Monthly Archives: January 2008

Lilly Considers $1 Billion Fine to Settle Case

New York Times

By ALEX BERENSON

Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company’s marketing of the antipsychotic drug Zyprexa that could result in Lilly’s paying more than $1 billion to federal and state governments.

Drug Files Show Maker Promoted Unapproved Use (December 18, 2006) If a deal is reached, the fine would be the largest ever paid by a drug company for breaking the federal laws that govern how drug makers can promote their medicines.

Several people involved in the investigation confirmed the settlement discussions, which began last year and took on new urgency this month. The people insisted on anonymity because they have not been authorized to talk about the negotiations.

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Eli Lilly show that from 2000 to 2003 the company encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously had a diagnosis of depression…

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Florida agency to review antipsychotic drug policy for kids

Daytona Beach News Journal

By M.C. MOEWE

The Florida Agency for Health Care Administration plans to create a subcommittee to review its guidelines on payments for medications after questions were raised about antipsychotics being prescribed for children in the state’s insurance program for the poor.

Medicaid will pay for a drug only if it is “medically necessary and prescribed for medically accepted indications,” according to the agency’s current guidelines.

The Daytona Beach News-Journal reported earlier this month that the number of Florida Medicaid children prescribed antipsychotics had nearly doubled — from 9,364 seven years ago to 18,137 in 2006. Among those children, the most common primary diagnosis was attention deficit hyperactivity disorder — an ailment not approved for treatment with antipsychotics by the Food and Drug Administration…

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Florida Medicaid To Review Antipsychotics & ADHD

Pharmalot

By Ed Silverman

The move comes amid growing scrutiny. The taxpayer bill for these meds jumped from $9 million seven years ago to nearly $30 million in 2006. Florida Medicaid records reportedly show the number of children – some just months old – who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. And even as drugmakers were being told to issue warnings about risks, a Florida Legislature-directed program partly funded by drugmakers was recommending the meds as treatment for ADHD, although FDA approval is lacking.

As a result, the Florida attorney general is considering whether to file a lawsuit. Now, the state’s Agency for Health Care Administration is responding to concerns that the meds are being used inappropriately for treating ADHD, in particular, and will review coverage. The AHCA’s own guidelines, by the way, state that “antipsychotics should not be used primarily to target ADHD symptoms, should not be used to promote weight gain, and should not be used as sedatives for children…and the use of antipsychotics in children under the age of six is generally not recommended.”

Yet, a recent report by the University of South Florida found the most common diagnosis for antipsychotic treatment for youngsters in Florida’s Medicaid program between July and December 2005 was for ADHD -and 54 percent involved children 5 years of age and younger, while 49 percent involved kids between ages 6 and 12 (please see table 5). And so nearly 40 percent of all antipsychotic scrips for youngsters were written for ADHD during that same period…

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Eli Lilly settles 900 more claims over Zyprexa

Indianapolis Star

INDIANAPOLIS — Eli Lilly and Co. has settled another 900 personal-injury claims against its antipsychotic drug Zyprexa, including five set to go to court next month, thus avoiding what would have been the first trial in the U.S. The Indianapolis drug maker confirmed the settlement Wednesday but declined to reveal the amount. With the latest agreements, Lilly has settled more than 25,000 claims, leaving about 1,100 unsettled. Many of the plaintiffs have claimed Lilly underplayed the drug’s side effects, including weight gain and elevated blood sugar. Lilly has set aside $1.2 billion to pay claims.

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Drugs for children? Prescriptions of anti-psychotics troubling

Daytona Beach News Journal

Editorial

Parents at their wits’ end, wearing long sleeves to hide bruises and bite marks inflicted by their own offspring. Psychiatrists struggling to cope with children as young as 2 who show intractable behavior problems. Drug companies ready to suggest powerful drugs that can produce marked changes in a child’s behavior — getting heavily involved in state-level determinations of which drugs should be prescribed for which conditions. And a state struggling to keep up with rapid changes that have pushed Medicaid costs for powerful anti-psychotic drugs from $9 million seven years ago to almost $30 million in 2006.

Something doesn’t add up. Do all these children need the drugs they’re being prescribed? Without a careful review of individual medical records, it’s difficult to say — but the trend is disturbing. Other states are already pushing hard for answers, and Florida should join in. The drugs in question are known as atypical anti-psychotics and include Risperdal, Abilify, Geodon and Seroquel. Originally intended to treat major mental illnesses like schizophrenia and bipolar mania, they have become increasingly widely prescribed for children with autism and attention-deficit disorder with tics.

Yet, the U.S. Food and Drug Administration has approved few of these drugs for use with children — especially in conjunction with many of the conditions for which the powerful drugs are prescribed. There’s little research on the effects of the drugs, and a growing number of reports suggest that the medication could be responsible for deaths or serious side effects, including tardive dyskenisa (involuntary jerking of the limbs and grimacing)…

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Florida undecided as states sue over costly drug program

Daytona Beach News Journal

Mary Moewe

They’re powerful psychotic drugs, used to treat conditions like schizophrenia. No one knows what their effects are on children, especially infants, yet within seven years the number of children prescribed the drugs in Florida’s health insurance program for the poor has nearly doubled.

There’s no doubting one side effect, though — drug companies watched sales soar, aided by a Florida program they helped create.

Florida is far from unique. Several states also noted the costly boom of atypical antipsychotics — a new class of the drug that was touted to have fewer side effects. The states are suing drug makers, alleging the companies pushed newer, untested drugs that proved no more effective in treatments — but were far more costly.

In Florida, the taxpayers’ bill for the drugs jumped from $9 million seven years ago to nearly $30 million in 2006. Whether Florida will join states like Texas, Pennsylvania and South Carolina in trying to recoup some of those costs is unclear.

“Our office is aware of concerns with antipsychotics in Florida’s Medicaid program but we cannot acknowledge nor provide any information pertaining to ongoing criminal investigations,” said Sandi Copes, a spokeswoman with the Florida Attorney General’s office.

Florida Medicaid records show the number of children — some just months old — who were prescribed the drugs went from 9,364 seven years ago to 18,137 in 2006. No records for privately insured patients are available…

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