Washington Post: Psychiatric Drug Hype Challenged

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Tue, 20 Sep 2005 14:17:18 -0700

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Washington Post: Psychiatric Drug Hype Challenged

 

 

 

 

 

MINDFREEDOM NEWS ALERT - 20 September 2005

http://www.MindFreedom.org - please forward

 

Below is an article from the front page

of today's _Washington Post_ about a new

federal study that " challenges widespread

assumptions " about one of psychiatry's

most frequently-used drugs, the neuroleptics,

also known as " antipsychotics. "

 

The _Post_ quotes David Oaks, Director,

MindFreedom International. AT BOTTOM is

MindFreedom's full public statement.

 

~~~~~~~~~~~~~~~

 

_WASHINGTON POST_

 

New Antipsychotic Drugs Criticized

 

Federal Study Finds No Benefit Over

Older, Cheaper Drug

 

By Shankar Vedantam

 

Washington Post Staff Writer

 

Tuesday, September 20, 2005; A01

 

Expensive new antipsychotic drugs that

are among the most widely prescribed

pills in medicine are no more effective

and no safer than an older, cheaper drug

that has been largely discontinued,

according to the most comprehensive

comparative study ever conducted.

 

The surprising result of a federally

funded study released yesterday

challenges widespread assumptions among

psychiatrists about the best way to treat

serious mental illness and underscores the

extent to which physicians, patients and

policymakers can be blindsided by

self-interested research by drugmakers.

 

The study also paints a sobering picture

of the state of treatment of

schizophrenia, a disabling illness that

afflicts about 3.2 million Americans with

symptoms such as delusions, hallucinations

and disordered thinking: Every drug, old

and new, caused serious side effects, and

the vast majority of patients stopped

taking each of them.

 

" The study has vital public health

implications, " said Thomas Insel,

director of the National Institute of

Mental Health, which funded the study.

" It is the largest, longest and most

comprehensive, independent trial ever

done to examine existing therapies for

this disease. "

 

Heavily marketed on the grounds they

caused fewer side effects, the newer

drugs, known as atypical antipsychotics,

cornered about 90 percent of the market.

 

All won Food and Drug Administration

approval on the basis of short-term

studies that showed they were better than

sugar pills, and researchers emphasized

yesterday that the medicines do work. But

they have never before been systematically

compared against each other in a long-term

trial designed to guide doctors in

deciding which to try first, and which

would best suit particular patients.

 

The new study tracked patients for 18

months, which allowed researchers to

compare the effectiveness of the

medications as they actually are used.

Patients had a variety of complicating

factors, much as they do in the real

world, and came from diverse backgrounds.

 

Columbia University psychiatrist Jeffrey

Lieberman, who led the new study, said 90

percent of trials in the scientific

literature -- which doctors rely on to

guide treatment -- are sponsored by drug

companies. Although the industry trials

serve a useful purpose, he said, they are

rarely designed to answer certain crucial

questions.

 

The industry has recently come under fire

for hiding unfavorable trial data,

especially in studies of antidepressant

medications for children. Companies

conduct trials to win FDA approval or for

marketing reasons, Lieberman said.

 

" These are not the same purposes that are

consistent with the needs of clinicians,

patients, family members, administrators

and policymakers, " he said. " How do

currently marketed treatments compare? If

there are differences in cost, are they

justified? There has not been any

consistent means to get that information. "

 

Although the National Institutes of

Health is increasingly funding such

trials, Lieberman said they also ought to

be funded by federal agencies that pay for

drug treatment for huge numbers of

patients, such as the Centers for

Medicare and Medicaid Services (CMS).

 

" CMS pays tens of billions to support

medication, and there is no way they know

what the appropriate value of these

medications is, " he said.

 

The new study, which will be published in

the New England Journal of Medicine, cost

taxpayers $44 million. Last year, the

United States spent $10 billion on the

newer antipsychotic drugs, which include

medications such as Zyprexa, Risperdal,

Seroquel and Geodon.

 

Lieberman and the other researchers said

they were surprised to find that an older

generic drug called perphenazine, which is

10 times cheaper than the newer drugs, was

about as effective -- and about as safe.

 

Older antipsychotics are known to cause

involuntary muscle movements, and the

newer drugs were heralded for not causing

that problem. But Lieberman said

comparisons with older drugs had mostly

used a highly potent drug called Haldol,

whereas the new study did not find the

same degree of movement problems with

perphenazine, a less potent drug.

 

In an editorial accompanying the study,

Robert Freedman, a psychiatrist at the

University of Colorado Health Sciences

Center, said the uncontrolled movements

caused by the older drugs were " less

troubling than potentially fatal

metabolic problems " associated with some

of the newer drugs.

 

Yale psychiatrist Robert Rosenheck, who

helped conduct the study, said it was

" not a horse race " that produced a

winner. Rather, he said, each drug had

benefits and risks. Doctors will have to

judge what works best for particular

patients.

 

" It would be a tremendous mistake to

assume from this study that the cheaper,

older drugs are, quote, 'just as good,' "

added Darrel Regier, director of the

division of research for the American

Psychiatric Association, who also said

that doctors' judgment is crucial.

 

The study is likely to stoke one of the

most contentious debates in psychiatry --

whether drug treatment ought to be forced

on unwilling patients. The fact that

three-quarters of patients discontinued

treatment because of side effects or a

lack of benefit showed that patients

" trying to say no to forced neuroleptics

[drugs] have had a better grip on reality

than the medical community, " said David

Oaks, a patient advocate who has himself

been given five antipsychotic drugs at

various times for a range of diagnoses,

including schizophrenia.

 

Pharmaceutical companies called attention

to aspects of the trial that showed their

products to advantage. Geodon kept

patients' weight gain and cholesterol

down, said Pfizer's Daniel J. Watts.

Zyprexa had a lower discontinuation rate,

manufacturer Eli Lilly said. The dose of

Risperdal used in the study was too

small, which was why the drug did not

work as well as it should have, said Ramy

A. Mahmoud, vice president for medical

affairs at Janssen Pharmaceutica Inc.

 

Alan Goldhammer of the Pharmaceutical

Research and Manufacturers of America,

said, " We have always made it clear

during drug development that it is only

the first stage, that it . . . never

tells the whole story about safety and

efficacy. "

 

Large studies, which compare different

drugs including generics, are beyond the

capabilities of individual companies, he

said: " They are so costly and

time-consuming that it would probably

bring drug development to a halt. "

 

Patient advocate Vera Hassner Sharav, who

said her son died at 32 because of toxic

side effects associated with the

antipsychotic drug Clozaril, said the new

study showed that the FDA is not doing its

job. " We really only seriously test drug

safety on the vast public, " she said.

" That is not right. "

 

http://www.washingtonpost.com/wp-dyn/content/article/2005/09/19/

AR2005091901867_pf.html

 

or

 

http://tinyurl.com/akaom

 

- end of _Wash. Post_ article -

 

