Anne Kirkman Campbell, a family practice doctor in Gadsden, Ala., apparently viewed a clinical trial for the Ketek antibiotic as one big piggy bank. She signed up 400 patients, more than any other doctor in the country and, when one patient backed out, she even forged the consent form and faked the data.

What’s more, Campbell enrolled her entire staff and several family members in the study. Patient consent forms had been signed every few minutes and, at times, when the office was closed. And though the trial required patients come in for three office visits and blood draws over five months, not one dropped out.

A subsequent audit, which was initiated by PPD, the firm running the trial, uncovered the fraud. The FDA’s Office of Criminal Investigation began looking into it, but the FDA’s drug review division recommended approval anyway, over the objections of a medical reviewer who subsequently disclosed the agency’s behind-the-scenes decision-making.

The episode has been well publicized, and both the FDA and Sanofi-Aventis came out looking badly. Meanwhile, Campbell, 49, pleaded guilty to one count of mail fraud and was sentenced to 57 months in prison.

In a phone interview from federal prison in Lexington, Ky., Campbell admits to The St. Petersburg Times that she forged a consent form but declined to discuss other allegations of wrongdoing. Instead, Campbell blames the drugmaker for fast-tracking the trial. “They seemed to want to rush you through everything,” said Campbell, who had performed a half-dozen clinical trials for other drugmakers. “They didn’t care how you did it. They wanted the trial over so they could get the data to the FDA.”

In the fall of 2002, when the FDA called to schedule a routine audit, Campbell says, the drugmaker told her to delay the agent for a week. “Then they flew in two doctors to prep me and four to six girls to go through my files.” The company, she continues “had been made aware of the fraud at my site by PPD. At no time did they attempt to stop my participation.”

More here.