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What To Do With A Risky Drug- Give It To Kids

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by Jane Akre

December 22, 2007
It sounds like a bad joke.
Zyprexa is an antipsychotic drug effectively given to treat millions of adults with schizophrenia and bipolar disorder.
Among a second generation of antipsychotics, Zyprexa was an “atypical” antipsychotic wonder drug developed in the 1990’s and thought to be a silver bullet in the battle against severe mental illness because it didn’t cause the tremors and facial tics of other drugs.
Atypical antipsychotics were more expensive but much heralded and with an intense marketing campaign, Zyprexa and other atypicals were increasingly prescribed by doctors for all sorts of mental health issues including “off label” to treat depression and anxiety.

But there were the downsides. Zyprexa caused serious weight gain and diabetes among patients who had no history of diabetes before taking it.

Internal Eli Lilly documents showed that 16 percent of patients on Zyprexa gained more than 66 pounds after taking the drug for a year, a figure higher than what Lilly revealed publicly.
In a St. Petersburg Times article, a sales rep says he was told to tell doctors that patients should drink a glass of water before they eat to suppress appetite to fight the weight gain.
The reps pitch was “Would you rather have a skinny, unwell patient or a fat, stable one?”
Ultimately some 30,000 patients sued the maker for these undisclosed side effects and Eli Lilly paid out more than $1-billion to settle the cases.
If you think that should be the end of the story you’d be wrong.
Eli Lilly has an application pending for approval of Zyprexa for adolescents and the FDA is poised to give the okay.
FDA Doc Overturns Experts
Lilly brought a six-week study of 107 teens with schizophrenia to the FDA as the basis for approval. Half of the teens were Russian.
But a three person expert advisory panel voted to deny approval for its use in adolescents based on insufficient data from those studies.
The reviewers were also concerned about the overwhelming positive responses among Russian patients and whether that might indicate fraud. The FDA found no evidence of fraud and the expert’s advice was overruled by the head of psychiatric drugs at the FDA.
In an April memo, Dr. Thomas Laughren of the FDA’s Division of Psychiatric Products wrote that the benefits of the drug outweigh the concerns. (His memo had to be released under a 2002 rule that requires the FDA to release summaries for pediatric use applications.)
Laughren concluded Zyprexa is effective and safe for treating children with schizophrenia and bipolar disorder.
Child Effects
Side effects in children include weight gain, sedation, fatigue and dry mouth - similar to what is seen in adults however “with some differences in magnitude” according to Laughren.
Kids on Zyprexa are reported to be always hungry and look puffy. Competitors told doctors that Zyprexa’s generic name, olanzapine, should be called “olanza-pig.” Some kids have reportedly gained 50 pounds on the drug.
Dr. Laughren believes that “These differences will need to be reflected in labeling.”
Another atypical antipsychotic, Johnson and Johnson’s Risperdal is the only one cleared by the FDA for use in children ages nine and older.
But Zyprexa is frequently given “off label” to children and teens to treat everything from behavioral problems including aggression and defiance to bipolar disorders. It is difficult to identify bipolar disorder or schizophrenia in adolescents as the symptoms can mimic depression or ADHD.
A St. Petersburg Times investigation finds in Florida children prescribed antipsychotics has increased some 250 percent over the last seven years. Children as young as three were included in the investigation. There have been no long term studies on the drugs’ affect on the brain.
The USA Today study finds that outpatient prescriptions for 2 to 18 year olds increased fivefold from 1995 to 2002 to about 2.5 million prescriptions. That is a rate growing dramatically faster than adult prescriptions.
Dr. David Healy a psychiatrist at the University of Wales says Zyprexa should be used as a last resort for adults and “it ought not to be used in children at all. It is going to be marketed as a safe and gentle drug, It is not a safe and gentle drug. I think it’s an extremely dangerous drug. The idea that it’s going to be given to children on a large scale is quite scary.”
A USA Today study of FDA data found that among 45 deaths among children where atypical antipsychotics were listed as the “primary suspect” at least six were related to diabetes. Many of the children were on a multitude of drugs. The youngest in the group was taking ten other drugs.
St. Petersburg, Florida attorney Joe Saunders has eight Zyprexa clients but still believes the drug may be helpful if properly monitored. “The fear is that based on its past history it’s a market grab” he tells IB News.
The litigation is not over for Zyprexa. A number of states are suing Lilly and other antipsychotic makers over aggressive advertising that downplayed the side effects. The states want to be reimbursed for Medicaid payouts in the hundreds of millions of dollars.
With fewer doctors writing prescriptions, sales for Zyprexa have been slipping from its high of $4.4 billion last year for Lilly’s biggest seller.
Lilly receives six extra months of protection under its patent which is set to expire in 2011 because of its pediatric studies. That amounts to an extra $1 billion in revenue according to estimates.
AstraZeneca is reportedly testing Seroquel in youngsters and may also apply for FDA approval.

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