadermatol.2015.3897. Available pre-embargo to the media at http://media.jamanetwork.com.)

Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Media Advisory: To contact corresponding author Steven P. Rosenberg, M.D., call Lisa Worley at 305-243-5184 or email LWorley2@med.miami.edu

Big pharma inconsistent with disclosure of information on clinical trials, new study finds

Public Release: 12-Nov-2015

 

‘Good Pharma Scorecard’ ranks drugs based on their transparency and ethical practices

NYU Langone Medical Center / New York University School of Medicine

Despite legal and ethical requirements, information on clinical trials for drugs approved by the U.S. Food and Drug Administration (FDA) varied widely among some of the world’s largest drug companies, according to a new study led by a researcher at NYU Langone Medical Center’s Division of Medical Ethics in the Department of Population Health.

Although the lack of publicly available clinical trial information has been widely acknowledged as a decades’ long problem, the researchers believe this is the first report that ranks specific drugs based on their sponsors’ legally-required disclosure of clinical trial information and their ethical obligation to share information. The study, published online in BMJ Open also suggests that U.S. law is both narrow and unenforced in this area.

In the study, the authors debut a solution to help fix the transparency problem: the “Good Pharma Scorecard.” The pilot rankings–which will be released annually–score the largest pharmaceutical companies for drugs approved by the FDA in 2012. The authors’ goal in releasing this scorecard is to incentivize pharmaceutical companies to strive toward greater transparency.

“Selectively disclosing trial information can distort the medical evidence and challenge the abilities of physicians, prescription guideline writers, payers, and formulary decision-makers to recommend and provide the right drugs for the right patients,” said Jennifer Miller, PhD, an assistant professor of medical ethics in the Department of Population Health at NYU Langone, and President of Bioethics International. She led the study, along with researchers from Harvard and Yale Universities.

The findings were sobering. Almost half of all reviewed drugs had at least one undisclosed Phase II or III trial. In addition, the investigators found that only 57 percent of trials per drug were properly registered; only 20 percent of final results were reported on ClinicalTrials.gov (a clinical trial registry and database maintained by the National Library of Medicine at the NIH); only 56 percent were published in academic journals, and; only 65 percent were published or had their results reported in some meaningful way.

Dr. Miller also noted that selectively disclosing information violates the rights of human research subjects laid out in the U.S. Common Rule, a rule of ethics that requires that human subject experiments have the potential to contribute to generalizable knowledge.

How the Study Was Conducted

The investigators examined publicly available information for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value. They identified 15 drugs from 10 companies with more than 318 associated clinical trials involving 99,599 research subjects.

Information was gathered from a variety of publicly available documents, including Drugs@FDA, a publicly accessible database containing records of drug approvals and medical and scientific reviews of approved drugs; ClinicalTrials.gov; and journals indexed in Medline.

To aid in their evaluation and reform strategy, the researchers created a “Good Pharma Scorecard,” which consisted of five critical elements of transparency for new drugs, including if the trials were publicly registered, if they were reported in ClinicalTrials.gov after FDA approval and if there was adherence with ethics standards established by the World Medical Association’s Declaration of Helsinki, the cornerstone document on human research ethics, among others.

Conducting transparency performance audits for new drugs hopefully will incentivize pharmaceutical companies to improve behaviors, give more publicity to best practices, and support the government’s monitoring capabilities,” Dr. Miller said. “The scorecard and rankings have the potential to benefit consumers by helping assure the integrity and completeness of clinical trial information. Full transparency of clinical trials would also strengthen the protection of human research subjects by avoiding their unknowing recruitment into already failed experiments.”

Dr. Miller and her team will publish this scorecard annually, ranking each new group of FDA approved drugs going forward. A ranking of 2015 approved drugs and their sponsors will be released in 2016.

###

David Korn, MD, of Harvard University and Joseph S. Ross, MD, MHS of Yale University are coauthors on this paper. The conceptualization and pilot of this study and index were supported by Harvard University’s Edmond J. Safra Center for Ethics; Duke University’s Kenan Institute for Ethics, Trinity College of Arts and Sciences and Fuqua School of Business; Fordham University’s Global Healthcare Innovation Management Center; Susan G. Komen Foundation; Raskob Foundation; and Bioethics International. Dr. Ross is supported by the National Institute on Aging (K08 AG032886) and by the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program and receives research support through Yale University from Medtronic, Inc. and Johnson & Johnson to develop methods of clinical trial data sharing, from the Centers of Medicare and Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting, and from the Food and Drug Administration (FDA) to develop methods for post-market surveillance of medical devices. Dr. Miller and Dr. Korn receive no financial support from pharmaceutical companies. Dr. Miller is the founder and president of Bioethics International (BEI). BEI and the Laura and John Arnold Foundation will financially support further development and implementation of the ranking system described in this paper. This paper remains an independent work product, and the views expressed do not necessarily represent those of the funders.

Discrepancies are common between reported medical outcomes and trial registry data

Public Release: 20-Oct-2015

“From 2005 to 2014, we found that only 26 percent of randomized trials published in core headache journals were compliant with trial registration requirements, and that 38 percent of registered trials published results that did not match what authors initially planned to report,”

Study covering clinical trial publications about headaches finds significant selective reporting, suggesting potential pitfalls in peer review process

University at Buffalo

BUFFALO, N.Y. — Only a quarter of publications reporting on headache clinical trials were registered in an approved clinical trial registry, a new study published Oct. 16 in Neurology has found.

That’s true, despite a 2005 decision by major medical journals that they would only consider for publication results of clinical trials that had been registered in an approved clinical trial registry, such as clinicaltrials.gov. The goal was to reduce selective reporting of clinical trials, where researchers publish results that are outside the scope of the study’s original design and, thus, cannot be considered scientifically accurate.

“From 2005 to 2014, we found that only 26 percent of randomized trials published in core headache journals were compliant with trial registration requirements, and that 38 percent of registered trials published results that did not match what authors initially planned to report,” explained Melissa Rayhill, MD, lead author, assistant professor of neurology in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo and a UBMD Neurology physician specializing in headache medicine.

“Our study suggests that selective reporting remains a problem in the headache medicine literature and should bring into question the quality of similar reporting in other disciplines throughout the medical literature,” she said.

Rayhill became interested in potential pitfalls of the peer review process while serving as an ad hoc reviewer for several journals during her fellowship training.

“Although rigorous, if the few people who are asked to review a paper fail to bring up a potential bias or study design flaw, it may potentially be published without addressing the issue at all,” she said. “Whether or not the paper answers a question the study was designed to address is critical but that issue may not even be considered in the peer review process.In addition, reviewers are working to meet deadlines and often receive no compensation or inadequate compensation for their time.

“These realities led me to more closely scrutinize the quality of data available in the literature from which we develop clinical guidelines and guide individual clinical decisions.”

Rayhill and her co-authors conducted their comprehensive study of every trial published between 2005 and 2014 in the top journals in the headache medicine field: Headache, Cephalagia and the Journal of Headache and Pain. A total of 225 randomized controlled trials were studied. In 26 percent of them, a trial registration number was reported that could be linked to a corresponding registry.

The authors note that the frequency of registering clinical trials has increased in recent years in the headache medicine literature and that percentages range from comparable to somewhat higher in other fields, such as geriatrics and surgery.

“I hope our findings can positively impact the medical research process, increase awareness of trial registration and its rationale, and that it may indirectly improve the quality of data available to physicians to make good clinical decisions for patients,” said Rayhill.

The UB Department of Neurology and the UBMD Neurology physician practice plan hired Rayhill earlier this year to start a headache medicine practice. She came to UB after completing fellowship training in headache medicine at Harvard Medical School/Brigham and Women’s Hospital.

###

The study, which was unfunded, was conducted while Rayhill was a fellow at Harvard. Her co-authors at Brigham and Women’s Hospital and Harvard Medical School are: Rebecca Burch, MD, instructor of neurology; Elizabeth Loder, MD, chief, Division of Headache and Pain and associate professor of neurology, and Roni Sharon, MD, former fellow at the hospital’s John R. Graham Headache Center.

Neurology is the medical journal of the American Academy of Neurology.

Founded in 1846, the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo is beginning a new chapter in its history with the largest medical education building under construction in the nation. The eight-story, 628,000-square-foot facility is scheduled to open in 2017. The new location puts superior medical education, clinical care and pioneering research in close proximity, anchoring Buffalo’s evolving comprehensive academic health center in a vibrant downtown setting. These new facilities will better enable the school to advance health and wellness across the life span for the people of New York and the world through research, clinical care and the education of tomorrow’s leaders in health care and biomedical sciences. The school’s faculty and residents provide care for the community’s diverse populations through strong clinical partnerships and the school’s practice plan, UBMD.

