Psychological ‘vaccine’ could help immunize public against ‘fake news’ on climate change

Public Release: 22-Jan-2017

 

University of Cambridge

 

In medicine, vaccinating against a virus involves exposing a body to a weakened version of the threat, enough to build a tolerance.

Social psychologists believe that a similar logic can be applied to help “inoculate” the public against misinformation, including the damaging influence of ‘fake news’ websites propagating myths about climate change.

A new study compared reactions to a well-known climate change fact with those to a popular misinformation campaign. When presented consecutively, the false material completely cancelled out the accurate statement in people’s minds – opinions ended up back where they started.

Researchers then added a small dose of misinformation to delivery of the climate change fact, by briefly introducing people to distortion tactics used by certain groups. This “inoculation” helped shift and hold opinions closer to the truth – despite the follow-up exposure to ‘fake news’.

The study on US attitudes found the inoculation technique shifted the climate change opinions of Republicans, Independents and Democrats alike.

Published in the journal Global Challenges, the study was conducted by researchers from the universities of Cambridge, UK, Yale and George Mason, US. It is one of the first on ‘inoculation theory’ to try and replicate a ‘real world’ scenario of conflicting information on a highly politicised subject.

“Misinformation can be sticky, spreading and replicating like a virus,” says lead author Dr Sander van der Linden, a social psychologist from the University of Cambridge and Director of the Cambridge Social Decision-Making Lab.

“We wanted to see if we could find a ‘vaccine’ by pre-emptively exposing people to a small amount of the type of misinformation they might experience. A warning that helps preserve the facts.

“The idea is to provide a cognitive repertoire that helps build up resistance to misinformation, so the next time people come across it they are less susceptible.”

To find the most compelling climate change falsehood currently influencing public opinion, van der Linden and colleagues tested popular statements from corners of the internet on a nationally representative sample of US citizens, with each one rated for familiarity and persuasiveness.

The winner: the assertion that there is no consensus among scientists, apparently supported by the Oregon Global Warming Petition Project. This website claims to hold a petition signed by “over 31,000 American scientists” stating there is no evidence that human CO2 release will cause climate change.

The study also used the accurate statement that “97% of scientists agree on manmade climate change”. Prior work by van der Linden has shown this fact about scientific consensus is an effective ‘gateway’ for public acceptance of climate change.

In a disguised experiment, researchers tested the opposing statements on over 2,000 participants across the US spectrum of age, education, gender and politics using the online platform Amazon Mechanical Turk.

In order to gauge shifts in opinion, each participant was asked to estimate current levels of scientific agreement on climate change throughout the study.

Those shown only the fact about climate change consensus (in pie chart form) reported a large increase in perceived scientific agreement – an average of 20 percentage points. Those shown only misinformation (a screenshot of the Oregon petition website) dropped their belief in a scientific consensus by 9 percentage points.

Some participants were shown the accurate pie chart followed by the erroneous Oregon petition. The researchers were surprised to find the two neutralised each other (a tiny difference of 0.5 percentage points).

“It’s uncomfortable to think that misinformation is so potent in our society,” says van der Linden. “A lot of people’s attitudes toward climate change aren’t very firm. They are aware there is a debate going on, but aren’t necessarily sure what to believe. Conflicting messages can leave them feeling back at square one.”

Alongside the consensus fact, two groups in the study were randomly given ‘vaccines’:

  • A general inoculation, consisting of a warning that “some politically-motivated groups use misleading tactics to try and convince the public that there is a lot of disagreement among scientists”.
  • A detailed inoculation that picks apart the Oregon petition specifically. For example, by highlighting some of the signatories are fraudulent, such as Charles Darwin and members of the Spice Girls, and less than 1% of signatories have backgrounds in climate science.

For those ‘inoculated’ with this extra data, the misinformation that followed did not cancel out the accurate message.

The general inoculation saw an average opinion shift of 6.5 percentage points towards acceptance of the climate science consensus, despite exposure to fake news.

When the detailed inoculation was added to the general, it was almost 13 percentage points – two-thirds of the effect seen when participants were just given the consensus fact.

The research team point out that tobacco and fossil fuel companies have used psychological inoculation in the past to sow seeds of doubt, and to undermine scientific consensus in the public consciousness.

They say the latest study demonstrates that such techniques can be partially “reversed” to promote scientific consensus, and work in favour of the public good.

The researchers also analysed the results in terms of political parties. Before inoculation, the fake negated the factual for both Democrats and Independents. For Republicans, the fake actually overrode the facts by 9 percentage points.

However, following inoculation, the positive effects of the accurate information were preserved across all parties to match the average findings (around a third with just general inoculation; two-thirds with detailed).

“We found that inoculation messages were equally effective in shifting the opinions of Republicans, Independents and Democrats in a direction consistent with the conclusions of climate science,” says van der Linden.

“What’s striking is that, on average, we found no backfire effect to inoculation messages among groups predisposed to reject climate science, they didn’t seem to retreat into conspiracy theories.

“There will always be people completely resistant to change, but we tend to find there is room for most people to change their minds, even just a little.”

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.

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.

Drug treatments to prevent hip fracture are neither viable, cost effective, yet dangerous

Public Release: 26-May-2015

“Pharmacotherapy can achieve at best a marginal reduction in hip fractures at the cost of unnecessary psychological harms, serious medical adverse events

Current strategy is inefficient and associated with considerable harms, say experts

Professor Teppo Järvinen and colleagues say drug treatment “can achieve at best a marginal reduction in hip fractures at the cost of unnecessary harms and considerable waste of monetary resources.” The article is part of The BMJ‘s Too Much Medicine campaign — to highlight the threat to human health and the waste of resources caused by unnecessary care.

Worldwide, about 1.5 million hip fractures occur each year. They impose an enormous burden on healthcare resources and, with a growing elderly population, their incidence is predicted to rise.

Before the late 1980’s, osteoporosis was diagnosed after a bone fracture. But in 1994, a new definition – based on low bone mineral density – was introduced to identify people at increased fracture risk who were likely to benefit from bone building drugs.

Fracture risk calculators now classify 72% of US white women aged over 65 years and 93% of those aged over 75 years as candidates for long term drug treatment. Yet rates of hip fracture have fallen steadily in most Western countries, regardless of access to drugs, say the authors.

Most hip fractures, they say, have little to do with osteoporosis, but rather are caused by falls in frail older adults.

Evidence on cost effectiveness of drug treatment is completely lacking, they add, while the focus on drug treatment means that feasible alternative strategies, such as physical activity, are overlooked.

They also point to the harms from overdiagnosis and treatment, including the psychological burden associated with a disease label, and adverse effects of drug treatment such as nausea, vomiting, and serious bone complications (osteonecrosis of the jaw and drug-induced pathological fractures of the thigh bone).

Recent evidence also challenges the justification for the general use of calcium and vitamin D supplements to prevent fractures, they write.

The dominant approach to hip fracture prevention “is neither viable as a public health strategy nor cost effective,” conclude the authors.

“Pharmacotherapy can achieve at best a marginal reduction in hip fractures at the cost of unnecessary psychological harms, serious medical adverse events, and forgone opportunities to have greater impacts on the health of older people,” they add. “As such, it is an intellectual fallacy we will live to regret.”

Another Major Blow to Statin Therapy

 

For patients in the lowest risk group, the researchers calculated that doctors would need to treat 57-66 patients for 10 years to prevent one heart attack. In the intermediate risk group, doctors would need to treat 42-47 patients over 10 years to get the same benefit. And in the highest risk group, 20-25 patients would need to take a statin for 10 years to prevent one heart attack.

Public Release: 3-Mar-2015

Study shows who benefits most from statins

Washington University School of Medicine

 

For each of the risk categories, Stitziel and his colleagues calculated the number of patients that doctors would need to treat with statins to prevent one heart attack over a 10-year period. This ‘number needed to treat’ statistic also showed the greater benefit of statins in patients in the high genetic-risk category. As an example, using data from the JUPITER clinical trial (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin), they stratified participants into groups at low, intermediate and high risk of having a heart attack. In the high-risk group, researchers calculated 25 people would need to take a statin for 10 years to prevent one heart attack. Such a strategy could help doctors decide which patients are at high risk and therefore most likely to benefit from statin therapy.

Credit: Eric Young, Washington University in St. Louis.

