Researchers' conflicts of interest appear to be prevalent in psychiatric
clinical trials and associated with a greater likelihood of reporting a drug
to be superior to placebo, according to a review of such trials.
Among 397 psychiatric clinical trials identified, the authors found 239 (60
percent) reported receiving funding from a pharmaceutical company or other
interested party. The review, published in the October American Journal of
Psychiatry, found that 187 studies (47 percent) included at least one
author with a reported financial conflict of interest.
"I was interested in knowing where these randomized, controlled
trials that we depend on when we write our treatment guidelines were coming
from and who pays for them," said Roy Perlis, M.D., the study's lead
author. "It was more curiosity than anything else."
Perlis, an instructor in psychiatry at Harvard Medical School who
previously performed a similar analysis and found similar results in the
dermatology literature, said the percentage of authors who reported a conflict
of interest or a competing interest is similar to rates reported in the
general medical literature. The author conflict rates in previously studied
areas of medicine generally range between 30 percent and 50 percent of
authors, which leaves psychiatry at the higher end of the number of author
Perlis said that the higher rates of conflict of interest in psychiatry did
not surprise him because of the growing number of new drugs entering the
psychiatric field in recent years, resulting in many large clinical
He said that industry involvement and collaboration with researchers have a
largely positive impact on psychiatry. His past research collaboration with
the pharmacological industry is part of what led him to seek to understand the
implications of that collaboration.
"We need to work with industry. [Pharmaceutical companies] are the
ones with the drugs. They are the ones with the resources to study the
drugs," he said. "But because I was doing this kind of work, I
wanted to understand what it meant, how it might influence me, how it might
influence my work."
The review was based on a MEDLINE search of articles published between
January 2001 and December 2003 in the American Journal of Psychiatry,
Archives of General Psychiatry, Journal of Clinical Psychiatry, and
Journal of Clinical Psychopharmacology. The journals were selected as
the most widely cited general psychiatric journals that publish clinical
The source of study funding, as well as potential author financial
conflicts of interest, were determined by published disclosures. The
researchers defined author financial conflict of interest as any report of
consulting or speaking fees or honoraria, stock ownership, or employment by
the study sponsor.
The impact of financial conflicts of interest among medical researchers has
raised concerns among physicians and in the general media, among others.
However, the prevalence and implications of conflict of interest in psychiatry
have received little attention, apart from occasional editorials.
The dearth of conflict-of-interest research in psychiatry is especially
important, according to the study authors, due to the extent of industry
involvement in drug development in psychiatry, the rapid growth in
FDA-approved pharmacotherapies in psychiatry, and recent calls for the
establishment of a clinical-trial registry to report the results of all
clinical trials, regardless of outcome.
The review found that among the 162 randomized, double-blind,
placebo-controlled studies examined, those studies with authors reported to
have conflicts of interest were 4.9 times more likely to find positive results
for the intervention. The association was significant only among the subset of
studies funded by the pharmaceutical industry.
The review was limited, Perlis said, by an inability to explain the link
between conflict of interest and positive studies. Although it found an
association, more research is needed to identify why that association
Perlis said some plausible explanations make the link between drug-industry
involvement and positive study outcomes "perfectly
One explanation is that the pharmaceutical industry's access to greater
resources allows researchers to conduct bigger studies, which are more likely
to eliminate random variables. Those same substantial resources allow for
better-designed studies, also more likely to yield a positive result.
"But there are also potentially less-good reasons for the
relationship between conflict of interest and a positive trial that we need to
understand," Perlis added.
The Perlis-led review should encourage organizers of a planned
clinical-trial registry and the companies weighing their participation in it
to continue moving forward, he said.
The review raises questions, Perlis said, regarding the appropriateness of
60 percent of the medical specialty's randomized, controlled trial results
originating from industry-funded studies.
Some may see the government-sponsored Clinical Antipsychotic Trial of
Intervention Effectiveness (CATIE) study that compared the effectiveness of
five drugs among 1,493 schizophrenia patients at 57 medical centers as a
better model for future drug studies (see
That study, which was released in September, was the type that could only
have been done with federal government support, because no single company
would have the incentive to do it, he said.
"Companies conduct trials in general because they are interested in
marketing their drugs. That's not bad—it's just the way businesses
work," he said. "But as clinicians and researchers, we often have
A question Perlis said he hopes his analysis leads researchers and
physicians to answer is the extent to which the federal government—and
not industry—should fund clinical-trial research.
"Industry Sponsorship and Financial Conflict of Interest in
the Reporting of Clinical Trials in Psychiatry" is posted at<http://ajp.psychiatryonline.org/cgi/content/full/162/10/1957>.▪
Am J Psychiatry