The New Hampshire-based Endowment for Health has awarded a grant to PPC to further explore issues related to questionable prescribing of certain antipsychotic drugs to children.

Initial funding for PPC’s Kids and Psych Drugs: Just Say Know initiative was supported by the Sadie and Harry Davis Foundation and the Maine Community Foundation. It enabled initial research to bring attention to the issue and highlight how states and the federal government are working to ensure safer and more effective prescribing of such drugs to kids.

The Endowment for Health grant will enable PPC to extend its research to better understand the extent of prescribing and use of antipsychotic drugs to kids participating in state health programs in New Hampshire. PPC will work with state policy makers and other stakeholders to identify best practices regarding the use of antipsychotic drugs in kids. The initiative will also include
working with consumer and children’s advocacy groups to gain an understanding of the issue, as well as potential risks associated with the drugs, and to empower parents and guardians to work with their doctors to make informed decisions about their children’s mental health care.

An FDA advisory panel’s recent recommendation that three antipsychotic drugs be approved for treatment in kids and adolescents is an example of why there is cause for great concern. The panel’s recommendation was lukewarm at best, with one of the drugs, Ziprasidone, receiving only eight votes in favor of acceptable safety. One panel member voted it was not safe, while nine abstained from voting. Concerns about cardiovascular risk, including sudden death, were raised about the drug’s use in kids. Risks associated with the other two antipsychotic drugs under consideration included substantial weight gain and metabolic problems, including increases in blood lipids and glucose, and certain movement disorders. Since the FDA usually follows recommendations made by its advisory panels, it appears approval is imminent.

If the lukewarm recommendation and associated risks of these drugs aren’t enough to cause concern, the diagnoses for which the drugs are being recommended should be. While young patients with severe diagnoses including schizophrenia may benefit, the panel’s recommendations includes possible use for patients with “mixed episodes associated with bipolar I disorder.” Since the diagnosis is not as specific as schizophrenia, worries about more children being unnecessarily prescribed the powerful
antipsychotic drug and being exposed to serious risks have been expressed.

Ziparasidone, for example, also marketed as Geodon, was front and center in the Justice Department’s recent drug settlement with Pfizer. The drug company settled allegations it violated the federal False Claims Act by “knowingly causing false or fraudulent claims for the drug . . . by illegally promoting it for uses not approved by the FDA and that were not medically-accepted indications . . .” The company created and disseminated unsubstantiated and false information about the safety and efficacy of the
drug and paid kickbacks to health care providers to induce them to prescribe it. While new panel recommendations include ensuring the FDA narrowly defines bipolar disorder on the label of the drug once it is approved for use in
kids, it is no guarantee the drug won’t be marketed by its maker more broadly. In fact, given the industry’s history of marketing drugs for off-label purposes, and its disregard for the law and patient safety in general, we anticipate these drugs will be heavily marketed for broader use than intended. PPC’s mission is to improve access to safe and effective medicine, and the Endowment for Health’s grant to support Kids and Psych Drugs: Just Say Know is timely and important in addressing possible inappropriate prescribing of powerful antipsychotic drugs to kids.

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