New research suggests that widely used statin therapy provides the most benefit to patients with the highest genetic risk of heart attack. Using a relatively straightforward genetic analysis, the researchers assessed heart attack risk independently of traditional risk factors such as age, sex, so-called good and bad cholesterol levels, smoking history, family history and whether the patient has diabetes.

Patients in intermediate and low-risk categories still benefit from statin therapy, but that benefit is progressively smaller because they’re starting at lower baseline risk, according to the investigators.

Continue reading “Another Major Blow to Statin Therapy”

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”

The European Union will make review of clinical trials for drugs ” absolutely impossible “

2014-05-27

Just look, but don’t touch: EMA terms of use for clinical study data are impracticable

Data are only allowed to be viewed on screen / Pre-censorship by drug manufacturers

The European Medicines Agency (EMA) receives comprehensive clinical study data from drug manufacturers. These data form the basis for the decision on the approval of new drugs. To make this information available to researchers and decision-makers, EMA issued a draft policy in 2013 for the publication of clinical study data, in which extensive data transparency was planned. Continue reading “The European Union will make review of clinical trials for drugs ” absolutely impossible “”

Patient Calls Medical Kickbacks Civil Battery

 

 

By TIM HULL

 

TUCSON (CN) – A patient filed a civil battery lawsuit against an Arizona neurosurgeon, claiming the doctor implanted devices in him without revealing that he was on the take from a company that paid $30 million to settle kickback claims.

John Sherman sued Dr. Harvey Thomas, Blackstone Medical, Orthofix, Orthofix International, and Orthofix Spinal Implants, in Pima County Court.

Sherman claims that Thomas, a neurosurgeon in Prescott, failed to tell him about his deal with Orthofix International subsidiary Blackstone Medical, before doing surgery on his neck and back.

“Between approximately 2000 and 2006 defendant Thomas was in a financial scheme with one or more of the Blackstone defendants where defendant Thomas received financial incentives to install Blackstone Medical devices,” Sherman claims in the lawsuit.

“During the relevant timeframe, defendant Thomas exclusively used Blackstone medical devices.”

The U.S. Justice Department announced a $30 million settlement with Orthofix International in 2012, after a whistleblower claimed the company paid spinal surgeons to use its devices.

“These alleged kickbacks took a number of forms, including sham consulting agreements, sham royalty arrangements, sham research grants, travel and entertainment,” the Department of Justice said in a statement in 2012.

Sherman claims his surgeries constituted battery because he would not have had them if he’d known about the doctor’s deal with Blackstone.

“Plaintiff would not have consented to a procedure such as the neck and back procedures performed by defendant Harvey Thomas, M.D. if informed that the surgeon had a financial incentive that impaired his ability to make a reasoned and proper medical decision,” the complaint states.

“Defendant Harvey Thomas, M.D. committed battery when he performed a surgery while receiving financial incentives from the device’s manufacturer.”

Sherman also claims that Blackstone and Orthofix engaged in a civil conspiracy to commit battery.

“Blackstone Medical Inc. enticed Dr. Thomas to use its equipment, exclusively, through a financial arrangement that impaired Dr. Thomas’s independent medical judgment,” the lawsuit states.

Sherman seeks punitive damages and costs.

Courthouse News Service failed to reach Thomas at his office in Prescott on Tuesday. A message left with his medical assistant was not returned.

Sherman is represented by Stephen Weeks, of Tucson.

http://www.courthousenews.com/2013/08/14/60262.htm

International Counterfeit Drug Ring Hit in Massive Sting / 1,677 illegal pharmacy Web Sites claiming to be CVS, Walgreens etc..

Pill of Goods: International Counterfeit Drug Ring Hit in Massive Sting

Court documents review process that led the FDA to shut down more than 1,600 illegal pharmacy Web sites

By Dina Fine Maron  | Wednesday, July 3, 2013 | 5


Pill of Goods Image: EssjayNZ

It may be the largest organized crime network that you have never heard of, and it deals in counterfeit drugs. So says the U.S. Food and Drug Administration, which seized and shut down 1,677 illegal pharmacy Web sites last month as part of the largest Internet-based counterfeit drug sting yet.

The shuttered Web sites all claimed to be “Canadian pharmacies” but the FDA says that not a single drug shipment actually came from the U.S.’s northern neighbor. And testing on the multiple undercover purchases of drugs made by FDA offices in Colorado, New Hampshire and western Pennsylvania—described in official court documents reviewed by Scientific American—found that the drugs were actually not cheap, generic versions of the drugs; they were all counterfeits.

The bust is expected to be a major blow to a complex web of online drug distribution that “appears to be highly nimble,” according to the agency. The FDA agent leading this operation believes that the Web sites are part of a major online drug distribution affiliate network that calls itself EvaPharmacy. That network processes roughly 30,000 orders and grosses around $2.7 million—monthly, according to earlier research (pdf) from of the University of California, San Diego. All the Web sites shut down by the FDA were displaying fake licenses and certifications to convince potential U.S. customers that the “FDA approved” and “brand name” drugs were legitimate.

The agency found “a clear linkage and presence of a large, organized online drug distribution network,” according to the affidavit of Daniel Burke, special agent in the FDA’s Office of Criminal Investigations. The crime network identified by the agency included 6,263 Web sites that all used one of at least eight site templates. Researchers believe the large international crime network is based in Russia and the Middle East, and that the seized Web sites were marketing directly to the U.S.

Most of the sites were slight adaptations of templates the network created, Burke said in his affidavit. (The agency declined to comment for this article.) They were carefully constructed to appear to be from real pharmacies like CVS, Walmart or Walgreens, according to the affidavit. In reality the shipments of counterfeit drugs came from India or Singapore instead of pharmacies in Canada. Federal agency warning banners displayed across Web sites like “www.walgreens-store.com” and “http://www.c-v-s-pharmacy.com/” now indicate that they are fraudulent and illegal. The U.S. government says it seized the domain names of the sites to prevent third parties from acquiring the Web site URLs and using them to commit additional crimes.

The FDA’s sting, which was carried out in conjunction with international partners, built on the work of academic researchers who have been carefully identifying these sites for the past several years. It took a coalition of computer scientists several years to identify the pages, as they worked through tracking which were legitimate Canadian pharmacies and which were illegal and did not ask for prescriptions. The only sure-fire test was to order drugs (pdf) and see how the Web site performed.  “Making the call” about whether a site was from a real Canadian pharmacy or was a fake “requires a little internet detective work,” says Chris Kanich, professor of computer science at the University of Illinois at Chicago, who led some of the research in this area.

Creating a complex computer algorithm that could capture all these sites is impossible, he says, because it remains too challenging to distinguish legitimate online pharmacies from fraudulent sites without making some online purchases. The FDA provides consumers with advice on how to find an online pharmacy through BeSafeRx: Know Your Online Pharmacy.

For this crime investigation there were no meetings in back alleys or surreptitious hand offs—just online purchases akin to what a consumer might do sitting at home. In one instance an FDA special agent purchased $105.45 of the diabetes drug Actos and arthritis medication Celebrex, and had them shipped to a U.S. address. As a free “bonus” the site offered to throw in four free pills of Viagra, according to official records. At no point during the purchase was the agent asked to provide a prescription from a licensed medical practitioner, complete a medical questionnaire or consult with a health professional.

Two weeks later, an agent received the purported drugs with a package postmarked from India. They were not the branded drugs as advertised; they were drugs that are illegal to sell in the U.S., and that purportedly contained the same active ingredient as the advertised drug. Some of the drugs came in a package simply labeled “sample-hermless [sic] medicine for personal use—‘Not for sale.’” Moreover, no directions for use or package inserts were included with the shipment.

Shutting down this slice of EvaPharmacy’s business amounts to a significant blow to the faux firm’s infrastructure, Kanich says. “They would need a really resilient business to recover from this.”

 

http://www.scientificamerican.com/article.cfm?id=pill-of-goods

FDA redactions policy violates Freedom of Information Act / Conceals Drug and Medical device dangers form the public

Open gov’t groups: FDA redactions rules skirt law

Transparency groups: Long-standing FDA redactions policy violates Freedom of Information Act

By Matthew Perrone, AP Health Writer | Associated Press – 22 hrs ago

 

WASHINGTON (AP) — A federal policy that allows the Food and Drug Administration to withhold key details about drugs, medical implants and other products is coming under new pressure from open government advocates.

A coalition of public interest groups asked the FDA on Friday to overturn the decades-old policy used to black out sections of federal documents before turning them over to journalists, investigators and others who request information from the government.

