here we go again…

Posted on Tuesday 26 June 2012

Ark. judge says no new trial in J&J Risperdal case
The Associated Press
June 20, 2012

An Arkansas judge has denied a request for a new trial after he fined Johnson & Johnson and a subsidiary $1.2 billion for downplaying and concealing risks associated with the antipsychotic drug Risperdal. Judge Tim Fox ruled earlier this year that Janssen Pharmaceuticals Inc. and its parent company would have to pay $5,000 for each of the nearly 240,000 Risperdal prescriptions issued to state Medicaid patients over a 3 1/2-year period in addition to other fines. Fox this week denied the new trial request. Janssen attorney James Simpson did not respond to a phone or email message. A spokesman for Attorney General Dustin McDaniel says they’re grateful for the judge’s ruling, which upholds the verdicts of a Pulaski County jury.

Johnson & Johnson is close to reaching a settlement with the U.S. Justice Department over allegations it promoted anti psychotic drug Risperdal for unapproved uses that could cost the health care conglomerate at least $1.5 billion, the Wall Street Journal reported on Wednesday. The report, citing anonymous sources familiar with the matter, said the sides are discussing a deal of between $1.5 billion and $1.7 billion that could be completed in a few weeks. It also said the final amount could exceed $2 billion.
As these reports of J&J’s legal wranglings dribble out in short reports on the wire services, it’s easy to forget what J&J did with Risperdal. They financed the Tri-University guidelines that were used by TMAP, a J&J financed program in Texas to insure Risperdal’s as a first-line drug in the Texas State system. They financed the Texas Mental Health Director [Stephen Shon] to spread the program to 17 other States and the Federal Government. They set up a Mass General Center for Dr. Biederman who in turn signed onto an article pushing Risperdal as a treatment for a near non-existent illness, Childhood Bipolar Disorder. They pushed Risperdal as an adjunct for Depression. Meanwhile, they actively hid the weight gain and propensity to Diabetes. Meanwhile, Exceptia Medica was not far from J&J’s headquarters turning out ghostwritten articles for multiple KOLs. Meanwhile, the Sales Reps were in the field pushing Risperdal off-label for use with children.

J&J set out to turn a middle-weight antipsychotic into a widely indicated drug across the psychiatric spectrum – and succeeded. While the risk benefit profile of the drug was not dis-similar to the previous generation of antipsychotics, that was not true for the other ways the drug was being used. It appears that J&J was well aware that they were promoting a potent and toxic drug as benign. So there’s nothing frivolous about these suits and the large settlements. At issue – why are the people behind this conscious, active, and damaging scenario able to simply pass the costs on to the J&J stockholders without loss of personal gain or criminal liability?

So how did it all start? Like this write-up of a business analysis:

Research and Markets [] has announced the addition of the "R&D Trends: Autism Spectrum Disorders – Pipeline Growth Reflects Increasing Interest in Autism" report to their offering. This report reviews the key trends in the autism spectrum disorders pipeline. The analysis is intended to support R&D decision-making by evaluating the dynamics of the pipeline and hypothesizing future treatments of autism spectrum disorders. The autism spectrum disorders [ASDs] market is a challenging one to penetrate; since 2006 only two products have been successful in entering this marketplace: Risperdal [risperidone; Johnson&Johnson] and Abilify [aripiprazole; Bristol-Myers Squibb]. However, as additional agents near the market, increasing interest in ASDs has led to a sizable growth in the clinical pipeline.

