While working as a fraud investigator in the Pennsylvania Office of Inspector General, Bureau of Special Investigations, Allen Jones discovered the off-the-books slush fund account where atypical makers were depositing money under the guise of "educational grants," to influence state officials and policy makers involved in developing the preferred drug list in Pennsylvania. Mr Fiorello was in the position to approve drugs for patients in prisons and 9 state hospitals.
The profits from this scheme were enormous. For instance, Zyprexa was listed for schizophrenia, and Mr Jones' estimates that Pennsylvania has roughly 9,000 schizophrenic patients in state prisons and mental hospitals at any given time.
"And based on the average length of stay," he reports, "an additional 4,000 patients move through the system each year resulting in the potential recruitment of 13,000 customers, worth about $6,000 each per year."
In addition, "when patients leave state institutions with prescriptions for medication," he says, "many of them continue to be supported through Medicaid."
Another former investigator, psychiatrist Dr Stefan Kruszewski, worked in the Pennsylvania Bureau of Program Integrity in the Department of Public Welfare, and says his investigations found serious abuses and over-drugging of patients in state care. One case he reported in 2003 involved four children and one adult who died due to substandard care and the off-label prescribing of atypical antipsychotics.
"The people most vulnerable to the medicating for profit scheme in Pennsylvania," Dr Kruszewski says, "were children in state care or involved in the juvenile justice system, the disabled, and the prison population."
He calls the over-prescribing that took place polypharmacy at its worst. "Nearly all the patients," he explains, "were prescribed a combination of drugs, an antipsychotic and an antiseizure medication."
"But worst of all," he says, "the medical records showed that most of the patients who were receiving the drugs had never been psychotic and had never had a seizure."
"That fact that Medicaid patients are over-medicated to the max," says patient advocate Vince Boehm, "is not debatable."
"According to provider's reports," he states, "even three antipsychotics, with a witches' brew of other preparations, is not unusual for patients being discharged from state hospitals."
Mr Boehm says the public system has failed these clients and "the taxpayers will be left to subsidize the cleanup of this mess for generations to come."
The ultimate goal in the drugging-for-profit scheme was to keep patients on the drugs for life. For example, Ellen testified that, although Zyprexa was approved only to treat the manic phase of bipolar disorder, which is typically brief, her son "was put on this drug for two years until he fell into a coma and died."
She pointed out that in 2000-2002, there was no FDA warning guide Zyprexa so she was completely in the dark about the new drug prescribed to Rob, but said the current guide on the FDA website is almost the same as having no guide at all.
"Nothing on this document would have been helpful to me," Ellen said. There is still no description for the symptoms of hyperglycemia that might have saved her son had she known about them the week before he died," she noted.
When Rob suddenly lapsed into a coma and died, Ellen was determined to find out what happened and she subsequently learned that other countries had required warnings about the risk of hyperglycemia, diabetes and death on the label of Zyprexa since the spring of 2002, on the website of the consumer advocacy group, Public Citizen.
During her testimony, Ellen reminded the FDA panel that back in 2001, before her son was killed, the FDA met with its equivalent agencies around the world, and they all agreed to cooperate with each other particularly on drug safety, and pointed out that this obviously did not happen with the FDA.
The profits from this scheme were enormous. For instance, Zyprexa was listed for schizophrenia, and Mr Jones' estimates that Pennsylvania has roughly 9,000 schizophrenic patients in state prisons and mental hospitals at any given time.
"And based on the average length of stay," he reports, "an additional 4,000 patients move through the system each year resulting in the potential recruitment of 13,000 customers, worth about $6,000 each per year."
In addition, "when patients leave state institutions with prescriptions for medication," he says, "many of them continue to be supported through Medicaid."
"The people most vulnerable to the medicating for profit scheme in Pennsylvania," Dr Kruszewski says, "were children in state care or involved in the juvenile justice system, the disabled, and the prison population."
He calls the over-prescribing that took place polypharmacy at its worst. "Nearly all the patients," he explains, "were prescribed a combination of drugs, an antipsychotic and an antiseizure medication."
"But worst of all," he says, "the medical records showed that most of the patients who were receiving the drugs had never been psychotic and had never had a seizure."
"That fact that Medicaid patients are over-medicated to the max," says patient advocate Vince Boehm, "is not debatable."
"According to provider's reports," he states, "even three antipsychotics, with a witches' brew of other preparations, is not unusual for patients being discharged from state hospitals."
Mr Boehm says the public system has failed these clients and "the taxpayers will be left to subsidize the cleanup of this mess for generations to come."
The ultimate goal in the drugging-for-profit scheme was to keep patients on the drugs for life. For example, Ellen testified that, although Zyprexa was approved only to treat the manic phase of bipolar disorder, which is typically brief, her son "was put on this drug for two years until he fell into a coma and died."
She pointed out that in 2000-2002, there was no FDA warning guide Zyprexa so she was completely in the dark about the new drug prescribed to Rob, but said the current guide on the FDA website is almost the same as having no guide at all.
"Nothing on this document would have been helpful to me," Ellen said. There is still no description for the symptoms of hyperglycemia that might have saved her son had she known about them the week before he died," she noted.
When Rob suddenly lapsed into a coma and died, Ellen was determined to find out what happened and she subsequently learned that other countries had required warnings about the risk of hyperglycemia, diabetes and death on the label of Zyprexa since the spring of 2002, on the website of the consumer advocacy group, Public Citizen.
During her testimony, Ellen reminded the FDA panel that back in 2001, before her son was killed, the FDA met with its equivalent agencies around the world, and they all agreed to cooperate with each other particularly on drug safety, and pointed out that this obviously did not happen with the FDA.
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