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Education Reporter

Antipsychotic Medicines For Children Come Under Suspicion
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A panel of federal drug experts warned that doctors are overprescribing antipsychotic drugs for children, despite their significant side effects. The experts met to review the antipsychotic medicines Risperdal and Zyprexa, specifically their suitability for children. Officials from the Food and Drug Administration (FDA) expected the panel to endorse the agency's current policies, but the panel unanimously rejected that course and called for the FDA to do much more to curb pediatric use.

In 2007, more than 389,000 American children and teens took Risperdal. 240,000 of them were age 12 or younger. The panel members focused their comments on Risperdal, a Johnson & Johnson product, but said their concerns were also relevant to other drugs like it. Risperdal is one of five popular "atypical antipsychotics" approved for adult use. The others are Zyprexa, Seroquel, Abilify and Geodon.

Once the Food and Drug Administration approves a drug to treat one illness, doctors can prescribe it to treat other illnesses at their own discretion, a practice called "off-label use." Risperdal prescriptions for children are often off-label, as doctors prescribe the powerful antipsychotic drug to treat attention deficit disorders.

"The data shows there is a substantial amount of prescribing for attention deficit disorder, and I wonder if we have given enough weight to the adverse event profile of the drug in light of this," said panel member Dr. Daniel Notterman of Princeton University.

Children are especially susceptible to Risperdal's side effects, which can be quite serious. Patients who take the drug frequently suffer significant weight gain, metabolic disorders, and muscular tics that can be permanent, even after the drug is discontinued. Between 1993 and March of 2008, 1,207 children experienced severe side effects from Risperdal, and in 31 of those children the side effects were fatal.

The other atypical antiphsychotics show similar potential to severely disable or kill some of the children who take them. But prescription rates continue to rise. Risperdal prescriptions for patients under 18 rose 10% in 2007, even as prescriptions for adults fell 5%. Overall, doctors prescribe antipsychotic drugs for five times as many children and teen patients as they did 15 years ago.

Dr. Thomas Laughren, who directs the FDA's psychiatric products division, said Risperdal's label already warns doctors of the potential side effects. The FDA can do little else to cut down on pediatric prescriptions, said Laughren, but medical specialty societies could try to reduce prescriptions by emphasizing to doctors the dangers to children. (New York Times, 11-19-08)

The financial interests of several very prominent psychiatrists has cast further suspicion on the use of psychotropic drugs for children. Dr. Joseph Biederman, a world-renowned Harvard child psychiatrist, has been the leading advocate of diagnosing children with bipolar disorder. Doctors diagnosed bipolar disorder in 40 times as many children in 2003 as in 1994, and the diagnosis often results in a prescription for antipsychotic medicine. Congressional investigators found early last year that Biederman had received over $1 million from drug companies, much of it from Johnson & Johnson. Biederman failed to report this income to Harvard, as the university requires. This suggested a conflict of interest.

Besides giving money directly to Biederman, Johnson & Johnson gave another $1 million to fund Biederman's Massachusetts General research center on bipolar disorder in children and adolescents. The center's publicly stated missions included "to move forward the commercial goals of Johnson & Johnson."

Emails and documents from Johnson & Johnson suggest that Biederman may have agreed to use his reputation and authority to promote the use of Risperdal to treat children. Johnson & Johnson obtained Biederman's signature on a scientific abstract on Risperdal, and presented it at a professional meeting as if Biederman were the author, though he was not.

The documents, which surfaced in a recent lawsuit, also show that Johnson & Johnson employees consulted Biederman on how to "spin" the fact that children given placebos improved, as well as those treated with Risperdal. The company left that information out of the abstract on Risperdal that it presented under Biederman's name.

Senator Charles Grassley (R-Iowa) discovered conflicts of interest in several other doctors' and researchers' ties to drug companies. Dr. Frederick Goodwin, a psychiatrist who hosted a radio show called "The Infinite Mind," never mentioned on air that drug companies paid him to give marketing lectures on some of the same products he mentioned favorably on his show.

On the same day in 2005 that Goodwin earned $2,500 from GlaxoSmithKline for promoting the mood stabilizer Lamictal at a medical conference, Goodwin recommended on air the use of mood stabilizers for children. "As we'll be hearing today," he said, "modern treatments — mood stabilizers in particular — have been proven safe and effective in bipolar children." Goodwin also made the controversial statement that children with untreated bipolar disorder could suffer brain damage. Over the course of that year, Goodwin received $329,000 for promoting Lamictal.

The program's producer said he was unaware of Goodwin's ties to drug companies, and that the relationship violated NPR's requirements. NPR removed the program, which had over one million listeners and had won more than 60 journalism awards. (New York Times, 11-30-08)

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