Company Hikes Price of Life-Saving AIDS, Cancer Drug by 5,000%

 

A drug that fights a common parasite preying on people with weakened immune systems has spiked in price by 5,000 percent to $750 per pill.

Daraprim (pyrimethamine) treats toxoplasmosis, the second most common food-borne disease, which easily affects people suffering from AIDS and cancer.

According to the Centers for Disease Control, about 60 million people in the United States may carry toxoplasmosis which can affect the brain potentially leading to blindness and brain damage.

Turing Pharmaceuticals of New York raised the price of Daraprim from $13.50 per pill last month after buying the rights for the drug from Impax Laboratories.

“This is a tremendous increase,” said Judith Aberg, a spokesperson for the HIV Medicine Association. “Even patients with insurance could have trouble affording the medication. That’s because insurance companies often put high-price drugs in the ‘specialty’ category, requiring patients to pay hundreds or even thousands of dollars a year. Patients whose insurance plans require them to pay 20 percent of the cost — a common practice — would shell out $150 a pill.”

The disease can be life threatening and it’s transmitted by eating under-cooked meat, cooking with contaminated knives and boards, drinking unclean water, and contact with infected cat feces. Pregnant mothers can pass it to their children, and organ transplant patients can get it through an infected donor.

“It [Daraprim] makes the difference between whether people see or don’t see, whether babies grow to live happy lives with families or not,” said Rima McLeod, medical director at the University of Chicago Toxoplasmosis Center.

Aberg says there are no alternative drugs for Daraprim and other treatments aren’t strong enough.

Craig Rothenberg, a spokesperson for Turing defended the price increase by saying it will fund further research for toxoplasmosis treatments. He also said the company is working with hospitals and providers to offer co-pay assistance programs, and no-cost options to uninsured patients.

“There has been no innovation in dealing with toxoplasmosis,” Rothenberg said. “That has been a long neglect in the patient community.”

Read more: http://sputniknews.com/us/20150920/1027276555/compan-hikes-price-of-life-saving-aids-cancer-drug-5000-percent.html#ixzz3mKbhfyRk

Study 329 – Reanalysis of antidepressant trial finds popular drug ineffective & unsafe for adolescents

Public Release: 16-Sep-2015

Results contradict original findings and have important implications for research and practice

BMJ

The widely used antidepressant paroxetine is neither safe nor effective for adolescents with depression, concludes a reanalysis of an influential study originally published in 2001.

The new results, published by The BMJ today, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.

It is the first trial to be reanalysed and published by The BMJ under an initiative called RIAT (Restoring Invisible and Abandoned Trials), which encourages abandoned or misreported studies to be published or formally corrected to ensure doctors and patients have complete and accurate information to make treatment decisions.

In 2001 SmithKline Beecham, now GlaxoSmithKline (GSK), funded a study (known as Study 329) to compare the effectiveness and safety of the antidepressant drugs paroxetine and imipramine with placebo for adolescents diagnosed with major depression.

It reported that paroxetine was safe and effective for adolescents and was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001.

The study was criticised by the Food and Drug Administration (FDA) in 2002. Yet, that year, over two million prescriptions were written for children and adolescents in the United States.

In 2012 GSK was fined a record $3bn in part for fraudulently promoting paroxetine.

The RIAT team, led by Professor Jon Jureidini at the University of Adelaide, identified this study as an example of a misreported trial in need of restoration.

Using previously confidential trial documents, they reanalysed the original data and found that neither paroxetine nor high dose imipramine was more effective than placebo in the treatment of major depression in adolescents. The authors considered the increase in harms with both drugs to be clinically significant.

They conclude that “paroxetine was ineffective and unsafe in this study.”

The reanalysis of Study 329 “illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base,” say the authors.

In an accompanying article, Peter Doshi, Associate Editor for The BMJ says the new paper “has reignited calls for retraction of the original study and put additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing.”

He points out that the original manuscript was not written by any of the 22 named authors but by an outside medical writer hired by GSK. And that the paper’s lead author – Brown University’s chief of psychiatry, Martin Keller – had been the focus of a front page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies.

Doshi also details the refusal of the American Academy of Child and Adolescent Psychiatry to intervene and retract the paper, and Brown University’s silence over its faculty’s involvement in Study 329.

“It is often said that science self corrects. But for those who have been calling for a retraction of the Keller paper for many years, the system has failed,” argues Doshi.

Dr Fiona Godlee, The BMJ Editor-in-Chief says publication of the reanalysed data from Study 329 “sets the record straight” and “shows the extent to which drug regulation is failing us.” It also shows that the public and clinicians do not have the unbiased information they need to make informed decisions.

She calls for independent clinical trials rather than trials funded and managed by industry, as well as legislation “to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third party scrutiny.”

Liberating the data from clinical trials has the potential to benefit patients, prevent harm, and correct misleading research, writes Professor David Henry at the University of Toronto, in an accompanying editorial.

Data sharing is not without its risks, he says, but the pay-off from a systematic effort to reactivate important clinical trials will be high and will further justify the original huge investments of time and money, he concludes

Children on an antidepressant were 11 times more likely to harm themselves over a placebo. The criminal cover up of Study 329

Public Release: 16-Sep-2015

University of Adelaide

A University of Adelaide led study has found that a psychiatric drug claimed to be a safe and effective treatment for depression in adolescents is actually ineffective and associated with serious side effects.

Professor Jon Jureidini, from the University of Adelaide’s newly created Critical and Ethical Mental Health Research Group (CEMH) at the Robinson Research Institute, led a team of international researchers who re-examined Study 329, a randomised controlled trial which evaluated the efficacy and safety of paroxetine (Aropax, Paxil, Seroxat) compared with a placebo for adolescents diagnosed with major depression.

Study 329, which was funded by SmithKline Beecham (now GlaxoSmithKline), was reported in 2001 as having found that paroxetine was effective and safe for depression in adolescents. However, Professor Jureidini’s reanalysis showed no advantages associated with taking paroxetine and demonstrated worrying adverse effects.

“Although concerns had already been raised about Study 329, and the way it was reported, the data was not previously made available so researchers and clinicians weren’t able to identify all of the errors in the published report,” says Professor Jureidini.

“It wasn’t until the data was made available for re-examination that it became apparent that paroxetine was linked to serious adverse reactions, with 11 of the patients taking paroxetine engaging in suicidal or self-harming behaviours compared to only one person in the group of patients who took the placebo,” he says. “Our study also revealed that paroxetine was no more effective at relieving the symptoms of depression than a placebo.”

“This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them,” he says.

Professor Jureidini says it is important that research data and protocols are accessible so they can be reviewed and scrutinised.

“In 2013, an international researcher consortium called for undisclosed outcomes of trials to be published and for misleading publications to be corrected. This initiative was called restoring invisible and abandoned trials (RIAT),” says Professor Jureidini.

“Study 329 was one of the trials identified as in need of restoration, and because the original funder was not interested in revisiting the trial, our research group took on the task.

“Our reanalysis of Study 329 came to very different conclusions to those in the original paper,” he says. “We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data.”

“Regulatory research authorities should mandate that all data and protocols are accessible,” he says. “Although concerns about patient confidentiality and ‘commercial in confidence’ issues are important, the reanalysis of Study 329 illustrates the necessity of making primary trial data available to increase the rigour of evidence-based research,” he says.

Professor Jureidini’s study was published in the leading medical journal BMJ today.

###

CEMH is committed to undertaking and promoting critical and ethical appraisal of evidence, to help improve decision-making in mental health policy and practice.

Almost 9 in 10 medical guideline creators have a Conflict of Interest

Public Release: 22-Jul-2015

Guidelines: Authors’ conflicts of interest should lead to consequences

Deutsches Aerzteblatt International

A guideline–recommendations on diagnosing and treating a particular disorder–aims to present the best possible treatment for patients. However, when guidelines are compiled their authors often have conflicts of interest, for example as a result of funding or membership in specialist societies that are in close contact with industry. In a recent original article in Deutsches Ärzteblatt International (Dtsch Arztebl Int 2015; 112: 445-51), Gisela Schott et al. determine that most guideline authors do declare their conflicts of interest. However, this rarely has consequences for their collaboration.

Their study analyzed the conflicts of interest of 2190 experts who had worked on 234 guidelines. Almost nine authors in ten declared a conflict of interest. These were mostly membership in a relevant specialist society or professional association. One in two declared a financial conflict of interest; this was particularly likely for guidelines that mainly concerned drug treatment. However, in only one case did this result in any consequences: one of the experts excluded himself from voting on guideline content because of his conflict of interest. The study authors stress that documenting a conflict of interest is not in itself sufficient: it must also lead to consequences. They advocate that conflicts of interest be assessed by independent third parties and that clear consequences be formulated. They also recommend that more guidelines be compiled by experts with no conflicts of interest

Antidepressant trials exclude most ‘real world’ patients with depression

Public Release: 14-Jul-2015

Wolters Kluwer Health

July 14, 2015 – More than 80 percent of people with depression in the general population aren’t eligible for clinical trials of antidepressant drugs, according to a study in the Journal of Psychiatric Practice. The journal is published by Wolters Kluwer.

