he issue of The American Journal of Psychiatry
that hit the desks of its 37,000 readers this month reported test
results for the antidepressant drug Celexa, indicating it could help
children and teenagers.
Before publication, the article received the kind of scrutiny
common among medical journals. The study's authors had been asked to
divulge their financial ties, if any, to the drug's marketer, Forest
Laboratories Inc., which sponsored the clinical trial. And the
report was sent to reviewers who examined the trial methodology and
checked to make sure that the article reflected other relevant
research about the use of antidepressants in youngsters.
But neither the article nor the 27 scholarly footnotes that
accompanied it mentioned another major drug-industry-sponsored trial
completed in 2002, which found that Celexa did not help depressed
adolescents any more than a placebo. Nor would the article's
reviewers have been likely to find any clues of that trial's
existence. The results of that trial were first noted last year on a
single line of a chart that appeared on Page 96 of a textbook - one
written in Danish.
Like most medical journals, The American Journal of Psychiatry
does not require company sponsors of drug trials to divulge
information about all relevant trials of a medication. But that may
soon change, as some leading journal editors try to address what
they see as shortcomings in the way clinical tests are designed and
analyzed by the drug industry, and how test results are
"There is so much sophistication, that if the journals are not
careful they could end up being part of the drug industry's
marketing arm," said Dr. Richard Smith, the editor of The British
In written responses to inquiries from The New
York Times, Forest stated that the negative Celexa test,
sponsored by a related company, was not mentioned in the recent
article because "there was no citable public reference for the
authors to examine."
But drug makers often announce trials with positive results
without waiting for the results to be published. Forest, for
example, issued a news release three years ago that highlighted the
outcome of the positive Celexa trial. That was shortly after the
test's completion, when the findings were first presented at a
medical conference, but before the study was even submitted to The
American Journal of Psychiatry for consideration. Three of the
authors of the Celexa drug article in this month's issue are Forest
Dr. Smith and other editors say the challenges they face are not
limited to the tendency by companies and academic researchers to
showcase positive tests results while playing down trials with
negative or inconclusive findings. Editors say they must also be
vigilant against companies' cherry-picking favorable but limited
data from a trial that had originally set out to test other aspects
of a drug's performance.
Some companies, several editors said, have also apparently milked
tests for maximum publicity by submitting different parts of them
under different authors' names to different medical journals.
A group of 12 medical journals worldwide including The Journal of
the American Medical Association, The New England Journal of
Medicine, The Lancet and The Annals of Internal Medicine are
weighing a proposal that would require a drug trial to be listed at
its start in a public database or registry as a prerequisite to its
results being considered for publication. The British Medical
Journal is not part of that group, which is known as the
International Committee of Medical Journal Editors, but Dr. Smith
said he also supported the initiative.
Editors say that a database could offer several benefits.
Assigning a test a unique number could allow it to be tracked from
start to finish. The results, be they positive or negative, could
then be put into context with other relevant trials of the same
drug. Moreover, journal editors say that if a trial's objectives
were listed at the outset, they would know how to better assess an
article that presented its results.
"It would be useful for us from an editorial perspective if
trials were registered, so we could see what was on the mind of
investigators when they started," said Dr. Jeffrey M. Drazen, the
editor of The New England Journal of Medicine.