Sunday, June 03, 2007

Minnesota Psych Busting Rampage - NY Times

 
All this story boils down to is DOCUMENTS
(1)   Disciplinary public recordsavailable in every state.
(2)   Public records that show how much money is given to doctors by drug companies.  This article says "Minnesota is the only state to make its records publicly available" but according to this USA Today story http://www.usatoday.com/news/health/2007-03-20-1488435574_x.htm there are also disclosure laws in Vermont, California, the District of Columbia, Maine and West Virginia and similar legislation was proposed last year in 11 other states. 

New York Times
June 3, 2007
After Sanctions, Doctors Get Drug Company Pay

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.

Dr. Faruk Abuzzahab

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.

Money for Sanctioned Doctors

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.”

More here: http://tinyurl.com/25honr

 

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