an unacknowledged history…

Posted on Saturday 17 March 2012

In case you haven’t noticed my flurry of postings lately are the ones I never finished because I was so preoccupied with those Gibbons’ papers. Here’s another oldie I finished:
J&J Wins First Risperdal Product Liability Case
Pharmalot
By Ed Silverman
February 17th, 2012

In the first lawsuit to go to trial over personal injuries attributed to the Risperdal antipsychotic, a New Jersey jury decided in a 5-to-1 vote that the Johnson & Johnson drug was not a substantial factor in causing a 56-year-old man to develop diabetes. However, the jury also voted 5-to-1 that the health care giant failed to adequately warn that about the risk that the med could cause the illness, Bloomberg News writes.

Nonetheless, Gary Skala was not awarded damages, handing J&J a welcome victory in what is likely to be closely watched litigation, given the controversy surrounding Risperdal marketing. J&J has reportedly reached a tentative deal to pay up to $1 billion to settle a federal probe into Risperdal marketing and resolve civil charges, and also agreed to a misdemeanor charge over the same issues…

Last month, J&J agreed to pay $158 million to settle a lawsuit filed by the Texas attorney general, who charged the Janssen pharmaceutical unit orchestrated a controversial program called the Texas Medication Algorithm Project, which was allegedly designed to boost the use of the Risperdal antipsychotic in the public sector throughout the country.

Despite the related setbacks, J&J is widely expected to fight the more than 400 product liability lawsuits over Risperdal, at least for now. The drugmaker, in fact, only settled the Texas lawsuit after overwhelmingly damaging testimony was given by various witnesses for the state about marketing practices during the first few days. The move was seen as an attempt to prevent additional evidence from becoming public [read this]…

Silverman’s post goes on to describe the case further. This patient had many other preconditions to develop Diabetes clouding the issue and putting the jury into the region that begged the question of "reasonable doubt."
In the latest trial, J&J attorneys convinced the jury that Skala, who is 5′8″ and 240 pounds, developed diabetes because he was an obese “couch potato,” and developed the illness thanks to his weight, heavy drinking, sedentary lifestyle and other risks, according to Bloomberg. Skala, who has chronic major depression, took the pill in 1996 after attempting suicide by taking an overdose of anti-anxiety medicine, and later drank up to 10 beers a day. But J&J lawyers argued that anxiety, stress, sleep problems and family history contributed to his diabetes.
It was a poor "test case." Besides the other risk factors in this case, Mr. Skala took Risperdal in 1996. The first reference I found for <depression+risperodone> in PubMed was 1998. And the studies Jannssen suppressed confirming Diabetes Risk came later. So this was, at best, a very muddy case.

It’s as easy to over-generalize from court cases as it is to over-generalize from a Clinical Trial – as if either defined the truth. There is plenty of evidence from the Texas Trial that Risperdal can induce Diabetes, that Janssen knew it, and that they actively suppressed the information [see Dr. Glenmullen’s Testimony]. There is ample evidence scattered throughout the testimony that minimizing or denying the Diabetes potential of Risperdal was company policy. Watching the incriminating internal documents dance across the screen and listening to what the Sales Reps were doing, I was kind of surprised that Janssen didn’t settle before that trial even started. Although this may be true,

    The drugmaker, in fact, only settled the Texas lawsuit after overwhelmingly damaging testimony was given by various witnesses for the state about marketing practices during the first few days. The move was seen as an attempt to prevent additional evidence from becoming public.
… there’s already more than enough information in the documents we did see at the trial to make the misbehavior beyond apparent.

