Reprimands didn’t halt doctors’ drug testing — (The New York Times)

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The New York Times

Originally published June 3, 2007 at 12:00 AM 

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, five 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 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 drug makers 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 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 Abuzzahab’s patients was David Olson, whom the psychiatrist tried repeatedly to recruit for clinical-drug trials. Drug makers paid Abuzzahab thousands of dollars for every patient he recruited. In July 1997, when Olson again refused to be a test subject, Abuzzahab discharged him from the hospital even though he was suicidal, records show. Olson committed suicide two weeks later.

In its disciplinary action against Abuzzahab, the state medical board referred to 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, 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’ 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 three 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. Abuzzahab received more than $55,000 from 1997 to 2005.

Drug makers either 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 FDA approach in keeping people safe in clinical trials,” 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 FDA plans to require such disclosures, 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’ 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,” 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.