nothing else to say…

Posted on Saturday 7 April 2012

Remember Arkansas? There’s a Janssen Risperdal Trial underway having completed its second week. Since I heard the plaintiff’s argument in the Texas Trial in January, I didn’t pay much attention except to notice that there was no news coming our way. Actually, the trial itself didn’t have a lot of appeal. No whistle-blower. No TMAP. Just Arkansas’ allegation that the people at Janssen are rotten people who sold them Risperdal under false pretenses. The only press coverage was in the Arkansas Democrat-Gazette which is subscription only. I found that I could buy a week’s worth of access for 99¢, so why not.

This was the week for the defense. I carefully cut and pasted the daily articles into a text file and read most of it. Here’s my summary: "It is not!" "It is too!" – daily haggling between lawyers. From what I can gather, the plaintiff’s arguments the week before had been similar to Texas, without the personae [Allen Jones, Stephen Shon, etc]. They must’ve done alright, because the defense was mostly about "It wasn’t that bad."  "Zyprexa is worse!"

I’ll spare you quotes as reporter John Lynch struggled to find something interesting to say about what sounded like rivals on an Elementary School playground – unsuccessfully, I might add [not his fault]. There are discussions going on about a settlement. Arkansas is more like South Carolina, West Virginia, Louisiana, and Pennsylvania. Janssen has prevailed twice – West Virginia and Pennsylvania – and has lost two – South Carolina and Louisiana – now being appealed. Only Texas has been definitively resolved. And Janssen’s problems with the Feds are still up in the air.

I was thinking about this whole Risperdal story. It’s the only Atypical Antipsychotic I’ve personally ever used. Once, in a Chronic Schizophrenic woman who could not tolerate the extrapyramidal side effects of Haldol, and in a couple of psychotic children. In both, they had been put on it in a hospital and I’m following the cases as outpatients. It’s a legitimate antipsychotic, not dramatically different from the drugs I used when I was a resident nearly forty years ago. I’ve taken many more people off of it that put on it, and nothing was lost by doing that – "off label" uses. I wish I lived in a world where the question of to give or not to give Risperdal never came up, but I don’t. I worry about each of these patients – whether they are on Risperdal, or are on Haldol, or are on no medications at all. It’s easy to talk about flagrant psychosis in the abstract. It’s a different matter up close and personal. Each case is a double bind and deserves its own individual struggle. At least that’s what I think.

These court cases are not about the drug itself. Risperdal has its assets and its liabilities. What’s on trial is that Janssen lied about both, hid the truth on purpose. They gave the impression that Risperdal could be used without the caution and guidelines we’d learned to exercise with the older antipsychotics. While the dangers were different, they were no less problematic, and for some, worse. The specter of Tardive Dyskinesia is still in the picture, but there’s the added chance for a metabolic syndrome that is only now as apparent as it needed to be on the day the drug was released.

In psychiatry, we don’t have casual medications. The anti-anxiety medications [Benzodiazepines] are addicting – effective but for short-term use only. The tricyclic anti-depressants are effective, but dangerous in overdose – a real possibility in depressed people. The SSRI/SNRI drugs are effective sometimes, but have the up-front problem of akisthisia and the possibility of a prolonged withdrawal syndromes. The anti-psychotics can cause irreversable neurological and/or metabolic illnesses. Stimulants can cause psychosis in overdose. Each class of medications can be useful, but there’s always a trade-off and each bears close scrutiny in practice. None of these medications are headed for OTC status; none should be blockbusters [yet they are]; none should be advertised direct to consumer [yet they are].

If I were to be asked personally what’s wrong with this story? I think I would point my finger at the organized medical profession itself, psychiatry in the specific. In my lifetime, things have changed. As a young physician, I could look to academic medicine and our medical literature for answers about the safety and efficacy of medications. Drug Reps have hyped their wares since the dawn of time. The glossy ads have always been advertisements with adverse effects in small print like the mumbled dangers at the end of the current television ask your doctor ads. But the articles in the Journals weren’t like that, nor were the conferences that we all attended to "keep up." That has changed, and the only people who can change that are the physicians who run our psychiatry departments, who edit our journals, who act as our sources for ongoing medical education. That’s actually the only solution and it will require two things – a clean break with the pharmaceutical industry, and a source of alternative funding to replace their thirty years of bank-rolling. There’s really nothing else to say about that. In fact, that’s where the States’ winnings in these court caes really ought to go…
  1.  
    Melody
    April 8, 2012 | 8:53 AM
     

    Mickey—

    I read your articles daily. I think the reason is two-fold: I have my own mental health issues, and a number of years ago, my husband (a long-time T1 diabetic) faced a treatment crisis. At the time, he was finding a way through the evolving medical establishment to maintain a treatment regime that worked for him. And, at the time, we arrived at the same conclusion you did, albeit from a different viewpoint. “. . . the only people who can change that are the physicians who run . . . departments, who edit our journals and who act as our sources for ongoing medical education.”

    When genetically-engineered insulin was being hyped as the latest-greatest, it was astounding the number of endo’s who eagerly jumped on the bandwagon. Instead of advocating for patients who had decades of successful maintenance/treatment with natural products, the treatment paradigm swiftly changed to embrace Pharma’s new model. Labile, unpredictable (and lightly-tested) insulins became the norm; testing became the new buzzword—and surprisingly (or not) the onus was shifted to the patient. While patients were encouraged to test and test often, they were given suboptimal testing equipment, and blamed when their ‘numbers’ were out-of-line. The doctors (from where we were viewing the situation) never stepped up to the plate to question the “new” insulin-like products; nor did they insist on refinement and accuracy of testing equipment. Instead the asymmetrical dissemination of information left the PATIENT chasing his tail—dealing with a new insulin regime, equipment that (oftentimes) presented inaccurate criteria for managing his disease, and medical professionals who were poster boys and girls for Pharma. Never could the patient be ‘right’; instead he wasn’t trying hard enough, he wasn’t compliant, he must trust his equipment/insulin/doctor—not his body. [If the doctors who were hawking the latest and greatest had seen the trials that brought FDA approval for synthetic insulins—information that should have been provided to them, as you say, by THEIR educators (department chairs, editors, CME programmers)—they would have advocated for their own patients instead of BigPharma.]

    I read your articles not only for the psychiatric information, but because your ‘insider’ (physician) recognition of the failings of psychiatric leaders parallels what we have found in another, different slice of medicine. All those years ago, we came to the conclusion that no one could effect the changes that we felt diabetics needed EXCEPT the physicians who were charged with getting medication and equipment into the hands of the patient—and most were unwilling to question the corporate masters who were profiting so handsomely by exploiting not only patients, but the doctors who provided that interface.

    Thanks for all your writing; it’s interesting to see the parallels between different areas of medicine. BigPharma encountered a few bumps in laying out the roadmap to profits, but once they learned how to deal with those bumps, they let nothing (not patients, not doctors, not public trust of the profession) get in the way of those profits.

  2.  
    April 8, 2012 | 10:41 AM
     

    Keep on keeping us posted.
    I heard J&J had up to 400 suits and Lilly 38 Zyprexa suits?
    I have to pinch myself,to wrap my mind around how Eli Lilly made $65 billion on Zyprexa!
    -Daniel Haszard Bangor Maine,4 year off label prescribed Zyprexa user who got diabetes from it.

  3.  
    April 8, 2012 | 3:32 PM
     

    “…the only people who can change that are the physicians who run our psychiatry departments, who edit our journals, who act as our sources for ongoing medical education.”

    Yes, and those other physicians who do everything they can to hold the culprits’ feet to the fire. Thanks so much for doing your part, Dr. Mickey.

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