After uninvolved staff members complained, the situation was investigated and the trial was stopped. As a result, all state hospital doctors were required to undergo re-certification in the ethics of medical research and the hospital's director, Dr Douglas Hughes, resigned after it was revealed that in the same year, he had received $30,000 in speaker's fees from Janssen.
In recent years the nation's children have become a major target for the pharmaceutical industry. The new antipsychotics are not approved to treat any condition in children but studies of children in Medicaid programs and HMOs have found a drastic increase in the use of the drugs with children, particularly for behavioral disorders, according to research published in the March/April 2006 Journal of Ambulatory Pediatrics.
Researchers lead by Dr William Cooper at Vanderbilt University in Nashville, TN, evaluated data drawn from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, which are national samples of health care services rendered to the US population and conducted by the National Center for Health Statistics.
Between 1995?2002, the study found that there were 5,762,193 outpatient visits to health care providers by children between the ages of 2?18 years-old, during which an antipsychotic was prescribed.
The study shows that Big Pharma has doctors in every setting prescribing these drugs to kids. Nearly 80% of the visits occurred in physician's offices, 14% in outpatient clinics, and 9% occurred in emergency departments. According to the study, 32% of the nearly 6 million prescriptions were written during visits to pediatricians, family physicians, emergency department physicians, or other types of providers.
According to Doctor Cooper, these antipsychotic medications have been studied in only a few controlled trials in children, and have not been studied at all for many behavioral diagnoses. But yet, the most common diagnosis for children prescribed an antipsychotic was attention deficit hyperactivity disorder or conduct disorder, accounting for 29.0% of all antipsychotic visits.
Affective disorders such as bipolar disorder or depression accounted for 23.6% of the visits so that together, behavioral and affective disorders represented more than half of the prescriptions during the study period. According to the authors, there is no evidence from controlled studies that supports the use of antipsychotics for behavioral conditions.
The report states that over 50% of the prescriptions were for a diagnosis for which antipsychotics have not been studied in children and that there is little recognized benefits to these medications in many of the children receiving them.
"Thus," the report notes, "the increasing prescribing of antipsychotic medications in children for behavioral indications is concerning given the paucity of information on the overall benefits and risks of this class of medications in children."
A finding in the study that demonstrates the ability of Big Pharma to successfully market drugs off-label to children is that the increased prescribing of antipsychotics for behavioral disorders coincided with the introduction of new atypical antipsychotic medications.
The study also explained that there has been no increase in mental health disorders such as schizophrenia that would account for the increases "as recent studies do not suggest significant increases in the incidence of schizophrenia," it concluded.
"In addition," the researchers explained, "schizophrenia and psychosis accounted for only 13.5% of the total antipsychotic visits during the study period, so this diagnosis alone could not explain the increase."
"Therefore, the most likely explanation for the study results is that similar to our findings in the Tennessee Medicaid population," the authors said, "there was a substantial increase in physician prescribing of antipsychotics during the study period."
The mass drugging of children on Medicaid is happening all over the country. In 2001, psychiatrist, Dr Stefan Kruszewski, was hired to review psychiatric care provided by government-funded agencies in Pennsylvania to identify fraud, waste, and abuse, and found cases of what he refers to as "insane polypharmacy," where children were placed in state-run treatment facilities and over-medicated with the new antipsychotics and anticonvulsants sometimes for years.
Over the past decade since the new antipsychotics came on the market, they have been linked to serious side effects, that include the risk of substantial weight gain, diabetes, and cardiac dysrythmias, and according to Dr Copper's report, preliminary studies suggest that side effects may occur more commonly and be more severe in children than in adults.
This assertion is proving to be true. The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with the new antipsychotic drugs, all of which are now required to carry a black box warning to alert doctors about the dangers of diabetes associated with the drugs.
In recent years the nation's children have become a major target for the pharmaceutical industry. The new antipsychotics are not approved to treat any condition in children but studies of children in Medicaid programs and HMOs have found a drastic increase in the use of the drugs with children, particularly for behavioral disorders, according to research published in the March/April 2006 Journal of Ambulatory Pediatrics.
Researchers lead by Dr William Cooper at Vanderbilt University in Nashville, TN, evaluated data drawn from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey, which are national samples of health care services rendered to the US population and conducted by the National Center for Health Statistics.
Between 1995?2002, the study found that there were 5,762,193 outpatient visits to health care providers by children between the ages of 2?18 years-old, during which an antipsychotic was prescribed.
According to Doctor Cooper, these antipsychotic medications have been studied in only a few controlled trials in children, and have not been studied at all for many behavioral diagnoses. But yet, the most common diagnosis for children prescribed an antipsychotic was attention deficit hyperactivity disorder or conduct disorder, accounting for 29.0% of all antipsychotic visits.
Affective disorders such as bipolar disorder or depression accounted for 23.6% of the visits so that together, behavioral and affective disorders represented more than half of the prescriptions during the study period. According to the authors, there is no evidence from controlled studies that supports the use of antipsychotics for behavioral conditions.
The report states that over 50% of the prescriptions were for a diagnosis for which antipsychotics have not been studied in children and that there is little recognized benefits to these medications in many of the children receiving them.
"Thus," the report notes, "the increasing prescribing of antipsychotic medications in children for behavioral indications is concerning given the paucity of information on the overall benefits and risks of this class of medications in children."
A finding in the study that demonstrates the ability of Big Pharma to successfully market drugs off-label to children is that the increased prescribing of antipsychotics for behavioral disorders coincided with the introduction of new atypical antipsychotic medications.
The study also explained that there has been no increase in mental health disorders such as schizophrenia that would account for the increases "as recent studies do not suggest significant increases in the incidence of schizophrenia," it concluded.
"In addition," the researchers explained, "schizophrenia and psychosis accounted for only 13.5% of the total antipsychotic visits during the study period, so this diagnosis alone could not explain the increase."
"Therefore, the most likely explanation for the study results is that similar to our findings in the Tennessee Medicaid population," the authors said, "there was a substantial increase in physician prescribing of antipsychotics during the study period."
The mass drugging of children on Medicaid is happening all over the country. In 2001, psychiatrist, Dr Stefan Kruszewski, was hired to review psychiatric care provided by government-funded agencies in Pennsylvania to identify fraud, waste, and abuse, and found cases of what he refers to as "insane polypharmacy," where children were placed in state-run treatment facilities and over-medicated with the new antipsychotics and anticonvulsants sometimes for years.
Over the past decade since the new antipsychotics came on the market, they have been linked to serious side effects, that include the risk of substantial weight gain, diabetes, and cardiac dysrythmias, and according to Dr Copper's report, preliminary studies suggest that side effects may occur more commonly and be more severe in children than in adults.
This assertion is proving to be true. The Children's Hospital of Philadelphia recently found that 19% of newly diagnosed Type 2 diabetic children were being treated with the new antipsychotic drugs, all of which are now required to carry a black box warning to alert doctors about the dangers of diabetes associated with the drugs.
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