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David Baxter

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NIMH Study of Schizophrenia Drugs Requires "New Thinking" in Research, Not Restrictions Based on Cost
December 1, 2006
by Ken Duckworth, M.D., Medical Director, NAMI

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.
 

HA

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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.

  • 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.
My initial concern was "Oh my God, now only the first generation atypical antipsychotics will be used and what will be the outcome?" From some of my understanding, few of the older drugs have been shown to cause more EPS in young males (dystonia), so this and other concerns may be present for the "first episode" group as mentioned.

I'm glad that we now have this new information and hope that it will spur new drug development and not just cost saving decisions, because the drugs we have are nowhere near good enough.

I have not read the studies but wonder if they measured effects on mood disorders?
 

David Baxter

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Apparently, the "managed care" and Medicare people in the US are already taking this approach to some extent, requiring that the patient "try" the older cheaper drugs first.

I agree: There are a LOT of questions not answered by these studies, and I'm happy to see NAMI taking a lead role in pointing out some of the deficiencies.

now only the first generation atypical antipsychotics will be used

I believe they are not talking about atypical antipsychotics here but the older drugs before the development of atypical antipsychotics - and as the article points out, those come with a siognificant risk of tardive dyskenesia, a very serious side-effect with long term use of the older medications (which is generally required for treating schizophrenia).
 

HA

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Sorry about the confusing error about atypical. I meant the older typical antipsychotics. Typical are the older drugs and atypical are the newer drugs.

One drug that is the first of the new (atypical) drugs is Clozapine. This drug will work when all of the others won't and is very expensive due to the low risk of agranulocytosis and the needed monitoring with blood draws. I sure hope that it won't be even more difficult to access. Clozapine has virtually no EPS and apparently can also reverse TD in some patients with this condition. it has been the miracle drug for our family.

I would like to see more of these kinds of studies that compare the various drugs against each other and patients individual responses.

Now the drug companies need to go back to the drawing boards instead of being satisfied with what they currently have.
 

David Baxter

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I believe Clozapine is also the only medication known to have a significant impact on the negative symptoms of schizophrenia.
 

ThatLady

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To me, it's shameful to expect people who need anti-psychotic medications to take those which are known to produce tardive dyskenesia and other negative, lasting effects. These side effects are no laughing matter, and shouldn't be treated as a necessary evil that goes along with anti-psychotic meds. It's NOT necessary anymore!
 

Daniel

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BTW, a new drug, bifeprunox, may eventually be available for treating stable forms of schizophrenia that don't require the most effective medication. The benefit is even less side effects:

In six-week trials, it helped stable patients -- those whose symptoms were already under control -- lose weight and improve blood cholesterol, which are common problems with current treatments.

Drug shows promise against schizophrenia
 

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