Monday, January 7, 2008

Antipsychotics Offer No Benefit

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, Johnson & Johnson's antipsychotic, Risperdal, or the older antipsychotic, Haldol, or a placebo. The study was led by Dr. Peter 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 frombaseline); 6.5 (65% for haloperidol from baseline.

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 ofprotecting 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.

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:

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,

FDA Advisory Committee Information Line, 1-800-741-8138

(301-443-0572 in the Washington, DC area), code 3014512544


Promoting Openness, Full Disclosure, and Accountability

Contact: Vera Hassner Sharav


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