F.D.A. Is Lax on Oversight During Trials, Inquiry Finds

By GARDINER HARRIS
13 jan 2009--The Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects, government investigators are reporting.

Moreover, the investigators say, agency officials told them that trying to protect patients from such conflicts was not worth the effort.

In 42 percent of clinical trials, the agency did not receive forms disclosing doctors’ financial conflicts and did nothing about the problem, according to the investigation, which was conducted by the inspector general of the Department of Health and Human Services and whose results were scheduled to be made public Monday.

In 31 percent of the trials in which the agency did receive the required forms, agency reviewers did not document that they looked at the information. And in 20 percent of the cases in which doctors revealed significant financial conflicts, neither the F.D.A. nor the sponsoring companies took any action to deal with the conflicts, the investigators found.

Karen Riley, a spokeswoman for the F.D.A, said the agency opposed reviewing doctors’ financial conflicts before trials because they represented just one possible source of bias.

A similar investigation by the inspector general last year found that the National Institutes of Health did almost nothing to police the financial conflicts of university professors who received federal money. And like their colleagues at the F.D.A., officials at the health institutes said they did not want to start doing so, that investigation found.

The inquiries feed a growing debate about how money that doctors routinely collect from drug and device makers may hurt patients and skew studies.

In 1999, the agency required drug and device companies to disclose the financial conflicts of doctors overseeing patient care in clinical trials. The rules require companies to collect this information before the start of any trial and to consult with the F.D.A. to resolve serious conflicts.

But the inspector general found that the agency had done almost nothing to enforce these rules or even to use the information generated.

Fewer than 1 percent of the doctors who helped oversee clinical trials registered with the agency and who filed the required financial disclosure forms reported that they had a significant conflict of interest. By contrast, studies have found that one-fifth to one-third of all doctors have such conflicts.

“This represents 206 of the 29,691 clinical investigators listed in financial interest forms,” the report says. “Of these 206 clinical investigators, almost all disclosed only one financial interest.”

Since the F.D.A. does not have a complete list of all clinical investigators, the agency has no way of knowing whether every doctor who is required to file a form actually did so.

The rules allow drug and device makers to avoid reporting doctors’ financial conflicts if the companies certify that they tried diligently to get the information but could not. Companies cited this exemption in 28 percent of drug and device applications, the inspector general found. But in an additional 23 percent of applications, companies filed neither an exemption nor the appropriate disclosure forms.

The inspector general recommended that the F.D.A. do a better job of making sure that companies follow the rules regarding financial disclosures, that agency reviewers actually read these disclosures, and that all of this is done before trials take place so patients are protected.

But the report said the agency replied that collecting and checking this information before the trials was not worth the effort for either the companies or the agency, even though the agency’s own rules required it.