| After Sanctions, Doctors Get Drug Company Pay |
Author: Jon Merz
Date: 06-03-07 11:24
http://www.nytimes.com/2007/06/03/health/03docs.html?hp
After Sanctions, Doctors Get Drug Company Pay
By GARDINER HARRIS and JANET ROBERTS
Published: June 3, 2007
A decade ago the Minnesota Board of Medical
Practice accused Dr. Faruk Abuzzahab of a
"reckless, if not willful, disregard" for the
welfare of 46 patients, 5 of whom died in his
care or shortly afterward. The board suspended
his license for seven months and restricted it
for two years after that.
But Dr. Abuzzahab, a Minneapolis psychiatrist, is
still overseeing the testing of drugs on patients
and is being paid by pharmaceutical companies for
the work. At least a dozen have paid him for
research or marketing since he was disciplined.
Medical ethicists have long argued that doctors
who give experimental medicines should be chosen
with care. Indeed, the drug industry's own
guidelines for clinical trials state,
"Investigators are selected based on
qualifications, training, research or clinical
expertise in relevant fields." Yet Dr. Abuzzahab
is far from the only doctor to have been
disciplined or criticized by a medical board but
later paid by drug makers.
An analysis of state records by The New York
Times found more than 100 such doctors in
Minnesota, at least two with criminal fraud
convictions. While Minnesota is the only state to
make its records publicly available, the problem,
experts say, is national.
One of Dr. Abuzzahab's patients was David Olson,
whom the psychiatrist tried repeatedly to recruit
for clinical trials. Drug makers paid Dr.
Abuzzahab thousands of dollars for every patient
he recruited. In July 1997, when Mr. Olson again
refused to be a test subject, Dr. Abuzzahab
discharged him from the hospital even though he
was suicidal, records show. Mr. Olson committed
suicide two weeks later.
In its disciplinary action against Dr. Abuzzahab,
the state medical board referred to Mr. Olson as
Patient No. 46.
"Dr. Abuzzahab failed to appreciate the risks of
taking Patient No. 46 off Clozaril, failed to
respond appropriately to the patient's rapid
deterioration and virtually ignored this
patient's suicidality," the board found.
In an interview, Dr. Abuzzahab dismissed the
findings as "without heft" and said drug makers
were aware of his record. He said he had helped
study many of the most popular drugs in
psychiatry, including Paxil, Prozac, Risperdal,
Seroquel, Zoloft and Zyprexa.
The Times's examination of Minnesota's trove of
records on drug company payments to doctors found
that from 1997 to 2005, at least 103 doctors who
had been disciplined or criticized by the state
medical board received a total of $1.7 million
from drug makers. The median payment over that
period was $1,250; the largest was $479,000.
The sanctions by the board ranged from reprimands
to demands for retraining to suspension of
licenses. Of those 103 doctors, 39 had been
penalized for inappropriate prescribing
practices, 21 for substance abuse, 12 for
substandard care and 3 for mismanagement of drug
studies. A few cases received national news media
coverage, but drug makers hired the doctors
anyway.
The Times included in its analysis any doctor who
received drug company payments within 10 years of
being under medical board sanction. At least 38
doctors received a combined $140,000 while they
were still under sanction. Dr. Abuzzahab received
more than $55,000 from 1997 to 2005.
Drug makers refused to comment, said they relied
on doctors to report disciplinary or criminal
cases, or said they were considering changing
their hiring systems.
Asked about the Minnesota analysis, the deputy
commissioner and chief medical officer of the
Food and Drug Administration, Dr. Janet Woodcock,
said the federal government needed to overhaul
regulations governing clinical trials and the
doctors who oversaw them.
"We recognize that we need to modernize the
F.D.A. approach in keeping people safe in
clinical trials," Dr. Woodcock said.
Drug makers are not required to inform the agency
when they discover that investigators are
falsifying data, and indeed some have failed to
do so in the past. The F.D.A. plans to require
such disclosures, Dr. Woodcock said. The agency
inspects at most 1 percent of all clinical
trials, she said.