    – Overview of drugs in late- and early-stage clinical development for autism spectrum disorders.
    – Identification of the target product profile for future autism spectrum disorders treatments.
    – Summary of clinical trial design in autism spectrum disorders including exploration of key endpoints and assessment methodology.
    – Identification of key challenges associated with the conduct of clinical trials in autism spectrum disorders.
    – Exploration of future treatment in autism spectrum disorders including the development of personalized treatments and the use of biomarkers.
    – The autism spectrum disorders (ASDs) pipeline remains sparse relative to other conditions that are treated with psychotropic medications. The unknown etiology of ASDs poses a fundamental challenge to the therapeutic discovery process. However, the pipeline growth is encouraging and reflects an increased interest in ASDs.
    – The two approved therapies for the management of autism spectrum disorders both target the symptoms of irritability. The comparator therapy identified by Datamonitor is Risperdal (risperidone; Johnson & Johnson) as it was the first to be approved in this indication, demonstrates a strong efficacy profile, and is regarded as a first-line therapy.
    – Key challenges associated with the conduct of clinical trials in autism spectrum disorders are: the unknown etiology of the disorders and heterogeneous symptomology. Communication and language impairments commonly associated with autism spectrum disorders further compound these challenges
Questions examined include:
    – How many drugs are in clinical development for the treatment of autism spectrum disorders? What deters companies from investing in this area?
    – What symptoms and mechanisms of action are most frequently targeted? What key companies are involved in the pipeline?
    – What is the target product profile and most appropriate comparator therapy?
    – What are the key challenges in conducting clinical trials in autism spectrum disorders?
    – How is the treatment of autism spectrum disorders likely to evolve over the next 10 to 20 years?

Companies Mentioned Include:

    – Celgene Corporation
    – Commerzbank AG
    – Forest Laboratories Inc.
    – GlaxoSmithKline Plc
    – Hutchison 3G UK Limited
    – Informa plc
    – Janssen Pharmaceuticals Inc.
    – LVMH Moet Hennessy Louis Vuitton SA
    – Wolters Kluwer nv
Lest you had questions about the impact of the DSM-5 categories…
    June 26, 2012 | 12:30 PM

    Increasing special interest in autism indeed $$$$$$$$$$$$$

    June 26, 2012 | 1:59 PM

    Mickey, with each and every post you write, I just have to chuckle at the fact that I work side-by-side with psychiatrists who still think this is a medical specialty driven by pure science treating real illness.

    June 26, 2012 | 2:41 PM

    Autism — yes, you see, those vaguely defined conditions, formerly rare but, with psychiatry’s help, might be extended to big chunks of the population, are gold mines for pharma. Psychiatry has been only too happy to oblige with diagnosis creep!

    June 26, 2012 | 7:49 PM

    Alto, let’s call a spade a spade. Surely you know that many parents are all too happy to get the autism (or ADHD) diagnosis for little Johnny or Jane. Yes, we psychiatrists acquiesce and hand it to them, but there are always two parties to this transaction.

    Sort of like the ever-present Seroquel seekers, one of whom cursed me yesterday when I refused to give him his fix.

    June 27, 2012 | 8:43 AM

    the table of contents for the market research report on the autism pipeline can be found at

    it includes a section


    – Clinical targets
    – – Clinical trial data indicate a lack of efficacy of investigated therapies
    – – Although superior to Risperdal, side effects are also prominent with Abilify treatment
    – – Ease of administration is a key consideration in the development of treatments for the pediatric population

    – Comparator therapy: Risperdal (risperidone; Johnson & Johnson)
    – – Risperdal was the first drug to receive FDA approval for irritability associated with autistic disorder
    – – Clinical trial data for Risperdal

    – Target product profile versus current level of attainment
    – – Target product for the treatment of irritability should demonstrate superior efficacy and side effect-profile to Risperdal

    June 27, 2012 | 9:56 PM

    SteveBMD, psychiatric drugging is not a totally demand-driven economy!

    Sure, patients or their parents might ask for drugs, but who puts the idea in the public mind?

    And why do doctors feel they have to give patients what they ask for? As I’ve said many times before, doctors have no problem saying no to antibiotics for the cold or flu, why do doctors accede when it comes to adult anomie or recalcitrance in children?

    June 29, 2012 | 9:29 AM

    Great post! I am very thankful that you share this.

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