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 “”

Serious studies on the many risks of statins

I have decided to post a quick data rebuttal, after the publishing of a few misguided headlines (i.e ” Statins have virtually no side-effects, study finds”, and “Give statins to all over-40s, says heart surgery pioneer”, from the London Telegraph ).  This coincides with the wildly unsubstantiated recommendations being presented in prescribing statins . I felt I was left with little choice to link some of the extreme risks associated with statins, that the media somehow forgot to cover. I only had time to post these few, since I am currently working on other projects.

facepalm

It is all about Risk to Benefit Ratio – You have a right to know both. You also have the right to access non industry sponsored peer reviewed studies on the benefits of statins ( #? ), when weighing your options.

Thank you for reading,

Ralph Turchiano – clinicalnews.org

  1. Statins have unexpected effect on pool of powerful brain cells : Reduces Glial progenitor cells
  2. Statins Lower Testosterone, Libido
  3. Long-term effects of statin therapy could lead to transient or permanent cognitive impairment
  4. Most heart attack patients’ cholesterol levels did not indicate cardiac risk: half of the patients with a history of heart disease had LDL cholesterol levels lower than 100 mg/dL
  5. Cure-all? Statins have had no effect on Britain’s heart disease rate, study claims
  6. Cholesterol-drugs cause unusual swellings within neurons resulting in cognitive disturbances
  7. Cholesterol medicine affects energy production in muscles: Up to 75 per cent of patients
  8. Statins: Benefits questionable in low-risk patients
  9. Cholesterol-reducing drugs may lessen brain function, says ISU researcher
  10. New insights into link between anti-cholesterol statin drugs and depression
  11. Cholesterol Lowerings Drugs May Create Manifestations of severe irritability included homicidal impulses, threats to others, road rage, generation of fear in family members, and damage to property.
  12. Wider use of statins ‘disturbing’
  13. Statins being overprescribed for growing number of kidney disease patients / But may Kill faster
  14. Statins risk for women: Taking cholesterol-lowering drug for more than ten years ‘doubles chances of the most common breast cancer’
  15. Statins block the ability of exercise to improve fitness levels
  16. Co-Q10 deficiency may relate to statin drugs, diabetes risk
  17. New insights into link between anti-cholesterol statin drugs and depression
  18. First comprehensive paper on statins’ adverse effects released: Benefits have not been found to exceed their risks in those over 70 or 75 years old, even those with heart disease
  19. Cholesterol Drugs ( Statins ) may contribute to Atherosclerosis
  20. Statins increase risk of postoperative delirium in elderly patients: 28% Increase
  21. Statins are unlikely to prevent blood clots
  22. Relationship between statins and cognitive decline more complex than thought
  23. Statins may increase risk of interstitial lung abnormalities in smokers
  24. Statins show dramatic drug and cell dependent effects in the brain
  25. Muscle damage may be present in some patients taking statins
  26. Millions of patients may be on statins needlessly
  27. Statin warning for pregnant women
  28. Cholesterol-lowering drug linked to sleep disruptions – Possibly promoting weight gain and insulin resistance
  29. Cholesterol-lowering drugs and the effect on muscle repair and regeneration
  30. Study finds association between low cholesterol levels and cancer
  31. ‘Bad’ Cholesterol Not As Bad As People Think, Shows Texas A&M Study Texas A&M News & Information Service
  32. Low cholesterol associated with cancer in diabetics ( cancers of digestive organs and peritoneum, genital and urinary organs, lymphatic and blood tissues )
  33. Cholesterol-lowering drugs and the risk of hemorrhagic stroke

 

 

 

 

 

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Annual screening does not cut breast cancer deaths, suggests Canadian study

Highlights:
– Annual screening in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination
– .Canada decided to compare breast cancer incidence and mortality up to 25 years in over 89,000 women aged 40-59 who did or did not undergo mammography screening
– During the 25 year study period, 3,250 women in the mammography arm and 3,133 in the control arm were diagnosed with breast cancer and 500 and 505, respectively, died of breast cancer
– Furthermore, the study shows that 22% of screen detected breast cancers were over-diagnosed
* 25-year study from Canada published on bmj.com today. FEB 2014 Continue reading “Annual screening does not cut breast cancer deaths, suggests Canadian study”

WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up

Conflicts of Interest

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee

The original advisory opinion was requested by...

– Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines?

– Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir?

– Why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO?

–  Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting

– FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

– conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.”

– the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

– “WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General.

Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: “I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met…The world is now at the start of the 2009 influenza pandemic.” Continue reading “WHO and the pandemic flu “conspiracies” – The BMJ and the Bureau of Investigative Journalism report that was covered up”

Is laughter really the best medicine?

Contact: Stephanie Burns sburns@bmj.com 44-020-738-36920 BMJ-British Medical Journal

Food for thought: Laughter and MIRTH (methodical investigation of risibility, therapeutic and harmful): Narrative synthesis

Laughter may not be the best medicine after all and can even be harmful to some patients, suggests the authors of a paper published in the Christmas edition of The BMJ.

Researchers from Birmingham and Oxford, in the UK, reviewed the reported benefits and harms of laughter. They used data published between 1946 and 2013. They concluded that laughter is a serious matter.

They identified benefits from laughter; harms from laughter; and conditions causing pathological laughter. Continue reading “Is laughter really the best medicine?”

Should your surname carry a health warning?

Contact: Stephanie Burns sburns@bmj.com 44-020-738-36920 BMJ-British Medical Journal

Research: The Brady Bunch? New evidence for nominative determinism in patients’ health: Retrospective, population based cohort study

Patients named Brady could be at an increased risk of requiring a pacemaker compared with the general population, say researchers in a paper published in the Christmas edition of The BMJ this week.

“Nominative determinism” describes how certain people are more likely to choose a profession because of the influence of their surname with a study by Pelham et al concluding that people have a preference for things “that are connected to the self” and are disproportionately more likely to find careers whose “label is closely related to their name”. Continue reading “Should your surname carry a health warning?”

Results from many large clinical trials are never published

Contact: Tom Hughes tahughes@unch.unc.edu 919-966-6047 University of North Carolina Health Care

Non-publication is more common among industry-funded trials, study finds

CHAPEL HILL, N.C. – A new analysis of 585 large, randomized clinical trials registered with ClinicalTrials.gov finds that 29 percent have not been published in scientific journals. In addition, nearly 78 percent of the unpublished trials had no results available on the website, either.

As a result, nearly 300,000 people who were enrolled in the 171 unpublished trials “were exposed to the risks of trial participation without the societal benefits which accompany the dissemination of trial results,” said Christopher W. Jones, MD, a former resident physician at University of North Carolina School of Medicine who is now an attending physician at Cooper Medical School of Rowan University in Camden, N.J. and lead author of the study published in the Oct. 29, 2013 issue of the British Medical Journal.

Continue reading “Results from many large clinical trials are never published”

Food poverty in UK has reached level of ‘public health emergency’, warn experts

The Government may be covering up the extent to which austerity and welfare cuts are adding to the problem

Charlie Cooper

Wednesday, 4 December 2013

Hunger in Britain has reached the level of a “public health emergency” and the Government may be covering up the extent to which austerity and welfare cuts are adding to the problem, leading experts have said.

In a letter to the British Medical Journal, a group of doctors and senior academics from the Medical Research Council and two leading universities said that the effect of Government policies on vulnerable people’s ability to afford food needed to be “urgently” monitored.

A surge in the number of people requiring emergency food aid, a decrease in the amount of calories consumed by British families, and a doubling of the number of malnutrition cases seen at English hospitals represent “all the signs of a public health emergency that could go unrecognised until it is too late to take preventative action,” they write.

Continue reading “Food poverty in UK has reached level of ‘public health emergency’, warn experts”

168th Health Research Report 16 NOV 2013

Health Research Report ( LOGO's )

168

Health Research Report

WHITE PAPER /ROUGH COPY

168th Issue Date 16 NOV 2013

Compiled By Ralph Turchiano

www.vit.bz www.youtube.com/vhfilm www.engineeringevil.com www.healthresearchreport.me

 

In this Issue:

1.      The most commonly prescribed treatment for Colds and Sore Throats offers no benefit and may actually make the illness worse

2.      Japanese super food prevents flu infection

3.      Study links intestinal bacteria to rheumatoid arthritis

4.      New research shows clear association between ACE inhibitors and acute kidney injury

5.      Scientists at the University of Granada have disproved the old idea that chocolate is fattening, in a study reported this week in Nutrition

6.      Vitamin C could ease muscle fatigue in chronic obstructive pulmonary disease patients

7.      Allergic to Gummy Bears? Be Cautious Getting the Flu Shot

8.      Oral allergy syndrome and high blood pressure medications can create lethal cocktail

9.      Acid levels in the diet could have profound effects on kidney health

10.  How zinc starves lethal bacteria to stop infection

11.  Study is the first to show higher dietary acid load increases risk of diabetes

12.  Scientists report human dietary supplement cures lab animals infected with human intestinal parasite

13.  Inflammatory skin damage in mice blocked by bleach solution, Stanford study finds

14.  Can Certain Herbs Stave Off Alzheimer’s Disease?

 

The most commonly prescribed treatment for Colds and Sore Throats offers no benefit and may actually make the illness worse

Questions have been raised about the advice given to patients with a cold and sore throat, in research published in the British Medical Journal.

A study carried out by the University of Southampton showed that compared with paracetamol, ibuprofen or a combination of both ibuprofen and paracetamol provide no advantage for patients overall with respiratory tract infections (otherwise known as colds or sore throats).

Additionally steam inhalation, another common treatment method, has no clear benefit and around 2 per cent of people get mild scalding but not bad enough to see a doctor.

Professor Paul Little, who led the study, comments: “Paracetamol, ibuprofen or a combination of both are the most common courses of treatment for respiratory tract infections. Clinicians should probably not advise patients to use steam inhalation in daily practice as it does not provide symptomatic benefit for acute respiratory infections and a few individuals are likely to experience mild thermal injury. Similarly, routinely advising ibuprofen or ibuprofen and paracetamol together than just paracetamol is also not likely to be effective. However our research has shown that ibuprofen is likely to help children, and those with chest infections.”

The research also showed that patients were more likely to come back within a month with worsening symptoms or new symptoms if they were prescribed with ibuprofen or ibuprofen with paracetamol. Between 50 per cent and 70 per cent of participants in the study who were prescribed ibuprofen or ibuprofen with paracetamol came back.

Professor Little admitted this was a surprising result and suggests the treatment may contribute to the progression of the illness. He adds: “This may have something to do with the fact the ibuprofen is an anti-inflammatory. It is possible that the drug is interfering with an important part of the immune response and leads to prolonged symptoms or the progression of symptoms in some individuals. Although we have to be a bit cautious since these were surprise findings, for the moment I would personally not advise most patients to use ibuprofen for symptom control for coughs colds and sore throat.”

The randomised control trial recruited 899 patients who presented at their GP with respiratory tract infection symptoms. They received different treatment types; paracetamol, ibuprofen or a combination of both. Participants were then told to either take it as needed or at regular intervals (four times a day) and some were also told to take steam inhalation.

###

The study was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme.

Japanese superfood prevents flu infection

Scientists have discovered that bacteria found in a traditional Japanese pickle can prevent flu. Could this be the next superfood?

The research, which assesses the immune-boosting powers of Lactobacillus brevis from Suguki – a pickled turnip, popular in Japan – in mice that have been exposed to a flu virus, is published today (06 November) in the SfAM journal, Letters in Applied Microbiology.

Lead researcher, Ms Naoko Waki of KAGOME CO., LTD. in Japan said: “Our results show that when a particular strain of Lactobacillus brevis is eaten by mice, it has protective effects against influenza virus infection.”

Suguki enthusiasts have often cited its protective powers but it is not known yet whether the same effects will be seen in humans. Human clinical trials using a probiotic drink containing Lactobacillus brevis KB290 bacteria are underway and scientists are hopeful that, given a suitable quantity of bacteria, foods containing them may turn out to be the next superfood.

What it is about the bacteria that gives them this amazing property is not known, but it is remarkably tolerant to stomach juices, which are too acidic for many bacteria. This is largely due to a protective layer of sugars called exopolysaccharides.

“We know that exopolysaccharides have immune boosting effects in other similar bacteria, so we wonder if the exopolysaccharides of KB290 are responsible for the effects we see,” said Ms Waki. Further studies will be undertaken to investigate this.

The effect of the bacteria is to increase the production of immune system molecules in the body – IFN-α and flu-specific antibodies – and to enhance activity to eradicate virus infected cells. In this study these effects were sufficient to prevent infection by the H1N1 flu and the scientists think that there could also be protection against other viral infections, including the deadly H7N9 flu, which has recently emerged in China.

Study links intestinal bacteria to rheumatoid arthritis

Findings suggest bacterial disturbances in the gut may play a role in autoimmune attacks on the joints, point the way to novel treatments and diagnostics

Researchers have linked a species of intestinal bacteria known as Prevotella copri to the onset of rheumatoid arthritis, the first demonstration in humans that the chronic inflammatory joint disease may be mediated in part by specific intestinal bacteria. The new findings by laboratory scientists and clinical researchers in rheumatology at NYU School of Medicine add to the growing evidence that the trillions of microbes in our body play an important role in regulating our health.

Using sophisticated DNA analysis to compare gut bacteria from fecal samples of patients with rheumatoid arthritis and healthy individuals, the researchers found that P. copri was more abundant in patients newly diagnosed with rheumatoid arthritis than in healthy individuals or patients with chronic, treated rheumatoid arthritis. Moreover, the overgrowth of P. copri was associated with fewer beneficial gut bacteria belonging to the genera Bacteroides.

“Studies in rodent models have clearly shown that the intestinal microbiota contribute significantly to the causation of systemic autoimmune diseases,” says Dan R. Littman, MD, PhD, the Helen L. and Martin S. Kimmel Professor of Pathology and Microbiology and a Howard Hughes Medical Institute investigator.

“Our own results in mouse studies encouraged us to take a closer look at patients with rheumatoid arthritis, and we found this remarkable and surprising association,” says Dr. Littman, whose basic science laboratory at NYU School of Medicine’s Skirball Institute of Biomolecular Medicine collaborated with clinical investigators led by Steven Abramson, MD, senior vice president and vice dean for education, faculty, and academic affairs; the Frederick H. King Professor of Internal Medicine; chair of the Department of Medicine; and professor of medicine and pathology at NYU School of Medicine.

“At this stage, however, we cannot conclude that there is a causal link between the abundance of P. copri and the onset of rheumatoid arthritis,” Dr. Littman says. “We are developing new tools that will hopefully allow us to ask if this is indeed the case.”

The new findings, reported today in the open-access journal eLife, were inspired by previous research in Dr. Littman’s laboratory, collaborating with Harvard Medical School investigators, using mice genetically predisposed to rheumatoid arthritis, which resist the disease if kept in sterile environments, but show signs of joint inflammation when exposed to otherwise benign gut bacteria known as segmented filamentous bacteria.

Rheumatoid arthritis, an autoimmune disease that attacks joint tissue and causes painful, often debilitating stiffness and swelling, affects 1.3 million Americans. It strikes twice as many women as men and its cause remains unknown although genetic and environmental factors are thought to play a role.

The human gut is home to hundreds of species of beneficial bacteria, including P. copri, which ferment undigested carbohydrates to fuel the body and keep harmful bacteria in check. The immune system, primed to attack foreign microbes, possesses the extraordinary ability to distinguish benign or beneficial bacteria from pathogenic bacteria. This ability may be compromised, however, when the gut’s microbial ecosystem is thrown off balance.

“Expansion of P. copri in the intestinal microbiota exacerbates colonic inflammation in mouse models and may offer insight into the systemic autoimmune response seen in rheumatoid arthritis,” says Randy S. Longman, MD, PhD, a post-doctoral fellow in Dr. Littman’s laboratory and a gastroenterologist at Weill-Cornell, and an author on the new study. Exactly how this expansion relates to disease remains unclear even in animal models, he says.

Why P. copri growth seems to take off in newly diagnosed patients with rheumatoid arthritis is also unclear, the researchers say. Both environmental influences, such as diet and genetic factors can shift bacterial populations within the gut, which may set off a systemic autoimmune attack. Adding to the mystery, P. copri extracted from stool samples of newly diagnosed patients appears genetically distinct from P. copri found in healthy individuals, the researchers found.

To determine if particular bacterial species correlate with rheumatoid arthritis, the researchers sequenced the so-called 16S gene on 44 fecal DNA samples from newly diagnosed patients with rheumatoid arthritis prior to immune-suppressive treatment; 26 samples from patients with chronic, treated rheumatoid arthritis; 16 samples from patients with psoriatic arthritis (characterized by red, flaky skin in conjunction with joint inflammation); and 28 samples from healthy individuals.

Seventy-five percent of stool samples from patients newly diagnosed with rheumatoid arthritis carried P. copri compared to 21.4% of samples from healthy individuals; 11.5% from chronic, treated patients; and 37.5% from patients with psoriatic arthritis.

Rheumatoid arthritis is treated with an assortment of medications, including antibiotics, anti-inflammatory drugs like steroids, and immunosuppressive therapies that tame immune reactions. Little is understood about how these medications affect gut bacteria. This latest research offers an important clue, showing that treated patients with chronic rheumatoid arthritis carry smaller populations of P. copri. “It could be that certain treatments help stabilize the balance of bacteria in the gut,” says Jose U. Scher, MD, director of the Microbiome Center for Rheumatology and Autoimmunity at NYU Langone Medical Center’s Hospital for Joint Diseases, and an author on the new study. “Or it could be that certain gut bacteria favor inflammation.”

The researchers plan to validate their results in regions beyond New York, since gut flora can vary across geographical regions, and investigate whether the gut flora can be used as a biological marker to guide treatment. “We want to know if people with certain populations of gut bacteria respond better to certain treatment than others,” says Dr. Scher. Finally, they hope to study people before they develop rheumatoid arthritis to see whether overgrowth of P. copri is a cause or result of autoimmune attacks.

New research shows clear association between ACE inhibitors and acute kidney injury

These and similar drugs are the second most prescribed on the NHS

Cambridge scientists have found an association between ACE inhibitors (and similar drugs) and acute kidney injury – a sudden deterioration in kidney function. The research is published today, 06 November, in the journal PLOS ONE.

ACE inhibitors and related drugs known as angiotensin receptor antagonists (ARAs or ‘sartans’) are the second most frequently prescribed medicines in UK clinical practice, and are used to treat common conditions such as high blood pressure, heart disease and kidney problems, especially in people with diabetes. Although concerns about a link between these drugs and kidney function have been raised in the past, the size of the problem had previously been unknown.

The researchers therefore examined the issue using data from the whole of England. They compared the admission rates for acute kidney injury to English hospitals with the prescribing rates of ACE inhibitors and ARAs. From 2007/8 to 2010/11, there was a 52 per cent increase in acute kidney injury admissions. During this same period of time, there was an increase in the number of prescriptions for ACE inhibitors and ARAs issued by GP surgeries by 16 per cent.

The results show a clear association between the increase in prescriptions and the increase in hospital admissions. The researchers estimate that 1636 hospital admissions with acute kidney injury – which has a mortality rate in the UK of around 25-30 per cent of patients – could potentially have been avoided if the prescribing rate had remained at the 2007/8 levels. They estimate that one in seven cases of acute kidney injury could be due to increased prescriptions for these drugs.

This is the first time that a study has been able to assess the extent to which these medications are linked to acute kidney injury. However, the researchers emphasise that we cannot assume that the medication was a direct cause of the acute kidney injury in this study, and no one should stop taking these medications unless advised by their doctor to do so.

Dr Rupert Payne, senior author of the study from the University of Cambridge’s Institute of Public Health, said: “There has been lots of anecdotal evidence suggesting these drugs may be a contributory factor in patients developing acute kidney injury, and this work gives us an opportunity to estimate the size of the problem, as well as making clinicians and patients more aware of the importance of using these drugs in accordance with current clinical guidelines.

“As both a GP and clinical pharmacologist, it also highlights to me the importance of improving our understanding of the risks and benefits of drugs more generally in the real world of clinical practice, away from the artificial setting of clinical trials.”

Dr Laurie Tomlinson, co-author of the study, added: “As a kidney doctor I have looked after many patients with acute kidney injury who were taking these medications prior to becoming unwell and have often worried that the drugs were doing more harm than good. These results are the first to estimate to what extent these drugs may be contributing to the growing incidence of acute kidney injury. Therefore, they represent the first step of research needed to better define when they can be prescribed safely, which should reduce the growing burden of acute kidney injury and save NHS costs and ultimately lives.”

