A former Chicago psychiatrist who was the nation's top prescriber of the most powerful and riskiest antipsychotic drug intends to plead guilty to a federal felony charge of taking kickbacks from its manufacturer in exchange for prescriptions, court records show.
The U.S. Attorney for the Northern District of Illinois filed a single felony charge against Dr. Michael Reinstein this week for taking $2,000 in November 2009 from drugmaker Teva "in return for Reinstein's referrals of patients" for clozapine prescriptions.
Clozapine, also known as Clozaril and FazaClo, is approved to treat schizophrenia patients who don't respond to other medications. But it can have dangerous side effects, including seizures, inflammation of the heart muscle, and a drop in white blood cells. The drug is considered particularly risky for elderly patients.
A note in court records says that Reinstein intends to plead guilty at his arraignment next Friday. The action was first reported by the Chicago Tribune.
Reinstein's prescribing patterns have been detailed in two ProPublica reports.
In 2009, ProPublica and the Chicago Tribune reported how in one year Reinstein prescribed more of the antipsychotic clozapine to patients in Medicaid's Illinois program than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that at least three patients under Reinstein's care had died of clozapine intoxication. At that time, Reinstein defended his prescription record, arguing that clozapine is effective and underprescribed.
Then, in 2013, as part of a ProPublica investigation into Medicare's failure to monitor problem prescribers, we reported that Reinstein prescribed even more clozapine in Medicare's prescription drug program for seniors and the disabled. Medicare continued to let him prescribe in the program even after the U.S. Department of Justice accused him of fraud and Illinois' Medicaid program suspended payments to him.
The U.S. Attorney's office declined to discuss Reinstein's upcoming plea. Reinstein's attorney, Terence Campbell, did not immediately return a phone call from ProPublica seeking comment. He told the Tribune on Thursday that Reinstein was "working toward resolving the issues raised by the government and hopes to put this episode behind him soon."
The Tribune reached Reinstein, as well, yesterday. He would not discuss the criminal case but denied any payments from Teva, clozapine's manufacturer, were for prescribing the drug. The doctor instead said the money was for lectures he gave.
In November 2012, the federal government filed a civil fraud lawsuit against Reinstein, saying he "received illegal kickbacks from pharmaceutical companies and submitted at least 140,000 false claims to Medicare and Medicaid for antipsychotic medications he prescribed for thousands of mentally ill patients in area nursing homes."
Last August, Illinois medical regulators indefinitely suspended Reinstein's medical license after determining that Reinstein received " illegal direct and indirect remuneration" from the maker of generic clozapine, did not consider alternative treatments for his patients, and disregarded patients' well-being. In response to the medical board's accusations, Reinstein's lawyers invoked his right against self-incrimination.
Early last year, Teva Pharmaceutical Industries Ltd., the maker of generic clozapine, agreed to pay more than $27.6 million to settle state and federal allegations that it induced Reinstein to prescribe the drug.
Reinstein's prescribing of clozapine appears to have declined after our 2009 articles about him. From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and the brand-name version, FazaClo. That figure dropped to about 8,000 in 2012, according to data obtained by ProPublica.