Re: More: Arkansas sues J&J, Risperdal- defective company lied

[Guest guest]

In a refreshingly candid remark, Dr. Tom Insel of NIMH and head of IACC said the following at the NAA conference recently, in response to the comment about the poor risk/benefit ratio of Risperdal as compared to other interventions"[risperdal] is not a treatment for core symptoms of autism and it comes with serious adverse effects, no question about that..."On Nov 23, 2007, at 4:08 PM, anacat_11 wrote:And the FDA helped! ALLIANCE FOR HUMAN RESEARCH PROTECTIONPromoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe Arkansas State Attorney General has filed a lawsuit against Janssen and & charging the company had "engaged in a direct, illegal,nationwide program of promotion of the use of Risperdal for non-medicallynecessary uses." [1]http://www.furiousseasons.com/legal%20documents/arrisperdalsuit.pdfA similar suit against Janssen / J & J was filed by the Texas State AttorneyGeneral in Dec. 2006. http://ahrp.blogspot.com/2006/12/houston-tx-drug-makers-accused-of.htmlIt is illegal--a criminal offense--for a company to promote drugs forunapproved, off-label uses. How, then, does one explain the pharmaceutical companies' widespreadpromotion of the most toxic patented drugs--i.e. 'atypicalantipsychotics'--for off-label uses for even for nursery school children andthe fragile elderly--even with FDA's knowledge that these drugs are cuttingshort lives? One explanation is the financial incentives drug manufacturers provide tomental health providers--especially to psychiatrists who receive substantialkickbacks for prescribing and recommending to other psychiatrists toprescribe these drugs.http://ahrp.blogspot.com/2007/11/children-need-protection.htmlThe other explanation puts the responsibility squarely in the lap of FDAofficials who knew before issuing a marketing license for Risperdal that thedrug had failed to demonstrate either safety or a benefit greater than theold neuroleptics (a.k.a. antipsychotics) whose well known adverse effectsled doctors for the most part, to restrict their use to adult schizophreniapatients.http://books.google.com/books?id=4T8sKI4cx_wC & pg=PA276 & lpg=PA276 & dq=mad+in+america+risperdal & source=web & ots=9Iz6-u5-z_ & sig=YAgJO9N3PP-93_1Onpk6zz2V4yUThe Arkansas suit alleges, among other things, that Janssen /J & J putRisperdal, a drug it knew to be defective, on the market in 1994--eventhough it knew the drug was defective and after the company had, in the AG'saccount, cooked and jury-rigged results of pre-marketing clinical trials tomake 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 EPSprofile as older drugs. FDA's complicity in giving industry a license to market defective drugs thatkill while sales rise to blockbuster profit makers is demonstrated by itsactions:1. FDA approved Risperdal and Zyprexa despite emergent safety issues duringpremarketing clinical trials, and despite lack of evidence of any improvedefficacy 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 involvingZyprexa.Yet, these drugs continue to kill, while the anti- inflammatory drug Vioxx(rofecoxib) was withdrawn from the market after 932 deaths were reported toMedWatch. 3. Adding insult to injury, following public furor over the revelationsabout these drugs' concealed hazards--for example, The New York Timesreports about the evidence contained in Eli Lilly documents of the company'sillegal marketing strategy for its antipsychotic drug, Zyprexa (olanzapine),FDA has subsequently lent the government seal of approval for use of thesetoxic killer drugs for use in children.http://ahrp.blogspot.com/2007/08/fda-approval-of-risperdal-for-children.htmlFDA officials did so without an advisory committee, without a publichearing, and without disclosing the data to justify the exposure of childrento high risk of severe debilitating drug-induced diseases--includingdiabetes, metabolic syndrome with attendant cardiovascular abnormalities.One suspects the FDA approved these drugs for children so as to shieldmanufacturers and psychiatrists who prescribed these drugs widely off-label,which renders them liable. Indeed, at least 30 other state attorneys general are investigating theillegal marketing of antipsychotics for unapproved uses before FDA's recenthasty approval for pediatric use.References: 1. The complaint in State of Arkansas v. Janssen Pharmaceutic, Inc., JannsenL.P. & & , Inc. is posted at Furious Seasons:http://www.furiousseasons.com/legal%20documents/arrisperdalsuit.pdf2. See: Discussion Re: FDA approval of Risperdal (risperidone) in 1994 withreference to memoranda by Leber, then Director of FDANeuropsychopharmacology: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,M13. Leber P. Director. FDA Neuropsychopharmacology. Memorandum Re: NDA 20-592Zyprexa (olanzapine). August 18, 1996..4. Serious Adverse Drug Events Reported to the Food and Drug Administration,1998-2005 J. , AB; R. Cohen, RPh, MS, ScD; Curt D.Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759. See Nov 21 commentary by Dawdy, Furious Seasons:http://www.furiousseasons.com/Contact: Vera Hassner Sharavveracareahrp (DOT) org212-595-8974http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJONESDJONLINE000498_FORTUNE5.htmArkansas AG Suing JNJ Over Anti-Psychotic Drug MarketingDow November 21, 2007:LITTLE ROCK (AP)--Drug companies improperly marketed an anti-psychotic drug,Arkansas Attorney General Mc claimed Tuesday as he asked astate judge to force the firms to repay millions shelled out by the state'sMedicaid program for unnecessary prescriptions.Mc filed a lawsuit in Pulaski County Circuit Court against JanssenPharmaceutica Inc., Janssen LP and & Inc. (JNJ). In thefiling, Mc said the companies "engaged in a direct, illegal,nationwide program of promotion of the use of Risperdal for non-medicallynecessary uses."New Brunswick, N.J.-based & is the parent company of bothJanssen Pharmaceutica and Janssen LP.The lawsuit did not specify how much the state is seeking, but Mc hasestimated that the state's Medicaid program spent about $200 million overeight years to pay for prescriptions for Zyprexa, Seroquel and Risperdal.The lawsuit filed Tuesday focuses solely on Risperdal.Gabe Holmstrom, a spokesman for Mc's office, said the state will filesimilar complaints about the marketing of the other drugs. Mc has saidother companies that will be targeted include Eli Lilly and Co. (LLY) ofIndianapolis and AstraZeneca PLC (AZN), a joint venture by a British firmand a Swedish firm.Mc has said the drugs were prescribed for uses not approved by federalregulators or indicated in labeling. Mc accused the companies ofdeceptive marketing practices that pushed doctors to prescribe Risperdalmuch more than necessary.The lawsuit also accuses drugmakers of not including warnings on Risperdal'sbottle about adverse effects such as neurological problems, weight gain anddiabetes.Ambre Morley, a spokeswoman for Janssen, defended the company and said itfully disclosed all information about Risperdal to doctors and governmentagencies.Copyright © 2007 Dow & Company, Inc.~~~~~~~~~~~~~~~ Furious SeasonsNovember 21, 2007Atypical Nation: J & J's Risperdal "Defective," Company Lied, Thousands Died As I reported earlier, the State of Arkansas yesterday sued Janssen and itsparent J & J over allegations concerning its atypical anti-psychotic Risperdaland how the company developed and marketed the drug. The lawsuit is a realeye-opener and confirms many things I've been saying on this site for overtwo years and for two years before that in print: there's something wrongwith the atypicals and how deeply they've ended up embedded in Americanculture.The suit alleges that, among other things, Janssen/J & J put a drug it knew tobe defective on the market in 1994, even though it knew the drug wasdefective and after the company had, in the AG's account, cooked andjury-rigged results of pre-marketing clinical trials to make it look asthough the drug had fewer extra-pyramidal side effects (EPS) than olderanti-psychotics when in fact it had virtually the same EPS profile as olderdrugs. There are other allegations--off-label marketing for use in childrenand the elderly, a campaign of covering up the drug's side effects,allegations of kickbacks to doctors and so on--but they almost pale incomparison to the EPS allegations, which ought to make anyone wonder how theheck this drug got approved in the first place.One of the charges against Janssen/J & J is for fraud.Sales of the drug in 2006 were $4.2 billion. Depending on who is estimating,Risperdal is the most used anti-psychotic in the world.The EPS allegation, the first I've seen in any of the ongoing lawsuitsagainst J & J, goes right to heart of why atypicals became so popular amongstdoctors: they were supposed to cause fewer side effects (a la SSRIs versusolder anti-depressants in the 1980s), and therefore docs could safely givethem to patients of every stripe for long-term use. Use of the olderanti-psychotics was tightly restricted by docs (except among schizophrenics)because they were felt to cause so much EPS (aka zombieism) that it would beunethical to hand them out to anyone but the very sickest of patients. Butatypicals like Risperdal were supposed to be safe for one and all.As it turns out, that was not the case. As a result, millions of people havepaid a heavy price for using Risperdal--I am one of them--including at least1,000 people who died as a result of using the drug, according to the FDA'sadverse events database, as I have previously reported.J & J and Janssen lied. People died, or were injured and sickened by thewillful action of one of the largest pharmaceutical companies on Earth.That's the view of the Arkansas Attorney General Mc. Otherstates including Texas are suing J & J over Risperdal as well.Anyone who thinks I have been too harsh in my commentary on these drugs, toorough on the pharma companies who make and market them, too tough on thedoctors who gave them to patients like me and, as a a result, wrote me offas a wingnut, ought to read this (and other) lawsuits against the makers ofthese drugs and see just how wingnutty Mc is. Because he isn't. Andneither am I. The lawsuit is here (.pdf 1.5 MB). The lies and deception thathave gone with the atypicals' use in America are right up there with thelies propagated about the use of cigarettes by American tobacco companies.Now for a few particulars from the suit. First, the EPS allegations:"Risperdal's pre-marketing clinical trials did not support an assertion thatit is less likely to cause EPS than traditionalantipsychotics....Defendants'trials were designed to produce similar rates of EPS in patients sorted intoplacebo groups and those taking Risperdal. In order to produce their desiredresult, defendants selected patients for the placebo groups that werealready in the course of treatment with high doses of typicalantipsychotics...."Defendants claimed in their marketing that patients taking Risperdal wereas likely to develop EPS as patients taking nothing and thus less likely todevelop EPS than patients taking traditional antipsychotics."That is a staggering accusation and I assume Mc has documents to backit up. So far Janssen and J & J have not commented on the suit or itsallegations.In 2002 and 2003, I experienced mild EPS on Risperdal after being on it at.5 mgs a day since December 2000, and took myself off the drug against mythen-doctor's wishes (he insisted that EPS and other problems didn't occuron Risperdal). Just so you know my bias on this issue.Other allegations:"Janssen heavily marketed and promoted Risperdal [in the mid-1990s] for itsapproved indication, treatment of adult with schizophrenia, and for multiplenon-medically necessary uses of the drug, for example, ADHD, depression,anxiety, mood disorder, bipolar disorder, and aggression associated withlate-onset dementia."I was pressed to take the drug off-label (my then-doctor never explainedthat part) three years before the drug received approval for use in bipolardisorder in 2003. Just so you know how I felt when I read the following:"Despite having been on notice for years of the potential for deadlydiabetes-related side effects, defendant opted for the bare minimum ofclinical trials, of limited duration, such that no side effects were likelyto be revealed."The suit further alleges that J & J knew of weight gain and resultant diabetesissues with the drug but worked to conceal the drug's true safety profile.The state introduces evidence that in 1999, the FDA busted Janssen formarketing Risperdal for off-label use in the elderly and that the FDAinformed Janssen it was engaged in "false and misleading" practices (seepages 9 and 10).As part of its strategy in the 1990s to expand Risperdal's market beyond itsapproved use in schizophrenia, the suit alleges that:"Defendants sough ghost written research and paid 'key opinion leaders' tosupport defendant's marketing aims. These 'key opinion leaders' were nothingmore than third-party consultants and researchers who were put ondefendants' payroll to support and lend credibility to defendants' speciousscientific and marketing representations."Can't wait to find out who the researchers were who helped them with bipolardisorder.There is more evidence and allegations contained in this lawsuit. I'll getinto those later.For now, this: Attorney General Mc alleges that Risperdal was"defective, unreasonably dangerous and hazardous" and that Janssen/J & J knewthis and put the drug on the market anyway. "At the time Risperdal was soldor placed on the market, it was in a defective condition and unreasonablydangerous to users and consumers."In addition to allegations that the companies violated the state's Medicaidfraud laws, the state alleges that the companies violated the state'sdeceptive trade practices act, engaged in negligent behavior, and engaged infraud and misrepresentation and "unjust enrichment."===========================================Furious SeasonsComments: Atypical Nation: J & J's Risperdal "Defective," Company Lied,Thousands Died In August of 1999, my daughter was 11 years old. After anadverse reaction[suicidal ideation]on Imipramine, I took her to apsychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox, whichaccelerated her "thoughts", and the psych recommended hospitalization.THERE,inpatient at age 11--was where they put her on Risperdal. Her eyes lockedlooking up, she was so pale and couldnt move her legs--I thought she wasdying. I was then clueless about psych meds, and trusted doctors.I will never forget seeing her and thinking my 11 year old looked like shewas dying. That was in 1999, what fucking nerve this company has to place mydaughter at risk that way, and the smack in my face as a mother and for mydaughter, is that Eli Lilly's Zyprexa is what replaced that Risperdal!For reading about Biederman,Wozniak, Wilens and Spencer and the study forRisperdal use in kids way back in 1999, as well as how it was approved foruse in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood Bipolar andjust need not wonder any further, what my daughter's "OCD" dx "changed" towithin weeks---yeah that's right, Childhood Bipolar Disorder, in 1999.I hope this company and Eli Lilly are ready for a patient lawsuit, becauseI'm rolling up my sleeves.They can f... pay for her to live somewhere decent, for her long term careat age 19. I have to say, this is a topic everyone should not disregard, pay attentionto these killers in our midst. I am lucky my daughter is alive, and at what cost!!?I really do not want to visit her in a residential care facility at age 19for Thanksgiving, and I am.Does anyone understand why this angers me.Posted by Stephany at November 21, 2007 08:52 AMPhil, your analysis is missing, what I think, is the critical point, whichis: disclosure of side effects of a particular drug, here Risperdal, is nota substitute for approval of the use of the drug in the first place. Inother words, knowing all the bad effects of Risperdal cannot substitute forits governmental approval for consumers' use. The FDA, a governmentalauthority charged with monitoring the safety and effectiveness ofmedications, approved Risperdal. Other than a few warnings, the FDA has donenothing to stop its marketing, notwithstanding the fact that Risperdal wasunnecessary at best (there are better or similar quality drugs on the marketalready), or dangerous (and should be banned) at worst. The FDA is not aparty to the lawsuit. The plaintiffs in the lawsuits are not consumers butthe states. The states are not representatives of consumers and whatevermoney they recover will go the states . The states are not seeking to banRisperdal and if they did, they probably couldn't. What's this lawsuit isall about? It's about local governments seeing an opportunity to get somemoney out of drug companies. What the lawsuit doesn't address is that drugsare not securities; a prescribing information is not a prospectus; theconcept of let the buyer beware (caveat emptor) can have no application toprescription medicines, that consumers cannot understand medications andthat individual doctors are in no better position that consumers tounderstand medications either. What the lawsuit proves is that the FDA hasfailed consumers once again. So it's a useless exercise as far asindividuals are concerned.Posted by Red Rover at November 21, 2007 09:03 AM"What the lawsuit proves is that the FDA has failed consumers once again."That's exactly right. So who really is at fault for innocent death andbodily injury to American citizens?Like Riley?Posted by Stephany at November 21, 2007 10:51 AM===========================================http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_risperdal.htmlNovember 20, 2007Arkansas Sues Over RisperdalThe State of Arkansas today filed a lawsuit against Janssen and J & J overallegations that the company "engaged in a direct, illegal, nationwideprogram of promotion of the use of Risperdal for non-medically necessaryuses." In other words, off-label marketing--specific charges would likelyinclude allegations of the drug being marketed for use in elders andchildren, as well as in depression and anxiety, conditions and age groupsfor which the drug does not have FDA approval (it did get two pediatricapprovals over the last two years, but this suit concerns allegations inprior years). This lawsuit had been expected for some time. The state didnot specify damages sought, but it would likely be over $100 million indamages and penalties. The state has also made it clear that it intends tosue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of Seroquel, oversimilar allegations. I'll have more on this once I've seen a copy of thestate's complaint, which I have requested, against Janssen/J & J.According to the AP, Janssen had no comment.Posted by Philip Dawdy at November 20, 2007 12:21 PM