The researchers will next use large primary care databases to examine the association between the drugs and acute kidney injury for individual patients and, in particular, the role of other medication, patient factors (such as the existence of chronic kidney disease) and infections in causing acute kidney injury.

Scientists at the University of Granada have disproved the old idea that chocolate is fattening, in a study reported this week in Nutrition

 

Higher chocolate consumption associated with lower levels of total fat—fat deposits all over the body—and central—abdominal—fat, independently of whether or not subjects are physically active, and of their diet

The study—possibly the most comprehensive to date—included 1458 European adolescents aged between 12 and 17 years

University of Granada researchers from the Faculty of Medicine and the Faculty of Physical Activity and Sports Sciences have scientifically disproven the old belief that eating chocolate is fattening. In an article published this week in the journal Nutrition, the authors have shown that higher consumption of chocolate is associated with lower levels of total fat (fat deposited all over the body) and central fat (abdominal), independently of whether or not the individual participates in regular physical activity and of diet, among other factors.

The researchers determined whether greater chocolate consumption associated with higher body mass index and other indicators of total and central body fat in adolescents participating in the HELENA (Healthy Lifestyle in Europe by Nutrition in Adolescence) study. This project, financed by the European Union, studies eating habits and lifestyle in young people in 9 European countries, including Spain.

Independent of diet and physical activity

The study involved 1458 adolescents aged between 12 and 17 years and results showed that a higher level of chocolate consumption associated with lower levels of total and central fat when these were estimated through body mass index, body fat percentage—measured by both skinfolds and bioelectrical impedance analysis—and waist circumference. These results were independent of the participant’s sex, age, sexual maturation, total energy intake, intake of saturated fats, fruit and vegetables, consumption of tea and coffee, and physical activity.

As the principle author Magdalena Cuenca-García explains, although chocolate is considered a high energy content food—it is rich in sugars and saturated fats—“recent studies in adults suggest chocolate consumption is associated with a lower risk of cardiometabolic disorders”.

In fact, chocolate is rich in flavonoids—especially catechins—which have many healthy properties: “they have important antioxidant, antithrombotic, anti-inflammatory and antihypertensive effects and can help prevent ischemic heart disease”.

Recently, another cross-sectional study in adults conducted by University of California researchers found that more frequent chocolate consumption also associated with a lower body mass index. What’s more, these results were confirmed in a longitudinal study in women who followed a catechin-rich diet.

The effect could be partly due to the influence of catechins on cortisol production and on insulin sensitivity, both of which are related with overweight and obesity.

Calorie impact is not the only thing that matters

The University of Granada researchers have sought to go further and analyse the effect of chocolate consumption at a critical age like adolescence by also controlling other factors that could influence the accumulation of fat. The research, which is both novel and, perhaps, the largest and best-controlled study to date, is the first to focus on the adolescent population. It includes a large number of body measures, objective measurement of physical activity, detailed dietary recall with 2 non-consecutive 24-hour registers using image-based software, and controls for the possible effect of a group of key variables.

In Nutrition, the authors stress that the biological impact of foods should not be evaluated solely in terms of calories. “The most recent epidemiologic research focuses on studying the relation between specific foods—both for their calorie content and for their components—and the risk factors for developing chronic illnesses, including overweight and obesity”.

Despite their results, the authors insist that chocolate consumption should always be moderate. “In moderate quantities, chocolate can be good for you, as our study has shown. But, undoubtedly, excessive consumption is prejudicial. As they say: you can have too much of a good thing”.

The University of Granada researchers stress that their findings “are also important from a clinical perspective since they contribute to our understanding of the factors underlying the control and maintenance of optimal weight”.

 

 

Vitamin C could ease muscle fatigue in chronic obstructive pulmonary disease patients

Bethesda, Md. (Nov. 7, 2013)—Chronic obstructive pulmonary disease—a health problem in which the lungs lose their inherent springiness, making it progressively harder to breathe—can have a dramatic effect on the ability to exercise and even perform simple activities of daily life because of the disease’s fallout effects on skeletal muscles. Several factors have been implicated in these muscle problems. These include loss of fitness from inactivity, problems with the part of cells that convert fuel to energy caused by the COPD itself, and oxidative stress, a phenomenon in which cells and tissues become damaged by unstable molecules called free radicals that harm other molecules in domino-like chain reactions. Some research suggests that easing oxidative stress could improve skeletal muscle function.

To test this idea, researchers led by Matthew J. Rossman of the George E. Whalen VA Medical Center and the University of Utah gave COPD patients intravenous (IV) infusions of vitamin C, a powerful antioxidant that can combat oxidative stress, or saline as a placebo before the patients performed knee extension exercises and underwent neuromuscular function tests. Their findings show that IV infusions of vitamin C can improve skeletal muscle fatigue in COPD patients, further implicating the role of oxidative stress in the skeletal muscle problems that accompany this disease.

The article is entitled “Ascorbate Infusion Increases Skeletal Muscle Fatigue Resistance in Patients with Chronic Obstructive Pulmonary Disease“. It appears in the online edition of the American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, published by the American Physiological Society.

Methodology

The researchers worked with 10 COPD patients. Each patient performed a set of knee extension exercises, receiving either an IV infusion of saline or an IV infusion of vitamin C before the set, but both the study volunteers and the researchers monitoring the exercises didn’t know which infusion the volunteers received. Two to three days later, the volunteers performed a second set of knee exercises after receiving the other type of infusion. Before and after they performed these exercises, the study subjects had blood drawn to test for antioxidant levels. Immediately after the exercises, the researchers measured a variety of other factors, including the volunteers’ breathing and heart rate, blood pressure, feelings of exertion of breathlessness, and blood flow.

Results

The researchers found that during exercises, patients had significantly less muscle fatigue after receiving vitamin C and breathed better and slower. After vitamin C infusions, the volunteers also had significantly higher blood antioxidant activity than when they received only saline. Additionally, vitamin C infusions lowered their resting blood pressure and blood flow.

Importance of the Findings

These findings suggest that IV infusions of antioxidants, such as vitamin C, can curb the skeletal muscle fatigue that plagues COPD patients. They also provide further evidence that oxidative stress plays a critical role in the skeletal muscle dysfunction that many COPD patients experience. They suggest that antioxidants could eventually be used as a treatment for these problems.

“Targeting oxidative stress with some form of antioxidant therapy in a clinical setting may represent an important therapeutic avenue for patients with COPD,” they write.

Allergic to Gummy Bears? Be Cautious Getting the Flu Shot

Those with gelatin allergy can have reaction from flu vaccinations

BALTIMORE, MD. (November 8, 2013) – Do marshmallows make your tongue swell? Gummy bears make you itchy? If you’ve answered yes and are allergic to gelatin, you will want to take some precautions when getting the flu shot. While the vaccine is recommended for those six months of age and older, a case report being presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting notes that individuals with a gelatin allergy can have a mild to severe reaction from the shot.

“Gelatin is used in the flu shot, as well as other vaccines, as a stabilizer,” said Stephanie Albin, MD, an allergist and ACAAI member. “Because it is found in the vaccine, those with a known allergy to gelatin can experience allergic reactions, such as hives, sneezing and difficulty breathing.”

There is a misconception about allergies and the flu shot, with many believing those with an egg allergy should not receive the vaccination. But last month, ACAAI published an update that found even those with a severe egg allergy can receive the vaccine without special precautions.

“Gelatin reactions can cause hives, swelling, itchiness, shortness of breath and a severe life-threatening reaction known as anaphylaxis,” explained Dr. Albin. “Because of this, precautions should be taken, such as having a board-certified allergist administer the vaccine in a person with known gelatin allergy in case a reaction occurs.”

Gelatin can contain proteins derived from cow, pig or fish. Gelatin can be found in a variety of foods and pharmaceuticals, including gummy vitamins, marshmallows and candy.

“Gelatin allergy is very rare,” said allergist Richard Weber, M.D., ACAAI president. “Many food intolerances can be mistaken as allergies. Those who believe they might have an allergy should be tested and diagnosed by an allergist before taking extreme avoidance measures or skipping vaccinations. The flu shot is an important vaccine and can even be life-saving for individuals that are at an increased risk for severe side effects associated with the flu.”

The Centers for Disease Control and Prevention (CDC) recommends receiving an annual flu shot, especially for high risk age groups as children and the elderly. The vaccination can be given either as a shot or a nasal spray, both of which can contain gelatin.

For more information about allergies and to locate an allergist in your area, visit AllergyandAsthmaRelief.org. The ACAAI Annual Meeting is being held Nov. 7-11 at the Baltimore Convention Center in Baltimore. For more news and research being presented at the meeting, follow the conversation on Twitter #ACAAI.

 

Oral allergy syndrome and high blood pressure medications can create lethal cocktail

Some allergy suffers with hypertension may be at increased risk for severe reaction

BALTIMORE, MD. (November 8, 2013) – Oral allergy syndrome sufferers that take high blood pressure medications may experience extreme facial swelling and difficulty breathing the next time they bite into a juicy apple. When patients with oral allergy syndrome take angiotensin-converting enzyme (ACE) inhibitors for hypertension and congestive heart failure, they are at an increased risk for a life-threatening allergic reaction known as anaphylaxis, according to new research.

The case studies, being presented at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), found use of ACE inhibitors can cause what is known as a “priming effect” in oral allergy syndrome sufferers.

“When a sufferer’s allergies are primed and they come in contact with a particular allergen, they experience a more severe than normal reaction,” said allergist Denisa Ferastraoaru, MD, ACAAI member and lead study author. “Symptoms can include extreme facial swelling (angioedema) and difficulty breathing, which can lead to death in some cases.”

Hay fever sufferers that experience an itchy mouth or scratchy throat after eating certain raw fruits or vegetables and some tree nuts, may have oral allergy syndrome. It is also known as pollen-food syndrome, since it is caused by cross-reacting allergens found in both pollen and raw produce.

“Sufferers can often mistake oral allergy syndrome symptoms for food allergy,” said allergist David Rosenstreich, MD, ACAAI fellow and study author. “But it isn’t a food allergy, and often patients can eat that food when it is cooked. For example, an individual may have a reaction to a raw apple but not to apples baked in a pie.”

When allergists advised patients to avoid raw produce and switched from ACE inhibitors to angiotensin II receptor blocker (ARB) therapy, no further oral allergy symptoms occurred.

Not everyone with a pollen allergy will experience oral allergy syndrome when eating raw produce and tree nuts. However, the syndrome is commonly associated with these allergens:

  • Birch Pollen: apple, almond, carrot, celery, cherry, hazelnut, kiwi, peach, pear, plum
  • Grass Pollen: celery, melons, oranges, peaches, tomato
  • Ragweed Pollen: banana, cucumber, melons, sunflower seeds, zucchini

While oral allergy symptoms are typically mild, including mouth and throat discomfort, swelling and itching, it is important sufferers discuss these symptoms with their allergist because anaphylaxis can sometimes occur.

Acid levels in the diet could have profound effects on kidney health

Atlanta, GA (November 9, 2013)—Three new studies suggest that controlling dietary acid intake could help improve kidney health. Results of these studies will be presented at ASN Kidney Week 2013 November 5-10 at the Georgia World Congress Center in Atlanta, GA.

A diet rich in wheat flour and animal protein produces an acidic environment in the body that worsens with age as kidney function declines. This acid load can be detrimental to a variety of tissues and processes. Research suggests that consuming more fruits and vegetables—which are highly alkaline—may help counteract these effects.

In a new study, a team led by Nimrit Goraya, MD (Texas A&M College of Medicine) investigated whether consuming fruits and vegetables can protect the kidney health of individuals with hypertensive nephropathy, a condition in which damage to the kidneys occurs due to high blood pressure. In this study, 23 hypertensive patients received extra dietary fruits and vegetables, 23 patients received an oral alkaline medication, and 25 patients received nothing. One year later, kidney injury progressed in patients who received no intervention, but kidney health was preserved in those receiving fruits and vegetables or oral alkaline medication.

In another study, Eiichiro Kanda, MD, PhD (Tokyo Kyosai Hospital) and his colleagues investigated the role of dietary acid levels in chronic kidney disease (CKD) progression. The retrospective study analyzed data from 249 CKD patients in Japan. High acid levels were linked with accelerated kidney function decline, and patients with elevated acid levels had an increased risk of CKD progression compared with patients with low acid levels. The findings suggest that monitoring and control of dietary acid levels are necessary for the prevention of CKD progression.

Another study led by Deidra Crews, MD, FASN (Johns Hopkins University School of Medicine) looked to see whether the effect of dietary acid on risk of kidney failure differed by race in a group of 159 non-Hispanic black and 760 non-Hispanic white CKD patients who had an annual household income below 300% of the federal poverty guideline. Participants were taking part in the 1999-2004 National Health and Nutrition Examination Survey. Overall, 12.4% of participants (38.3% whites and 61.7% blacks) developed kidney failure during an average of 6.4 years of follow up. Blacks had higher acid levels than whites. They also had a 3-fold higher risk of developing kidney failure compared with whites after adjusting for factors such as age, sex, and caloric intake. Increased acid levels were more strongly associated with kidney failure among blacks than among whites. The findings indicate that among CKD patients with low socioeconomic status, the detrimental effect of high dietary acid levels on progression to kidney failure appears to be greater for blacks than for whites.

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Highlights

  • In patients with hypertensive nephropathy, kidney health was preserved in those consuming extra fruits and vegetables, which are highly alkaline.
  • In patients with chronic kidney disease, those with high dietary acid levels experienced accelerated kidney function decline.
  • In chronic kidney disease patients with low socioeconomic status, the detrimental effect of high dietary acid levels on progression to kidney failure was greater for blacks than for whites.

Studies:

“Fruits and Vegetables or Oral NaHCO3 Prevent Progression of Kidney Injury in Stage 1 CKD Due to Hypertensive Nephropathy.” (Abstract FR-PO816)

“Dietary Acid Load Is Associated with Chronic Kidney Disease Progression in Elderly Patients.” (Abstract TH-PO243)

How zinc starves lethal bacteria to stop infection

Australian researchers have found that zinc can ‘starve’ one of the world’s most deadly bacteria by preventing its uptake of an essential metal.

The finding, by infectious disease researchers at the University of Adelaide and The University of Queensland, opens the way for further work to design antibacterial agents in the fight against Streptococcus pneumoniae.

Streptococcus pneumoniae is responsible for more than one million deaths a year, killing children, the elderly and other vulnerable people by causing pneumonia, meningitis, and other serious infectious diseases.

Published today in the journal Nature Chemical Biology, the researchers describe how zinc “jams shut” a protein transporter in the bacteria so that it cannot take up manganese, an essential metal that Streptococcus pneumoniae needs to be able to invade and cause disease in humans.

“It’s long been known that zinc plays an important role in the body’s ability to protect against bacterial infection, but this is the first time anyone has been able to show how zinc actually blocks an essential pathway causing the bacteria to starve,” says project leader Dr Christopher McDevitt, Research Fellow in the University of Adelaide’s Research Centre for Infectious Diseases.

“This work spans fields from chemistry and biochemistry to microbiology and immunology to see, at an atomic level of detail, how this transport protein is responsible for keeping the bacteria alive by scavenging one essential metal (manganese), but at the same time also makes the bacteria vulnerable to being killed by another metal (zinc),” says Professor Bostjan Kobe, Professor of Structural Biology at The University of Queensland.

The study reveals that the bacterial transporter (PsaBCA) uses a ‘spring-hammer’ mechanism to bind the metals. The difference in size between the two metals, manganese and zinc, causes the transporter to bind them in different ways. The smaller size of zinc means that when it binds to the transporter, the mechanism closes too tightly around the zinc, causing an essential spring in the protein to unwind too far, jamming it shut and blocking the transporter from being able to take up manganese.

“Without manganese, these bacteria can easily be cleared by the immune system,” says Dr McDevitt. “For the first time, we understand how these types of transporters function. With this new information we can start to design the next generation of antibacterial agents to target and block these essential transporters.”

Study is the first to show higher dietary acid load increases risk of diabetes

A study of more than 60 000 women has shown that higher overall acidity of the diet, regardless of the individual foods making up that diet, increases the risk of type 2 diabetes. The study, the first large prospective study to demonstrate these findings, is published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), and is by Dr Guy Fagherazzi and Dr Françoise Clavel-Chapelon, Center for Research in Epidemiology and Population Health, INSERM, Paris, France, and colleagues.

A western diet rich in animal products and other acidogenic foods can induce an acid load that is not compensated for by fruit and vegetables; this can cause chronic metabolic acidosis and lead to metabolic complications. Most importantly from a blood-sugar control perspective, increasing acidosis can reduce the ability of insulin to bind at appropriate receptors in the body, and reduce insulin sensitivity. With this in mind, the authors decided to analyse whether increased acidosis caused by dietary acid loads increased the risk of type 2 diabetes.

A total of 66,485 women from the E3N study (the French Centre of the European Prospective Investigation into Cancer and Nutrition, a well-known ongoing epidemiological study) were followed for new diabetes cases over 14 years. Their dietary acid load was calculated from their potential renal acid load (PRAL) and their net endogenous acid production (NEAP) scores, both standard techniques for assessing dietary acid consumption from nutrient intake.

During follow-up, 1,372 new cases of incident type 2 diabetes occurred. In the overall population, those in the top 25% (quartile) for PRAL had a 56% increased risk of developing type 2 diabetes compared with the bottom quartile. Women of normal weight (BMI of 25 and under) had the highest increased risk (96% for top quartile versus bottom) while overweight women (BMI 25 and over) had only a 28% increased risk (top quartile versus bottom). NEAP scores showed a similar increased risk for higher acid load.

The authors say: “A diet rich in animal protein may favour net acid intake, while most fruits and vegetables form alkaline precursors that neutralise the acidity. Contrary to what is generally believed, most fruits such as peaches, apples, pears, bananas and even lemons and oranges actually reduce dietary acid load once the body has processed them. In our study, the fact that the association between both PRAL and NEAP scores and the risk of incident type 2 diabetes persisted after adjustment for dietary patterns, meat consumption and intake of fruit, vegetables, coffee and sweetened beverages suggests that dietary acids may play a specific role in promoting the development of type 2 diabetes, irrespective of the foods or drinks that provide the acidic or alkaline components.”

They conclude: “We have demonstrated for the first time in a large prospective study that dietary acid load was positively associated with type 2 diabetes risk, independently of other known risk factors for diabetes. Our results need to be validated in other populations, and may lead to promotion of diets with a low acid load for the prevention of diabetes. Further research is required on the underlying mechanisms.”

Scientists report human dietary supplement cures lab animals infected with human intestinal parasite

Preliminary success using ‘probiotics’ against hookworms raises hope for treating afflictions that burden 1.5 billion and cause stunting, development delays in children

WASHINGTON, D.C. (November 15, 2013) — Laboratory animals fed a modified version of a common human dietary supplement were completely cured of intestinal worms that belong to a family of parasites that currently infect 1.5 billion people, or almost one quarter of the world’s population, according to new research presented today at the annual meeting of the American Society of Tropical Medicine and Hygiene (ASTMH).

“We need to replicate the results in other animals and also in humans, but this is an important development in our effort to find a safe, affordable and effective way to confront a major global health problem,” said Raffi Aroian, PhD, principal investigator of a team of scientists at the University of California, San Diego who are seeking new treatments for a variety of parasitic worms known as “soil-transmitted helminths” or STHs.

While rarely fatal, STHs and other intestinal worms are leading contributors to disease in school-age children in low-income countries and are viewed by many experts as among the most burdensome of the world’s “neglected tropical diseases” or NTDs.

The study conducted by Aroian’s team focused on hookworms, common STHs that are found in soil that has been contaminated with human feces. Hookworms can linger in the intestines for years, where they feed on blood and tissue, robbing their hosts of iron and protein and interfering with absorption of critical nutrients. They frequently cause stunting and cognitive delays in infected children. They also can have long-term effects on educational achievement and productivity.

Currently, the only drugs available to treat hookworms in humans were originally developed to combat parasites that infect farm animals. Aroian said they are only partially effective against the range of intestinal parasites that infect humans. There is also evidence of reinfections occurring rapidly after treatment and low levels of efficacy in some places.

