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NAMI Critiques Latest Schizophrenia Study: Interesting Science, Bad Policy Tool

Implications for Medicare, Medicaid, Veterans Affairs; Longer, Larger Studies Still Needed

October 3, 2006

Arlington, VA—A British study published in the current issue of the Archives of General Psychiatry, comparing old and new antipsychotic medications, has two major implications for federal and state policies, the National Alliance on Mental Illness (NAMI) today advised.

The first involves the nation's science agenda. The second involves individual access to the right medications for treatment under Medicare, Medicaid and the Veterans Administration—which is expected to fuel ongoing federal and state political battles.

In April 2006, Jeffery Lieberman, M.D., Chairman of the Columbia University Department of Psychiatry—who heads a series of studies on schizophrenia funded by the National Institute of Mental Health (NIMH) which has made findings similar to those of the British study (and who wrote an editorial that accompanied its publication)—warned:

"The most important message of the results is the need for better treatments. Until we have those new treatments, given the substantial limitations of current medications and the diversity of patient response, clinicians need a broad range of treatment options, not restrictions on choices."

Science & Medicine

"It is essential that science and access to care not be confused, and that key distinctions, limitations and flaws in the study not be overlooked," said NAMI executive director Michael J. Fitzpatrick.

"For science and medicine, the study reflects much of NAMI's research agenda and points to the need for the President and Congress to push harder for investment in long-term, independent and comprehensive studies."

"There is a need for a more effective, third generation of medications that can ultimately lead to a cure for schizophrenia, one of the most severe mental illnesses," said NAMI medical director Ken Duckworth, M.D.

Medicare, Medicaid & Veterans Policy

"For Medicare, Medicaid, and the Department of Veterans Affairs, it would be a grave mistake to use the study to restrict access to newer medications, based on general findings that older medications seem to work as well as the newest generation," Duckworth said.

"General findings cannot be substituted for specific choices made in treating individuals with schizophrenia. One size does not fit all. It is critical that the study's limitations be recognized."

For one, the British study relies heavily on an older drug, sulpiride that has never been approved by the Food & Drug Administration (FDA) and is unavailable in the United States. In addition:

The study's comparisons are limited to classes of drugs, rather than specific medications.
The study does not include comparison of doses of drugs, either between classes or specific medications.
Although longer than clinical trials required for FDA approval of specific drugs, the study's one-year test period is still largely inadequate for evaluating treatment outcomes over time. NAMI's own research agenda includes support for life-long studies such as the Framingham Heart Study (See below).
Many of the newer anti-psychotic medications have been approved by the FDA for both schizophrenia and bipolar disorder. Older ones are approved only for schizophrenia and the study focuses only on schizophrenia.

"It is important to note that the study focuses only on medication," Duckworth said. "This is only one dimension of discussion for policymakers. Treatment of schizophrenia also requires psychosocial interventions, such as supportive counseling, housing and employment."

"Finding the right medication may be the cornerstone in building the right foundation for recovery for an individual. If you don get the medication right, you run up costs elsewhere. That's another reason that unrestricted access to both old and new medications is a critical factor for budget concerns."

The Framingham Heart Study

"It is important too to understand that one-year studies still do not tell us much about the treatment of any mental illness over time," Duckworth said.

"We need a comprehensive study to track the progress of a community of individuals over their life courses, looking at a range of factors and real-world conditions. The Framingham Heart Study is a model that urgently needs to be included in the nation's research agenda on mental illness.

Directed by the National Heart, Lung and Blood Institute, the FHS is a landmark study begun in 1948 that continues today. Approximately 12,000 residents of Framingham, Massachusetts originally were enrolled in a study designed to gather medical data, and more recently DNA samples. New generations of participants were added in 1971 and 2002. The study has helped to identify risk factors and related concerns, contributing to improvements in treatment.

http://archpsyc.ama-assn.org

http://www.nhlbi.nih.gov/about/framingham

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