Lilly, J&J Antipsychotics No Better for Kids Than Older Generic
By Rob Waters
Sept. 15 (Bloomberg) -- Best-selling antipsychotic medicines by Eli Lilly & Co. and Johnson & Johnson caused more side effects and were less effective for children with schizophrenia than a little-used 30-year-old generic drug costing one-fourth as much.
For the study, published today in the American Journal of Psychiatry, 116 children ages 8 to 19 were given molindone, an older drug available as a generic, or a newer antipsychotic, either Lilly's Zyprexa, which generated $4.8 billion in sales in 2007, or J&J's Risperdal, with $4.7 billion in revenue.
Most children failed to improve on any of the drugs; side effects were more common in those taking the newer ones. Zyprexa, in particular, caused weight gain and unwanted boosts in insulin, blood fat and liver function tests. The trial is the latest in a series of studies finding that the newer, more expensive drugs don't produce greater benefits for patients of varying ages, researchers said.
``This is yet one more study which has failed to find any significant area of advance or superiority of the second- generation medicines,'' said Jeffrey Lieberman, senior author and a professor of psychiatry at Columbia University in New York, in a Sept. 12 telephone interview. The drugs sell because of ``very aggressive marketing campaigns and a wish among patients there was something better out there,'' he said.
Lilly, based in Indianapolis, fell 12 cents to $46.60 in New York Stock Exchange composite trading on Sept. 12. Johnson & Johnson, of New Brunswick, N.J., dropped 57 cents to $70.59.
J&J's Risperdal was cleared by U.S. regulators last year for treating adolescents with schizophrenia and bipolar disorder; Lilly's Zyprexa isn't approved for any pediatric use.
4.4 Million Prescriptions
Use among children of the newer antipsychotics, including Zyprexa, Risperdal and three other drugs, more than doubled to 4.4 million prescriptions between 2003 and 2006, according to data provided in 2007 by Wolters Kluwer NV, a pharmaceutical industry tracking company.
Both companies are facing lawsuits by states, labor unions and insurers, alleging that they marketed the drugs for unapproved uses and withheld information about side effects.
Schizophrenia causes hallucinations and disrupts people's ability to think clearly and affects about 1.1 percent of the U.S. population age 18 and older, according to the Web site of the National Institute of Mental Health, which funded the study.
The results reflect the difficulty of helping children and teenagers with early signs of serious mental illness, and point to the need for newer, better drugs, said NIMH Director Thomas Insel, director of the National Institute of Mental Health in Bethesda, Maryland.
``It is time to realize that the compounds we have now help some patients get better but they really don't help many to get well,'' Insel said in a Sept. 12 telephone interview.
Easing of Symptoms
about half of the children and teenagers taking molindone had an easing of their symptoms, compared with 46 percent of those taking Risperdal and 34 percent of those taking Zyprexa, the study found. Zyprexa costs $215 for the lowest dose used in the study, Risperdal is priced at $123 and molindone is $56, according to Drugstore.com, an on-line retailer.
The fact few children taking Zyprexa benefited while many gained weight led the independent board monitoring the safety of patients in the trial to stop recruiting patients to take the Lilly drug.
Levels of a hormone, prolactin, rose among patients taking Risperdal. This could trigger early menstruation in girls and cause growth of breast tissue in boys, Lieberman said.
``When it comes to the weight and metabolic side effects of the newer antipsychotic drugs, the younger you are, the more susceptible you are,'' he said.
To contact the reporter on this story: Rob Waters in San Francisco at firstname.lastname@example.org.
Last Updated: September 15, 2008 00:00 EDT