The response from senior management in the Office of Drug Safety was equally stressful he said. "I was pressured to change my conclusions and recommendations," he told the panel, "and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference."
In fact, one Drug Safety manager recommended that he should be barred from presenting the poster at the meeting, and also said that Merck needed to know about the study results.
Finally, he said they wrote a manuscript for publication in a peer-reviewed medical journal and senior managers in the Office of Drug Safety would not grant clearance for its publication, even though it was accepted by a prestigious journal after rigorous peer review.
"Until it is cleared," Dr Graham told the panel, "our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper."
As for the FDA conduct in responding to the studies that showed the dangers of Vioxx, Dr Graham discussed what he referred to as two "revelatory milestones," in 2004.
"In mid-August," he said, "despite our study results showing an increased risk of heart attack with Vioxx, and despite the results of other studies published in the literature, FDA announced it had approved Vioxx for use in children with rheumatoid arthritis."
"Also, on September 22," he told the committee, "at a meeting attended by the director of the reviewing office that approved Vioxx, the director and deputy director of the reviewing division within that office and senior managers from the Office of Drug Safety, no one thought there was a Vioxx safety issue to be dealt with."
At this meeting, the reviewing office director asked Dr Graham why he had even thought to study Vioxx and heart attacks because the FDA had made its labeling change and nothing more needed to be done.
At the same meeting, a senior manager from ODS labeled the latest Vioxx study conducted by Dr Graham's team, “a scientific rumor.”
"Eight days later," Dr Graham told the panel, "Merck pulled Vioxx from the market."
"My experience with Vioxx is typical of how CDER responds to serious drug safety issues in general," he said.
On December 31, 2004, Dr Graham told Inter Press Service that the Vioxx debacle did not phase the FDA. "You have an agency in denial," he said in the interview with IPS, "the FDA still maintains it made no mistake in the approval or regulation of Vioxx."
He said, "intimidation of scientists who threaten the status quo at FDA is routine," and described how, his FDA superior reacted after he sought withdrawal of another arthritis drug called Arava.
"The division director spent the first 10 minutes of that meeting screaming at me," he said. "Basically, standing up, jugular veins bulging in his neck, eyes sort of bugging out of his head, screaming," he recalled, "basically trying to intimidate me so that I'd change my conclusion."
In fact, once Dr Graham went public, history shows that there was a full-court press by FDA officials against the agency Whistleblower.
Dr Steven Galson, the acting director of the FDA drug-evaluation division at the time, told reporters that Graham's work "constitutes junk science," and sent an email to an editor at the British medical journal The Lancet, questioning the "integrity" of Dr Graham's data.