At the ASTMH meeting, Aroian’s colleague Yan Hu, PhD reported findings from a study in which hamsters were deliberately infected with hookworms. The hamsters were later divided into two groups. One group received a common strain of the bacteria Bacillus subtilis, which is often marketed as a “probiotic”—a dietary supplement consumed as a pill or added to food that is intended to promote digestive health. It also is the key ingredient in a popular Japanese fermented soybean dish called Natto. The other group received the same probiotic, except the researchers modified it to express a protein derived from a closely related bacterium, Bacillus thuringiensis or Bt, which is known to be safe in humans but potentially lethal to intestinal worms.

“Five days after we administered the bacteria, we examined the animals’ intestines,” Hu said. “We found no worms in the animals that received the modified probiotic, while those that did not receive the modified probiotic remained infected.”

Hu said the next step will be to conduct tests in different types of animals and against different types of STHs. If the probiotic continues to perform well against multiple intestinal parasites and is shown to be safe, then researchers would consider testing in humans, she said.

The research is supported by grants from the Bill & Melinda Gates Foundation and the National Institutes of Health.

“While the research has yet to move beyond tests in animals, the human health burden is so immense and the solutions so few that it’s gratifying to see progress being made toward finding new treatments for intestinal worm diseases,” said ASTMH President David H. Walker, MD. “It shows that new investments in neglected tropical diseases are inspiring creative solutions for the more than a billion people in need.”

Aroian said the overall goal of the work is to produce a treatment for intestinal worms that is safe, effective and affordable in the world’s poorest countries, where hookworms and other STHs do the most damage. “This probiotic is a food-grade bacterial product that can be easily produced in large quantities in a simple fermenter, and it can be manufactured in a form that has a long shelf-life,” he said. “It could be well-suited to providing the cheap, mass treatment we need to substantially reduce the burden of this disease.”

Aroian said Bt is attractive because it is a well-understood, natural substance for controlling plant pests that is believed to be safe for animals and humans. It is frequently sprayed on organic crops and is mainly lethal to insects in their larva stage. Bt also is a bacteria used in genetically engineered corn and soybean to endow the crops with resistance to plant pests.

Aroian said that while the modified probiotic under development in his lab should be safe to consume, if it proves to be an effective intervention for intestinal worms it would be marketed as a treatment, not as a dietary supplement.

Inflammatory skin damage in mice blocked by bleach solution, Stanford study finds

STANFORD, Calif. — Processes that age and damage skin are impeded by dilute bleach solution, according to a new study by researchers at the Stanford University School of Medicine.

The study was conducted on mice. But if shown to work similarly in humans, the inexpensive, widely available household chemical could provide a new way to treat skin damage caused by radiation therapy, excess sun exposure or aging.

Dilute bleach baths have been used for decades to treat moderate to severe eczema in humans, but it has not been clear until now why they work. “Originally it was thought that bleach may serve an antimicrobial function, killing bacteria and viruses on the skin,” said Thomas Leung, MD, PhD, an instructor in dermatology at Stanford and a pediatric dermatologist at Lucile Packard Children’s Hospital. “But the concentrations used in clinic are not high enough for this to be the sole reason. So we wondered if there could be something else going on.”

Leung is the lead author of the study, which will be published online Nov. 15 in the Journal of Clinical Investigation. Seung Kim, MD, PhD, professor of developmental biology and a Howard Hughes Medical Institute investigator, is the study’s senior author.

“Dr. Leung relentlessly followed his hunch that an antimicrobial effect of dilute bleach wasn’t the whole story,” Kim said. “And his work has revealed new mechanisms for targeting inflammatory pathways with this versatile small molecule. It has also identified new possible clinical applications.”

Leung and his colleagues knew that many skin disorders, including eczema and radiation dermatitis, have an inflammatory component. When the skin is damaged, immune cells rush to the site of the injury to protect against infection. Because inflammation itself can be harmful if it spirals out of control, the researchers wondered if the bleach (sodium hypochlorite) solution somehow played a role in blocking this response.

To find out, they homed in on a molecule called nuclear factor kappa-light-chain-enhancer of activated B cells, or NF-kB, which is known to play a critical role in inflammation, aging and response to radiation. When activated by signaling molecules, it enters the cell’s nucleus and binds to DNA to control gene expression. When inactive, it is sequestered in the cytoplasm, away from the DNA.

Leung wondered if there could be a link between the effect of the dilute bleach solution and NF-kB’s role in skin. He exposed human keratinocytes, or skin cells, to 0.005 percent bleach for one hour before treating them with a signaling molecule that normally activates NF-kB function. He found that exposure to the solution blocked the expression of two genes known to be regulated by NF-kB. The effect was reversible, however — waiting 24 hours after the bleach treatment restored NF-kB’s ability to activate expression of the target genes.

Further investigation divulged how this happens.

“We found that the bleach solution oxidizes and inhibits an activator necessary for NF-kB to enter the nucleus, essentially blocking NF-kB’s effect,” Leung said. When the researchers mutated the activator to be oxidation-resistant, NF-kB’s gene targeting activity was unhindered.

Next, the researchers turned to potential clinical applications. Radiation dermatitis is a common side effect of radiation therapy for cancer. While radiation therapy is directed at cancer cells inside the body, the normal skin in the radiation therapy field is also affected. Radiation therapy often causes a sunburn-like skin reaction. In some cases, these reactions can be quite painful and can require interrupting the radiation therapy course to allow the skin to heal before resuming treatment. However, prolonged treatment interruptions are undesirable.

“An effective way to prevent and treat radiation dermatitis would be of tremendous benefit to many patients receiving radiation therapy,” said Susan Knox, MD, PhD, associate professor of radiation oncology and study co-author.

Leung and his colleagues tested the effect of daily, 30-minute baths in bleach solution on laboratory mice with radiation dermatitis. They found that the animals bathed in the bleach solution experienced less severe skin damage and better healing and hair regrowth than animals bathed in water.

They then turned their attention to old — but healthy — laboratory mice.

“Multiple research studies have linked increased NF-kB activity with aging,” Leung said. “We found that if we blocked NF-kB activity in elderly laboratory mice by bathing them in the bleach solution, the animals’ skin began to look younger. It went from old and fragile to thicker, with increased cell proliferation.” The effect diminished soon after the dilute-bleach baths were stopped, indicating that regular exposure is necessary to maintain skin thickness.

The researchers are now considering clinical trials in humans, and they are also looking at other diseases that could be treated by dilute-bleach baths. “It’s possible that, in addition to being beneficial to radiation dermatitis, it could also aid in healing wounds like diabetic ulcers,” Leung said. “This is exciting because there are so few side effects to dilute bleach. We may have identified other ways to use hypochlorite to really help patients. It could be easy, safe and inexpensive.”

Can Certain Herbs Stave Off Alzheimer’s Disease?

 

ST. LOUIS — Enhanced extracts made from special antioxidants in spearmint and rosemary improve learning and memory, a study in an animal model at Saint Louis University found.

“We found that these proprietary compounds reduce deficits caused by mild cognitive impairment, which can be a precursor to Alzheimer’s disease,” said Susan Farr, Ph.D., research professor geriatrics at Saint Louis University School of Medicine.

Farr added, “This probably means eating spearmint and rosemary is good for you. However, our experiments were in an animal model and I don’t know how much — or if any amount — of these herbs people would have to consume for learning and memory to improve. In other words, I’m not suggesting that people chew more gum at this point.”

Farr presented the early findings at Neuroscience 2013, a meeting of 32,000 on Monday, Nov. 11. She tested a novel antioxidant-based ingredient made from spearmint extract and two different doses of a similar antioxidant made from rosemary extract on mice that have age-related cognitive decline.

She found that the higher dose rosemary extract compound was the most powerful in improving memory and learning in three tested behaviors. The lower dose rosemary extract improved memory in two of the behavioral tests, as did the compound made from spearmint extract.

Further, there were signs of reduced oxidative stress, which is considered a hallmark of age-related decline, in the part of the brain that controls learning and memory.

“Our research suggests these extracts made from herbs might have beneficial effects on altering the course of age-associated cognitive decline,” Farr said. “It’s worth additional study.”

The research, which was supported by the VA Medical Center in St. Louis, was conducted in conjunction with Kemin Industries, which manufactures specialty ingredients for vitamin/dietary supplements or that can be added to food to enhance its nutritional and health benefits.

Established in 1836, the School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: infectious disease, liver disease, aging and brain disease, cancer and heart/lung disease.

 

v

These reports are done with the appreciation of all the Doctors, Scientist, and other Medical Researchers who sacrificed their time and effort. In order to give people the ability to empower themselves. Without base aspirations of fame, or fortune. Just honorable people, doing honorable things.

 

Wider use of statins ‘disturbing’

Wider use of statins will have minimal benefit and could needlessly expose   thousands to severe side effects, doctors warn following change in US   prescription guidelines

Wider use of statins will have minimal benefit and could needlessly expose thousands to severe side effects, doctors warn following change in US prescription guidelines

New US guidelines on statins, issued on Tuesday by the American College of Cardiology and the American Heart Association, recommend that doctors should consider prescribing the drugs to all people with at least a 7.5 per cent risk of suffering a heart attack or stroke within the next decade Photo: ALAMY

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Nick Collins

By , Science Correspondent

2:55PM GMT 14 Nov 2013

Prescribing statins to millions more healthy people would make only a minimal   difference to their average lifespan but risk exposing thousands to harmful   side effects, a leading doctor has claimed.

Dr Aseem Malhotra, a cardiology specialist registrar at Croydon University   Hospital, said he would be “disturbed” if Britain followed America   in changing prescription guidelines to widen use of statins.

There is “no doubt” that the cholesterol-lowering drugs reduce the   likelihood of heart attacks and strokes in people with heart disease, he   said, but the potential benefits of medicating millions more who are at low   risk could be dramatically outweighed by the associated harms.

Side effects experienced by up to one in five patients include severe muscle   aches, memory disturbance, sexual dysfunction, cataracts and diabetes.

New   US guidelines on statins, issued on Tuesday by the American College of   Cardiology and the American Heart Association, recommend that doctors should   consider prescribing the drugs to all people with at least a 7.5 per cent   risk of suffering a heart attack or stroke within the next decade.

US experts who drafted the new guidance said doctors had been “undertreating”   patients and that the new advice would mean “more people who would   benefit from statins are going to be on them”.

But the guidelines have also raised concerns among doctors in America, and in   Britain where current advice that statins should be prescribed to those with   a 20 per cent risk over 10 years is under review.

The National Institute of Health and Care Excellence has confirmed that the   same recent clinical evidence which prompted the change in US policy will   form part of its own decision, and experts believe the threshold could be   lowered.

Dr Malhotra said: “I think it is very possible that this will also happen   in Britain.

“One thing we have learned in the past decade is the considerable   influence of a very financially powerful pharmaceutical industry over   prescribing and modern medicine, and the trends suggest that this influence   will have the same kind of effect over in the UK [as in America].”

Statins, which cost the NHS less than 10p per day, have become the most widely   prescribed drugs in Britain and are currently used by an estimated six   million people.

Some experts have claimed that all over-50s should take the drugs routinely to   lower their levels of “bad” LDL cholesterol and protect against   heart attacks and strokes.

Dr David Wald, a cardiologist at Queen Mary, University of London, said on Wednesday it would be “sensible” to lower the threshold on eligibility, which would be “heading towards the point where statins may eventually be offered to everyone once they reach a certain age of around 55.”

But a recent   analysis published in the British Medical Journal found that even   patients with a 20 per cent risk of a heart attack or stroke who were over   the age of 50 may not benefit from the drugs.

“This expansion of use of statins is not good for public health,”   Dr Malhotra said. “There is no doubt that for people with established   heart disease the benefits outweigh the risks, but for people who do not   have established heart disease this isn’t the case … I would be very   disturbed if the UK were to follow suit.”

Writing in the New York Times Dr John D Abramson, who co-wrote the BMJ review,   and Dr Rita F Redberg said wider use of statins “will   benefit the pharmaceutical industry more than anyone else”.

“For people who have less than a 20 per cent risk of getting heart   disease in the next 10 years, statins not only fail to reduce the risk of   death, but also fail even to reduce the risk of serious illness,” they   said.

“Instead of converting millions of people into statin customers, we   should be focusing on the real factors that undeniably reduce the risk of   heart disease: healthy diets, exercise and avoiding smoking.”

http://www.telegraph.co.uk/health/healthnews/10449514/Wider-use-of-statins-disturbing.html

 

The most commonly prescribed treatment for Colds and Sore Throats offers no benefit and may actually make the illness worse

Contact: Becky Attwood r.attwood@soton.ac.uk 44-075-454-22512 University of Southampton

Ibuprofen no good in treating colds or sore throats

Questions have been raised about the advice given to patients with a cold and sore throat, in research published in the British Medical Journal.

A study carried out by the University of Southampton showed that compared with paracetamol, ibuprofen or a combination of both ibuprofen and paracetamol provide no advantage for patients overall with respiratory tract infections (otherwise known as colds or sore throats).

Additionally steam inhalation, another common treatment method, has no clear benefit and around 2 per cent of people get mild scalding but not bad enough to see a doctor.

Professor Paul Little, who led the study, comments: “Paracetamol, ibuprofen or a combination of both are the most common courses of treatment for respiratory tract infections. Clinicians should probably not advise patients to use steam inhalation in daily practice as it does not provide symptomatic benefit for acute respiratory infections and a few individuals are likely to experience mild thermal injury. Similarly, routinely advising ibuprofen or ibuprofen and paracetamol together than just paracetamol is also not likely to be effective. However our research has shown that ibuprofen is likely to help children, and those with chest infections.”

The research also showed that patients were more likely to come back within a month with worsening symptoms or new symptoms if they were prescribed with ibuprofen or ibuprofen with paracetamol. Between 50 per cent and 70 per cent of participants in the study who were prescribed ibuprofen or ibuprofen with paracetamol came back.

Professor Little admitted this was a surprising result and suggests the treatment may contribute to the progression of the illness. He adds: “This may have something to do with the fact the ibuprofen is an anti-inflammatory. It is possible that the drug is interfering with an important part of the immune response and leads to prolonged symptoms or the progression of symptoms in some individuals. Although we have to be a bit cautious since these were surprise findings, for the moment I would personally not advise most patients to use ibuprofen for symptom control for coughs colds and sore throat.”

The randomised control trial recruited 899 patients who presented at their GP with respiratory tract infection symptoms. They received different treatment types; paracetamol, ibuprofen or a combination of both. Participants were then told to either take it as needed or at regular intervals (four times a day) and some were also told to take steam inhalation.

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The study was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme.

Unpublished trial data ‘violates an ethical obligation’ to study participants, say researchers / 1 in 3 large clinicals not Published

Contact: Stephanie Burns
sburns@bmj.com
44-020-738-36920
BMJ-British Medical Journal

 

Study finds almost 1 in 3 large clinical trials still not published 5 years after completion

Almost one in three (29%) large clinical trials remain unpublished five years after completion. And of these, 78% have no results publicly available, finds a study published on bmj.com today.

This means that an estimated 250,000 people have been exposed to the risks of trial participation without the societal benefits that accompany the dissemination of their results, say the authors.

They argue that this “violates an ethical obligation that investigators have towards study participants” and call for additional safeguards “to ensure timely public dissemination of trial data.”

Randomized clinical trials are a critical means of advancing medical knowledge. They depend on the willingness of people to expose themselves to risks, but the ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial.

But when trial data remain unpublished, the societal benefit that may have motivated someone to enrol in a study remains unrealized.

US law requires that many trials involving human participants be registered – and their results posted – on the largest clinical trial website ClinicalTrials.gov. But evidence suggests that this legislation has been largely ignored.

So a team of US-based researchers set out to estimate the frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.

They searched scientific literature databases and identified 585 trials with at least 500 participants that were registered with ClinicalTrials.gov and completed prior to January 2009. The average time between study completion and the final literature search (November 2012) was 60 months for unpublished trials.

Registry entries for unpublished trials were then reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Of 585 registered trials, 171 (29%) remained unpublished. Of these, 133 (78%) had no results available in ClinicalTrials.gov. Non-publication was more common among trials that received industry funding (32%) than those that did not (18%).

“Our results add to existing work by showing that non-publication is an important problem even among large randomized trials,” say the authors. Furthermore, the sponsors and investigators of these unpublished trials infrequently utilize the ClinicalTrials.gov results database.

The lack of availability of results from these trials “contributes to publication bias and also constitutes a failure to honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation,” they add. “Additional safeguards are needed to ensure timely public dissemination of trial data,” they conclude.

1 in 2000 Britons may carry ‘mad cow’ prion protein

 

“We were all supposed to die of mad cow disease!” People who accuse public health agencies of crying wolf are fond of citing the discovery, in 1996, that a cattle disease widespread in the UK causes the deadly disease vCJD in people. Despite widespread dismay at the time, there have been only 177 cases of vCJD in the country – and 51 elsewhere – to date.

The biggest survey yet, however, shows  the UK did not really dodge that bullet – it just hasn’t killed many of the people it hit. What we don’t know is how many might still die.

A study of 32,000 appendixes removed between 2000 and 2012 from British people born between 1941 and 1985 suggests that 1 in every 2000 people in the UK is carrying the abnormal protein, or prion, that causes the disease. This means as many as 31,000 people may carry the prion – twice the previous best estimate.

The researchers, mostly from the UK’s national human and animal health labs and led by Sebastian Brandner of University College London, warn that we do not know what further damage those infections may cause. In particular, there seems to have been less transmission of the prion via blood transfusions than would have been expected. The researchers are calling for development of a reliable blood test for the prion so we can make sure it is not spreading undetected.

Silver lining

Half the people infected are at particular risk: they carry the genetic form of the protein that has been found in all cases of vCJD to date. However, the researchers warn that they do not know whether such people will simply be lifelong carriers, or may one day develop vCJD. Meanwhile, other genetic forms of the prion could be affecting people in unrecognised ways.

The silver lining, says Richard Salmon, a retired neurologist who wrote an editorial accompanying the research, is that recent research shows that the vCJD prion behaves much like the pathological proteins behind a number of other diseases involving brain degeneration, including Alzheimer’s and Parkinson’s diseases. These are huge threats to ageing populations.

“We have developed, of necessity, a huge body of expertise in studying prion diseases in Britain,” says Salmon. This knowledge could be used to study treatments for such things as Alzheimer’s. However, he fears as worries about vCJD wane, funding to maintain that expertise is waning too.

How it happened

Bovine spongiform encephalopathy (BSE) is caused by a misfolded protein – a prion – which accumulates in brain tissue, causing death. It is spread when susceptible animals eat tissues from infected animals that contain the prion. BSE was discovered in British cattle in 1987 and has been blamed on the widespread use of cattle remains as cattle fodder in the UK. The UK government initially claimed the prion could not spread to humans – but it was found to do so in 1996.

By that time inadequate controls meant infected beef had been in the human food chain for years, and there were fears of a mass plague of agonising, invariably fatal vCJD. Fortunately, they did not materialise, but it was unclear whether that was because the prion had not infected people or because for some reason it didn’t make them sick.

A decade ago it was discovered that the prion lodges in the appendix, offering a way to search for it in living people who have their appendix removed. Early studies suggested widespread infection was possible, but the samples were too small to be sure.

Where we are now

Now it is clear that people of all ages and across the country were widely infected, regardless of whether they had the genetic form of the prion protein associated with the disease. In fact, more people with the alternate, resistant forms were found to be carrying the prion than would be expected if its distribution was random, for reasons unknown.

“This shows we need to understand more about the natural history of the prion,” says Salmon. “Infections don’t lead to disease as readily as we originally feared, but we don’t know why, or whether these infections have a sting in their tail.”

Models suggest infected people could still develop vCJD in coming decades. Salmon worries that the prion might cause diseases in people with the resistant genotypes that do not look like classic vCJD and so could be missed. This is especially likely in older people, in whom dementia is more common and not often investigated after death.

Meanwhile we could soon discover even more precisely who was infected during the days of BSE in the UK. Tests for prions in blood are almost ready. Markus Moser, CEO of Prionics, a BSE test manufacturer in Zurich, Switzerland, says his company and the National Institutes of Health in the US have developed the eQuIC assay, which detects prions at low enough levels that “in hamster and sheep, it works as a blood test”.

It has not been validated on blood samples from people with vCJD, because these have not been made available, says Moser – but the test can detect highly diluted vCJD brain homogenates, which contain the prion, in blood.

