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Psychotropic prescriptions for children soar; conflicts of interest, informed consent under scrutiny

A series of articles in the Dallas Morning News focuses on alleged financial conflicts of interest of psychiatrists involved in the Children’s Medication Algorithm Project (CMAP). The CMAP protocol has been “quietly shelved” after objections were raised by Texas Attorney General Greg Abbott.

The state of Texas is suing a pharmaceutical company that allegedly used false advertising and improper influence to get its products on the now-mandatory adult protocol, the Texas Medication Algorithm Project (TMAP).

The newer drugs chosen for the protocol are ten times as expensive than traditional drugs, but have no substantial advantage, according to a report by the National Institute of Mental Health.

Sen. Charles Grassley (R-IA) stated that three Harvard experts whose research contributed to an explosion of antipsychotic drug use in children failed to report a combined $3.2 million in company consulting fees, in violation of Harvard’s rules.

Dr. Graham Emslie of University of Texas Southwestern, on the other hand, said he had never witnessed improper drug company influence in CMAP research.

Without the protocol, CMAP advocates warn that Texas children will be treated by individual doctors who have “their own personal influences” (Emily Ramshaw, Dallas Morning News 8/18/08).

Controversy about promotion of psychotropics in children is breaking out in other states also. New Jersey state assemblyman Michael Coherty wrote to the state department of health on Aug 20, asking about the policy that permited the NJ Medicaid program to spend $73 million between 2000 and 2007 on antipsychotic drugs for children under the age of 18 although the drugs are not FDA approved for pediatric use. Lawsuits are pending in several states (Pharmalot.com 9/3/08).

Issues include improper marketing and failure to disclose serious side effects, which prompted state programs to overpay for olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal).

While slightly fewer people stopped taking atypical antipsychotics Zyprexa and Seroquel because of tremors, compared with older drugs, the new drugs allegedly gave some of them diabetes. (St. Petersburg Times 4/12/08).

Particularly in children, it is not just the drugs prescribed, but the diagnoses that are in question. Six million children have been diagnosed with serious psychiatric disorders warranting drug treatment—1 million with bipolar disorder, long believed to occur only in adults (PBS Frontline, The Medicated Child).

Many children are being identified as potential recipients of psychotropic drugs through government-supported, school-based mental health “screening.” Is this uncovering a vast, previously unrecognized epidemic, as Richard Friedman, M.D., of the Psychopharmacology Clinic at Weill Cornell Medical School, holds (N Engl J Med 2006;355:2717-2719)?

The predictive value of a positive test in the Columbia University TeenScreen program is 16%, although it “demonstrated good sensitivity and reasonable specificity identifying students at risk for suicide,” according to its author (Schaffer D et al., J Am Acad Child Adolesc Psychiatry 2004;43:71-79).

A federal court has given the green light to a civil rights lawsuit filed on behalf of Chelsea Rhoades, who was subjected to TeenScreen without parental consent, and, like a majority of her classmates, was told she suffered from mental health problems.

A BBC All in the Mind radio commentary, which covers the Rhoades case and issues related to screening, is available online.

One ethical concern raised in Texas is the use of psychotropic drugs in children who are in foster care.

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