Where Have All the Studies Gone?

With all the attention on Vytorin and Xetia’s unfortunate research results this week, the media is (for the moment anyway) hot on the trail of Big Pharma’s indiscretions. The latest dirt highlights the industry’s so-called “file drawer” treatment of negative drug research findings. The New England Journal of Medicine report focuses on the publication (or lack thereof) of antidepressant drug studies, but it’s clear these selective practices are commonplace.

Take a look:

Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday. In some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University. Even if not deliberate, this can be bad news for patients, they wrote in their report, published in the New England Journal of Medicine. ‘Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health,’ they wrote.

via Yahoo News

As cynical as I am about Big Pharma’s doings, I acknowledge that medical research isn’t always a perfectly clear cut process. Research with humans, in particular, is especially difficult to tightly control, and there are sometimes unknown factors that cloud findings. Researchers can only limit variables they are aware of. Ten years ago, for example, we didn’t know as much about the role of inflammation in heart disease, and researchers wouldn’t have checked for it in targeting or assessing their samples.

This report, however, exposes the insidious side that exists in research, particularly when there’s profit to be had. Industry spokespeople were quick to deflect blame, saying they are “committed” to disclosing results but “negative” outcomes aren’t chosen for publication by medical journals as often as positive results. Others, including a representative from Pfizer, said that all findings are reported on the Internet.

The fact is, I’d bet my bottom dollar that these companies don’t spend a fraction of the time and energy informing doctors of unflattering study results as they do courting them with their latest concoctions. It’s clear where the industry’s “commitment” is.

Last week I brought you news that Big Pharma was spending twice the amount on advertising in the U.S. as it was on research and development. This week’s Vytorin/Xetia outrage highlighted the comparative drug costs: these drugs cost more than three times the amount of their now generic statin predecessors, drugs that (according to the purposefully delayed study results) did the assigned job better than the slick new products. The insane greed boggles the mind.

There are a host of losers in this game – many with huge economic stakes. But the biggest stake of all is the life, the health of patients, patients who can’t get the appropriate care and advice because their doctors are just as blind (although with distinct advantages and, I would argue, much more responsibility). It’s a wretched fix we’re all in.

The industry, the medical community, conventional medical practices and assumptions, government, insurance companies, consumer buy in: where do we begin? Give me your answers, your rants, your reactions.

Bethany L King Flickr Photo (CC)

Further Reading:

Vytorin: Big Blow for Big Pharma

The Almighty Power of the Pill

Pharmalot: Clinical Trials Exaggerate Antidepressant Benefits

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About the Author

Mark Sisson is the founder of Mark’s Daily Apple, godfather to the Primal food and lifestyle movement, and the New York Times bestselling author of The Keto Reset Diet. His latest book is Keto for Life, where he discusses how he combines the keto diet with a Primal lifestyle for optimal health and longevity. Mark is the author of numerous other books as well, including The Primal Blueprint, which was credited with turbocharging the growth of the primal/paleo movement back in 2009. After spending three decades researching and educating folks on why food is the key component to achieving and maintaining optimal wellness, Mark launched Primal Kitchen, a real-food company that creates Primal/paleo, keto, and Whole30-friendly kitchen staples.

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