In a letter to the agency, OpenTheGovernment.org says that the FDA’s so-called “minor deletions” policy is illegal and undermines the Obama administration’s goal of making government more accountable.

“It is impossible to square the deletions policy with the President’s stated commitment to transparency,” said Patrice McDermott, the group’s president, in the letter obtained by The Associated Press. The letter comes a few days before the start of Sunshine Week, when transparency advocates promote freedom of information.

McDermott asks FDA Commissioner Margaret Hamburg to take action on a formal petition from Public Citizen that would do away with the deletion policy. The consumer advocacy group, founded by Ralph Nader in the 1970s, submitted the petition in September, but has not heard from the FDA. Public Citizen is a member of the OpenTheGovernment.org coalition.

Over the years, Public Citizen has drawn attention to dozens of drug safety issues by requesting FDA documents on patient side effects and clinical studies. In the case of the arthritis drug Bextra, Public Citizen’s disclosures brought to light information about blood clots that led to the drug’s market withdrawal in 2005 due to concerns about stroke and heart attack.

Public Citizen says the FDA has repeatedly redacted large portions of text from documents, in some cases blacking out a half-page or more.

The agency justifies this approach in its staff manual, saying that: “The overwhelming majority of requesters who receive documents with minor deletions are satisfied and do not request withheld material.”

Regardless of whether most requestors accept the deletions, Public Citizen and other critics say the FDA is still ignoring the law. In 1991 the federal government’s own watchdog arm, the Government Accountability Office, urged the FDA to do away with the policy, saying it conflicted with the Freedom of Information Act.

Under that law, anyone who seeks information from the federal government is supposed to get it unless disclosure would hurt national security, violate personal privacy or expose business secrets or confidential decision-making in certain areas. If any information is withheld, the government is supposed to give the requester an immediate option to appeal the decision. But the FDA requires requesters to make a second request to release the redacted information. Only after this second request is denied does the FDA inform the person of their right to an appeal.

Some FDA documents contain proprietary company information about drug testing or manufacturing techniques. The FDA claims the deletions policy actually benefits the public because it allows the agency to release documents that might have to be withheld indefinitely if they were not redacted.

But the agency’s critics say the policy is simply an extra logistical hurdle that is unprecedented in the federal government.

“The steps that the FDA has created leave requesters in a state of limbo and add a procedural barrier that is neither lawful nor necessary,” said Julie Murray, an attorney with Public Citizen who worked on the petition.

Murray said the deletions policy also distorts the FDA’s record of compliance with the Freedom of Information Act, which it must report annually. In 2011, the FDA reported that 97 percent of the documents it released under the Freedom of Information Act were “full releases.”

That number is higher than any other agency in the Department of Health and Human Services, which includes the Centers for Disease Control, the National Institutes of Health and other institutions. But Public Citizen says the FDA’s figure is likely inflated since the agency apparently doesn’t count “minor deletions” as withheld information.

An FDA spokesman said this week that the agency is still reviewing Public Citizen’s petition. Under FDA rules, the agency has 180 days to respond to petitions, placing a March 19 deadline on the group’s request.

http://news.yahoo.com/open-govt-groups-fda-redactions-192253137.html

 

Think that’s ACTUAL fruit in your cereal? How food companies replace the real deal with ‘imposter’ sugar balls and soybean oil

  • Consumer watchdogs warn lebals are fooling  us with high-sugar ‘fruit imposters’ inside packaging promising ‘real fruit,  full of vitamins’
  • The FDA permits labels to say ‘real fruit’  as long as the word ‘flavoured’ also appears on the  packaging

By Daily Mail Reporter

PUBLISHED:12:41 EST, 14  November 2012| UPDATED:18:15 EST, 14 November 2012

When consumers see a picture of fresh berries  on a cereal box, yogurt tub, and other food packaging, they are lead to believe  they are buying ‘real berry pieces  inside.’

But food experts have pointed out that the  ‘fruit’ many companies claim on their packaging is actually just balls of sugar  and soybean oil, mixed with tiny bits of dried fruit.

Consumer watchdogs warn that some of biggest  food companies are fooling us with unhealthy and high-sugar ‘fruit  imposters’ inside labels promising  ‘real fruit, full of  vitamins’.

Scroll down for video

How real? Food experts warn that the 'real fruit' many companies claim on their packaging is actually just balls of sugar and soybean oil, mixed with tiny bits of dried fruit

How real? Food experts warn that the ‘real fruit’ many  companies claim on their packaging is actually just balls of sugar and soybean  oil, mixed with tiny bits of dried fruit

An example is Special K Fruit and Yogurt  cereal, with fresh berries on the front of the box.

Michael Jacobson, the head of the Center for  Science in the Public Interest, a consumer watchdog group, told Today it actually contains ‘no berries  whatsoever’.

Mr Jacobson explained that these berry  ‘imposters’ are in a lot of foods, like blueberry Eggos and Aunt Jemima’s  Blueberry Pancakes.

While the label proclaims ‘made with real  blueberries,’ it  actually contains ‘blueberry bits’ which  are blue chucks shaped into balls made from ‘mostly sugar and soybean oil, then  little bits of real blueberry that’s been artificially colored.’

Today’s National Investigative  Correspondent  Jeff RossenIf said: ‘If the companies were in this room,  they would say: “Look,  we’re printing the ingredients on the label. No  misleading advertising  here”‘

False advertising: Consumer watchdogs say that some of biggest food companies are fooling us with unhealthy and high-sugar 'fruit imposters' inside labels promising 'real fruit, full of vitamins'

False advertising: Consumer watchdogs say that some of  biggest food companies are fooling us with unhealthy and high-sugar ‘fruit  imposters’ inside labels promising ‘real fruit, full of vitamins’

Fresh fruit: Some food companies said the real fruit on the package is meant as a serving suggestion, which is disclosed in small print

Fresh fruit: Some food companies said the real fruit on  the package is meant as a serving suggestion, which is disclosed in small  print

Fruity breakfast: While the label proclaims 'made with real blueberries,' it actually contains 'blueberry bits' which are blue chucks shaped into balls made from sugar and soybean oil, with little bits of blueberry that is artificially colored

Fruity breakfast: The label proclaims ‘made with real  blueberries,’ but it actually contains ‘blueberry bits’ shaped into balls made  from sugar and soybean oil, with little bits of blueberry that is artificially  colored

But Mr Jacobsen disagreed: ‘You can’t deceive  people in big print and pictures on the front of the label, and then give the  correct answers on the back of the label,’

One shopper said: ‘I think they’re duping  people. It’s complete false advertising.’

The Food and Drug Administration, which  oversees such labeling, told Today that it ‘supports laws requiring labels to be  truthful and non-misleading,’ and these labels ‘are permitted’ under FDA  regulations as long as the word ‘flavored’ is also printed.

Nutritionist Joy Bauer explained:  ‘If you see the word “flavored,” either  natural or artificial, it could be a red flag that there’s actually no fruit  within that product.’

‘The Food and Drug Administration is asleep  at the wheel. It rarely brings  complaints against these companies, said Mr  Jacobsen, whose own group is suing Coca-Cola, which owns vitaminwater  because ‘there aren’t any strawberries  and there aren’t any kiwis in there,’

Read the back: The FDA says it is consumers' responsibility to read the entire label, not just the front

Read the back: The FDA says it is consumers’  responsibility to read the entire label, not just the front

‘I suspect the FDA doesn’t want to tangle  with big companies who could keep them tied up in court for years… [But] that bottle contains almost as much sugar  as a 12-ounce can of Coca-Cola.

‘Companies are gonna make a lot more money if they can  imply that there are berries in the product, but not put them there. They’re  saving a lot of money, but they’re cheating consumers.’

Mr RossenIf added: ‘The  food companies told us some of that real fruit on the package is meant as a  serving suggestion, and is disclosed in small print.

‘The FDA says it does inspect labels, and  it’s cracking down on companies that break the law. The agency told us it’s your  responsibility to read the entire label, not just the front.’

Read more: http://www.dailymail.co.uk/femail/article-2232897/How-food-companies-replace-fruit-imposter-sugar-balls-soybean-oil.html#ixzz2CG5PH200 Follow us: @MailOnline on Twitter | DailyMail on Facebook

Class Action Lawsuit Against Eli Lilly and Company Regarding Cymbalta ” Alleges that Lilly misrepresented the risks associated with taking Cymbalta and misled consumers about the frequency, severity, and duration of “Cymbalta withdrawal.”

