If you know of anyone who is in a clinical drug program this is something they should be made aware of. I know I would be very cautious in choosing one after reading this article.
I think we all are aware that doctors get payback from the drug companies for recommending their product but this goes above and beyond those standards of paybacks and can be more harmful than good. End results can be fatal. An important note to remember is that a lot of the doctors conducting these trial are doctors who have received disciplinary action for one reason or another.
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.”