[Guest guest]

Forgive my cynicism- at so many junctures, there was always so much

more that Insel could have said but didn't say and, most

importantly, didn't do regarding drug safety concerns. In light of

school shootings, drug-induced suicidality, iatrogenic diabetes,

100% increase in drug-induced movement disorders among children in

just ten months, massive rise in drug-induced mania leading to

polypharmacy and exponentially rising rates of so-called bipolarity,

terrible mortality rates for those chronically treated with certain

psychotropes, Riley, New Freedom Initiative, regulatory

capture, the scamming of Medicaid, Teenscreen, mass doping of foster

children- you know, all of that- he was in the unprecedented

position of facing situations which required more commentary and

action than anyone in the history of his post. If this man were

truly earning taxpayer's money, he would be hated by industy.

I'm sure J & J didn't appreciate his remark, so I'll grudgingly give

him that.

>

> > And the FDA helped!

> >

> > ALLIANCE FOR HUMAN RESEARCH PROTECTION

> >

> > Promoting Openness, Full Disclosure, and Accountability

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

> >

> > FYI

> > The Arkansas State Attorney General has filed a lawsuit against

> > Janssen and

> > & 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?

> >

> > 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

> >

> > 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 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. & & , 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 Leber, then Director of FDA

> > Neuropsychopharmacology:

> > http://books.google.com/books?

> > id=4T8sKI4cx_wC & pg=PA275 & lpg=PA275 & dq=leber+ri

> > sperdal+approval & source=web & ots=9Iz6-u0-

> > FW & sig=RD13Lj1EUJatYprqYggMG7pjfPM#P

> > PA276,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 J. , AB; R. Cohen, RPh, MS, ScD;

Curt

> > D.

> > Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.

> >

> > See Nov 21 commentary by Dawdy, Furious Seasons:

> > http://www.furiousseasons.com/

> >

> > Contact: Vera Hassner Sharav

> > veracare@...

> > 212-595-8974

> >

> >

http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJO

> > NESDJON

> > LINE000498_FORTUNE5.htm

> > Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing

> > Dow

> > November 21, 2007:

> >

> > LITTLE ROCK (AP)--Drug companies improperly marketed an anti-

> > psychotic drug,

> > Arkansas Attorney General Mc claimed Tuesday as he

> > asked a

> > state judge to force the firms to repay millions shelled out by

the

> > state's

> > Medicaid program for unnecessary prescriptions.

> >

> > Mc filed a lawsuit in Pulaski County Circuit Court against

> > Janssen

> > Pharmaceutica Inc., Janssen LP and & Inc. (JNJ).

In

> > the

> > filing, Mc said the companies " engaged in a direct,

illegal,

> > nationwide program of promotion of the use of Risperdal for non-

> > medically

> > necessary uses. "

> >

> > New Brunswick, N.J.-based & is the parent

company of

> > both

> > Janssen Pharmaceutica and Janssen LP.

> >

> > The lawsuit did not specify how much the state is seeking, but

> > Mc has

> > estimated that the state's Medicaid program spent about $200

million

> > over

> > eight years to pay for prescriptions for Zyprexa, Seroquel and

> > Risperdal.

> > The lawsuit filed Tuesday focuses solely on Risperdal.

> >

> > Gabe Holmstrom, a spokesman for Mc's office, said the state

> > will file

> > similar complaints about the marketing of the other drugs.

Mc

> > has said

> > other companies that will be targeted include Eli Lilly and Co.

> > (LLY) of

> > Indianapolis and AstraZeneca PLC (AZN), a joint venture by a

British

> > firm

> > and a Swedish firm.

> >

> > Mc has said the drugs were prescribed for uses not

approved by

> > federal

> > regulators or indicated in labeling. Mc accused the

companies

> > of

> > deceptive marketing practices that pushed doctors to prescribe

> > Risperdal

> > much more than necessary.

> >

> > The lawsuit also accuses drugmakers of not including warnings on

> > Risperdal's

> > bottle about adverse effects such as neurological problems,

weight

> > gain and

> > diabetes.

> >

> > Ambre Morley, a spokeswoman for Janssen, defended the company and

> > said it

> > fully disclosed all information about Risperdal to doctors and

> > government

> > agencies.

> >

> > Copyright © 2007 Dow & Company, Inc.

> > ~~~~~~~~~~~~~~~

> >

> > Furious Seasons

> > November 21, 2007

> >

> > Atypical Nation: J & J's Risperdal " Defective, " Company Lied,

> > Thousands Died

> > As I reported earlier, the State of Arkansas yesterday sued

Janssen

> > and its

> > parent J & J over allegations concerning its atypical anti-

psychotic

> > Risperdal

> > and how the company developed and marketed the drug. The lawsuit

is

> > a real

> > eye-opener and confirms many things I've been saying on this site

> > for over

> > two years and for two years before that in print: there's

something

> > wrong

> > with the atypicals and how deeply they've ended up embedded in

> > American

> > culture.

> >

> > The suit alleges that, among other things, Janssen/J & J put 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. There are other allegations--off-label marketing for use

in

> > children

> > and the elderly, a campaign of covering up the drug's side

effects,

> > allegations of kickbacks to doctors and so on--but they almost

pale

> > in

> > comparison to the EPS allegations, which ought to make anyone

wonder

> > how the

> > heck this drug got approved in the first place.

> >

> > One of the charges against Janssen/J & J is for fraud.

> > Sales of the drug in 2006 were $4.2 billion. Depending on who is

> > estimating,

> > Risperdal is the most used anti-psychotic in the world.

> >

> > The EPS allegation, the first I've seen in any of the ongoing

> > lawsuits

> > against J & J, goes right to heart of why atypicals became so

popular

> > amongst

> > doctors: they were supposed to cause fewer side effects (a la

SSRIs

> > versus

> > older anti-depressants in the 1980s), and therefore docs could

> > safely give

> > them to patients of every stripe for long-term use. Use of the

older

> > anti-psychotics was tightly restricted by docs (except among

> > schizophrenics)

> > because they were felt to cause so much EPS (aka zombieism) that

it

> > would be

> > unethical to hand them out to anyone but the very sickest of

> > patients. But

> > atypicals like Risperdal were supposed to be safe for one and

all.

> >

> > As it turns out, that was not the case. As a result, millions of

> > people have

> > paid a heavy price for using Risperdal--I am one of them--

including

> > at least

> > 1,000 people who died as a result of using the drug, according to

> > the FDA's

> > adverse events database, as I have previously reported.

> >

> > J & J and Janssen lied. People died, or were injured and sickened

by

> > the

> > willful action of one of the largest pharmaceutical companies on

> > Earth.

> > That's the view of the Arkansas Attorney General Mc.

> > Other

> > states including Texas are suing J & J over Risperdal as well.

> >

> > Anyone who thinks I have been too harsh in my commentary on these

> > drugs, too

> > rough on the pharma companies who make and market them, too

tough on

> > the

> > doctors who gave them to patients like me and, as a a result,

wrote

> > me off

> > as a wingnut, ought to read this (and other) lawsuits against the

> > makers of

> > these drugs and see just how wingnutty Mc is. Because he

> > isn't. And

> > neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and

> > deception that

> > have gone with the atypicals' use in America are right up there

with

> > the

> > lies propagated about the use of cigarettes by American tobacco

> > companies.

> >

> > Now for a few particulars from the suit. First, the EPS

allegations:

> >

> > " Risperdal's pre-marketing clinical trials did not support an

> > assertion that

> > it is less likely to cause EPS than traditional

> > antipsychotics....Defendants'

> > trials were designed to produce similar rates of EPS in patients

> > sorted into

> > placebo groups and those taking Risperdal. In order to produce

their

> > desired

> > result, defendants selected patients for the placebo groups that

were

> > already in the course of treatment with high doses of typical

> > antipsychotics....

> > " Defendants claimed in their marketing that patients taking

> > Risperdal were

> > as likely to develop EPS as patients taking nothing and thus less

> > likely to

> > develop EPS than patients taking traditional antipsychotics. "

> >

> > That is a staggering accusation and I assume Mc has

documents

> > to back

> > it up. So far Janssen and J & J have not commented on the suit or

its

> > allegations.

> >

> > In 2002 and 2003, I experienced mild EPS on Risperdal after

being on

> > it at

> > .5 mgs a day since December 2000, and took myself off the drug

> > against my

> > then-doctor's wishes (he insisted that EPS and other problems

didn't

> > occur

> > on Risperdal). Just so you know my bias on this issue.

> >

> > Other allegations:

> >

> > " Janssen heavily marketed and promoted Risperdal [in the mid-

1990s]

> > for its

> > approved indication, treatment of adult with schizophrenia, and

for

> > multiple

> > non-medically necessary uses of the drug, for example, ADHD,

> > depression,

> > anxiety, mood disorder, bipolar disorder, and aggression

associated

> > with

> > late-onset dementia. "

> > I was pressed to take the drug off-label (my then-doctor never

> > explained

> > that part) three years before the drug received approval for use

in

> > bipolar

> > disorder in 2003. Just so you know how I felt when I read the

> > following:

> >

> > " Despite having been on notice for years of the potential for

deadly

> > diabetes-related side effects, defendant opted for the bare

minimum

> > of

> > clinical trials, of limited duration, such that no side effects

were

> > likely

> > to be revealed. "

> > The suit further alleges that J & J knew of weight gain and

resultant

> > diabetes

> > issues with the drug but worked to conceal the drug's true safety

> > profile.

> > The state introduces evidence that in 1999, the FDA busted

Janssen

> > for

> > marketing Risperdal for off-label use in the elderly and that

the FDA

> > informed Janssen it was engaged in " false and misleading "

practices

> > (see

> > pages 9 and 10).

> >

> > As part of its strategy in the 1990s to expand Risperdal's market

> > beyond its

> > approved use in schizophrenia, the suit alleges that:

> >

> > " Defendants sough ghost written research and paid 'key opinion

> > leaders' to

> > support defendant's marketing aims. These 'key opinion leaders'

were

> > nothing

> > more than third-party consultants and researchers who were put on

> > defendants' payroll to support and lend credibility to

defendants'

> > specious

> > scientific and marketing representations. "

> > Can't wait to find out who the researchers were who helped them

with

> > bipolar

> > disorder.

> >

> > There is more evidence and allegations contained in this lawsuit.

> > I'll get

> > into those later.

> >

> > For now, this: Attorney General Mc alleges that Risperdal

was

> > " defective, unreasonably dangerous and hazardous " and that

> > Janssen/J & J knew

> > this and put the drug on the market anyway. " At the time

Risperdal

> > was sold

> > or placed on the market, it was in a defective condition and

> > unreasonably

> > dangerous to users and consumers. "

> >

> > In addition to allegations that the companies violated the

state's

> > Medicaid

> > fraud laws, the state alleges that the companies violated the

state's

> > deceptive trade practices act, engaged in negligent behavior, and

> > engaged in

> > fraud and misrepresentation and " unjust enrichment. "

> > ===========================================

> > Furious Seasons

> >

> > Comments: Atypical Nation: J & J's Risperdal " Defective, " Company

Lied,

> > Thousands Died In August of 1999, my daughter was 11 years old.

> > After an

> > adverse reaction[suicidal ideation]on Imipramine, I took her to a

> > psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox,

> > which

> > accelerated her " thoughts " , and the psych recommended

> > hospitalization.THERE,

> > inpatient at age 11--was where they put her on Risperdal. Her

eyes

> > locked

> > looking up, she was so pale and couldnt move her legs--I thought

she

> > was

> > dying. I was then clueless about psych meds, and trusted doctors.

> >

> > I will never forget seeing her and thinking my 11 year old looked

> > like she

> > was dying. That was in 1999, what fucking nerve this company has

to

> > place my

> > daughter at risk that way, and the smack in my face as a mother

and

> > for my

> > daughter, is that Eli Lilly's Zyprexa is what replaced that

> > Risperdal!

> >

> > For reading about Biederman,Wozniak, Wilens and Spencer and the

> > study for

> > Risperdal use in kids way back in 1999, as well as how it was

> > approved for

> > use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood

> > Bipolar and

> > just need not wonder any further, what my daughter's " OCD "

> > dx " changed " to

> > within weeks---yeah that's right, Childhood Bipolar Disorder, in

> > 1999.

> >

> > I hope this company and Eli Lilly are ready for a patient

lawsuit,

> > because

> > I'm rolling up my sleeves.

> >

> > They can f... pay for her to live somewhere decent, for her long

> > term care

> > at age 19.

> > I have to say, this is a topic everyone should not disregard, pay

> > attention

> > to these killers in our midst.

> > I am lucky my daughter is alive, and at what cost!!?

> >

> > I really do not want to visit her in a residential care facility

at

> > age 19

> > for Thanksgiving, and I am.

> > Does anyone understand why this angers me.

> >

> > Posted by Stephany at November 21, 2007 08:52 AM

> >

> > Phil, your analysis is missing, what I think, is the critical

point,

> > which

> > is: disclosure of side effects of a particular drug, here

Risperdal,

> > is not

> > a substitute for approval of the use of the drug in the first

place.

