Relative to FDA oversight of clinical trial investigator conflict of interest, the New York Time opines:
"The inspector general of the Department of Health and Human Services reviewed all 118 applications for marketing drugs and medical devices that were approved by the F.D.A. in fiscal year 2007. It found appalling failures to collect information and act on it ...The inspector general made several suggestions, including stressing that the due diligence exemption should be used rarely. The agency accepted most, but it strongly opposed a recommendation that it require companies to submit financial conflict information before a clinical trial is started, not after it is completed. The F.D.A. complained that that would increase its workload for no clear gain, especially since many drugs or devices that enter clinical trials never reach the market ... Such bureaucratic excuses seem lame. Surely it would be better for the F.D.A. to eliminate potential conflicts before they can bias a trial than try to mitigate them after the results are in."
Absolutely. Transparency. Transparency. Transparency. The agency's lack of funding (and ensuing lack of manpower to accomplish the task in a thorough and timely manner) must be remedied. Editorializing about the problem is important -- doing so about the solution, even more so. Want the problem fixed? Show me the money! Otherwise it's just rhetoric.
The Times continues:
"The agency’s lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank. That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the F.D.A."
Not so fast. Beyond the obvious fact that such a database would help nobody other than trial lawyers, a more dire unintended consequence would be the unfair stigmatization of doctors and scientists who participate in clinical trials sponsored by pharmaceutical companies. Fearful of jeopardizing their reputations, this could motivate many to leave clinical trial research altogether -- making trials more difficult tand more expensive to field in the first place. And this outcome is most definitely not in the best interests of the public health.
Let's do the right thing -- but not get carried away.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
