The plan, news of which had emerged earlier this week, represents a major policy shift by influential gatekeepers in the medical profession as they seek to increase the distribution and accuracy of research data. Too often, experts contend, medical studies with dramatic findings are highlighted as breakthroughs, while inconclusive or negative tests of the same treatment are ignored or undisclosed.
‘Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavorably on a research sponsor’s product,’ the editors of the 12 publications stated in a group editorial that was released yesterday and will appear in the next issues of the individual journals. ‘Unfortunately, selective reporting does occur and it distorts the body of evidence available for clinical decision-making.’
The group, which calls itself the International Committee of Medical Journal Editors, includes such high-profile publications as The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and Annals of Internal Medicine.” (New York Times)
I join those in applauding this as an important first step toward full disclosure in clinical drug research. Anyone who is an intelligent consumer of medical research studies has no confidence in the body of literature. Biases in favor of publishing positive findings arise both from the simple fact that a positive finding is more ‘sexy’ to report and from the increasingly, and depressingly, consistent reliance for research funding on precisely those pharmaceutical companies with a stake in the outcome. Publishing preponderantly positive findings skews medical practice toward newer and newer (and more and more expensive) medications, of course. Several sorts of studies tend never to make it to the light of day. There are those which say that a particular treatment did not show benefits significantly different than placebo. Other studies show that a new medication is no better than the old standard reference medication against which it is being compared. And a third sort of study will show that adverse effects emerged, or a medication was not tolerated well enough, often enough that patients would not stick with it to derive therapeutic gains. When these studies are not published, the adverse reactions they describe, of obvious importance for a physician to know, are from that point potentially dead and buried forever.
The impact of this reform on the evidentiary basis for medical practice will depend on whether it is adopted far more widely than by just a handful of, admittedly influential, journals. (I see none of the preeminent journals in which psychiatric medication findings are published on the list, for one thing.) Of course, since the proportion of physicians who keep up with their field of practice by actually reading the refereed journals is so small and continues to decline, the pharmaceutical representatives’ ‘detail’ visits and the drug-company-sponsored dinner talks and junkets from which many physicians learn about new medications will be free to continue to spin the merits of their latest and greatest breakthrough drug with no pretense of being fair and balanced. Even among those consumers of the medical literature, we will have to face the inherent cognitive bias toward remembering and being influenced by positive findings as well.
Critics of the reform plan are asking for government regulations requiring this sort of registration database for clinical trials, rather than a voluntary system initiated by a fragment of the medical publications. A more profound step would be to get the pharmaceutical industry out of the role of funding the preponderance of drug studies and returning to the old system of government-funded research. Or perhaps pharmaceutical companies should pool their research funds and endow a foundation to give out grants rather than each doing it individually. It is hard to see what incentive the industry would have to do so and forego both the PR value of their research funding and the potential influence over the findings unless, again, there is some government mandate. This impetus for reform may well be the silver lining in the midst of the cloud of the furor about SSRIs and suicidality among adolescents and children, about which FmH readers doubtless know my position.