> > In

> > other words, knowing all the bad effects of Risperdal cannot

> > substitute for

> > its governmental approval for consumers' use. The FDA, a

governmental

> > authority charged with monitoring the safety and effectiveness of

> > medications, approved Risperdal. Other than a few warnings, the

FDA

> > has done

> > nothing to stop its marketing, notwithstanding the fact that

> > Risperdal was

> > unnecessary at best (there are better or similar quality drugs on

> > the market

> > already), or dangerous (and should be banned) at worst. The FDA

is

> > not a

> > party to the lawsuit. The plaintiffs in the lawsuits are not

> > consumers but

> > the states. The states are not representatives of consumers and

> > whatever

> > money they recover will go the states . The states are not

seeking

> > to ban

> > Risperdal and if they did, they probably couldn't. What's this

> > lawsuit is

> > all about? It's about local governments seeing an opportunity to

get

> > some

> > money out of drug companies. What the lawsuit doesn't address is

> > that drugs

> > are not securities; a prescribing information is not a

prospectus;

> > the

> > concept of let the buyer beware (caveat emptor) can have no

> > application to

> > prescription medicines, that consumers cannot understand

medications

> > and

> > that individual doctors are in no better position that consumers

to

> > understand medications either. What the lawsuit proves is that

the

> > FDA has

> > failed consumers once again. So it's a useless exercise as far as

> > individuals are concerned.

> >

> > Posted by Red Rover at November 21, 2007 09:03 AM

> >

> > " What the lawsuit proves is that the FDA has failed consumers

once

> > again. "

> >

> > That's exactly right. So who really is at fault for innocent

death

> > and

> > bodily injury to American citizens?

> > Like Riley?

> >

> > Posted by Stephany at November 21, 2007 10:51 AM

> >

> > ===========================================

> >

> >

http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_ris

> > perdal.

> > html

> > November 20, 2007

> >

> > Arkansas Sues Over Risperdal

> > The State of Arkansas today filed a lawsuit against Janssen and

J & J

> > over

> > allegations that the company " engaged in a direct, illegal,

> > nationwide

> > program of promotion of the use of Risperdal for non-medically

> > necessary

> > uses. " In other words, off-label marketing--specific charges

would

> > likely

> > include allegations of the drug being marketed for use in elders

and

> > children, as well as in depression and anxiety, conditions and

age

> > groups

> > for which the drug does not have FDA approval (it did get two

> > pediatric

> > approvals over the last two years, but this suit concerns

> > allegations in

> > prior years). This lawsuit had been expected for some time. The

> > state did

> > not specify damages sought, but it would likely be over $100

million

> > in

> > damages and penalties. The state has also made it clear that it

> > intends to

> > sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of

> > Seroquel, over

> > similar allegations. I'll have more on this once I've seen a

copy of

> > the

> > state's complaint, which I have requested, against Janssen/J & J.

> >

> > According to the AP, Janssen had no comment.

> >

> > Posted by Philip Dawdy at November 20, 2007 12:21 PM

> >

> >

> >

>

[Guest guest]

I think you are being realistic, not cynical, and I could not agree with you more. But, as you say, at least Dr. Insel was candid in saying about Risperdal what we all know, but what other government officials and elected officials have rarely, if ever, said.At least now it is on record - Risperdal is ineffective and dangerous - the Director of NIMH and the IACC has said so. May children be spared Risperdal in favor of more effective and safer alternatives because of this official's willingness to speak! On Nov 23, 2007, at 8:14 PM, anacat_11 wrote:Forgive my cynicism- at so many junctures, there was always so much more that Insel could have said but didn't say and, most importantly, didn't do regarding drug safety concerns. In light of school shootings, drug-induced suicidality, iatrogenic diabetes, 100% increase in drug-induced movement disorders among children in just ten months, massive rise in drug-induced mania leading to polypharmacy and exponentially rising rates of so-called bipolarity, terrible mortality rates for those chronically treated with certain psychotropes, Riley, New Freedom Initiative, regulatory capture, the scamming of Medicaid, Teenscreen, mass doping of foster children- you know, all of that- he was in the unprecedented position of facing situations which required more commentary and action than anyone in the history of his post. If this man were truly earning taxpayer's money, he would be hated by industy. I'm sure J & J didn't appreciate his remark, so I'll grudgingly give him that. > > > And the FDA helped!> >> > ALLIANCE FOR HUMAN RESEARCH PROTECTION> >> > Promoting Openness, Full Disclosure, and Accountability> > http://www.ahrp.org and http://ahrp.blogspot.com> >> > FYI> > The Arkansas State Attorney General has filed a lawsuit against> > Janssen and> > & 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?> >> > 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> >> > 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 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. & & , 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 Leber, then Director of FDA> > Neuropsychopharmacology:> > http://books.google.com/books?> > id=4T8sKI4cx_wC & pg=PA275 & lpg=PA275 & dq=leber+ri> > sperdal+approval & source=web & ots=9Iz6-u0-> > FW & sig=RD13Lj1EUJatYprqYggMG7pjfPM#P> > PA276,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 J. , AB; R. Cohen, RPh, MS, ScD; Curt> > D.> > Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.> >> > See Nov 21 commentary by Dawdy, Furious Seasons:> > http://www.furiousseasons.com/> >> > Contact: Vera Hassner Sharav> > veracare@...> > 212-595-8974> >> > http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJO> > NESDJON> > LINE000498_FORTUNE5.htm> > Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing> > Dow > > November 21, 2007:> >> > LITTLE ROCK (AP)--Drug companies improperly marketed an anti-> > psychotic drug,> > Arkansas Attorney General Mc claimed Tuesday as he> > asked a> > state judge to force the firms to repay millions shelled out by the> > state's> > Medicaid program for unnecessary prescriptions.> >> > Mc filed a lawsuit in Pulaski County Circuit Court against> > Janssen> > Pharmaceutica Inc., Janssen LP and & Inc. (JNJ). In> > the> > filing, Mc said the companies "engaged in a direct, illegal,> > nationwide program of promotion of the use of Risperdal for non-> > medically> > necessary uses."> >> > New Brunswick, N.J.-based & is the parent company of> > both> > Janssen Pharmaceutica and Janssen LP.> >> > The lawsuit did not specify how much the state is seeking, but> > Mc has> > estimated that the state's Medicaid program spent about $200 million> > over> > eight years to pay for prescriptions for Zyprexa, Seroquel and> > Risperdal.> > The lawsuit filed Tuesday focuses solely on Risperdal.> >> > Gabe Holmstrom, a spokesman for Mc's office, said the state> > will file> > similar complaints about the marketing of the other drugs. Mc> > has said> > other companies that will be targeted include Eli Lilly and Co.> > (LLY) of> > Indianapolis and AstraZeneca PLC (AZN), a joint venture by a British> > firm> > and a Swedish firm.> >> > Mc has said the drugs were prescribed for uses not approved by> > federal> > regulators or indicated in labeling. Mc accused the companies> > of> > deceptive marketing practices that pushed doctors to prescribe> > Risperdal> > much more than necessary.> >> > The lawsuit also accuses drugmakers of not including warnings on> > Risperdal's> > bottle about adverse effects such as neurological problems, weight> > gain and> > diabetes.> >> > Ambre Morley, a spokeswoman for Janssen, defended the company and> > said it> > fully disclosed all information about Risperdal to doctors and> > government> > agencies.> >> > Copyright © 2007 Dow & Company, Inc.> > ~~~~~~~~~~~~~~~> >> > Furious Seasons> > November 21, 2007> >> > Atypical Nation: J & J's Risperdal "Defective," Company Lied,> > Thousands Died> > As I reported earlier, the State of Arkansas yesterday sued Janssen> > and its> > parent J & J over allegations concerning its atypical anti-psychotic> > Risperdal> > and how the company developed and marketed the drug. The lawsuit is> > a real> > eye-opener and confirms many things I've been saying on this site> > for over> > two years and for two years before that in print: there's something> > wrong> > with the atypicals and how deeply they've ended up embedded in> > American> > culture.> >> > The suit alleges that, among other things, Janssen/J & J put 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. There are other allegations--off-label marketing for use in> > children> > and the elderly, a campaign of covering up the drug's side effects,> > allegations of kickbacks to doctors and so on--but they almost pale> > in> > comparison to the EPS allegations, which ought to make anyone wonder> > how the> > heck this drug got approved in the first place.> >> > One of the charges against Janssen/J & J is for fraud.> > Sales of the drug in 2006 were $4.2 billion. Depending on who is> > estimating,> > Risperdal is the most used anti-psychotic in the world.> >> > The EPS allegation, the first I've seen in any of the ongoing> > lawsuits> > against J & J, goes right to heart of why atypicals became so popular> > amongst> > doctors: they were supposed to cause fewer side effects (a la SSRIs> > versus> > older anti-depressants in the 1980s), and therefore docs could> > safely give> > them to patients of every stripe for long-term use. Use of the older> > anti-psychotics was tightly restricted by docs (except among> > schizophrenics)> > because they were felt to cause so much EPS (aka zombieism) that it> > would be> > unethical to hand them out to anyone but the very sickest of> > patients. But> > atypicals like Risperdal were supposed to be safe for one and all.> >> > As it turns out, that was not the case. As a result, millions of> > people have> > paid a heavy price for using Risperdal--I am one of them--including> > at least> > 1,000 people who died as a result of using the drug, according to> > the FDA's> > adverse events database, as I have previously reported.> >> > J & J and Janssen lied. People died, or were injured and sickened by> > the> > willful action of one of the largest pharmaceutical companies on> > Earth.> > That's the view of the Arkansas Attorney General Mc.> > Other> > states including Texas are suing J & J over Risperdal as well.> >> > Anyone who thinks I have been too harsh in my commentary on these> > drugs, too> > rough on the pharma companies who make and market them, too tough on> > the> > doctors who gave them to patients like me and, as a a result, wrote> > me off> > as a wingnut, ought to read this (and other) lawsuits against the> > makers of> > these drugs and see just how wingnutty Mc is. Because he> > isn't. And> > neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and> > deception that> > have gone with the atypicals' use in America are right up there with> > the> > lies propagated about the use of cigarettes by American tobacco> > companies.> >> > Now for a few particulars from the suit. First, the EPS allegations:> >> > "Risperdal's pre-marketing clinical trials did not support an> > assertion that> > it is less likely to cause EPS than traditional> > antipsychotics....Defendants'> > trials were designed to produce similar rates of EPS in patients> > sorted into> > placebo groups and those taking Risperdal. In order to produce their> > desired> > result, defendants selected patients for the placebo groups that were> > already in the course of treatment with high doses of typical> > antipsychotics....> > "Defendants claimed in their marketing that patients taking> > Risperdal were> > as likely to develop EPS as patients taking nothing and thus less> > likely to> > develop EPS than patients taking traditional antipsychotics."> >> > That is a staggering accusation and I assume Mc has documents> > to back> > it up. So far Janssen and J & J have not commented on the suit or its> > allegations.> >> > In 2002 and 2003, I experienced mild EPS on Risperdal after being on> > it at> > .5 mgs a day since December 2000, and took myself off the drug> > against my> > then-doctor's wishes (he insisted that EPS and other problems didn't> > occur> > on Risperdal). Just so you know my bias on this issue.> >> > Other allegations:> >> > "Janssen heavily marketed and promoted Risperdal [in the mid-1990s]> > for its> > approved indication, treatment of adult with schizophrenia, and for> > multiple> > non-medically necessary uses of the drug, for example, ADHD,> > depression,> > anxiety, mood disorder, bipolar disorder, and aggression associated> > with> > late-onset dementia."> > I was pressed to take the drug off-label (my then-doctor never> > explained> > that part) three years before the drug received approval for use in> > bipolar> > disorder in 2003. Just so you know how I felt when I read the> > following:> >> > "Despite having been on notice for years of the potential for deadly> > diabetes-related side effects, defendant opted for the bare minimum> > of> > clinical trials, of limited duration, such that no side effects were> > likely> > to be revealed."> > The suit further alleges that J & J knew of weight gain and resultant> > diabetes> > issues with the drug but worked to conceal the drug's true safety> > profile.> > The state introduces evidence that in 1999, the FDA busted Janssen> > for> > marketing Risperdal for off-label use in the elderly and that the FDA> > informed Janssen it was engaged in "false and misleading" practices> > (see> > pages 9 and 10).> >> > As part of its strategy in the 1990s to expand Risperdal's market> > beyond its> > approved use in schizophrenia, the suit alleges that:> >> > "Defendants sough ghost written research and paid 'key opinion> > leaders' to> > support defendant's marketing aims. These 'key opinion leaders' were> > nothing> > more than third-party consultants and researchers who were put on> > defendants' payroll to support and lend credibility to defendants'> > specious> > scientific and marketing representations."> > Can't wait to find out who the researchers were who helped them with> > bipolar> > disorder.> >> > There is more evidence and allegations contained in this lawsuit.> > I'll get> > into those later.> >> > For now, this: Attorney General Mc alleges that Risperdal was> > "defective, unreasonably dangerous and hazardous" and that> > Janssen/J & J knew> > this and put the drug on the market anyway. "At the time Risperdal> > was sold> > or placed on the market, it was in a defective condition and> > unreasonably> > dangerous to users and consumers."> >> > In addition to allegations that the companies violated the state's> > Medicaid> > fraud laws, the state alleges that the companies violated the state's> > deceptive trade practices act, engaged in negligent behavior, and> > engaged in> > fraud and misrepresentation and "unjust enrichment."> > ===========================================> > Furious Seasons> >> > Comments: Atypical Nation: J & J's Risperdal "Defective," Company Lied,> > Thousands Died In August of 1999, my daughter was 11 years old.> > After an> > adverse reaction[suicidal ideation]on Imipramine, I took her to a> > psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox,> > which> > accelerated her "thoughts", and the psych recommended> > hospitalization.THERE,> > inpatient at age 11--was where they put her on Risperdal. Her eyes> > locked> > looking up, she was so pale and couldnt move her legs--I thought she> > was> > dying. I was then clueless about psych meds, and trusted doctors.> >> > I will never forget seeing her and thinking my 11 year old looked> > like she> > was dying. That was in 1999, what fucking nerve this company has to> > place my> > daughter at risk that way, and the smack in my face as a mother and> > for my> > daughter, is that Eli Lilly's Zyprexa is what replaced that> > Risperdal!> >> > For reading about Biederman,Wozniak, Wilens and Spencer and the> > study for> > Risperdal use in kids way back in 1999, as well as how it was> > approved for> > use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood> > Bipolar and> > just need not wonder any further, what my daughter's "OCD"> > dx "changed" to> > within weeks---yeah that's right, Childhood Bipolar Disorder, in> > 1999.> >> > I hope this company and Eli Lilly are ready for a patient lawsuit,> > because> > I'm rolling up my sleeves.> >> > They can f... pay for her to live somewhere decent, for her long> > term care> > at age 19.> > I have to say, this is a topic everyone should not disregard, pay> > attention> > to these killers in our midst.> > I am lucky my daughter is alive, and at what cost!!?> >> > I really do not want to visit her in a residential care facility at> > age 19> > for Thanksgiving, and I am.> > Does anyone understand why this angers me.> >> > Posted by Stephany at November 21, 2007 08:52 AM> >> > Phil, your analysis is missing, what I think, is the critical point,> > which> > is: disclosure of side effects of a particular drug, here Risperdal,> > is not> > a substitute for approval of the use of the drug in the first place.> > In> > other words, knowing all the bad effects of Risperdal cannot> > substitute for> > its governmental approval for consumers' use. The FDA, a governmental> > authority charged with monitoring the safety and effectiveness of> > medications, approved Risperdal. Other than a few warnings, the FDA> > has done> > nothing to stop its marketing, notwithstanding the fact that> > Risperdal was> > unnecessary at best (there are better or similar quality drugs on> > the market> > already), or dangerous (and should be banned) at worst. The FDA is> > not a> > party to the lawsuit. The plaintiffs in the lawsuits are not> > consumers but> > the states. The states are not representatives of consumers and> > whatever> > money they recover will go the states . The states are not seeking> > to ban> > Risperdal and if they did, they probably couldn't. What's this> > lawsuit is> > all about? It's about local governments seeing an opportunity to get> > some> > money out of drug companies. What the lawsuit doesn't address is> > that drugs> > are not securities; a prescribing information is not a prospectus;> > the> > concept of let the buyer beware (caveat emptor) can have no> > application to> > prescription medicines, that consumers cannot understand medications> > and> > that individual doctors are in no better position that consumers to> > understand medications either. What the lawsuit proves is that the> > FDA has> > failed consumers once again. So it's a useless exercise as far as> > individuals are concerned.> >> > Posted by Red Rover at November 21, 2007 09:03 AM> >> > "What the lawsuit proves is that the FDA has failed consumers once> > again."> >> > That's exactly right. So who really is at fault for innocent death> > and> > bodily injury to American citizens?> > Like Riley?> >> > Posted by Stephany at November 21, 2007 10:51 AM> >> > ===========================================> >> > http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_ris> > perdal.> > html> > November 20, 2007> >> > Arkansas Sues Over Risperdal> > The State of Arkansas today filed a lawsuit against Janssen and J & J> > over> > allegations that the company "engaged in a direct, illegal,> > nationwide> > program of promotion of the use of Risperdal for non-medically> > necessary> > uses." In other words, off-label marketing--specific charges would> > likely> > include allegations of the drug being marketed for use in elders and> > children, as well as in depression and anxiety, conditions and age> > groups> > for which the drug does not have FDA approval (it did get two> > pediatric> > approvals over the last two years, but this suit concerns> > allegations in> > prior years). This lawsuit had been expected for some time. The> > state did> > not specify damages sought, but it would likely be over $100 million> > in> > damages and penalties. The state has also made it clear that it> > intends to> > sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of> > Seroquel, over> > similar allegations. I'll have more on this once I've seen a copy of> > the> > state's complaint, which I have requested, against Janssen/J & J.> >> > According to the AP, Janssen had no comment.> >> > Posted by Philip Dawdy at November 20, 2007 12:21 PM> >> >> >>

