The Dangers of Selective Science - NewsGrabs 27 April 2008

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NewsGrabs

Health Supreme's NewsGrabs - a selection of contrary and underprivileged news in health and a wide range of (mostly) related sectors. Find what trends you may have missed - watch out for the weekly News Grabs.

The controversy over yet another "meta analysis" that allegedly found antioxidants don't prevent people from dying, was in full swing this week. A famous quip comes to mind: "There are lies, there are damned lies and then there are statistics". Apparently, anything can be manipulated using statistical analysis. The outcome of course depends what you put in in the first place. Garbage in, garbage out, it used to be called.

An observation I just made and sent to a few friends:

After saying "no evidence to support antioxidant supplements for primary or secondary prevention" and "vitamin A, beta-carotene and vitamin E may increase mortality", the concluding sentence of the whole piece is

"Antioxidant supplements need to be considered medicinal products and should undergo sufficient evaluation before marketing."

(http://www.cochrane.org/reviews/en/ab007176.html)

That is really a policy statement, not something that should concern the authors of a scientific meta-analysis, unless ... unless of course they are working directly or indirectly for someone with a clear agenda. Someone who would like to push through world wide legislation to have vitamins considered medicines and reserve their production and sale as much as possible to pharmaceutical channels.

So maybe we should look for that connection...

The dangers of selective science
Looking at the details of the new analysis shows us that 67 randomised clinical trials were included, focussing on beta-carotene, vitamin A, vitamin C, vitamin E, and selenium supplements versus placebo. But amazingly, 748 trials were excluded for several reasons, including 405 trials that showed no mortality in the study groups. I attempted to contact the lead reviewer for his comments on why they had excluded 405 death-free trials, asking whether such an exclusion would skew results towards increased death statistics… I am still awaiting a reply.

Celebrities join industry experts in speaking out against alarmist vitamin story…
Some of Britain’s most popular celebrities have spoken out against this week’s alarmist and grossly misleading vitamin story, which wrongly questioned the safety of the antioxidant supplements...

Antioxidants and Cancer: Researcher admits she got it wrong
But the researchers, led by Isabelle Bairati from the Quebec Research Centre, who published the 2005 study, have re-analysed their original data, and have discovered they got it wrong. The only people in the study who were seeing their cancer return were smokers who refused to kick the habit while they were receiving radiation therapy or chemotherapy. Strangely, not a single newspaper has run with the story.

Nutrition intervention trials in Linxian, China
Supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population
The findings indicate that vitamin and mineral supplementation of the diet of Linxian adults, particularly with the combination of beta carotene, vitamin E, and selenium, may effect a reduction in cancer risk in this population.

Study shows common vitamin and other micronutrient supplements reduce risks of TB recurrence
Nutritional assessment and support in tuberculosis therapy, once common before the advent of anti-TB drugs, is no longer an integral part of clinical therapy in most low-income countries even though poor nutrition impairs the immune system and leads to risk of further infection and relapse.

Villamor noted, "We found that providing micronutrients to patients with tuberculosis who were undergoing anti-TB treatment appeared to decrease the risk of recurrences. This effect was stronger in patients infected with HIV than in those who were HIV-negative. This could be relevant because TB reactivation is common among HIV-infected persons.”

Vitamin D necessary for proper brain function
“This critical analysis of vitamin D function and the brain is a model of careful thinking about nutrition and behavior”, says Gerald Weissmann, MD, Editor-in-Chief of the FASEB Journal “One wishes that all studies of nutritional supplements or requirements were this thoughtful. Drs. McCann and Ames deftly show that while vitamin D has an important role in the development and function of the brain, its exact effects on behavior remain unclear. Pointing to the need for further study, the authors argue for vitamin D supplementation in groups at risk.”

Vitamin D has long been known to promote healthy bones by regulating calcium levels in the body. Lack of sufficient vitamin D in very young children results in rickets, which can be easily prevented by vitamin D supplements. Only recently the scientific community has become aware of a much broader role for vitamin D. For example, we now know that, in addition to its role in maintaining bone health, vitamin D is involved in differentiation of tissues during development and in proper functioning of the immune system.

Treatment Of Statin Damage
It appears that Statins produce permanent damage and are far more risky. Possibly the only benefit statins provide is some reduction in inflammation but possibly at a irreversible cost. This is particularly sad given that low cost Turmeric may well be a safer if not more effective alternative than statins and aspirin to reduce inflammation. Indeed those who have used Turmeric in lieu of statins in this regard can attest to its striking efficacy....

FDA Set to Approve Ghost-Writing
All the major newspapers that circulate in the nation's capital (the New York Times, the Wall Street Journal, and the Washington Post) carried stories this morning about a new study in the Journal of the American Medical Association that showed about half of articles that appeared in the medical literature touting Vioxx had been ghost-written by employees or contractors working for Merck, the drug's manufacturer.

What none of those stories or the study mentioned was the regulatory context in which this study (and an accompanying one alleging Merck manipulated the data in one of those studies to hide the mortality risk among Alzheimer's patients who used the drug) appears. The Food and Drug Administration wants to give drug manufacturers like Merck a blank check to distribute to physicians nearly any article advocating off-label use of drugs that appears in the medical literature. The only substantive criteria in the proposed guidance is that the article be peer-reviewed and reflect "well-controlled" clinical studies.

Shareholders question Merck about credibility
Karen Clark of Spring Lake, a shareholder and former Merck employee, asked about recent media reports that Merck paid ghostwriters to prepare medical journal articles on withdrawn painkiller Vioxx.

A few shareholders raised other questions about Vioxx. Rennie Krayewsky, an economics professor at Essex County Community College, said the company should have pulled it off the market faster after problems surfaced.

Wyeth Acted In ‘Bad Faith’ In Prempro Case
A Nevada judge has ordered Wyeth to post a $58 million bond and pay $1.6 million in attorney fees for acting in ‘bad faith’ during settlement talks with lawyers for three women who sued the drugmaker over charges the Prempro hormone replacement treatment caused their breast cancer.

This is the same Wyeth that, with a Citizens' petition, induced the FDA to go after bio-identical hormones commonly used as a more natural alternative to their horse-urine based Prempro.

‘Lethal’ drugs given for dementia
The Alzheimer’s Society estimates that antipsychotic drugs are being prescribed to 105,000 elderly people with dementia in Britain, and that in two-thirds of cases the drugs are unnecessary. Studies show they can increase the risk of strokes and have other side effects, such as the disorder suffered by Ramsay.

According to his family, Ramsay was given Olanzapine in October 2001 without their knowledge. When he refused to take the drug his carers allegedly ground the pills into powder to put in his yoghurt.

Eli-Lilly, the manufacturer of Olanzapine, said the side effect suffered by Ramsay was “very rare” and the drug was neither licensed nor promoted in the UK to treat patients with dementia.

Involuntary drugging of US detainees, a crisis for the health professions
A major article in the Washington Post collects the accounts of US detainees who, in large numbers, report that they were the recipients of unknown psychotropic drugs.

While both the military and the Defense Department deny the reports, as the Post carefully notes, these reports are especially plausible as it is known that the CIA conducted a decades-long research program to develop truth serums and pharmacological approaches to manipulating human behavior. And, as discussed below, the CIA in 2003 was actively discussing the use of drugs in interrogations. Further, the recentl