At least five patients would need to be screened to enroll just one patient meeting the typical inclusion and exclusion criteria for antidepressant registration trials (ARTs), suggests the new research by Drs. Sheldon Preskorn and Matthew Macaluso of University of Kansas School of Medicine-Wichita and Dr. Madhukar Trivedi of Southwestern Medical School, Dallas. The study highlights some major differences between patients with depression seen in everyday clinical practice and those enrolled in ARTs–the studies of antidepressants that lead to FDA drug approval.

Continue reading “Antidepressant trials exclude most ‘real world’ patients with depression”

Statin Data Criminally Manipulated to Deceive Doctors


Statin Data Criminally Manipulated to Deceive Doctors

= Their paper is an analysis of the data in the statin trials which led them to conclude that “statin advocates have used statistical deception to create the illusion that statins are ‘wonder drugs,’ when the reality is that their modest benefits are more than offset by their adverse effects.”

The paper also describes how the basis of the deception is in how authors of the statin studies present the rate of beneficial and adverse effects. The effect of the drugs on the population is called the ‘absolute risk,’ which has shown that statins benefit only about 1% of the population. This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don’t present the 1% effect to the public. Instead they transform the 1% effect using another statistic, called the “relative risk,” which creates the appearance that statins benefit 30-50% of the population.
* How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease
March 2015, Vol. 8, No. 2 , Pages 201-210 (doi:10.1586/17512433.2015.1012494) Continue reading “Statin Data Criminally Manipulated to Deceive Doctors”

Statin drug data criminaly manipulated to show exaggerated benefit and reduced risk?

“This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don’t present the 1% effect to the public. Instead they transform the 1% effect using another statistic, called the “relative risk,” which creates the appearance that statins benefit 30-50% of the population.”

CNO Video review: Statins and Statistics

Public Release: 20-Feb-2015

Safety and life-saving efficacy of statins have been exaggerated, says USF scientist
By using statistical tool that amplifies the beneficial effects of statins, advocates have created the appearance that cholesterol-lowering drugs are wonder drugs that have substantially reduced cardiovascular disease.

University of South Florida (USF Health)

Tampa, Florida (Feb. 20, 2015) – Hailed as miracle drugs when they hit the market two decades ago, statins, the cholesterol-lowering drugs prescribed to prevent heart attacks, are not as effective nor as safe as we have been led to believe, say Dr. David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr. Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular disease.

According to Diamond and Ravnskov, statins produce a dramatic reduction in cholesterol levels, but they have “failed to substantially improve cardiovascular outcomes.” They further state that the many studies touting the efficacy of statins have not only neglected to account for the numerous serious adverse side effects of the drugs, but supporters of statins have used what the authors refer to as “statistical deception” to make inflated claims about their effectiveness.

Their critique of the exaggerated claims regarding statins’ ability to prevent strokes, heart attacks and heart disease-related deaths on a large scale has been published in the medical journal “Expert Review of Clinical Pharmacology” at http://informahealthcare.​com/​ .

Their paper is an analysis of the data in the statin trials which led them to conclude that “statin advocates have used statistical deception to create the illusion that statins are ‘wonder drugs,’ when the reality is that their modest benefits are more than offset by their adverse effects.”

The paper also describes how the basis of the deception is in how authors of the statin studies present the rate of beneficial and adverse effects. The effect of the drugs on the population is called the ‘absolute risk,’ which has shown that statins benefit only about 1% of the population. This means that only one out of 100 people treated with a statin will have one less heart attack. Statin researchers, however, don’t present the 1% effect to the public. Instead they transform the 1% effect using another statistic, called the “relative risk,” which creates the appearance that statins benefit 30-50% of the population. Continue reading “Statin drug data criminaly manipulated to show exaggerated benefit and reduced risk?”

Corporate crime in the pharmaceutical industry is common, serious and repetitive

Requested Re-print of BMJ 2012;345:e8462  – Original PDF File: Pharma Crime Pays

Corporate crime in the pharmaceutical industry is common, serious and repetitive

by Peter C. Gøtzsche, Professor

MD, DrMedSci, MSc

Nordic Cochrane Centre Rigshospitalet, Dept. 7811 Copenhagen

14 Dec 2012

A short version of this article has been published in the BMJ:

Gøtzsche PC. Big pharma often commits corporate crime, and this must be stopped.

BMJ 2012;345:e8462

Abstract

Objectives: To study whether large drug companies routinely break the law.

Design: Literature review, using Google searches combining the names of the ten largest drug companies with “fraud.”

Results: I found recent examples (2007 to 2012) of serious crimes committed by each company. The crimes included marketing drugs for off-label uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud. Doctors were often complicit in the crimes, as kickbacks were common. The crimes were repetitive.

Conclusions: The crimes persist because crime pays. Harder sanctions are thereforee needed, including prison sentences for CEOs and other senior executives. Doctors and their organisations should consider carefully whether they find it ethically acceptable to receive money that may have been partly been earned by crimes that are harmful to patients.

Conflicts of interest: none.

Funding: none.

In recent years, numerous articles and books have described serious cases of research misconduct and marketing fraud committed by drug companies.1-9 When a company has been caught, the standard response from the drug industry is that there are a few bad apples in any enterprise. The interesting question is whether we are seeing a lone bad apple now and then, which might be excusable, or whether the companies routinely break the law.  Continue reading “Corporate crime in the pharmaceutical industry is common, serious and repetitive”

FDA often ignored or just not there for many drug approvals and trials

Study examines FDA influence on design of pivotal drug studies

An examination of the potential interaction between pharmaceutical companies and the U.S. Food and Drug Administration (FDA) to discuss future studies finds that one-quarter of recent new drug approvals occurred without any meeting, and when such meetings occurred, pharmaceutical companies did not comply with one-quarter of the recommendations made by the FDA regarding study design or primary outcome, according to a study in the November 26 issue of JAMA.

To enhance protocol quality, federal regulations encourage but do not require meetings between pharmaceutical companies and the FDA during the design phase of pivotal studies assessing drug efficacy and safety for the proposed indication. These meetings often generate FDA recommendations for improving research, although companies are not bound to follow them, according to background information in the article.

Steven Woloshin, M.D., M.S., of the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, N.H., and colleagues reviewed and analyzed approximated 200 FDA documents (memos; meeting minutes; filing checklists; and medical, statistical, and summary reviews) for 35 new drugs approved between February 1, 2011, and February 29, 2012. The researchers identified all FDA comments and analyzed recommendations about pivotal study design or primary outcomes and characterized the effect of recommendations on study quality. Continue reading “FDA often ignored or just not there for many drug approvals and trials”

Corruption of the Health Care Delivery System

” consumer demand for healthcare is manufactured and manipulated, driving up cost, waste and harm ”

Public Release: 14-Oct-2014

Higher Integrity Health Care for Evidence-Based Decision Making

LEBANON, NH – The foundation of evidence-based research has eroded and the trend must be reversed so patients and clinicians can make wise shared decisions about their health, say Dartmouth researchers in the journal Circulation: Cardiovascular Quality and Outcomes.

Drs. Glyn Elwyn and Elliott Fisher of The Dartmouth Institute for Health Policy & Clinical Practice are authors of the report in which they highlight five major problems set against a backdrop of “obvious corruption.” There is a dearth of transparent research and a low quality of evidence synthesis. The difficulty of obtaining research funding for comparative effectiveness studies is directly related to the prominence of industry-supported trials: “finance dictates the activity.”

The pharmaceutical industry has influenced medical research in its favor by selective reporting, targeted educational efforts, and incentivizing prescriber behavior that influences how medicine is practiced, the researchers say. The pharmaceutical industry has also spent billions of dollars in direct-to-consumer advertising and has created new disease labels, so-called disease-mongering, and by promoting the use of drugs to address spurious predictions.

Continue reading “Corruption of the Health Care Delivery System”

Discrepancies between trial results reported on clinical trial registry and in journals ( nearly all had discrepancies )

– nearly all had at least 1 discrepancy in the study group

– Our findings raise questions about accuracy of both ClinicalTrials.gov and publications, as each source’s reported results at times disagreed with the other.

Shhh...Can you keep a secret?

During a one year period, among clinical trials published in high-impact journals that reported results on a public clinical trial registry (ClinicalTrials.gov), nearly all had at least 1 discrepancy in the study group, intervention, or results reported between the 2 sources, including discrepancies in the designated primary end points for the studies, according to a study in the March 12 issue of JAMA.

