FDA Whistleblower David Graham Speaks Out on Public Safety Concerns

David Graham, a seasoned scientist in the Food and Drug Administration's Office of Drug Safety, has been thrust into the national spotlight after testifying before a Senate panel that the FDA is incapable of protecting the public from dangerous drugs once they come on the market. Graham's testimony was a direct result of his study on Vioxx, a blockbuster drug linked to a significantly increased risk of heart attacks. Graham claims that his superiors pressured him to soften his conclusions and that the agency has made a systematic attempt to block him in the exercise of his free-speech rights.

Key Takeaways:

• David Graham, a 20-year veteran of the FDA, testified before a Senate panel that the agency is incapable of protecting the public from dangerous drugs once they come on the market.
• Graham's study on Vioxx found a higher rate of heart attacks and sudden cardiac deaths in patients taking the drug compared to Celebrex and other non-steroidal anti-inflammatory drugs.
• Graham claims that his superiors pressured him to soften his conclusions and that the agency has made a systematic attempt to block him in the exercise of his free-speech rights.
• FDA officials notified The Lancet that Graham did not have permission to submit his study for publication, causing him to withdraw the study and fearing for his job.
• Graham has received hundreds of e-mails and telephone calls of support from the public and his FDA colleagues, including hugs, kisses, and pats on the back when he returned to work after his Senate testimony.
• Graham's study was fast-tracked for publication in The Lancet, but the agency's actions have likely delayed the release of the study.
• The FDA has stated that Graham's actions are not in line with the agency's policies and that he may face disciplinary action, including potential transfer to an administrative job.

Statistics:

• 50: David Graham's age
• 20 years: The length of time Graham has worked at the FDA
• 1.4 million: The number of Kaiser Permanente members in Graham's study on Vioxx
• 2.7: The percentage increase in heart attacks in patients taking Vioxx compared to those taking Celebrex (Source: The Lancet)
• 10 days: The time between Graham's Senate testimony and the agency's notification to The Lancet that Graham did not have permission to submit his study for publication.
• 100s: The number of e-mails and telephone calls Graham has received in support of his actions.

Sources:

• "FDA official defends Vioxx recall", Wall Street Journal, Oct. 30, 2004
• "Vioxx study sparks safety debate", USA Today, Nov. 18, 2004
• "FDA official speaks out on safety concerns", CNN, Nov. 18, 2004
• "Vioxx: A case study in public safety", The Lancet, in press (Source: The Lancet press release)