FDA, Facing Criticism, Bars Doctors From Drug Trials (Update1)

June 6 (Bloomberg) -- U.S. regulators have barred seven doctors from conducting clinical trials of drugs and medical devices so far this year, as many as in the three previous years combined, after lawmakers complained about delays in discipline.

The Food and Drug Administration disqualifies researchers that the agency finds were involved in misconduct, including falsifying results, during studies. Among those banned this year, according to the FDA's Web site, was Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 in connection with a study on a Sanofi-Aventis SA antiobiotic.

Lawmakers, including Representative Joe Barton, a Texas Republican, have criticized the agency for taking years in some cases to act against researchers, such as Campbell, after finding violations. The doctors and others working on clinical trials are eligible to continue conducting studies for submission to the FDA until they are disqualified.

``Doing something is a good sign,'' Barton said in an interview. Delays in banning researchers have allowed ``people that do things that they shouldn't be doing to continue,'' he said.

In February, Bloomberg News reported that the FDA had failed to complete disciplinary action against 12 researchers after proposing that they be disqualified from trials based on findings that they violated rules designed to protect patients and ensure accurate data. Cases remained unresolved for as long as a decade.

Patients at Risk

The FDA relies on the results of clinical trials to determine whether drugs and medical devices are safe and effective enough to clear for sale. Delays in disciplining doctors who don't properly supervise the tests put patients at risk and threaten the validity of the studies, according to medical ethicists.

The increase in disqualifications, which are posted on the FDA Web site, is a result of changes in how the agency handles enforcement, said spokesman Christopher DiFrancesco in an e- mail.

``We've established new timelines for disqualifications, and we are in the process of adding additional staff,'' DiFrancesco said.

DiFrancesco said he didn't know how many disciplinary cases remain pending against researchers. In an e-mailed response to questions, the FDA said that the ``backlog of older cases is about half a dozen.''

Texas Urologist

Among the doctors cited in the Bloomberg story in February was James C. Vestal, a Texas urologist, who exposed patients to ``unnecessary risk'' and ``submitted false information in required reports'' in a study of a prostate cancer drug, according to an FDA letter to Vestal.

The agency didn't send the letter, which started disciplinary action against Vestal, until May 2007, more than three years after his violations of agency rules were detailed in reports by the FDA's own staff investigators.

Vestal was disqualified from studies last month, according to the FDA Web site. He didn't return a phone call. A Washington lawyer representing Vestal, Philip Katz of the firm Hogan & Hartson, said that neither he nor Vestal would comment.

Vestal accused an assistant of falsely reporting physical exams and vital signs that were never performed, according to FDA documents. The assistant denied it. Vestal responded to the FDA investigators' findings with a letter promising changes in procedures in future drug trials.

Campbell, 50, who was sentenced to 57 months in prison, also was disqualified last month, according to the FDA Web site. She was released from a federal prison into a halfway house in February and then placed on home confinement last month, said Rita Teel, a spokeswoman for the U.S. Bureau of Prisons.

Campbell's Regret

Campbell, who worked as a family physician, said in a phone interview today from Gadsden, Alabama, that she regretted what she had done, and didn't know that the FDA had banned her from clinical trials. She was accused of fabricating data for the drug Ketek, and pleaded guilty to one count of mail fraud.

``I pretty much succumbed to the pressure that Aventis was putting on me,'' she said. ``My life is ruined. I have no career or anything.''

Sanofi, based in Paris, didn't know at the time about fraud committed by Campbell, the company has said. Campbell's case has been ``thoroughly investigated'' and she was ``criminally prosecuted for her actions and pleaded guilty,'' said Marc Greene, a spokesman for Sanofi, in an interview today.

Barton said the FDA's approach in barring Campbell from research was ``a little bit light and would also seem to be a little bit late.'' The agency should have banned Campbell from working in the pharmaceutical industry, he said.

Government investigators, including the inspector general for the Health and Human Services Department, have found flaws in the FDA's oversight of drug trials. The agency inspected fewer than 1 percent of 350,000 sites where drug trials were conducted from fiscal 2000 through 2005, according to a report released in September by the inspector general.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Last Updated: June 6, 2008 13:49 EDT

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