[Guest guest]

Risperdol is not suitable for ANYONE. Especially children, but adults as well.

My

grandmother, while in advanced stages of Parkinsons and Alzheimer's, was put on

Risperdol " to make her last days happier " . She developed Tardive Diskinesia, and

her

tremors became much worse. This is after a legal battle to keep her small home

from

giving flu shots (in Alaska), not only to her, but to the rest of the residents

after proving

that they were ineffective for their age group anyway. I could really rant about

this and

other related drugs, and what they did to the elderly people in this home, but

I'll spare

everyone, as that is OT.

> >

> > > And the FDA helped!

> > >

> > > ALLIANCE FOR HUMAN RESEARCH PROTECTION

> > >

> > > Promoting Openness, Full Disclosure, and Accountability

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

> > >

> > > FYI

> > > The Arkansas State Attorney General has filed a lawsuit against

> > > Janssen and

> > > & 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?

> > >

> > > 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

> > >

> > > 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 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. & & , 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 Leber, then Director of FDA

> > > Neuropsychopharmacology:

> > > http://books.google.com/books?

> > > id=4T8sKI4cx_wC & pg=PA275 & lpg=PA275 & dq=leber+ri

> > > sperdal+approval & source=web & ots=9Iz6-u0-

> > > FW & sig=RD13Lj1EUJatYprqYggMG7pjfPM#P

> > > PA276,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 J. , AB; R. Cohen, RPh, MS, ScD;

> Curt

> > > D.

> > > Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.

> > >

> > > See Nov 21 commentary by Dawdy, Furious Seasons:

> > > http://www.furiousseasons.com/

> > >

> > > Contact: Vera Hassner Sharav

> > > veracare@

> > > 212-595-8974

> > >

> > >

> http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJO

> > > NESDJON

> > > LINE000498_FORTUNE5.htm

> > > Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing

> > > Dow

> > > November 21, 2007:

> > >

> > > LITTLE ROCK (AP)--Drug companies improperly marketed an anti-

> > > psychotic drug,

> > > Arkansas Attorney General Mc claimed Tuesday as he

> > > asked a

> > > state judge to force the firms to repay millions shelled out by

> the

> > > state's

> > > Medicaid program for unnecessary prescriptions.

> > >

> > > Mc filed a lawsuit in Pulaski County Circuit Court against

> > > Janssen

> > > Pharmaceutica Inc., Janssen LP and & Inc. (JNJ).

> In

> > > the

> > > filing, Mc said the companies " engaged in a direct,

> illegal,

> > > nationwide program of promotion of the use of Risperdal for non-

> > > medically

> > > necessary uses. "

> > >

> > > New Brunswick, N.J.-based & is the parent

> company of

> > > both

> > > Janssen Pharmaceutica and Janssen LP.

> > >

> > > The lawsuit did not specify how much the state is seeking, but

> > > Mc has

> > > estimated that the state's Medicaid program spent about $200

> million

> > > over

> > > eight years to pay for prescriptions for Zyprexa, Seroquel and

> > > Risperdal.

> > > The lawsuit filed Tuesday focuses solely on Risperdal.

> > >

> > > Gabe Holmstrom, a spokesman for Mc's office, said the state

> > > will file

> > > similar complaints about the marketing of the other drugs.

> Mc

> > > has said

> > > other companies that will be targeted include Eli Lilly and Co.

> > > (LLY) of

> > > Indianapolis and AstraZeneca PLC (AZN), a joint venture by a

> British

> > > firm

> > > and a Swedish firm.

> > >

> > > Mc has said the drugs were prescribed for uses not

> approved by

> > > federal

> > > regulators or indicated in labeling. Mc accused the

> companies

> > > of

> > > deceptive marketing practices that pushed doctors to prescribe

> > > Risperdal

> > > much more than necessary.

> > >

> > > The lawsuit also accuses drugmakers of not including warnings on

> > > Risperdal's

> > > bottle about adverse effects such as neurological problems,

> weight

> > > gain and

> > > diabetes.

> > >

> > > Ambre Morley, a spokeswoman for Janssen, defended the company and

> > > said it

> > > fully disclosed all information about Risperdal to doctors and

> > > government

> > > agencies.

> > >

> > > Copyright © 2007 Dow & Company, Inc.

> > > ~~~~~~~~~~~~~~~

> > >

> > > Furious Seasons

> > > November 21, 2007

> > >

> > > Atypical Nation: J & J's Risperdal " Defective, " Company Lied,

> > > Thousands Died

> > > As I reported earlier, the State of Arkansas yesterday sued

> Janssen

> > > and its

> > > parent J & J over allegations concerning its atypical anti-

> psychotic

> > > Risperdal

> > > and how the company developed and marketed the drug. The lawsuit

> is

> > > a real

> > > eye-opener and confirms many things I've been saying on this site

> > > for over

> > > two years and for two years before that in print: there's

> something

> > > wrong

> > > with the atypicals and how deeply they've ended up embedded in

> > > American

> > > culture.

> > >

> > > The suit alleges that, among other things, Janssen/J & J put 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. There are other allegations--off-label marketing for use

> in

> > > children

> > > and the elderly, a campaign of covering up the drug's side

> effects,

> > > allegations of kickbacks to doctors and so on--but they almost

> pale

> > > in

> > > comparison to the EPS allegations, which ought to make anyone

> wonder

> > > how the

> > > heck this drug got approved in the first place.

> > >

> > > One of the charges against Janssen/J & J is for fraud.

> > > Sales of the drug in 2006 were $4.2 billion. Depending on who is

> > > estimating,

> > > Risperdal is the most used anti-psychotic in the world.

> > >

> > > The EPS allegation, the first I've seen in any of the ongoing

> > > lawsuits

> > > against J & J, goes right to heart of why atypicals became so

> popular

> > > amongst

> > > doctors: they were supposed to cause fewer side effects (a la

> SSRIs

> > > versus

> > > older anti-depressants in the 1980s), and therefore docs could

> > > safely give

> > > them to patients of every stripe for long-term use. Use of the

> older

> > > anti-psychotics was tightly restricted by docs (except among

> > > schizophrenics)

> > > because they were felt to cause so much EPS (aka zombieism) that

> it

> > > would be

> > > unethical to hand them out to anyone but the very sickest of

> > > patients. But

> > > atypicals like Risperdal were supposed to be safe for one and

> all.

> > >

> > > As it turns out, that was not the case. As a result, millions of

> > > people have

> > > paid a heavy price for using Risperdal--I am one of them--

> including

> > > at least

> > > 1,000 people who died as a result of using the drug, according to

> > > the FDA's

> > > adverse events database, as I have previously reported.

> > >

> > > J & J and Janssen lied. People died, or were injured and sickened

> by

> > > the

> > > willful action of one of the largest pharmaceutical companies on

> > > Earth.

> > > That's the view of the Arkansas Attorney General Mc.

> > > Other

> > > states including Texas are suing J & J over Risperdal as well.

> > >

> > > Anyone who thinks I have been too harsh in my commentary on these

> > > drugs, too

> > > rough on the pharma companies who make and market them, too

> tough on

> > > the

> > > doctors who gave them to patients like me and, as a a result,

> wrote

> > > me off

> > > as a wingnut, ought to read this (and other) lawsuits against the

> > > makers of

> > > these drugs and see just how wingnutty Mc is. Because he

> > > isn't. And

> > > neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and

> > > deception that

> > > have gone with the atypicals' use in America are right up there

> with

> > > the

> > > lies propagated about the use of cigarettes by American tobacco

> > > companies.

> > >

> > > Now for a few particulars from the suit. First, the EPS

> allegations:

> > >

> > > " Risperdal's pre-marketing clinical trials did not support an

> > > assertion that

> > > it is less likely to cause EPS than traditional

> > > antipsychotics....Defendants'

> > > trials were designed to produce similar rates of EPS in patients

> > > sorted into

> > > placebo groups and those taking Risperdal. In order to produce

> their

> > > desired

> > > result, defendants selected patients for the placebo groups that

> were

> > > already in the course of treatment with high doses of typical

> > > antipsychotics....

> > > " Defendants claimed in their marketing that patients taking

> > > Risperdal were

> > > as likely to develop EPS as patients taking nothing and thus less

> > > likely to

> > > develop EPS than patients taking traditional antipsychotics. "

> > >

> > > That is a staggering accusation and I assume Mc has

> documents

> > > to back

> > > it up. So far Janssen and J & J have not commented on the suit or

> its

> > > allegations.

> > >

> > > In 2002 and 2003, I experienced mild EPS on Risperdal after

> being on

> > > it at

> > > .5 mgs a day since December 2000, and took myself off the drug

> > > against my

> > > then-doctor's wishes (he insisted that EPS and other problems

> didn't

> > > occur

> > > on Risperdal). Just so you know my bias on this issue.

> > >

> > > Other allegations:

> > >

> > > " Janssen heavily marketed and promoted Risperdal [in the mid-

> 1990s]

> > > for its

> > > approved indication, treatment of adult with schizophrenia, and

> for

> > > multiple

> > > non-medically necessary uses of the drug, for example, ADHD,

> > > depression,

> > > anxiety, mood disorder, bipolar disorder, and aggression

> associated

> > > with

> > > late-onset dementia. "

> > > I was pressed to take the drug off-label (my then-doctor never

> > > explained

> > > that part) three years before the drug received approval for use

> in

> > > bipolar

> > > disorder in 2003. Just so you know how I felt when I read the

> > > following:

> > >

> > > " Despite having been on notice for years of the potential for

> deadly

> > > diabetes-related side effects, defendant opted for the bare

> minimum

> > > of

> > > clinical trials, of limited duration, such that no side effects

> were

> > > likely

> > > to be revealed. "

> > > The suit further alleges that J & J knew of weight gain and

> resultant

> > > diabetes

> > > issues with the drug but worked to conceal the drug's true safety

> > > profile.

> > > The state introduces evidence that in 1999, the FDA busted

> Janssen

> > > for

> > > marketing Risperdal for off-label use in the elderly and that

> the FDA

> > > informed Janssen it was engaged in " false and misleading "

> practices

> > > (see

> > > pages 9 and 10).

> > >

> > > As part of its strategy in the 1990s to expand Risperdal's market

> > > beyond its

> > > approved use in schizophrenia, the suit alleges that:

> > >

> > > " Defendants sough ghost written research and paid 'key opinion

> > > leaders' to

> > > support defendant's marketing aims. These 'key opinion leaders'

> were

> > > nothing

> > > more than third-party consultants and researchers who were put on

> > > defendants' payroll to support and lend credibility to

> defendants'

> > > specious

> > > scientific and marketing representations. "

> > > Can't wait to find out who the researchers were who helped them

> with

> > > bipolar

> > > disorder.

> > >

> > > There is more evidence and allegations contained in this lawsuit.

> > > I'll get

> > > into those later.

> > >

> > > For now, this: Attorney General Mc alleges that Risperdal

> was

> > > " defective, unreasonably dangerous and hazardous " and that

> > > Janssen/J & J knew

> > > this and put the drug on the market anyway. " At the time

> Risperdal

> > > was sold

> > > or placed on the market, it was in a defective condition and

> > > unreasonably

> > > dangerous to users and consumers. "

> > >

> > > In addition to allegations that the companies violated the

> state's

> > > Medicaid

> > > fraud laws, the state alleges that the companies violated the

> state's

> > > deceptive trade practices act, engaged in negligent behavior, and

> > > engaged in

> > > fraud and misrepresentation and " unjust enrichment. "

> > > ===========================================

> > > Furious Seasons

> > >

> > > Comments: Atypical Nation: J & J's Risperdal " Defective, " Company

> Lied,

> > > Thousands Died In August of 1999, my daughter was 11 years old.

