Sunday - When her schizophrenic son dies, a mother files a lawsuit
claiming he was coerced into a drug study. Link:
http://tinyurl.com/6o996z
Monday - Who is responsible for protecting the people enrolled in
drug studies at the University of Minnesota? Link:
http://tinyurl.com/657xj3
Tuesday - An analysis of state data looks at whether psychiatrists
still receive the most money for drug studies. Link:
http://tinyurl.com/4v3945

Comments here: http://tinyurl.com/4v3945
Letters to the Editor here: letters@pioneerpress.com

St. Paul Pioneer Press (Minnesota)
What they spend: A look at drug company spending in Minnesota — on top
specialties and select psychiatrists. Critics say drug firms' payments
to doctors are conflict of interest
By Jeremy Olson and Paul Tosto
05/19/2008

Drug companies have given $88 million in gifts, grants and fees to
Minnesota doctors and caregivers since 2002, according to state
payment records, including $782,000 to the two University of Minnesota
psychiatrists who oversaw Dan Markingson's participation in a clinical
drug trial.

A lawsuit over Markingson's suicide, which happened during the drug
trial, accused Dr. Stephen Olson and Dr. S. Charles Schulz, chairman
of the U's psychiatry department, of coercing the schizophrenic
Markingson into the study.

The lawsuit, brought by Markingson's mother, Mary Weiss, charged that
the doctors were under pressure to recruit patients such as Markingson
to maximize payments from AstraZeneca and gain prestige by
participating in the drug company's national study.

Both doctors said in court depositions that their roles were
appropriate and that the money didn't influence their decisions over
Markingson — including when his mother argued that he wasn't getting
better in the study and should be withdrawn.

Schulz was dismissed from the lawsuit in February; Olson settled this
spring for an amount a university official described as little more
than court costs. Federal reviews of the death didn't result in any
penalties against the doctors or the university.

The case nonetheless offered an inside look at the kind of financial
payments to doctors that some health policy experts and congressional
representatives say should be restricted or at least fully disclosed
to the public.

It also scrutinized the ethics of drug company funding of research —
something that has received less public attention and criticism than
the free lunches, dinners and trips that drug companies have provided
to doctors to promote their drugs.

Markingson, 27, killed himself May 8, 2004, in the bathroom of a West
St. Paul halfway house. He had been enrolled for more than five months
in the university's "CAFE" study, which compared three antipsychotic
drugs.

Weiss sued the university and the psychiatrists. In an interview, she
said doctors have a conflict of interest when they are financially
benefiting from studies and caring for patients in those studies at
the same time.

"I think they lose sight that these are people," she said, "not their
own special little guinea pigs."

Minnesota is unique in requiring drug companies to report how much
money they give to each doctor, but the reporting system has
limitations. It doesn't always distinguish between money for a
doctor's travel expenses and money for a research trial, nor does it
distinguish money that was in a doctor's name but was passed directly
to a research institution.

U.S. Sen. Chuck Grassley, R-Iowa, is urging a national reporting
system. Grassley held a hearing last year in which two doctors said
their colleagues have become trapped by the lures and pressures of
drug company money.

"Physicians face a difficult choice," testified Dr. Greg Rosenthal, an
Ohio eye specialist. "One path is to go along. With drug company
money, you can increase your income, prestige, build your practice or
fund a department, research or professorships. The middle ground is to
simply look away. The hard choice is to fight back."

Olson received $220,000 from six companies since 2002, including
$149,000 from AstraZeneca, according to the state records. Schulz
received $562,000, including $112,000 as a researcher and consultant
to AstraZeneca.

Olson said his AstraZeneca money went straight to the U but did
support his salary. Markingson's full participation in the yearlong
study meant up to $15,000 for the university.

The amounts aren't unusual, according to the payment records collected
by the Minnesota Board of Pharmacy. The records, which were updated
this month to include 2007 figures, show 167 Minnesota doctors who
have received $100,000 or more since 2002. One in four psychiatrists
has received funding from pharmaceutical companies, averaging about
$50,000 over the six years.

Greater awareness of drug company payments has prompted tighter rules
among some Minnesota health care organizations. The Mayo Clinic
prohibits its doctors from being paid by drug companies to serve on
their speaker's bureaus. Doctors in speaker's bureaus give lectures to
other doctors about the company's medications.

The St. Mary's clinic system in Duluth recently banned pens, mugs or
other freebies bearing drug company logos.

There have been fewer steps to restrict drug company funding of
research, though most medical journals long ago required doctors to
disclose the funding source of any research results they publish. Some
health officials are now questioning the drug companies' use of
"ghostwriters" to revise articles about research results to promote
the drugs they sell.

Many universities view industry-sponsored research as a necessity amid
tightening state and federal science budgets. Drug company funding
makes up less than 7 percent of the psychiatry department budget at
the University of Minnesota, but Schulz said it is needed as the U
tries to move up the list of top-funded U.S. research institutions.

Since Olson was recruited in 2001 to boost the university's expertise
in schizophrenia, he has led the U's efforts in three drug trials
funded by AstraZeneca. He also took part in the federally funded
"CATIE" trial, which suggested that older antipsychotic drugs were as
effective as AstraZeneca's Seroquel and other newer drugs.

A growing body of research suggests that drug company money has an
influence on study outcomes. One analysis found that industry-funded
research was four to five times more likely to produce positive
outcomes for a paying company's drug than federally funded research. A
report last year found that drug company-funded studies of cholesterol
medications were much more likely to produce results that favored
their own drugs as well.

The CAFE results didn't show that AstraZeneca's Seroquel offered much
benefit over two competitors — Zyprexa and Risperdal. Patients gained
control over schizophrenic symptoms and tended to stop taking the
medications at the same rate, regardless of which drug they took. The
level of unhealthy weight gain was comparable, too, albeit slightly
higher among the Zyprexa patients.

Weiss sued AstraZeneca as well, though the company also was dismissed
from the lawsuit. Her attorneys argued that AstraZeneca's goal with
the CAFE study was to gain a marketing edge and that the company used
selective information from the study to promote Seroquel.

The attorneys cited internal documents, which have been sealed under
court order, in which AstraZeneca discussed its use of ghostwriters
and strategies to present CAFE results in a way that "sells" Seroquel.

AstraZeneca declined to discuss documents from the case, but brand
corporate affairs manager Abigail Baron said the company's financial
arrangements with doctors are necessary to improve health through drug
discovery.

"That mission cannot be fulfilled," she said, "without close
partnership with those on the front lines of patient care and ...
research."