Polypharm & New Antipsychotics Not More Beneficial-Just More Expensive

[Guest guest]

More Beneficial? How about more detrimental? How about comparing them to other

brain poisons? How detrimental they are to health? What we really need are

studies to see how much damage these drugs do to the person's brain. How they

cause many forms of " mental illness " . How they cause actual brain damage,

cancer, liver damage, eye damage, etc..

 

 

 

 

SSRI-Research@

Thu, 2 Feb 2006 22:15:59 -0500

[sSRI-Research] Sharav - Polypharm & New Antipsychotics Not

More Beneficial-Just More Expensive

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

 

" The sky is falling, the sky is falling! " The harsh light of reality

is shattering the psychiatric profession's drug-dependency sending

alarm bells throughout the mental health community.

 

The truth is tumbling out faster than psychiatry's PR firms can come

up with spin to deflect the impact from the demise of a belief system

contrived by marketers.

 

First to be stripped of their allure were the antidepressants which

were knocked out of their " safe and effective " packaging mold.

Assurances from psychiatry's leadership to the contrary, the fact is,

FDA's Patient Information Sheet reiterated drug-induced suicide

warnings (July 2005): " Taking antidepressants may increase suicidal

thoughts and actions in about 1 out of 50 people 18 years or younger. "

 

Next on the chopping block are the most toxic of all psychotropic

drugs-the neuroleptics-a.k.a. atypical ant-psychotics. Though approved

for very limited uses, the drugs are used as chemical restraints; they

are mainly prescribed off-label, which explains their market share of

about $9 billion in the U.S.

 

The myth about the " safety and effectiveness " of antipsychotics was

blown first by the government-funded CATIE schizophrenia study (New

England Journal of Medicine, September, 2005) and now a second study,

STEP-BD (The American Journal of Psychiatry, 2006) found the drugs

not to be effective for bi-polar disorder.

 

The Pink Sheet reports that an AJP editorial by J. Raymond DePaulo

(Johns Hopkins University) concludes: " modern pharmacological

treatment may be no more beneficial than older ones, despite their

added cost. "

 

Bloomberg New reports that a report by Dr. William Honer, (University

of British Columbia) in the current issue of the NEJM found:

 

" Six of 34 chronic schizophrenia patients taking the antipsychotic

drug clozapine improved when Johnson & Johnson's Risperdal was added

to their treatment regimen. " However, " nine improved when a placebo

was added. "

 

Joseph Woolston, acting chief of child psychiatry at Yale-New Haven

Hospital, confirmed that the use of multiple psychiatric drugs has

become ``extremely common'' in children. ``The vast majority of

kids.are on at least two different medications and many are on three

or four or five different medications.''

 

This is a powerful example illustrating how remote " evidence-based "

treatment is from prevailing practices in psychiatry. Using more than

one psychoactive drug to treat mentally ill patients has no

therapeutic basis-it has a strong financial basis.

 

To understand how psychiatry's prescribing guidelines are arrived at,

one needs to examine TMAP-the Texas Medication Algorithm Project. The

TMAP prescription guidelines (and their clones) are industry's Fifth

Column-they have infiltrated clinical practice and corrupted the

research literature.

 

 

Rob Waters (Bloomberg News) reports that an editorial in the NEJM by

John Davis (Psychiatric Institute of the University of Illinois at

Chicago), claimed that the results reported by Dr. Honer were

contradicted by two earlier studies which ``showed a clear benefit for

(Risperdal) augmentation.''

 

However, when challenged with the fact that the two previous studies

were split, Dr. Davis acknowledged that the error was ``a bad

mistake.'' He said Honer's study ``raised substantial doubt as to

whether (polypharmacy) is useful.''

