Looking beyond the spin of Big Pharma PR. But encouraging gossip. Come in and confide, you know you want to! “I’ll publish right or wrong. Fools are my theme, let satire be my song.”
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Jiji PressNovartis Pharma K.K. said it has failed to report to the health ministry at least 2,579 cases of serious side effects, including a fatality, from its drugs for leukemia and other diseases even though its employees were aware of the problems.
Of the total, 1,313 cases were related to Glivec and 514 cases to Tasigna, both drugs for leukemia treatment, and 261 cases involved cancer drug Afinitor, said the Japanese unit of Swiss drug giant Novartis AG on Friday.
The findings were reported to the Health, Labor and Welfare Ministry the same day.
Marketing employees at the firm had recognized the side effects, but failed to report them to its division in charge in violation of its internal rules, Novartis Pharma said. They were not fully aware of the seriousness of the problem, while higher-ranking officials failed to supervise them properly, it said
Illinois medical regulators have indefinitely suspended the medical license of psychiatrist Michael Reinstein, who prescribed more of the most powerful and riskiest antipsychotic drug clozapine than any other doctor in the country.
The decision by Illinois' Department of Financial and Professional Regulation, signed Friday, suspends Reinstein's license for a minimum of three years, at which time he can apply to have it reinstated.
The state's medical disciplinary board recommended the sanction in May after determining that Reinstein, 71, 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 because of potentially life-threatening side effects of the drug. Reinstein's motion for a rehearing was denied Friday, making the matter public.
Clozapine is approved to treat 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 dangerous for elderly patients.
Reinstein's prescribing patterns have been explored in two ProPublica reports.
In 2009, ProPublica and the Chicago Tribune detailed how he had prescribed more of the antipsychotic clozapine to patients in Medicaid's Illinois program in 2007 than all doctors in the Medicaid programs of Texas, Florida and North Carolina combined. Autopsy and court records showed that, by 2009, 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.
Last year, as part of an investigation into Medicare's failure to monitor problem prescribers, ProPublica reported that Reinstein prescribed even more clozapine in Medicare's prescription drug program for seniors and the disabled. We found that the program continued to let him prescribe even after the U.S. Department of Justice accused him of fraud and Illinois' Medicaid program suspended payments to him.
Reinstein's attorney did not return a phone call or email seeking comment. An outgoing message on Reinstein's cell phone said, "Due to a personal emergency I will not be working as of today. I will return to work as quickly as I can."
In their response to the medical board's accusations, Reinstein's lawyers invoked his right against self-incrimination.
The state of Illinois has the authority to permanently revoke a doctor's license, but typically only does so for sex crimes or assaults on patients, a spokeswoman said by email. When a doctor's license is indefinitely suspended, as is the case with Reinstein, the doctor must apply after a set time to return to practice; the state's approval is not automatic.
The federal fraud lawsuit against Reinstein is pending in U.S. District Court in Chicago. In a November 2012 news release announcing the case, the government said that Reinstein "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."
Prosecutors allege that Reinstein's prescribing decisions were motivated by money and perks from pharmaceutical companies. He allegedly switched patients from one brand of clozapine to another based on money and other enticements he received from a drugmaker.
Reinstein's prescribing of clozapine appears to have declined after the 2009 articles about him. From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and a brand-name version, FazaClo. That figure dropped to about 8,000 in 2012, according to data obtained by ProPublica.
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