New York Times
June 3, 2007
By GARDINER HARRIS and JANET ROBERTS
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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