Karl Uhlendorf, a spokesman for the
Pharmaceutical Research and Manufacturers of
America, said the trade group would not comment
on The Times's findings.
The records most likely understate the extent of
the problem because they are incomplete. And the
Minnesota Board of Medical Practice disciplines a
smaller share of the state's doctors than almost
any other medical board in the country, according
to rankings by Public Citizen, an advocacy group
based in Washington.
Dr. David Rothman, president of the Institute on
Medicine as a Profession at Columbia University,
said the Times analysis revealed a national
problem. "There's no reason to think Minnesota is
unique," Dr. Rothman said.
"Clinical trial investigators must be culled from
only the finest physicians in the country," he
said, "since they work on the frontiers of new
knowledge. That drug makers are scraping the
bottom of the medical barrel is an outrage."
Payments by drug companies to doctors, whether or
not the doctors have been disciplined, are a
matter of much debate. Drug makers and doctors
say the money finances vital research and helps
educate doctors about helpful medicines. But
others in the medical profession say the payments
are thinly disguised incentives for doctors to
prescribe more, and more expensive, drugs.
Among the other doctors who were disciplined or
criticized by the board and paid by
pharmaceutical companies:
¶Dr. Barry Garfinkel, a child psychiatrist from
Minneapolis who was convicted in federal court in
1993 of fraud involving a study for Ciba-Geigy.
His criminal case made headlines across the
state. From 2002 to 2004, Eli Lilly paid him more
than $5,500 in honoraria, according to state
records.
Dr. Garfinkel said in an interview that he had
wondered why drug makers would hire him as a
speaker considering his statewide notoriety. He
decided that "they're hiring me to influence my
prescribing habits," so he quit giving sponsored
talks and taking money from drug makers, he said.
¶Dr. John Simon, a Minneapolis psychiatrist who
for years shared an office with Dr. Abuzzahab and
was told by the state medical board in 1994 to
complete a clinical training program after it
concluded in a report that he "frequently makes
abrupt and drastic changes in type and dosage of
medication which seem erratic, not well
considered and poorly integrated with
nonmedication strategies." He prescribed
addictive drugs to addicts and failed to stop
giving medicines to patients suffering severe
drug side effects, the board concluded.
Dr. Simon earned more than $350,000 from five
drug makers from 1998 to 2005 for consulting and
giving drug marketing talks. Of this, Eli Lilly
paid more than $314,000. Dr. Simon said in an
interview that the board's action was a learning
experience, and that drug makers continued to
hire him to speak because "I am respected by my
peers."
Asked about Drs. Garfinkel and Simon, Phil Belt,
a spokesman for Eli Lilly, said that both doctors
were licensed to practice medicine and that the
company relied on doctors to report disciplinary
actions or criminal convictions against them.
¶Dr. Ronald Hardrict, a psychiatrist from
Minneapolis who pleaded guilty in 2003 to
Medicaid fraud. In 2004 and 2005, he collected
more than $63,000 in marketing payments from
seven drug makers. In an interview, Dr. Hardrict
said it was "insulting" and "ridiculous" to
suggest that income from drug makers might
influence doctors' prescribing habits.
"I bought the Mercedes because it has air bags,
and I use Risperdal because it works," Dr.
Hardrict said, referring to an antipsychotic
medicine for schizophrenia. Johnson & Johnson,
the maker of Risperdal, paid Dr. Hardrict more
than $30,000 in 2003 and 2004.
Srikant Ramaswami, a spokesman for Johnson &
Johnson, said the company removed Dr. Hardrict as
a speaker in 2004 when, as a result of his
conviction, his name appeared in a government
database.
Asked why other drug makers continue to hire him
despite a fraud conviction, Dr. Hardrict
responded with an e-mail message stating only, "I
will pray for you daily."
