http://bmj.com/cgi/content/full/323/7308/301
BMJ 2001;323:301 ( 11 August )
Scott Gottlieb
Researchers at the centre of a row over data presented to JAMA, the journal
of the American Medical Association, which showed the results of
only the first six months of a trial of a new arthritis drug have
defended their actions, following a controversial article in the
Washington Post earlier this week (5 August).
The newspaper article accuses researchers of intentionally giving a
prominent gastroenterologist incomplete data on the safety of a
popular arthritis drug so that he might write a more favourable editorial
about their study.
The editorial, published in the 13 September issue of JAMA
(2000;284:1297-9) was cowritten by Dr Michael Wolfe, a gastroenterologist at
Boston University, and concerned data from a then unpublished study
involving more than 8000 patients. The drug involved, celecoxib, was
associated with lower rates of stomach and intestinal ulcers than
two older drugs for arthritis, diclofenac and ibuprofen.
The data made available to Wolfe encompassed only the first six months of
the study. JAMA's editors reportedly wanted to rush these findings
into print, and Wolfe and a colleague provided a favourable
editorial to accompany the paper.
But in February Wolfe was shown the complete data from the same study as a
member of the Food and Drug Administration's arthritis advisory
committee, and he saw a different picture, said the story in the Washington
Post.
The study, already completed at the time Wolfe wrote the editorial, had
lasted a year, not six months as he had thought, and almost all of
the ulcer complications that had occurred during the second half of
the study were in users of celecoxib. When all of the data were
considered, some of the drug's apparent safety advantage was diminished.
"For a group of researchers to send incomplete information to a journal
for consideration while knowing that a more complete set will be
reviewed by an authority figure like the FDA would seem very
strange," said former JAMA editor in chief George Lundberg. "That
is, unless the time-sensitive marketing advantage of a drug with
blockbuster sales potential was so compelling that the manufacturer was
willing to take that chance to gain an early mass sales advantage."
Jay Goldstein, professor of medicine at the University of Illinois in
Chicago and one of the study's authors, said the Washington Post's
account was inaccurate. He said the issue largely involved how best
to present the results of the trial after there were an unusually
large number of dropouts from the diclofenac arm of the study,
mostly because of adverse events. "To put it bluntly, if you
were looking to see if patients bleed at a different rate then when
a lot of patients that leave are on diclofenac, you really can't
continue the study."
Goldstein said the best data on outcomes in all three arms of the study were
available by looking at the six month timeframe. The 12 month
data were widely available, so there was never an effort to deceive
the public, he said. "The original intent was to follow
patients for at least six months and compare [the three drugs], so
for that particular study, the researchers believed that data best
reflected the comparisons they were trying to make."
© BMJ 2001
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