Juicy news: Scientist says FDA called journal to block Vioxx article]

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>Posted 11/28/2004 11:41 PM

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

>

>Scientist says FDA called journal to block Vioxx article

>By Rita Rubin, 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. Following is a chronology of the events surrounding the paper's

>withdrawal:

>

>• Nov. 12. 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. " As you will see, there are some ambiguities here, " Galson

>said in his e-mail.

>

>In a later e-mail to Horton that day, Galson brought up points from a

>nine-page review of Graham's study by Ann Trontell, deputy director of

>the FDA's drug safety office. Galson and Trontell noted discrepancies

>between the article submitted to The Lancet and an abstract of the study

>that had been submitted in May for presentation at a second scientific

>meeting, an American College of Rheumatology conference. Trontell's

>review, which Graham had forwarded to Horton, refers to " potential

>charges of data manipulation. "

>

>Graham says he had already explained the discrepancies to his superiors

>at the FDA. 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.

>

>Graham says the rheumatology group told him that it was too late to

>correct the printed abstract, but that he could present the corrected

>analysis at its annual meeting in October, as he had at the epidemiology

>meeting in August.

>

>• Nov. 14. In an e-mail to Galson, Horton wrote, " You will not be

>surprised if I say that I was a little taken aback to get your call on

>Friday (Nov. 12). " It is very unusual indeed for a member of the

>employing institution of an author to contact us in the middle of the

>review and publication process of a manuscript. "

>

>Horton wrote that Galson's call could be perceived as an improper

>attempt to interfere with The Lancet's review process. Raising the

>possibility that a scientist manipulated data " is an extremely serious

>allegation, " Horton wrote. " One could read such an allegation as an

>attempt to introduce doubt into our minds about the honesty of the

>authors — doubt that might be sufficient to delay or stop publication of

>research that was clearly of serious public interest. "

>

>• Nov. 18. Graham told a Senate panel that the FDA is " virtually

>defenseless " against another " terrible tragedy and a profound regulatory

>failure " like Vioxx.

>

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