Eli Lilly & Co.
LLY  | 10/31/2012 9:10:25 PM
Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC File a Class Action Lawsuit Against Eli Lilly and Company Regarding Cymbalta — LLY

SEATTLE, Oct. 31, 2012 (GLOBE NEWSWIRE) — Attorney Advertisement Material. Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC filed a class action lawsuit today against Eli Lilly and Company (“Lilly”) (NYSE:LLY). Lilly, an Indiana based pharmaceutical company, is the maker of Cymbalta. The class action complaint was filed in the United States District Court for the Central District of California, in Los Angeles, on behalf of all consumers who purchased Cymbalta at any time since the product’s launch in August 2004 to the present.

Cymbalta is prescribed to individuals that have been diagnosed with generalized anxiety disorder, fibromyalgia, and musculoskeletal pain. Plaintiff alleges that Lilly misrepresented the risks associated with taking Cymbalta and misled consumers about the frequency, severity, and duration of “Cymbalta withdrawal.” Withdrawal symptoms include, among others, headaches, dizziness, nausea, fatigue, nightmares, insomnia, anxiety, and suicidal ideation. Cymbalta withdrawal symptoms can range from mild to severe—the latter consisting of debilitating and painful symptoms that last several months.

If you used Cymbalta or you would like more information regarding the Cymbalta class action, please contact one of the following attorneys: Michael Woerner or Mark Samson, Keller Rohrback at 800-776-6044 or via e-mail at consumer@kellerrohrback.com.

If you used Cymbalta, suffered serious side effects, and want more information about pursuing an individual personal injury claim, please contact Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC via the contact form on the website: http://cymbaltasideeffects.com or at 800-897-8930 or via email at cymbalta@deskinlawfirm.com.

CONTACT: Keller Rohrback L.L.P.
         Michael Woerner, Attorney
         1201 Third Ave., Ste. 3200
         Seattle, WA 98101
         Keller Rohrback P.L.C.
         Mark Samson, Attorney
         3101 North Central Ave., Ste. 1400
         Phoenix, AZ  85012
         800-776-6044
         consumer@kellerrohrback.com
         www.krcomplexlit.com

         Pogust Braslow Millrood LLC
         Harris Pogust, Attorney
         8 Tower Bridge, Suite 1520
         161 Washington Street
         Conshohocken, PA 19428
         888-348-6787
         http://cymbaltasideeffects.com

         Deskin Law Firm, a PLC
         Samuel Deskin, Attorney
         16944 Ventura Blvd., Office
         Encino, CA 91316
         800-709-8978
         consumer@deskinlawfirm.com
         http://cymbaltasideeffects.com

Globe Newswire
October 31, 2012 – 9:10 PM EDT

Most scientific paper retractions due to misconduct: study

By Agence France-Presse Monday, October 1, 2012 21:13 EDT

Scientist looking through microscope via AFP

WASHINGTON — When a biomedical study is retracted, most of the time it is because of misconduct rather than error, a report published Monday said.

Two-thirds of all retractions around the world stem from acts like fraud, suspected fraud or plagiarism, it added.

And as a percentage of all scientific articles published, retractions because of fraud or suspected fraud have jumped 10-fold since 1975, said the study.

Its lead author was Arturo Casadevall, a professor of microbiology and immunology at Albert Einstein College of Medicine of Yeshiva University, in New York. The study was published in Proceedings of the National Academy of Sciences.

“Biomedical research has become a winner-take-all game, one with perverse incentives that entice scientists to cut corners and, in some instances, falsify data or commit other acts of misconduct,” Casadevall wrote.

He said the numbers stand in stark contract to earlier studies which suggested mistakes accounted for the majority of retracted scientific papers.

Casadevall and two other scientists reviewed 2,047 papers that were removed from biomedical literature through May of this year.

The authors consulted secondary sources to determine why the papers were yanked, such as the National Institutes of Health’s Office of Research Integrity, and Retractionwatch.com. Both probe scientific misconduct.

They found that 21 percent of the retractions were attributable to error, but 67 percent stemmed from misconduct. Miscellaneous or unknown reasons accounted for the rest.

“What’s troubling is that the more skillful the fraud, the less likely that it will be discovered, so there likely are more fraudulent papers out there that haven’t yet been detected and retracted,” Casadevall wrote.

He said that earlier studies which underestimated the scope of scientific cheating were based just on journals’ retraction notices, written by the original authors themselves.

“Many of those notices are wrong,” he said.

“Authors commonly write, ‘We regret we have to retract our paper because the work is not reproducible,’ which is not exactly a lie. The work indeed was not reproducible because it was fraudulent. Researchers try to protect their labs and their reputations, and these retractions are written in such a way that you often don’t know what really happened.”

Prestigious journals had particularly high rates of retractions.

This reflects a prevailing culture in science in which researchers are disproportionately rewarded for publishing a lot and getting published in top-notch journals, he said

The drugs don’t work: a modern medical scandal

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling.

    Ben Goldacre The Guardian,   Friday 21 September 2012 18.00 EDT

    a0158-000112

    Drugs are tested by their manufacturers,  in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits. Photograph: Photograph: Getty Images. Digital manipulation: Phil Partridge for GNL Imaging

    Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

    But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

    It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

    I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

    Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

    Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

    In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

    Now, on to the details.

    In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.

    These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

    It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.

    In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:

    “The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”

    How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.

    Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.

    And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.

    In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

    This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.

    For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.

    When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

    Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.

    Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.

    To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.

    Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.

    So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.

    When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.

    It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.

    People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

    Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.

    This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.

    How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

    After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.

    That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.

    Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.

    But we are more concerned with the safety and efficacy data. In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

    During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

    Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.

    The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.

    Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.

    Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

    • This is an edited extract from Bad Pharma, by Ben Goldacre, published next week by Fourth Estate at £13.99. To order a copy for £11.19, including UK mainland p&p, call 0330 333 6846, or go to guardian.co.uk/bookshop.

    http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-ben-goldacre

    Retraction record rocks community: One of the biggest purges of the scientific literature in history is finally getting under way

    Anaesthesiology tries to move on after fraud investigations.

    David Cyranoski 19 September 2012

    One of the biggest purges of the scientific literature in history is finally getting under way. After more than a decade of suspicion about the work of anaesthesiologist Yoshitaka Fujii, formerly of Toho University in Tokyo, investigations by journals and universities have concluded that he fabricated data on an epic scale. At least half of the roughly 200 papers he authored on responses to drugs after surgery are in line for retraction in the coming months.

    Like many cases of fraud, this one has raised questions about how the misconduct went undetected for so long. But the scope and duration of Fujii’s deception have shaken multiple journals and the entire field of anaesthesiology, which has seen other high-profile frauds in the past few years.

    Fujii, who could not be contacted for this article, was dismissed from Toho University in February because he lacked proper ethics approval for clinical studies that were detailed in eight papers. But suspicions about his entire 20-year publication record had been growing since 2000, when Peter Kranke, an anaesthesiologist at University Hospital Würzburg in Germany, first started to question Fujii’s superhuman publication rate.

    In some years, Fujii published more than a dozen randomized clinical trials that purported to test the efficacy and side effects of drugs such as granisetron, given to reduce nausea and vomiting after surgery. “It’s impossible to publish so many,” says Kranke. “If you just look at mere output, everybody who has performed at least one clinical trial should have some suspicion.”

    Fujii’s data were also “too perfect”, he says. Kranke analysed 47 of Fujii’s articles on granisetron, published between 1994 and 1999, and found that the frequency of headaches — a common side effect of the drug — was identical or nearly identical in a suspiciously high number of groups involved in the trials1.

    At the time, Fujii responded merely by saying that he stood by his data2, which seemed to show that granisetron had fewer side effects than other anti-emetic drugs. “We were disappointed that the journal accepted that,” says Kranke. “Editors and peer reviewers advised us to pursue more worthwhile endeavours, rather than whistle-blowing. But it wasn’t just whistle-blowing — we wanted people to know that” granisetron wasn’t necessarily better than alternatives.

    In the following years, similar doubts emerged about Fujii’s studies of other drugs, such as the anti-emetic ramosetron. Yet the deception began to unravel only in September 2011, after growing doubts among anaesthesiologists prompted Toho University to begin an investigation into Fujii’s lack of approval from institutional review boards for several clinical trials.

