article: after sanctions, doctors get drug company pay ...

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After Sanctions, Doctors Get Drug Company Pay

By GARDINER HARRIS and JANET ROBERTS

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 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. 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. 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. 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. & , the maker of

Risperdal, paid Dr. Hardrict more than $30,000 in 2003 and 2004.

Srikant Ramaswami, a spokesman for & , 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 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. "