In Texas, a review of prescription records for the months of July and August 2004, found that more than 19,400 teenagers were prescribed antipsychotics billed to a publicly funded program, according to ACS-Heritage, a medical consulting firm hired by the state to investigate the use of psychotropic drugs on children.
With nearly 98% of the teens, ACS reported, the antipsychotics were prescribed off-label and in more than half of the cases, the dosage appeared to be inappropriately high. The study also said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drugs, and one-third were on 2 or more drugs.
Research published in the March/April 2006 Journal of Ambulatory Pediatrics, led by Dr William Cooper at Vanderbilt University, analyzed 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 nearly 6 million outpatient visits to health care providers by children between the ages of 2 and 18, during which an antipsychotic was prescribed. Nearly 80% of the visits occurred in physician's offices, 14% in outpatient clinics, and 9% in emergency departments.
The authors of the research pointed out that there had been no increase in mental health disorders that could account for the increases "as recent studies do not suggest significant increases in the incidence of schizophrenia," they stated.
"In addition," the researchers noted, "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," they said, "the most likely explanation for the study results is that similar to our findings in the Tennessee Medicaid population, there was a substantial increase in physician prescribing of antipsychotics during the study period."
Experts say the side effects of Zyprexa are more common and severe in children than in adults. The Children's Hospital of Philadelphia recently found that 19% of children who were newly diagnosed with Type 2 diabetes were being treated with the new antipsychotics.
Zyprexa is not only dangerous when used by children, it is less effective than the older cheaper antipsychotics. A study published in August 2006, by the New York Psychiatric Institute, found that the older antipsychotics worked much better, with the average response rate in children using the new antipsychotics at only 55.7%, compared to a 72.3% response rate among children who were given the older drugs.
The study also found that the average weight gain in patients treated with the older drugs was much lowers and the sedation side effect was less common. The authors of this study also pointed out that the FDA "has not approved any antipsychotic drugs for treating childhood schizophrenia; yet, clinicians routinely use medications for this disorder."
There is no doubt that Lilly knew about these serious health risks long before it issued warnings in the US in 2003. In a study published in the July 2002, journal Pharmacotherapy, P Murali Doraiswamy, the chief of biological psychiatry at Duke University, reviewed the FDA adverse event reports submitted on Zyprexa and found 289 cases of diabetes reported, with 225 patients being newly diagnosed.
In addition, the review showed that 100 patients developed ketosis, a serious complication of diabetes, and 22 people developed pancreatitis or inflammation of the pancreas that is life-threatening. The review identified 23 deaths, including a 15-year-old who died of necrotizing pancreatitis.
Last month, the New York Times reported details from the documents that Lilly wants to keep hidden, and revealed that Lilly sales representatives were promoting Zyprexa with primary care physicians specifically for the off-label treatment of dementia.
Before allowing Lilly to keep this information secret, the court needs to consider the harm being done to elderly citizens. On April 11, 2005, the FDA announced that elderly patients with dementia who were given antipsychotics were far more likely to die prematurely than those given placebos and also announced the addition of black box warnings about the increased risk of death on the labels of Zyprexa and the other atypical antipsychotics.
A June 13, 2005, study in the Archives of Internal Medicine, reviewed antipsychotic use in nursing home for approximately 2.5 million Medicaid beneficiaries and found that "over half (58.2%)," received drugs that exceeded the maximum recommended dosage, received duplicate therapy, or had inappropriate conditions for the drugs to begin with. The study determined that more than 200,000 residents received antipsychotic therapy but had "no appropriate indications for use."
In October 2005, the Journal of the American Medical Association published a meta-analysis of trials of more than 5,000 elderly patients treated with atypical antipsychotics that found that patients had a 54% increased chance of dying within 3 months, compared to patients taking a placebo.
