J&J, Risperdal & Dementia: A Smoking Gun?

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nursing-homeLast month, the US government intervened, or joined, a whistleblower lawsuit filed against Johnson & Johnson and its Janssen unit over allegations the health care giant paid kickbacks - in the form of rebates and educational grants - to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often. The lawsuit also alleged J&J hid the payments from Medicaid to avoid reporting a ‘best price’ that would have triggered paying rebates to Medicaid (The US Department of Justice recently reached a settlement with Omnicare).

One exhibited contained in the lawsuit appears to raise the issue of off-label promotion. A report prepared about Omnicare by J&J long-term care business managers includes this passage: “In June of 1999, Omnicare was willing to provide a prescriber list to the J&J Group and Janssen Elder Care Sales Force. These names were provided to the sales force in an effort to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient. As of July 1999, over 350 names have been acquired and the representatives have begun their targeting on these prescribers.” (see page 21).

However, Risperdal was not approved for use in patients with dementia-related psychosis, according to the label, which now includes a warning that such patients are at an increased risk of death. You may recall that, last year, Eli Lilly paid a $1.3 billion fine to settle civil and criminal charges for off-label promotion of Zyprexa, specifically for promoting the antipsychotic for dementia in elderly people (look here). So could the report on Omnicare and Risperdal be a smoking gun?

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  1. What’s the difference between dementia and Alzheimers? what is the difference? I think my father may be suffering one of these? does anyone know the warning signs? thanks

  2. leaving a message for the previous poster
    (symptoms of dementia) and also for Ed Silverman.

    dementia refers to a syndrome =
    cluster of symptoms.
    It can be caused by numerous diseases, including Parkinson’s disease, Alzheimer’s disease, multiple sclerosis, and diabetes.

    symptoms include not only problems with
    memory,
    apraxia [coordinated motor movements]
    agnosia [failured to recognize objects]
    aphasia [language problems]
    and
    executive functions [planning, organizing, abstract thought]
    but also
    psychiatric features, such as
    depression, mania, and/or psychosis

    back to Risperdal >>>
    Ed, when will the public finally hear
    that the antipsychotics — old AND new,
    including Risperdal >>> are
    major inducers of dementia …….
    through numerous mechanisms ?

    I published my book, Drug-Induced Dementia: a perfect crime, in May 2009 but no one will pay attention to it.

    The elephant in the room that Pharmalot and other will not acknowledge is not just the
    “off label” marketing of Risperdal and other drugs, but the unacknowledged public health crisis that these drugs are contributing to an epidemic of premature death, early-onset dementia, and dementia among the usual elderly set of patients [many of whom die from the stroke-inducing and pneumonia-inducing features of these drugs].

    I strongly recommend that Mr. Silverman
    begin to blog about the fundamental mechanisms through which pharmaceuticals cause pneumonia, strokes, sudden cardiac death, and dementia
    [neurodegeneration] because this is one of the
    most important crises facing allopathic medicine at this moment in history.

    respectfully,

    Grace E. Jackson, MD
    author of
    Drug Induced Dementia: a perfect crime
    and
    Rethinking Psychiatric Drugs: a guide for informed consent

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