Journal references: BMJ, DOI: 10.1136/bmj.f5675; Salmon’s editorial

http://www.newscientist.com/article/dn24416-1-in-2000-britons-may-carry-mad-cow-prion-protein.html#.Ul-Rn8Hn_Vg

 

Current study shows: Important information on effects and side effects of drugs is missing in most publications

IQWiG: Reliable assessment of drugs is only possible on the basis of clinical study reports (CSRs)

In 2012 researchers from the German Institute for Quality and Efficiency in Health Care (IQWiG) presented a study in the BMJ analysing information sources used in 16 health technology assessment (HTA) reports of drugs (“benefit assessments”). This study clearly demonstrated that publicly available sources, such as scientific journals and entries posted in trial registries (“registry reports”), contained far less information on methods and outcomes of clinical trials than non-public CSRs prepared by pharmaceutical companies.

In a second article published today in PLOS Medicine, the IQWiG researchers now show that if, instead of only assessing selected outcomes as in the first study, all patient-relevant outcomes of the clinical trials are assessed, the information deficit in the publicly available sources is even greater.

Data analysed for more than 1000 outcomes

All HTA reports of drugs completed by IQWiG between 2006 and 2011 also formed the basis for the new study. The authors included those trials from the HTA reports for which the pharmaceutical companies had provided complete CSRs to IQWiG. Publicly available information in scientific journals and trial registries was available for 86 out of 101 of these trials, so that the information provided in all 3 sources could be compared. The trials contained data on more than 1000 patient-relevant outcomes such as mortality or disease symptoms.

Huge difference in the information provided

IQWiG assessed whether the results on the patient-relevant outcomes in the trials were “completely” or “incompletely” reported. The difference in the information provided was immense: Whereas 86% of all outcomes were fully reported in unpublished CSRs, the corresponding number was only 39% for combined publicly available sources. Likewise, negative effects on patients (“harm outcomes”) such as serious adverse events or treatment discontinuations were reported far less often in the publicly available sources (27 to 72% versus 84 to 92%, depending on the harm outcome investigated).

Make CSRs publicly accessible

Beate Wieseler, Head of the Drug Assessment Department, comments on this first comprehensive quantification of the information gain through full CSRs: “The publicly available journal articles and registry entries thus report less than half of outcomes of clinical trials comprehensively. At the same time, with CSRs documents are available that provide complete information on methods and outcomes. The consequence can only be: all CSRs must be made publicly accessible. One should note that IQWiG is already in a privileged position due to its legal remit to conduct benefit assessments. Other researchers and physicians wishing to be fully informed about the advantages and disadvantages of an intervention have even more difficulties in gaining access to data.

Although the proportion of clinical trials published as scientific articles or registry reports has increased in the past few years, this is unfortunately not accompanied by more complete reporting of patient-relevant outcomes. Large information gaps still remain and we cannot even guess how large these gaps are in other types of drug trials or in trials of non-drug interventions.”

Need for legislation

Beate Wieseler further points out: “The plan by the European Medicines Agency (EMA) to make all clinical trial data submitted for marketing authorization publicly available from January 2014 onwards can therefore only be a first step. A central repository is required, also including data from older trials, as such trials investigate drugs widely used in current medical practice. These data would probably shed a totally new light on several drugs and their position in their therapeutic area. However, a voluntary commitment by the pharmaceutical industry, which would like to decide on a case-by-case basis which data it discloses, is insufficient. We are hoping for legislation and continue to support the All Trials Campaign (see below) so that the problem stays on the agenda.”

Investigation into safety of new diabetes drugs — will manufacturers release their data?

Contact: Emma Dickinson edickinson@bmj.com 44-207-383-6529 BMJ-British Medical Journal

Joint BMJ/Channel 4 Dispatches investigation

The BMJ and Channel 4 Dispatches investigated and found that evidence suggesting potential harm from the drugs in industry studies has not been published.

Some independent studies challenge the conclusions of the drugs manufacturers’ own research. Now some medical experts and patient groups are calling on the pharmaceutical companies to be more transparent in reporting of study data and to enter into dialogue about safety concerns.

As a result, millions of patients around the world have not been fully informed about some of the possible risks.

Some critics say the drug regulators in Europe and the US have been slow to pursue concerns about the potential adverse effects of these new diabetes drugs, despite the emerging warning signs in the medical literature, regulatory documents, and adverse event databases.

Full details will be published on bmj.com on Monday 10 June and broadcast in Diets, Drugs and Diabetes – Channel 4 Dispatches on Monday 10 June at 8pm on Channel 4.

GLP-1 based drugs are used to treat type 2 diabetes by regulating blood sugar. Some of these drugs also suppress appetite and are currently being tested as a possible treatment for obesity.

In the course of this investigation, the BMJ has reviewed thousands of pages of regulatory documents obtained under freedom of information and found unpublished data pointing to “unwanted proliferative or inflammatory pancreatic effects.”

The BMJ has also found that, despite published reports that indicated safety concerns, companies have not done certain critical safety studies; nor have regulators requested them yet. And access to raw data that might help resolve doubts about the safety of these drugs has been denied.

Dr Deborah Cohen, the BMJ‘s Investigation Editor, says: “On their own the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug.”

Three publications this year have raised concerns long held by some experts about the potential side effects of GLP-1 based drugs, prompting both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to launch a review into whether the drugs may cause or contribute to the development of pancreatic cancer. And in America, hundreds of people are suing manufacturers alleging that the drugs caused pancreatitis and in some cases cancer.

Yet the evidence is fiercely contested amongst scientists and manufacturers stoutly defending the safety of their products.

Some argue that the published evidence against the drugs is weak, while others say we can’t yet be sure that these drugs are safe and are calling for all the study data to be made public for independent analysis.

Research by Professor Peter Butler at the University of California Los Angeles, for example, found worrying changes in the pancreases of animals that received a GLP-1 based drug. He has also found abnormal changes, including pre-cancerous lesions, in the pancreases of eight organ donors taking GLP-1 based drugs compared with patients taking other anti-diabetic drugs.

And studies of side effects reported to the regulators have also started turning up cases of pancreatic cancer among patients on GLP-1 based drugs. Both EMA and the FDA have confirmed to the BMJ that they have “signal” for pancreatic cancer – but this does not mean there is a causal link.

Together these findings raise important and troubling questions about a possible link between these diabetes drugs and pancreatic cancer, but no safety alert has yet been issued by the regulators.

More information is expected later this month, when the US National Institutes of Health hold a two-day meeting on possible links between diabetes, diabetes drugs and pancreatic cancer.

But some consumer groups are calling for the drugs to be withdrawn as a diabetes treatment to prevent potential harm to patients while we wait for this evidence – and they don’t want to see them licensed as an obesity treatment.

Writing in the BMJ, Dr Fiona Godlee, Editor in Chief said: “All drug licensing is about balancing benefits and risks. But instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.”

She adds: “The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors and ultimately patients could make up their own minds.”

In an editorial in the BMJ, Edwin Gale, Professor of diabetic medicine, says this shows once again that current regulatory procedures are inadequate to deal with the challenge of drug treatments that have more than one biological target, which he calls “shotgun therapies.” He says: “Similar scenarios will be re-enacted while secrecy rules and the companies control access to the data.”

In statements to Channel 4 Dispatches airing tonight, the drug companies all maintain their commitment to patient safety. On monitoring, the companies all say they have regular, close and vigorous safety processes in place, including large scale, long term trials, and the results are routinely submitted to the regulatory authorities.

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The BMJ is campaigning for improved access to data from clinical trials – see bmj.com/opendata

If patients have any concerns about the diabetes drugs they are taking, they are asked to consult with a doctor before changing their medication.

 

Young people who undergo CT scans are 24 percent more likely to develop cancer compared with those who do not, a study published today on bmj.com suggests

Contact: Emma Dickinson edickinson@bmj.com 44-020-738-36529 BMJ-British Medical Journal

Small cancer risk following CT scans in childhood and adolescence confirmed

But the absolute excess for all cancers combined is low

The researchers say that in a group of 10,000 young people, they would expect 39 cancers to occur during the next 10 years, but if they all had one CT scan, up to six extra cancers would occur.

CT (computed tomography) scans have great medical benefits, but their increasing use since the 1980s has raised some concerns about possible cancer risks, particularly following exposures in childhood. Most previous studies have estimated risks indirectly, and some radiation experts have questioned the validity of these estimates.

There is currently much uncertainty and as such, researchers from Australia and Europe carried out a study comparing cancer rates in patients exposed to CT scans at ages 0-19 years compared with unexposed persons of a similar age. All participants were born between 1985 and 2005 with total follow-up ending at the end of 2007. This is the largest ever population-based study of medical radiation exposure.

Data were taken from Australian Medicare records and from national cancer records. The main outcome of the research was to identify cancer rates in individuals exposed to a CT scan more than one year before any cancer diagnosis. Mean length of follow-up was 9.5 years for the exposed group and 17.3 for the unexposed group.

The cohort included 10.9 million people, 680,211 of whom were CT-exposed at least 12 months before any cancer diagnosis. 18% of these had more than one scan.

By the end of 2007, 3150 of the exposed group and 57,524 of the unexposed group had been diagnosed with cancer. The incidence rate was 24% greater in the exposed group after adjusting for age, sex and year of birth. Risk increased by 16% for each additional CT scan.

For brain cancer, although the incidence in the exposed group declined with time since first CT-exposure, brain cancer incidence was still significantly increased more than 15 years after first exposure. For other solid cancers (tumours as opposed to cancers of the blood or bone marrow) the absolute excess cancer incidence increased significantly with time since first exposure.

For all cancers combined, although the proportional increase declined with years since first CT scan, it was still increased at 15+ years after first exposure.

For brain cancer, the highest risk was seen in children exposed before the age of five years and this risk decreased with increasing age at first exposure. However, despite this decrease, risk for all cancers combined remained significantly increased in the oldest age at exposure group (15-19 years).

For solid cancers other than brain cancer, the proportional increase in risk was somewhat greater in females: 23% compared with 14% in males.

The researchers say that almost 60% of CT scans were of the brain and recognise that “in some cases the brain cancer may have led to the scan rather than vice versa”. They add that they “cannot assume that all the excess cancers […] were caused by CT scans” and they “cannot rule out the possibility of some reverse causation, particularly for some cases of brain cancer”.

Nevertheless, they conclude that the “increased incidence of many different types of cancer […] is mostly due to irradiation”. They point out that because the cancer excess was still continuing at the end of follow-up, the “eventual lifetime risk from CT scans cannot yet be determined”. They recommend that practitioners will need to weigh the benefits against the potential risks to justify each CT scan decision.

In an accompanying editorial, Dr Sodickson from Harvard Medical School says it is important to recognise that the incidence of cancer in children is extremely small and so “a 24% increase makes this risk just slightly less small”. He says that there are many methods to manage radiation dose and with further validation of risk models, “more accurate risk assessment “can be performed to “better inform imaging decisions”.

Expert questions US public health agency advice on influenza vaccines: “All influenza is “flu,” but only one in six “flus” might be influenza”

Contact: Emma Dickinson edickinson@bmj.com 44-020-738-36529 BMJ-British Medical Journal

Marketing influenza vaccines involves marketing influenza as a threat of great proportions, argues Johns Hopkins fellow

Promotion of influenza vaccines is one of the most visible and aggressive public health policies today, writes Doshi. Today around 135 million doses of influenza vaccine annually enter the US market, with vaccinations administered in drug stores, supermarkets – even some drive-throughs.

This enormous growth has not been fuelled by popular demand but instead by a public health campaign that delivers a straightforward message: influenza is a serious disease, we are all at risk of complications from influenza, the flu shot is virtually risk free, and vaccination saves lives.

Yet, Doshi argues that the vaccine might be less beneficial and less safe than has been claimed, and the threat of influenza appears overstated.

To support its case, the CDC cites two studies of influenza vaccines, published in high-impact, peer-reviewed journals and carried out by academic and government researchers with non-commercial funding. Both found a large (up to 48%) relative reduction in the risk of death.

“If true, these statistics indicate that influenza vaccines can save more lives than any other single licensed medicine on the planet,” says Doshi. But he argues that these studies are “simply implausible” and likely the product of the ‘healthy-user effect’ (in this case, a propensity for healthier people to be more likely to get vaccinated than less healthy people).

In addition, he says, there is virtually no evidence that influenza vaccines reduce elderly deaths – the very reason the policy was originally created.

He points out that the agency itself acknowledges the evidence may be undermined by bias. Yet, he says “for most people, and possibly most doctors, officials need only claim that vaccines save lives, and it is assumed there must be solid research behind it.”

He also questions the CDC’s recommendation that beyond those for whom the vaccine is contraindicated, influenza vaccine can only do good, pointing to serious reactions to influenza vaccines in Australia (febrile convulsions in young children) and Sweden and Finland (a spike in cases of narcolepsy among adolescents).

Doshi suggests that influenza is yet one more case of “disease mongering” – medicalising ordinary life to expand markets for new products. But, he warns that unlike most stories of selling sickness, “here the salesmen are public health officials, worried little about which brand of vaccine you get so long as they can convince you to take influenza seriously.”

But perhaps the cleverest aspect of the influenza marketing strategy surrounds the claim that “flu” and “influenza” are the same, he concludes. “All influenza is “flu,” but only one in six “flus” might be influenza. It’s no wonder so many people feel that “flu shots” don’t work: for most flus, they can’t.”

Earlier this year, the BMJ launched a ‘Too Much Medicine’ campaign to help tackle the threat to health and the waste of money caused by unnecessary care. The journal will also partner at an international conference Preventing Overdiagnosis to be held in September in the USA

Are antidepressants overused? : 75% of those who write these definitions have links to drug companies.

Contact: Emma Dickinson edickinson@bmjgroup.com 44-020-738-36529 BMJ-British Medical Journal

Head to head: Are antidepressants overprescribed?

Antidepressant prescriptions in the UK have increased by 9.6% in 2011, to 46 million prescriptions. Does this reflect overmedicalisation or appropriate treatment? Two experts debate the issue on bmj.com today.

Glasgow GP, Dr Des Spence, thinks that “we use antidepressants too easily, for too long, and that they are effective for few people (if at all)”

He acknowledges that depression is an important illness, but argues that the current definition of clinical depression (two weeks of low mood – even after bereavement) “is too loose and is causing widespread medicalisation.” He also points out that 75% of those who write these definitions have links to drug companies.

National Institute for Health and Clinical Excellence (NICE) guidelines do not support the use of antidepressant medication in mild depression, nor necessarily as first line treatment of moderate depression. Instead, they promote talking therapies.

“But even if we accept that antidepressants are effective, a Cochrane review suggests that only one in seven people actually benefits. Thus millions of people are enduring at least six months of ineffective treatment,” he writes.

He is unconvinced by research showing that depression is undertreated and that antidepressants are being used appropriately, saying “the only explanation is that we are prescribing more antidepressants to ever more people.”     He also questions the view that depression is a mere chemical imbalance and concludes: “Improving society’s wellbeing is not in the gift of medicine nor mere medication, and overprescribing of antidepressants serves as a distraction from a wider debate about why we are so unhappy as a society. We are doing harm.”

But Ian Reid, Professor of Psychiatry at the University of Aberdeen, says the claim that antidepressants are overprescribed “needs careful consideration.”

He argues that the rise in prescriptions is due to small but appropriate increases in the duration of treatment, rather than more patients being treated, and that increased use of antidepressants in other conditions “has compounded misunderstanding.”

He refutes the idea that GPs are handing out antidepressants “like sweeties” and points to a survey showing “cautious and conservative prescribing” among GPs in Grampian. He also points to “methodological flaws and selective reporting” of data showing that antidepressants are no better than placebo except in severe depression. Instead, he says, practice is supported by evidence.

Finally, he dismisses reports that limited availability of psychological therapy leads to inappropriate antidepressant prescription, saying there is no consistent relation between the availability of psychological therapies and antidepressant use.

“Antidepressants are but one element available in the treatment of depression, not a panacea,” he writes. “Like ‘talking treatments’ (with which antidepressants are entirely compatible), they can have harmful side effects, and they certainly don’t help everyone with the disorder. But they are not overprescribed. Careless reportage has demonised them in the public eye, adding to the stigmatisation of mental illness, and erecting unnecessary barriers to effective care.”

Experts discover why Rudolph’s nose is red

Contact: Emma Dickinson edickinson@bmjgroup.com 44-020-738-36529 BMJ-British Medical Journal

Researchers solve the age-old mystery of why Rudolph has a bright red nose

Rudolph’s nose is red because it is richly supplied with red blood cells which help to protect it from freezing and to regulate brain temperature.

This superior “nasal microcirculation” is essential for pulling Santa Claus’s sleigh under extreme temperatures, reveals a study in the Christmas issue published on bmj.com today.

Tiny blood cells (known as micro-vessels) in the nose are vital for delivering oxygen, controlling inflammation, and regulating temperature, but few studies have assessed their function in detail.

Knowing how important this regulation is for flying reindeer, who have to deal with extremes of temperature while pulling a sleigh, researchers in the Netherlands and Norway set out to test whether Rudolph’s infamous red nose was due to “a highly dense and rich nasal microcirculation” compared with human noses.

Using a hand-held video microscope, they first assessed the noses of five healthy human volunteers and found a circulating blood vessel density of 15 mm/mm2.

When the technique was applied to two reindeer noses, the researchers found a 25% higher density of blood vessels, carrying a super-rich concentration of red blood cells.

They also found a high density of mucous glands scattered throughout the reindeer noses, which they say helps “maintain an optimal nasal climate during changing weather conditions and extremes of temperature as well as being responsible for fluid transport and acting as a barrier.”

Infrared thermal images showed that reindeer do indeed have red noses.

“The microcirculation of the nasal mucosa in reindeer is richly vascularised and 25% denser than that in humans,” say the authors. “These factors explain why the nose of Rudolph, the lead flying reindeer employed by Santa Claus to pull his sleigh, is red and well adapted to carrying out his duties in extreme temperatures.”

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Experts warn of misbehaving tooth fairy

Contact: Stephanie Burns sburns@bmjgroup.com 44-020-738-36920 BMJ-British Medical Journal

Teeth discovered in children’s ears and wind pipe

The tooth fairy and malpractice

Opinions of the tooth fairy as kind and giving may need to be revised following “mounting reports of less child-friendly activity”, says a paper published in the BMJ Christmas edition and appearing online today.

Researchers from across London became concerned following misdemeanours of the mythical character and a worrying trend in malpractice. One boy in particular became extremely distressed because the tooth fairy “had put a tooth in his left ear” after he left it under his pillow. Further investigation turned out he was right.

Further supporting their evidence are another two cases showing teeth being found in the oesophagus (causing “a trauma situation”) and a man who developed an abscess after placing his child’s tooth in his nipple piercing so it could be “near to his heart”.

The researchers conclude that as there is no clear guidance on how to avoid such complications, they suggest that clinicians have a “high index of suspicion with tooth related presenting complaints”.

They add: “As far as we are aware there is no revalidation procedure for the tooth fairy and no clear guidance or standard operating procedures in place to ensure outcomes are avoided”.

UK doctor testifies that under socialized medicine, sick babies are sent home to die

Posted By Jessica Stanton On 3:22 AM  11/30/2012 @ 3:22 AM In DC Exclusives – Blurb,World | No Comments

A British physician’s disturbing testimony is shedding light on the increasingly common practice of National Health Service (NHS) hospitals sending sick or severely disabled newborn babies home or to hospices to die of starvation or dehydration.

Newborn babies are being being placed on the Liverpool Care Pathway for end-of-life care, a system originally allotted and designed for elderly or terminally ill adults. That end-of-life care involves the removal of food and fluid tubes, a method which can take an average of ten days to result in death.

The Daily Mail reports an investigation is being launched to determine “whether cash payments to hospitals to hit death pathway targets have influenced  doctors’ decisions.”

The physician, who wishes to remain anonymous, recounted his experience in a submission to the British Medical Journal, titled “How it feels to withdraw feeding from newborn babies.”

Parents must give doctors to permission to put their child on the pathway to death.

“I know, as they cannot, the unique horror of witnessing a child become smaller and shrunken, as the only route out of a life that has become excruciating to the patient or to the parents who love their baby,” the doctor writes. “I reflect on how sanitised this experience seems within the literature about making this decision.”

The doctor dispelled the notion that the children die without suffering.

“Survival is often much longer than most physicians think. …Parents and care teams are unprepared for the sometimes severe changes that they will witness in the child’s physical appearance as severe dehydration ensues.”

The testimony addresses the “emotional burden” the care team experiences throughout the end-of-life process, describing monitoring the baby as “an indescribable mixture of compassion, revulsion and pain.”