The 2007 Food and Drug Administration (FDA) Amendments Act expanded requirements for ClinicalTrials.gov, mandating results reporting within 12 months of trial completion for all FDA-regulated medical products. “To our knowledge, no studies have examined reporting and accuracy of trial results information. Accordingly, we compared trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications,” write Jessica E. Becker, A.B., of the Yale University School of Medicine, New Haven, Conn., and colleagues. Continue reading “Discrepancies between trial results reported on clinical trial registry and in journals ( nearly all had discrepancies )”

Scandal of experts who rule on NHS statins but get paid by drugs firms

MOST of the experts who are set to recommend the widespread use of statins next month are in the pay of the drug ­companies that manufacture them.

Published: Sun, March 9, 2014

        

Dr Anthony Wierzbicki Chairman of statin panel has links to drug firms including PfizerDr Anthony Wierzbicki: Chairman of statin panel has links to drug firms including Pfizer [COLLECT]

Any suggestion that medics or officials stand to personally profit from decisions about our care will rightly worry patients  Andrew Gwynne, Shadow Health Minister

The specialists sit on the Government health watchdog, the National Institute for Health and Care Excellence (Nice).Nice is expected to issue new national advice saying statins, now prescribed to about seven million people a year, should be offered to at least one in four adults.

The move has been criticised by many doctors who say that for many low-risk patients the benefits of statins do not outweigh poss­ible side effects including diabetes, impotence, cataracts, muscle pains, mental impairment, fatigue and liver dysfunction. Continue reading “Scandal of experts who rule on NHS statins but get paid by drugs firms”

How computer-generated fake papers are flooding academia

More and more academic papers that are essentially gobbledegook are being written by computer programs – and accepted at conferences
'I've written five PhDs on Heidegger just this afternoon. What next?'
‘I’ve written five PhDs on Heidegger just this afternoon. What next?’ Photograph: Blutgruppe

Like all the best hoaxes, there was a serious point to be made. Three MIT graduate students wanted to expose how dodgy scientific conferences pestered researchers for papers, and accepted any old rubbish sent in, knowing that academics would stump up the hefty, till-ringing registration fees.

It took only a handful of days. The students wrote a simple computer program that churned out gobbledegook and presented it as an academic paper. They put their names on one of the papers, sent it to a conference, and promptly had it accepted. The sting, in 2005, revealed a farce that lay at the heart of science. Continue reading “How computer-generated fake papers are flooding academia”

No standard for the placebo?

Public release date: 18-Oct-2010 HRR- Requested Repost , in regards to  how to rig double blind cross over placebo drug trial.

“there isn’t anything actually known to be physiologically inert. On top of that, there are no regulations about what goes into placebos

–  what is in them is often determined by the makers of the drug being studied, who have a vested interest in the outcome

–  And there has been no expectation that placebos’ composition be disclosed

Prescription placebos used in research and pra...
Prescription placebos used in research and practice (Photo credit: Wikipedia)

Much of medicine is based on what is considered the strongest possible evidence: The placebo-controlled trial. A paper published in the October 19 issue of Annals of Internal Medicine – entitled “What’s In Placebos: Who Knows?” calls into question this foundation upon which much of medicine rests, by showing that there is no standard behind the standard – no standard for the placebo.

The thinking behind relying on placebo-controlled trials is this: to be sure a treatment itself is effective, one needs to compare people whose only difference is whether or not they are taking the drug. Both groups should equally think they are on the drug – to protect against effects of factors like expectation. So study participants are allocated “randomly” to the drug or a “placebo” – a pill that might be mistaken for the active drug but is inert. Continue reading “No standard for the placebo?”

Ghostwritten articles overstate benefits of ( Prempro ) hormone replacement therapy and downplay harms

Public release date: 7-Sep-2010 HRR-Re-Posted at Request

analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro

The analysis revealed that DesignWrite was paid US$25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro

– DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid US$20,000 each.

The first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer) reveals unprecedented insights into how pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy (HT)—and to cast competing therapies in a negative light. These articles were widely circulated to drug reps and doctors to disseminate the company’s marketing messages. The analysis appears in this week’s PLoS Medicine. Continue reading “Ghostwritten articles overstate benefits of ( Prempro ) hormone replacement therapy and downplay harms”

Dosing schedule of pneumococcal vaccine linked with increased risk of getting multiresistant strain

Public release date: 7-Sep-2010 – EEV: Requested Re-Post from the HRR site.

Infants who received heptavalent pneumococcal conjugate vaccination (PCV-7) at 2, 4, and 11 months were more likely than unvaccinated controls to have nasopharyngeal acquisition of pneumococcal serotype 19A

– the increase in serotype 19A disease was associated in time with the widespread implementation of PCV-7 in routine infant immunization programs

– A rapid increase in the presence of pneumococcal serotype 19A strains that are often multiresistant to antibiotics has been observed over the last decade

– serotype 19A is now the leading causative pneumococcal serotype of invasive and respiratory pneumococcal disease

Question mark in Esbjerg
Question mark in Esbjerg (Photo credit: alexanderdrachmann)

Infants who received heptavalent pneumococcal conjugate vaccination (PCV-7) at 2, 4, and 11 months were more likely than unvaccinated controls to have nasopharyngeal (in the nasal passages and upper part of the throat behind the nose) acquisition of pneumococcal serotype 19A, a leading cause of respiratory pneumococcal disease, according to a study in the September 8 issue of JAMA. Continue reading “Dosing schedule of pneumococcal vaccine linked with increased risk of getting multiresistant strain”

FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients

Public release date: 16-Aug-2010

– HRR: UPDATE As of 15 FEB 2014 ProAmatine or generic versions are still on the market being prescribed

– According to the GAO, the FDA has never once pulled a drug off the market due to missing or unimpressive follow-up data

– company has never conducted a mandatory follow-up study to actually prove the long-term benefits of the drug

Fail Road

By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer

WASHINGTON – Federal health regulators are pushing to withdraw a blood pressure drug that has been on the market for 14 (Update that to 18 years )years in spite of the manufacturer’s failure to submit evidence that it actually helps patients. Continue reading “FDA fails to withdraw unproven blood pressure drug that has been on the market for 18 years in spite of the manufacturer’s failure to submit evidence that it actually helps patients”

WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up

Conflicts of Interest

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee

The original advisory opinion was requested by...

– Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines?

– Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir?

– Why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO?

–  Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting

– FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

– conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.”

– the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

– “WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General.

Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: “I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met…The world is now at the start of the 2009 influenza pandemic.” Continue reading “WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up”

Doctors Group Sues FDA over ( Daxas, Daliresp) , Roflumilast for COPD

Highlights:

-Physicians for Integrity in Medical Research says in its federal complaint against Food and Drug Administration Commissioner Margaret Hamburg

– best-case scenario showed that roflumilast reduced the number of exacerbations by one episode a year for every five patients treated

– the regulator ignored the “statistically significant increase in incidents of prostate and lung cancer in patients taking roflumilast.”

———- Possible safe Option Vinpocetine

-Published today in the Proceedings of the National Academy of Sciences vinpocetine has great potential for the treatment of COPD and other inflammatory diseases.”

-has no evidence of toxicity or noticeable side effects in human patients Continue reading “Doctors Group Sues FDA over ( Daxas, Daliresp) , Roflumilast for COPD”

Eli Lilly and Zyprexa Under the Spotlight / (( Employees WROTE the MEDICAL STUDIES ))

Public release date: 16-Jun-2009 – Reposted at request here, so it can be permalinked…

 – was done despite Lilly’s access and knowledge of at least seven studies that showed the drug was apparently ineffective for the treatment of dementia

– use of the drug resulted in “significantly” more deaths than patients taking placebo pills in the studies

Side effects were, according to the latest unsealed documents, acknowledged, but minimized

– documents unsealed also showed that Lilly company employees wrote a number of the medical studies that demonstrated Zyprexa’s effectiveness

– studies were then submitted to medical journals and published under doctors’ names who agreed to put their names on the studies

Reviewed by John M. Grohol, Psy.D. on June 14, 2009 Eli Lilly & Co.’s atypical antipsychotic medication, Zyprexa, was not only marketed to doctors for an unapproved, off-label use — the treatment of dementia in elderly patients — but it was done despite Lilly’s access and knowledge of at least seven studies that showed the drug was apparently ineffective for the treatment of dementia.

The studies also showed that the use of the drug resulted in “significantly” more deaths than patients taking placebo pills in the studies.

Eli Lilly plead guilty to federal charges in January 2009 for illegally marketing Zyprexa for off-label uses to older Americans from 1999 to 2001.

