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FDA Validated Machinery

Since 1988, Dr. David Graham has called for the removal of 12 drugs from pharmacy shelves, leading to 10 recalls that have likely saved hundreds, if not thousands, of lives.

Each recall is an embarrassment for Graham's employer, the FDA's Center for Drug Evaluation and Research, which approved the drugs in the first place.

The trouble is that the roughly 2,300 staffers who support the approval process, and the 109, like Graham, who study the safety of drugs after their release, all fall under the same leadership, and that leadership is highly responsive to industry.

In recent years, nearly half of the center's $400 million budget has been paid for by drug companies. This arrangement stems from a 1992 agreement, made partly at the urging of AIDS activists, that the FDA would speed up approvals in exchange for "user fees" from industry.

"The focus at FDA is efficacy," says Dr. Curt Furberg, a scientist at Wake Forest University who advises the agency. "Safety is a stepchild."

For the pharmaceutical companies the system works just fine. "The drug-approval process [in the United States ] is second to none," says Jeff Trewhitt, a spokesman for PHRMA, the drug industry's trade group. "This is an exhaustive process."

Companies eventually recall about 3 percent of their drugs for safety reasons.

Behind many of these recalls are scientists like Graham, who often find themselves pitted against their own supervisors. "If you say something negative about a drug, they try to shut you up," says Dr. Sidney Wolfe, an FDA watchdog for the group Public Citizen, which has been exposing dangerous drugs for three decades. "David is not the only one, by any means, who has raised issues that later proved to be correct."

In 1998, for instance, an FDA drug reviewer named Dr. Robert Misbin wrote a paper showing that the diabetes drug Rezulin had caused liver failure in a patient during a controlled study. When his bosses tried to prevent him from publishing, Misbin saw first hand how the system encouraged the sacrifice of public health to the interests of the industry.

"One of my supervisors said something to me that I have never forgotten," Misbin says, "that we have to maintain good relations with the drug companies because they are our customers.

" Misbin eventually went public with his concerns, and the drug was pulled a year later. But he has paid for sticking to his principles. "I am no longer given any good projects," he says.

Dr. Andrew Mosholder, another FDA reviewer, faced similar pressures last year when he completed a study showing that antidepressants increased suicidal behavior in children.

Further studies proved that Mosholder's science was spot on. But his bosses told him not to report the findings. When someone with access to the study passed his results to the press, the FDA launched an investigation into the leak. According to Tom Devine at the Government Accountability Project, who later became

Graham's lawyer, several scientists were interrogated and threatened with possible jail time.

Such intimidation has worked. In 2002, about one in five FDA scientists told federal investigators that they felt pressure to approve drugs despite reservations about safety and efficacy. Two-thirds said they lacked confidence that the agency adequately monitors drug safety after approval.

 

Merck and the Vioxx Scandal Continued...

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