Summary

Question: Isn't this precisely the kind of information the FDA should be trying to get published in order to protect the public? You can bet your last dollar that if the report had been about a Chinese herb, rather than a prescription drug, the FDA wouldn't have blocked it. In fact, the agency would have held a press release and issues national warnings about the herb.

But when it's a prescription drug that's killing people, that's all okay with the FDA.

Original source:
http://www.usatoday.com/news/health/2004-11-28-fda-vioxx_x.htm

Details

• 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.
• 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.
• 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."
• Galson called Horton to tell him that the FDA had not cleared Graham's paper for publication.
• He then e-mailed Horton a link to a document describing the FDA's internal review process for journal articles.
• After the abstract was submitted to the rheumatology group, Graham says, he discovered two problems: A computer program had misclassified the amount of Vioxx some patients had taken; and one of his co-authors noticed that an analysis Graham had done was incorrect.

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