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By wzambon
April 17, 2008

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JAMA and other medical journals are in a battle for their own credibility. The tempo of the battle has increased in the last decade as pharmaceuticals increasingly dominate the research landscape and egregious violations of ethical standards in research involving human subjects continue to mount...

-Comprising the objectivity of the researchers themselves by huge payouts to the primary investigators.

-Suppression of study results that do not support foregone "conclusions."

-Increasing use of human subjects in the developing world without consent or knowledge of the subjects.

-Proceeding with study protocols without proper authorization by an Institutional Review Board.

-Proceeding with study protocols when the known risk/benefit ratio is out of kilter with the unstated purpose of the protocol..... which often has nothing to do with researching a new drug- but simply to buttress an advertising claim concerning a specific drug by comparing it to a competitor's drug that does the same thing... particularly prevalent in areas where no standard of care is agreed upon... adolescent depression, for instance, where subjects are usually taken off their prescribed meds and put on "study" drug, which has a randomized chance of being a placebo.

Increased financial renumeration to study subjects, which is baldly proclaimed as "payment" rather than "renumeration for time lost"... creating a pool of "study subjects" for whom volunteering for drug protocols becomes a supplemental source of income. Until recently, this practice was seen as "coercive" and in violation of both the Nuremberg Protocols and Belmont Report that gave rise to federally mandated Institutional Review Boards to oversee the protection of human research subjects in medical studies.

Twenty five years ago, the majority of medical research was funded by the NIH and university sources. Now, the vast majority are funded by pharmaceuticals- whose interest is not in subject safety except as they can skirt the law without being caught.

The FDA, under pressure from well funded big pharma, has pursued a policy of increased laxness and regulatory easing over the last eight years.

After Tuskegee, the seriousness with which the feds and research institutions took their responsibility to "do no harm" increased remarkably, and for over a decade- from the early nineties to early 2000's, I was proud to serve on an Institutional Review Board that oversaw the protection of human research subjects in a major medical research facility, but the fix seemed increasingly "in". About a year after I left, both of the chairs of the IRB resigned in protest over the ethical lapses that they saw were so big that a truck could be driven through them.

I spoke with one of them two years ago, and he privately said: "Pharma funding has become a huge source of income for medical institutions. And it's increasingly evident that medical institutions are no longer interested in holding the safety of research subjects as a primary concern."

I wouldn't sign a consent form to participate in medical research.... if my life depended on it, because it may very well.

So now, an unexpected ally in the fight to protect human research subjects has appeared, as this thread makes evident: the medical journals who are tightening up their editorial policies in an effort to screen out study results that rest upon egregious violations of scientific methodology and the rights of human research subjects.

May their tribe increase.

Unfortunately, the JAMAS and the Lancets of the world do not get a hold of the matter until the horse is well out of the barn and already processed at the glue factory.

Bill Z