Psychoactive drug under fire

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    Psychoactive drug under fire

    Last year, the health care division in Massachusetts Attorney General Martha Coakley's office filed a lawsuit against Janssen Pharmaceutica, originator of the psychoactive medicine Risperdal and a division of Johnson & Johnson--also naming two manufacturers of generic risperidone. In that lawsuit, Massachusetts joined ranks with 10 other states previously taking similar actions and at least 30 more considering them. [ Amie Breton, Suit against Ortho-McNeil-Janssen, Massachusetts Attorney General's Office, August 1, 2011, at http://www.mass.gov/ago/news-and-updates/press-releases/2011/ag-files-suit-for-illegally-marketing-risperdal.html ]

    Business pages of the Globe recorded that action in a footnote. Atty. Gen. Coakley, who wants to be known as proactive and innovative, came very late to the party. The FDA cited Janssen for deceptive marketing in 2004. Texas sued Janssen for deceptive marketing in 2006. Arkansas and Pennsylvania filed lawsuits in 2007. [ Evelyn Pringle, Makers of Zyprexa, Risperdal and Seroquel under fire, Lawyers and Settlements, March 9, 2007, at http://www.lawyersandsettlements.com/articles/drugs-medical/zyprexa-medical-costs-00660.html ]

    In October, 2010, a Louisiana jury assessed $258 million in penalties. In December, 2011, a jury trial in South Carolina resulted in penalties of $327 million. This month, a jury trial in Arkansas ended with $1.2 billion in penalties. Janssen did not risk a trial in Texas, reaching a $158 million settlement in January, before the Arkansas trial began. [ David Sell, J&J unit fined $1.1 billion-plus in Risperdal case, Philadelphia Inquirer, April 12, 2012, at http://www.philly.com/philly/business/147069775.html ]

    One of the "terrible three" psychoactive medicines--along with Seroquel from AstraZeneca and Zyprexa from Lilly--Risperdal is a target of federal, state and hundreds of individual lawsuits. Courts in New Jersey have been flooded with so many claims that in 2006 the state initiated "mass tort" consolidation of cases involving all three medicines. [ Byron G. Stier, Mass tort litigation, Law Professor Network, September 11, 2006, at http://lawprofessors.typepad.com/mass_tort_litigation/2006/10/nj_mass_tort_de.html ]

    Core issues in Risperdal lawsuits are promotion of the medicine for unapproved uses and misleading information about severe side effects. In 2004, a review by the Texas state comptroller found that half the prescriptions written for children in Texas foster care were Risperdal and Zyprexa, neither approved for child use. [ Carole Keeton Strayhorn, Forgotten children, Texas Comptroller, April, 2004, 49 MB, available from the Hope for Kids foundation (Austin, TX) at http://www.hope4kidz.org/pdf/FORGOTTEN_CHILDREN.pdf ]

    In 2007, Scott Allen described the aggressive treatment of a four-year-old girl from Hull, Massachusetts, employing psychoactive medicines prescribed for unapproved uses--causing her death. [ Backlash on bipolar diagnoses in children, Boston Globe, June 17, 2007, at http://www.boston.com/yourlife/health/diseases/articles/2007/06/17/backlash_on_bipolar_diagnoses_in_children/ ]

    In 2003, the FDA required "black box" warnings about severe side effects on labels of several psychoactive medicines, including Risperdal. Janssen Pharmaceutica sent a letter to many thousands of physicians discounting the warnings. The FDA issued a "cease and desist" notice to Janssen, stating that its letter "misleadingly omits material information about Risperdal, minimizes potentially fatal risks associated with the drug, and claims superior safety to other drugs in its class without adequate substantiation"--all violations of U.S. law. [ Thomas W. Abrams, Director, FDA Division of Drug Marketing, Advertising and Communications to Ajit Shetty, M.D., Janssen Pharmaceutica, U.S. Food and Drug Administration, April 19, 2004, at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055315.pdf ]

     
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    Re: Psychoactive drug under fire

    All psychotropics have side effects!    Do you think Prolixin, Haldol, Thorazine,  Stelazine, Trilafon, Mellaril, Loxitane etc are any better?   Diagnosing kids with Bipolar disorder among other psychiatric illnesses and putting them on psychotropics... I don't get that, but there are severe cases, the parents would have to approve and sign off on any medications.  What about Geodon?  Clozaril?  Last I heard they're being used a lot.   Poly-pharmacy is another problem.   Ever seen anyone with Neuroleptic Malignant Syndrome?  Not pretty.         What do you suggest a patient who is violent and at risk of harming himself or others due to psychosis be treated with?  Remember they only hospitalize the extreme cases and insurance isn't big on "talk therapy".   Restraining a patient is frowned upon (in-pt setting) and discouraged, any ideas?    Haldol Decanoate, Prolixin Decanoate, Risperdal Consta long acting shots for the non-compliant?   ECT?   What about Mao Inhibitors,  one diet mistake and you have a potential medical emergency!