> > > After an

> > > adverse reaction[suicidal ideation]on Imipramine, I took her to a

> > > psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox,

> > > which

> > > accelerated her " thoughts " , and the psych recommended

> > > hospitalization.THERE,

> > > inpatient at age 11--was where they put her on Risperdal. Her

> eyes

> > > locked

> > > looking up, she was so pale and couldnt move her legs--I thought

> she

> > > was

> > > dying. I was then clueless about psych meds, and trusted doctors.

> > >

> > > I will never forget seeing her and thinking my 11 year old looked

> > > like she

> > > was dying. That was in 1999, what fucking nerve this company has

> to

> > > place my

> > > daughter at risk that way, and the smack in my face as a mother

> and

> > > for my

> > > daughter, is that Eli Lilly's Zyprexa is what replaced that

> > > Risperdal!

> > >

> > > For reading about Biederman,Wozniak, Wilens and Spencer and the

> > > study for

> > > Risperdal use in kids way back in 1999, as well as how it was

> > > approved for

> > > use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood

> > > Bipolar and

> > > just need not wonder any further, what my daughter's " OCD "

> > > dx " changed " to

> > > within weeks---yeah that's right, Childhood Bipolar Disorder, in

> > > 1999.

> > >

> > > I hope this company and Eli Lilly are ready for a patient

> lawsuit,

> > > because

> > > I'm rolling up my sleeves.

> > >

> > > They can f... pay for her to live somewhere decent, for her long

> > > term care

> > > at age 19.

> > > I have to say, this is a topic everyone should not disregard, pay

> > > attention

> > > to these killers in our midst.

> > > I am lucky my daughter is alive, and at what cost!!?

> > >

> > > I really do not want to visit her in a residential care facility

> at

> > > age 19

> > > for Thanksgiving, and I am.

> > > Does anyone understand why this angers me.

> > >

> > > Posted by Stephany at November 21, 2007 08:52 AM

> > >

> > > Phil, your analysis is missing, what I think, is the critical

> point,

> > > which

> > > is: disclosure of side effects of a particular drug, here

> Risperdal,

> > > is not

> > > a substitute for approval of the use of the drug in the first

> place.

> > > In

> > > other words, knowing all the bad effects of Risperdal cannot

> > > substitute for

> > > its governmental approval for consumers' use. The FDA, a

> governmental

> > > authority charged with monitoring the safety and effectiveness of

> > > medications, approved Risperdal. Other than a few warnings, the

> FDA

> > > has done

> > > nothing to stop its marketing, notwithstanding the fact that

> > > Risperdal was

> > > unnecessary at best (there are better or similar quality drugs on

> > > the market

> > > already), or dangerous (and should be banned) at worst. The FDA

> is

> > > not a

> > > party to the lawsuit. The plaintiffs in the lawsuits are not

> > > consumers but

> > > the states. The states are not representatives of consumers and

> > > whatever

> > > money they recover will go the states . The states are not

> seeking

> > > to ban

> > > Risperdal and if they did, they probably couldn't. What's this

> > > lawsuit is

> > > all about? It's about local governments seeing an opportunity to

> get

> > > some

> > > money out of drug companies. What the lawsuit doesn't address is

> > > that drugs

> > > are not securities; a prescribing information is not a

> prospectus;

> > > the

> > > concept of let the buyer beware (caveat emptor) can have no

> > > application to

> > > prescription medicines, that consumers cannot understand

> medications

> > > and

> > > that individual doctors are in no better position that consumers

> to

> > > understand medications either. What the lawsuit proves is that

> the

> > > FDA has

> > > failed consumers once again. So it's a useless exercise as far as

> > > individuals are concerned.

> > >

> > > Posted by Red Rover at November 21, 2007 09:03 AM

> > >

> > > " What the lawsuit proves is that the FDA has failed consumers

> once

> > > again. "

> > >

> > > That's exactly right. So who really is at fault for innocent

> death

> > > and

> > > bodily injury to American citizens?

> > > Like Riley?

> > >

> > > Posted by Stephany at November 21, 2007 10:51 AM

> > >

> > > ===========================================

> > >

> > >

> http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_ris

> > > perdal.

> > > html

> > > November 20, 2007

> > >

> > > Arkansas Sues Over Risperdal

> > > The State of Arkansas today filed a lawsuit against Janssen and

> J & J

> > > over

> > > allegations that the company " engaged in a direct, illegal,

> > > nationwide

> > > program of promotion of the use of Risperdal for non-medically

> > > necessary

> > > uses. " In other words, off-label marketing--specific charges

> would

> > > likely

> > > include allegations of the drug being marketed for use in elders

> and

> > > children, as well as in depression and anxiety, conditions and

> age

> > > groups

> > > for which the drug does not have FDA approval (it did get two

> > > pediatric

> > > approvals over the last two years, but this suit concerns

> > > allegations in

> > > prior years). This lawsuit had been expected for some time. The

> > > state did

> > > not specify damages sought, but it would likely be over $100

> million

> > > in

> > > damages and penalties. The state has also made it clear that it

> > > intends to

> > > sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of

> > > Seroquel, over

> > > similar allegations. I'll have more on this once I've seen a

> copy of

> > > the

> > > state's complaint, which I have requested, against Janssen/J & J.

> > >

> > > According to the AP, Janssen had no comment.

> > >

> > > Posted by Philip Dawdy at November 20, 2007 12:21 PM

> > >

> > >

> > >

> >

>

[Guest guest]

Hi ,

I agree, it's a huge step for Insel to state that Risperdol is ineffective and

dangerous! The

one and only time I can credit the man with something sensible to say. I hope

that this is a

genuine step in the right direction for him (but i'm not holding my breath!)

> > >

> > > > And the FDA helped!

> > > >

> > > > ALLIANCE FOR HUMAN RESEARCH PROTECTION

> > > >

> > > > Promoting Openness, Full Disclosure, and Accountability

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

> > > >

> > > > FYI

> > > > The Arkansas State Attorney General has filed a lawsuit against

> > > > Janssen and

> > > > & 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?

> > > >

> > > > 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

> > > >

> > > > 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 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. & & , 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 Leber, then Director of FDA

> > > > Neuropsychopharmacology:

> > > > http://books.google.com/books?

> > > > id=4T8sKI4cx_wC & pg=PA275 & lpg=PA275 & dq=leber+ri

> > > > sperdal+approval & source=web & ots=9Iz6-u0-

> > > > FW & sig=RD13Lj1EUJatYprqYggMG7pjfPM#P

> > > > PA276,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 J. , AB; R. Cohen, RPh, MS, ScD;

> > Curt

> > > > D.

> > > > Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.

> > > >

> > > > See Nov 21 commentary by Dawdy, Furious Seasons:

> > > > http://www.furiousseasons.com/

> > > >

> > > > Contact: Vera Hassner Sharav

> > > > veracare@

> > > > 212-595-8974

> > > >

> > > >

> > http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJO

> > > > NESDJON

> > > > LINE000498_FORTUNE5.htm

> > > > Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing

> > > > Dow

> > > > November 21, 2007:

> > > >

> > > > LITTLE ROCK (AP)--Drug companies improperly marketed an anti-

> > > > psychotic drug,

> > > > Arkansas Attorney General Mc claimed Tuesday as he

> > > > asked a

> > > > state judge to force the firms to repay millions shelled out by

> > the

> > > > state's

> > > > Medicaid program for unnecessary prescriptions.

> > > >

> > > > Mc filed a lawsuit in Pulaski County Circuit Court against

> > > > Janssen

> > > > Pharmaceutica Inc., Janssen LP and & Inc. (JNJ).

> > In

> > > > the

> > > > filing, Mc said the companies " engaged in a direct,

> > illegal,

> > > > nationwide program of promotion of the use of Risperdal for non-

> > > > medically

> > > > necessary uses. "

> > > >

> > > > New Brunswick, N.J.-based & is the parent

> > company of

> > > > both

> > > > Janssen Pharmaceutica and Janssen LP.

> > > >

> > > > The lawsuit did not specify how much the state is seeking, but

> > > > Mc has

> > > > estimated that the state's Medicaid program spent about $200

> > million

> > > > over

> > > > eight years to pay for prescriptions for Zyprexa, Seroquel and

> > > > Risperdal.

> > > > The lawsuit filed Tuesday focuses solely on Risperdal.

> > > >

> > > > Gabe Holmstrom, a spokesman for Mc's office, said the state

> > > > will file

> > > > similar complaints about the marketing of the other drugs.

> > Mc

> > > > has said

> > > > other companies that will be targeted include Eli Lilly and Co.

> > > > (LLY) of

> > > > Indianapolis and AstraZeneca PLC (AZN), a joint venture by a

> > British

> > > > firm

> > > > and a Swedish firm.

> > > >

> > > > Mc has said the drugs were prescribed for uses not

> > approved by

> > > > federal

> > > > regulators or indicated in labeling. Mc accused the

> > companies

> > > > of

> > > > deceptive marketing practices that pushed doctors to prescribe

> > > > Risperdal

> > > > much more than necessary.

> > > >

> > > > The lawsuit also accuses drugmakers of not including warnings on

> > > > Risperdal's

> > > > bottle about adverse effects such as neurological problems,

> > weight

> > > > gain and

> > > > diabetes.

> > > >

> > > > Ambre Morley, a spokeswoman for Janssen, defended the company and

> > > > said it

> > > > fully disclosed all information about Risperdal to doctors and

> > > > government

> > > > agencies.

> > > >

> > > > Copyright © 2007 Dow & Company, Inc.

> > > > ~~~~~~~~~~~~~~~

> > > >

> > > > Furious Seasons

> > > > November 21, 2007

> > > >

> > > > Atypical Nation: J & J's Risperdal " Defective, " Company Lied,

> > > > Thousands Died

> > > > As I reported earlier, the State of Arkansas yesterday sued

> > Janssen

> > > > and its

> > > > parent J & J over allegations concerning its atypical anti-

> > psychotic

> > > > Risperdal

> > > > and how the company developed and marketed the drug. The lawsuit

> > is

> > > > a real

> > > > eye-opener and confirms many things I've been saying on this site

> > > > for over

> > > > two years and for two years before that in print: there's

> > something

> > > > wrong

> > > > with the atypicals and how deeply they've ended up embedded in

> > > > American

> > > > culture.

> > > >

> > > > The suit alleges that, among other things, Janssen/J & J put 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. There are other allegations--off-label marketing for use

> > in

> > > > children

> > > > and the elderly, a campaign of covering up the drug's side

> > effects,

> > > > allegations of kickbacks to doctors and so on--but they almost

> > pale

> > > > in

> > > > comparison to the EPS allegations, which ought to make anyone

> > wonder

> > > > how the

> > > > heck this drug got approved in the first place.

> > > >

> > > > One of the charges against Janssen/J & J is for fraud.

> > > > Sales of the drug in 2006 were $4.2 billion. Depending on who is

> > > > estimating,

> > > > Risperdal is the most used anti-psychotic in the world.

> > > >

> > > > The EPS allegation, the first I've seen in any of the ongoing

> > > > lawsuits

> > > > against J & J, goes right to heart of why atypicals became so

> > popular

> > > > amongst

> > > > doctors: they were supposed to cause fewer side effects (a la

> > SSRIs

> > > > versus

> > > > older anti-depressants in the 1980s), and therefore docs could

> > > > safely give

> > > > them to patients of every stripe for long-term use. Use of the

> > older

> > > > anti-psychotics was tightly restricted by docs (except among

> > > > schizophrenics)

> > > > because they were felt to cause so much EPS (aka zombieism) that

> > it

> > > > would be

> > > > unethical to hand them out to anyone but the very sickest of

> > > > patients. But

> > > > atypicals like Risperdal were supposed to be safe for one and

> > all.

> > > >

> > > > As it turns out, that was not the case. As a result, millions of

> > > > people have

> > > > paid a heavy price for using Risperdal--I am one of them--

> > including

> > > > at least

> > > > 1,000 people who died as a result of using the drug, according to

> > > > the FDA's

> > > > adverse events database, as I have previously reported.

> > > >

> > > > J & J and Janssen lied. People died, or were injured and sickened

> > by

> > > > the

> > > > willful action of one of the largest pharmaceutical companies on

> > > > Earth.

> > > > That's the view of the Arkansas Attorney General Mc.

> > > > Other

> > > > states including Texas are suing J & J over Risperdal as well.

> > > >

> > > > Anyone who thinks I have been too harsh in my commentary on these

> > > > drugs, too

> > > > rough on the pharma companies who make and market them, too

> > tough on

> > > > the

> > > > doctors who gave them to patients like me and, as a a result,

> > wrote

> > > > me off

> > > > as a wingnut, ought to read this (and other) lawsuits against the

> > > > makers of

> > > > these drugs and see just how wingnutty Mc is. Because he

> > > > isn't. And

> > > > neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and

> > > > deception that

> > > > have gone with the atypicals' use in America are right up there

> > with

> > > > the

> > > > lies propagated about the use of cigarettes by American tobacco

> > > > companies.

> > > >

> > > > Now for a few particulars from the suit. First, the EPS

> > allegations:

> > > >

> > > > " Risperdal's pre-marketing clinical trials did not support an

> > > > assertion that

> > > > it is less likely to cause EPS than traditional

> > > > antipsychotics....Defendants'

> > > > trials were designed to produce similar rates of EPS in patients

> > > > sorted into

> > > > placebo groups and those taking Risperdal. In order to produce

> > their

> > > > desired

> > > > result, defendants selected patients for the placebo groups that

> > were

> > > > already in the course of treatment with high doses of typical

> > > > antipsychotics....

> > > > " Defendants claimed in their marketing that patients taking

> > > > Risperdal were

> > > > as likely to develop EPS as patients taking nothing and thus less

> > > > likely to

> > > > develop EPS than patients taking traditional antipsychotics. "

> > > >

> > > > That is a staggering accusation and I assume Mc has

> > documents

> > > > to back

> > > > it up. So far Janssen and J & J have not commented on the suit or

> > its

> > > > allegations.

> > > >

> > > > In 2002 and 2003, I experienced mild EPS on Risperdal after

> > being on

> > > > it at

> > > > .5 mgs a day since December 2000, and took myself off the drug

> > > > against my

> > > > then-doctor's wishes (he insisted that EPS and other problems

> > didn't

> > > > occur

> > > > on Risperdal). Just so you know my bias on this issue.

> > > >

> > > > Other allegations:

> > > >

> > > > " Janssen heavily marketed and promoted Risperdal [in the mid-

> > 1990s]

> > > > for its

> > > > approved indication, treatment of adult with schizophrenia, and

> > for

> > > > multiple

> > > > non-medically necessary uses of the drug, for example, ADHD,

> > > > depression,

> > > > anxiety, mood disorder, bipolar disorder, and aggression

> > associated

> > > > with

> > > > late-onset dementia. "

> > > > I was pressed to take the drug off-label (my then-doctor never

> > > > explained

> > > > that part) three years before the drug received approval for use

> > in

> > > > bipolar

> > > > disorder in 2003. Just so you know how I felt when I read the

> > > > following:

> > > >

> > > > " Despite having been on notice for years of the potential for

> > deadly

> > > > diabetes-related side effects, defendant opted for the bare

> > minimum

> > > > of

> > > > clinical trials, of limited duration, such that no side effects

> > were

> > > > likely

> > > > to be revealed. "

> > > > The suit further alleges that J & J knew of weight gain and

> > resultant

> > > > diabetes

> > > > issues with the drug but worked to conceal the drug's true safety

> > > > profile.

