U.S. Senator Probes American Psych Assoc. Drug $ - Pharmalot and NY
Times
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PharmalotGrassley Probes Psychiatrists Over Ties To PharmaBy Ed
SilvermanJuly 11th, 2008The investigation by the Senate Finance
Committee, where Chuck Grassley is the ranking Republican, into the
ties between drugmakers and medicine is expanding. After targeting
grants issued to academic psychiatrists, Grassley now wants the
American Psychiatric Association to open its books for a look-see at
pharma funding.

Psychiatrists, of course, prescribe antidepressants and
antipsychotics, both of which have stirred controversy. And
psychiatrists have frequently shown up at the top of lists of doctors
receiving pharma money. This week, for instance, Vermont's Attorney
General released its annual report showing that, of the top 100
recipients, psychiatrists received the highest level of payments, and
11 psychiatrists received a total of about $626,000, or approximately
20 percent of the total value of payments. The average amount
received by psychiatrists was nearly $57,000.

Not coincidentally, the Senate committee's conflicts-of-interest
probe into oversight of grants issued by drugmakers and the NIH has
focused on three psychiatrists - Harvard University's Joe Biederman,
Stanford University's Alan Schatzberg and the University of
Cincinnati's Melissa DelBello.

The following e-mail was sent to APA members.

Date: 07/11/2008 11:07AM

Subject: Message from APA Leadership

Fellow Members of the APA:

The APA Office has just received a letter from Senator Grassley of
Iowa, requesting a complete accounting of APA revenues, except those
from advertising in our journals, from pharmaceutical companies,
starting in 2003. We will, of course, provide this information, which
had already been available to our members.

These monies have supported activities including symposia, program
bags, buses, and exhibits at our annual meetings and research and
leadership training for outstanding residents. Our compliance with
the rules governing these revenues has earned us accolades from the
accrediting agency.

We are not alone; recent public focus on relationships between
medicine and the pharmaceutical industry is a challenge for the whole
field of medicine. The APA fully endorses the concept of transparency
in our relationships with pharma and other entities and has been in
the forefront of the disclosure process. In March, 2008, long before
this inquiry from Senator Grassley, your Board of Trustees empaneled
a working group charged to review all APA pharmaceutical revenues,
sort them into categories; and provide the Board with options for
ending pharmaceutical support in each category and the implications
for the activities they currently fund. We are proud of what we do.

We will continue to keep you informed aout this and all matters of
importance to members of the APA.

UPDATE: The New York Times now has a story about this in its Saturday
paper.



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Letters: letters@...

New York Times
Psychiatric Group Faces Scrutiny Over Drug Industry Ties
By BENEDICT CAREY and GARDINER HARRIS
July 12, 2008

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.


Senator Charles E. Grassley, right, Republican of Iowa, is demanding
that the American Psychiatric Association give an accounting of its
financing from the pharmaceutical industry.

Dr. Alan F. Schatzberg, president-elect of the American Psychiatric
Association.

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." Link to story:
http://www.nytimes.com/2008/07/12/washington/12psych.html?
pagewanted=1&_r=1&hp&adxnnlx=1215864652-m2tZw2kjyNNEhUZnR2r/ng

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