     
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    Alternatives

    It's not clear whether the growth in lawsuits over Risperdal was prompted by the severity of side effects, the foolish mistake made by its manufacturer in November, 2003, or the surge in use after the generic was available. Yes, working in mental hospitals before the era of first-generation antipsychotics (except Thorazine) was a different world. Electroshock was a common treatment. We did handle those difficult conditions, and we did see some patients on Thorazine gradually turn into vegetables.

    There are ten FDA-approved drugs currently classed as "second-generation" or "atypical" antipsychotics, in the order they were marketed in the United States:
    Clozaril (clozapine, Novartis)
    Risperdal (risperidone, Janssen/J&J)
    Zyprexa (olanzapine, Eli Lilly)
    Seroquel (quetiapine, AstraZeneca)
    Geodon (ziprasidone, Pfizer)
    Abilify (aripiprazole, Bristol Myers Squibb)
    Invega (paliperidone, Janssen/J&J)
    Fanapt (iloperidone, Vanda)
    Saphris (asenapine, Schering–Plough)
    Latuda (lurasidone, Dai-nippon Sumitomo)

    The first three are off-patent, but clozapine is rarely used because of agranulocytosis. It was one of three drugs being used to treat the child from Hull who died and has been reported as a likely cause of death. A strong concern of the FDA "black box" label in 2003 was drug-induced diabetes. Subsequent studies suggest around a five-percent chance with extended use of olanzapine and potential reversal in some but not all cases. Some of the newer alternatives may substantially lower that particular hazard, but the relatively short durations of clinical trials do not give much assurance. A molecular mechanism has been proposed.

    [ T. Cohen, S. Sundaresh and F. Levine, Antipsychotics activate the TGFβ pathway effector SMAD3, Molecular Psychiatry, January 31, 2012, at http://www.nature.com/mp/journal/vaop/ncurrent/full/mp2011186a.html ]

     
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    Re: Psychoactive drug under fire

    What about antidepressants? Thay have side effects too.    Recent NYT article regarding antidepressants during pregnancy.   http://well.blogs.nytimes.com/2012/04/09/antidepressants-can-raise-blood-pressure-during-pregnancy/?pagemode=print
     
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    Problem-drugs

    What about ACE inhibitors or cephalosporins or--for that matter--Aspirin? All with side effects. Getting far afield from a class of drugs is likely to generate more heat than light. The intensity of lawsuits tends to rank problem-drugs. For several years, "atypical" antipsychotics have led that parade.

    By comparison, fluoxetine was--for some time--seemingly prescribed as an all-purpose remedy for the anxious patient. While it, too, generated some lawsuits, those never reached the intensity of lawsuits aimed at the manufacturers of "atypical" antipsychotics. The rough sorting of lawsuits appears to have identified a type of drug with an unusual tendency toward harm and misuse.
     
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    Re: Psychoactive drug under fire

    I understand what you're saying, I have seen the diabetes in relation to Zyprexa, but I assumed anything that slows down the metabolisim can also cause weight gain.  They are still using Lithium despite the kidney damage it tends to cause over time. But I guess the ones you mentioned are the worst of the worst for now.  I thought that poor little girl in Hull died due to too much clonidine (antihypertensive) that was used to sedate her possibly causing her blood pressure to go dangerously low, I suppose the other meds didnt help, I didn't realize she was on Clozaril.  
     
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    Poorly understood problems

    There is something about most, if not all, of the "atypical" antipsychotic drugs that causes grave health problems for a segment of the population. A diagnosis of "diabetes" can be obtained with a longstanding dipstick or laboratory test, yet it remains almost as purely symptomatic as "pneumonia" or "pleurisy." So far, there is no reliable way to predict who will be stricken.

