Tuesday, February 19, 2008

Antipsychotics Pounded Again - Philadelphia Inquirer

 
 
Philadelphia Inquirer,
Tarnished View of Wonder Drugs
Feb. 17, 2008
By Karl Stark
CHIP ELLIS / For The Inquirer
Tammy Wandling of West Virginia hired legal counsel in Philadelphia after son Austin developed a growth in his breast while taking Risperdal for autism.
 
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SARAH J. GLOVER / Inquirer Staff Photographer
John Huff of Pleasantville, N.J., required surgery to remove the female-size breasts he developed at 14 while on Risperdal.
 
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SARAH J. GLOVER / Inquirer Staff Photographer
John Huff, 17, of Pleasantville, N.J., took the antipsychotic Risperdal for seven years for behavioral problems. "He would ask me 'Am I a girl?' said his mother, Nicola. A spokeswoman for Risperdal's maker, Janssen, said the side effect was rare. 
 
When they were first introduced in the early 1990s, new antipsychotic medications for severe mental illness were seen as wonder drugs that were safer and more effective than their predecessors.

Sales soared as doctors tried them on new conditions, including dementia, aggression and other behavioral problems. Children and the elderly were among the biggest users.

But now, several studies questioning some of the drugs' benefits have led many doctors to talk of using them for shorter periods and with tighter monitoring, because of side effects that include sedation, obesity and diabetes.

"You can't just pop someone on it and see them in a year," said Jason Karlawish, a geriatric psychiatrist at the University of Pennsylvania.

These drugs, known as atypical antipsychotics, offer a contentious case study of a common pattern in pharmaceuticals. New drugs are typically approved for narrow uses and get tried off-label on conditions that are difficult to treat. Companies' sales efforts stoke up overall use until the research catches up years later, dulling the early enthusiasm. While some patients are helped, lawsuits are also a common legacy.

The atypicals were originally approved for severe mental illness - schizophrenia and bipolar disorder - which had limited markets.

But under a determined marketing effort portraying them as safer and more effective than their predecessors, the atypicals came to be tried beyond their approved uses for nursing-home residents, prisoners, and children younger than 6 years old.

Total U.S. sales for the class reached $13 billion in 2007, doubling sales of 2002, according to IMS Health Inc., a pharmaceutical-information firm. Atypicals carry such names as Risperdal, made by Janssen Pharmaceutica, part of Johnson & Johnson; Zyprexa from Eli Lilly & Co.; Seroquel by AstraZeneca P.L.C.; Geodon by Pfizer Inc.; and Abilify by Bristol-Myers Squibb Co.

All over the country, state officials are discovering that atypicals have become the largest drug class in Medicaid, the health program for the poor. And many state officials question whether that reflects overzealous marketing or real need. Several states, including Pennsylvania, are suing some drugmakers for allegedly promoting the drugs beyond approved uses and commissioning "ghost-written" articles to stoke use of the drugs.

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