Quoting a New York Times article, Evidence in Vioxx Suits Shows Intervention by Merck Officials, April 24, 2005:
The Advantage trial [of VIOXX] was completed in 2000, but its results were not published until 2003, when they appeared in the Annals of Internal Medicine, a well-regarded journal. Dr. Jeffrey R. Lisse, a rheumatologist at the University of Arizona who is listed as the study's first author, said in an interview that at least two other journals had rejected the study because its results were not novel.
In the published study, Dr. Lisse reported that five patients taking Vioxx had suffered heart attacks during the trial, compared with one taking naproxen, a difference that did not reach statistical significance. But the paper never mentioned the three additional cardiac deaths of patients taking Vioxx, including the 73-year-old woman.
Dr. Lisse said that while he was listed as the paper's first author, Merck actually wrote the report, an unusual practice. "Merck designed the trial, paid for the trial, ran the trial," Dr. Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."
Dr. Lisse said he had never heard of the case of the woman who died, until told of it by a reporter. "Basically, I went with the cardiovascular data that was presented to me," he said.
-- SS
1 comment:
Apart from the awful ethics when a drug trial is involved, even at a 'lower' level the issue of ghostwriting needs to be addressed. I think editors (myself included) must begin asking the specific question: "Has this paper been substantially edited or written by anyone not listed as an author? If so, please identify this person in the Acknowledgements." Something along these lines will help editors, reviewers and readers decide if the supposed senior author is truly a brilliant writer or just someone who has enough resources to hire a good ghost. How well papers are written figures in acceptance rates, who is asked to review, and the reputation authors achieve. It is not a trivial matter
Post a Comment