The latest Zyprexa revelation comes as Eli Lilly continues to fight in U.S. District Court in New York against claims brought against the company by pension plans and health care insurance companies seeking to get back money spent on purchasing Zyprexa for their customers. Lilly has settled numerous previous cases related to Zyprexa for approximately $2.62 billion, including a $615 million fine for the federal charge of marketing the drug for off-label uses. Continue reading “Eli Lilly and Zyprexa Under the Spotlight / (( Employees WROTE the MEDICAL STUDIES ))”

US ranks near bottom among industrialized nations in efficiency of health care spending

Contact: Carla Denly cdenly@support.ucla.edu 310-825-6738 University of California – Los Angeles

UCLA, McGill study also shows women fare worse than men in most countries

A new study by researchers at the UCLA Fielding School of Public Health and McGill University in Montreal reveals that the United States health care system ranks 22nd out of 27 high-income nations when analyzed for its efficiency of turning dollars spent into extending lives.

The study, which appears online Dec. 12 in the “First Look” section of the American Journal of Public Health, illuminates stark differences in countries’ efficiency of spending on health care, and the U.S.’s inferior ranking reflects a high price paid and a low return on investment.   Continue reading “US ranks near bottom among industrialized nations in efficiency of health care spending”

Food and Chemical Toxicology Editor-in-Chief, A. Wallace Hayes, publishes response to letters to the editor / Was Monsanto involved in the retraction?

Contact: Meghan Jendrysik m.jendrysik@elsevier.com 617-397-2845 Elsevier

Cambridge, MA, December 10, 2013 – The following statement will be published in the journal, Food and Chemical Toxicology, alongside a selection of letters to the editors regarding the decision to retract the paper by Séralini et al.(Séralini et al., 2012).

In November 2012, this journal published an article titled “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” by Séralini et al. (Séralini et al., 2012).  The publication of this article caused quite a stir in the media, as well as in the scientific community.  The journal received many letters expressing concerns about the validity of the findings.  A careful and time-consuming analysis found that the data were inconclusive, and therefore the conclusions described in the article were unreliable. Accordingly, the article was retracted.  Since the public announcement of the retraction, the journal has received many letters to the editor; a selection of these letters will be published, along with this response to those letters. Many of these letters expressed concerns about the decision making process behind this action, particularly what role (if any) current or former Monsanto employees played, whether or not COPE guidelines were followed, and if the journal was also considering retraction of a similar paper by Hammond et al.(Hammond et al., 2004). The answers to these questions are below. Continue reading “Food and Chemical Toxicology Editor-in-Chief, A. Wallace Hayes, publishes response to letters to the editor / Was Monsanto involved in the retraction?”

Swine flu pandemic media pundits with pharma links more likely to talk up risks and promote drugs

Contact: Stephanie Burns sburns@bmj.com 44-020-738-36529 BMJ-British Medical Journal

 

Competing interests should be declared — and reported — to maintain credibility of public health, say researchers

Academics with links to the pharmaceutical industry were more likely to talk up the risks of the 2009-10 swine flu pandemic in the media and promote the use of drugs than those without these ties, finds research published online in the Journal of Epidemiology and Community Health

During the 2009-2010 swine flu pandemic, the UK spent an estimated £1 billion on pharmaceuticals, including antiviral drugs (neuraminidase inhibitors) and an H1N1 specific vaccine.  Pharma made £4.5-6.5 billion out of H1N1 vaccines alone.  

Concerns were subsequently raised about the links (competing interests) experts on influential scientific advisory committees, including the WHO’s Emergency Committee, had with drug companies. 

Researchers retrospectively analysed UK newspaper print coverage of the HIN1 swine flu pandemic, to assess the extent of competing interests among sources quoted on the topic between April and July 2009—the period when major decisions were being made about how best to respond to the emerging threat. 

Daily, Sunday, tabloid, middle market, and broadsheet publications on both sides of the political spectrum were included, to reflect a range of perspectives and reporting styles. Broadcast media were excluded on the grounds that print media offered more in-depth analysis and more divergent viewpoints. 

The final sample of 425 articles was scrutinised for the sources quoted, the assessment of the risk to the population made by each source, and the promotion or rejection of drugs/vaccines. 

Competing interests for each named academic quoted were then unearthed, using conflict of interest statements, funding sources detailed on profile pages, Google searches, and funding declarations on all publications in the previous four years. 

Grants, honoraria, speakers’ fees, consultancies, advisory roles, employment, and directorship/stock ownership were all considered competing interests. 

The analysis showed that during the study period, health ministers were the most frequently quoted source (34%) in media articles on swine flu, followed by academics (30%). Sixty one academics were quoted, 18 (30%) of whom had competing interests. 

The academics made 74 risk assessments, over half of which (44; 59.5%) were higher than those made by official agencies, such as the Department of Health, in the same article.  

Of these, 35 were made by academics with competing interests, meaning that risk assessments from these academics were almost six times as likely to be higher than those from official agencies, compared with risk assessments made by academics without any industry links. 

Twenty academics commented specifically on drugs/vaccines in 36 articles (8.5% of the total). Half of them had competing interests—a higher proportion than the one in three on the WHO’s Emergency Committee. 

Half of the commentators promoted the use of antiviral drugs and around half (45%) promoted the use of a vaccine. Some 15% promoted both. 

Academics promoting the use of antiviral drugs in newspaper articles were eight times more likely to have pharma industry links than those not commenting on their use.  

Only three articles out of the 425 mentioned that the quoted academic had a potential competing interest. 

The researchers acknowledge that the interviews may have contained more nuanced views than appeared in print, and that journalists may have sought divergent views to balance a story or increase its newsworthiness.

But academics are a trusted and accessible source of comment for journalists and are in a unique and powerful position during emerging public health threats, they say.

“Our results provide some evidence that the provision of higher risk assessments and the promotion of [antiviral drugs] are associated with [competing interests] among academics,” they write. 

“These add to the growing body of literature highlighting the potential influence of the pharmaceutical industry on policy decisions through multiple avenues, including advisory committees, drafting of guidelines, and media commentary,” they note.

“Undisclosed [competing interests] degrades public confidence in medical research, to the detriment of the whole scientific community,” they write, concluding: “Academics should declare, and journalists report, relevant [competing interests] for media interviews.”

Commenting on the research, the journal’s joint editors, Martin Bobak and Jim Dunn, add: “This paper clearly shows that ‘scientific advice’ is not necessarily independent and that it is influenced by often undisclosed interests. From an editor’s point of view, this is disturbing, because there are limits as to how far journals can go in establishing authors’ conflicts of interest.”

###

[Academics and competing interests in H1N1 influenza media reporting Online First doi 10.1136/jech-2013-203128]

Wider use of statins ‘disturbing’

Wider use of statins will have minimal benefit and could needlessly expose   thousands to severe side effects, doctors warn following change in US   prescription guidelines

Wider use of statins will have minimal benefit and could needlessly expose thousands to severe side effects, doctors warn following change in US prescription guidelines

New US guidelines on statins, issued on Tuesday by the American College of Cardiology and the American Heart Association, recommend that doctors should consider prescribing the drugs to all people with at least a 7.5 per cent risk of suffering a heart attack or stroke within the next decade Photo: ALAMY

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Nick Collins

By , Science Correspondent

2:55PM GMT 14 Nov 2013

Prescribing statins to millions more healthy people would make only a minimal   difference to their average lifespan but risk exposing thousands to harmful   side effects, a leading doctor has claimed.

Dr Aseem Malhotra, a cardiology specialist registrar at Croydon University   Hospital, said he would be “disturbed” if Britain followed America   in changing prescription guidelines to widen use of statins.

There is “no doubt” that the cholesterol-lowering drugs reduce the   likelihood of heart attacks and strokes in people with heart disease, he   said, but the potential benefits of medicating millions more who are at low   risk could be dramatically outweighed by the associated harms.

Side effects experienced by up to one in five patients include severe muscle   aches, memory disturbance, sexual dysfunction, cataracts and diabetes.

New   US guidelines on statins, issued on Tuesday by the American College of   Cardiology and the American Heart Association, recommend that doctors should   consider prescribing the drugs to all people with at least a 7.5 per cent   risk of suffering a heart attack or stroke within the next decade.

US experts who drafted the new guidance said doctors had been “undertreating”   patients and that the new advice would mean “more people who would   benefit from statins are going to be on them”.

But the guidelines have also raised concerns among doctors in America, and in   Britain where current advice that statins should be prescribed to those with   a 20 per cent risk over 10 years is under review.

The National Institute of Health and Care Excellence has confirmed that the   same recent clinical evidence which prompted the change in US policy will   form part of its own decision, and experts believe the threshold could be   lowered.

Dr Malhotra said: “I think it is very possible that this will also happen   in Britain.

“One thing we have learned in the past decade is the considerable   influence of a very financially powerful pharmaceutical industry over   prescribing and modern medicine, and the trends suggest that this influence   will have the same kind of effect over in the UK [as in America].”

Statins, which cost the NHS less than 10p per day, have become the most widely   prescribed drugs in Britain and are currently used by an estimated six   million people.