    Those badly affected are now so numerous that they now dominate victims of therapeutic drugs. The medical crises of Vioxx and Thalidomide were also terrible and costly but unlike "atypical" antipsychotic drugs obtained only in a specific drug and not an entire class of drugs. As Zyprexa, Seroquel and possibly their successors in the class reach larger volumes, with the introductions of generic equivalents, the intensity of cases and lawsuits is likely to grow.

     
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    Re: Psychoactive drug under fire

    For anyone defending common use of drugs such as reisperdal, keep in mind that these drugs are often used for "off label" use, causing un-necessary danger. I know someone who entered a hospital with mild dementia who was administered this drug with no fanfare. The family witnessed him having delusions and advanced dementia with no knowledge of this drug having these wild side effects. The family did find out about the strong side effects of this drug, including death in the elderly, and had him taken off it. For scenarios like this it is crucial,even life-saving, to know the side effects. It was not imperative or life-saving for it to be administered. Full 'transparency' is essential for patients and families to weigh factors accurately. In other words, his life was not in danger - until they gave him that drug!
     
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    Nursing home residents at risk

    A recent article from Kay Lazar and Matt Carroll recounts controversies over increasing use of antipsychotic drugs in nursing homes. Their article mentions only Seroquel among the drugs of concern, and it gives little credit to the many individuals, organizations and government agencies that have raised similar concerns in recent years. [ Rampant prescriptions, hidden perils (first of two parts), Boston Globe, April 29, 2012, at http://www.boston.com/news/local/massachusetts/articles/2012/04/29/nursing_home_residents_with_dementia_often_given_antipsychotics_despite_health_warnings/?page=full ]

    Last year Daniel R. Levinson, Inspector General for the U.S. Department of Health and Human Services, issued a report on a similar topic. [ Antipsychotic drug claims for elderly nursing home residents, May, 2011, at http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf ]

    The focus of the Levinson report was specific, the so-called "atypical" or "second generation" antipsychotic drugs that have been linked with problems in the general population: Clozaril (clozapine, Novartis), Risperdal (risperidone, Janssen/J&J), Zyprexa (olanzapine, Eli Lilly), Seroquel (quetiapine, AstraZeneca), Geodon (ziprasidone, Pfizer), Abilify (aripiprazole, Bristol Myers Squibb), Invega (paliperidone, Janssen/J&J), Fanapt (iloperidone, Vanda), Saphris (asenapine, Schering–Plough) and Latuda (lurasidone, Dai-nippon Sumitomo).

    Mr. Levinson investigated the first eight of the ten drugs--those approved by FDA before January, 2007. He reported, for the first six months of 2007, that 14 percent of nursing home residents aged 65 and older had Medicare claims for those drugs and that 7 out of every 8 claims represented unapproved uses. His report references two previous studies, one by the HHS inspector general in 2001 and one by the federal Agency for Healthcare Research and Quality in 2007. [ Psychotropic drug use in nursing homes, Inspector General, HHS OEI-02-00-00490, November, 2001, at http://oig.hhs.gov/oei/reports/oei-02-00-00490.pdf ] [ Efficacy and comparative effectiveness of off-label use of atypical antipsychotics, AHRQ 07-EHCOO3-EF, January, 2007, 10 MB at http://www.ncbi.nlm.nih.gov/books/NBK43235/pdf/TOC.pdf ]

    The AHRQ report shows a particularly strong incidence of stroke for Risperdal (risperidone, Janssen/J&J). This report considered hundreds of published studies. It found almost no reliable studies about a common problem with elderly people in nursing homes, also a key focus of the Lazar-Carroll article, saying, "More research is urgently needed about how to treat agitation in dementia safely" [p. 69]. The other major focus of the AHRQ report was the treatment of depression, which was not mentioned in the first segment of the Lazar-Carroll article.

     
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    Re: Psychoactive drug under fire

    I read the article but I see both sides of it,  some of those old folks are pretty feisty!  Also they keep putting more psych patients (seniors) that have assaultive histories in these Nursing Homes mixed in with the fragile elderly patients.  Instead of increasing staff they keep decreasing staff.
     
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    Unwillingness to provide effective care

    We don't see any "sides" at all to the off-label use of antipsychotic medicines. Instead, we see a rush to intervene and a focus on drastic "solutions" that have long characterized medicine as practiced in the U.S. Someone who never worked in a nursing home or mental hospital might joke about people there, but those of us with first-hand experience readily remember coarse attitudes often found among staff and irresponsible uses of many prescription drugs. They are chronic problems reflecting unwillingness to provide effective care.
     
