Lansdale, PA—December 3, 2008— Hayes Inc., a leading medical technology research and consulting firm, has completed an exhaustive evaluation of clinical evidence behind popular treatments for pediatric Bipolar Disorder.

Hayes has recently completed reviewing the clinical evidence behind a range of anticonvulsants and antipsychotics that are prescribed as treatments for pediatric BD. The results are not pretty: none of the pharmaceuticals received Hayes ratings higher than C. Hayes found that evidence regarding the safety and efficacy of anticonvulsants and antipsychotics in pediatric BD is very limited, and, at this time, no strong conclusions can be drawn regarding the safety or clinical effectiveness of these agents. Overall, clinical study designs had serious limitations, including the lack of placebo conditions, lack of randomization and blinding procedures, small sample sizes, and the financial involvement of the pharmaceutical companies whose products were being evaluated.
In addition, certain classes of antipsychotics cause potentially serious side effects in children.

Elisabeth Houtsmuller, Ph.D., Senior Analyst for Hayes says, “Our findings indicate that at this time, anticonvulsants and atypical antipsychotics cannot be recommended for children diagnosed with Bipolar Disorder. We have serious concerns about the depth of clinical research that has been done to demonstrate the effectiveness of these pharmacological treatments; in addition, in many cases the potential side effects are alarming. We suggest that parents of B-D diagnosed children carefully weigh the potential benefits against the known health risks of these medications and proceed with caution when doctors recommend anticonvulsants or antipsychotics.”

Pharmaceuticals evaluated in Hayes’ review of clinical evidence for anticonvulsants were carbamazepine (Novartis’ Tegretol®), divalproex (Abbott Labs’ Dekapote®), lamotrigine (GlaxoSmithKline’s Lamictal®), oxcarbazepine (Novartis’ Trileptal), topiramate (Ortho’s Topamax).
Atypical antipsychotics reviewed in the study included aripiprazole (Bristol-Myers-Squibb’s Abilify®), olanzapine (Eli Lilly’s Zyprexa®;), quetiapine (AstraZeneca’s Seroquel® and Orion’s Ketipinor®), risperidone (Ortho’s Risperdal®; a generic formulation is also available by Teva UK Ltd. and Patriot Pharmaceuticals), and ziprasidone (Pfizer’s Geodon®).

For both antipsychotics and anticonvulsants, no Hayes Ratings above C (“Potential but unproven benefit”) were assigned as a result of Hayes’ evidence-based review of clinical research, and for many medications currently being prescribed, the Rating was D (No proven benefit and/or unsafe’.)

Dr. Houtsmuller concluded, “Healthcare payers and providers look to evidence-based medicine to make fully-informed decisions about the use of clinical technologies such as pharmaceuticals and medical devices. Unfortunately for parents who are desperate for a solution that will help children diagnosed with BD, evidence that anticonvulsants and antipsychotics are safe and effective is lacking at this time. Additional clinical research is required to clearly demonstrate effectiveness, and to alleviate concerns about potential side effects before widespread use of these drugs for children with BD can be recommended.”

About Hayes, Inc.

Hayes, Inc. is an independent health technology research and consulting company dedicated to promoting better health outcomes. Hayes performs unbiased, evidence-based assessments of the safety and efficacy of new, emerging, and controversial health technologies and evaluates the impact of these technologies on healthcare quality, utilization, and cost. Hayes’ worldwide clients include hospitals, healthcare systems, managed care organizations, government agencies and employers.

Hayes products and services include:

• A dynamic, web-based Knowledge Center designed to support professionals who are responsible for strategic planning, technology acquisition, and policy development
• Consulting services that enhance strategic technology planning and support evidence-based technology acquisition so that hospitals can anticipate and prepare for the financial, clinical, and operational impact of new technologies prior to their adoption.
• Customized services that help payers update coverage policies, develop and maintain clinical guidelines, and make decisions about new technologies in the absence of an existing coverage policy.
• Employee benefit programs that help patients make well-informed decisions about their healthcare choices.

Press Contact:
Joe Crivelli
Gregory FCA
610-228-2100

Company Contact:
Karen Matthias
Hayes, Inc.
215-855-0615 ext. 7918