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NIMH Study of Schizophrenia Drugs Requires "New Thinking" in Research, Not Restrictions Based on Cost

Statement of Ken Duckworth, M.D., Medical Director, National Alliance on Mental Illness

December 1, 2006

The third installment of studies funded by the National Institute of Mental Health (NIMH) on the treatment of schizophrenia with anti-psychotic medications confirms a basic fact that many physicians, consumers, and policymakers already know. "First generation" generic drugs cost less than "second-generation" advancements.

The study's significance lies in its limitations. Where it falls short precisely defines issues that remain to be explored over time.

Previous installments of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) have shown that as a class, the second generation of drugs for treating schizophrenia generally is no more effective than first generation. However, broad findings remain subject to the fact that "one size does not fit all" in choosing the right medication for a patient—which NIMH itself has emphasized.

In an explicit warning to Medicaid state programs and the managed care industry, CATIE III states: "Treatment decisions must be based on the clinical situation of each individual patient. This study clearly would not justify policies that would unconditionally restrict access to any particular medication or that would thoughtlessly force patients or doctors who are satisfied with a current treatment to change to a treatment just because it might be less expensive."

The American Journal of Psychiatry also chose to publish the CATIE III findings despite what it calls in an editorial "serious reservations" about the study's methodology. They include:

  • CATIE excludes "first episodes" involving the onset of schizophrenia—the very point in which the initial choice of medication may be most important in minimizing damage and maximizing opportunities for improvement over time.
  • The 18-month period of study, although superior to most other clinical trials, is still not long enough to reveal the development of tardive dyskenesia or other serious side effects that may differ from drug to drug.
  • Methodology is still "too crude" to demonstrate differences between specific medications that are important for individual patients. "Failure to find difference does not mean there is no difference," the Journal's editorial warns.

The Journal editorial also reflects a fundamental concern that NAMI has consistently stated as the CATIE findings have unfolded. The time has come for a third generation of medications for schizophrenia.  It notes that second generation drugs "have primarily changed side effects, rather than clinical efficacy." But it is important to understand that in terms of side effects, the choice of first generation drugs runs the risk of permanent, untreatable, debilitating and stigmatizing movement disorders.

The Journal calls for discussion now of what "drug discovery model" can best improve treatment of schizophrenia. Greater scientific research must fuel that discussion. The most important contribution of the CATIE studies lies in stimulating "new ways of thinking" about medication treatment for schizophrenia, and providing a base for the next generation.

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