> > > > The state introduces evidence that in 1999, the FDA busted

> > Janssen

> > > > for

> > > > marketing Risperdal for off-label use in the elderly and that

> > the FDA

> > > > informed Janssen it was engaged in " false and misleading "

> > practices

> > > > (see

> > > > pages 9 and 10).

> > > >

> > > > As part of its strategy in the 1990s to expand Risperdal's market

> > > > beyond its

> > > > approved use in schizophrenia, the suit alleges that:

> > > >

> > > > " Defendants sough ghost written research and paid 'key opinion

> > > > leaders' to

> > > > support defendant's marketing aims. These 'key opinion leaders'

> > were

> > > > nothing

> > > > more than third-party consultants and researchers who were put on

> > > > defendants' payroll to support and lend credibility to

> > defendants'

> > > > specious

> > > > scientific and marketing representations. "

> > > > Can't wait to find out who the researchers were who helped them

> > with

> > > > bipolar

> > > > disorder.

> > > >

> > > > There is more evidence and allegations contained in this lawsuit.

> > > > I'll get

> > > > into those later.

> > > >

> > > > For now, this: Attorney General Mc alleges that Risperdal

> > was

> > > > " defective, unreasonably dangerous and hazardous " and that

> > > > Janssen/J & J knew

> > > > this and put the drug on the market anyway. " At the time

> > Risperdal

> > > > was sold

> > > > or placed on the market, it was in a defective condition and

> > > > unreasonably

> > > > dangerous to users and consumers. "

> > > >

> > > > In addition to allegations that the companies violated the

> > state's

> > > > Medicaid

> > > > fraud laws, the state alleges that the companies violated the

> > state's

> > > > deceptive trade practices act, engaged in negligent behavior, and

> > > > engaged in

> > > > fraud and misrepresentation and " unjust enrichment. "

> > > > ===========================================

> > > > Furious Seasons

> > > >

> > > > Comments: Atypical Nation: J & J's Risperdal " Defective, " Company

> > Lied,

> > > > Thousands Died In August of 1999, my daughter was 11 years old.

> > > > After an

> > > > adverse reaction[suicidal ideation]on Imipramine, I took her to a

> > > > psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox,

> > > > which

> > > > accelerated her " thoughts " , and the psych recommended

> > > > hospitalization.THERE,

> > > > inpatient at age 11--was where they put her on Risperdal. Her

> > eyes

> > > > locked

> > > > looking up, she was so pale and couldnt move her legs--I thought

> > she

> > > > was

> > > > dying. I was then clueless about psych meds, and trusted doctors.

> > > >

> > > > I will never forget seeing her and thinking my 11 year old looked

> > > > like she

> > > > was dying. That was in 1999, what fucking nerve this company has

> > to

> > > > place my

> > > > daughter at risk that way, and the smack in my face as a mother

> > and

> > > > for my

> > > > daughter, is that Eli Lilly's Zyprexa is what replaced that

> > > > Risperdal!

> > > >

> > > > For reading about Biederman,Wozniak, Wilens and Spencer and the

> > > > study for

> > > > Risperdal use in kids way back in 1999, as well as how it was

> > > > approved for

> > > > use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood

> > > > Bipolar and

> > > > just need not wonder any further, what my daughter's " OCD "

> > > > dx " changed " to

> > > > within weeks---yeah that's right, Childhood Bipolar Disorder, in

> > > > 1999.

> > > >

> > > > I hope this company and Eli Lilly are ready for a patient

> > lawsuit,

> > > > because

> > > > I'm rolling up my sleeves.

> > > >

> > > > They can f... pay for her to live somewhere decent, for her long

> > > > term care

> > > > at age 19.

> > > > I have to say, this is a topic everyone should not disregard, pay

> > > > attention

> > > > to these killers in our midst.

> > > > I am lucky my daughter is alive, and at what cost!!?

> > > >

> > > > I really do not want to visit her in a residential care facility

> > at

> > > > age 19

> > > > for Thanksgiving, and I am.

> > > > Does anyone understand why this angers me.

> > > >

> > > > Posted by Stephany at November 21, 2007 08:52 AM

> > > >

> > > > Phil, your analysis is missing, what I think, is the critical

> > point,

> > > > which

> > > > is: disclosure of side effects of a particular drug, here

> > Risperdal,

> > > > is not

> > > > a substitute for approval of the use of the drug in the first

> > place.

> > > > In

> > > > other words, knowing all the bad effects of Risperdal cannot

> > > > substitute for

> > > > its governmental approval for consumers' use. The FDA, a

> > governmental

> > > > authority charged with monitoring the safety and effectiveness of

> > > > medications, approved Risperdal. Other than a few warnings, the

> > FDA

> > > > has done

> > > > nothing to stop its marketing, notwithstanding the fact that

> > > > Risperdal was

> > > > unnecessary at best (there are better or similar quality drugs on

> > > > the market

> > > > already), or dangerous (and should be banned) at worst. The FDA

> > is

> > > > not a

> > > > party to the lawsuit. The plaintiffs in the lawsuits are not

> > > > consumers but

> > > > the states. The states are not representatives of consumers and

> > > > whatever

> > > > money they recover will go the states . The states are not

> > seeking

> > > > to ban

> > > > Risperdal and if they did, they probably couldn't. What's this

> > > > lawsuit is

> > > > all about? It's about local governments seeing an opportunity to

> > get

> > > > some

> > > > money out of drug companies. What the lawsuit doesn't address is

> > > > that drugs

> > > > are not securities; a prescribing information is not a

> > prospectus;

> > > > the

> > > > concept of let the buyer beware (caveat emptor) can have no

> > > > application to

> > > > prescription medicines, that consumers cannot understand

> > medications

> > > > and

> > > > that individual doctors are in no better position that consumers

> > to

> > > > understand medications either. What the lawsuit proves is that

> > the

> > > > FDA has

> > > > failed consumers once again. So it's a useless exercise as far as

> > > > individuals are concerned.

> > > >

> > > > Posted by Red Rover at November 21, 2007 09:03 AM

> > > >

> > > > " What the lawsuit proves is that the FDA has failed consumers

> > once

> > > > again. "

> > > >

> > > > That's exactly right. So who really is at fault for innocent

> > death

> > > > and

> > > > bodily injury to American citizens?

> > > > Like Riley?

> > > >

> > > > Posted by Stephany at November 21, 2007 10:51 AM

> > > >

> > > > ===========================================

> > > >

> > > >

> > http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_ris

> > > > perdal.

> > > > html

> > > > November 20, 2007

> > > >

> > > > Arkansas Sues Over Risperdal

> > > > The State of Arkansas today filed a lawsuit against Janssen and

> > J & J

> > > > over

> > > > allegations that the company " engaged in a direct, illegal,

> > > > nationwide

> > > > program of promotion of the use of Risperdal for non-medically

> > > > necessary

> > > > uses. " In other words, off-label marketing--specific charges

> > would

> > > > likely

> > > > include allegations of the drug being marketed for use in elders

> > and

> > > > children, as well as in depression and anxiety, conditions and

> > age

> > > > groups

> > > > for which the drug does not have FDA approval (it did get two

> > > > pediatric

> > > > approvals over the last two years, but this suit concerns

> > > > allegations in

> > > > prior years). This lawsuit had been expected for some time. The

> > > > state did

> > > > not specify damages sought, but it would likely be over $100

> > million

> > > > in

> > > > damages and penalties. The state has also made it clear that it

> > > > intends to

> > > > sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of

> > > > Seroquel, over

> > > > similar allegations. I'll have more on this once I've seen a

> > copy of

> > > > the

> > > > state's complaint, which I have requested, against Janssen/J & J.

> > > >

> > > > According to the AP, Janssen had no comment.

> > > >

> > > > Posted by Philip Dawdy at November 20, 2007 12:21 PM

> > > >

> > > >

> > > >

> > >

> >

>

[Guest guest]

