It’s no news that the federal Food and Drug Administration has not always been diligent in vetting medicines and medical devices American consumers trust it to oversee. If it had, we wouldn’t have had the scandal with Vioxx that shook people’s confidence in the agency.
But the culture of suppression and retaliation that actually existed at the FDA dwarfs the worst that many people imagined, according to new information uncovered following the filing of a suit against the agency in January by six of its current and/or former scientists. Some had been fired; all had come under pressure from the agency because they were unwilling to distort or suppress safety information about medical devices under FDA review. The suit is only one stage in a conflict between the FDA and its reviewers that has been going on since the latter years of the George W. Bush presidency.
The pressure tactics used against the reviewers by FDA management were aided by a massive email spying campaign. Spyware put in place at the behest of agency administrators photographed some 80,000 pages of emails and other documents from the scientists’ computers, including emails some had sent members of Congress and congressional oversight committees to sound the alarm about flawed evaluation procedures for medical devices and drugs. One scientist had contacted PBS about contributing to an investigative program on the subject.
The scientists became aware that they were being spied on when one stumbled onto the spyware’s database, but even then they didn’t grasp the scale of the surveillance. It came to light when a contractor working for the FDA inadvertently posted information dredged up by the spyware on the Web.
On the medication side, Ronald Kavanagh, Pharm.D, Ph.D., who worked for 10 years as a drug reviewer with the FDA, talked to Truthout reporter Martha Rosenberg about safety issues with medicines under the FDA’s purview, including faulty procedures for evaluating the effects of drugs on children (read the full interview at http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety). Kavanagh told Rosenberg that at the FDA, “…drug reviewers were clearly told not to question drug companies and that our job was to approve drugs.” When he uncovered information suggesting that a medicine was unsafe, he said, his superiors often ignored it or shifted the responsibility for reviewing the medicine to someone who would issue an uncritical approval.
Kavanagh spoke in more detail about specific concerns, such as the unsafe dose levels that were sometimes approved for children.
“Pediatric approvals are based on the assumption that children will respond similarly to similar exposures,” he explained. “Yet dosages that are used for studies in children are often based on approved adult dosages rather than a scientific determination of whether children achieve the same or higher exposures than adults. This is because companies don’t want to develop lower dosages for children if they don’t have to. …Since no allowance is made for race, age, puberty, or actual weight and since there are differences in children’s clearance of drugs, there are often higher exposures to active and toxic metabolites in children compared to adults. Thus there are often unnecessary risks with the doses that are approved.”
Kavanagh told Rosenberg he was told he would go to prison for transmitting pharmaceutical trade secrets to Congress—a mere scare tactic, he says, since it’s not illegal for FDA reviewers to pass on such information to Congress. FDA administrators used such threats, he claims, because he had gathered information that might be legally prejudicial to them.
“I believe that actual felonies may well have occurred,” he said. “For example, I found evidence of insider trading of drug company stocks reflecting knowledge that likely only FDA management would have known. I believe I also have documentation of falsification of documents, fraud, perjury, and widespread racketeering, including witnesses tampering and witness retaliation.”