“Some say withdrawing medically provided hydration and nutrition is akin to withdrawing any other form of life support. Maybe, but that is not how it feels. The one thing that helps me a little is the realisation that this process is necessarily difficult. It needs to be.”


Article printed from The Daily Caller: http://dailycaller.com

URL to article: http://dailycaller.com/2012/11/30/uk-doctor-testifies-that-under-socialized-medicine-sick-babies-are-sent-home-to-die/

Release all Tamiflu data as promised, argue researchers

Contact: Emma Dickinson edickinson@bmjgroup.com 44-020-738-36529 BMJ-British Medical Journal

Company plans to set up review board, but researchers want it to keep its promise

The latest correspondence is posted online today as part of the BMJ‘s open data campaign, aimed at persuading Roche to honour the promise it made almost three years ago to make key Tamiflu trial data available for independent scrutiny.

Last week, Donald MacLean, Life Cycle Leader for Tamiflu, wrote to Professor Chris Del Mar in his capacity as coordinating editor of the Cochrane Acute Respiratory Infections Group, concerning “our debate on Tamiflu data.”

The Cochrane researchers say they object to Roche’s suggestion that there is a debate on Tamiflu data. “There is no debate nor can there be any debate about the data whilst you do not honour your promise,” they say. “The only reason we keep asking Roche to keep its promise, rather than simply getting the data from the European Medicines Agency directly, is because Roche has not supplied all of the data to the European regulator.”

Roche’s letter also mentions “disagreements” over the type of analyses the Cochrane team wish to do, but the researchers point out that their methods and analyses have been public for nearly two years and “follow Cochrane procedure” and state that they are not aware of any specific concerns from Roche.

Roche’s letter goes on to say that, in order to reach “an amicable resolution” Roche plans to set up “a multi-party advisory board to review the totality of Tamiflu data” …. which they believe is “a sensible, fair and transparent way of addressing this public debate.”

But the Cochrane team argue that Roche’s offer is merely a belated attempt at turning the clock back, and call on the company to expand its data sharing pledges “to become compatible with current regulatory norms.”

They say: “The European Medicines Agency and the EU Ombudsman have made abundantly clear that there is no reason for anonymised clinical data to be withheld from public scrutiny once a marketing authorisation has been obtained for a pharmaceutical.  Why should Roche not – at the minimum – meet this standard?”

In summary, they say, “we ask to you to honour your promise of three years ago and make public full clinical study reports in your possession.”

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WHO and the pandemic flu “conspiracies” – FULL report from the BMJ and The Bureau of Investigative Journalism 2010

2010 report posted for filing

Conflicts of Interest

WHO and the pandemic flu “conspiracies”

Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as “conspiracy theories.” Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: “I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met…The world is now at the start of the 2009 influenza pandemic.”

It was the culmination of 10 years of pandemic preparedness planning for WHO—years of committee meetings with experts flown in from around the world and reams of draft documents offering guidance to governments. But one year on, governments that took advice from WHO are unwinding their vaccine contracts, and billions of dollars’ worth of stockpiled oseltamivir (Tamiflu) and zanamivir (Relenza)—bought from health budgets already under tight constraints—lie unused in warehouses around the world.

 

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines? Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir? And why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO? We are left wondering whether major public health organisations are able to effectively manage the conflicts of interest that are inherent in medical science.

Already WHO’s handling of the pandemic has led to an unprecedented number of reviews and inquiries by organisations including the Council of Europe, European Parliament, and WHO itself, following allegations of industry influence. Dr Chan has dismissed these as “conspiracies,” and earlier this year, during a speech at the Centers for Disease Control and Prevention in Atlanta, she said: “WHO anticipated close scrutiny of its decisions, but we did not anticipate that we would be accused, by some European politicians, of having declared a fake pandemic on the advice of experts with ties to the pharmaceutical industry and something personal to gain from increased industry profits.”

The inquiry by British MP Paul Flynn for the Council of Europe Parliamentary Assembly—due to be published today—will be critical. It will say that decision making around the A/H1N1 crisis has been lacking in transparency. “Some of the outcomes of the pandemic, as illustrated in this report, have been dramatic: distortion of priorities of public health services all over Europe, waste of huge sums of public money, provocation of unjustified fear amongst Europeans, creation of health risks through vaccines and medications which might not have been sufficiently tested before being authorised in fast-track procedures, are all examples of these outcomes. These results need to be critically examined by public health authorities at all levels with a view to rebuilding public confidence in their decisions.”

The investigation by the BMJ/The Bureau reveals a system struggling to manage the inherent conflict between the pharmaceutical industry, WHO, and the global public health system, which all draw on the same pool of scientific experts. Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting. Yet these interests have never been publicly disclosed by WHO and, despite repeated requests from the BMJ/The Bureau, WHO has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them.

It is this lack of transparency over conflicts of interests—coupled with a documented changing of the definition of a pandemic and unanswered questions over the evidence base for therapeutic interventions1—that has led to the emergence of these conspiracies.

WHO says: “Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and a profit-driven industry. Similar considerations apply when experts advising the Organization have professional links with pharmaceutical companies. Numerous safeguards are in place to manage possible conflicts of interest or their perception.”

Another factor that has fuelled the conspiracy theories is the manner in which risk has been communicated. No one disputes the difficulty of communicating an uncertain situation or the concept of risk in a pandemic situation. But one world expert in risk communication, Gerd Gigerenzer, director of the Centre for Adaptive Behaviour and Cognition at the Max Planck Institute in Germany, told the BMJ/The Bureau: “The problem is not so much that communicating uncertainty is difficult, but that uncertainty was not communicated. There was no scientific basis for the WHO’s estimate of 2 billion for likely H1N1 cases, and we knew little about the benefits and harms of the vaccination. The WHO maintained this 2 billion estimate even after the winter season in Australia and New Zealand showed that only about one to two out of 1000 people were infected. Last but not least, it changed the very definition of a pandemic.”

WHO for years had defined pandemics as outbreaks causing “enormous numbers of deaths and illness” but in early May 2009 it removed this phrase—describing a measure of severity—from the definition.2

 

The beginnings

The routes to the Council of Europe’s criticisms can be traced back to 1999, a pivotal year in the influenza world. In April that year WHO—spurred on by the 1997 chicken flu outbreak in Hong Kong—began to organise itself for a feared pandemic. It drew up a key document, Influenza Pandemic Plan: The Role of WHO and Guidelines for National and Regional Planning.

WHO’s first influenza pandemic preparedness plan was stark in the scale of the risk the world faced in 1999: “It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected.”

In the small print of that document it states: “R Snacken, J Wood, L R Haaheim, A P Kendal, G J Ligthart, and D Lavanchy prepared this document for the World Health Organization (WHO), in collaboration with the European Scientific Working Group on Influenza (ESWI).” What this document does not disclose is that ESWI is funded entirely by Roche and other influenza drug manufacturers. Nor does it disclose that René Snacken and Daniel Lavanchy were participating in Roche sponsored events the previous year, according to marketing material seen by the BMJ/The Bureau.

Dr Snacken was working for the Belgian ministry of public health when he wrote about studies involving neuraminidase inhibitors for a Roche promotional booklet. And Dr Lavanchy, meanwhile, was a WHO employee when he appeared at a Roche sponsored symposium in 1998. His role at that time was in the WHO Division of Viral Diseases. Dr Lavanchy has declined to comment.

In 1999 other members of the European Scientific Working Group on Influenza included Professor Karl Nicholson of Leicester University, UK, and Professor Abe Osterhaus of Erasmus University in the Netherlands. These two scientists are also identified in Roche marketing material seen by this investigation which was produced between 1998 and 2000. Professor Osterhaus told the BMJ that he had always been transparent about any work he has done with industry. Professor Nicholson similarly has consistently declared his connections with pharmaceutical companies, for example, in papers published in journals such as the BMJ and Lancet.

Both experts were also at that time engaged in a randomised controlled trial on oseltamivir supported by Roche. The trial was subsequently published in the Lancet in 2000.3 It remains one of the main studies supporting oseltamivir’s effectiveness—and one that was subsequently shown to have employed undeclared industry funded ghostwriters.1

The influence of the European Scientific Working Group on Influenza would continue as the decade wore on and the calls for pandemic planning became more strident. Founded in 1992, this “multidisciplinary group of key opinion leaders in influenza aims to combat the impact of epidemic and pandemic influenza” and claims links to WHO, the Robert Koch Institute, and the European Centre for Disease Prevention and Control, among others.4 Despite the group’s claims of scientific independence its 100% industry funding does present a potential conflict of interest. One if its roles is to lobby politicians, as highlighted in a 2009 policy document.5

At a pre-pandemic preparation workshop of the European Scientific Working Group on Influenza in January last year, Professor Osterhaus said: “I can tell you that ESWI is working on that idea [that is, convincing politicians] quite intensively. We have contact with MEPs [members of the European Parliament] and with national politicians. But it is they who have to decide at the end of the day, and they will only act at the request of their constituencies. If the latter are not prompted, nothing will happen.”

The group’s policy plan for 2006-10 specifically stated that government representatives needed to “take measures to encourage the pharmaceutical industry to plan its vaccine/antivirals production capacity in advance” and also to “encourage and support research and development of pandemic vaccine” and to “develop a policy for antiviral stockpiling.” It also added that government representatives needed to know that “influenza vaccination and use of antivirals is beneficial and safe.” It said that the group provided “evidence based, palatable information”; and also “networking/exchange with other stakeholders (eg, with industry in order to establish pandemic vaccine and antivirals contracts).” In the meantime, in Roche’s own marketing plan, one goal was to “align Roche with credible third party advocates”. They “leveraged these relationships by enlisting our third-party partners to serve as spokespeople and increase awareness of Tamiflu and its benefits.”6

Barbara Mintzes, assistant professor in the Department of Pharmacology and Therapeutics at the University of British Columbia, is currently part of a group working with Health Action International and WHO developing model curricula for medical and pharmaceutical students on drug promotion and interactions with the industry, including conflicts of interest. She thinks that caution is advised when working with medical bodies of this sort.

“It is legitimate for WHO to work with industry at times. But I would have concerns about involvement with a group that looks like it is for independent academics that is actually mainly industry funded,” she told the BMJ/The Bureau, adding: “The Institute of Medicine has raised concerns about the need to have a firewall with medical groups. To me this does not sound like an independent group, as it is mainly funded by manufacturers.”

She also thinks that there is a difference between the conflict of interest in having a clinical trial funded by a company and the conflict of interest in being involved in marketing a drug—for example, on a paid speaker’s bureau or in marketing material. “Some academic medical departments, for example Stanford University, have banned staff from being involved in marketing or being on a paid speakers bureau,” she said.

The presence of leading influenza scientists at promotional events for oseltamivir reflected not just the concern of an impending pandemic, but the excitement over the potential of a new class of drugs—neuraminidase inhibitors—to offer treatment and protection against seasonal influenza.

In 1999 two new drugs first came to market: oseltamivir, from Roche; and zanamivir, manufactured by what is now GlaxoSmithKline. The two drugs would battle it out over the coming years, with oseltamivir—aided by its oral administration—trumping its rival in global sales as the decade wore on.

The potential was quickly grasped. Indeed, that year Professor Osterhaus published an article proposing the use of neuraminidase inhibitors in pandemics: “Finally, during a possible future influenza pandemic, in view of their broad reactivity against influenza virus neuraminidase subtypes and the expected lack of sufficient quantities of vaccine, the new antivirals will undoubtedly have an essential role to play in reducing the number of victims.”7

However, he also warned that antivirals should not be seen as a replacement for vaccinations. “Close collaboration and consultation between, on the one hand, companies marketing influenza vaccines and, on the other, those marketing antivirals will therefore be absolutely essential. It is important that a clear and uniform message indicating the complementary roles of vaccines and antivirals is delivered.”

That article appeared in the European Scientific Working Group on Influenza’s bulletin of April 1999; Professor Osterhaus signs off with the affiliation of WHO National Influenza Centre Rotterdam, The Netherlands.

Other experts soon followed suit—recommending the role neuraminidase inhibitors could play in any future pandemic—in both the academic literature and in the general media.

Food and Drug Administration

While the excitement over these drugs fuelled scientific symposiums, the US Food and Drug Administration (FDA) was less than convinced. The BMJ/The Bureau has since spoken to people from within the American and European drug regulators, the FDA and the European Medicines Agency (EMEA), who said that both regulators struggled with the paucity of the data presented to them for zanamivir and oseltamivir, respectively, during the licensing process. At the end of last year, the BMJ called for access to raw data for key public health drugs after the Cochrane Collaboration found the effectiveness of the drugs impossible to evaluate.8 The group are continuing to negotiate access to what they say they need to fully assess the effectiveness of antivirals.

In the US, the FDA first approved zanamivir in 1999.9 Michael Elashoff, a former employee of the FDA, was the statistician working on the zanamivir account. He told the BMJ how the FDA advisory committee initially rejected zanamivir because the drug lacked efficacy.

After Dr Elashoff’s review (he had access to individual patient data and summary study reports) the FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

 

“When I was reviewing the data, I tried to replicate the analyses in their summary study reports. The issue was not of data quality, but sensitivity analyses showed even less efficacy,” he said. “The safety analysis showed there were safety concerns, but the focus was on if Glaxo had demonstrated efficacy.” Dr Elashoff’s view was that zanamivir was no better than placebo—and it had side effects. And when the FDA medical reviewer made a presentation, her conclusion was that it could either be approved or not approved. It was a fairly borderline drug.

There were influenza experts on the FDA’s advisory committee and much of the discussion hinged on why a drug that looked so promising in earlier studies wasn’t working in the largest trials in the US. One hypothesis was that people in the US were taking other drugs for symptomatic relief that masked any effect of zanamivir. So zanamivir might have no impact on symptoms over and above the baseline medications that people take when they have influenza.

Two other trials—one in Europe and one in Australia— showed a bit more promise. But there was a very low rate of people taking other medications. “So in the context of not being allowed to take anything for symptomatic relief, there might be some effect of Relenza. But in the context of a typical flu, where you have to take other things to manage your symptoms, you wouldn’t notice any effect of Relenza over and above those other things,” Dr Elashoff said. The advisory committee recommended that the drug should not be approved.

Nevertheless, FDA management decided to overturn the committee’s recommendation.

 

“They would feel better if there was something on the market in case of a pandemic. It wasn’t a scientific decision,” Dr Elashoff said.

While Dr Elashoff was working on the zanamivir review, he was assigned the oseltamivir application. But when the review and the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

 

European Medicines Agency

In Europe the EMEA was similarly troubled by the evidence for oseltamivir. By early 2002 Roche had sought a European Union-wide licence from the EMEA. It was a lengthy process, taking three meetings of the Committee for Medicinal Products for Human Use as well as expert panels, according to one of the two rapporteurs, Pekka Kurki of the Finnish Medicines Agency. Echoing the Cochrane Collaborations’s 2009 findings6 Kurki told us: “We discussed the same issues that are still discussed today: does it show clinically significant benefits in treatment and prophylaxis of flu and what was the magnitude of the benefits presented in the RCTs? Our assessment and Cochrane’s in 2009 are very similar with regard to the effect size in RCTs. The data show that the effects of Tamiflu were clear but not very impressive.

“What was unclear and is still unclear is what is the impact of Tamiflu on serious complications. Circulating influenza was very mild when Tamiflu was developed and therefore it is very difficult to say anything about serious complications. The data did not clearly show an effect on serious complications—it was not demonstrated by the RCTs.”

In documents obtained under the freedom of information legislation, two of the experts who provided opinions during the EMEA licensing process have also featured in Roche marketing material: Annike Linde and Rene Snacken. In Dr Snacken’s EMEA presentation dated 18 February 2002, he discussed the need for chemoprophylaxis and called for the use of oseltamivir during a pandemic. He made his presentation as a representative of the Belgian Ministry of Public Health. At the time Dr Snacken was also “liaison officer” for the European Scientific Working Group on Influenza. He also played a key role in the Belgian government during its pandemic planning, and he later became a senior expert at the Preparedness and Response Unit, European Centre for Disease Prevention and Control. We do not know what, if anything, he declared to the EMEA about his relationship with Roche.

Annike Linde has confirmed in an email that she has had connections with Roche over a number of years. She made a presentation to the EMEA on “influenza surveillance” in her capacity as a representative of the Swedish Institute for Infectious Disease. Again, it is not clear what, if anything, she declared to the EMEA concerning her previous relationship with Roche.

Dr Linde, now the Swedish state epidemiologist, has told the BMJ/The Bureau that she received payments from Roche International in respect of various pieces of work she did for the company until 2002. She has subsequently given occasional lectures for Roche Sweden. All money she has received from Roche was given, Dr Linde says, to the Swedish Institute for Infectious Disease Control.

We asked the scientists whether they declared their relationship with Roche at the time to the EMEA. Neither has answered that question entirely satisfactorily. Dr Snacken has not replied to repeated emails posing this question. Dr Linde responded by telling the BMJ/The Bureau: “We contribute with our expertise to the regulatory agencies when asked. When we do so, a declaration of interest, where e.g. participation at advisory meetings at Roche, is given and evaluated by the regulatory agency.” The BMJ/The Bureau requested Linde and Snacken’s declaration of interest statements for the 2002 meeting from the EMEA under the freedom of information act. The EMEA was unable to provide statements for those particular people at that time.

Developing the guidelines

In October 2002 WHO convened a meeting of influenza experts at its Geneva headquarters. Their purpose was to develop WHO’s guidelines for the use of vaccines and antivirals during an influenza pandemic.

Included at this meeting were representatives from Roche and Aventis Pasteur and three experts who had lent their name to oseltamivir’s marketing material (Professors Karl Nicholson, Ab Osterhaus, and Fred Hayden).

Two years later the WHO published a key report from that meeting, WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics 2004. The specific guidance on antivirals, Considerations for the Use of Antivirals During an Influenza Pandemic, was written by Fred Hayden. Professor Hayden has confirmed to the BMJ/The Bureau in an email that he was being paid by Roche for lectures and consultancy work for the company at the time the guidance was produced and published. He also told us in an email that he had received payments from GlaxoSmithKline for consultancy and lecturing until 2002. According to Prof Hayden: “DOI [declaration of interest] forms were filled out for the 2002 consultation.”

The WHO guidance concluded that: “Based on their pandemic response goals and resources, countries should consider developing plans for ensuring the availability of antivirals. Countries that are considering the use of antivirals as part of their pandemic response will need to stockpile in advance, given that current supplies are very limited.” Many countries around the world would adopt this guidance.

The previous year Professor Hayden was also one of the main authors of a Roche sponsored study that claimed what was to become one of oseltamivir’s main selling points—a claimed 60% reduction in hospitalisations from flu, which the Cochrane Collaboration was later unable to verify.8

Our investigation has also identified relevant and declarable interests relating to the two other named authors of annexes to WHO’s 2004 guidelines. Arnold Monto was the author of the annexe dealing with vaccine usage in pandemics. Between 2000 and 2004—and at the time of writing the annexe—Dr Monto has consistently and openly declared honorariums, consultancy fees, and research support from Roche, 10 11 12 consultancy fees and research support from GlaxoSmithKline 10 12 13 14; and also research funding from ViroPharma.15

No conflict of interest statement was included in the annex he wrote for WHO. When asked if he had signed a declaration of interest form for WHO, Dr Monto told the BMJ/The Bureau: “Conflict of Interest forms are requested before participation in any WHO meeting”.

Professor Karl Nicholson is the author of the third annex, Pandemic Influenza. According to declarations made by Professor Nicholson in the BMJ16and Lancet in 2003,17 he had received travel sponsorship and honorariums from GlaxoSmithKline and Roche for consultancy work and speaking at international respiratory and infectious diseases symposiums. Before writing the annexe, he had also been paid and declared ad hoc consultancy fees by Wyeth, Chiron, and Berna Biotech.

Even though the previous year these declarations had been openly made in the Lancet and the BMJ, no conflict of interest statement was included in the annex he wrote for WHO. Professor Nicholson told the BMJ/The Bureau that he last had “financial relations” with Roche in 2001. When asked if he had signed a declaration of interest form for WHO, Prof Nicholson replied: “The WHO does require attendees of meetings, such as those held in 2002 and 2004, to complete declarations of interest.”

Leaving aside the question of what declarations experts made to WHO, one simple fact remains: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not known whether information about these conflicts of interest was relayed privately to governments around the world when they were considering the advice contained in the guidelines.

