FDA Routinely Ignores Financial Conflicts of Interest in Clinical Trials Relied on to Approve Drugs
By Mike Adams, January 13, 2009 | Key concepts: FDA, Conflicts of interest and Clinical trials
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The FDA claims it sets the "gold standard" of scientific integrity in approving drugs, but in reality, the agency utterly fails to address the issue of financial conflicts of interests in clinical trials, it turns out.
That's the conclusion from the Inspector General of the Department of Health and Human Services (HHS). As the NY Times reported, the following disturbing facts have emerged from this HHS investigation:
• In a whopping 42 percent of clinical trials used by the FDA to approve drugs and medical devices, the agency received no financial conflicts disclosure forms whatsoever. Furthermore, the FDA did nothing to address this problem. It simply allowed the lapses in disclosure to continue.
• Out of the 58 percent of clinical trials in which the FDA did receive financial disclosure information, the FDA didn't even look at nearly one-third of the financial disclosure reforms, the inspector general says. (In other words, the FDA is filing the financial disclosure forms in the "round file.")
• When doctors and researchers admitted serious conflicts of interest on the disclosure forms, the FDA did absolutely nothing to deal with the conflicts in 20 percent of the cases.
• The NYT interviewed an FDA spokesperson who admitted on the record that the FDA does not review doctors' conflicts of interest in drug trials because, they say, the conflicts are not a sufficient source of bias to disqualify those researchers.
• The NYT also reports that from 20 to 33 percent of all doctors who oversee clinical trials have financial conflicts of interest.
• The FDA believes that collecting and reviewing financial disclosure information from doctors overseeing clinical trials is "not worth the effort" and really has no commitment to the process.
The upshot of all this is that the FDA is utterly failing to investigate and act on conflicts of interest in the clinical trials it relies on to approve prescription medications.
No wonder so many dangerous, deadly drugs manage to get through the FDA approval process.
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