If I may be indulged for a moment and slip into another identity. In working with traumatized patients or people who had been genuine victimized in some way, I learned that the only real solution would be that the trauma had never happened in the first place, which is, of course, impossible – the one sure thing that can never happen. The fantasy that the offending event[s] must be "un-happened" to get better is almost universal. In many traumatized people, repression or dissociation is an "un-happening" that causes innumerable ongoing problems. Others are preoccupied with some kind of revenge – understandable, but it still doesn’t change the past. Thus, part of the treatment of traumatized people is helping them incorporate the truth of what happened to them as a part of the life experience that has made them who they are, has defined them for all times, something that will always be with them even though unwanted. As the bard said, "what might have been is an abstraction remaining a perpetual possibility only in a world of speculation." And the consequence of ongoing "unhappening" is paradoxical. It results in re-experiencing the traumatic event repetatively. As another bard said, "the truth will out," and out it does…

I don’t think this analogy of Psychiatry as traumatized is far fetched [though it’s more often portrayed as traumatizing these days]. Something monumental has happened in the specialty of Psychiatry in the last thirty years. A trauma to Psychiatry. Worse – Psychiatry was indeed involved in its perpetration. We were in a tangle back then. The boundaries between Psychiatry and Psychoanalysis were hopelessly blurred. There had been a massive de-Institutionalization of chronic mental patients largely due to the coming of antipsychotic medications. The Community Mental Health funds to respond to de-Institutionalization were disappearing. Other Mental Health disciplines were on the rise. And there was an anti-psychiatrist of some sort on every corner. Managed Care had arrived, determined to trim the fat [and they considered almost all of Psychiatry as fat]. Training programs were starved for funding as the State and Private placements for trainees rapidly disappeared. Things were a real mess.

We all know what happened – the DSM-III Revision that would redefine Psychiatry in both planned and unanticipated ways. From that time, there emerged a growing collusion between the Pharmaceutical Industry and the upper levels of Psychiatry that would reign to the present – suffused with increasing corruption at many levels lasting for at least the last two decades. And while some of us inside of Psychiatry and even more outside Psychiatry write about this [almost daily], it remains rarely mentioned officially – it’s under a veil of relative secrecy – unspoken. It actually reminds me of a term from the trauma literature – the unforgettable unremembered. It’s not discussed by the people on the DSM-5 Task Force, many of whom were involved in some of the corruption. Dr. Insel of the NIMH barely acknowledges any of it. The Pharmaceutical Companies certainly remain mum ["an attempt to prevent additional evidence from becoming public"]. The APA which should be leading the fight against corruption is silent. Even worse, some of the APA’s top dogs were part of the problem. So if your only sources were from official circles, you would know very little if anything about what happened [is happening].

I have no  investment in these suits against the drug companies having to do with punishment or revenge. That’s for the injured parties to work out. It won’t undo the damage, but at least it will be some compensation for their injuries. Instead, my interest is for wide awareness of what happened, particularly the contribution of Psychiatrists and our Institutions. But even more than just public awareness, Psychiatry itself has to stop pretending it’s business as usual. It may help our public image to come clean; or it may damage it even further; or both. But that’s not the point. We can’t move forward pretending as if something this big, a front page headline story, didn’t happen. The collusion of segments of Psychiatry with the Pharmaceutical Industry and the widespread corruption it brought about is far and away the most important thing that has happened in Psychiatry in its history. While we claimed to be ‘medicalizing,’ in 1980, we actually ended up betraying some of the most essential ethical tenets of Medicine and Science in the process – probably more than any other specialty, ever. It’s a part of us now. As a hidden part, it’s cancer. Openly spoken, it’s a great big blemish that we’d rather not have, but a clear reminder for the future.

So Janssen may want to keep things hidden from sight …
    The drugmaker, in fact, only settled the Texas lawsuit after overwhelmingly damaging testimony was given by various witnesses for the state about marketing practices during the first few days. The move was seen as an attempt to prevent additional evidence from becoming public.
… to cut their future losses in the courtroom. But psychiatry doesn’t have the same luxury. We actually need for the evidence to be made public. It may be embarrassing and further tarnish the specialty’s reputation, but without that – all of psychiatry is suspect rather than the specific people who misbehaved, and we will stay on the same misguided trajectory, our professional identity remaining discolored by an unacknowledged past.
  1.  
    March 17, 2012 | 6:56 PM
     

    I often wonder what the APA annual meeting is like now. Some of the pharma glitz has disappeared, right? Are there any talks about “Dilemmas in Psychiatry Today”? Does anyone decry having to practice in med-check modules? Are there still “chemical imbalance” presentations? Do the docs wander around, looking at exhibits, chit-chatting with each other, in a protective bubble of their own privilege?

