Review of Risperdal/placebo study from AHRP

[Guest guest]

At the bottom of this email is information on an FDA public hearing

on Zyprexa. As many know, Zyprexa is next in line (and pretty much

guaranteed) for approval for use on children with

autistic " symptoms " . For this reason, this subject isn't OT. For FDA

Zyprexa committee hearing website information (these urls from the

FDA are all broken), go to http://www.ahrp.org and click

on " blogspot " at the upper right of home page. The same article will

appear with the websites at the bottom, in the midst of the FDA

advisory hearing information.

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

FYI

The latest scientific evidence from a placebo-controlled study pulls

the rug

from under the rationale for current widespread prescribing of

antipsychotic

drugs as tranquilizers to calm aggressive behavior. The findings led

the

authors to conclude:

" Antipsychotic drugs should no longer be regarded as an acceptable

routine

treatment for aggressive challenging behaviour in people with

intellectual

disability. "

The rationale for prescribing antipsychotics--which are major

tranquilizers--for people with very low I.Q.'s is that they are quick

to

anger and lash out at others, bang their heads or fists into the wall

in

frustration, or singe the air with obscenities when annoyed.

A multi-site international study tracked 86 adults with low IQ for

over a

month during which they were treated with either, & 's

antipsychotic, Risperdal, or the older antipsychotic, Haldol, or a

placebo.

The study was led by Dr. J. Tyrer, a professor of psychiatry at

Imperial College London. Caregivers tracked the behavior of the

subjects.

After a month, people in all three groups had settled down, losing

their

temper less often and causing less damage when they did.

The findings, published in The Lancet: " the placebo group showing the

greatest change in the modified aggression scale (MOAS) score after 4

weeks=9 ( 79% for placebo from baseline; 7 (58% for risperidone from

baseline); 6.5 (65% for haloperidol from baseline.

http://www.thelancet.com/journals/lancet/article/PIIS0140673608600720/

abstra

ct

The New York Times reports: " Yet unexpectedly, those in the placebo

group

improved the most, significantly more so than those on medication. "

In point of fact, those on Risperdal improved the least!

The authors conclusion: " Antipsychotic drugs should no longer be

regarded as

an acceptable routine treatment for aggressive challenging behaviour

in

people with intellectual disability. "

This study challenges FDA's approval of Risperdal for " aggressiveness

in

autistic youth. "

Even as evidence is lacking in support of the current widespread use

of

antipsychotics; even as their life-shortening effects are documented;

and

the drugs carry black box warnings about drug-induced deaths; these

most

toxic of all psychotropic drugs are being widely and irresponsibly

misused

" as all-purpose tranquilizers " for aggressive behavior -- " in children

with

attention deficit disorder, for people with Alzheimer's disease, and

for

intellectually handicapped children. "

It is their misuse and Medicaid reimbursement that has made these

toxic

drugs profitable blockbuster sellers. Those at greatest risk of

prescribed

abuse are vulnerable children and the elderly who are incapable of

protecting themselves from harmful " treatments. " Medicaid is

misusing

taxpayer funds to divert resources from life-saving medicines to

life-shortening antipsychotic drugs.

The drugs' hazards can be measured by the legal settlements: Eli

Lilly, for

example, has shelled out more than $1.2 billion dollars to settle

lawsuits

charging the company with concealing Zyprexa's increased risk of

diabetes

from physicians and consumers.

Worst of all is FDA's complicity in promoting even wider usage of

antipsychotics, such as Zyprexa.

The FDA has issued approvable letters (prior to broadening the label)

that

would legitimize and broaden the use of Zyprexa for children.

Furthermore, Eli Lilly has submitted a NDA (New Drug Application) to

the

FDA for long-acting--2-week--intramuscular injection of Zyprexa in

doses:

210 milligrams (mg), 300 mg, and 405 mg per/ vial.

The FDA has scheduled a hearing by the Psychopharmacology advisory

committee

for Feb. 6, to deliberate on just one of the drug's attributes,

somnolence.

