Facing criticism, U.S. agency bars 7 doctors from drug trials

[flashl]

U.S. regulators have barred seven doctors from conducting clinical trials of drugs and medical devices 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 agency's Web site, was Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 in connection with a study on a Sanofi-Aventis antibiotic.

...

In February the FDA was found to have 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.

The agency 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 do not properly supervise the tests put patients at risk and threaten the validity of the studies, according to medical ethicists.

IHT

[Clear Blue Sky]

1. Good. Like cheating on taxes. Illegal and should be punished.

[hvn_nbr_2]

2. Barred from conducting trials "this year"

So that means they have to wait 6 months till 2009 before they start new clinical trials (and new kickbacks?)? Probably just long enough to plan the next set. A real disciplinary action would be to require that any future trial's report include a disclaimer about their shady past.

[varkam]

3. Is it that they are only barred for 2008, or...

that they took action this year and the barring is indefinite? It's kind of hard to tell from that wording.

[hvn_nbr_2]

4. You're right. That's a possible reading, probably the more likely.

The full article has tales of prison time and ruined careers, so I doubt that they'll be back soon. The article doesn't say anything specifically about how long they're barred or if it's permanent or some indefinite time.

[varkam]

5. I wouldn't be surprised if it's indefinite

I would assume that, if you're a researcher, when your credibility is shot then you're sunk.

But yeah, the wording in the article isn't too terribly clear.