    Fujii’s subsequent dismissal was soon followed by a flood of damning evidence about his work. On 8 March, Anaesthesia published an analysis3 by John Carlisle, a consultant anaesthetist at Torbay Hospital in Torquay, UK, finding that 168 of Fujii’s papers had results with “likelihoods that are infinitesimally small”. One month later, 23 anaesthesiology journal editors wrote to the heads of six universities and medical centres with which Fujii had been affiliated, notifying them that 193 papers would be retracted unless the institutions could vouch for the data.

    Five of those institutions have responded to say that they could not find evidence to corroborate the veracity of 88 papers. The sixth institution, the University of Tsukuba, has so far found only five papers to be valid. It is still investigating another 92 publications.

    Late last month, Steven Shafer — editor-in-chief of Anesthesia & Analgesia — who has led the campaign to examine Fujii’s papers, posted online the responses from the institutions, along with a notice of retraction for three papers in his own journal. Shafer expects other editors to begin retracting the remaining fraudulent papers, probably including those being considered by Tsukuba, in the forthcoming issues of their journals.

    Meanwhile, an investigation begun in March by the Japanese Society of Anesthesiologists reported in June that 172 of Fujii’s papers were probably fraudulent, in some cases because there was no evidence that the data had actually been collected. On 30 August, the society announced that Fujii, who had already left the society of his own volition, would be permanently barred. All of Fujii’s co-authors have denied knowledge of his wrongdoing, according to Koji Sumikawa, a member of the society’s board of directors who was involved in the investigation, and an anaesthesiologist at Japan’s Nagasaki University School of Medicine.

    Sumikawa says that Fujii’s work has had little impact on clinical practice, because the anti-emetics he studied are rarely used in Japan. But it has embarrassed the field of anaesthesiology, which was already reeling from two high-profile fraud cases. In 2009, 21 publications by Scott Reuben, who was based at Tufts University School of Medicine in Boston, Massachusetts, were retracted because they contained fabricated data4. The following year, around 90 papers by Joachim Boldt, formerly of the Ludwigshafen Hospital in Germany, were retracted from 11 journals, because of fabrication and because Boldt did not have proper ethics approval for the trials.

    The cases have prompted a spate of articles in anaesthesiology journals lamenting the scale of the frauds, and discussing ways to avoid similar incidents. In an letter sent to journal subscribers in March, Shafer said that he regretted that the journal had not investigated further after Kranke’s original article (Shafer was not the editor-in-chief at that time). “The journal’s response to the allegations of research fraud … was inadequate,” he wrote. “The subsequent submissions to the Journal by Dr. Fujii should not have been published without first vetting the allegations of fraud.”

    Kranke thinks that anaesthesiologists are now more attuned to the possibility of misconduct, and that journal editors are much more willing to act on allegations. “After the Boldt and Reuben cases, it became fashionable to dig up these things.”

    Ample opportunities

    Most anaesthesiologists insist that there is no evidence that their field is more prone to fraud than any other. But Carlisle says that anaesthesiology does offer many opportunities to generate large sets of clinical data very quickly. Millions of anaesthetic procedures are performed every year during surgeries, and patient outcomes are immediate and easy to measure. There are “frequent opportunities for anaesthetists to conduct clinical studies very quickly, potentially by themselves, without overview from other people”, he says. “This might contribute to greater opportunities for them to succumb to the temptation of fraud.”

    How did Fujii get away with his deception for so long? One reason could be that he spread his publications over a wide range of journals, in fields as diverse as gynaecology and ophthalmology, suggests Sumikawa. “No one is looking at all of these,” he says.

    Fujii’s peripatetic career may have also provided a smokescreen for his fraudulent behaviour. Over two decades, he held posts at five institutions, and adjunct positions at two more, making it easy for him to claim that data had been generated or ethics approval had been granted while he was in a previous post. If any of Fujii’s colleagues were suspicious, they did not come forward at the time, says Sumikawa, who plans to set up a mechanism for whistle-blowers to report concerns about colleagues.

    Kranke says he is pleased that his field is finally focusing its attention on misconduct. He is convinced that although Fujii’s is an exceptional case, the researcher cannot be written off as merely a “bad apple”. “It’s a system failure,” he says.

    Nature489,346–347(20 September 2012)

    http://www.nature.com/news/retraction-record-rocks-community-1.11434

    Stanford researcher criticizes FDA plans to reduce oversight of off-label drug use: Pharmaceutial Free For All (No Rules)

    Repost From April 2008

    Contact: Rosanne Spector manishma@stanford.edu 650-725-5374 Stanford University Medical Center

    STANFORD, Calif. – Proposed guidelines from the U.S. Food and Drug Administration would allow companies to market more drugs for unapproved uses and are a step in the wrong direction, said a researcher from the Stanford University School of Medicine.

    In an editorial to be published in the April 3 issue of The New England Journal of Medicine, Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, criticized the draft guidelines, which are subject to public comment through April 21. They curtail the FDA’s already limited authority over the marketing of drugs for off-label uses, Stafford said.

    While most people assume that the medicines prescribed by doctors in the United States have the FDA’s stamp of approval, that’s only partially true. The FDA approves drugs for specific purposes, but doctors can use drugs “off-label” for medical conditions not approved by the FDA.

    Off-label prescribing for medical conditions not scrutinized during the FDA approval process is common. There’s nothing illegal about off-label prescribing, and in many cases it’s good medicine, said Stafford, who directs Stanford’s Program on Prevention Outcomes and Practices. As long as the FDA has approved a drug for one condition, physicians are free to prescribe it for anything.

    Unfortunately, what’s known about the use of a drug for one situation may not apply to other clinical scenarios. Stafford pointed to the use of antidepressants in children and the use of antipsychotic medications for dementia as key examples.

    “The FDA should not suddenly start telling physicians how to practice. Physician judgment is critical, especially when approved therapies have not succeeded. Off-label prescribing can be an important tool in such cases,” he said. “But in other cases, off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety. This is problematic.”

    Stafford said these types of situations suggest the need for a better way to evaluate and regulate off-label drug use. Ideally, he said, a drug company would go back to the FDA with additional clinical studies and obtain supplemental approval for a new clinical use.

    Off-label drug use is already common, but applications to the FDA for approval of new uses are uncommon, said Stafford. This process may be seen as irrelevant by drug manufacturers, who have strategies for expanding their off-label markets and boosting drug sales without formal FDA approval.

    Although FDA regulations restrict drug manufacturers from overtly promoting their drugs for unapproved conditions, they are free to share educational materials with physicians, most often as published journal articles. According to current FDA guidelines, this practice is acceptable, but only if the manufacturer submits the articles to the FDA for review and is pursuing formal FDA approval for the new use. In reality, however, FDA enforcement is limited, said Stafford.

    The new draft guidelines further pull back FDA involvement by eliminating both of these requirements. In addition, they reduce the remaining policies to non-binding recommendations.

    This concerned Stafford, who wrote in the NEJM editorial: “The FDA may be conceding to drug manufacturers the responsibility for regulating their own off-label marketing practices. The agency may also believe that its limited resources can be put to better or more effective use in confronting other ongoing challenges. Nevertheless, I believe that the FDA must take an active role in fostering evidence-based practice, eliminating subversion of the approval process, and requiring a balanced and fair presentation of the scientific evidence.”

    One of the proposed guidelines’ major pitfalls, said Stafford, would be allowing drug manufacturers to skip obtaining approval for potentially lucrative drug uses. Instead, companies might seek approval only for a narrower use that’s more easily and less expensively tested, and sponsor research on more commercially promising uses that are never evaluated by the FDA. Stafford warned that this might encourage widespread treatment of conditions with drugs never approved by the FDA for those purposes.

    Off-label use is already burgeoning. In a 2006 examination of off-label prescribing of 160 common drugs, Stafford found that off-label use accounted for 21 percent of all prescriptions and 73 percent of these uses had little or no scientific support (Archives of Internal Medicine, May 8, 2006). Drugs approved for depression, schizophrenia and seizures were most likely to be used off-label without adequate support for other conditions.

    ###

    The FDA is accepting comments on the draft guidelines through April 21. Comments can be made online: Go to http://regulations.gov, search for the docket “FDA-2008-D-0053” and use the “send a comment” option.

    Stanford University Medical Center integrates research, medical education and patient care at its three institutions – Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital at Stanford. For more information, please visit the Web site of the medical center’s Office of Communication & Public Affairs at http://mednews.stanford.edu.

