Saturday, November 25, 2006

Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine

The latest issue of the New England Journal of Medicine includes an article about Bayer's attempted suppression of data from an observational study of Trasylol (aprotinin). [Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med 2006; 355: 2169-2171] We had first blogged about this case, based on a story reported in September, 2006 in the New York Times, here. Avorn's comments on the case are notable:

The health care system has a hard time performing drug-safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them, and despite the $220 billion we spend on drugs each year, we apparently can't find the resources to provide public support for these studies, even if the results could be of great clinical importance and save millions of dollars.

Avorn suggested:

A good start would be to make a national commitment to publicly supported studies of drug risks so that no company could take possession of critical findings for its own purposes. The results of that research could be discussed openly at an annual conference on the risks and benefits of drugs.

In my humble opinion, it does not make sense to let pharmaceutical (and bio-technology and device) companies be responsible for performing relatively unmonitored studies on human subjects to test their own products. One solution would be to put scientists, physicians, and organizations who are not beholden to such companies in charge of such studies. Another would be much more intense regulation of any human studies sponsored by commercial firms.

At least this issue has now come out in the perhaps world's most prestigious medical journal, so it is squarely in front of doctors, other health professionals, and health policy makers.

But I now realize that Avorn's article, and, for that matter, my previous post, both seemed to avoid the issue of accountability of the drug, bio-tech, and device companies who are currently performing (or funding, and then at least partically controlling) studies on humans. So let me correct that omission.

Also in my humble opinion, as long as commercial firms (e.g., pharma, bio-tech, or device) sponsor, and to any extent control studies on human beings, these firms should be held accountable for any failure to disseminate study findings, even if, and maybe especially if the findings are not favorable to their product. Because their products affect peoples' health and safety, suppressing data about their products' adverse effects, or failure to provide beneficial effects is an affront to any patient who might take or be subject to such products. There should be severe negative consequences for any company that withholds such findings.

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