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Thousands of schizophrenics might be alive if they had been on clozapine

Rating

2 Star

Thousands of schizophrenics might be alive if they had been on clozapine

Our Review Summary

This story is about a study in which the strongest finding is that treatment with antipsychotics lowers mortality.  The differences between drugs is less convincing and the opening statement that "thousands of lives could have been saved" if patients had been prescribed clozapine is simply not explained or justified adequately.    There are cardiac and other long-term risks associated with most anti-psychotic medications (including clozapine) and schizophrenics generally have a higher rate of suicide than the general population, so we cannot say how many lives would have been saved with clozapine.

The story focuses on clozapine as a viable drug treatment for schizophrenia when other anti-psychotic medication does not work.  Use of the drug as a "last resort" may be reconsidered based on new evidence that there is lower long-term mortality risks with this drug compared to other commonly prescribed anti-psychotic medications.  However, the story does not mention more common side effects of this drug which may limit tolerability.  The story also does not mention that patients taking clozapine are typically monitored frequently (weekly to monthly) for white blood cell counts (loss of white blood cells led to the death of patients taking the drug in the 1970s). This would increase cost, which is also not mentioned.

One strength of the story is that it used two independent sources who provide good clinical perspective on the results of this 10-year retrospective study.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not give the cost of Clozapine nor a cost comparison between it and other anti-psychotic medications.  Frequent monitoring and dealing with common side effects increase costs and potential for hospitalization. But even giving the cost of the drug alone is not giving the entire cost picture.

Clozapine is usually prescribed from specialized clinics and requires frequent monitoring (weekly for 6 months, then biweekly for 6 months, then ongoing). So there is the cost of the drug and monitoring and dealing with side effects and any effects on health care utilization (e.g. hospitalization for decompensation) vs other regimens. The story does not mention costs for additional monitoring.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

One problem is that only relative risks are given without any information on baseline risk.  It would be much better if the story provided the annual or 10-year risk of dying untreated, with clozapine and with other antipsychotics.  This would give the reader a better idea of the potential benefit (lower mortality) vs. harms (rare agranulocytosis, common – constipation etc) and hassles (weekly monitoring initially) and costs (one of the most expensive drugs).

The story leads with a statement that "thousands of lives could have been saved" if more schizophrenics were prescribed clozapine instead of no medication or newer anti-psychotics.  This is an overstatement and not an entirely correct interpretation of the study.  There are cardiac risks associated with most anti-psychotic medications and schizophrenics generally have a higher rate of suicide than the general population, so we cannot say how many lives would have been saved with clozapine. 

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story notes the rare, serious harms of clozapine and there is a comparison of mortality data of this medication with other anti-psychotics from the Finnish study.  However, the story does not mention the other long-term, more common and also potentially serious side effects of clozapine and many other anti-psychotic medications.  Clozapine is poorly tolerated (hypotension, sedation, constipation and others) and more common side effects limit tolerability and use.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story briefly discusses the design of the Finnish observational study comparing death rates of schizophrenics with the general non psychotic population.  The story provides data that schizophrenics prescribed a once-considered dangerous drug actually had lower mortality rates than those prescribed other (newer) anti-psychotics.   The story also mentions that people with schizophrenia typically die two decades earlier than other people.  The story speculates about the reasons for reduced mortality, but there are many (medication and non-medication) reasons for earlier death among people with schizophrenia.

Does the story commit disease-mongering?

Not Satisfactory

The story didn’t give adequate explanation for the statement that thousands of lives worldwide could have been saved if patients had been treated differently.  This is an overstatement and not an entirely correct interpretation of the study.  There are cardiac risks associated with most anti-psychotic medications and schizophrenics generally have a higher rate of suicide than the general population, so we cannot say how many lives would have been saved with clozapine.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

Information in this story is based on a recently study published in the medical journal The Lancet.   The story cites one author and two independent sources who provide good clinical perspective on results of this 10-year retrospective study of schizophrenics taking clozapine or newer anti-psychotics .

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story focuses on clozapine as a viable drug treatment for schizophrenia when other anti-psychotic medication does not work.  Use of the drug as a "last resort" should be reconsidered based on new evidence that there is lower long-term mortality risk with this drug compared to other commonly prescribed anti-psychotic medications.  The story does not mention that patients taking clozapine are typically monitored frequently (weekly to monthly) for white blood cell counts (loss of white blood cells led to the death of patients taking the drug in the 1970s).  The story also does not mention that some forms of psychotherapy are useful as adjunct treatment with medications for schizophrenics.  There are also intensive community help programs that appear effective.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story does not mention that access to Clozapine (Clozaril) is still restricted in the U.S. WWW.CLOZARILCARE.COM.  The story does note physicians’ reluctance to prescribe this medication based on rare but serious side effects which affect white blood cells and can lead to death. The story mentions the drug was "banned" from the market, but it was voluntarily removed from the market by the manufacturer after reports of rare but serious side effects. 

The story is also inaccurate when it says the drug is sold generically as Clozaril.  Clozapine is the generic name.  

Does the story establish the true novelty of the approach?

Satisfactory

Clozapine is not a new medication; the story notes it has been available since the 1970’s.  

Does the story appear to rely solely or largely on a news release?

Satisfactory

Since there is independent reporting and interviews with clinicians not affiliated with the Lancet paper it does not appear that the story relied on a news release.

Total Score: 4 of 10 Satisfactory

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