    Consumer group sues FDA over Aricept safety

    By LINDA A. JOHNSON | Associated Press – 38 mins ago

    TRENTON, N.J. (AP) — A consumer group pressing the Food and Drug Administration to remove the highest dose of an Alzheimer’s disease drug from the market is suing the agency for what it calls “foot-dragging.”

    Public Citizen said Wednesday that the FDA’s own medical and statistical reviewers found that high-dose Aricept doesn’t work better at controlling symptoms of moderate-to-severe Alzheimer’s than two low doses.

    However, the group said the high dose has more-dangerous, potentially deadly side effects including vomiting, which in Alzheimer’s patients “can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.” Other side effects more common at the high dose are nausea, diarrhea, anorexia and confusion.

    Public Citizen filed a petition in May 2011 with the FDA. The group urged the agency to halt sales of the 23-milligram dose of Aricept and put safety warnings about the high-dose risks on two low doses, 5 and 10 milligrams. The low doses are available under both the Aricept brand, made by Japan’s Eisai Co. Ltd., and as inexpensive generic pills.

    The FDA has yet to act.

    The lawsuit, filed in federal court in Washington, asks the court to declare the FDA’s failure to act unlawful and to order the agency to decide within 30 days of the court’s ruling whether to approve Public Citizen’s request. The suit also seeks attorneys’ fees and other reasonable costs.

    “By ignoring Public Citizen’s petition for more than a year, the agency has ignored (its) responsibility,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement. “During the past year alone approximately 350,000 prescriptions have been filled in the U.S. for Aricept 23.”

    “Allowing Eisai to exploit and harm vulnerable patients with Alzheimer’s disease is unconscionable,” Wolfe added.

    An FDA spokeswoman said Wednesday in an email that the agency doesn’t comment on pending litigation. Last December, the associate policy director in its Center for Drug Evaluation and Research, Jane Axelrad, notified Public Citizen the FDA was doing a detailed evaluation of the case.

    “FDA has been unable to reach a decision on your petition because it raises significant issues requiring extensive review and analysis by agency officials,” she wrote. “We will respond to your petition as soon as we have reached a decision on your request.”

    Marcia Diljak, a spokeswoman at Eisai’s U.S. subsidiary, Eisai Inc. of Woodcliff Lake, N.J., said the company was aware of the complaint filed against the FDA but won’t comment on the litigation.

    “We stand by the FDA’s decision” to approve high-dose Aricept as a safe, effective Alzheimer’s treatment, she wrote in an email.

    According to Public Citizen, Eisai sought approval of the higher Aricept dose ahead of the November 2010 expiration of the patents for the two low doses. The ensuing generic competition would have slashed their sales.

    The lawsuit states that the FDA required the company to prove in a study that the high dose improved patients’ mental and physical functioning, but the study failed to show the high-dose “has any clinically meaningful benefit.”

    That led FDA’s medical reviewer to recommend against approving the high dose, but the head of FDA’s division of neurology products decided to approve the product anyway, the lawsuit states. The high dose was approved on July 23, 2010, extending Eisai’s patent protection for an additional three years, the suit notes

    Thalidomide – Lies, Greed, Fabricated Data, Brainwashed Doctors, Lazy Press, and Smugness of profits made on the horrific horrors inflicted on children

    Still no shame for thalidomide cover-up

    Victims of the drug scandal have been offered an apology, but Harold Evans, who was in charge of the Sunday Times and broke the story, says there is still no proper recompens

    Harold Evans guardian.co.uk,             Saturday 1 September 2012 16.58 EDT

    Thalidomide

    Thalidomide victims have said the latest apology is an insult. Photograph: Jane Bown for the Guardian

    Justice delayed is justice denied. We know that too well. But how do you wrestle with your conscience when the injustice you have perpetrated has destroyed the lives of children and left thousands of thalidomide victims still enduring pain and suffering, without adequate compensation? The German company Chemie Grünenthal, having denied justice for 50 long years, has now unveiled a bronze statue of a child born without limbs, and its chief executive, Harald Stock, says: “We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching to you from human being to human being. Instead we remained silent.”

    Actually, Chemie Grünenthal remains silent still on adjusting compensation for inflation and the dreadful effects on the victims – the men and women in adulthood, many now without parental support.

    CG did not just remain silent. It  brought forth the drug thalidomide on 1 October 1957, from very murky origins indeed. It licensed its manufacture worldwide as a safe sleeping drug for mothers in pregnancy. One of the licensees was the British whisky company, Distillers, which put “Distaval” on the market as a tranquilliser in April 1958 and marketed it until 1962. Chemie Grünenthal was reckless. It had not tested the effect on pregnant women or animals to see if it could cross the placental barrier. It ignored early warnings. The wife of one of its own employees had given birth to a baby without ears 10 months before it puts its poison on the market. It made no difference. Nor did warning signs of deformed births and nerve damage from Australia.

    It produced sales leaflets for doctors stressing the drug’s safety. It engaged – bribed might be a better word – compliant doctors who vouched for it though they did not know how it worked. A testimonial appeared in the American Journal of Obstetrics and Gynecology signed by Dr Ray Nulson Cincinnati, Ohio.

    Eventually, he gave evidence in Germany that he had not tested the drug on pregnant women at all and was not even the author of the article. It had been written for him by an employee of the renowned American company, Richardson-Merrell in Cincinnati, a CG licensee. And the employee, like others around the world, had relied on Chemie Grünenthal which had itself done no tests on the effect on a foetus .

    And to crown this pyramid of infamy none of the public authorities was curious enough to know how it all happened. In Britain, thanks to Chemie Grünenthal’s connections with the Ministry of Health, and a lazy press, fed pap by the ministry, the truth did not come out. It would never have come out either had it been left to the legal profession who dealt with the litigation the desperate families were forced to start.

    I well remember the astonishment  in the Sunday Times when the Insight team began opening three suitcases containing CG’s own documents. They showed a reckless get-rich-quick mentality yet the parents’ lawyers had allowed themselves to be convinced they could not win 100% damages in court.

    I have described some of this in My Paper Chase, but what is new to me is the depth of iniquity exposed by investigative work since, primarily by Jonathan Stone, a former solicitor with Lord Goodman’s firm, Goodman Derrick, working with Roger Williams. Stone has been a special adviser to the victims in various countries. He and Williams trace the origins of thalidomide to murderous experiments in second world war concentration camps and they name names. There is the Wirtz family, esteemed as philanthropists in the German town of Stolberg, the sole owners of the company, notorious for its pro-Nazi sympathies.

    There is Heinrich Mückter (1914-1987), responsible for the deaths of hundreds of prisoners in typhoid experiments; there’s Otto Ambros (1901-1990), chairman of the supervisory committee when thalidomide was developed; there’s Martin Staemmler (1890-1974), who played a role in Nazi racial hygiene programmes; there’s the SS doctor Ernst-Günther Schenck, who experimented with medicinal plants; there are the US companies ready to forgive and forget in their postwar haste to get their hands on the chemical expertise.

    But decency requires me to identify some heroes in the struggle for justice – the thalidomide victims, now in middle age, who continue to fight for others: Freddie Astbury, president of Thalidomide UK, who describes the CG apology without compensation as a disgrace; the Lords Jack Ashley and Alf Morris, who fought so hard for the victims in their lifetimes, and Labour’s minister of health, Mike O’Brien.

    On 14 January 2010 O’Brien made a dramatic announcement in parliament. He apologised to the victims and their parents but he also committed the government to give £20m to the Thalidomide Trust.

    In the light of all this, one can only repeat to CG the words of Joseph Welch examining Joe McCarthy: “Have you no sense of decency, sir? At long last, have you left no sense of decency?”

    Study: Media perpetuates unsubstantiated chemical imbalance ( Serotonin ) theory of depression

    Contact: Jeffrey Lacasse jeffreylacasse@mac.com 850-294-0875 Florida State University

    TALLAHASSEE, Fla. — The theory that depression is caused by a chemical imbalance is often presented in the media as fact even though there is little scientific evidence to support it, according to a new study co-authored by a Florida State University visiting lecturer.

    Jeffrey Lacasse, an FSU doctoral candidate and visiting lecturer in the College of Social Work, and Jonathan Leo, a neuroanatomy professor at Lincoln Memorial University in Tennessee, found that reporters who included statements in news articles about depression being caused by a chemical imbalance, or a lack of serotonin in the brain, were unable to provide scientific evidence to support those statements.