In cases involving Dr. Abuzzahab over 15 years in
the 1980s and '90s, the medical board found that
he repeatedly prescribed narcotics and other
controlled substances to addicts, renewing one
patient's prescriptions six weeks after the
patient was jailed and telling another that his
addictive pills should be thought of as
"Hamburger Helper." He prescribed narcotics to
pregnant patients, one of whom prematurely
delivered a baby who soon died.
In explaining his abrupt discharge of the
suicidal Mr. Olson, Dr. Abuzzahab told the
medical board that "if a patient is determined to
kill himself, he can't be prevented from doing it
and hospitalization postpones the event," records
show.
Mr. Olson's sister, Susie Olson, said Dr.
Abuzzahab "had no time for my brother unless
David agreed to get into a drug study. He said,
'You're wasting my time and the hospital's.' It
was all about money."
Separately, the F.D.A. in 1979 and 1984 concluded
that Dr. Abuzzahab had violated the protocols of
every study he led that they audited, and
reported inaccurate data to drug makers. He
routinely oversaw four to eight drug trials
simultaneously, often moved patients from one
study to another, sometimes gave experimental
medicines to patients at their first
consultation, and once hospitalized a patient for
the sole purpose of enrolling him in a study, the
F.D.A. found.
Dr. Abuzzahab, 74, was president of the Minnesota
Psychiatric Society and two decades ago was
chairman of its continuing education and ethics
committees. He would not discuss the specifics of
his disciplinary record, saying he did not have
the time. But in 1998 he signed an agreement with
the board saying that his conduct "constitutes a
reasonable basis in law and fact to justify the
disciplinary action."
A simple Google search reveals Dr. Abuzzahab's
1998 medical board disciplinary file, which was
reported at the time by a local newspaper and a
TV station. In 1998, The Boston Globe featured
Dr. Abuzzahab in a front-page article questioning
the safety of psychiatric drug experiments. And
in 1999, the NBC program "Dateline" did a segment
about a woman who committed suicide while in a
drug experiment he supervised.
In June 2006, the medical board criticized Dr.
Abuzzahab, this time for writing narcotics
prescriptions for patients he knew were using
false names, a violation of federal narcotics
laws.
Despite all this, drug makers continued to hire
him. Dr. Abuzzahab's résumé lists 11 publications
or research presentations since 2000, when the
medical board lifted its restrictions on his
license.
Takeda, a Japanese drug maker, confirmed that Dr.
Abuzzahab was doing a study financed by the
company on its sleep medicine, Rozerem. Eisai,
another Japanese drug maker, said that although
Dr. Abuzzahab had signed a clinical trial
agreement with the company to study its
Alzheimer's drug, Aricept, it told him two days
after a reporter asked for comment on the case
that he was not qualified to be an investigator.
And at AstraZeneca, for which Dr. Abuzzahab said
he had performed clinical trials and still gave
drug marketing lectures, a spokesman said the
company was "concerned" about Dr. Abuzzahab's
disciplinary record.
"We have our own internal processes for dealing
with these matters, which are under way," said
Jim Minnick, an AstraZeneca spokesman.
The Minnesota records often fail to distinguish
between drug company payments to doctors for
research and for marketing, so it is sometimes
impossible to determine why doctors were paid.
Some doctors, like Dr. Abuzzahab, clearly
performed both research and marketing.
Gene Carbona, who left Merck on good terms in
2001 as a regional sales manager after 12 years
in drug sales, said the only thing the company
considered when hiring doctors to give marketing
lectures was "the volume or potential volume of
prescribing that doctor could do."
A Merck spokesman declined to comment.
Mr. Carbona, now executive director of sales for
The Medical Letter, which reviews drugs, said
that had he known that a doctor had a
disciplinary record for excessive prescribing, "I
would have been more inclined to use them as a
speaker."
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Author |
Date |
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After Sanctions, Doctors Get Drug Company Pay new |
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Jon Merz |
06-03-07 11:24 |
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