The year before WHO issued the 2004 guidance, it published a set of rules on how WHO guidelines should be developed and how any conflicts of interest should be handled. This guidance included recommendations that people who had a conflict of interest should not take part in the discussion or the piece of work affected by that interest or, in certain circumstances, that the person with the conflict should not participate in the relevant discussion or work at all. The WHO rules make provision for the director general’s office to allow declarations of interest to be seen if the objectivity of a meeting has been called into question.18

The BMJ/The Bureau has asked WHO for the conflict of interest declarations for the Geneva 2002 meeting and those related to the guidance document itself. WHO told us that the query went directly up to Margaret Chan’s office. “WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General. In this case, we put in a request on your behalf but it was not granted. In more recent years, many WHO committees have published summaries of relevant interests with their meeting reports.”

In a BMJ interview (see film on bmj.com), WHO spokesperson Gregory Hartl reiterated the fact that Dr Margaret Chan, “is very committed personally to transparency.” Yet her office has turned down repeated requests for declaration of interest statements and declines to comment on the allegations that authors of the guidelines had declarable interests.

Nevertheless, Prof Hayden told the BMJ/The Bureau: “I strongly support transparency in declarations of interest, in part because this allows those reading documents, particularly ones authored by specific individuals (eg, Annex 5) [the part he wrote], to make their own judgments about the possible relevance of any potential conflicts.”

While experts need to work with industry to develop the best possible drugs for illnesses, questions remain about what level of involvement experts with industry ties should have in the formulation of public health policy decisions and guidelines. Professor Nicholson told the BMJ/The Bureau: “The WHO and decision makers must be informed of ongoing developments and research findings to ensure that they are as up to date as possible. Some of the most relevant expertise and information are held by companies or individuals with conflicts of interest. I understand the view that experts with conflicts of interest should not advise governments or organisations such as the WHO. But to exclude such people from discussions could deprive WHO and decision makers of important new information.”

But not everyone agrees. Barbara Mintzes is unequivocal about what role they should play. “No one should be on a committee developing guidelines if they have links to companies that either produce a product—vaccine or drug—or a medical device or test for a disease. It would be preferable that there are no financial ties when it comes to making big decisions on public health—for example, stockpiling a drug—and that includes if they have a currently funded clinical trial,” she said.

“Ideally, what you want are independent experts who are in the public sector to provide expertise on drugs and vaccines. But they can be hard to find. One solution is consult with the experts who are involved in industry, but not put them on any decision making committee. You need a firewall,” she added.

Indeed, Professor Harvey Fineberg, president of the Institute of Medicine and chairman of the panel reviewing WHO’s management of the pandemic, takes a similarly hard line. His own institution went through a detailed review of how they interact with industry and experts with conflicts of interests last year.19 “Sometimes publication of conflict of interests is enough—for example with a journal. But if you are giving expert judgment to influence policy, revealing is not enough,” he told the BMJ, referring to the Institute of Medicine’s policy.

WHO also says that it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But what action does it take when a scientist declares a conflict of interest, and when does it judge a scientist to be too conflicted to play a leading role in the formulation of global health policy? Since WHO has not provided us with an answer to this question, we are left to guess.

As it stands, this situation is the worst possible outcome for WHO, according to Professor Chris Del Mar, a Cochrane Review author and expert on WHO’s Strategic Advisory Group of Experts on Immunization group. “If it proves to be the case that authors of WHO guidance which promoted the use of certain drugs were being paid at the same time by the makers of those drugs for other work they were doing for these companies that is reprehensible and should be condemned in the strongest possible terms.”

WHO’s endorsement of oseltamivir was not lost on Roche. In an advert placed by the company for the drug in the main conference programme of the European Scientific Working Group on Influenza’s 2005 conference in Malta, it says: “Antivirals will initially be the principal medical intervention in a pandemic situation and Roche is working as a responsible partner with governments to assist in their pandemic planning.” The source reference for this is the WHO Global Influenza Preparedness Plan.

Throughout the following years, WHO would appear to have been inconsistent in how it treated conflicts of interest. Updated pandemic plans would continue to be prepared by experts who openly had work funded and acted as consultants to manufacturers of vaccines and antivirals. WHO produced its global influenza preparedness plan in 2005, and in 2006 it constituted an interim Influenza Pandemic Task Force. No public declarations of interest have been made and to date no details have been provided by WHO in response to our requests.

WHO’s stance that it does not publish declarations of interest from its experts is far from consistent. It is undermined, for example, by the position WHO adopts in relation to the Strategic Advisory Group of Experts on Immunization, its standing vaccine advisory body. Here, contrary to its approach to pandemic planning advisers, WHO does publish summaries of declarations of interest.

Emergency Committee

These seeming inconsistencies in WHO’s approach to transparency and its handling of conflicts of interest extend into the workings of the Emergency Committee formed last year to advise the director general on the pandemic. The identities of its 16 members are unknown outside WHO. This secret committee has guided WHO pandemic policy since then—including deciding when to judge that the pandemic is over.

WHO says it has to keep the identities secret to protect the scientists from being influenced or targeted by industry. In a phone call to the BMJ/The Bureau in March, WHO spokesperson Gregory Hartl explained: “Our general principle is we want to protect the committee from outside influences.”

The committee advised the WHO director general on phase changes as well as temporary recommendations. According to WHO, When the Emergency Committee met to discuss a possible move to a declaration of a pandemic, the meeting additionally included members who represented Australia, Canada, Chile, Japan, Mexico, Spain, the UK, and the US, eight countries that experienced widespread outbreaks at the time. These national representatives were present to ensure full consideration of the views and possible reservations of the countries expected to bear the initial brunt of economic and social repercussions.

WHO says all members of the Emergency Committee sign a confidentiality agreement, provide a declaration of interests, and agree to give their consultative time freely, without compensation. However, only one member of the committee has been publicly named: Professor John MacKenzie, who chairs it.

This is a troubling stance: it suggests that WHO considers other advisory groups whose members are not anonymous —such as the Strategic Advisory Group of Experts on Immunization—to be potentially subject to outside influences, and it allows no scrutiny of the scientists selected to advise WHO and global governments on a major public health emergency.

Under the International Health Regulations framework, the membership of the Emergency Committee is drawn from a roster of about 160 experts covering a range of public health areas. This framework provides guidelines about how WHO deals with acute public health risks. The BMJ/The Bureau has identified approximately 15 scientists from the International Health Regulations roster with influenza expertise and has emailed them to ask if they were on the Emergency Committee. Under the framework at least some of these scientists are members of the Emergency Committee. Yet because of the confidentiality agreements they have signed, these scientists cannot acknowledge their membership of the committee, putting them in an invidious position.

David Salisbury, chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) committee at the time of the pandemic and a member of the International Health Regulations, says the secrecy has caused problems for his group. “It certainly caused problems for SAGE. Since all of the details of SAGE are in the public domain, there was a perception that it had been SAGE that had given advice about the changing of definitions or the pandemic levels—when we had not done so. SAGE members came in for unfair personal abuse by journalists,” he told the BMJ/The Bureau.

“Given the importance of the advice, the transparency of the source of the advice was important. I believe it is necessary to keep confidential the source of advice if revealing details might put individuals at risk, for example when bioterrorism is being discussed. This does not seem to be the case for pandemic flu,” he added.

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee, who then put pressure on WHO to declare a pandemic. It was the declaring of the pandemic that triggered the contracts.

The BMJ/The Bureau can confirm that Dr Monto, Dr John Wood, and Dr Masato Tashiro are members of the Emergency Committee.

Although Dr Monto did not answer the question directly, his Infectious Disease Society of America biography states that he is a member.20

Last year, according to figures made public in the US by GlaxoSmithKline, Professor Monto received $3000 speakers fees from the company in the period between the second quarter and the last quarter of 2009. As a national official of the Japanese government, Dr Tashiro says that he must “have nothing concerning conflict of interest with private companies”. Dr John Wood works for the UK National Institute for Biological Standards and Control (NIBSC). Dr Wood, like Dr Tashiro, has no personal conflict of interests but he told the BMJ/The Bureau that as part of its statutory role in developing standards for measurement of biological medicines to ensure accurate dosing and carrying out independent control testing to assure their safety and efficacy, the institute must work closely with the pharmaceutical industry. This is made clear on their website.

“The International Federation of Pharmaceutical Manufacturers and Associations has also made publicly available the nature of their close interaction with NIBSC and similar organisations in order to develop influenza vaccines,” he said.21

Those who said that they were not on the committee include David Salisbury, Alan Hampson, Albert Osterhaus, Donato Greco, and Howard Njoo. Maria Zambon, from the UK’s Health Protection Agency told the BMJ: “I undertake various advisory roles to WHO. Declaration of interest statements are prepared before undertaking such roles.

“The HPA Centre for Infection, as part of its role in national infectious disease surveillance, provision of specialist and reference microbiology and vaccine efficacy monitoring, works closely with vaccine manufacturers and biotechnology companies.”

International Health Regulations review

WHO’s own review into the operation of the International Health Regulations and WHO’s handling of the pandemic is now being conducted by Harvey Feinberg, president of the US Institute of Medicine, and will report its findings next year. Dr Chan and Professor Feinberg have both made clear the need for a thorough investigation. But questions are already arising about how independent the review will turn out to be. According to the International Health Regulations list in our possession, some 13 of the 29 members of the review panel are members of the International Health Regulations itself and one is the chair of the Emergency Committee. To critics that might suggest a somewhat incestuous approach.

Professor Mintzes does not agree with WHO’s explanation that secrecy was needed to protect against the influence of outside interest on decision making. “I can’t understand why the WHO kept this secret. It should be public in terms of accountability like the expert advisory committees. If the rationale of secret membership is not to be unduly influenced, there are other ways of dealing with this through strong conflict of interest provisions,” she said.

She also believes that the very nature of allowing a trigger point for vaccine contracts opens the system up unnecessarily to exploitation. “It seems a problem that this declaration might trigger contracts to be realised. There should be safeguards in place to make sure those with an interest in vaccine manufacturers can’t exploit the situation. The WHO will have to look long and hard at this in future,” she said.

The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse.. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim—the credibility of the WHO and the trust in the global public health system.

Cite this as: BMJ 2010;340:c2912

——————————————————————————–

Competing interests: PC declares no competing interests. DC has been paid expenses by WHO for giving talks at two conferences.

Trial results ‘do not support the use of general health checks’ warn experts

Contact: Stephanie Burns
sburns@bmjgroup.com
44-020-738-36920
BMJ-British Medical Journal

Checks have not reduced number of deaths from cardiovascular disease or cancer

Research: General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis

Editorial: The value of conducting periodic health checks

Researchers have found that routine general health checks, which have become common practice in some countries, do not reduce the number of deaths from cardiovascular disease or cancer. They do, however, increase the number of new diagnoses.

Health checks were defined as screening for more than one disease or risk factor in more than one organ system offered to a general population unselected for disease or risk factors.

Health checks were introduced with the intention of reducing morbidity and prolonging life and there are many potential benefits, including: detection of both increased risk factors and precursors to disease (thus preventing cancer from developing); counselling on diet, weight and smoking; reassuring healthy people thus reducing worry about potential disease.

However, screening healthy people can be harmful and can lead to overdiagnosis and overtreatment, a topic which was featured in the BMJ in October. The researchers also point out that invasive diagnostic tests may cause harm. Being labelled as having a disease may also negatively impact healthy people’s views of themselves and their health behaviour.

Few of the individual tests commonly used in health checks have been adequately studied in trials and it is not clear whether they do more harm than good. When tests have been studied in trials, the results have been varied. Authors from the Nordic Cochrane Centre in Denmark therefore carried out a review of a total of 14 trials that looked at systematic health checks. The studies had between 1 and 22 years of follow-up.

Nine of the 14 trials had data on mortality and included 182,880 participants, 11,940 of whom died during the study period. 76,403 were invited to health checks and the remainder were not. All participants were over 18 years old and the study excluded trials specifically targeting older people or trials that only enrolled people aged 65 or over.

Despite some variation regarding the risk of death from cardiovascular disease and cancer, no evidence was found for a reduction of either total mortality, cardiovascular mortality, or cancer mortality. Unsurprisingly, the researchers found that health checks led to more diagnoses and more medical treatment for hypertension, although this was infrequently studied.

The lack of beneficial effects indicates that the interventions did not work as intended in the included trials. Health checks are likely to increase the number of diagnoses, but in the absence of benefits, this suggests over-diagnosis and overtreatment.

The researchers also note that people who accept a health check invitation are often different from those who do not, so the checks might not reach those who need prevention the most. Plus, many physicians already carry out testing for cardiovascular risk factors or diseases in patients that they judge to be at risk when they see them for other reasons.

In conclusion, the results do not support the use of general health checks aimed at the general population. The researchers say that further research should “be directed at the individual components of health checks e.g. screening for cardiovascular risk factors, chronic obstructive pulmonary disease, diabetes, or kidney disease”.

In an accompanying editorial, Professor Macauley, Primary Care Editor at the BMJ, agrees that although health checks are “seductive” and “seem sensible” there is little evidence to show that they reduce morbidity and mortality. As well questioning whether they do more harm than good, Dr Macauley says that Krogsbøll and colleagues’ study finds that “regular health checks are ineffective” and show “evidence of little effect” and adds that policy should be based on “wellbeing rather than […] well meant good intentions”.

Low muscle strength in adolescence linked to increased risk of early death

Contact: Stephanie Burns
sburns@bmjgroup.com
44-020-738-36920
BMJ-British Medical Journal

Effect similar to classic risk factors such as weight and blood pressure

Research: Muscular strength in male adolescents and premature death: cohort study of one million participants

Low muscle strength in adolescence is strongly associated with a greater risk of early death from several major causes, suggests a large study published on bmj.com today.

The effect is similar to well established risk factors for early death like being overweight or having high blood pressure, leading the authors to call for young people, particularly those with very low strength, to engage in regular physical activity to boost their muscular fitness.

High body mass index (BMI) and high blood pressure at a young age are known risk factors for premature death, but whether muscular strength in childhood or adolescence can predict mortality is unclear.

So a team of researchers, led by Professor Finn Rasmussen at the Karolinska Institutet in Sweden, tracked more than one million Swedish male adolescents aged 16 to 19 years over a period of 24 years.

Participants underwent three reliable muscular strength tests at the start of the study (knee extension strength, handgrip strength and elbow flexion strength). BMI and blood pressure were also measured. Premature death was defined as death before age 55 years.

During the follow-up period, 26,145 participants (2.3% of the group) died. Suicide was the most common cause of death (22.3%) compared with cardiovascular diseases (7.8%) or cancer (14.9%).

High muscular strength was associated with a 20-35% lower risk of early death from any cause and also from cardiovascular diseases, independently of BMI or blood pressure. No association was seen with cancer deaths.

Stronger adolescents also had a 20-30% lower risk of early death from suicide and were up to 65% less likely to have any psychiatric diagnosis, such as schizophrenia and mood disorders. These results suggest that physically weaker individuals might be more mentally vulnerable, say the authors.

In contrast, male adolescents with the lowest level of muscular strength showed the greatest all-cause mortality and also the greatest mortality in cardiovascular disease and suicide before age 55 years.

Death rates from any cause (per 100,000 person years) ranged between 122.3 and 86.9 for weakest and strongest adolescents respectively. Rates for cardiovascular diseases were 9.5 and 5.6 and for suicide were 24.6 and 16.9.

The authors say that low muscular strength in adolescents “is an emerging risk factor for major causes of death in young adulthood, such as suicide and cardiovascular diseases.” The effect sizes of these associations “are similar to classic risk factors such as body mass index and blood pressure,” they add.

They suggest that muscular strength tests, in particular handgrip strength, could be assessed with good reliability in almost any place, including clinical settings, schools and workplaces.

They also support the need for regular physical activity in childhood and adolescence, saying: “People at increased risk of long term mortality, because of lower muscular strength, should be encouraged to engage in exercise programmes and other forms of physical activity.”

Chemical exposure before mid-30s may be critical in breast cancer development

2010 study posted for filing

Contact: Emma Dickinson edickinson@bmjgroup.com 44-020-738-36529 BMJ-British Medical Journal

Postmenopausal breast cancer and occupational exposures

Occupational exposure to certain chemicals and pollutants before a woman reaches her mid-30s could treble her risk of developing cancer after the menopause, suggests research published in Occupational and Environmental Medicine .

Women exposed to synthetic fibres and petroleum products during the course of their work seem to be most at risk, the research suggests.

The researchers base their findings on more than 1100 women, 556 of whom were diagnosed with breast cancer in 1996/7 in Montreal, Canada, when aged between 50 and 75 and who had gone through the menopause.

The other 613 women, who were matched for age and date of diagnosis, had a range of other cancers, and were intended to act as a comparison group.

An expert team of chemists and industrial hygienists then set about investigating the women’s levels of exposure to around 300 different substances throughout the course of their employment history.

After taking account of the usual factors associated with an increased risk of breast cancer, the analysis indicated a link between occupational exposure to several of these substances.

Compared with the comparison group, this risk peaked for exposures before the age of 36, and was magnified with each additional decade of exposure before this age.

This resulted in women occupationally exposed to acrylic fibres running a seven-fold risk of breast cancer, while those exposed to nylon fibres almost doubled their risk.

When tumours were divided into their hormonal responsiveness, women whose cancers responded to oestrogen, but not progesterone, were at least twice as likely to have breast cancer for every 10 year period they were exposed to monaromatic hydrocarbons (a byproduct of crude oil) and acrylic and rayon fibres.

Exposure to polycyclic aromatic hydrocarbons, found in petroleum products, before the age of 36, tripled the risk for women whose tumours were responsive to both oestrogen and progesterone.

The authors concede that their findings could be due to chance alone, but say they are consistent with the theory that breast tissue is more sensitive to harmful chemicals if the exposure occurs when breast cells are still active – in other words, before a woman reaches her 40s. And they point to the rising incidence of breast cancer in developed countries, which is likely to be due to a range of factors, including diagnosis of small slow growing tumours and changes in alcohol consumption.

But environmental and workplace factors are also thought to have a role, they suggest, with previously published evidence implicating exposure to certain chemicals, low frequency electromagnetic fields, and disruption of the body clock.

###

BMJ editor urges Roche to fulfil promise to release Tamiflu trial data: Or anything that shows the drug does more good than harm.

Contact: Stephanie Burns
sburns@bmjgroup.com
44-020-738-36920
BMJ-British Medical Journal

BMJ editor urges Roche to fulfil promise to release Tamiflu trial data

Journal launches open data campaign to compel greater accountability in healthcare

In an open letter to company director, Professor Sir John Bell, she says: “Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny.”

The letter is published on the BMJ‘s website (bmj.com/tamiflu) alongside correspondence by the Cochrane team with Roche, the US Centres for Disease Control (CDC) and the World Health Organisation (WHO), as part of an open data campaign aimed at persuading Roche to give doctors and patients access to the full data on Tamiflu.

Dr Godlee’s letter follows recent reports that the European Medicines Agency (EMA) has initiated infringement proceedings against Roche to investigate deficiencies in safety reporting, including the processing of around 80,000 reports on suspected adverse drug reactions.

Dr Godlee is also one of 28 signaturies to a letter published in The Times today (thetimes.co.uk/letters) calling on drug companies to “come clean” and make clinical trial data for all drugs in current use available to healthcare professionals.

Pressure from politicians is also mounting. Last week, Sarah Wollaston, a GP and Conservative MP, raised the issue of missing data in Parliament, while Health Minister Norman Lamb has agreed to meet experts to discuss the issue of access to clinical trial data.

In December 2009, Roche made a public promise to release full clinical trial reports of its antiviral drug oseltamivir (Tamiflu) in response to a major investigation by the BMJ and researchers Peter Doshi and Tom Jefferson from the Cochrane Collaboration.

The investigation found no clear evidence that Tamiflu prevents complications like pneumonia in healthy people. It also raised serious concerns about access to drug data, the use of ghost writers in drug trials, and the drug approval process.

Since the investigation, some further data have been released to the Cochrane reviewers, but the full data set has still not been provided.

The Cochrane reviewers now know that there are at least 123 trials of Tamiflu and that the majority (60%) of patient data from Roche Phase 3 completed treatment trials remain unpublished. Their main concerns relate to “the likely overstating of effectiveness and the apparent under-reporting of potentially serious adverse effects.”

Meanwhile, Tamiflu has been a great commercial success for Roche and has been added to the World Health Organisation’s list of essential medicines.