Dr. Insel is a separate story. My purpose is not to praise or attack him (there was plenty to criticize in his presentation, although in other ways he was balanced in his approach) – my only point here is to emphasize the significance of having someone in his position who is highly critical of the use of Risperdal, which has been touted by some autism "authorities" as a beneficial drug for autism. It shows that those who have looked at Risperdal, if honest, concede that this drug, the only drug approved for use in children with autism (approved to treat "irritability" in autism, not autism itself, whatever autism is) is likely more dangerous than it is worth.Around the country legislation has been introduced, disguised as insurance reform for autism, that really are targeted efforts at legislating insurance coverage for the so-called atypical anti-psychotics, such as Risperdal, Seroquel, Geodon, Abilify, Zyprexa, Seroquel, Clozapine, Clozaril etc. This is a pharmaceutical ploy masquerading as an effort to help people with autism. (The efforts are supported by NAMI). The reason is the multi-billion dollar potential market for each of these drugs. (Risperdal already brings in billions).Recently an autism center in our region - one connected with a leading hospital - was recruiting children for a clinical trial with Abilify. No doubt we will see FDA approval for this drug and others. It helps to have leading establishment health officials speak honestly about these drugs, even if the clinical trial and FDA approval process is corrupt.Schools routinely seek psychiatric evaluations of children with the result being a rx for Risperdal - the educators like this for some reason. Seems like the new drug pushers are the ones running some of our public schools (not all, not everywhere, but it is happening - I see it routinely in my representation of children under IDEA).Now I can quote the head of NIMH regarding Risperdal when the school conspires with the psych to push Risperdal. RJK J. KrakowAttorney at Law1205 lin Avenue, Suite 110Garden City, New York 11530516-354-3300646-349-1771 (fax)rkrakow@... On Nov 24, 2007, at 1:27 AM, King wrote:Hi ,I agree, it's a huge step for Insel to state that Risperdol is ineffective and dangerous! The one and only time I can credit the man with something sensible to say. I hope that this is a genuine step in the right direction for him (but i'm not holding my breath!) > > >> > > > And the FDA helped!> > > >> > > > ALLIANCE FOR HUMAN RESEARCH PROTECTION> > > >> > > > Promoting Openness, Full Disclosure, and Accountability> > > > http://www.ahrp.org and http://ahrp.blogspot.com> > > >> > > > FYI> > > > The Arkansas State Attorney General has filed a lawsuit against> > > > Janssen and> > > > & 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?> > > >> > > > 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> > > >> > > > 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 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. & & , 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 Leber, then Director of FDA> > > > Neuropsychopharmacology:> > > > http://books.google.com/books?> > > > id=4T8sKI4cx_wC & pg=PA275 & lpg=PA275 & dq=leber+ri> > > > sperdal+approval & source=web & ots=9Iz6-u0-> > > > FW & sig=RD13Lj1EUJatYprqYggMG7pjfPM#P> > > > PA276,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 J. , AB; R. Cohen, RPh, MS, ScD;> > Curt> > > > D.> > > > Furberg, MD, PhD Arch Intern Med. 2007;167:1752-1759.> > > >> > > > See Nov 21 commentary by Dawdy, Furious Seasons:> > > > http://www.furiousseasons.com/> > > >> > > > Contact: Vera Hassner Sharav> > > > veracare@> > > > 212-595-8974> > > >> > > >> > http://money.cnn.com/news/newsfeeds/articles/djf500/200711210636DOWJO> > > > NESDJON> > > > LINE000498_FORTUNE5.htm> > > > Arkansas AG Suing JNJ Over Anti-Psychotic Drug Marketing> > > > Dow > > > > November 21, 2007:> > > >> > > > LITTLE ROCK (AP)--Drug companies improperly marketed an anti-> > > > psychotic drug,> > > > Arkansas Attorney General Mc claimed Tuesday as he> > > > asked a> > > > state judge to force the firms to repay millions shelled out by> > the> > > > state's> > > > Medicaid program for unnecessary prescriptions.> > > >> > > > Mc filed a lawsuit in Pulaski County Circuit Court against> > > > Janssen> > > > Pharmaceutica Inc., Janssen LP and & Inc. (JNJ).> > In> > > > the> > > > filing, Mc said the companies "engaged in a direct,> > illegal,> > > > nationwide program of promotion of the use of Risperdal for non-> > > > medically> > > > necessary uses."> > > >> > > > New Brunswick, N.J.-based & is the parent> > company of> > > > both> > > > Janssen Pharmaceutica and Janssen LP.> > > >> > > > The lawsuit did not specify how much the state is seeking, but> > > > Mc has> > > > estimated that the state's Medicaid program spent about $200> > million> > > > over> > > > eight years to pay for prescriptions for Zyprexa, Seroquel and> > > > Risperdal.> > > > The lawsuit filed Tuesday focuses solely on Risperdal.> > > >> > > > Gabe Holmstrom, a spokesman for Mc's office, said the state> > > > will file> > > > similar complaints about the marketing of the other drugs.> > Mc> > > > has said> > > > other companies that will be targeted include Eli Lilly and Co.> > > > (LLY) of> > > > Indianapolis and AstraZeneca PLC (AZN), a joint venture by a> > British> > > > firm> > > > and a Swedish firm.> > > >> > > > Mc has said the drugs were prescribed for uses not> > approved by> > > > federal> > > > regulators or indicated in labeling. Mc accused the> > companies> > > > of> > > > deceptive marketing practices that pushed doctors to prescribe> > > > Risperdal> > > > much more than necessary.> > > >> > > > The lawsuit also accuses drugmakers of not including warnings on> > > > Risperdal's> > > > bottle about adverse effects such as neurological problems,> > weight> > > > gain and> > > > diabetes.> > > >> > > > Ambre Morley, a spokeswoman for Janssen, defended the company and> > > > said it> > > > fully disclosed all information about Risperdal to doctors and> > > > government> > > > agencies.> > > >> > > > Copyright © 2007 Dow & Company, Inc.> > > > ~~~~~~~~~~~~~~~> > > >> > > > Furious Seasons> > > > November 21, 2007> > > >> > > > Atypical Nation: J & J's Risperdal "Defective," Company Lied,> > > > Thousands Died> > > > As I reported earlier, the State of Arkansas yesterday sued> > Janssen> > > > and its> > > > parent J & J over allegations concerning its atypical anti-> > psychotic> > > > Risperdal> > > > and how the company developed and marketed the drug. The lawsuit> > is> > > > a real> > > > eye-opener and confirms many things I've been saying on this site> > > > for over> > > > two years and for two years before that in print: there's> > something> > > > wrong> > > > with the atypicals and how deeply they've ended up embedded in> > > > American> > > > culture.> > > >> > > > The suit alleges that, among other things, Janssen/J & J put 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. There are other allegations--off-label marketing for use> > in> > > > children> > > > and the elderly, a campaign of covering up the drug's side> > effects,> > > > allegations of kickbacks to doctors and so on--but they almost> > pale> > > > in> > > > comparison to the EPS allegations, which ought to make anyone> > wonder> > > > how the> > > > heck this drug got approved in the first place.> > > >> > > > One of the charges against Janssen/J & J is for fraud.> > > > Sales of the drug in 2006 were $4.2 billion. Depending on who is> > > > estimating,> > > > Risperdal is the most used anti-psychotic in the world.> > > >> > > > The EPS allegation, the first I've seen in any of the ongoing> > > > lawsuits> > > > against J & J, goes right to heart of why atypicals became so> > popular> > > > amongst> > > > doctors: they were supposed to cause fewer side effects (a la> > SSRIs> > > > versus> > > > older anti-depressants in the 1980s), and therefore docs could> > > > safely give> > > > them to patients of every stripe for long-term use. Use of the> > older> > > > anti-psychotics was tightly restricted by docs (except among> > > > schizophrenics)> > > > because they were felt to cause so much EPS (aka zombieism) that> > it> > > > would be> > > > unethical to hand them out to anyone but the very sickest of> > > > patients. But> > > > atypicals like Risperdal were supposed to be safe for one and> > all.> > > >> > > > As it turns out, that was not the case. As a result, millions of> > > > people have> > > > paid a heavy price for using Risperdal--I am one of them--> > including> > > > at least> > > > 1,000 people who died as a result of using the drug, according to> > > > the FDA's> > > > adverse events database, as I have previously reported.> > > >> > > > J & J and Janssen lied. People died, or were injured and sickened> > by> > > > the> > > > willful action of one of the largest pharmaceutical companies on> > > > Earth.> > > > That's the view of the Arkansas Attorney General Mc.> > > > Other> > > > states including Texas are suing J & J over Risperdal as well.> > > >> > > > Anyone who thinks I have been too harsh in my commentary on these> > > > drugs, too> > > > rough on the pharma companies who make and market them, too> > tough on> > > > the> > > > doctors who gave them to patients like me and, as a a result,> > wrote> > > > me off> > > > as a wingnut, ought to read this (and other) lawsuits against the> > > > makers of> > > > these drugs and see just how wingnutty Mc is. Because he> > > > isn't. And> > > > neither am I. The lawsuit is here (.pdf 1.5 MB). The lies and> > > > deception that> > > > have gone with the atypicals' use in America are right up there> > with> > > > the> > > > lies propagated about the use of cigarettes by American tobacco> > > > companies.> > > >> > > > Now for a few particulars from the suit. First, the EPS> > allegations:> > > >> > > > "Risperdal's pre-marketing clinical trials did not support an> > > > assertion that> > > > it is less likely to cause EPS than traditional> > > > antipsychotics....Defendants'> > > > trials were designed to produce similar rates of EPS in patients> > > > sorted into> > > > placebo groups and those taking Risperdal. In order to produce> > their> > > > desired> > > > result, defendants selected patients for the placebo groups that> > were> > > > already in the course of treatment with high doses of typical> > > > antipsychotics....> > > > "Defendants claimed in their marketing that patients taking> > > > Risperdal were> > > > as likely to develop EPS as patients taking nothing and thus less> > > > likely to> > > > develop EPS than patients taking traditional antipsychotics."> > > >> > > > That is a staggering accusation and I assume Mc has> > documents> > > > to back> > > > it up. So far Janssen and J & J have not commented on the suit or> > its> > > > allegations.> > > >> > > > In 2002 and 2003, I experienced mild EPS on Risperdal after> > being on> > > > it at> > > > .5 mgs a day since December 2000, and took myself off the drug> > > > against my> > > > then-doctor's wishes (he insisted that EPS and other problems> > didn't> > > > occur> > > > on Risperdal). Just so you know my bias on this issue.> > > >> > > > Other allegations:> > > >> > > > "Janssen heavily marketed and promoted Risperdal [in the mid-> > 1990s]> > > > for its> > > > approved indication, treatment of adult with schizophrenia, and> > for> > > > multiple> > > > non-medically necessary uses of the drug, for example, ADHD,> > > > depression,> > > > anxiety, mood disorder, bipolar disorder, and aggression> > associated> > > > with> > > > late-onset dementia."> > > > I was pressed to take the drug off-label (my then-doctor never> > > > explained> > > > that part) three years before the drug received approval for use> > in> > > > bipolar> > > > disorder in 2003. Just so you know how I felt when I read the> > > > following:> > > >> > > > "Despite having been on notice for years of the potential for> > deadly> > > > diabetes-related side effects, defendant opted for the bare> > minimum> > > > of> > > > clinical trials, of limited duration, such that no side effects> > were> > > > likely> > > > to be revealed."> > > > The suit further alleges that J & J knew of weight gain and> > resultant> > > > diabetes> > > > issues with the drug but worked to conceal the drug's true safety> > > > profile.> > > > The state introduces evidence that in 1999, the FDA busted> > Janssen> > > > for> > > > marketing Risperdal for off-label use in the elderly and that> > the FDA> > > > informed Janssen it was engaged in "false and misleading"> > practices> > > > (see> > > > pages 9 and 10).> > > >> > > > As part of its strategy in the 1990s to expand Risperdal's market> > > > beyond its> > > > approved use in schizophrenia, the suit alleges that:> > > >> > > > "Defendants sough ghost written research and paid 'key opinion> > > > leaders' to> > > > support defendant's marketing aims. These 'key opinion leaders'> > were> > > > nothing> > > > more than third-party consultants and researchers who were put on> > > > defendants' payroll to support and lend credibility to> > defendants'> > > > specious> > > > scientific and marketing representations."> > > > Can't wait to find out who the researchers were who helped them> > with> > > > bipolar> > > > disorder.> > > >> > > > There is more evidence and allegations contained in this lawsuit.> > > > I'll get> > > > into those later.> > > >> > > > For now, this: Attorney General Mc alleges that Risperdal> > was> > > > "defective, unreasonably dangerous and hazardous" and that> > > > Janssen/J & J knew> > > > this and put the drug on the market anyway. "At the time> > Risperdal> > > > was sold> > > > or placed on the market, it was in a defective condition and> > > > unreasonably> > > > dangerous to users and consumers."> > > >> > > > In addition to allegations that the companies violated the> > state's> > > > Medicaid> > > > fraud laws, the state alleges that the companies violated the> > state's> > > > deceptive trade practices act, engaged in negligent behavior, and> > > > engaged in> > > > fraud and misrepresentation and "unjust enrichment."> > > > ===========================================> > > > Furious Seasons> > > >> > > > Comments: Atypical Nation: J & J's Risperdal "Defective," Company> > Lied,> > > > Thousands Died In August of 1999, my daughter was 11 years old.> > > > After an> > > > adverse reaction[suicidal ideation]on Imipramine, I took her to a> > > > psychiatrist, who dx her OCD in 30 minutes. Placed her on Luvox,> > > > which> > > > accelerated her "thoughts", and the psych recommended> > > > hospitalization.THERE,> > > > inpatient at age 11--was where they put her on Risperdal. Her> > eyes> > > > locked> > > > looking up, she was so pale and couldnt move her legs--I thought> > she> > > > was> > > > dying. I was then clueless about psych meds, and trusted doctors.> > > >> > > > I will never forget seeing her and thinking my 11 year old looked> > > > like she> > > > was dying. That was in 1999, what fucking nerve this company has> > to> > > > place my> > > > daughter at risk that way, and the smack in my face as a mother> > and> > > > for my> > > > daughter, is that Eli Lilly's Zyprexa is what replaced that> > > > Risperdal!> > > >> > > > For reading about Biederman,Wozniak, Wilens and Spencer and the> > > > study for> > > > Risperdal use in kids way back in 1999, as well as how it was> > > > approved for> > > > use in kids in 2007, read my post 1999>2007:OCD>ADHD>Childhood> > > > Bipolar and> > > > just need not wonder any further, what my daughter's "OCD"> > > > dx "changed" to> > > > within weeks---yeah that's right, Childhood Bipolar Disorder, in> > > > 1999.> > > >> > > > I hope this company and Eli Lilly are ready for a patient> > lawsuit,> > > > because> > > > I'm rolling up my sleeves.> > > >> > > > They can f... pay for her to live somewhere decent, for her long> > > > term care> > > > at age 19.> > > > I have to say, this is a topic everyone should not disregard, pay> > > > attention> > > > to these killers in our midst.> > > > I am lucky my daughter is alive, and at what cost!!?> > > >> > > > I really do not want to visit her in a residential care facility> > at> > > > age 19> > > > for Thanksgiving, and I am.> > > > Does anyone understand why this angers me.> > > >> > > > Posted by Stephany at November 21, 2007 08:52 AM> > > >> > > > Phil, your analysis is missing, what I think, is the critical> > point,> > > > which> > > > is: disclosure of side effects of a particular drug, here> > Risperdal,> > > > is not> > > > a substitute for approval of the use of the drug in the first> > place.> > > > In> > > > other words, knowing all the bad effects of Risperdal cannot> > > > substitute for> > > > its governmental approval for consumers' use. The FDA, a> > governmental> > > > authority charged with monitoring the safety and effectiveness of> > > > medications, approved Risperdal. Other than a few warnings, the> > FDA> > > > has done> > > > nothing to stop its marketing, notwithstanding the fact that> > > > Risperdal was> > > > unnecessary at best (there are better or similar quality drugs on> > > > the market> > > > already), or dangerous (and should be banned) at worst. The FDA> > is> > > > not a> > > > party to the lawsuit. The plaintiffs in the lawsuits are not> > > > consumers but> > > > the states. The states are not representatives of consumers and> > > > whatever> > > > money they recover will go the states . The states are not> > seeking> > > > to ban> > > > Risperdal and if they did, they probably couldn't. What's this> > > > lawsuit is> > > > all about? It's about local governments seeing an opportunity to> > get> > > > some> > > > money out of drug companies. What the lawsuit doesn't address is> > > > that drugs> > > > are not securities; a prescribing information is not a> > prospectus;> > > > the> > > > concept of let the buyer beware (caveat emptor) can have no> > > > application to> > > > prescription medicines, that consumers cannot understand> > medications> > > > and> > > > that individual doctors are in no better position that consumers> > to> > > > understand medications either. What the lawsuit proves is that> > the> > > > FDA has> > > > failed consumers once again. So it's a useless exercise as far as> > > > individuals are concerned.> > > >> > > > Posted by Red Rover at November 21, 2007 09:03 AM> > > >> > > > "What the lawsuit proves is that the FDA has failed consumers> > once> > > > again."> > > >> > > > That's exactly right. So who really is at fault for innocent> > death> > > > and> > > > bodily injury to American citizens?> > > > Like Riley?> > > >> > > > Posted by Stephany at November 21, 2007 10:51 AM> > > >> > > > ===========================================> > > >> > > >> > http://www.furiousseasons.com/archives/2007/11/arkansas_sues_over_ris> > > > perdal.> > > > html> > > > November 20, 2007> > > >> > > > Arkansas Sues Over Risperdal> > > > The State of Arkansas today filed a lawsuit against Janssen and> > J & J> > > > over> > > > allegations that the company "engaged in a direct, illegal,> > > > nationwide> > > > program of promotion of the use of Risperdal for non-medically> > > > necessary> > > > uses." In other words, off-label marketing--specific charges> > would> > > > likely> > > > include allegations of the drug being marketed for use in elders> > and> > > > children, as well as in depression and anxiety, conditions and> > age> > > > groups> > > > for which the drug does not have FDA approval (it did get two> > > > pediatric> > > > approvals over the last two years, but this suit concerns> > > > allegations in> > > > prior years). This lawsuit had been expected for some time. The> > > > state did> > > > not specify damages sought, but it would likely be over $100> > million> > > > in> > > > damages and penalties. The state has also made it clear that it> > > > intends to> > > > sue Eli Lilly, makers of Zyprexa, and AstraZeneca, makers of> > > > Seroquel, over> > > > similar allegations. I'll have more on this once I've seen a> > copy of> > > > the> > > > state's complaint, which I have requested, against Janssen/J & J.> > > >> > > > According to the AP, Janssen had no comment.> > > >> > > > Posted by Philip Dawdy at November 20, 2007 12:21 PM> > > >> > > >> > > >> > >> >>

[Guest guest]

I used to be such a nice person. Sigh. It would be great if Insel's

words were at least a sign of a sea change, though I would have

trouble believing that Insel would ever actually effect that change.

Using Chomsky's simple (and fun!) method for determining ideological

leanings, here's a word count breakdown of the NIMH's website on

autism, which was authored under Insel's watch (drug promotions on

this site have doubled since this time last year, when I last did a

word count):

-1077 words to promote and describe psychotropic drug treatments,

including a few sentences on seizure control (promoting Depakote and

other drugs by name) and a few advising parents to read drug company

inserts (the inserts contain dangerously incomplete warnings which do

not amount to informed consent) and to watch for side effects.

- 6 words total are used to describe negative side effects and only

for neuroleptics, 3 of which are used to describe side effects for

only the older, unpatented Thorazine (despite the fact that these

effects are the same for all but one of the atypicals).

-255 words to describe dietary interventions, supplements, secretin

(half of the words used are caveats and denial of effectiveness)

- 641 words *combined* to describe school programs, home therapy,

therapy and behavioral interventions

My sense about Insel is that he's not an agent for humanitarian

changes within the agency, not a " Schindler " who'll turn out to be

secretly on the side of right. It's one of those things that I'd

really like to be wrong about. I think he paralyzes people's judgement

with that tephlon, boyscout facade and makes people hope that- down

deep- he means well and tries to do good. But if his career were on

the line in a confrontation or he were ever pushed into a corner to

really speak out against industry, I feel pretty sure everyone would

see a distinctly different face. He may be self-protectively riding a

fence here in an attempt not to land on the wrong side of an ethical

battle, which might be a hopeful reflection that there's even a battle

going on, or a piece of explosive information on the drugs dangling

over the rash of neuroleptic approvals for children which the press

may or may not report on. If the press really goes with it (headlining

on CNN, etc., since most in the US don't read the NYT or alternative

blogs) and this ever becomes a big tobacco debacle, Insel will have

been on the record saying (squeaky mouse voice) " those drugs might not

be the best thing " and he's got his Nuremberg alibi.

If the next neuroleptic in line is approved for children without a

hitch, if the words he spoke don't end up on the NIMH's website

section on autism, we'll know he's just a political animal, not a shy,

good-hearted soul who's in over his head and finally gathering the

courage to speak out and take action. And there will be a portrait of

him in some attic gaining a few more gnarls and fangs.

>

> I think you are being realistic, not cynical, and I could not agree

> with you more. But, as you say, at least Dr. Insel was candid in

> saying about Risperdal what we all know, but what other government

> officials and elected officials have rarely, if ever, said.

