US: Psychiatric Group Faces Scrutiny Over Drug Industry Ties

It seemed an ideal marriage, a scientific
partnership that would attack mental illness from all sides.
Psychiatrists would bring to the union their expertise and clinical
experience, drug makers would provide their products and the money to
run rigorous studies, and patients would get better medications, faster.

But now the profession itself
is under attack in Congress, accused of allowing this relationship to
become too cozy. After a series of stinging investigations of
individual doctors' arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field's premier professional organization, give an accounting of its financing.

The
association is the voice of establishment psychiatry, publishing the
field's major journals and its standard diagnostic manual.

"I
have come to understand that money from the pharmaceutical industry can
shape the practices of nonprofit organizations that purport to be
independent in their viewpoints and actions," Mr. Grassley said
Thursday in a letter to the association.

In 2006, the latest year
for which numbers are available, the drug industry accounted for about
30 percent of the association's $62.5 million in financing. About half
of that money went to drug advertisements in psychiatric journals and
exhibits at the annual meeting, and the other half to sponsor
fellowships, conferences and industry symposiums at the annual meeting.

This weekend in Chicago, the psychiatry association's board will
meet behind closed doors, in part to discuss how to respond to the
increasingly intense scrutiny and questions about conflicts of interest.

"With
every new revelation, our credibility with patients has been damaged,
and we have to protect that first and foremost," said Dr. Steven S.
Sharfstein, a former president of the association and now president of
the Sheppard Pratt Health System in Baltimore. "I think we need to
review all arrangements between doctors and industry and be very clear
about what constitutes a conflict of interest and what does not."

One
of the doctors named by Mr. Grassley is the association's
president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million
stock holdings in a drug development company raised the senator's
concern. In a telephone interview, Dr. Schatzberg said he had fully
complied with Stanford's rigorous disclosure policies and federal
guidelines that pertained to his research.

Blocking or
constraining researchers from trying to bring medications to market
"will mean less opportunities to help patients with severe illnesses,"
Dr. Schatzberg said, adding, "Drugs that are helpful may not be
developed by big pharmaceutical companies, for a variety of reasons,
and we need some degree of communication between academia and industry"
to expand options for patients.

Commercial arrangements are
rampant throughout medicine. In the past two decades, drug and device
makers have paid tens of thousands of doctors and researchers of all
specialties. Worried that this money could taint doctors' research
plans or clinical judgment, government agencies, medical journals and
universities have been forced to look more closely at deal details.

In
psychiatry, Mr. Grassley has found an orchard of low-hanging fruit. As
a group, psychiatrists earn less in base salary than any other
specialists, according to a nationwide survey by the Medical Group
Management Association. In 2007, median compensation for psychiatrists
was $198,653, less than half of the $464,420 earned by diagnostic
radiologists and barely more than the $190,547 earned by doctors
practicing internal medicine.

But many psychiatrists supplement
this income with consulting arrangements with drug makers, traveling
the country to give dinner talks about drugs to other doctors for fees
generally ranging from $750 to $3,500 per event, for instance.

While
data on industry consulting arrangements are sparse, state officials in
Vermont reported that in the 2007 fiscal year, drug makers gave more
money to psychiatrists than to doctors in any other specialty. Eleven
psychiatrists in the state received an average of $56,944 each. Data
from Minnesota, among the few other states to collect such information,
show a similar trend.

In both states, individual psychiatrists
are not top earners, but consulting arrangements are so common that
their total tops all others. The worry is that this money may subtly
alter psychiatrists' choices of which drugs to prescribe.

An
analysis of Minnesota data by The New York Times last year found that
on average, psychiatrists who received at least $5,000 from makers of
newer-generation antipsychotic drugs appear to have written three times
as many prescriptions to children for the drugs as psychiatrists who
received less money or none. The drugs are not approved for most uses
in children, who appear to be especially susceptible to the side
effects, including rapid weight gain.

Senator Grassley's
investigations have not only detailed how lucrative those arrangements
can be but have also shown that some top psychiatrists failed to report
all their earnings as required.

After The Times reported on such an arrangement involving Dr. Melissa P. DelBello of the University of Cincinnati,
Mr. Grassley asked the university to provide her income disclosure
forms and asked AstraZeneca, the maker of the antipsychotic Seroquel,
to reveal how much it paid her.