Some experts have claimed that all over-50s should take the drugs routinely to   lower their levels of “bad” LDL cholesterol and protect against   heart attacks and strokes.

Dr David Wald, a cardiologist at Queen Mary, University of London, said on Wednesday it would be “sensible” to lower the threshold on eligibility, which would be “heading towards the point where statins may eventually be offered to everyone once they reach a certain age of around 55.”

But a recent   analysis published in the British Medical Journal found that even   patients with a 20 per cent risk of a heart attack or stroke who were over   the age of 50 may not benefit from the drugs.

“This expansion of use of statins is not good for public health,”   Dr Malhotra said. “There is no doubt that for people with established   heart disease the benefits outweigh the risks, but for people who do not   have established heart disease this isn’t the case … I would be very   disturbed if the UK were to follow suit.”

Writing in the New York Times Dr John D Abramson, who co-wrote the BMJ review,   and Dr Rita F Redberg said wider use of statins “will   benefit the pharmaceutical industry more than anyone else”.

“For people who have less than a 20 per cent risk of getting heart   disease in the next 10 years, statins not only fail to reduce the risk of   death, but also fail even to reduce the risk of serious illness,” they   said.

“Instead of converting millions of people into statin customers, we   should be focusing on the real factors that undeniably reduce the risk of   heart disease: healthy diets, exercise and avoiding smoking.”

http://www.telegraph.co.uk/health/healthnews/10449514/Wider-use-of-statins-disturbing.html

 

Blue Cross Conspired to Destroy Company Serving Hemophiliacs, Firm Says

 

 

 

By IULIA FILIP

 

WEST PALM BEACH (CN) – Blue Cross Blue Shield destroyed a health care company by refusing to pay claims of its hemophiliac patients and conducting a “witch hunt” that destroyed its reputation, the company claims in court.

Factor Health Management sued The Blue Cross Blue Shield Association, six of its licensees, several employees, and pharmacy benefit management company Express Scripts Holding Co., in Palm Beach County Court. Factor subsidiaries FHM Group and FCS Pharmacy also are plaintiffs.

Factor Health was a disease management company and pharmaceutical wholesaler that provided specialty drugs and services to hemophiliacs.

FCS Pharmacy was a Boca Raton-based specialty pharmacy that focused on hemophilia, hepatitis and HIV treatments.

Factor Health claims that Blue Cross Blue Shield and its licensees conspired to drive it out of business and steer its hemophilia patients to pharmacy chains and pharmacy benefit management companies and to government programs such as Medicare and Medicaid.

According to the lawsuit, the conspirators falsely accused the FHM companies of fraud, reported them to state and federal law enforcement, fabricated reasons to deny payment of their patients’ claims, defamed them to patients, vendors, insurance companies and regulators, and harmed their relationships with customers.

They also reduced payouts to the FHM companies to sabotage a deal to sell FHM’s pharmacy business to a private equity firm and to force it out of business, according to the complaint.

Factor Health and FCS Pharmacy claim that before the defendants drove them out of business they were the preferred suppliers of drugs and disease management services for hemophiliacs in the United States.

Hemophilia, a hereditary genetic disorder, impairs the body’s ability to control blood clotting. It affects around 20,000 people in the United States. Hemophiliacs often suffer from spontaneous internal bleeding that can cause serious injuries or death, and rely on synthetic drugs, known as factor drugs, to replace the missing clotting factor in their blood.

Pharmaceutical companies developed the drugs, which can cost tens of thousands of dollars a month, after the 1990s, when the blood supply in the United States was contaminated with hepatitis and the HIV virus, infecting 6,000 to 10,000 hemophiliacs who used drugs derived from human blood plasma.

Most pharmacies do not stock synthetic clotting factor drugs, which are expensive and have a limited shelf life.

Factor Health and FCS Pharmacy claim they had experience in meeting the specific needs of patients with hemophilia, and also provided disease management services – including counseling, education and disease-tracking services – at no cost to patients or insurers.

Factor Health claims that by the end of 2009, Blue Cross Blue Shield, several of its licensees and affiliated pharmacies managed to destroy its once-profitable business through a series of investigations based on unfounded allegations and their refusal to pay its patients’ claims.

The complaint states: “In a concerted, calculated and intentional effort to neutralize and ultimately extinguish a quickly growing competitor, defendants, under the guise of completely bogus various and never-ending ‘investigations,’ actively participated in a scheme to: (a) drive plaintiffs out of business by improperly withholding millions of dollars in payments for factor drugs dispensed by plaintiffs to the licensees defendants’ insureds after the licensee defendants had specifically authorized the delivery of factor drugs to those insureds, (b) steer plaintiffs’ hemophilia patients to chain pharmacies and pharmacy benefit managers (‘PBMs’) from whom defendants receive a direct or indirect financial benefit and/or in which defendants have a financial interest, and (c) purge hemophiliacs from the rosters of their insureds and push plaintiffs’ hemophilia patients to government programs such as Medicare and Medicaid. Defendants accomplished this scheme by: (a) filing wild, baseless and completely false reports to state and federal law enforcement authorities alleging criminal conduct on the part of plaintiffs, (b) actively conspiring to create ways to avoid paying plaintiffs sums owed pursuant to health insurance contracts, (c) falsely and regularly defaming plaintiffs to patients, vendors, workers, insurance companies, regulators and others, (d) tortiously interfering in the existing and prospective business relationships plaintiffs enjoyed with their customers and potential customers, and (e) reducing payouts to the FHM parties in order to scuttle a deal to sell the FHM parties’ pharmacy business to a private equity firm and to force the FHM parties out of business.”

The Factor Health companies claim that Blue Cross Blue Shield, its licensees and pharmacy benefit management companies such as defendant Express Scripts conspired to drive hemophilia patients away from Factor Health’s business, to their own benefit.

Pharmacy benefits managers process and pay prescription drug claims on behalf of health insurance companies. They also oversee, and can investigate and audit, pharmacies on their own initiative or at the request of their health insurer clients, according to the complaint.

“PBMs therefore, on the one hand, directly compete with independent pharmacies by owning and operating their own retail and mail order pharmacies and, on the other hand, play a role in the adjudication of claims and the investigation of pharmacies by health insurers, including the investigation of the very pharmacies with whom the PBMs compete,” the complaint states.

“This conflict of interest is intensified when the health insurers own or have direct or indirect interests in PBMs. On information and belief, PBMs associated with defendants – including Express Scripts – participated in the ‘investigation’ of the FHM parties at the same time as the licensee defendants were ‘suggesting’ that patients switch to the pharmacies run by those same PBMs.”

Blue Cross Blue Shield of Florida and other Blue Cross licensees contacted the FBI, the Food and Drug Administration and other federal and state agencies with baseless allegations that Factor Health was diverting millions of dollars worth of factor drugs, according to the complaint.

Factor Health claims all the investigations were closed without any finding of wrongdoing.

It claims the defendants tried to persuade satisfied patients to switch to pharmacies preferred by the insurers, including by telling patients that they would process claims only from those pharmacies.

The 38 licensees of the Blue Cross Blue Shield Association insure more than 100 million Americans, about one-half of all Americans with private health insurance. They each have a license for an exclusive geographic area and an agreement not to compete with each other, according to the lawsuit.

Factor Health claims that some licensees tried to cancel health coverage for its employees, many of whom suffered from hemophilia.

It claims the investigations and audits triggered by the Blue Cross licensees and affiliates were “nothing more than a convenient excuse for defendants to use as cover for their witch hunt and as a reason to deny timely payment.”

Blue Cross Blue Shield and its licensees in fact were trying to purge their rolls of patients with hemophilia, to avoid “exposure” to claims for expensive drugs, according to the complaint.

Factor Health claims that Blue Cross and its licensees have a policy of denying claims for expensive medical treatment and trying to remove patients requiring expensive treatment from their insurance rolls.

The defendants’ refusal to reimburse Factor Health for millions of dollars worth of pre-authorized drugs, even after no evidence of wrongdoing was found, caused the company’s accounts receivable to spike and left it unable to pay its creditors, according to the lawsuit.

Factor Health claims that as a result of the conspiracy, its revenue dropped by nearly half in a very short time, it defaulted on loans, and reported millions of dollars in losses.

It claims it was forced out of business, its hemophilia patients were denied the services of the health care provider of their choice, and the market for hemophilia drugs and related disease management services was destroyed.

What’s more, independent pharmacies may not be willing to carry expensive specialty drugs to avoid being harassed by insurers, the complaint states.

Factor Health claims that by reducing the payout on claims, Blue Cross Blue Shield of Florida caused it to lose a deal with a private investment firm one day before the transaction was completed.

Factor Health seeks more than $100 million in damages for tortious interference with business relationships, civil conspiracy, defamation and unfair competition.

It is represented by Ryon McCabe with McCabe Rabin of West Palm Beach and Anthony Paduano and Jason Snyder with Paduano & Weintraub of New York City.

