In a series of testy e-mail exchanges with his bosses, a federal drug-safety reviewer contends that an effort to publish his study demonstrating the dangers of Vioxx was delayed and demeaned by top officials at the Food and Drug Administration.
The e-mail and meeting notes also show that Dr. David Graham, an official in the F.D.A.'s Office of Drug Safety, is seeking to launch a study of the safety of Bextra and Mobic, two arthritis pills that are similar to Vioxx. Merck withdrew Vioxx in September after finding that it caused an increase in the risk of heart attacks. . . .
In e-mail dated Oct. 25, 2004, Dr. Graham said one of his bosses, Dr. Anne Trontell, referred to his Vioxx study's conclusions "as nothing more than a scientific rumor."
Dr. Graham defended his study and chided Drs. Trontell and Seligman for taking weeks to decide whether they would approve the study's publication in the Lancet, a leading medical journal. Dr. Trontell is the office's deputy director. Dr. Graham's study concluded that Vioxx, also known as rofecoxib, had a dangerous effect on the heart. The study has been submitted to the Lancet for peer review and possible publication. Meanwhile, the F.D.A. posted a version of the study on its Web site on Tuesday, after certain parts of the study were first published in The Wall Street Journal.
"For all the center claims in its operating principles that respect for others is a core value, my experience with rofecoxib was just the opposite from management, once the results from this study and their potential implications came to light in August," Dr. Graham wrote in e-mail dated Oct. 26.
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