 

Once again, the editors of the NENM are shown asleep at the helm as

misinformation enters its pages. Waters reports that, in an e-mailed

statement, the editors said they " had been made aware of the error

this week but did not believe it affected the substance of the editorial. "

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

 

BLOOMBERG NEWS

 

For Schizophrenia, Two Drugs No Better Than One, Study Finds

2006-02-01 17:03 (New York)

 

By Rob Waters

 

Feb. 1 (Bloomberg) -- Schizophrenia patients taking one

antipsychotic medication get little benefit from adding a second,

researchers said.

 

Six of 34 chronic schizophrenia patients taking the antipsychotic

drug clozapine improved when Johnson & Johnson's Risperdal was added

to their treatment regimen, said a study in the Feb. 2 New England

Journal of Medicine. Nine improved when a placebo was added.

 

Using more than one drug to treat mentally ill patients, a

practice known as polypharmacy, has grown in recent years though it

greatly increases costs and there's little evidence it improves

outcomes. It also may raise the risk of side effects, said lead author

William Honer, a psychiatric researcher at the University of British

Columbia.

 

``The study is a call for all of us who treat patients with

schizophrenia to exercise more caution when combining

antipsychotics,'' said Leslie Citrome, of the Nathan S. Kline

Institute for Psychiatric Research in Orangeburg, New York, who was

not involved in the study. ``Other strategies need to be considered

first.''

 

Newer drugs are far more expensive than older, first-generation

antipsychotics such as haloperidol or chlorpromazine. Monthly costs

for the newer drugs can run $300 and more for each medication,

according to online drug retailer Drugstore.com. That cost has

been a key cause of soaring drug expenditures in state Medicaid

programs, prompting some states to try to restrict access to them,

Citrome said.

 

3.2 million patients

 

About 3.2 million Americans suffer from schizophrenia, a severe

mental illness that causes hallucinations and delusions and leaves

many unable to care for themselves. The $14 billion global market for

schizophrenia drugs is competitive. Lilly's Zyprexa, with annual sales

of $4.8 billion, for instance, has lost market share in recent years

to rivals claiming fewer side effects.

 

Last year, a $44 million study funded by the National Institute

of Mental Health found that the newer antipsychotics were neither more

effective nor safer than the older drugs, which are now rarely used.

Nearly three of four patients enrolled switched drugs before the

18-month study was completed because they failed to work or caused

intolerable side effects.

 

``I think the results are a measure of the frustration that

psychiatrists have with the limited response that we see with

antipsychotic drugs,'' said Honer in a Jan. 31 telephone interview.

 

`Basic Principles'

 

``The alternative is to use good old basic principles of medical

practice,'' he said. ``If one drug isn't working, ask why not? Is the

person hearing voices because they're smoking marijuana or using crack

cocaine? Is the psychosocial support that's available to the person

optimized?''

 

Last year, a study of 796 adult schizophrenic patients found that

nearly 60 percent spent at least 60 days on more than one

antipsychotic drug.

 

Clozapine is the most rarely used of the newer antipsychotics,

most of which entered the market in the past decade, because it is

known to cause agranulocytosis, a drop in white blood cells. Other

antipsychotics are more commonly used and combined, including Lilly's

Zyprexa, Pfizer Inc.'s Geodon, Bristol-Myers Squibb's Abilify and

AstraZeneca Plc's Seroquel and Risperdal.

 

The use of multiple psychiatric drugs has also become ``extremely

common'' in children, says Joseph Woolston, acting chief of child

psychiatry at Yale-New Haven Hospital. ``The vast majority of kids who

are seriously psychiatrically disturbed are on at least two different

medications and many are on three or four or five different medications.''

 

Side Effects

 

The new treatments were seen as an improvement over the earlier

antipsychotics, which caused serious side effects including sedation,

social withdrawal, and muscle and facial tics like those in people

with Parkinson's disease. But the newer drugs have been found in

recent years to cause rapid weight gain and diabetes in many patients.

