Teva Pharmaceutical Industries
Ltd. has agreed to pay more than $27.6 million to settle state and federal
allegations that it induced Chicago psychiatrist Michael Reinstein
to overprescribe clozapine, a powerful antipsychotic drug.
Reinstein has twice figured into ProPublica investigations.
Four years ago, ProPublica and the
Chicago Tribune spotlighted Reinstein’s prescribing
pattern, findingthat in 2007 he had prescribed
more clozapine to patients in Medicaid’s Illinois program than all of the doctors in the Medicaid
programs of Texas, Florida and North Carolina combined. At least three
of Reinstein’s patients died of clozapine
intoxication. At that time, Reinstein defended his
prescription record, arguing that clozapine is effective and underprescribed.
Then, last spring, ProPublica
reported that Reinstein prescribed even more of the
drug in Medicare’s prescription drug program for seniors and the disabled. ProPublica cited Reinstein in an
investigation about how Medicare
fails to monitor problem prescribers, finding that the program continued to
let him prescribe even after federal prosecutors accused him of fraud and
Illinois’ Medicaid program suspended payments to him.
Generic clozapine, an anti-schizophrenia drug manufactured
by Teva, is approved to treat cases that don’t
respond to other medications. But clozapine can have dangerous side effects,
including seizures, inflammation of the heart muscle and a drop in white blood
cells. The drug is considered to be particularly dangerous for elderly
patients.
Illinois Attorney General Lisa Madigan and the U.S. Justice
Department claimed that IVAX, a Teva Pharmaceuticals
subsidiary, paid Reinstein to overprescribe clozapine
to Medicare and Medicaid patients. Yesterday Teva agreed
to pay almost $15.5 million to the federal government and more than $12.1
million to Illinois to settle those allegationsout of court. Teva spokeswoman Denise Bradley told
Reuters that the settlement does not mean that the company has admitted any
liability.
“Pharmaceutical companies must not be allowed to improperly
influence physicians’ decisions in prescribing medication for their patients,”
Zachary T. Fardon, U.S. Attorney for the Northern
District of Illinois, said
in a statement on Tuesday. “Instead, those decisions must be made solely on
the basis of the patient’s best medical interests.”
In November 2012, federal
prosecutors also filed
suit against Reinstein, alleging that IVAX hadpaid him $50,000 a year to work as a consultant, paid his nurse to
promote the drug and funded a study at an affiliated research institute. After the payments, Reinstein began overprescribing clozapine. The company also
allegedly paid for trips and entertainment for Reinstein
and his friends.
The suit against Reinstein is
still pending. Reinstein’s attorney did not immediately
respond to request for comment.
