On November 18, 2004, Dr. David Graham, a 20 year veteran Food and Drug Administration (FDA) scientist, rocked the pharmaceutical industry with Senate Committee testimony that shook six multinational corporations, and drew vital public attention to the secret life inside the FDA. His testimony exposed tragic public health consequences stemming from a legalized conflict of interest: the FDA is one of the few government agencies whose funding depends largely on the success of products of the industry it regulates. Due to Graham’s appearance, the deadly market for pain relievers will never be the same. Read Graham’s testimony.
Graham’s dissent already has made a threefold difference:
- In a preemptive move, the Merck Corporation withdrew Vioxx prior to the hearing, unable to discredit research by Graham and colleagues that the expensive painkiller had caused 88,000 to 139,000 heart attacks – 30-40% of which were fatal – over the previous five years.
- Congress is strongly considering legislation to address conflicts of interest contained within the Prescription Drug User Fee Act (PDUFA), a “Contract with America" reform linking the FDA’s budget to the number of new drug applications it approves.
- Graham “committed the truth" and survived. His story may spark a rebirth of scientific freedom at the FDA. Despite contradictory rhetoric, this unusually repressive agency traditionally has not been content with firing whistleblowers, but has repeatedly sought criminal prosecution.
Graham’s association with GAP began a year ago, following the FDA’s criminal investigation of scientists working within the Office of Drug Safety (ODS). The inquiry sought to discover who leaked the truth about Paxil, an antidepressant set for approval for use by teenagers despite epidemiological studies that it had sparked a rise of teenage suicides in Britain. The FDA banned a key scientist, Dr. Andy Mosholder, from attending a public Advisory Committee meeting to make final recommendations. Later, the agency told him that his attendance was permissible under the condition that he only answer questions from an approved script. This attempt to suppress information was thwarted when the research was anonymously disclosed to the San Francisco Chronicle. Under intense public scrutiny, the FDA declined approval for unrestricted use of Paxil, and many lives may have been saved. But ODS chief Dr. Paul Seligman continued the investigation to determine the person responsible for leaking the report.
Frightened by threats of incarceration, Graham sought help from GAP officials after being referred by congressional staff and members of the media. GAP Legal Director Tom Devine warned FDA investigators, outlining how they were incurring personal liability by violating laws such as the Whistleblower Protection Act and Anti-gag Statute, resulting in a swift halt of the investigation.
Graham contacted GAP last year when the same FDA managers made attempts to suppress his Vioxx study. Running the bureaucratic gauntlet, he was able to present preliminary results at a conference that sent shock waves through the industry. Graham’s supervisors privately criticized him for trying to hurt Merck on the basis of “junk science" and “scientific rumor." Senate Finance Committee Chair Charles Grassley (R.-Iowa) intervened to ensure the research was not suppressed, and scheduled the November 18 hearing.
In the weeks before the hearing, FDA officials repeatedly charged that Graham’s study should not be publicly aired due to possible scientific misconduct, industry jargon for fraud. FDA supervisors contacted medical journals that obtained the study’s results, urging that the research not be published. Supervisors then warned Graham that he could be disciplined for releasing it under his own name, prompting him to ask the journals to delay publication. Supervisors characterized Graham as a dangerous demagogue and bully who had to be stopped. Acting FDA Commissioner Lester Crawford personally offered Graham a new position that did not allow for research opportunities.
Graham’s testimony at the hearing became front-page news after he identified the FDA’s handling of Vioxx as the worst public health disaster in its history, resulting in a probable 30,000-55,000 deaths. No official could credibly challenge his Vioxx findings, and he identified five other suspect drugs: Accutane, Bextra, Crestor, Meridia, and Serevent.
A week after the hearing, sympathetic insider colleagues and press contacts warned Graham that the FDA was finalizing plans to exile him from drug safety work within days. Sen. Grassley and the media rallied to his defense, and the FDA retreated. Commissioner Crawford issued a memo to all staff that they no longer need prior approval to communicate with Congress. Graham’s supervisors later approved publication of the study.
Unfortunately, the FDA’s actions were only a temporary reprieve. This past January, the FDA’s Advisory Committee was scheduled to meet in a policy showdown on Cox-2 drugs, a new type of pain reliever. FDA supervisors again told Graham that he could not present results from a new study detailing the drugs’ effects. After Grassley intervened again, Crawford overruled FDA officials, agreeing it would be illegal to suppress his views. Although dominated by hand-picked industry and agency scientists, the Committee placed unprecedented safety restrictions on all Cox-2 pain relievers, finding that the drugs were dangerous. Treating Vioxx like cigarettes, it banned product advertisements and required large warning labels.
The Senate Finance Committee is preparing new legislation to strengthen whistleblower rights for FDA and drug industry scientists. Other committees are considering hearings.
Graham has become an active champion of scientific freedom and a model for other federal workers. As he puts it, “Most government employees don’t have Senator Grassley, the media and GAP to defend their professional lives. Most government workers remain silent when there’s no credible right to defend themselves. Federal workers don’t have free speech rights like Congress created in the Sarbanes Oxley law after Enron, MCI and similar scandals. It’s as important for Federal whistleblowers to have reliable rights when defending American families’ health or lives, as for corporate workers when defending America’s stocks and pension funds."
For more then a decade GAP has defended FDA whistleblowers. However, it will take persistence and courage to break this ingrained pattern of whistleblower harassment. As GAP’s Devine summarized, “Secrecy enforced by repression is a severe threat to public health and safety. It prevents government scientists from warning the public of tragedies that don’t have to happen."
