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Pharmaceutical scam: Whistleblower charges medical oversight bureau with corruption

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BMJ  2004;329:69 (10 July), doi:10.1136/bmj.329.7457.69

Whistleblower charges medical oversight bureau with corruption
Jeanne Lenzer

Source: British Medical Journal

New York

Dr Stefan Kruszewski, a psychiatrist hired by the Bureau of Program Integrity in the Pennsylvania Department of Public Welfare, filed a law suit on 1 July in a federal court in the Middle District of Pennsylvania, charging that he was fired on 11 July 2003 after he uncovered widespread abuse and fraud in the bureau.

Dr Kruszewski's role at the bureau was to oversee the state's mental health and substance misuse programmes to protect against fraud, waste, and abuse. When he uncovered serious abuses, including deaths of children in the state's custody possibly due to substandard care and the off-label use of potent atypical antipsychotic medications, "they fired the messenger," Dr Kruszewski told the BMJ.

Dr Kruszewski's efforts to clarify the causes of death in four children and one adult in the state's care were blocked when he was denied postmortem or coroner's reports and hospital records. Some of the patients were taking as many as five antipsychotic medications at the same time—something Dr Kruszewski says is "hard to justify."

When Dr Kruszewski warned that off-label use of the drugs was potentially harmful to patients and could expose the state to liability he was told that "it's none of your business," said Dr Kruszewski.

Dr Kruszewski charges in his suit that a number of drug companies used "political friendships, money, and other emoluments" to achieve "a level of influence with Pennsylvania's state government" and with the "current president of the United States, George W Bush" to promote "the use of their products in violation of the law and of the rights of Pennsylvania citizens."

Dr Kruszewski charges that corrupt practices, supported by political contributions from drug companies, resulted in off-label use of medication, misuse of medication that resulted in the deaths of children under the care of the Pennsylvania Office of Medical Assistance and the Bureau of Program Integrity, overmedication of adults and children, and fraudulent billing, among other abuses.

His charges mirror those of other whistleblowers, including Allen Jones, who reported that drug companies gave money to officials with influence over the Pennsylvania state formulary (19 June, p 1458), and David Franklin, who recently won a $240m (£131m; 195m) settlement with Pfizer for its promotion of the off-label use of gabapentin (Neurontin) (22 May, p 1217).

Dr Stefan Kruszewski warned against off-label use of drugs

Dr Kruszewski told the BMJ that it was money and influence, not good medicine, that drove prescribing practices. "There was horrendous polypharmacy," said Dr Kruszewski. "They were putting almost all patients on the same concoction of antipsychotic and antiseizure drugs—but many of the patients weren't psychotic and they didn't have seizures. Many were simply drug addicts. This [kind of prescribing] didn't happen five years ago."

Political and drug company influence, said Dr Kruszewski, was evident when George W Bush, then governor of Texas, bragged about the Texas Medication Algorithm Plan (TMAP) during his presidential campaign while at the same time receiving large campaign contributions from the same drug companies that funded—and benefit from—the medication algorithm (19 June, p 1458). TMAP recommends the use of newer, more expensive, antipsychotics and antidepressants—drugs manufactured by the same companies that paid for the development of TMAP. One of Dr Kruszewski's supervisors was instrumental in bringing TMAP to Pennsylvania.

When Allen Jones, an investigator with the Office of the Inspector General of Pennsylvania, discovered that an off the record bank account was funded by drug companies to pay state officials to promote TMAP, he was fired for persisting with the investigation after he was warned off, according to his whistleblower suit.

Dr Kruszewski, who voted for Bush in the 2000 presidential election, now regrets his vote, saying, "I was terminated because I did my job. It turns out that drug companies and politicians were influencing the drugs prescribed for patients."

A spokeswoman for the Pennsylvania Department of Public Welfare said the department never commented on pending litigation.



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