In scientific publications, Dr.
DelBello has reported working for eight drug makers and told university
officials that from 2005 to 2007 she earned about $100,000 in outside
income, according to Mr. Grassley.

But AstraZeneca told Mr.
Grassley it paid her more than $238,000 in that period. AstraZeneca
sent some of its payments through MSZ Associates, an Ohio corporation
Dr. DelBello established for "personal financial purposes."

The University of Cincinnati agreed to monitor those payments more closely.

In
early June, the senator reported to Congress that Dr. Joseph Biederman,
a renowned child psychiatrist at Harvard Medical School, and a
colleague, Dr. Timothy E. Wilens, had reported to university officials
earning several hundred thousand dollars apiece in consulting fees from
drug makers from 2000 to 2007 when in fact they had earned at least
$1.6 million each.

Another member of the Harvard
group, Dr. Thomas Spencer, reported earning at least $1 million after
being pressed by Mr. Grassley's investigators. The Harvard
psychiatrists said they took conflict-of-interest policies seriously
and had abided by disclosure rules.

In late June, after Mr.
Grassley singled out Dr. Schatzberg, Stanford disputed some of the
numbers in the report and has denied that Dr. Schatzberg violated any
research rules devised to police such conflicts.

In an
interview on Wednesday, Dr. Nada L. Stotland, president of the
psychiatric association, said the group had studied Mr. Grassley's
letter and Stanford's response and agreed with Stanford. Dr. Schatzberg
will take over as president of the association as planned, she said.

"The
larger issue here is that there's a revolution going on" in how
medicine handles industry money, said Dr. Stotland, a psychiatrist at
Rush Medical College in Chicago. "That's good, that's what we need, and
I believe we've been on the cutting edge of that revolution in many
ways."

Dr. Stotland said that the association began reviewing
the income it received from pharmaceutical companies last March, to
identify potential conflicts. Doctors and academic researchers
generally worked at arm's length from industry until the early 1980s,
when Congress passed the Bayh-Dole Act. This legislation encouraged
closer collaboration between researchers and industry to bring products
to market more quickly. The act helped foster the growth of the biotech
industry, and soon professors and universities were busy obtaining
patents and building relationships with industry.

Some
psychiatrists have long argued that consulting with a company - to help
design a rigorous drug trial, for instance - benefits patients, as long
as the researcher has no financial stake in the product and is not paid
to speak about the drug to other doctors, like a traveling pitchman.

Others say industry and academic researchers are now so deeply
intertwined that exposing doctors' private arrangements only stokes
suspicion without correcting the real problem: bias.

"Having everyone stand up like a Boy Scout
and make a pledge isn't going to quell suspicion," said Dr. Donald
Klein, an emeritus professor at Columbia, who has consulted with drug
makers himself. "The only hope to rule out bias is to have open access
to all data that's produced in studies and know that there are people
checking it" who are not on that company's payroll.

Studies have
shown that researchers who are paid by a company are more likely to
report positive findings when evaluating that company's drugs. The
private deals can directly affect patient care, said Dr. William
Niederhut, a psychiatrist in private practice in Denver who receives no
industry money.

Dr. Niederhut said company-sponsored doctors
had spread the word that new and expensive drugs were better in
treating bipolar disorder than lithium, the cheaper old standby
treatment.

"It's a sales pitch, and now it's looking like a
whole lot of people would have done better if they'd started on lithium
in the first place," Dr. Niederhut said in a telephone interview. "The
profession absolutely has to come clean on these industry deals, and
soon."

Tighter rules, stronger statements and more debate may not
make much difference, if Mr. Grassley's findings are any guide.
Universities have rules requiring that faculty members disclose their
outside income so that conflicts of interest in research or patient
care can be managed. But some of the psychiatrists named in the
investigations apparently ignored the rules.

"I think we may be
coming to a point where hospitals and medical schools have to get
serious about sanctioning," said Dr. Paul S. Appelbaum, director of the
division of psychiatry, medicine and the law at Columbia. "You can
suspend doctors' privileges, or suspend their right to treat patients;
both have a huge impact on income and career. But if you're serious
about these disclosure policies, you have to be willing to back them
up."

• 182 Health
• 208 Regulation