From USA Today:
Just days before a medical journal was to publish a Food and Drug Administration-sponsored study that raised concerns about the safety of the arthritis drug Vioxx, an FDA official took the unusual step of calling the editor to raise questions about the findings' scientific integrity, suggests e-mail obtained by USA TODAY.
Lead author David Graham says the call was part of an effort to block publication of his research, an analysis of a database of 1.4 million Kaiser Permanente members showing that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, Vioxx's rival. Graham had reported his study in August at an epidemiology meeting in France, but publication in a medical journal would have exposed it to a wider audience.
Graham, associate director for science and medicine at the FDA's Office of Drug Safety, says The Lancet, a medical journal published in London, had planned to post the study on its Web site Nov. 17, a day in advance of his appearance before the Senate Finance Committee to testify about the FDA's handling of Vioxx.
Merck had pulled the drug from the market Sept. 30 because of safety concerns. Publication of the study could have embarrassed the FDA, which was being criticized for not warning patients sooner of Vioxx's cardiovascular risks.
Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said Sunday that Graham's charges are unfounded. "We didn't make any efforts to block publication in The Lancet," he said. "What we did is let The Lancet know that the paper was submitted in violation of the agency's clearance process." Graham had sought to publish his study before getting the FDA's OK, Galson said.
And in a written statement, FDA Acting Commissioner Lester Crawford said that Galson contacted Lancet editor Richard Horton "out of respect for the scientific review process."
Galson said he would like to see the paper published some day but didn't see the value of timing its release to the Senate hearing, "not exactly a scientific imperative."
Graham says he pulled his paper at the last minute because he feared for his job.
Terrific, just terrific. There are lots of little Mikey Powells running other agencies, agencies that control your health.