Failed Drug Treatments for Schizophrenia–Letters to the Editor – NYT

Fri, 23 Sep 2005

Letters to the NY Times editor (below) demonstrate the combative reaction of stakeholders in the psychotropic drug industry to the evidence-based overthrow of psychiatry’s treatment recommendations.

Psychiatrists who have financial contracts with psychotropic drug manfuacturers, have been prescribing atypical antipsychotic drugs on and off-label, as if they were jelly beans, only to be confronted with evidence that they are, in fact, no better and no safer than the old, cheap, generic drugs.

The landmark government sponsored study, CATIE, was conducted by the pillars of the American psychiatric establishment who themselves have substantial on-going financial ties to the manufacturers of these drugs.

Even these investigators could not deny the evidence contradicting the false and unsubstantiated claims made about these drugs’ safety and efficacy. Atypical antipsychotics have been promoted as safe and improved and recommended in practice guidelines–such as TMAP–as first line treatment. But when tested, they failed to demonstrate any of the claimed improvements that have raised sales to $10 billion dollars annually.

As more information will be brought to light–both when the CATIE data is made available to other expert trial analysts, and company data is uncovered during the course of discovery during court proceedings–physicians and the public will learn just how the market for these drugs was created by hype, misinformation, and out right fraud.

One letter among the 5 published by the Times, by psychiatrist, J. Wesley Boyd, M.D., says it all– It is the first one posted below –though it appeared as the last in the Times.

Another letter by psychiatrist Jeffrey Kluggman, MD, reveals psychiatry’s culture of denial–about the ineffectiveness and hazardous side-effects of the drugs they prescribe–and the utter contempt he (and his colleagues) have for patients for whom they prescribe toxic drugs that produce diabetes, raise cholesterol and blood pressure to dangerous levels, cause blood clots, strokes and cardiac abnormalities. Dr. Klugman defends the drugs, fails to recognize that his profession has failed utterly to improve patients lives, and fails to take responsibility for blindly prescribing drugs that are proven to be defective:

“When three-quarters of the patients drop out, all that is demonstrated is that you’re treating a very difficult population.”

In 2000, a major British meta-analysis of 52 clinical trials in which more than 12,500 patients participated–found that the atypical antipsychotic drugs–(amisulpride, clozapine, olanzapine, quetiapine, risperidone, and sertindole), are no more effective than the older drugs at low doses. Comparing the efficacy (i.e., symptom reduction), tolerability (i.e., drop out rates), and side effects (motor movements, restlessness), the investigators concluded:

“When the dose was 12 mg/day of haloperidol (or equivalent), atypical antipsychotics had no benefits in terms of efficacy or overall tolerability, but they still caused fewer extrapyramidal side effects.”

See: Atypical antipsychotics in the treatment of schizophrenia: systematic overview and meta-regression analysis by John Geddes, senior clinical research fellow a, Nick Freemantle, reader in epidemiology and biostatistics b, Paul Harrison, professor a, Paul Bebbington, professor of social and community psychiatry c, for the National Schizophrenia Guideline Development Group. BMJ 2000;321:1371-1376 ( 2 December ) http://www.bmj.com/cgi/content/full/321/7273/1371#related_editorials

Contact: Vera Hassner Sharav
212-595-8974

www.nytimes.com/2005/09/23/opinion/l23drug.html

THE NEW YORK TIMES
Letters
September 23, 2005
Drug Treatments for Schizophrenia (5 Letters)

To the Editor:

As a psychiatrist, I welcome the study that found no appreciable therapeutic differences between the older antipsychotic drugs and newer ones. But I’m not too hopeful that this news is going to change the prescribing habits of doctors.

Many of the psychiatric residents I work with know little about the older medications, but this is not too surprising given that many of their teachers are on the payroll of one or more of the major drug companies.

Nobody who receives money from a pharmaceutical company should be trusted to speak objectively about any medication.

We ask judges to recuse themselves from cases in which they have some financial or other conflict of interest. Is it too much to ask doctors to do the same?

J. Wesley Boyd, M.D.
Needham, Mass., Sept. 21, 2005
The writer is a lecturer in psychiatry at Harvard Medical School.

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To the Editor:

Re “Comparing Schizophrenia Drugs” (editorial, Sept. 21):

The study you discuss was financed by the same government that gave us the Food and Drug Administration of the Vioxx mess and a FEMA director who knows a lot about horses.

This study used Trilafon (perphenazine) as the older-generation antipsychotic. The vast majority of uninsured and state patients are still given Haldol and Prolixin, drugs implicated in the revelations about tardive dyskinesia, a disorder that causes involuntary movements.

The side effects of these medications became known only because patients were institutionalized for an extended time.

To return to these drugs as a “cheaper” alternative reeks of the business mentality in health care today. It is rehospitalization and bureaucracy that eat up our mental health care budgets.

The real contradiction in your editorial is that Zyprexa, one of the new drugs in the study, controlled symptoms better! Fix this drug to reduce the side effects, and we are on our way to medications that patients will take. That will cost a bit of money. But it will save money, too.

M. A. Simmons
Southfield, Mich., Sept. 21, 2005

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To the Editor:

Your editorial about schizophrenia drugs left out an important point.

The reason for the greater use of the newer, more expensive drugs, besides their marketing, is that they cause a much lower incidence of tardive dyskinesia, a movement disorder that occurred at a rate of 5 percent a year with the older drugs.

The study that you cite was too short for this difference to become apparent, but the percentage of patients discontinuing the older drug (perphenazine) because of a movement disorder was four times as high as the percentage discontinuing the most effective of the newer drugs (olanzapine) for the same reason.

Mark Abramowicz, M.D.
Editor, The Medical Letter
New Rochelle, N.Y., Sept. 21, 2005

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To the Editor:

You say the study filled the gap in our knowledge about the relative efficacy and tolerability of the second-generation of antipsychotic drugs.

When three-quarters of the patients drop out, all that is demonstrated is that you’re treating a very difficult population.

The issues of tolerability and especially the risk of tardive dyskinesia are not addressed in an 18-month study with a 75 percent dropout rate.

As a private practitioner who prescribes the newer medications for bipolar disorder, not schizophrenia, I have followed patients on these medicines for years at a time. I suggest that you ask the researchers, “If a family member required an antipsychotic drug, which drugs would you prefer?”

As a psychiatrist who is familiar with all these drugs, I know what my answer would be – I’d prefer the new ones – and I would wager that the answers of the researchers would be no different.

Jeffry Klugman, M.D.
New Haven, Sept. 21, 2005

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To the Editor:

You mention that there’s a need for better medicines, and certainly, America’s pharmaceutical research companies are striving to develop new products to treat more effectively those suffering from schizophrenia, depression, anxiety disorders and other mental illnesses.

Through the end of last year, there were 15 potential new drugs for schizophrenia in human clinical testing, as well as 14 for depression and 18 for anxiety disorders. Over all, there were 109 medications being developed for all mental illnesses.

We recognize, as our critics should, that one medicine alone does not work for everyone.

Ken Johnson
Senior Vice President
Pharmaceutical Research
and Manufacturers of America
Washington, Sept. 22, 2005

Copyright 2005 The New York

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