>

> At least now it is on record - Risperdal is ineffective and

dangerous

> - the Director of NIMH and the IACC has said so. May children be

> spared Risperdal in favor of more effective and safer alternatives

> because of this official's willingness to speak!

>

>

>

[Guest guest]

Thank you for your insightful post and analysis (especially the Chomsky word count( - I agree.My only point is that we can use Insel's candor about Risperdal in this one instance. I am not suggesting there is something more dramatic going on with Dr. Insel.  On Nov 24, 2007, at 11:43 AM, anacat_11 wrote:I used to be such a nice person. Sigh. It would be great if Insel's words were at least a sign of a sea change, though I would have trouble believing that Insel would ever actually effect that change. Using Chomsky's simple (and fun!) method for determining ideological leanings, here's a word count breakdown of the NIMH's website on autism, which was authored under Insel's watch (drug promotions on this site have doubled since this time last year, when I last did a word count):-1077 words to promote and describe psychotropic drug treatments, including a few sentences on seizure control (promoting Depakote and other drugs by name) and a few advising parents to read drug company inserts (the inserts contain dangerously incomplete warnings which do not amount to informed consent) and to watch for side effects.- 6 words total are used to describe negative side effects and only for neuroleptics, 3 of which are used to describe side effects for only the older, unpatented Thorazine (despite the fact that these effects are the same for all but one of the atypicals). -255 words to describe dietary interventions, supplements, secretin (half of the words used are caveats and denial of effectiveness)- 641 words *combined* to describe school programs, home therapy, therapy and behavioral interventionsMy sense about Insel is that he's not an agent for humanitarian changes within the agency, not a "Schindler" who'll turn out to be secretly on the side of right. It's one of those things that I'd really like to be wrong about. I think he paralyzes people's judgement with that tephlon, boyscout facade and makes people hope that- down deep- he means well and tries to do good. But if his career were on the line in a confrontation or he were ever pushed into a corner to really speak out against industry, I feel pretty sure everyone would see a distinctly different face. He may be self-protectively riding a fence here in an attempt not to land on the wrong side of an ethical battle, which might be a hopeful reflection that there's even a battle going on, or a piece of explosive information on the drugs dangling over the rash of neuroleptic approvals for children which the press may or may not report on. If the press really goes with it (headlining on CNN, etc., since most in the US don't read the NYT or alternative blogs) and this ever becomes a big tobacco debacle, Insel will have been on the record saying (squeaky mouse voice) "those drugs might not be the best thing" and he's got his Nuremberg alibi. If the next neuroleptic in line is approved for children without a hitch, if the words he spoke don't end up on the NIMH's website section on autism, we'll know he's just a political animal, not a shy, good-hearted soul who's in over his head and finally gathering the courage to speak out and take action. And there will be a portrait of him in some attic gaining a few more gnarls and fangs. >> I think you are being realistic, not cynical, and I could not agree > with you more. But, as you say, at least Dr. Insel was candid in > saying about Risperdal what we all know, but what other government > officials and elected officials have rarely, if ever, said.> > At least now it is on record - Risperdal is ineffective and dangerous > - the Director of NIMH and the IACC has said so. May children be > spared Risperdal in favor of more effective and safer alternatives > because of this official's willingness to speak!> > >

[Guest guest]

I'd also be very, very happy if Insel's words can be used to ward

off school drugging mandates.

Please pardon my shadow boxing. I'm like a blood hound trained on

Insel's socks: wave the man's hankie in front of me and I start

barking and yanking at the leash. I don't mean to preach to the

pulpit. You're more than aware of all of it, of course.

And thank you for mentioning school coercion. We've become painfully

aware of this from stories by local parents and reports around the

country. We're actually shaking in our boots on behalf of our

effected four year old twins, particularly our willful daughter,

which is why we've kept the kids out of public school programs for

the moment.

I went to the ICSPP conference in October and wondered if you'd

consider attending next year's conference (unless you were there and

I didn't know it! Next year's is in Miami, I think). This year's was

all about mental health dragnet-ing, IDEA, No Child Left Behind's

screening stipulations, Teenscreen, coerced medicating in schools

and I think next year's conference will be more of the same, since

the issue is not diminishing in urgency.

I went out of interest in the issues in general and also to guage

where many members stood on the issue of vaccine/environmental

injury theories. I won't go into all the conversations I had during

that three days, but I wasn't disappointed.

I heard Jim Gottstein speak on some of the legal aspects of coerced

drugging and there were quite a few legal advocates present. There

were so many great presentations that I can't recount them all but

some highlights were ph Tarantola's Congressional briefing, a

talk by Indiana Rep. Noe, a fantastic (and funny

presentation) by LaCasse regarding his published study into

how the myth that psychotropes " correct brain chemical imbalances "

perpetuates itself, a presentation by Grace and of course a

few by Breggin himself, though he seemed to be enjoying having

others take up the banner (and the industry fatwahs). Great stuff.

Vera Sharav spoke a few times as well. She and AHRP have been

showing our community some love in regards to the articles and

materials they post.

There was lots of waving around of the socks of FDA and NIH

officials, lol.

> >

> > I think you are being realistic, not cynical, and I could not

agree

> > with you more. But, as you say, at least Dr. Insel was candid in

> > saying about Risperdal what we all know, but what other

government

> > officials and elected officials have rarely, if ever, said.

> >

> > At least now it is on record - Risperdal is ineffective and

> dangerous

> > - the Director of NIMH and the IACC has said so. May children be

> > spared Risperdal in favor of more effective and safer

alternatives

> > because of this official's willingness to speak!

> >

> >

> >

>

[Guest guest]

The legislation being advocated to get autism covered

by insurance is NOT geared towards getting a-typ

antipsychotics, SSRI's, stimulants, etc. covered.

These already are. I know plenty of families with

autistic children who have been getting these drugs

and others fully covered by both private HMO and

Medicaid/medical card for years, even those drugs

which are being prescribed in " off-label " usages.

The primary push for legislated insurance companies is

being done for theraputic services, such as ABA,

speech and OT, which ARE being routinely denied by the HMO's.

________________________________________________________________________________\

____

Be a better pen pal.

Text or chat with friends inside . See how.

http://overview.mail./

[Guest guest]

Dear Dad Fourkids:It appears your message is responsive to my earlier message, in which I described legislation disguised as autism health insurance reform legislation, that in some cases is geared toward authorizing approval for atypical antipsychotics. Perhaps my message's context was not clear and my point lost, so let me clarify what I was trying to explain.Drugs like Seroquel may be prescribed and sometimes insurance may cover it, but these drugs often cannot be put on prescription algorithms or included in Medicaid programs, where the manufacturers of the drugs get their big volume sales. Unlike Risperdal,  Seroquel, Geodon, Abilify and others are not approved for use in autism, nor do I believe they are approved for use in children. That is why you see widespread clinical trial for these drugs, like the national clinical trial now being conducted for Abilify. In New York we passed an insurance reform bill for autism. It was one geared toward the "primary push" for therapeutic services. I know this because I helped lead the advocacy effort of A-CHAMP, coordinated expertly by my A-CHAMP colleague Gilmore which, after years of frustration experienced by the autism community,  succeeded in putting together a broad coalition of organizations and got the bill passed! That was, more or less, a first in the nation or, at least, a significant step forward.After that success, another bill was introduced with which we had no involvement and arrived on the legislative landscape as a surprise – to us. Among the groups supporting this bill was the National Alliance for the Mentally Ill, NAMI, suspected by many advocates as being a front group for PHARMA (I have no confirmation of this) and a group that has pushed for approval of certain pharmaceuticals. They may well have their reasons for advocating for such a position, but this is not an effort we support. The bill's sponsor had received contributions from pharmaceutical companies, including the maker of Seroquel, Aztrazeneca. No doubt Astrazeneca marketers observed the blockbuster success of Risperdal, utilizing aggressive (and some AG's say illegal) research and marketing schemes, and wanted to participate in this type of profitable drug pushing.This is the effort to which I am referring, and it is being replicated in other states. I think we need to be aware of the effect of some insurance reform legislation and the intent of the sponsors and supporters.Separately, I established last year anw A-CHAMP health insurance advocacy campaign that has worked on good legislation in many states, and we have supported other efforts in South Carolina and elsewhere, that are geared primarily toward coverage of ABA.My point here, so as not to be misunderstood, is that the push for coverage may sometimes, and we have seen this more than once, be enabled by forces that would like to capitalize on the increase of children with autism. The landscape is very complicated.While many of us push for insurance coverage for the therapies you describe we need to be aware that the powerful lobbying forces that exist can coopt and distort our agenda, and sometimes we don't even know it. It has happened time and again over the last several years.Thank you for the opportunity to clarify my earlier remarks.Bob KrakowOn Nov 28, 2007, at 1:27 PM, Dad Fourkids wrote:The legislation being advocated to get autism coveredby insurance is NOT geared towards getting a-typantipsychotics, SSRI's, stimulants, etc. covered. These already are. I know plenty of families withautistic children who have been getting these drugsand others fully covered by both private HMO andMedicaid/medical card for years, even those drugswhich are being prescribed in "off-label" usages.The primary push for legislated insurance companies isbeing done for theraputic services, such as ABA,speech and OT, which ARE being routinely denied by the HMO's.__________________________________________________________Be a better pen pal. Text or chat with friends inside . See how. http://overview.mail./

[Guest guest]

Dear Dad Fourkids:It appears your message is responsive to my earlier message, in which I described legislation disguised as autism health insurance reform legislation, that in some cases is geared toward authorizing approval for atypical antipsychotics. Perhaps my message's context was not clear and my point lost, so let me clarify what I was trying to explain.Drugs like Seroquel may be prescribed and sometimes insurance may cover it, but these drugs often cannot be put on prescription algorithms or included in Medicaid programs, where the manufacturers of the drugs get their big volume sales. Unlike Risperdal,  Seroquel, Geodon, Abilify and others are not approved for use in autism, nor do I believe they are approved for use in children. That is why you see widespread clinical trial for these drugs, like the national clinical trial now being conducted for Abilify. In New York we passed an insurance reform bill for autism. It was one geared toward the "primary push" for therapeutic services. I know this because I helped lead the advocacy effort of A-CHAMP, coordinated expertly by my A-CHAMP colleague Gilmore which, after years of frustration experienced by the autism community,  succeeded in putting together a broad coalition of organizations and got the bill passed! That was, more or less, a first in the nation or, at least, a significant step forward.After that success, another bill was introduced with which we had no involvement and arrived on the legislative landscape as a surprise – to us. Among the groups supporting this bill was the National Alliance for the Mentally Ill, NAMI, suspected by many advocates as being a front group for PHARMA (I have no confirmation of this) and a group that has pushed for approval of certain pharmaceuticals. They may well have their reasons for advocating for such a position, but this is not an effort we support. The bill's sponsor had received contributions from pharmaceutical companies, including the maker of Seroquel, Aztrazeneca. No doubt Astrazeneca marketers observed the blockbuster success of Risperdal, utilizing aggressive (and some AG's say illegal) research and marketing schemes, and wanted to participate in this type of profitable drug pushing.This is the effort to which I am referring, and it is being replicated in other states. I think we need to be aware of the effect of some insurance reform legislation and the intent of the sponsors and supporters.Separately, I established last year anw A-CHAMP health insurance advocacy campaign that has worked on good legislation in many states, and we have supported other efforts in South Carolina and elsewhere, that are geared primarily toward coverage of ABA.My point here, so as not to be misunderstood, is that the push for coverage may sometimes, and we have seen this more than once, be enabled by forces that would like to capitalize on the increase of children with autism. The landscape is very complicated.While many of us push for insurance coverage for the therapies you describe we need to be aware that the powerful lobbying forces that exist can coopt and distort our agenda, and sometimes we don't even know it. It has happened time and again over the last several years.Thank you for the opportunity to clarify my earlier remarks.Bob KrakowOn Nov 28, 2007, at 1:27 PM, Dad Fourkids wrote:The legislation being advocated to get autism coveredby insurance is NOT geared towards getting a-typantipsychotics, SSRI's, stimulants, etc. covered. These already are. I know plenty of families withautistic children who have been getting these drugsand others fully covered by both private HMO andMedicaid/medical card for years, even those drugswhich are being prescribed in "off-label" usages.The primary push for legislated insurance companies isbeing done for theraputic services, such as ABA,speech and OT, which ARE being routinely denied by the HMO's.__________________________________________________________Be a better pen pal. Text or chat with friends inside . See how. http://overview.mail./

[Guest guest]

, I know in my state the meds given to kids with autism are paid

for by Tncare. I have never had it, but a friend who is on Tncare has

given her son several of the psychiatric meds. His have always been

covered. In fact, she uses the Tncare/welfare recipient status as

reasoning for not trying biomedical treatments, in spite of my pleas

not to go straight to drugs that don't work for him anyway. But I

don't know if they are giving them to the child with a different code

or not. Tncare has paid for his meds for at least the last 4 years,

don't know if that time frame means anything or not.

Debi

[Guest guest]

Well articulated Bob! Thanks. The landscape is complicated as you describe. We

have a

insurance bill A539 in NY for " experimental coverage for autism " . While we may

get

excited to hear this, the bill actually has a majority of bureaucrats approving

specific

treatments if it gets passed in its current language. These are the ones like

seroquel by

AstraZeneca which funds the campaign coffers of those on the Mental Health and

Developmental Disabilities committee. They are networked with the powerful and

influential lobbyists as well. Our state health departments autism publications

slam all

biomedical and nutrition interventions in NY. We have ZERO, yes ZERO autism

medical

doctors calling on these health departments and legislators in NY. While we do

not want to

try to kill the bill we have a uphill battle to persuade them to change the

language of the

bill. We desperately need to persuade the doctors and therapy professionals to

help us in

our efforts to insure our efforts pay off.

In my humble opinion and experience in working these issues at the state level,

a

insurance mandate is nearly impossible. Parity bills are the best opportunity

because we

don't treat autism on paper, we treat the health symptoms such as GI,

immunology, low

muscle tone, etc. The good news/ bad news is that autism issues are starting to

affect

many of these legislators families, friends and staffers. I hope I didn't get

too much off

topic.

Mike

>

> > The legislation being advocated to get autism covered

> > by insurance is NOT geared towards getting a-typ

> > antipsychotics, SSRI's, stimulants, etc. covered.

> > These already are. I know plenty of families with

> > autistic children who have been getting these drugs

> > and others fully covered by both private HMO and

> > Medicaid/medical card for years, even those drugs

> > which are being prescribed in " off-label " usages.

> >

> > The primary push for legislated insurance companies is

> > being done for theraputic services, such as ABA,

> > speech and OT, which ARE being routinely denied by the HMO's.

> >

> > __________________________________________________________

> > Be a better pen pal.

> > Text or chat with friends inside . See how. http://

> > overview.mail./

> >

> >

>