J&J Fighting Federal Risperdal Deal Over Language Regarding Breasts

Kermit Cole
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Johnson & Johnson is negotiating with federal authorities over language that might be used in dozens of civil lawsuits regarding abnormal breast development and milk production, sometimes in boys, resulting from its antipsychotic Risperdal. The Wall Street Journal says the feds want J&J to acknowledge it downplayed relevant data.

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected]

5 COMMENTS

  1. Again, we have to ask, how are these drugs getting through the FDA? To be fair, the FDA Director from 2000-2007 had concerns about the drug being prescribed “off-label” to children, but that raises another issue. How is it that the FDA can balance their stance of: You can’t market the drug off label, but you’re within your rights as a physician to prescribe it off-label?

    Why do we allow physicians to give these drugs to children when the FDA has not approved them for this use in this population? A drug is dangerous enough AFTER getting approved by the FDA. Using it off-label increases the danger exponentially.

  2. Totally off topic, but as one of the most “use the current system to inflict the maximum damage to psychiatry as possible” posters here, I have been thinking all week what legal action would be possible against psychiatry now that the NIMH is on record saying,

    “The weakness is its lack of validity. Unlike our definitions of ischemic heart disease, lymphoma, or AIDS, the DSM diagnoses are based on a consensus about clusters of clinical symptoms, not any objective laboratory measure. In the rest of medicine, this would be equivalent to creating diagnostic systems based on the nature of chest pain or the quality of fever.”

    Can any of the many outrageous cases that have been decided on the advise of a forensic psychiatrist be overturned (I am thinking not only civil commitments but divorce, estate, criminal, whatever) in order to initiate a legal battle that could go all they way up to the US Supreme Court? Tom Insel might be called to take the witness stand and either stand by what he said or retract. Either way, our side wins.

    Thoughts anyone?

    • I think the fact that Insel is the current Director of such a high profile governmental agency makes this a possibility. Typically, expert witnesses get called by both sides to negate each other, but he is a unique voice. Maybe the defense will call Biederman! Just joking.

      You may have read/heard the story recently of the IRS admitting that they unfairly targeted “tea party” organizations for audit during the last election cycle. When these complaints were originally made, everyone laughed and called the complainers conspiracy nuts and “Preppers”

      Moments of honesty from our Government anymore seem to be few and far between. I know Insel has another angle, he definitely wants to continue to pursue a diagnostic system with biological assumptions of so-called illnesses in view.

      Maybe we need someone like Jim Gottstein, or another attorney to weigh in cannotsay. I believe a case could be made that the assessment tool relied upon to render a diagnosis has been shown to be invalid therefore negating the diagnosis and any subsequent action taken because of the diagnosis. I’m not sure though. I like the idea of “hijacking” or working within existing systems to change/dismantle them. I get a chance to do that daily!

      • Agree with much of what you say, including, as one of the few conservatives here, with the outrage about the IRS unfairly targeting Tea Party groups (although I have never been part of the movement).

        Many things can be accomplished by dealing mortal blows from within. Lets not forget that the most important damages done to psychiatry in the US were a series of SCOTUS decisions during the 70s. This statement by Insel represents an opportunity that we are unlikely to see in decades. The window of opportunity might last 1 or 2 years at most (Insel could get fired or become friends with the APA again; I am under no illusions with him either). The key is to find the right test case, one in which the final decision was based on the scientific validity of the DSM, in which some great personal damage resulted from accepting said validity and that would have a reasonable chance of reaching the SCOTUS.

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