Healthy Skepticism Library item: 14925

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Not What We Call Due Diligence
The New York Times 2009 Jan 13
http://www.nytimes.com/2009/01/13/opinion/13tue2.html?_r=1

Full text:

Despite rising concern that conflicts of interest may bias the outcome of clinical trials, the Food and Drug Administration has distressingly limited interest in rooting out the problem.

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 makers of drugs or medical devices are required to obtain financial information from the scientists conducting clinical trials before the trials start, consult with the F.D.A. to resolve serious conflicts and submit all the financial information to the F.D.A. when they apply for marketing approval after the trials end. The agency is supposed to evaluate whether any conflicts that are uncovered undermine the reliability of the trial data, and if so, how tainted data should be handled.

The inspector general found that fewer than 1 percent of the doctors who helped oversee clinical trials reported any financial conflicts – such as consulting payments, honoraria, grants, patents or stock options – that might influence their studies. That number seems unbelievably low given credible estimates that one-fifth to one-third of all doctors have such conflicts.

In 42 percent of the approved marketing applications, the agency did not receive all the required financial information, mostly because the sponsoring companies took advantage of a loophole that allowed them to say they had tried with due diligence to get the information from clinical investigators but were unable to. Even when the doctors did report significant conflicts to the companies, in 20 percent of the cases neither the F.D.A. nor the companies took action to minimize potential bias.

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.

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.