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Every psychiatric expert involved in writing the standard diagnostic
criteria for disorders such as depression and schizophrenia has had financial
ties to drug companies that sell medications for those illnesses, a new analysis
has found.
Of the 170 experts in all who contributed to the manual that defines disorders
from personality problems to drug addiction, more than half had such ties, including
100 percent of the experts who served on work groups on mood disorders and psychotic
disorders. The analysis did not reveal the extent of their relationships with
industry or whether those ties preceded or followed their work on the manual.
"I don't think the public is aware of how egregious the financial ties
are in the field of psychiatry," said Lisa Cosgrove, a clinical psychologist
at the University of Massachusetts in Boston, who is publishing her analysis
today in the peer-reviewed journal Psychotherapy and Psychosomatics.
The analysis comes at a time of growing debate over the rising use of medication
as the primary or sole treatment for many psychiatric disorders, a trend driven
in part by definitions of mental disorders in the psychiatric manual.
Cosgrove said she began her research after discovering that five of six panel
members studying whether certain premenstrual problems are a psychiatric disorder
had ties to Eli Lilly & Co., which was seeking to market its drug Prozac
to treat those symptoms. The process of defining such disorders is far from
scientific, Cosgrove added: "You would be dismayed at how political the
process can be."
The American Psychiatric Association, which publishes the guidelines in its
bible of disorders, the Diagnostic and Statistical Manual (DSM), said it is
planning to require disclosure of the financial ties of experts who write the
next edition of the manual -- due around 2011. The manual carries vast influence
over the practice of psychiatry in the United States and around the world.
Darrel Regier, director of the association's division of research, said that
concerns over disclosure are a relatively recent phenomenon, which may be why
the last edition, published in 1994, did not note them. Regier and John Kane,
an expert on schizophrenia who worked on the last edition, agreed with the need
for transparency but said financial ties with industry should not undermine
public confidence in the conclusions of its experts. Kane has been a consultant
to drug companies including Abbott Laboratories, Eli Lilly, Janssen and Pfizer
Inc.
"It shouldn't be assumed there is a true conflict of interest," said
Kane, who said his panel's conclusions were driven only by science. "To
me, a conflict of interest implies that someone's judgment is going to be influenced
by this relationship, and that is not necessarily the case. . . ."
The DSM defines disorders in terms of constellations of symptoms. While neuroscience
and genetics are revealing biological aspects to many disorders, there has been
unease that psychiatry is ignoring social, psychological and cultural factors
in its pursuit of biological explanations and treatments.
"As a profession, we have allowed the biopsychosocial model to become
the bio-bio-bio model," Steven Sharfstein, president of the American Psychiatric
Association, said in an essay last year to his colleagues. He later added, "If
we are seen as mere pill pushers and employees of the pharmaceutical industry,
our credibility as a profession is compromised."
He stressed that the association has strict guidelines to police the role of
the pharmaceutical industry but said the profession as a whole needs to do a
better job monitoring ethical conflicts.
Sharfstein added yesterday that the presence of experts with ties to companies
on the manual's expert panels is understandable, given that many of the top
experts in the field are involved in drug research.
"I am not surprised that the key people who participate have these kinds
of relationships," he said. "They are the major researchers in the
field, and are very much on the cutting edge, and will have some kind of relationship
-- but there should be full disclosure."
At least one psychiatrist who worked on the current manual criticized the analysis.
Nancy Andreasen of the University of Iowa, who headed the schizophrenia team,
called the new analysis "very flawed" because it did not distinguish
researchers who had ties to industry while serving on the panel from those who
formed such ties afterward.
Two out of five researchers on her team had had substantial ties to industry,
she said. Andreasen said she would have to check her tax statements to know
whether she received money from companies at the time she worked on the panel,
but said, "What I do know is that I do almost nothing with drug companies.
. . . My area of research is neuroimaging, not psychopharmacology."
The analysis could not determine the extent or timing of the financial ties
because it relied on disclosures in journal publications and other venues that
do not mention many details, said Sheldon Krimsky, a science policy specialist
at Tufts University who also was an author of the new study. Whether the researchers
received money before, during or after their service on the panel did not remove
the ethical concern, he said.
Krimsky, the author of the book "Science in the Private Interest,"
added that although more transparency is welcome, the psychiatric association
should staff its panels with disinterested experts.
"When someone is establishing a clinical guideline for the bible of psychiatric
diagnosis, I would argue they should have no affiliation with the drug companies
in those areas where the companies could benefit from those decisions,"
he said.