Drugs Offer No Benefit in Curbing Aggression, Study Finds
By BENEDICT CAREY, THE NEW YORK TIMES
January 4, 2008
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 Johnny 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 Johnson & Johnson 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. Peter 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 theirheads 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
"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 scientificfacts - 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 inbipolar 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
Deaths (not from Suicide): 392
Homicidal Ideations: 10Homicides/Murders: 10
See: Adverse antipsychotic drug effect reports submitted to the FDA MedWatch posted at PsychRights:http://www.psychdrugdangers.com/?drugtable=aripiprazole
[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.
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,
e-mail: mailto:diemkieu.ngo%40fda.hhs.gov, 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?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click the year 2008 and scroll down to the appropriateadvisory 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 athttp://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]
BILLING CODE 4160-01-S
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