CLINICAL TRIALS: Under Watchful Eye of HHS Inspector Gen.
Prompted by recent newspaper reports of clinical trials "fraught with conflicts of interest," HHS Inspector General June Gibbs Brown has launched two separate inquiries into whether investigators are complying with required patients' safeguards, the New York Times reports. HHS is working to keep pace with a "pharmaceutical renaissance" that has changed the clinical trials system from one in which trials were conducted by professional researchers to one where "hundreds of testing and drug companies wor[k] with thousands of private doctors who mine their patient lists for test subjects." The inspector general's office said it will examine doctors' participant recruitment practices, with an eye out for conflicts of interest and financial incentives in an attempt to identity "practices that appear questionable." To that end, the HHS office will visit three investigative sites and will accompany the FDA on reviews of both investigators and ethics boards, which give the green light for trials on human subjects. The second inquiry will determine whether there is sufficient oversight of clinical researchers who are subject to FDA regulation. Specifically, the officials will determine whether the FDA's authority to bar investigators who fail to follow procedure "is being used in a way that properly protects participants."
California Case Study
A series of New York Times articles in May profiled Dr. Robert Fiddes of California, whose research center was involved for years in undetected research fraud before an insider came forward. Even then, Fiddes was not disqualified by the FDA until he was in prison for fraud. The House Commerce Committee immediately held a hearing on the FDA's slow response to the Fiddes case and surveyed other federal health agencies involved in oversight or regulation of clinical reviews. The committee recently contacted Gibbs Brown regarding the two inquiries, asking that the findings be shared with Congress (Eichenwald, 7/14).