OT: NYT: Psychatric Group Faces Scrutiny Over Drug Industry [Gardiner ]

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NY Times

July 12, 2008

Psychiatric Group Faces Scrutiny Over Drug Industry Ties

By BENEDICT CAREY and GARDINER HARRIS

http://www.nytimes.com/2008/07/12/washington/12psych.html?th & emc=th

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 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.

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.

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. ph

Biederman, a renowned child psychiatrist at Harvard Medical School,

and a colleague, Dr. 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. 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. 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. 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. 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. "