An Illinois-based psychiatrist, Michael J. Reinstein, M.D., has been sentenced to nine months in federal prison. In total, Reinstein took nearly $600,000 in consulting fees, vacation trips and other kickbacks in return for prescribing various forms of the antipsychotic drug clozapine to mentally ill patients in Chicago-area nursing homes and hospitals. At one point, Reinstein was the largest prescriber of the drug to Medicare recipients in the U.S.

The sentencing has prompted discussions about ethical conduct in the medical community and pharmaceutical industry.

Assistant U.S. Attorney Eric Pruitt argued that Reinstein abused his position as a physician and “took advantage of the faith and trust” of his mentally ill patients for his own financial benefit. Many medical providers are troubled by the case and believe that when physicians allow drug-company money to influence clinical decisions, it damages public trust and affects the ability of doctors to develop the therapeutic relationships needed to engage patients in their own care.

“We as physicians are honor-bound to hold ourselves to the utmost ethical standards of practice within our profession. Any physician who would betray public trust is despicable and dishonorable,” said Richard Bunt, M.D., who is in private practice in Palm Bay, Florida, and is also involved in drug research through the Psykeira/Space Coast Neuropsychiatric Research Institute. “The damage wrought by a man of this sort extends far, far beyond the lives of his patients.”

When he pleaded guilty last year, Reinstein, 72, paid $3.79 million to settle a lawsuit brought by the U.S. attorney’s office alleging that he submitted more than 140,000 false Medicare and Medicaid claims as part of the kickback scheme. Teva Pharmaceuticals and IVAX Pharmaceuticals also paid $27.6 million to settle federal and state civil charges associated with the case.

Reinstein admitted in his plea agreement that he first began accepting payments from a drug manufacturer during the 1990s for prescribing the brand-name version of clozapine to hundreds of patients. Court records show he stopped accepting speaking contracts and other payments in 2009.

Noted bioethicist Arthur Caplan, Ph.D., said the legal system moved slowly in convicting and sentencing Reinstein for long-ago behavior and the kickbacks at the core of the case largely represent “last generation issues.”

During the past decade, many steps have been taken to minimize the chance of dubious relationships between pharmaceutical companies and physicians. The Physician Payment Sunshine Act, which Congress passed in 2010, requires drug manufacturers to post detailed information about any physician payment or benefit worth more than $10 on a publicly available website. Even before the law took effect, companies including Pfizer, Eli Lilly and GlaxoSmithKline went public about payments they made to doctors. In addition, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a set of guidelines in 2002 that changed how drug representatives interact with doctors and a short time later, the U.S. Department of Health and Human Services issued similar guidelines that added severe penalties.

“This (Reinstein) case is like a trip to the past. This sort of ‘bribe the doctors and take them out for dinner’ is a last generation issue. The companies are sharp enough to know that they are not going to get away with that stuff. They are being watched and they don’t do it,” said Caplan, head of the Division of Medical Ethics at New York University, Langone Medical Center in New York City. “I’m not going to say it couldn’t happen again. It might. But I think it’s widely recognized that the kind of shenanigans and outrageous behavior that he engaged in have no place in medicine.”

At the same time, Caplan said new ethical issues have emerged, such as conflict of interest in research and arguments between institutions over patents, such as the dispute over who will benefit from gene-editing technology. In addition, sponsor companies have moved away from the historical focus on blockbuster drugs, which relies on making money through sales volume, and toward a model that emphasizes personalized medicines and therapies for rare diseases. As a result, rather than try to convince doctors to prescribe their drug in bulk, many sponsors are positioning themselves for higher-priced drugs. Another top area of concern for bioethicists today is the industry’s use of direct-to-consumer advertising for medications.

“We told companies not to bribe the doctors, so they are bombarding patients with direct-to-consumer ads. They have shifted their marketing efforts. We should prohibit direct-to-consumer advertising. It does not educate and it serves no purpose other than to generate ill-informed demand,” said Caplan.

Reinstein was sentenced about a month after another doctor was sentenced in a high-profile case involving the over-prescription of drugs. Los Angeles practitioner Hsiu-Ying Tseng, M.D., was sentenced to 30 years to life in prison for the murders of three patients who fatally overdosed on addictive drugs.

“There is no denying that we have witnessed the deterioration of certain basic social mores in our country,” said Bunt. “Statistically speaking, there will always be a certain small percentage of smooth sociopaths who ‘go off the rails’ with their behavior. These outliers should be severely punished and removed from their positions where they can do further damage. It’s not about ‘making an example of them.’ It’s simply about demonstrating that part of the system works, at least when it comes to extreme cases.” 

Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master’s of Science degree from the Columbia University Graduate School of Journalism. Email karyn.korieth@centerwatch.com.

This article was reprinted from Volume 20, Issue 12, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »