… “The whole thing is profit driven,” says Michael Carome at Public Citizen, a consumer advocacy organization in Washington, D.C. “You can see where corners might be cut, looking the other way when there might be concerns about an investigator.” 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.
But it’s more than simply the nomenclature and regulations that come from these academic traditions. The ersatz authors are usually listed with their academic rank and university affiliations as if either have much to do with the initiation or conduct of the studies themselves, other that as perhaps a locus for recruitment and administration [if even that]. More bizarre, in many cases, the authors don’t come into the picture in a substantive way until the final revision process. The fact that the trial was conducted by a contracted commercial enterprise, analyzed by the industrial sponsor, and written by a ghost is rarely apparent on reading the article. Likewise, the appearance of the published articles on Clinical Trials in peer-reviewed professional journals lends a further aura of academic legitimacy – rarely earned in the case of Clinical Trials. The bizarre CV’s of these authors listing hundreds of publications is no more significant than the body counts that we read about during the Viet Nam War – falsely inflated indices disembodied from their true meanings – more sales pitch than honorific.
Many of our best and brightest scientists occupy themselves these days poring over the published scientific articles of others looking for evidence of illusion – the use of scientific and statistical methodology to either enhance weak signals or misrepresent negative findings. Others, like the Cochrane Collaboration, sift through the assembled literature hoping to find the studies with enough scientific rigor to be taken seriously. This has indeed become an age of meta·analysis – porting the application of critical science from the studies themselves to a later re·analyses of a group of studies, a laudable goal but one with an unfortunate built-in lag time – a science of science once removed. Likewise, the traditional scientific debate of letters to the editor or rapid responses [BMJ] require a vigilance not practiced by the majority of clinicians. So the counter to the scientific distortions in clinical trial reporting becomes a low hum overwhelmed by the music in the foreground.
In pointing out the dark under-belly of Clinical Trials, Elliot and Aldhous aren’t just talking about a piece of the Clinical Trial world that has to do with discredited doctors and the exploitation of homeless people – something to excise. They’re talking about only the most visible symptoms of a sick system – publicly modeled on academic medical science of yore in form but not substance. Many of these trials and the publications they’ve generated give only the illusion of evidence worth attending to – a sham exercise of the scientific method. Speaking of illusions, it is unlikely that regulations per se will ever fix the problems so long as the current levels of conflict of interest remain in the system. The biggest illusion of all may well be that conflicts of interest are relative, or that they can be regulated. Almost by definition, they can either be allowed to continue to dominate this scene or be eliminated…