Suspended doctors taint drug trials
By A TIMES EDITORIAL
Published September 8, 2007
Here's a good rule of thumb: If a doctor is not allowed to treat patients, he shouldn't be trusted to do drug trials.
You would think that this bit of self-evident wisdom would be incorporated into the standards and practices of the pharmaceutical industry and that any physician with a suspended license would be barred from supervising testing to determine the safety and efficacy of new drugs. Thanks to an investigation by Times staff writer Kris Hundley, we know otherwise.
According to Hundley's account, a number of doctors in Florida who have had their medical licenses suspended, or received other professional black marks from the Florida Board of Medicine, were nonetheless hired by drug companies as clinical investigators. These doctors were paid upward of $1,000 per patient, and were trusted to keep accurate records, follow protocols and protect patient safety. Yet they had demonstrated in some cases extreme malpractice in their dealings with patients.
In one of the most egregious examples, Dr. William Espinoza, a Coral Gables surgeon, was allowed to conduct a drug trial after his license was temporarily suspended. A patient died after he performed a liposuction and tummy tuck on her, then he proceeded with another surgery after being ordered to stop.
In some cases the Health Department had fined physicians for failing to keep proper medical records, yet the drug companies hired them anyway. The companies either didn't bother to check or were willing to disregard findings that directly implicated a doctor's ability to gather data and maintain adequate records - skills essential for dependable drug studies.
The greed of the pharmaceutical industry is certainly not news. And its demonstrably slipshod approach to whom it enlists to help speed new drugs to market isn't a surprise either. But the U.S. Food and Drug Administration has a responsibility to police drug trials and make sure they are conducted under the highest professional standards.
The unfortunate fact is that a doctor has to mess up pretty substantially to earn formal action by state regulators, who are notoriously lax. In light of that, the FDA should disqualify any physician who has been found by an official body to have endangered the health or safety of patients or provided an insufficient standard of care.
The FDA says that it spot checks maybe 1 percent of drug trial sites, which means the doctors are essentially on the honor system to conduct the trials ethically and properly. At least the agency should preclude those who have already shown that such trust is misplaced.