 

An editorial accompanying Honer's article by John Davis, a

researcher at the Psychiatric Institute of the University of Illinois

at Chicago, claimed Honer's results contrasted with two earlier

studies which ``showed a clear benefit for (Risperdal) augmentation.''

 

In fact, the two previous studies were split. Davis, in a Feb. 1

telephone interview, said the error was ``a bad mistake.'' He said

Honer's study ``raised substantial doubt as to whether (polypharmacy)

is useful.'' Editors of the New England Journal, in an e-mailed

statement, said they had been made aware of the error this week but

did not believe it affected the substance of the editorial.

 

--Editor: Gale.

 

To contact the reporter on this story: Rob Waters in San Francisco at

(1) (415) 743-3549 or Rwaters5.

To contact the editor responsible for this story: Robert Simison at

(1) (202) 624-1812 or rsimison.

 

 

 

 

" The Pink sheet "

Number 008

Atypical Antipsychotics Falter In STEP-BD Study

 

 

A series of articles in the February issue of the American Journal of

Psychiatry provide further evidence that second-generation

antipsychotics are not necessarily more effective than older drugs.

 

In an editorial accompanying the publication of the Systematic

Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study, J.

Raymond DePaulo (Johns Hopkins University) concludes that " modern

pharmacological treatment may be no more beneficial than older ones,

despite their added cost. "

 

The STEP-BD study, authored by Roy Perlis (Massachusetts General

Hospital) et al., suggests that " in spite of modern evidence-based

treatment, " additional treatments are needed to control bipolar disorder.

 

The results are similar to the findings of the Clinical Antipsychotics

Trials of Intervention Effectiveness (CATIE) study comparing four

atypical antipsychotics and a conventional antipsychotic in treatment

of schizophrenia, which was published in the New England Journal of

Medicine Sept. 22, 2005.

 

While Lilly's Zyprexa (olanzapine) was found to have some advantages

in CATIE, particularly in terms of low incidence of side effects,

second-generation antipsychotics were in general not found to be more

efficacious than the older, cheaper option (1 " The Pink Sheet " DAILY,

Sept. 19, 2005).

 

The National Institute of Mental Health-sponsored STEP-BD trial, the

largest bipolar disorder treatment study to be conducted, monitored

1,469 patients up to two years. Although 58.4% of patients

subsequently achieved full remission, nearly half of them (48.5%) had

recurrences.

 

Of the recurrences, the study found that more than twice as many

relapses involved depressive episodes (34.7%) than manic, hypomanic,

or mixed episodes (13.8%).

 

The results of the STEP-BD study demonstrate that " mood episodes in

bipolar disorder, and particularly depressive episodes, are prevalent

and likely to recur in spite of guideline-based treatments, " Perlis et

al. write.

 

In addition, the nearly 50% relapse rate " highlights the need for

development of new interventions in bipolar disorder. "

 

" It is not at all clear therefore whether clinicians could get better

results with the treatments now available to them, " DePaulo writes in

the editorial.

 

The February issue of the American Journal of Psychiatry also includes

an analysis comparing the results of head-to-head studies of several

atypical antipsychotics. The study, by Stephan Heres (Technical

University of Munich) et al., demonstrated " a clear link between

sponsorship and study outcomes...as 90.0% of the abstracts were rated

as showing an overall superiority of the sponsor's drug. "

 

Further, the study found that " different comparisons of the same two

antipsychotic drugs led to contradictory overall conclusions,

depending on the sponsor of the study. "

 

[Editor's note: Additional coverage of the AJP studies will appear in

the Feb. 6 issue of " The Pink Sheet. " ]

 

A third study compared the efficacy of three treatments for

treatment-resistant bipolar depression. Used as adjunct therapy to

antidepressant treatment, there were no statistically significant

differences between GlaxoSmithKline's Lamictal (lamotrigine), J & J's

Risperdal (risperidone) or inositol, Andrew Nierenberg (Massachusetts

General Hospital) et al. concluded. - Jonathan Block

 

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