By all counts, including the false rationale for prescribing

antipsychotics

for aggression, somnolence is the drug's primary 'desirable' effect.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24627.htm

The FDA is ignoring the serious adverse effect reports accumulating

on its

own MedWatch database.

See: PsychRights break down of adverse effect reports (2004 to 2006)

for

antipsychotic drugs submitted to the FDA MedWatch:

http://www.psychdrugdangers.com/?drugtable=olanzapine

http://www.psychdrugdangers.com/?drugtable=risperidone

http://www.psychdrugdangers.com/?drugtable=aripiprazole

If you can bear witness at the Feb. 6 advisory meeting, sign up:

Written Testimony may be submitted until Jan 18:

Location: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777

Georgia Ave., Silver Spring, MD.

The hotel phone number is 301-587-4791.

FDA Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and

Research

(HFD-21),

301-827-7001, FAX: 301-827-6776, e-mail: diemkieu.ngo@...,

or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-

0572 in

the Washington, DC area),

code 3014512544

Contact: Vera Hassner Sharav

veracare@...

212-595-8974

http://www.nytimes.com/2008/01/04/health/04aggression.html?

ei=5070 & en=52f1ce

1495c1dd77 & ex=1200114000 & emc=eta1 & pagewanted=print

THE NEW YORK TIMES

January 4, 2008

Drugs Offer No Benefit in Curbing Aggression, Study Finds

By BENEDICT CAREY

The drugs most widely used to manage aggressive outbursts in

intellectually

disabled people are no more effective than placebos for most patients

and

may be less so, researchers report. The finding, being published

Friday,

sharply challenges standard medical practice in mental health clinics

and

nursing homes in the United States and around the world.

In recent years, many doctors have begun to use the so-called

antipsychotic

drugs, which were developed to treat schizophrenia, as all-purpose

tranquilizers to settle threatening behavior - in children with

attention-deficit problems, college students with depression, older

people

with Alzheimer's disease and intellectually handicapped people.

The new study tracked 86 adults with low I.Q.'s in community housing

in

England, Wales and Australia over more than a month of treatment. It

found a

79 percent reduction in aggressive behavior among those taking dummy

pills,

compared with a reduction of 65 percent or less in those taking

antipsychotic drugs.

The researchers focused on two drugs, Risperdal by Janssen, and an

older

drug, Haldol, but said the findings almost certainly applied to all

similar

medications. Such drugs account for more than $10 billion in annual

sales,

and research suggests that at least half of all prescriptions are for

unapproved " off label " uses - often to treat aggression or irritation.

The authors said the results were quite likely to intensify calls for

a

government review of British treatment standards for such patients,

and

perhaps to prompt more careful study of treatment for aggressive

behavior in

patients with a wide variety of diagnoses.

Other experts said the findings were also almost certain to inflame a

continuing debate over the widening use of antipsychotic drugs.

Patient

advocates and some psychiatrists say the medications are overused.

Previous studies of the drugs' effect on aggressive outbursts have

been

mixed, with some showing little benefit and others a strong calming

influence. But the drugs have serious side effects, including rapid

weight

gain and tremors, and doctors have had little rigorous evidence to

guide

practice.

" This is a very significant finding by some very prominent

psychiatrists " -

one that directly challenges the status quo, said ny L. Matson, a

professor of psychology at Louisiana State University in Baton Rouge,

co-author of an editorial with the study in the journal Lancet.

While it is unclear how much the study by itself will alter

prescribing

habits, " the message to doctors should be, think twice about

prescribing, go

with lower doses and monitor side effects very carefully, " Dr. Matson

continued, adding:

" Or just don't do it. We know that behavioral treatments can work

very well

with many patients. "

Other experts disagreed, saying the new study was not in line with

previous

research or their own experience. Janssen, a &

subsidiary,

said that Risperdal only promotes approved uses, which in this country

include the treatment of irritability associated with autism in

children.