“Defendants have destroyed a once-thriving business and deprived the hemophilia community of a valued and trusted provider of life-saving medicine and disease management services,” attorney Jason Snyder said in a statement. “The FHM parties look forward to the opportunity to vindicate their rights, and the rights of the hemophilia community, in court.”

Representatives for the Blue Cross Blue Shield Association did not reply to requests for comment.

http://www.courthousenews.com/2013/11/13/62853.htm

Unpublished trial data ‘violates an ethical obligation’ to study participants, say researchers / 1 in 3 large clinicals not Published

Contact: Stephanie Burns
sburns@bmj.com
44-020-738-36920
BMJ-British Medical Journal

 

Study finds almost 1 in 3 large clinical trials still not published 5 years after completion

Almost one in three (29%) large clinical trials remain unpublished five years after completion. And of these, 78% have no results publicly available, finds a study published on bmj.com today.

This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, say the authors.

They argue that this “violates an ethical obligation that investigators have towards study participants” and call for additional safeguards “to ensure timely public dissemination of trial data.”

Randomized clinical trials are a critical means of advancing medical knowledge. They depend on the willingness of people to expose themselves to risks, but the ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial.

But when trial data remain unpublished, the societal benefit that may have motivated someone to enrol in a study remains unrealized.

US law requires that many trials involving human participants be registered – and their results posted – on the largest clinical trial website ClinicalTrials.gov. But evidence suggests that this legislation has been largely ignored.

So a team of US-based researchers set out to estimate the frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.

They searched scientific literature databases and identified 585 trials with at least 500 participants that were registered with ClinicalTrials.gov and completed prior to January 2009. The average time between study completion and the final literature search (November 2012) was 60 months for unpublished trials.

Registry entries for unpublished trials were then reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Of 585 registered trials, 171 (29%) remained unpublished. Of these, 133 (78%) had no results available in ClinicalTrials.gov. Non-publication was more common among trials that received industry funding (32%) than those that did not (18%).

“Our results add to existing work by showing that non-publication is an important problem even among large randomized trials,” say the authors. Furthermore, the sponsors and investigators of these unpublished trials infrequently utilize the ClinicalTrials.gov results database.

The lack of availability of results from these trials “contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation,” they add. “Additional safeguards are needed to ensure timely public dissemination of trial data,” they conclude.

“Merck and Schering-Plough must pay $688 million for lying to shareholders about the benefits of cholesterol drug Vytorin over its cheaper, generic version”

$688 Million Settlement Approved in Merck Case

By ROSE BOUBOUSHIAN

(CN) – Merck and Schering-Plough must pay $688 million for lying to shareholders about the benefits of cholesterol drug Vytorin over its cheaper, generic version, a federal judge ruled.

The complaint, filed in New Jersey federal court in 2008, accused Merck & Co. Inc. fka Schering-Plough Corp. of hiding from the public that its drug Vytorin, a fixed-dose combination pill containing the anti-cholesterol agent Zetia, was no more effective at reducing formation of plaque in carotid arteries than Zocor, a cheaper, generic drug containing only Simvastatin. Though the drugs’ clinical trial ended in May 2006, Merck and Schering – to avoid damaging their common stock price – only partially reported the results in January 2008, and did not release the full results until several months later, the complaint states.

The defendants meanwhile not only blamed the delay on data issues, but also publicly touted the purportedly greater benefits of Vytorin over Simvastatin alone, the plaintiffs say.

Around the time the partial results were published, reports on Congressional and regulatory investigations into Merck and Schering’s improper marketing were released, causing the manufacturer’s common stock price to drop from $60.55 to $54.87 per share.

The price had dropped to $38.75 per share by the end of March, according to an unpublished ruling by U.S. District Judge Dennis Cavanaugh in September 2012.

Therein, the judge certified a class of all those who purchased or acquired Merck common stock or call options and/or sold Merck put options from Dec. 6, 2006 to March 28, 2008 and did not sell them on or before Jan. 14, 2008.

Lead plaintiffs included Stichting Pensioenfonds ABP, the Netherlands’ pension fund for government employees; Luxembourg’s International Fund Management S.A.; the Jacksonville Police and Fire Retirement System in Florida; and Detroit’s General Retirement System.

Also named as defendants were Merck’s American and Singapore distribution services companies, as well as its Chairman, President, and former CEO Richard Clark and several other executivess.

After a 36-state settlement was reached in 2009, Merck and Schering ultimately agreed to pay a total of $688 million to damaged investors.

Upon reviewing two special masters’ report and recommendation on the matter, Judge Cavanaugh finally approved the settlement as consistent with the 3rd Circuit’s 1975 decision in Girsh v. Jepson, on Oct. 1.

Although more than a million potential class members were notified of the settlement, only two oppositions have been filed, the unpublished ruling states.

“Here, the litigation is at a very advanced stage, as the settlements were reached only a few weeks before trial was to begin,” Cavanaugh wrote. “Discovery has been going on for years and has consisted of a vast number of depositions, the review of millions of documents, mock trials, and extensive pre-trial-preparation. The parties have clearly had the opportunity to gain a detailed understanding of the case during this time.”

The court further held that the benefits of accepting the immediate settlement funds outweigh the potential woes of a jury trial.

Cavanaugh also agreed to award co-lead counsel in the Schering case more than $4 million attorneys’ fees and costs.

http://www.courthousenews.com/2013/10/11/61977.htm

40 years of CDC nutrition research fatally flawed

Contact: Jeff Stensland stenslan@mailbox.sc.edu 803-777-3686 University of South Carolina

40 years of federal nutrition research fatally flawed

University of South Carolina study shows flaws in NHANES data

Four decades of nutrition research funded by the Centers for Disease Control and Prevention (CDC) may be invalid because the method used to collect the data was seriously flawed, according to a new study by the Arnold School of Public Health at the University of South Carolina.

The study, led by Arnold School exercise scientist and epidemiologist Edward Archer, has demonstrated significant limitations in the measurement protocols used in the National Health and Nutrition Examination Survey (NHANES). The findings, published in PLOS ONE (The Public Library of Science), reveal that a majority of the nutrition data collected by the NHANES are not “physiologically credible,” Archer said.

These results suggest that without valid population-level data, speculations regarding the role of energy intake in the rise in the prevalence of obesity are without empirical support, he said.

The NHANES is the most comprehensive compilation of data on the health of children and adults in the United States. The survey combines interviews of self-reported food and beverage consumption over 24 hours and physical examinations to assess the health and nutritional status of the US population. Conducted by the CDC and the U.S. Department of Agriculture, the NHANES is the primary source of data used by researchers studying the impact of nutrition and diet on health.

The study examined data from 28,993 men and 34,369 women, 20 to 74 years old, from NHANES I (1971 – 1974) through NHANES (2009 – 2010), and looked at the caloric intake of the participants and their energy expenditure, predicted by height, weight, age and sex. The results show that — based on the self-reported recall of food and beverages — the vast majority of the NHANES data “are physiologically implausible, and therefore invalid,” Archer said.

In other words, the “calories in” reported by participants and the “calories out,” don’t add up and it would be impossible to survive on most of the reported energy intakes. This misreporting of energy intake varied among participants, and was greatest in obese men and women who underreported their intake by an average 25 percent and 41 percent (i.e., 716 and 856 Calories per-day respectively).

“Throughout its history, the NHANES survey has failed to provide accurate estimates of the habitual caloric consumption of the U.S. population,” Archer said. “Although improvements were made to the NHANES measurement protocol after 1980, there was little improvement to the validity of U.S. nutritional surveillance.”

These limitations “suggest that the ability to estimate population trends in caloric intake and generate public policy relevant to diet-health relationships is extremely limited,” said Archer, who conducted the study with colleagues at the Arnold School.

“The nation’s major surveillance tool for studying the relationships between nutrition and health is not valid. It is time to stop spending tens of millions of health research dollars collecting invalid data and find more accurate measures,” he said.

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To access the current study, please visit: http://dx.plos.org/10.1371/journal.pone.0076632.

Current study shows: Important information on effects and side effects of drugs is missing in most publications

IQWiG: Reliable assessment of drugs is only possible on the basis of clinical study reports (CSRs)

In 2012 researchers from the German Institute for Quality and Efficiency in Health Care (IQWiG) presented a study in the BMJ analysing information sources used in 16 health technology assessment (HTA) reports of drugs (“benefit assessments”). This study clearly demonstrated that publicly available sources, such as scientific journals and entries posted in trial registries (“registry reports”), contained far less information on methods and outcomes of clinical trials than non-public CSRs prepared by pharmaceutical companies.

In a second article published today in PLOS Medicine, the IQWiG researchers now show that if, instead of only assessing selected outcomes as in the first study, all patient-relevant outcomes of the clinical trials are assessed, the information deficit in the publicly available sources is even greater.