  2.  
    March 17, 2012 | 7:13 PM
     

    Would it be a consolation to you to know that genetic behaviorists have it worse?

    http://www.criticalpsychiatry.net/?p=624

  3.  
    Stan
    March 17, 2012 | 9:55 PM
     

    Mickey wrote:

    “If I may be indulged for a moment and slip into another identity. In working with traumatized patients or people who had been genuine victimized in some way, I learned that the only real solution would be that the trauma had never happened in the first place, which is, of course, impossible – the one sure thing that can never happen. The fantasy that the offending event[s] must be “un-happened” to get better is almost universal. In many traumatized people, repression or dissociation is an “un-happening” that causes innumerable ongoing problems. Others are preoccupied with some kind of revenge – understandable, but it still doesn’t change the past. Thus, part of the treatment of traumatized people is helping them incorporate the truth of what happened to them as a part of the life experience that has made them who they are, has defined them for all times, something that will always be with them even though unwanted. As the bard said, “what might have been is an abstraction remaining a perpetual possibility only in a world of speculation.” And the consequence of ongoing “unhappening” is paradoxical. It results in re-experiencing the traumatic event repetatively. As another bard said, “the truth will out,” and out it does…”

    If I may, I would like to examine & expend upon this thought while seeking your insight. Many of those who have been traumatized by significant events that may manifest themselves in dis-associative/denial/un-happening/revenge seeking states that can cause innumerable ongoing problems; also appear to lack a key ingredient in the process of healing or moving forward (Closure) .

    I don’t believe anyone is going to argue there is a way to undo the events that have conspired in the past. It no doubt becomes a long process of coming to terms with, a journey of self discovery, developing proper context & rational, gaining a deeper, richer, further understanding, & eventually a newly created sense of acceptance.

    When the traumatic event or events that lead to serious personal resulting maladies are in origin those of a pre-calculated & malice action of another…[such as in the case of an aggravated assault, rape, death or life long term damage caused by a pharmaceutical product, etc..] Would it not make therapeutic and rational sense that to move on or to reach some form of closure ( a starting place for healing)…the overt act of holding “those” responsible for their egregious actions using the standards of accountability should be considered a key & vitally important element within this process whenever reasonably possible….I would tend to believe that those traumatized by these types of criminal actions would be further traumatized by the stark knowledge & ever present reality that there was never a palatable sense of justice given/offered to them.

    This in turn would seem to further devalue their precious lived experience, damage their sense of self worth, and intensify the resulting traumatic or powerless state of mind.

    In fact I would tend to believe that the sense of un-doing or longing for revenge would only be further precipitated when those responsible for those crimes were not only never brought before the scales of justice (bringing with it some measure of resolution); but in fact further enrage/complicate victims suffering knowing that the perpetrators were actually profiteering and openly flaunting their crimes out in the open causing a deeper shame to be inflicted upon them (and thus their personal victimization & trauma).

    I happen to personally believe there is no lasting change or resolution without some sense of accountability which can or may give hope to closure. A wound left to its own demise, can fester, lead to infection, & may eventual lead to terminal resulting consequences. Whether that be framed within the context of personal trauma, or something as broad & convoluted as the practice of Psychiatry.

    History is the greatest of teachers…for when we forget the lessons it has taught us through our great sacrifices & unfathomable sorrow….we just hasten the repetition of like or mirrored events happening once again into our future.

  4.  
    March 19, 2012 | 11:27 PM
     

    Great job Mickey

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