In the study, Dr. J. Tyrer, a professor of psychiatry at

Imperial

College London, led a research team who assigned 86 people from ages

18 to

65 to one of three groups: one that received Risperdal; one that

received

another antipsychotic, the generic form of Haldol; and one that was

given a

placebo pill. Caregivers tracked the participants' behavior. Many

people

with very low I.Q.'s are quick to anger and lash out at others, bang

their

heads or fists into the wall in frustration, or singe the air with

obscenities when annoyed.

After a month, people in all three groups had settled down, losing

their

temper less often and causing less damage when they did. Yet

unexpectedly,

those in the placebo group improved the most, significantly more so

than

those on medication.

In an interview, Dr. Tyrer said there was no reason to believe that

any

other antipsychotic drug used for aggression, like Zyprexa from Eli

Lilly or

Seroquel from AstraZeneca, would be more effective. Being in the

study, with

all the extra attention it brought, was itself what apparently made

the

difference, he said.

" These people tend to get so little company normally, " Dr. Tyrer said.

" They're neglected, they tend to be pushed into the background, and

this

extra attention has a much bigger effect on them that it would on a

person

of more normal intelligence level. "

The study authors, who included researchers from the University of

Wales and

the University of Birmingham in Britain and the University of

Queensland in

Brisbane, Australia, wrote that their results " should not be

interpreted as

an indication that antipsychotic drugs have no place in the treatment

of

some aspects of behavior disturbance. "

But the routine prescription of the drugs for aggression, they

concluded,

" should no longer be regarded as a satisfactory form of care. "

Copyright 2008 The New York Times Company

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

The Institute for Nearly Genuine Research which is worth a visit

(apart from

having a funny side, amidst the doom). " Side Effects Made Simple "

http://www.bonkersinstitute.org/simpleside.html> from its " Science

Made

Simple Series " <http://www.bonkersinstitute.org/simplescience.html>

Notice how vague information is in official mental health sources of

information about causes, diagnoses, adverse drug effects:

The DSM is aptly dubbed: a science free zone - inasmuch as no

scientific

proof exists or is needed to establish mental " conditions. "

" Bipolar Made Simple " is a must see disinformation compilation of

manufacturers direct to consumer ads:

http://www.bonkersinstitute.org/simplebipolar.html

If your children or a relative are ever prescribed " mental health "

drugs,

you have good reason to be worried. Below are some nuggets

demonstrating

that psychiatry's prescribing practices are devoid of any scientific

facts--the entire field relies on " faith-based belief " --a science

free zone

where no mention is made of scientific evidence in support of these

" beliefs " ---

ABILIFY: " symptoms of bipolar disorder are thought to be caused by an

imbalance of key chemicals in the brain....Many scientists believe

that when

the levels of these neurotransmitters aren't quite right, it may

result in

bipolar disorder...The exact way Abilify (or any other medicine for

bipolar

disorder) works is unknown. "

GEODON: " No one knows the exact causes of bipolar disorder...Doctors

believe

Geodon helps balance certain natural chemicals in your brain. "

LAMITCAL: " Bipolar disorder may be related to a chemical imbalance in

the

brain, genetics, or abnormalities in brain structure....Special

chemicals in

the brain, called neurotransmitters, may be involved in the disease. "

RISPERDAL: " No one knows for sure what causes bipolar I disorder or

bipolar

mania. It is believed that the illness is caused by chemical

imbalances in

the brain....Scientists believe an imbalance of these chemicals may

cause

mood swings. These chemicals may include dopamine and serotonin.... "

ZYPREXA: " Bipolar disorder is a mental illness related to an

imbalance of

brain chemicals called neurotransmitters. No one knows exactly what

causes

this chemical imbalance, but researchers are looking for specific

genes that

may play a role. "

If your child or relative is prescribed Zyprexa (for example) here

are facts

you need to know:

