Curbs sought on psychiatric drugs given to children - KENTUCKY MEDICAID OFFICIAL SAYS THEY COULD POSE HEALTH RISKS

October 7, 2008

Maker expected to pay more than $1 billion in fines and plead guilty to criminal chargesTuesday, October 7, 2008, 9:12 AM

Note: Geodon, Seroquel and Zyprexa are controversial antipsychotic drugs not FDA approved for children

By Jim Warren, Lexington Herald Leader

Letters to the editor: http://www.kentucky.com/369/#

http://www.kentucky.com/news/state/story/547565.html

Kentucky's Medicaid program has spent more than $40 million since 2001 filling prescriptions for certain powerful drugs that help youngsters with emotional problems, but also could pose risks for their physical health.

Now, the program's medical director, Dr. Thomas Badgett, wants to rein in prescriptions for so-called "atypical anti-psychotic" drugs in children. Badgett plans to launch an effort early next year alerting Kentucky Medicaid providers to prescribe the drugs for youngsters only when their use is appropriate and to carefully monitor patients for problems.

Similar efforts in other states have reduced prescriptions of atypical anti-psychotics and saved millions of dollars, officials say.

Atypical anti-psychotics are a relatively new class of drugs often prescribed for conditions in both adults and children such as schizophrenia, bipolar disorder and irritability associated with autism. But mounting evidence suggests that they also can cause dramatic weight gains in some children and put youngsters at increased risk for Type II diabetes.

Badgett said an in-house assessment three years ago showed Kentucky Medicaid was "spending an incredible amount of money" on atypical anti-psychotics, and that many young Medicaid patients were taking four or more of the potent drugs at the same time, often obtaining them from multiple prescribers. According to Badgett, 42,000 Kentucky children under age 18, including children in foster care, were receiving atypical anti-psychotics through Medicaid as recently as 2005. He said numbers have been dropping since then.

According to figures provided by the state, Medicaid has spent more $40 million since 2001 filling prescriptions of just three atypical anti-psychotics — Geodon, Seroquel and Zyprexa — for Kentucky youngsters covered by the medical welfare program. Prescriptions for those drugs were filled more than 25,000 times during the period, the figures show.

Badgett, who is a pediatrician, said he began questioning such drugs when he was in private practice before joining Medicaid in 2004.

"I would have young patients go off to see a behavioral health specialist, and some would come back on these drugs," he said. "Frequently, they would experience just an incredible weight gain.

"That can be very emotionally upsetting to a young person, even though these drugs are supposed to deal with emotional problems. I got quite concerned about it."

Some recent studies suggest that atypical anti-psychotics could be no more effective that some older anti-pschyotic medications in treating emotional problems. Physicians and other experts also acknowledge that the atypicals do pose a risk for rapid weight gain in children, with reports of some young patients quickly putting on 30 pounds or more.

But Robert Kuhn, a pharmacy professor at the University of Kentucky, said atypical anti-psychotics do offer a significant advantage: They are less likely to cause young patients to develop movement disorders, such as jerks or tics, than the older drugs are.

"Clearly, there are some children who are going to do better on these drugs than on more traditional medications," he said.

Kuhn added that regular monitoring of young patients' weight, glucose levels and other markers should enable doctors to spot early signs of weight gains or other risks and head them off by switching to other drugs or putting patients on exercise programs.

In extreme cases, some weight gain might be a worthwhile trade-off, some practitioners suggest ...

33 States to Get $62 Million in Zyprexa Case Settlement

October 6, 2008By ALEX BERENSON, New York Times

http://www.nytimes.com/2008/10/07/business/07zyprexa.html?_r=1 & ref=business & oref=slogin

Eli Lilly has agreed to pay $62 million to 33 states to settle claims that it improperly marketed Zyprexa, its top-selling drug, to patients who did not have schizophrenia or bipolar disorder, its only approved uses.The settlement, to be announced Tuesday, ends an 18-month investigation led by the offices of the attorneys general of Illinois and Oregon, which contended that Lilly had violated consumer protection laws by urging doctors to prescribe Zyprexa to patients who did not need it.It is the largest settlement paid by a drug company in a state consumer protection case, topping the $58 million that Merck paid to settle similar allegations about Vioxx, lawyers for the states said.The agreement may also be a sign that a much larger deal is near in a separate but related civil and criminal investigation led by federal prosecutors in Philadelphia. In that case, Lilly is expected to pay more than $1 billion in fines and restitution to states and the federal government and may also plead guilty to a misdemeanor criminal charge related to off-label marketing of Zyprexa.“We know they’re working hard to get that settlement done,” said James D. Kole, the chief of the consumer fraud bureau for the Illinois office.The states’ investigation and the Philadelphia case center on Lilly’s marketing of Zyprexa, a potent brain tranquilizer that calms the hallucinations associated with schizophrenia and bipolar mania. Internal Lilly documents and e-mail messages appear to show that the company marketed it for patients with dementia and milder forms of bipolar disorder, a violation of federal law.Zyprexa can cause severe weight gain and an increase in blood sugar in many patients and is more likely to cause diabetes than most other medicines for schizophrenia and bipolar disorder, according to the American Diabetes Association.Once the Food and Drug Administration approves a drug for sale, doctors can prescribe it for whatever disease they see fit because the F.D.A. does not regulate the practice of medicine. But pharmaceutical companies can market and advertise their medicines only for the uses specified on the drug’s label.“The company’s deceptive marketing practices were illegal and highly dangerous,” Lisa Madigan, the attorney general of Illinois, said in a statement.A spokesman and a lawyer for Lilly did not return a call and an e-mail message for comment.David Hart, senior assistant attorney general for Oregon, said, “We’re trying to send a message to the pharmaceutical industry that consumer fraud is something we’re going to investigate and prosecute.”

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