In her letter, Dr Godlee appeals to Professor Bell “to bring your influence to bear on your colleagues on Roche’s board.” She adds: “In refusing to release these data of enormous public interest, you put Roche outside the circle of responsible pharmaceutical companies. Releasing the data would do a great deal to restore confidence in your company and its board of directors.”

In a response not for publication, Professor Bell said he has referred the matter to Roche and is awaiting a response.

“The open correspondence on bmj.com aims to hold specific individuals and organisations to account,” writes Dr Godlee in an accompanying editorial. “Their actions are preventing independent scrutiny of the results of clinical trials and putting patients’ lives at risk. We also hope it will contribute to a sea change in the public mood.”

A poll on bmj.com last week asked: “Who is mainly at fault for denying access to negative clinical trial results?” Of the 569 votes, 69% said pharma, 13.5% said regulators, and 9% said legislators.

The BMJ plans to launch other campaigns linked to its investigations in the future.

###

Breast cancer screening saves lives, says study??? that screening only narrowly decreased risks that a 50-year-old woman would die from breast cancer within 10 years — from 0.53 percent to 0.46 percent.

Engineering Evil Note: There seems to be conflicting studies being utilized to favor screening. I found this report stating that they used no current data for the meta analysis. The data they claimed to have used here was over 20 years old. I am withholding my humble opinion to see if there were current studies, and if they used the superior MRI  overt he  antiquated mammograms. There seems to be a few different press releases quoting different studies, in addition now to a few broken links to those reports.

i.e. http://todayhealth.today.com/_news/2012/10/29/14787480-breast-cancer-checks-save-lives-despite-over-diagnosis-reportsays?lite

Breast cancer screening saves lives, says study

PARIS (AFP)  Benefits of preemptive breast cancer screening outweigh the risks, a study said Tuesday, insisting the practice saves thousands of lives.The new research adds to the debate about the dangers of overdiagnosis, which sees some women undergo invasive treatment for cancers that would never have made them ill or even been diagnosed were it not for the scans.”Breast screening extends lives,” concluded a panel of researchers in The Lancet medical journal.

The team had analysed data from other trials conducted over many years in Britain, where women aged 50 to 70 are invited for a screening mammogram every three years.

The data, it said, pointed to a 20 percent reduction in mortality — or one death prevented for every 180 women screened.

This meant that the UK screening programmes “probably prevent about 1,300 breast cancer deaths every year,” said the report.

But there is a cost.

Nearly 20 percent of breast cancer diagnosed by screening would never have caused any problems, said the study.

The panel, set up to advise British policymakers, estimated that among every 10,000 women invited to screening from the age of 50 in the Britain, 681 cancers would be discovered, of which 129 would be overdiagnoses, and 43 deaths prevented.

The report showed that “the UK breast-screening programme extends lives and that, overall, the benefits outweigh the harms,” The Lancet wrote in an editorial.

“Women need to have full and complete access to this latest evidence in order to make an informed choice about breast cancer screening.”

The team conceded there were limitations to its work, including that all the data scrutinised was more than 20 years old.

Cancer experts have been at loggerheads for years about whether the benefits of screening outweigh the harm of overdiagnosis.

All cancer, once picked up in the screening process, is treated, often with surgery as well as radio- and chemotherapy, as it is impossible to tell which growths would have remained undetected for the remainder of a woman’s life.

In August, medical experts Steven Woloshin and Lisa Schwartz wrote in the British Medical Journal (BMJ) that screening only narrowly decreased risks that a 50-year-old woman would die from breast cancer within 10 years — from 0.53 percent to 0.46 percent.

Up to half of women screened annually over 10 years experienced at least one false alarm that required a biopsy, they said.

And in 2010, a report in the New England Journal of Medicine said mammograms have only a “modest” impact on reducing breast cancer deaths.

The latest panel had been created by the national cancer director for England, Mike Richards and Cancer Research UK chief executive officer Harpal Kumar.

Its work, said The Lancet, “should begin to lay the benefits versus harm controversy to rest”.

http://www.afp.com/en/news/topstories/breast-cancer-screening-saves-lives-says-study

BMJ and Daily Telegraph’s fake hip exposes failing European device regulation: EU Places Personal Profit over Safety

Contact: Stephanie Burns sburns@bmjgroup.com 44-020-738-36920 BMJ-British Medical Journal

Responsible bodies more interested in attracting business than patient safety

A joint investigation by the BMJ and Daily Telegraph has exposed the major flaws in the current EU system used for regulating medical devices, such as hip replacements and breast implants.

It reveals that some “notified bodies” (the agencies charged with assessing how safe medical devices are before they are sold) are more interested in attracting business than safeguarding patients.

Undercover reports created  a fake large diameter metal on metal total hip—called the Changi TMH (Total Metal Hip)—that was based on a device which has been recalled globally for safety reason. .

The hip was presented to 14 notified bodies in five countries and undercover reporters applied to get quotations for CE certification.

The dossier created for the Changi TMH said that tests had shown it produced potentially toxic levels of metal ions in the body—however; it was passed as having an acceptable design for use in patients across Europe.

The investigation found some notified bodies are more concerned with repeat business and making profits than the safety of their patients. In fact,  an official from ITC, one of the notified bodies in the Czech Republic, admitted that it is “one the side of [the] manufacturer and their products, not on the side of patients” but when later questioned said it was “in full accordance with the law”.

It was also discovered that agencies compete for business based on price, speed and promised rates of successful certification. Prices for a coveted CE certificate cost between €2,750 and €50,000 and there are further costs charged for annual checks. With over 500,000 medical devices on the market, competition is therefore rife.

An employee of a Turkish notified body said it is a “money making business” with notified bodies dropping their standards to attract further work. Hip implants are classed as one of the most high risk devices and should therefore be subject to the most rigorous pre-market appraisal. However, this investigation found that some of the notified bodies are prepared to omit crucial tests and only a small number said they would insist on a clinical study. Many could not even give specifics about what form a clinical study should take.

The investigation also found evidence of companies who are prepared to exploit loopholes in the European legislation banning direct consultation. EVPU, a notified body based in Slovakia said it would be prepared to “cross the line” and give advice when assessing the fake submission.

Undercover reporters also went to South Korea, where three legally separate companies come together under one umbrella organisation to offer manufacturers a “one stop service” that they say can help companies to “increase profit.”

One of them performs notified body duties across Asia and has certified over 1000 products for access to the European market. The other two offer consultation services for manufacturers hoping to gain market access to the European Union, US, South Korea, and other parts of Asia.

The European system of regulating medical implants has been heavily criticised after a series of high profile device failures and recalls and both the UK government and the European Commission is currently looking into whether the system is fit for purpose. Deborah Cohen, Investigations Editor at the BMJ, believes the weakest link in the regulatory system is a “complete delegation of responsibility”. Unlike the US, Europe relies on over 70 notified bodies across the word to decide whether a medical device is fit for purpose.

Another problem raised is the varying standards across the board – something acknowledged by one member of staff at a notified body who said: “The certification approach from one notified body to another differs”. The investigation also suggests that few devices fail to obtain approval with one notified body in Hungary stating that clients rarely “if ever”, fail.

In his linked editorial, Peter McCulloch clinical reader at the University of Oxford, says that “patient safety and not trade should take centre stage of the system to regulate medical devices” and that although costly, a new system that “improved scientific evidence of safety, require evidence of efficacy, and rewarded responsible innovation with protection against piracy would be well worth considering”.

Doctors speak out about unnecessary care as cost put at $800 billion a year

Contact: Emma Dickinson
edickinson@bmjgroup.com
44-020-738-36529
BMJ-British Medical Journal

Prominent doctors are challenging the assumption in US healthcare that more is better

Leading doctors are calling for action to tackle unnecessary care that is estimated to account for up to $800bn in the United States every year.

In a special report for this week’s BMJ, journalist Jeanne Lenzer describes how a new movement led by prominent doctors is challenging the basic assumption in US healthcare that more is better.

The report comes as an international conference ‘Preventing Overdiagnosis‘ is announced for September 2013 in the United States, hosted by The Dartmouth Institute for Health Policy and Clinical Practice, in partnership with the BMJ, the leading consumer organisation Consumer Reports and Bond University, Australia.

In the US, overly aggressive treatment is estimated to cause 30,000 deaths among Medicare recipients alone each year, while unnecessary interventions are estimated to account for 10-30% of spending on healthcare, or $250bn-$800bn (£154bn-£490bn) annually.

Examples range from the overuse of screening tests and imaging technology to an epidemic of questionable surgery.

Such statistics led a group of prominent doctors from the US, Canada and the UK to come together and discuss how to avoid the harm caused to patients by overtreatment.

Many of them have been warning for decades about the harms of overtreatment, but it is only now, with global financial downturns and growing awareness of the unsustainability of healthcare spending, that the issue is receiving significant attention from the American media and politicians.

They identified several reasons for overtreatment, including malpractice fears, biased research, patient demand, and financial conflicts of guideline writers. Other commonly cited problems included the rapid uptake of unproved technology and the failure to inform patients fully of the potential harms of elective treatments. Several speakers highlighted the way physicians are paid and trained in the US as central factors, and nearly 80% believed that more radical payment reform is necessary to reduce the problem meaningfully.

But as these initiatives begin to move forward, they will face formidable challenges from the healthcare industry and the general public who argue that the overtreatment movement is simply a scheme to ration care, reports Lenzer.

Supporters of reducing overtreatment vigorously oppose this view. “Rationing means that you are limiting necessary care. What we are proposing is limiting unnecessary care – harmful care,” argues Dr Diane Meier, Professor of Geriatrics and Internal Medicine at Mount Sinai School of Medicine.

Jerome R Hoffman, Emeritus Professor of Medicine at the University of California, Los Angeles, adds: “There’s already lots of rationing in healthcare; wouldn’t it be better for us to decide what should be available, based on what’s best for our health, rather than having insurance companies decide, based on what’s most profitable for them?”

They also point out that resources wasted on unnecessary care can be much better spent treating and preventing genuine illness in those who are underinsured or uninsured.

Ultimately, engaging clinicians at an international level will be key to moving these issues forward. Dr Shannon Brownlee, author of Overtreated: How Too Much Medicine is Making Us Sicker and Poorer says: “The crucial step right now is to get the medical community mobilized around the idea that overtreatment harms patients.”

Dementia risk from sleeping tablets: Increases risk to Seniors by 50%

Dementia risk from sleeping tablets: Pensioners on pills taken by 1.5m are  50% more likely to be hit, warns Harvard study

  • Academics  say side effects could be so harmful doctors should avoid prescribing  them
  • Scientists  believe sleeping pills may interfere with neurotransmitters in the brain,  possibly causing dementia
  • Doctors  made 10million sleeping pill prescriptions last year

By Sophie Borland

PUBLISHED:18:00 EST, 27  September 2012 | UPDATED:02:17 EST, 28 September 2012

Around 1.5m Britons are thought to be taking sleeping pills at any one time, with over 10million prescriptions handed out every year
Around 1.5m Britons are thought to be taking sleeping  pills at any one time, with over 10million prescriptions handed out every  year

Sleeping pills taken by more than a million  Britons significantly increase the risk of dementia, researchers warn  today.

Pensioners who used benzodiazepines – which  include temazepam and diazepam – were 50 per cent more likely to succumb to the  devastating illness, a Harvard University study found.

Academics believe the side effects of the  drugs may be so harmful that doctors should avoid prescribing them.

Around 1.5million Britons are believed to be  taking the pills at any one time and more than 10million  prescriptions are  handed out a year.

The researchers also estimate that up to 8  per cent of the over-65s have  used them within the last few years to treat  insomnia or anxiety.

But there is growing evidence that they have  serious side effects and a  number of studies have linked them to falls, memory  problems, panic  attacks and early death.

Academics from Harvard University in the US  and the University of Bordeaux in  France discovered that over-65s who had taken  the drugs within the last  15 years were 50 per cent more likely to get  dementia.

The drugs can only be obtained by a  prescription. They work by changing the way messages are transmitted to the  brain, which induces a calming  effect.

But scientists believe that at the  same time  they may be interfering with chemicals in the brain known as  neurotransmitters,  which may be causing dementia.

Professor Tobias Kurth, who works jointly at  Harvard University’s School of  Public Health and the University of Bordeaux,  said: ‘There is a  potential that these drugs are really harmful.

‘If it is really true that these drugs are  causing dementia that will be  huge. But one single study does not necessarily  show everything that is  going on, so there is no need to panic.

‘These drugs certainly have their benefits  and if you prescribe them in a way they should be prescribed they treat very  well.’

The study, published today in the British  Medical Journal, involved 1,063 men and women over the age of 65 for a period of  20 years in south west France. Initially none of the participants had dementia  and no one was taking benzodiazepines.

Risk: Academics believe the side-effects of some sleeping tablets could be so harmful doctors should avoid prescribing themRisk: Academics believe the side-effects of some  sleeping tablets could be so harmful doctors should avoid prescribing them

The researchers followed them up after 15  years and found that 253 had developed dementia. They worked out that out of 100  not taking the drug, 3.2 would be expected to get the illness.

But among 100 patients on these drugs, 4.8  would get dementia – a significantly higher proportion. The patients had taken  the pills at least once – over the course of a week or so – at some point in the  previous 15 years.

The study concluded: ‘Considering the extent  to which benzodiazepines are prescribed and the number of potential adverse  effects, indiscriminate widespread use should be cautioned against.’

In the last 20 years the number of  prescriptions for benzodiazepines has fallen by 40 per cent, largely due to  concerns that patients were becoming addicted.

But they remain one of the most commonly used  drugs and there are fears some patients are taking them for far too  long.

‘Considering the extent to which  benzodiazepines are prescribed and the number of potential adverse  effects,  indiscriminate widespread use should be cautioned against.’

A spokesman for the Alzheimer’s Society said: ‘This is the not the first time it has been suggested that these drugs could  have a negative impact on cognition. With this long-term study adding to the  evidence, it emphasises how important it is we properly monitor how treatments  for anxiety or sleep problems are used.’

A study last year from Cardiff University  found that Britons who had used the pills were 60 per cent more at risk from  dementia. The study of 1,160 men aged 45 to 85 found that 9 per cent had taken  them at least once over the last two decades.

Earlier this year American researchers found  the drugs heightened the risk of early death. Their study showed that even  patients taking between four and 18 pills a year were 3.6 times more likely to  die prematurely. Those on more than 132 pills a year were 5.3 times more likely  to die.

Dementia is one of the biggest burdens facing  the NHS. Some experts believe the cost of caring for patients will rise to £35billion annually within the next two decades.

There are currently 800,000 Britons with  dementia, including Alzheimer’s disease

Read more: http://www.dailymail.co.uk/health/article-2209694/Dementia-risk-sleeping-tablets-Pensioners-pills-taken-1-5m-50-likely-hit-warns-Harvard-study.html#ixzz27owqC77N Follow us: @MailOnline on Twitter | DailyMail on Facebook

137th Health Research Report 07 SEP 2008

 Full Report at www.healthresearchreport.me

Editors Top Five:

 

1. Study Finds How BPA Affects Gene Expression, Anxiety; Soy Mitigates Effects

2. Vitamin B3 may offer new tool in fight against ‘superbugs’

3. Johns Hopkins team finds ICU misdiagnoses may account for as many annual deaths as breast cancer

4. Prenatal exposure to pesticide additive linked with childhood cough

5. Childhood virus RSV shows promise against adult cancer

 

 

In this Issue:

1. Vitamin B3 may offer new tool in fight against ‘superbugs’

2. How a virus might make you diabetic later in life

3. Adolescent pot use leaves lasting mental deficits

4. Nutrition tied to improved sperm DNA quality in older men

5. Energy drinks improve heart function

6. Breast milk promotes a different gut flora growth than infant formulas

7. Johns Hopkins team finds ICU misdiagnoses may account for as many annual deaths as breast cancer

8. WSU researcher documents links between nutrients, genes and cancer spread

9. Antibiotic residues in sausage meat may promote pathogen survival

10. Smoking after stroke increases death risk by 3-fold

11. The raccoon spreads dangerous diseases as it invades Europe

12. Chocolate: A sweet method for stroke prevention in men?

13. Bacterial cause found for skin condition rosacea

14. WSU researchers discover mechanism leading from trichomoniasis to prostate cancer

15. Lyme retreatment guidance may be flawed

16. Chemical exposure in the womb from household items may contribute to obesity

17. Affluent people less likely to reach out to others in times of chaos, study suggests

18. Coconut oil could combat tooth decay

19. Heavy drinking rewires brain, increasing susceptibility to anxiety problems

20. Even in normal range, high blood sugar linked to brain shrinkage

21. High doses of Vitamin D help tuberculosis patients recover more quickly

22. High levels of DDT in breast milk

23. Large Review Finds Some Evidence for “Chemo Brain” in Breast Cancer Survivors, Moffitt Cancer Center Says

24. Are restrictions to scientific research costing lives?

25. Toddlers increasingly swallowing liquid detergent capsules

26. Brainy beverage: Study reveals how green tea boosts brain cell production to aid memory

27. Children exposed to 2 phthalates have elevated risk of asthma-related airway inflammation

28. Prenatal exposure to pesticide additive linked with childhood cough

29. Nutritional supplement offers promise in treatment of unique form of autism

30. Diagnostic chest radiation before 30 may increase breast cancer risk

31. Report: Strategies to prevent noise-induced hearing loss, tinnitus in soldiers

32. Childhood virus RSV shows promise against adult cancer

33. Stress prompts some to retain as much salt as eating fries

34. Study Finds How BPA Affects Gene Expression, Anxiety; Soy Mitigates Effect

 

 

Health Technology Research Synopsis

137th Issue Date 07 SEP 2012

Compiled By Ralph Turchiano

www.healthresearchreport.me www.vit.bz

www.youtube.com/vhfilm http://www.facebook.com/vitaminandherbstore

www.engineeringevil.com


Osteoporosis Drugs, Reduce Fracture Risk by ONLY 0.9% according to studies

Contact: Emma Dickinson edickinson@bmj.com 44-020-738-36529 BMJ-British Medical Journal

Value of drugs for pre-osteoporosis exaggerated

Drugs for pre-osteoporosis: Prevention or disease-mongering?

Public release date: 17-Jan-2008

A series of recent scientific publications have exaggerated the benefits and underplayed the harms of drugs to treat pre-osteoporosis or “osteopenia” potentially encouraging treatment in millions of low risk women, warn experts in this week’s BMJ.

The authors believe that this represents a classic case of disease-mongering: a risk factor being transformed into a medical disease in order to sell tests and drugs to relatively healthy people.

Osteopenia or “pre-osteoporosis” is said to affect around half of all older women and, in at least one country, drug companies have already begun to market their drugs to women with osteopenia, based on re-analyses of four osteoporosis drug trials.

But the authors of this week’s BMJ paper argue that this move raises serious questions about the benefit-risk ratio for low risk individuals, and about the costs of medicalising and potentially treating an enormous group of healthy people.

These reanalyses tend to exaggerate the benefits of drug therapy, they say. For example, the authors of one reanalysis cite a 75% relative risk reduction, though this translates into only a 0.9% reduction in absolute risk.

In other words, up to 270 women with pre-osteoporosis might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture.

Most of the reanalyses also play down the harms of drug therapy, they add. For example, the reanalysis of data for the drug raloxifene focuses solely on the potential benefits, with no mention of an increased risk of blood clots.

Finally, like much of the published literature on osteoporosis, these analyses have potential conflicts of interest, they write. For instance, all of the original drug trials being re-analysed were funded by industry and, in three out of four cases, drug company employees were part of the team conducting the reanalyses.

The World Health Organisation is currently developing guidance on how to deal with women categorised as having osteopenia. Whether this will stop industry efforts to encourage treatment in low risk women is, however, questionable, they say.

“We need to ask whether the coming wave of marketing targeting those women with pre-osteoporosis will result in the sound effective prevention of fractures or the unnecessary and wasteful treatment of millions more healthy women,” they conclude.

Repsoted study from 2008…Requested repost

I swam with my contact lenses in – now I’m blind in one eye : Even Tap Water

By Anna Hodgekiss

PUBLISHED:17:05 EST, 20  August 2012| UPDATED:17:05 EST, 20 August 2012

As a contact lens wearer, Jennie Hurst knew  the importance of good hygiene to prevent eye infections.

‘I was meticulous about removing my lenses  before bed and making sure I did so with clean hands,’ says the 28-year-old from  Southampton.