Depression Suicidal/Suicidal Ideations: 104

Attempted Suicides (not completed): 119

Completed Suicides: 149

Deaths (not from Suicide): 392

Homicidal Ideations: 10

Homicides/Murders: 10

Hypomania/Mania: 94

See: Adverse antipsychotic drug effect reports submitted to the FDA

MedWatch

posted at PsychRights:

http://www.psychdrugdangers.com/?drugtable=aripiprazole

~~~~~~~~~

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24627.htm

[Federal Register: December 19, 2007 (Volume 72,

Number

243)]

[Page 71923-71924]

From the Federal Register Online via GPO Access

[wais.access.gpo.gov]

----------------------------------------------------------------------

-

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee; Notice

of

Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

----------------------------------------------------------------------

-

This notice announces a forthcoming meeting of a public

advisory committee of the Food and Drug Administration (FDA). The

meeting will be open to the public.

Name of Committee: Psychopharmacologic Drugs Advisory

Committee.

General Function of the Committee: To provide advice and

recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 6, 2008,

from 8 a.m. to 5 p.m.

Location: Crowne Plaza Silver Spring, Kennedy Ballroom, 8777

Georgia Ave., Silver Spring, MD. The hotel phone number is

301-587-4791.

Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation

and Research (HFD-21), Food and Drug Administration, 5600

Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093),

Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:

diemkieu.ngo@..., or FDA Advisory Committee

Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC

area), code 3014512544. Please call the Information Line for up-to-

date information on this meeting. A notice in the Federal Register

about last minute modifications that impact a previously announced

advisory committee meeting cannot always be published quickly enough

to provide timely notice. Therefore, you should always check the

agency's Web site and call the appropriate advisory committee hot

line/phone line to learn about possible modifications before coming

to the meeting.

Agenda: The committee will discuss new drug application(NDA) 22-

173, ZYPREXA ADHERA (olanzapine pamoate depot) long acting

[[Page 71924]]

intramuscular injection (210 milligrams (mg), 300 mg, and

405 mg per/ vial), Eli Lilly and Co., for the treatment of

schizophrenia. A particular safety concern for discussion is the

occurrence of severe somnolence in some patients who are administered

this depot formulation of olanzapine.

FDA intends to make background material available to the

public no later than 2 business days before the meeting. If FDA is

unable to post the background material on its Web site prior to the

meeting, the background material will be made publicly available at

the location of the advisory committee meeting, and the background

material will be posted on FDA's Web site after the meeting.

Background material is available at

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi

rom=leavingFR.html & log=

linklog & to=

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm,

click the year 2008 and scroll down to the appropriate

advisory committee link.

**[the url does NOT provide background material]

Procedure: Interested persons may present data, information,or

views, orally or in writing, on issues pending before the

committee. Written submissions may be made to the contact person on or

before January 18, 2008. Oral presentations from the public will be

scheduled between approximately 1:30 p.m. and 2:30 p.m. Those desiring

to make formal oral presentations should notify the contact person

and submit a brief statement of the general nature of the evidence or

arguments they wish to present, the names and addresses of proposed

participants, and an indication of the approximate time requested to

make their presentation on or before January 10, 2008. Time allotted

for each presentation may be limited. If the number of registrants

requesting to speak is greater than can be reasonably accommodated

during the scheduled open public hearing session, FDA may conduct a

lottery to determine the speakers for the scheduled open public

hearing session.

The contact person will notify interested persons regarding

their request to speak by January 11, 2007.

Persons attending FDA's advisory committee meetings are

advised that the agency is not responsible for providing access to

electrical outlets.

FDA welcomes the attendance of the public at its advisory committee

meetings and will make every effort to accommodate persons

with physical disabilities or special needs. If you require

special accommodations due to a disability, please contact Diem-Kieu

Ngo at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory

committee meetings. Please visit our Web site at

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?

from=leavingFR.html & log=

linklog & to=http://www.fda.gov/oc/advisory/default.htm

for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee

Act (5 U.S.C. app. 2).

Dated: December 12, 2007.

Randall W. Lutter,

Deputy Commissioner for Policy.

[FR Doc. E7-24627 Filed 12-18-07; 8:45 am]

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