Monday, August 18, 2014

Research on Pharmaceuticals: From Confidence to Commercialism

The main thrust of this commentary comes from Dr. Roy Poses and:
--which in turn draws on two prior posts:

A little background: HOOKED described a major shift in pharmaceutical research. Initially, the vast majority of drug trials were conducted by universities. Over the past 30 years, companies found that universities were too slow in doing this research for maximum financial gains, and so gradually, contract research organizations replaced universities as the major players. Dr. Carl Elliott (first of two prior posts) has been one of the major writers about the fallout from these policies.

Dr. Elliott describes in some detail a group of subjects who can be found in typical contract research organizations, who talk openly about their ways of qualifying for research trials, and also of dodging the painful and burdensome procedures that typically form a part of some trials. It seems quite clear that the money, and not any goal of contributing to science, is the main and indeed the sole motivator. Dr. Elliott had previously described this "guinea pigging" in earlier published work.

The second prior post, by Peter Aldhous, describes some of the physicians who run the contract studies, and focuses on those who have been censured and who have various licensure problems. Aldhous admits that these misfits count as a minority of all the doctors running the contract research organizations, but adds, "My trawl netted dozens of doctors selected to work on clinical trials over the past five years who had previously been censured by state medical boards. Thousands of doctors are hired each year to test experimental drugs, making this a small minority. But most doctors have clean records, so companies should have few problems finding recruits without red flags against their name."

Aldhous concludes, "Some experts argue that the FDA’s entire rulebook for clinical trials, with its talk of things like 'institutional' review boards, reflects the academic past of clinical research—not today’s industrial juggernaut of for-profit clinical trials firms and for-hire review boards, which oversee a workforce of doctors drawn from regular medical practice. 'They are regulations for a world that doesn’t exist anymore,' says Elizabeth Woeckner, president of Citizens for Responsible Care and Research, which campaigns for the safety of medical research volunteers."

Dr. Poses then notes: "So given the push to do research rapidly at the lowest cost, the lack of supervision and regulation by the FDA, the hiring of physicians with problematic backgrounds, the willingness to take vulnerable patients desperately motivated by money, can we trust that the nice, clean, detailed descriptions of clinical trials implemented by contract research organizations presented in research articles and trial registries have anything to do with the reality of what went on? If not, what then should we make of the validity of the results of such trials?...This is yet another reason to ask whether we need to take research on human subjects meant to evaluate commercial products or services out of the hands of the companies that make those products and provide those services."

In other words, bait and switch. Get everyone used to research on human subjects while research institutions are running the shop and people who sign up as subjects have at least some motivation to behave in the interests of science. Then gradually change the system so that it's all about money and one can no longer trust the results. The money affects different players in different ways-- the companies and the CROs have their financial motives, the "guinea pigs" have theirs--but the one thing we can count on is that the money plays a role that's different from the ideal of scientific research. The end result is that things look legitimate up front, and all the people involved have strong motives to do what's less legitimate behind the scenes. We have no idea how that plays out in terms of scientific rigor.

And this is now how drugs are tested before we use them.

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