‘I wore monthlies — where the lenses are  removed each night and replaced once a month — but I was so conscious of getting  an infection that I replaced them every two weeks.

And I always cleaned them with  contact lens  cleaning solution, unlike some of my friends who’d run  their lenses under the  tap or even moisten them with saliva.’

Despite this, Jennie, who works as an  environmental co-ordinator, is now blind  in her left eye — the result of a  vicious infection.

The cause?

Swimming while wearing her contact lenses,  something she never realised put her at risk.

Jennie is one of a growing number of people — the majority of them young — suffering potentially devastating eye infections  due to a lack of  knowledge of the risks of contact lenses, say  experts.

In her case the problem is acanthamoeba  keratitis, caused by an amoeba — a parasite found in almost all soil, fresh  water and sea water.

It thrives where limescale and bacteria are  present, but contact lens wearers are at highest risk if they clean their lenses  or lens cases in tap water, or if they swim, shower or bathe while wearing their  lenses.

This means the parasite can become trapped  between the lens and the eye, allowing it to burrow into the eyeball.

Indeed, Jennie’s problems began after a quick  swim in a hotel pool while on a break in the West Country last  summer.

‘The irony is that I don’t even like swimming — I only did a few laps,’ says Jennie, who had worn contact lenses for five  years at that point.

‘I had no idea of the dangers of swimming in  lenses — my biggest concern was simply losing a lens in the pool.

‘I remember getting some water in my eye, but  thought nothing of it.

'I felt so guilty - if I'd known I'd have whipped them out in seconds and worn my glasses instead,' said Jennie‘I felt so guilty – if I’d known I’d have whipped them  out in seconds and worn my glasses instead,’ said Jennie

‘Then, three days later, I noticed my left  eye was very sensitive to light and felt like it had a chemical irritation.

‘It was a bit red but there wasn’t any  discharge like a normal eye infection — I’d had one of those years before,  although not from contact lenses.

‘Then, over the next day, the most  excruciating pain kicked in, so I drove myself to hospital.’

There, doctors referred her to the specialist  eye casualty at Southampton General Hospital, where she was given eye drops and  told to return a week later.

‘With no improvement, the doctors explained  they’d have to take a scrape of the surface of my eye to see if there was an  infection.

‘They also asked if I’d done anything unusual  and I said swimming. They said this was the most likely cause, explaining  contact lens wearers should never do that with their lenses in.

‘I felt so guilty — if I’d known I’d have  whipped them out in seconds and worn my glasses instead.’

The initial scrape of her eye revealed she  had acanthamoeba keratitis and this began six months off work for Jennie, who by  this point was ‘almost blind’ in that eye.

‘I had my first operation that day — the top  layers of my eye were scraped off, and I then administered half hourly drops day  and night.

‘The drops, which contained strong chemicals,  were really painful. And when you’re having them so often you just don’t sleep.

‘I spent the majority of time in a dark room — even the light on my phone screen was too bright to look at.

It's estimated that 3.7 million Britons wear contact lensesIt’s estimated that 3.7 million Britons wear contact  lenses

‘I was in hospital three times in six months  (about two weeks in total) and then had to move in with my parents, as I  couldn’t do anything for myself.

‘On the rare occasions I did leave the house,  I had to literally follow my Dad’s footsteps because I couldn’t see.’

Even light hitting the good eye would make  her bad eye painful, and her vision was blurred due to watery  eyes.

It’s estimated that  3.7 million Britons  wear contact lenses.

Though rare, acanthamoeba keratitis is an  extremely painful, sight-threatening condition.

The organism eats the cornea, the  transparent cover of the eye, says Parwez Hossain, the consultant  ophthalmologist at Southampton General Hospital’s eye unit who treated Jennie.

Left to burrow, the amoeba can penetrate  through the eyeball, causing total vision loss within weeks.

‘The condition is pure torture — the amoeba  is attacking the nerves of the cornea — and treatment itself is very painful.

‘It can involve a year of regular and toxic  eye drops,’ says Mr Hossain.

‘Jennie has been particularly unlucky — hers  is one of the most severe cases I’ve seen.

‘The problem is that people have no idea of  the risks of swimming or showering while wearing lenses.’

What’s more, cases are on the rise.

‘At Southampton we have noticed an increase,  as have other eye units around the country, perhaps due to a lack of awareness  of contact lens hygiene,’ says Mr Hossain.

A letter from doctors at Bristol Eye Hospital  to the BMJ last year stated that many acanthamoeba keratitis patients had been  washing lenses in tap water and showering or swimming wearing them.

And there are many more common eye infections  linked to poor lens hygiene that can have similarly devastating results.

‘Psuedomonas bacteria cause the most common  type of infection in contact lens wearers,’ adds Mr Hossain.

‘It’s another bug that lives in water and  can destroy your sight within 24-36 hours.

‘A common symptom is green pus and pain,  discomfort and light sensitivity after only a few hours.

‘It’s often mistaken for conjunctivitis but,  if you have these symptoms, it’s vital to seek medical help, as after two or  three days, the cornea may perforate.’

The problem generally occurs with poor  hygiene.

‘Even daily disposables are risky if your  hands aren’t clean,’ says Mr Hossain.

‘You need to wash hands with soap and water  to get rid of bacteria, then dry them on a clean towel.

‘And never run lenses under a tap, as  parasites could get onto your lens and into your eye.’

Not changing contact lenses when you’re  supposed to is another problem.

But by far the biggest culprit for infections  is not replacing your lens case every month.

Over time, cracks in the case can form in  which micro-organisms can thrive.

Mr Hossain warns that young people are  leaving themselves particularly vulnerable to infections.

‘They tend to be quite relaxed when it comes  to the hygiene standards required for wearing contact lenses and that’s  reflected in the number of people under 50 being treated for severe cases of  corneal infection, with an average age of 30.

‘This, coupled with an explosion of cheap  online stores, means the consequences can be grim,’ he explains.

‘An audit we performed at Southampton  discovered a number of patients presenting to eye casualty had bought  online.’

Keith Tempany, of the British Contact Lens  Association, agrees.

‘There is little policing of buying lenses on  the internet.

‘Australian research has found you’re five  times more likely to get an infection buying this way, as there are fewer  reminders about good lens hygiene.

‘When you have a check-up at the opticians  they can assess the health of your eyes, ensure you’re changing the case  regularly and that you have the right type of lens for your  lifestyle.

‘For example, if you do a lot of water sports  then orthokeratology is a good option.

‘This is where lenses are worn at night and  gently re-shape the cornea to correct myopia (shortsight).’

For Jennie, such advice is too late.

In the past year she has undergone six  operations to try to remove the parasite — and is still having treatment to try  to regain some vision in the damaged eye.

She is gradually adjusting to her limited  sight.

‘I misjudge slopes and uneven pavements are a  nightmare.

‘In crowds I’ve accepted I’ll walk into  people, as I just don’t see them.

‘The good news is I’m driving again so life  is slowly returning to normal.

‘But I consider myself lucky that only one  eye was affected.

‘I’d urge contact lens wearers to be  extremely careful — I never imagined this could happen from a quick  swim.’

Jennie  is fundraising for research into eye conditions: Justgiving.com/see-the-light.  For contact lens advice visit http://www.bcla.org.uk.

Read more: http://www.dailymail.co.uk/health/article-2191190/I-swam-contact-lenses–Im-blind-eye.html#ixzz249B1THOV

Drugs companies ‘are putting profits ahead of medical discoveries’, claims hard-hitting report

  • For every £1 spent on basic research a  whopping £19 is spent on marketing, claim experts

  • Current reward system discourages  innovation, they add

PUBLISHED:10:13 EST, 8  August 2012| UPDATED:11:08 EST, 8 August 2012

Read more: http://www.dailymail.co.uk/health/article-2185437/Drugs-companies-putting-profits-ahead-medical-discoveries.html#ixzz23E8u5ocy

The pharmaceutical industry is in crisis  because companies are rewarded for developing new drugs that have few clinical  advantages over existing ones, experts say.

Writing in the British Medical  Journal, Professor Donald Light from the  University of Medicine and Dentistry of New Jersey and Joel Lexchin from York  University in Toronto, say this has discouraged innovation for the past five  decades.

They pointed to independent reviews that  found between 85 and 90 per cent of all new drugs developed over the past 50  years have provided few benefits and considerable harms.

Has the pharmaceutical industry lost its way? Professor Light and Mr Lexchin say profits have been given priority over innovationHas the pharmaceutical industry lost its way? Professor  Light and Mr Lexchin say profits have been given priority over  innovation

They said most  research funds don’t go  towards finding breakthrough drugs but towards developing scores of minor  variations that  produce a steady stream of profits. Heavy promotion of these  drugs can  account for up to 80% of a nation’s drug spending, they add.

The duo warn  that companies exaggerate research and development costs to lobby for more  protection from free market competition. Yet, according to an independent  analysis, the 1.3 per cent of revenues devoted to discovering new molecules  compares with an estimated 25 per cent spent on promotion.

This means for every £1 spent on basic  research a whopping £19 is spent on marketing.

Professor Light and Mr Lexchin said urgent  changes needed to be made to make the industry focus on more cost effective and  safer medicines.

They said the first step should be to stop  approving so many new drugs of little therapeutic value.

‘EU countries are paying billions more than  necessary for drugs that provide little health gain because prices are not being  set to reward new drugs in proportion to their clinical value,’ they  say.

 They also believe that regulators should be  publicly funded and that new ways of rewarding innovation should be considered.

‘This approach would save countries billions  in healthcare costs and produce real gains for people’s health’, they  conclude.

In a second paper, researchers from the  London School of Economics said drug manufacturers should be made to demonstrate  that  their products are superior to existing treatments.

However, Stephen Whitehead, chief executive  of the Association of the British Pharmaceutical Industry, said: ‘We strongly  disagree with the claims made in these papers.

‘Medical research has always rested on  iterative and gradual innovation rather than breakthrough advances which are  very rare. If it were not for the incremental improvements made in the treatment  of HIV, the disease would still be terminal rather than a manageable long term  condition.

‘The pharmaceutical industry’s medicines  pipeline is promising with many new treatments in development. But the discovery  of medicines is an increasingly difficult process as the cost of research and  development continues to rise and regulation becomes more onerous. In 2012, it  costs on average over £1 billion to develop a new medicine and takes between 12  and 15 years to develop

Read more: http://www.dailymail.co.uk/health/article-2185437/Drugs-companies-putting-profits-ahead-medical-discoveries.html#ixzz23E8fr0cN

US cancer body oversells mammograms: experts

AFP 2 Aug 2012

Medical experts on Friday accused a major US breast cancer foundation known for its high-profile “pink ribbon” campaign of overselling pre-emptive mammography and understating the risks.

The Susan G. Komen for the Cure foundation uses misleading statistics in its pro-screening campaigns, two doctors from The Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire wrote in the BMJ medical journal.

“Unfortunately, there is a big mismatch between the strength of evidence in support of screening and the strength of Komen’s advocacy for it,” professors Steven Woloshin and Lisa Schwartz wrote.

They take issue with a Komen poster comparing the 98-percent five-year survival rate for breast cancer when caught early, with a of 23-percent rate for later diagnosis.

Comparing the two figures did not tell you anything about the benefits of screening, they argued, and in reality a mammogram only narrowly decreases the chances that a 50-year-old woman will die from breast cancer within 10 years from 0.53 percent to 0.46 percent.

Breast cancer treatments are more effective today, and some question whether screening mammography has any benefit whatsoever, wrote the pair.

They accused Komen of overlooking the potential harms, with up to half of women screened annually over 10 years experiencing at least one false alarm that requires a biopsy.

Screening also results in overdiagnosis — detecting cancers that would never have killed or even caused symptoms in a person’s lifetime, and unnecessary treatment.

“The Komen advertisement campaign failed to provide the facts,” said the piece. “Worse, it undermined decision making by misusing statistics to generate false hope about the benefit of mammography screening.”

In 2010, a report in the New England Journal of Medicine said mammograms have only a “modest” impact on reducing breast cancer deaths.

Komen, in a response to the BMJ comment, insisted that early detection enables early treatment, which gives the best shot at survival.

“Everyone agrees that mammography isn’t perfect, but it’s the best widely available detection tool that we have today,” said Chandini Portteus, the foundation’s vice president of research, evaluation and scientific programmes.

“We’ve said for years that science has to do better, which is why Komen is putting millions of dollars into research to detect breast cancer before symptoms start, through biomarkers, for example.”

In February, Komen was embroiled in a controversy over its decision to stop funding for an abortion clinic group in the United States.

New study supports claim that breast screening may be causing more harm than good

Requested Repost from Dec 2011

Research: Possible net harms of breast cancer screening: Updated modelling of Forrest report

A new study published on bmj.com today supports the claim that the introduction of breast cancer screening in the UK may have caused more harm than good.

Harms included false positives (abnormal results that turn out to be normal) and overtreatment (treatment of harmless cancers that would never have caused symptoms or death during a patient’s lifetime). This may be because the cancer grows so slowly that the patient dies of other causes before it produces symptoms, or the cancer remains dormant or regresses.

It shows that the harms of screening largely offset the benefits up to 10 years, after which the benefits accumulate, but by much less than predicted when screening was first started.

The Forrest report in 1986, which led to the introduction of breast cancer screening in the UK, estimated the number of screened and unscreened women surviving each year over a 15-year period.  Costs and benefits were measured in quality adjusted life years or QALYs (a combined measure of quantity and quality of life) but it omitted harms.

It suggested that screening would reduce the death rate from breast cancer by almost one third with few harms and at low cost.

Since the Forrest report, the harms of breast cancer screening have been acknowledged. So, researchers at the University of Southampton set out to update the report’s survival estimates by combining the benefits and harms of screening in one single measure.

The results are based on 100,000 women aged 50 and over surviving by year up to 20 years after entry to the screening programme.

Inclusion of false positives and unnecessary surgery reduced the benefits of screening by about half. The best estimates generated negative net QALYs for up to eight years after screening and minimal gains after 10 years.

After 20 years, net QALYs accumulate, but by much less than predicted by the Forrest report.

The authors say more research is needed on the extent of unnecessary treatment and its impact on quality of life. They also call for improved ways of identifying those most likely to benefit from surgery and for measuring the levels and duration of the harms from surgery. From a public perspective, the meaning and implications of overdiagnosis and overtreatment need to be much better explained and communicated to any woman considering screening, they add.

However, the continuing uncertainty surrounding the extent of overtreatment is apparent in a study of French women published on bmj.com last month, which put overdiagnosis of invasive breast cancer due to screening at around 1%.

###

Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

2 years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today

Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today.

A new report by the Cochrane Collaboration says Roche’s refusal to provide full access to all its data leaves critical questions about how well the drug works unresolved.

A BMJ investigation, published to coincide with today’s report, also raises serious concerns about access to drug data, the use of ghost writers in drug trials, and the drug approval process.

Meanwhile, Tamiflu has become the mainstay of influenza treatment in the UK. It has also made it onto the World Health Organisation’s list of Essential Medicines and Roche’s claims continue to be supported by influential health agencies.

The Cochrane researchers set out to test Roche’s claim that Tamiflu prevented complications and reduced the number of people needing hospital treatment. But their investigation was hampered by Roche’s refusal to provide all of its trial data for analysis. The team obtained some clinical study reports from the European Medicines Agency (EMA), but found inconsistencies with published reports and possible under-reporting of side effects.

When previously questioned by the BMJ, Roche also admitted that some of the published papers had been ghost written.

The BMJ investigation reveals how different regulators took different approaches to the data submitted to them, leading to conflicting messages about it effectiveness.

For example, the EMA released a proportion of the clinical study reports relating to the Tamiflu trials to Cochrane, but it admits that it did not ask for the remainder from the manufacturer, although it was legally entitled to do so. The EMA has since told the BMJ that it plans to start publishing reports for all drugs submitted for approval in the next few years.

Dr Fiona Godlee, BMJ Editor-in-Chief says: “We hope very much that the EMA will indeed take this important step in making the full study reports available. But we are still a long way away from having a full trial history for all drugs in clinical use. Public safety and the proper use of public money demands that we should stop at nothing less than this.”

Meanwhile, the US Food and Drug Administration (FDA), which has reviewed the Tamiflu trial programme in perhaps more detail than anyone outside of Roche, chose not to review the largest ever trial of Tamiflu when considering the drug for approval. It states that “Tamiflu has not been shown to prevent such complications [serious bacterial infections].”

However, the US Centers for Disease Control and Prevention (CDC) continue to cite key published trials of Tamiflu, claiming a reduced risk of influenza complications, even after Roche admitted that some of these trials have been ghost written.

Dr Godlee says: “The discrepancies between the conclusions reached by different regulators around the world highlights the absurd situation we find ourselves in. In a globalised world, regulators should cooperate and pool their limited resources. Otherwise we will continue to waste money and risk people’s health on drugs that don’t work.”

The investigation also raises questions about Tamiflu’s clinical effects. After careful evaluation of trial data, the Cochrane group say that Tamiflu appears to affect antibody production – a claim that Roche refutes. This is important, say Cochrane, because influenza vaccination relies on an antibody response to be effective. But when asked by the BMJ, Roche refused to explain how the drug works.

As such, the Cochrane group say that “until more is known about the mode of action of neuraminidase inhibitors, health professionals, patients and other decision makers need to reflect on the findings of this review before making any decision about the use of the drug.”

Cochrane also argue that Tamiflu’s ability to prevent the spread of influenza has not been demonstrated in trials. Yet this is one of the main reasons governments around the world have spent billions of dollars stockpiling Tamiflu in case of a pandemic.

Roche maintain they provided the Cochrane team with enough information to conduct their evaluation, but the Cochrane team say this is not the case. Dr Peter Doshi from Johns Hopkins University School of Medicine says: “In the BMJ in December 2009, Roche promised full study reports to any legitimate investigators.  They have not provided a single full study report to Cochrane, despite our repeated requests.”

Overdiagnosis poses significant threat to human health

International conference: Preventing Overdiagnosis

Overdiagnosis poses a significant threat to human health by labeling healthy people as sick and wasting resources on unnecessary care, warns Ray Moynihan, Senior Research Fellow at Bond University in Australia, in a feature published on bmj.com today.

The feature comes as an international conference ‘Preventing Overdiagnosis’ is announced for Sept. 10-12, 2013, in the United States, hosted by The Dartmouth Institute for Health Policy and Clinical Practice, in partnership with the BMJ, the leading consumer organization Consumer Reports and Bond University, Australia.

The conference is timely, says Moynihan because “as evidence mounts that we’re harming the healthy, concern about overdiagnosis is giving way to concerted action on how to prevent it.”

“The Dartmouth Institute for Health Policy and Clinical Practice has long been a leader in understanding and communicating the problems of overdiagnosis,” say Drs. Steven Woloshin and Lisa Schwartz, professors of medicine at The Dartmouth Institute for Health Policy and Clinical Practice. “We are extremely excited to host this international conference to advance the science and develop concrete proposals to reduce overdiagnosis and its associated harms.”

Overdiagnosis occurs when people are diagnosed and treated for conditions that will never cause them harm and there’s growing evidence that this occurs for a wide range of conditions.

For example, a large Canadian study finds that almost a third of people diagnosed with asthma may not have the condition; a systematic review suggests up to one in three breast cancers detected through screenings may be overdiagnosed; and some researchers argue osteoporosis treatments may do more harm than good for women at very low risk of future fracture.

Many factors are driving overdiagnosis, including commercial and professional vested interests, legal incentives and cultural issues, say Moynihan and co-authors, Professors Jenny Doust and David Henry. Ever-more sensitive tests are detecting tiny “abnormalities” that will never progress, while widening disease definitions and lowering treatment thresholds mean people at ever lower risks receive permanent medical labels and life-long therapies that will fail to benefit many of them.

Added to this, is the cost of wasted resources that could be better used to prevent and treat genuine illness.

But Moynihan argues that the main problem of overdiagnosis lies in a strong cultural belief in early detection, fed by deep faith in medical technology. “Increasingly we’ve come to regard simply being ‘at risk’ of future disease as being a disease in its own right,” he says.

“It took many years for doctors to accept that bacteria caused peptic ulcers,” says co-author of the BMJ feature, Dr. David Henry, chief executive officer of the Institute for Clinical Evaluative Sciences, and professor in the Department of Medicine at the University of Toronto, Canada. “Likewise, it will be hard for doctors and the public to recognize that the earliest detection of disease is not always in the best interests of patients.”

So what can we do about overdiagnosis?