Pharma Money Maybe Funny Business

Pharma Money Maybe Funny Business



One of the major problems with the exchange of money between
pharmaceutical companies and professional health organizations and
practitioners is the possibility of the money tainting the objectivity
of the professional recommendations. Below is a clear example of how
this behavior muddies the scientific waters, especially in light of
recent studies that question the effectiveness of antidepressants.

Below is an article from the New York Times, at the end of the article
is a link to the story in the online pages of the Times.

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

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."



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