US doctor faces jail in pharma bribery case

A US doctor is facing a jail sentence after pleading guilty to over-prescribing a hazardous anti-psychotic drug to patients in return for kickbacks.

71-year-old Michael Reinstein from Chicago admitted to accepting around $600,000 in bribes in return for prescribing the schizophrenia treatment Clozaril (clozapine) as well as generic versions of the drug to his patients.

Clozaril was originally developed by Novartis' unit Sandoz and was one of the first drugs to show any impact on the negative symptoms of schizophrenia such as apathy and social withdrawal, as well as dampening down positive symptoms such as hallucinations.

Its use is however limited by serious side effects including agranulocytosis, a dramatic decline in white blood cells, as well as cardiovascular complications and seizures, and it is generally considered a last-line medicine for resistant cases. Generics are sold by Mylan and Teva, which acquired its product when it bought IVAX in 2006.

Reinstein prescribed the drug to thousands of patients after agreeing to promote the drug in 2003, according to a Chicago Tribune investigation, which claims at least three of his patients died as a direct result of exposure to the drug.

He has already lost his licence to practice medicine and faces four years in prison, although his legal counsel is attempting to reduce that to one and a half years via a plea bargain, and must also pay a $592,000 fine.

Meanwhile Reinstein has also agreed a settlement in a civil lawsuit - brought by the US attorney's office - which alleged he had filed 140,000 fraudulent Medicare and Medicaid claims and was the most prolific prescriber of the drug in the US, once writing scrips for 490 patients in the space of just five days.

The settlement calls for him to pay more than $3.7 million in penalties to the US government and the state of Illinois.

In 2003 he agreed to start promoting IVAX/Teva's generic in return for a $50,000 a year consulting agreement and $100,000 in annual speaking fees along with other benefits including all-expenses-paid trips to Miami for him and his wife. Last year, Teva agreed to pay $27.6 million to settle charges that it made bribery payments to Reinstein.

The Physician Payment Sunshine Act in the US - implemented in 2010 - is designed to throw a spotlight on pharma's payments to physicians by offering them up to public scrutiny.

The first disclosure of payments last September revealed that doctors and teaching hospitals received around $3.5 billion from pharma and medical device companies between August and December 2013.