~~~~~~~~~

 

Statement by David Oaks, Director

 

MindFreedom International

 

I have heard zealots lobby for a massive

increase in involuntary psychiatric

drugging by claiming that the newer

neuroleptics are far more effective and

that the side effect nightmare that

plagued older neuroleptics had been

solved.

 

But this new federal study shows that

many of our members who have been

desperately trying to say " no " to forced

neuroleptics have had a better grip on

reality than the medical community.

 

The drug industry hype about miracle

wonder pills turns out, once more, to be

fraud. The drug industry has seriously

mis-informed the public, the medical

community, government decision-makers,

families and patients. This fraud has

caused serious suffering among a very

marginalized group. The bizarrely high

costs of these drugs threaten to bankrupt

many state and local health care systems.

 

The New England Journal of Medicine

official editorial warns that patients

face " difficult choices " about drugs that

can potentially cause " fatal metabolic

problems " and therefore the answer is

" informed patient preference. " But when the

rubber hits the road, patients and their

families are routinely lied to about

efficacy and hazards of these drugs, and

far too many patients are forced and

coerced to take neuroleptics, including

with court orders on an outpatient basis

in their own homes.

 

And of course, families in crisis are seldom

offered humane and safe alternatives to

psychiatric drugs.

 

I have personally experienced

forced neuroleptics and the experience

can feel overwhelmingly horrible, a

profound intrusion of our basic human

rights, like a wrecking ball to the mind.

That qualitative experience doesn't tend

to get out in these studies.

 

The controversy here is beyond being pro

or con drugs. Some of our members willingly

choose to take prescribed psychiatric drugs.

The issue is really about freedom. And the

drug corporation domination threatens basic

human rights in our society.

 

The big picture is what we at MindFreedom

call the take-over of the mental health

system by the drug industry, which

impacts research, conferences, medical

associations and choice of treatments.

 

While it's good to see a study focus on

efficacy and side-effect problems such as

weight gain and diabetes, the biggest

story that the public hasn't heard yet is

that taking long-term high-dosage

neuroleptic is associated with actual

structural damage to the higher level

parts of the brain. These brain changes

can make it very difficult to quit

neuroleptics by creating dependence.

 

It would also be good to see far more

studies about non-drug alternatives that

have been shown to be effective, safer

and more sustainable, especially ten,

twenty or thirty years down the road. A

core recommendation of President Bush's

New Freedom Commission was more study of

the long-term effects of psychiatric

drugs but we haven't seen that happen yet.

 

A drug-based approach to psychiatric

problems is also poised to globalize as

never before. There ought to be open,

honest and public debate about these

questions to prevent that from happening.

It's time for democracy to get informed

and hands-on with the mental health

system.

 

After thirty years of watching the

psychiatric drug industry I've come to

see it as a traveling medical show.

Whenever their current approach is

finally debunked they already have a load

of new drugs waiting in the pipeline. We

expect to see a number of new

neuroleptics produced in the next few

years and the public's skepticism ought

to be on high alert.

 

- end statement -

 

~~~~~~~~~~

 

ACTION: Please forward.

 

~~~~~~~~~~

 

This news update is a free public

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