Data analysed for more than 1000 outcomes

All HTA reports of drugs completed by IQWiG between 2006 and 2011 also formed the basis for the new study. The authors included those trials from the HTA reports for which the pharmaceutical companies had provided complete CSRs to IQWiG. Publicly available information in scientific journals and trial registries was available for 86 out of 101 of these trials, so that the information provided in all 3 sources could be compared. The trials contained data on more than 1000 patient-relevant outcomes such as mortality or disease symptoms.

Huge difference in the information provided

IQWiG assessed whether the results on the patient-relevant outcomes in the trials were “completely” or “incompletely” reported. The difference in the information provided was immense: Whereas 86% of all outcomes were fully reported in unpublished CSRs, the corresponding number was only 39% for combined publicly available sources. Likewise, negative effects on patients (“harm outcomes”) such as serious adverse events or treatment discontinuations were reported far less often in the publicly available sources (27 to 72% versus 84 to 92%, depending on the harm outcome investigated).

Make CSRs publicly accessible

Beate Wieseler, Head of the Drug Assessment Department, comments on this first comprehensive quantification of the information gain through full CSRs: “The publicly available journal articles and registry entries thus report less than half of outcomes of clinical trials comprehensively. At the same time, with CSRs documents are available that provide complete information on methods and outcomes. The consequence can only be: all CSRs must be made publicly accessible. One should note that IQWiG is already in a privileged position due to its legal remit to conduct benefit assessments. Other researchers and physicians wishing to be fully informed about the advantages and disadvantages of an intervention have even more difficulties in gaining access to data.

Although the proportion of clinical trials published as scientific articles or registry reports has increased in the past few years, this is unfortunately not accompanied by more complete reporting of patient-relevant outcomes. Large information gaps still remain and we cannot even guess how large these gaps are in other types of drug trials or in trials of non-drug interventions.”

Need for legislation

Beate Wieseler further points out: “The plan by the European Medicines Agency (EMA) to make all clinical trial data submitted for marketing authorization publicly available from January 2014 onwards can therefore only be a first step. A central repository is required, also including data from older trials, as such trials investigate drugs widely used in current medical practice. These data would probably shed a totally new light on several drugs and their position in their therapeutic area. However, a voluntary commitment by the pharmaceutical industry, which would like to decide on a case-by-case basis which data it discloses, is insufficient. We are hoping for legislation and continue to support the All Trials Campaign (see below) so that the problem stays on the agenda.”

The widespread acceptance of an atrocious manuscript, fabricated by an investigative journalist, reveals the near absence of quality at some journals

Fake Paper Exposes Failed Peer Review

By Kerry Grens  | October 6, 2013

 

Having an authentic name, representing a real research institution, and offering actual scientific results are apparently not required for publication in many open access journals, Science has found. A completely invented scientist—“Ocorrafoo Cobange”—who worked at a fabricated institution—“the Wassee Institute of Medicine in Asmara”—was able to get the same terribly faked paper accepted for publication in 157 journals. “My hope is that now that we have a map of at least some of the good versus bad journals, scientists can submit their paper to one of the good guys and for the same amount of money get the real deal,” John Bohannon, the Science correspondent who did the investigation, told NPR.

Many of the journals were already flagged by Beall’s List, which catalogs questionable publications, but others were present in the Directory of Open Access Journals, which aims to list credible publications. One example Bohannon highlighted in his report was a journal published by Sage, which was named “the Independent Publishers Guild Academic and Professional Publisher of the Year” in 2012. “The Sage publication that accepted my bogus paper is the Journal of International Medical Research. Without asking for any changes to the paper’s scientific content, the journal sent an acceptance letter and an invoice for $3,100,” Bohannon wrote.

Bohannon’s article details what others have also found: that open-access publishers have varied standards. But some have criticized the investigation as hostile toward open access, given that Bohannon didn’t compare the acceptance rate among open access journals to those that require a subscription. “In short, Bohannon’s article isn’t really about open access. It’s about a flawed system of trusting journals and the inherent problems in peer review, but he targets only open access here,” Martin Eve from the University of Lincoln in the UK wrote at The Conversation.

http://www.the-scientist.com/?articles.view/articleNo/37798/title/Fake-Paper-Exposes-Failed-Peer-Review/

 

Drug companies paid big bucks to attend FDA painkiller meetings

  • Article by: Peter Whoriskey
  • Washington Post
  • October 6, 2013 – 11:15 PM

 

WASHINGTON – A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration (FDA), according to hundreds of e-mails obtained by a public records request.

The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”

Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States.

FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and cowrote papers with employees of pharmaceutical companies.

The FDA has been criticized for not taking precautions that might have averted the epidemic of addiction to prescription drugs including OxyContin and other opioids.

“These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington. “Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.”

Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a “pay to play process.”

FDA officials did not benefit financially from their participation in the meetings, the agency said. But two later went on to work as pharmaceutical consultants and more than this, the critics said, the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.

In a statement, the FDA said “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” associated with the group.

http://www.startribune.com/business/226694611.html

 

© 2013 Star Tribune

Japan to raid Novartis over alleged data fabrication

27    Sep   2013
Tokyo (AFP)

Japanese authorities are preparing to raid the local arm of Swiss pharmaceutical giant Novartis over data fabrication claims, reports said Friday.

A health ministry panel of experts has concluded that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on a popular blood pressure drug, the Asahi Shimbun and other media said.

The studies suggested the drug — sold under the name Diovan in Japan and licensed for use in more than 100 countries — had some prophylactic effect on strokes and angina.

The firm used data from the studies to market its drug, playing up its supposed additional benefits.

“The panel is examining the possibility of exaggerated advertisement which is a violation of the Pharmaceutical Affairs Act and will urge the government to take strict actions,” against Novartis Pharma KK, the Asahi said.

Upon receipt of the panel’s interim report next week, “the health ministry plans to carry out an on-site investigation” into the company, the Asahi said.

The panel’s report will also say the company and the universities must be held accountable for the faulty studies, regardless of the degree of their involvement, the Mainichi Shimbun said.

The panel will also urge the authorities to estimate the financial impact of the studies on the nation’s health insurance finances, the Mainichi said.

Novartis has maintained that the company had no knowledge of episodes in which a now-former employee allegedly used bogus data in a string of Japanese university studies that exaggerated the drug’s effectiveness in preventing strokes and angina.

The worker had hidden his affiliation with Novartis during the studies at various institutions that used incomplete clinical data to demonstrate the effects of the drug, hospitals and media reports have said.

The worker and other researchers involved in studies have denied to the panel that they manipulated the data, the Mainichi previously said.

Novartis Pharmaceuticals chief David Epstein was called to meet with Health Minister Norihisa Tamura and promised Thursday to cooperate with Tokyo’s probe into the matter.

Epstein apologised for the concern the incident has caused, but did not admit the company’s role in the data fixing allegations, a company spokeswoman said.

Tokyo’s Jikei University School of Medicine has retracted research that appeared in respected medical journal The Lancet six years ago due to data fabrication.

Kyoto Prefectural University of Medicine also concluded that its studies on the drug used incomplete clinical data.

Eli Lilly ‘concerned’ by China bribery allegations

23   Aug   2013
SHANGHAI (AFP)

US drugmaker Eli Lilly said it was “deeply concerned” about allegations it bribed Chinese doctors to prescribe its products, the latest accusations of malpractice by foreign firms in the country.

A former Eli Lilly sales manager claimed the firm paid at least 30 million yuan ($4.9 million) in kickbacks to doctors for promoting two insulin drugs in Shanghai and neighbouring Anhui province, the 21st Century Business Herald reported Thursday.

The whistleblower, using a pseudonym, said bribery was a “very common” practice at the company, which also offered doctors payments through speeches and conferences, the paper said.

“We are deeply concerned about the allegations made against Lilly China,” the drugmaker said in an emailed statement late Thursday.

It admitted being aware of similar allegations last year and had conducted an “exhaustive” investigation through employee interviews, email monitoring and expense report audits.

“Although we have not been able to verify these allegations, we take them seriously, and we are continuing our investigation,” the statement said.

Eli Lilly is the third foreign drug firm embroiled in corruption scandals in China, after similar accusations against Britain’s GlaxoSmithKline (GSK) and France’s Sanofi emerged over the past two months.

Authorities have detained four Chinese GSK executives and formally arrested a foreign husband-and-wife team of fraud investigators whose firm did work for GSK, after allegations that GSK employees used nearly $500 million in bribes to boost sales.

Chinese regulators have opened an investigation into Sanofi, state media reported earlier this month.

It is common practice in China for pharmaceutical firms to offer doctors and hospitals bribes to have their products used, industry insiders say.

 

http://www.afp.com/en/news/topstories/eli-lilly-concerned-china-bribery-allegations