    Lacasse and Leo spent about a year in late 2006 and 2007 monitoring the daily news for articles that included statements about chemical imbalances and contacting the authors to request evidence that supported their statements. Several reporters, psychiatrists and a drug company responded to the researchers’ requests, but Lacasse and Leo said they did not provide documentation that supported the chemical imbalance theory. Their findings were published in the journal Society.

    “The media’s presentation of the theory as fact is troublesome because it misrepresents the current status of the theory,” Lacasse said. “For instance, there are few scientists who will rise to its defense, and some prominent psychiatrists publicly acknowledge that the serotonin hypothesis is more metaphor than fact. As the current study documents, when asked for evidence, reporters were unable to cite peer-reviewed primary articles in support of the theory.”

    Moreover, the researchers said, several of the responses received from reporters seem to suggest a fundamental misunderstanding of the theory’s scientific status. The “Diagnostic and Statistical Manual of Mental Disorders,” which almost all psychiatrists use to diagnose and treat their patients, clearly states that the cause of depression and anxiety is unknown, according to Lacasse and Leo.

    The Society article builds on the pair’s 2005 study, which focused on pharmaceutical advertisements that claim depression is caused by an imbalance of serotonin — an imbalance the drug companies say can be corrected by a class of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs).

    ”The chemical imbalance theory, which was formulated in the 1960s, was based on the observation that mood could be artificially altered with drugs, rather than direct observation of any chemical imbalances,” Leo said. “Since then there has been no direct evidence to confirm the theory and a significant number of findings cast doubt on the theory.”

    The researchers said the popularity of the theory is in large part based on the presumed efficacy of the SSRIs, but they say that several large studies now cast doubt on this efficacy. A review of a full set of trial data published in the journal PLoS (Public Library of Science) Medicine last month concluded that much of the perceived efficacy of several of the most common SSRIs was due to the placebo effect. Other studies indicate that for every 10 people who take an SSRI, only one to two people are truly receiving benefit from the medication, according to Lacasse and Leo.

    Still, the National Center for Health Statistics found that antidepressants are the most prescribed drugs in the United States, with doctors writing more than 31 million prescriptions in 2005. Both Lacasse and Leo emphasized the importance of patients being given factual information so they can make informed decisions about medications and the role of other potentially useful interventions, such as psychotherapy, exercise or self-help strategies.

    *Requested Repost

    “Patients might make different choices about the use of medications and possibly use alternative approaches to their distress if they were fully informed,” Lacasse said. “We believe the media can play a positive role by ensuring that their mental health reporting is congruent with scientific literature.”

    ###

    Want to live longer? Ditch the diet, cancel your gym session – just eat less ( Dangerous Misinformation )

    Want to live longer? Ditch the diet, cancel your gym session – just eat  less

    By Liz Thomas

    PUBLISHED:19:44 EST, 30 July  2012 | UPDATED:03:18  EST, 31 July 2012

    Dr Michael Mosley said he did not believe it was  necessary to eat three meals a day

    Forget exercise, fad diets or so-called  miracle pills – if you want to live longer simply eat less, a leading scientist  has claimed.

    Dr Michael Mosley, a presenter on BBC science  show Horizon, said ongoing research suggested that a high metabolic rate – how  much energy the body uses for normal body functions – is a risk factor for  earlier mortality.

    And he revealed that communities in Japan and  the U.S. which  follow strict, low-calorie diets  appear to have a  lifespan longer than the global average.

    The 55-year-old said of calorie restriction  diets, which are often as low as 600 calories a day: ‘The bottom line is that it  is the only thing that’s ever really been shown to prolong life.

    ‘Ultimately, ageing is a product of a high  metabolic rate, which in turn increases the number of free radicals we consume.

    ‘If you stress the body out by restricting  calories or fasting, this seems to cause it to adapt and slow the metabolism  down. It’s a version of “what doesn’t kill you makes you stronger”.’

    Dr Mosley said he did not believe it was  necessary to eat three meals a day because ‘what we think of as hunger is mainly  habit’.

    In a new Horizon programme, he also suggests  that intermittent fasting could offer the same benefits as calorie restriction  by reducing the growth of hormone IGF-1.

    While the hormone maintains and repairs  tissue, high levels have been shown to contribute towards cancer and ageing.

    New approach: Forget exercise, fad diets or so-called miracle pills ¿ if you want to live longer simply eat less, a leading scientist has claimedNew approach: Forget exercise, fad diets or so-called  miracle pills – if you want to live longer simply eat less, a leading scientist  has claimed

    His comments, made to the Radio Times, come  after the Institute of Health Ageing at University College London suggested  eating 40 per cent less could extend a person’s life by 20 years.

    A researcher said: ‘If you reduce the diet of  a rat by 40 per cent it will live for 20 per cent longer. So we would be talking  20 years of human life.

    ‘This has shown on all sorts of organisms,  even labradors.’

    Read more: http://www.dailymail.co.uk/health/article-2181370/Want-live-longer-Ditch-diet-cancel-gym-session–just-eat-less.html#ixzz22oo7jvyN

    * Why the Info is Wrong and Evil

    It is either the Doctor being Misquoted, or the Reporter Not understanding. Many understand it is the type of nutrition being consumed, not just blind caloric intake. Many foods contain antioxidants that squelch free radicals. At 600 Calories a day, there is no way you can maintain adequate vitamin/mineral intake just from food. You would eventually succumb to malnutrition

    Eating less may not extend life, Jan. 13 3009 in advance of print publication in the Journal of Nutrition

    New clue into how diet and exercise enhance longevity, July 20, 2007, issue of the journal Science

    Even occasional exercise can extend life for older people,  Jul 2004  Journal of Preventive Medicine

    Low-level exercise delays heart failure, markedly extends lives, even with hypertension, 2005 November edition of the American Journal of Physiology-Heart and Circulatory Physiology

    Good news: Light and moderate physical activity reduces the risk of early death, Aug 2010  International Journal of Epidemiology

    Thats just off the top of my head

    £200,000 cystic fibrosis drug ‘could transform lives’

    From the Telegraph 10:25AM BST 30 Jul 2012 (No Reporters name)

    A drug which could transform the lives of people with cystic fibrosis has been   developed, as the health watchdog investigates whether it can be provided on   the NHS at an annual cost of £200,000

    Trials of the drug Ivacaftor have shown improvement in patients’ breathing and weight gain, with use reducing their need for antibiotics.

    It has been shown to help some of those who suffer from cystic fibrosis, and has been hailed by one trial co-ordinator as “remarkable”.

    It is now being studied by the National Institute for Clinical Excellence (NICE) to determine whether it is value for money, at a cost of £200,000 per year.

    It has already been approved for use in patients over six years of age in the United States, and by EU watchdogs.

    It is expected to become available in France, Germany and the Irish Republic shortly, according to the Times newspaper

    Cystic fibrosis currently affects more than 9,000 people in Britain and is   incurable, causing internal organs to be “clogged up” with a sticky mucus.

    Caused by a faulty gene, it places severe limitations on sufferers and   significantly shortens life expectancy.

    Ivacaftor works by targeting a particular mutation, G551D, which is present in   around 600 people with cystic fibrosis in Britain – around six per cent.

    Stuart Elborn, lead coordinator of the trials from Queen’s University, Belfast, told the newspaper: “When the first slide went up, we were speechless.

    “The hair was standing on the back of my neck.

    “It was the moment the drug went from being one that might not even work to   one that will transform thousands of lives.”

    According to the Times, the £200,000 a year cost would use more than half of   the £110m UK budget currently used on cystic fibrosis.

    Vertex, the company which spent 13 years developing and making the drug, says   the cost will be offset against money spent on patients’ spending time in   hospital or taking time off work.

    A spokesman said they were “working with the health authorities to make it   available as quickly as possible”.

    https://engineeringevil.com/2012/07/24/researchers-show-cystic-fibrosis-defect-in-mice-corrected-with-turmeric-extract/

     

     

    Sepsis: Blood Poisoning Kills Thousands, But No Drugs to Help / Vitamin C: A potential life-saving treatment for sepsis

    Rory Staunton’s death started with a simple cut on his arm.

    Rory, a 12-year-old New Yorker, cut himself when he dove for a basketball at his school gym in late March, according to the New York Times. Two days later, he was vomiting, feverish and had a pain in his leg. A few days later, on April 1, Rory died at NYU-Langone Medical Center of a kind of blood poisoning known as sepsis.

