(Yet More) Negative Study Results with Blockbuster Anti-Psychotic Drugs Prescribed to the Young

 

-Network Medica

09/15/2008- A study funded by the National Institute of Mental Health, and published in the American Journal of Psychiatry by author and research team leader Dr Jeffrey Lieberman, a professor of psychiatry at Columbia University in New York, reveals that most of the 116 children – ages 8 to 19 - prescribed the new anti-psychotic drugs Eli Lilly´s Zyprexa or Johnson & Johnson´s (J&J) Risperdal failed to improve, and side effects were more common, than those given molindone, an older drug available as a generic.

Lieberman remarked when interviewed after the publication of the article that “This is yet one more study which has failed to find any significant area of advance or superiority of the second- generation medicines,'' and that the drugs sell because of “very aggressive marketing campaigns and a wish among patients there was something better out there.''

J&J´s Risperdal (risperidone/paliperidone) was cleared by the Food and Drug Administration (FDA) last year for treating adolescents with schizophrenia and bipolar disorder. In the first half of this year, it generated almost $ 2.2 billion dollars in sales.

Eli Lilly´s Zyprexa is approved for the same uses, but not for children as yet – this drug is the eight placed best-selling drug worldwide, with sales of almost $ 2.4 billion dollars in the first six months of 2008.

Both Eli Lilly and J&J are facing lawsuits by states, labor unions and insurers, alleging that they marketed the drugs for unapproved uses and withheld information about side effects.

The study revealed that 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.

According to the study, most children failed to improve on any of the drugs; side effects were more common in those taking Zyprexa or Risperdal.

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.

Zyprexa, in particular, caused weight gain and unwanted boosts in insulin, blood fat and liver function tests.

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 Eli 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, Dr. 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 added.

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