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    Irresponsible prescriptions

    The second half of the Globe's long story on uses and abuses of antipsychotic drugs in nursing homes makes it clear that there are realistic alternatives and that they are being used effectively in some places. [ Kay Lazar, Finding alternatives to potent sedatives (second of two parts), Boston Globe, April 30, 2012, at http://www.boston.com/lifestyle/health/articles/2012/04/30/finding_alternatives_to_potent_sedatives/?page=full ]

    Writing about qualitative issues and human reactions in care, Ms. Lazar shines--in ways that the Globe of former times, with editor Thomas Winship, often did. She makes it clear that there are costs to alternatives that work: they take more staff and more training. In particularly difficult cases, they may not succeed.

    Ms. Lazar and Mr. Carroll have also been frank about causes of the situation:
    "...in Massachusetts many nursing homes use psychiatrists as consultants, and they tend to be more aggressive in recommending antipsychotics than nursing home staff...." [part 1 of 2]
    "...trained as physicians to think that every problem has a potential solution...the most widely used solution is a medication...." [part 2 of 2]

    The 2011 report from HHS Inspector General Daniel R. Levinson doesn't seem to have been read carefully by Globe writers or their readers. [ Antipsychotic drug claims for elderly nursing home residents, Inspector General, HHS OEI-07-08-00150, May, 2011, at http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf ]

    Mr. Levinson reported 7 out of every 8 Medicare claims for "atypical" antipsychotic drug prescriptions in nursing homes represented unapproved uses. That is a situation comparable to the deluge of unsupported Medicaid claims for which Johnson & Johnson was recently fined more than $1.1 billion, as the outcome of a state trial--the latest salvo in a long struggle against abuse of antipsychotic drugs.

    Some nursing homes and some institutions are run like warehouses. They go "doctor shopping" for on-call physicians who will cooperate in keeping patients quiet, and they do not care much about patient health. There is an underbrush of physicians unable to join quality practices or attract stable rosters of private patients; they often form symbiotic relationships.

    If you have troubles with this, you might not know what has been going on for the last 50 years. Read comments from some who do--to the Globe's first article:
    http://www.boston.com/lifestyle/health/articles/2012/04/29/nursing_home_residents_with_dementia_often_given_antipsychotics_despite_health_warnings/?comments=all#readerComm

    Government agencies have begun to police the behaviors of drug manufacturers, but they have been less concerned with irresponsible physicians, as long as they are not involved with recreational drugs. The manifold problems of irresponsible prescriptions will not abate until that changes.

     
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    Fines and penalties for Depakote promotions

    Depakote, from Abbott, recently joined Risperdal, from the Janssen division of Johnson & Johnson, in a rogue's gallery of illegally promoted psychiatric drugs. Depakote was approved as an anti-seizure medicine, but like J&J, Abbott saw off-label opportunities. Rather than carry out clinical trials and get approval for use with dementia, Abbott simply trained a sales staff to promote the drug to nursing homes. [ Pete Yost, Associated Press, Abbott Labs agrees to pay $1.5 billion over Depakote, WTOP (Washington, DC), May 7, 2012, at http://www.wtop.com/209/2855799/Abbott-Labs-agrees-to-pay-15B-over-Depakote ]

    The case of Depakote (sodium valproate plus valproic acid) also involved "federal regulations designed to prevent the use of unnecessary medications in nursing homes," according the the AP story. Those include Risperdal and other "second-generation" or "atypical" antipsychotics. Because Depakote did not belong to that family of medicines, Abbott could expect that excessive prescriptions would not be tracked by the Centers for Medicare and Medicaid. Depakote is involved in a multiple scam, based on minor variants and extended-release packaging. Valproates have been off-patent for some time and are available as generics.

     
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    Re: Psychoactive drug under fire

    What about Neurontin?  An anti-seizure med used for everything from dissociative disorder, anxiety, headaches, leg cramps, pain, insomnia etc.   Topamax? Clonidine?  The list goes on and on and on...
     
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    Off-label prescriptions

    It looks like the previous reader didn't actually read the article that was referenced. Otherwise the reader would have seen that while U.S. physicians are authorized to prescribe medicines for uses not approved by FDA, pharmaceutical manufacturers are authorized to market their products only for approved uses.

     
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