    His death, and others, point to a major problem in treating sepsis — there are currently no drugs approved to fight it. The only drug developed for it, called Xigris, was withdrawn from the market in 2011, when the drug failed rigorous testing required to maintain regulatory approval. The drug’s fall from grace highlights just how difficult fighting sepsis is, and leaves doctors wondering whether developing a drug will ever be possible.

    Bleak Prognosis, Then Brief Promise

    About 750,000 people in the U.S. each year get sepsis, and about 225,000 of them die from it. The condition is an infection of the bloodstream, and it can arise from any number of infectious bugs that attack the body, such as meningitis, pneumonia and infections of the skin or bladder, to name a few. The blood poisoning is caused not by the germs themselves, but by the body’s hyper-response to those germs, when it releases a barrage of chemicals that can lead to organ failure.

    Those chemicals cause the body to go into shock, and patients have symptoms such as chills, fever, confusion, rapid heartbeat, headache and skin rashes.

    The best shot patients have is for doctors to treat them early, ideally giving a patient antibiotics and fluids within the first hour that they show symptoms. Dr. Andre Kalil, an associate professor of medicine at the University of Nebraska Medical Center, said even in the best-case scenario, antibiotics don’t always help.

    “Unfortunately even with the best antibiotics and supportive care, a third of these patients will die,” Kalil said. “We don’t have other drugs that actually can act in the body in response to the infection. We just don’t.”

    That wasn’t always in the case. In 2001 when the U.S. Food and Drug Administration approved Xigris, made by the pharmaceutical company Eli Lilly, hopes were high that it would keep thousands of patients from dying. The company’s initial clinical trials of the drug showed that it reduced the chances of dying by 20 percent in patients at risk of developing sepsis.

    But the drug’s initial performance was somewhat disappointing. Some patients benefited from the drug, others did not, and doctors had trouble defining which type of patient would benefit the most. The drug was also very expensive, so many hospitals put protocols in place that strictly limited when the drug could be given — usually when all other methods had failed.

    Dr. Jonathan Janes, medical director of acute care for Eli Lilly, said the company was encouraged by studies of the drug in real-life clinical settings, which showed that it kept many patients alive.

    “We felt encouraged by those results, they seemed to support that the drug worked,” Janes said. “Obviously, you need your clinical trial data, but these results were nice to have.”

    But questions about the drug’s effectiveness and safety began to surface. Patients getting Xigris had a slightly increased risk of bleeding. Increasingly skeptical that the expensive drug was actually effective, European regulators asked Eli Lilly to conduct a second clinical trial. The results were the nail in Xigris’ coffin — the trial showed that the drug was little better than placebo. Based on those results, Eli Lilly voluntarily pulled the drug from the market in October 2011.

    “This was the first drug specifically licensed for sepsis, which leaves us essentially with nothing now,” said Dr. Greg Martin, director of the medical and coronary intensive care units at Emory University.

    Drug’s Withdrawal A Premature Decision, Some Say

    But a new analysis, published Monday in the journal Lancet Infectious Diseases, throws into question whether or not Xigris should have been withdrawn at all. In it, Nebraska’s Kalil analyzed the results of more than two dozen studies of Xigris, most performed in the “real-world” of clinics and hospitals, trying to save patients with sepsis.

    The results suggest that Xigris is effective after all. The study found that Xigris reduced patients’ risk of dying by 18 percent, similar to the results Eli Lilly had reported in its first study of the drug.

    “I was expecting to see a very small effect, close to no effect. I was surprised when we saw these kinds of results,” Kalil said.

    So should the drug be put back on the market? The answer is uncertain and, as far as Eli Lilly is concerned, unfeasible. Putting the drug back on the market would mean conducting another long, expensive clinical trial to clear regulatory hurdles. Janes said the company has no plans to do that, even in the face of evidence suggesting the drug’s effectiveness.

    “We have to live with the results of our clinical trials,” Janes said. “It goes back to the point of deciding what the company is going to invest in.”

    Although the drug would likely help hundreds of thousands of patients, it will likely never be as profitable as drugs that can help millions of patients with more common conditions, such as high blood pressure, diabetes or cancer.

    And questions remain about whether the drug was ever truly helpful for patients. Doctors never really identified the type of patient who would benefit the most from Xigris. The new study suggests that perhaps only the sickest patients really improve after taking the drug. Trials of the drug in pediatric patients like Rory never succeeded.

    Dr. Cliff Deutschman, a professor of anesthesiology and critical care at the University of Pennsylvania, said he was never really convinced that the drug was better than treating patients with antibiotics and fluids.

    “Ultimately, it’s pretty hard to know what to make of the results of these studies,” he said.

    Since Xigris was introduced and withdrawn, doctors and hospitals also seem to have gotten a little better at screening and stopping sepsis in its early stages. Programs like the Stop Sepsis campaign, a program started by the Greater New York Hospital Association, emphasize promoting awareness of the condition and the critical importance of getting care to patients in the first hours of their symptoms.

    But many doctors say a drug like Xigris would be invaluable in saving the lives of hundreds of thousands of patients. Martin said he still believes Xigris could be that drug.

    “There’s real potential that this drug has the ability to treat and cure people. But we don’t know who the drug works best in, and that’s probably where the interest was lost,” Martin said.

    And for now, it seems that doctors will never know. Since Eli Lilly withdrew the drug from the market, it is no longer available even for research purposes.

    Deutschman said the biggest blow is that given the Xigris’s failure and Eli Lilly’s experience, other pharmaceutical companies will be reluctant to spend the money to pursue any treatment for sepsis. For now, the scientific and regulatory bar for a drug is very high.

    “There still may be groups of people that it [Xigris] does work on, but because the drug is no longer available we’ll never know. And that’s discouraging,” he said.

    Vitamin C: A potential life-saving treatment for sepsis

    Public release date: 17-Nov-2010

    Physicians caring for patients with sepsis may soon have a new safe and cost-effective treatment for this life-threatening illness.  Research led by Dr. Karel Tyml and his colleagues at The University of Western Ontario and Lawson Health Research Institute have found that vitamin C can not only prevent the onset of sepsis, but can reverse the disease.

    Sepsis is caused by a bacterial infection that can begin anywhere in your body.  Your immune system goes into overdrive, overwhelming normal processes in your blood. The result is that small blood clots form, blocking blood flow to vital organs. This can lead to organ failure. Babies, the elderly and those with weakened immune systems are most likely to get sepsis. But even healthy people can become deathly ill from the disease.

    According to Dr. Tyml, a professor at Western’s Schulich School of Medicine & Dentistry, patients with severe sepsis have a high mortality rate, nearly 40 percent, because there is no effective treatment.

    “There are many facets to sepsis, but the one we have focused on for the past 10 years is the plugging of capillaries,” says Dr. Tyml.  Plugged capillaries prevent oxygenation and the supply of life-supporting materials to your organ tissue and stop the removal of metabolic waste product.  Plugged capillaries are seen in organs of septic patients.  These organs may eventually fail, leading to multiple organ failure and death.  Dr. Tyml’s lab was the first to discover this plugging by using intravital microscopy, a technique Dr. Tyml pioneered in Canada.

    According to Dr. Tyml’s most recent publication, oxidative stress and the activated blood clotting pathway are the major factors responsible for the capillary plugging in sepsis. Through his research, Dr. Tyml has discovered that a single bolus of vitamin C injected early at the time of induction of sepsis, prevents capillary plugging.  He has also found that a delayed bolus injection of vitamin C can reverse plugging by restoring blood flow in previously plugged capillaries.

    “Our research in mice with sepsis has found that early as well as delayed injections of vitamin C improves chance of survival significantly,” explains Dr. Tyml.  “Furthermore, the beneficial effect of a single bolus injection of vitamin C is long lasting and prevents capillary plugging for up to 24 hours post-injection.”

    Dr. Tyml and his colleagues are eager to find appropriate support to move this research from the bench to the bedside to see if these findings translate to patients with sepsis.

    The potential benefit of this treatment is substantial.  “Vitamin C is cheap and safe. Previous studies have shown that it can be injected intravenously into patients with no side effects,” says Dr. Tyml.  “It has the potential to significantly improve the outcome of sepsis patients world-wide.  This could be especially beneficially in developing countries where sepsis is more common and expensive treatments are not affordable.”