Vera Sharav
http://www.ahrp.org and http://ahrp.blogspot.com
The Arkansas State Attorney General has filed a lawsuit against Janssen and Johnson & Johnson charging the company had “engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for non-medically necessary uses.” [1] http://www.furiousseasons.com/legal%20documents/arrisperdalsuit.pdf
A similar suit against Janssen / J & J was filed by the Texas State Attorney General in Dec. 2006. http://ahrp.blogspot.com/2006/12/houston-tx-drug-makers-accused-of.html
It is illegal–a criminal offense–for a company to promote drugs for unapproved, off-label uses.
How, then, does one explain the pharmaceutical companies’ widespread promotion of the most toxic patented drugs–i.e. ‘atypical antipsychotics’–for off-label uses for even for nursery school children and the fragile elderly–even with FDA’s knowledge that these drugs are cutting short lives?
(1) One explanation is the financial incentives drug manufacturers provide to mental health providers–especially to psychiatrists who receive substantial kickbacks for prescribing and recommending to other psychiatrists to prescribe these drugs. http://ahrp.blogspot.com/2007/11/children-need-protection.html
(2) The other explanation puts the responsibility squarely in the lap of FDA officials who knew before issuing a marketing license for Risperdal that the drug had failed to demonstrate either safety or a benefit greater than the old neuroleptics (a.k.a. antipsychotics) whose well known adverse effects led doctors for the most part, to restrict their use to adult schizophrenia patients.
http://books.google.com/books?id=4T8sKI4cx_wC&pg=PA276&lpg=PA276&dq=mad+in+a
merica+risperdal&source=web&ots=9Iz6-u5-z_&sig=YAgJO9N3PP-93_1Onpk6zz2V4yU
The Arkansas suit alleges, among other things, that Janssen /J&J put Risperdal, a drug it knew to be defective, on the market in 1994–even though it knew the drug was defective and after the company had, in the AG’s account, cooked and jury-rigged results of pre-marketing clinical trials to make it look as though the drug had fewer extra-pyramidal side effects (EPS) than older anti-psychotics when in fact it had virtually the same EPS profile as older drugs.
FDA’s complicity in giving industry a license to market defective drugs that kill while sales rise to blockbuster profit makers is demonstrated by its actions:
1. FDA approved Risperdal and Zyprexa despite emergent safety issues during premarketing clinical trials, and despite lack of evidence of any improved efficacy compared to the old neuroleptics. [2] [3]
2. An independent analysis of FDA’s MedWatch adverse event reports, 1998-2005, found: [4] http://archinte.ama-assn.org/cgi/content/short/167/16/1752
FDA received 3,277 death reports involving the antipsychotic, Clozaril, 1,093 death reports involving Risperdal, and 1,005 death reports involving Zyprexa.Yet, these drugs continue to kill, while the anti-inflammatory drug Vioxx (rofecoxib) was withdrawn from the market after 932 deaths were reported to MedWatch.
3. Adding insult to injury, following public furor over the revelations about these drugs’ concealed hazards–for example, The New York Times reports about the evidence contained in Eli Lilly documents of the company’s illegal marketing strategy for its antipsychotic drug, Zyprexa (olanzapine), FDA has subsequently lent the government seal of approval for use of these toxic killer drugs for use in children.
http://ahrp.blogspot.com/2007/08/fda-approval-of-risperdal-for-children.html
FDA officials did so without an advisory committee, without a public hearing, and without disclosing the data to justify the exposure of children to high risk of severe debilitating drug-induced diseases—including diabetes, metabolic syndrome with attendant cardiovascular abnormalities.
One suspects the FDA approved these drugs for children so as to shield manufacturers and psychiatrists who prescribed these drugs widely off-label, which renders them liable.
* Indeed, at least 30 other state attorneys general are investigating the illegal marketing of antipsychotics for unapproved (off-label) uses before FDA’s recent hasty approval for pediatric use.
References:
1. The complaint in State of Arkansas v. Janssen Pharmaceutic, Inc., Jannsen L.P. & Johnson & Johnson, Inc. is posted at Furious Seasons: http://www.furiousseasons.com/legal%20documents/arrisperdalsuit.pdf
2. See: Discussion Re: FDA approval of Risperdal (risperidone) in 1994 with reference to memoranda by Paul Leber, then Director of FDA Neuropsychopharmacology:
http://books.google.com/books?id=4T8sKI4cx_wC&pg=PA275&lpg=PA275&dq=leber+
risperdal+approval&source=web&ots=9Iz6-u0-FW&sig=RD13Lj1EUJatYprqYggMG7pjfPM#PPA276,M1
3. Leber P. Director. FDA Neuropsychopharmacology. Memorandum Re: NDA 20-592 Zyprexa (olanzapine). August 18, 1996.
4. Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005 Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.
* See Nov 21 commentary by Phillip Dawdy, Furious Seasons: http://www.furiousseasons.com/
Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974
###
CNN.comhttp://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJONESDJON LINE000498_FORTUNE5.htm
Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing, Dow Jones, November 21, 2007
The information herein shall not be considered an endorsement of anyone discontinuing psychiatric drugs. If you are stopping taking medication it is advisable to reduce the dose gradually WITH EXTREME CAUTION, as it is difficult to predict who will have problems withdrawing. It is worth getting as much information and support as you can, and involving your doctor wherever possible. You will find withdrawal information HERE: http://www.mind.org.uk/Information/Booklets/Making+sense/Making+sense+of+coming+off+psychiatric+drugs.htm
FOR MORE INFORMATION ON WITHDRAWAL:: Get Peter Lehmann’s book, Coming off Psychiatric Drugs: Successful Withdrawal from Neuroleptics, Antidepressants, Lithium, Carbamazepine and Tranquilizers. This valuable resource comes in US, UK, and German editions.
I, Kathleen Maire Hill, present this information in my capacity as a natural person, exercising my natural rights and freedoms. This information represents my private thoughts and beliefs and has been compiled and expressed for peer-to-peer educational purposes only.
· “Apathy is the glove into which evil slips its hand.” Bodie Thoene
· “Non-cooperation with evil is as much a duty as is cooperation with good.” Gandhi
· “(Freedom) is the will to be responsible to ourselves.” Friedrich Nietzsche
· “Freedom is what you do with what’s been done to you.” Jean-Paul Sartre
· “Ultimately we know deeply that the other side of every fear is a freedom.” Marilyn Ferguson
· “Alone with one’s conscience there are no alibis!” Tristano Ajmone
· “Ethical. existence [is] the highest manifestation of spirituality.” Albert Schweitzer
A Model Consent Form for Psychiatric Drug Treatment
by David Cohen, Ph.D., and David Jacobs, Ph.D.
http://laingsociety.org/colloquia/polofdiagnosis/modelconsent.htm
How Mercury Causes Brain Neuron Degeneration (5-minute video)
http://commons.ucalgary.ca/showcasetv/displayVideo?movieID=1000073&videoID=1000023
