seroquel XII: an opinionated postscript…

Posted on Monday 14 February 2011

Okay, you win. I’ll say it. No, there was no real reason to approve Seroquel. I didn’t say it because I don’t think I would’ve been able to turn it down myself in 1997. It wasn’t really a different time, but we didn’t know it then. There were Speaker’s Bureaus, and ghost-written articles [and textbooks], conflicts of interest galore, but such things were still under wraps and Psychiatry was in the middle of a tsunami of biology and false hopes – still in the after-glow of the SSRIs and hoping things from the newer drugs. And in 1997, we still believed what we were told. We thought that the Brave New World of Atypical Antipsychotics would liberate our patients from fear of Tardive Dyskinesia.

In 1997, I was practicing in Atlanta, teaching Psychoanalytic Candidates, and doing something like "outreach" – giving talks to Psychologists and Social Workers about Object Relations Theory and Traumatic Neurosis. We have a Psychoanalytic Studies program in the college were I also taught. heady graduate students, heads filled with Lacan. That is to say I no longer had any direct connection with the Psychiatry Department, even though I was on the clinical faculty. I thought the then Chairman, Dr. Charlie Nemeroff, was a self promoter and extremely naive in his blind adherence to some simplistic biological models of illness. By 1997, when he spoke at meetings, I would cut class because … well, I would just cut class. But I had no idea about how much he was in bed with the industry, or about his "poster-child" status , or that he was raking in personal money, or that many of his colleagues were too. I guess I thought he actually believed what sounded to me like drivel. I didn’t know the drivel was a cash cow.

By 1997, most of the public mental health facilities were running on bare bones, and an insurance policy with good coverage was about the only ticket into a hospital – so if you saw a psychotic patient, all you had was medication. The possibility of a medication that didn’t have all the extrapyramidal side effects and the specter of Tardive Dyskinesia would’ve looked mighty good. One line from Dr. Arvanitis’ papers worked, "Clinically significant weight gain, which was associated with SEROQUEL treatment, is often seen during treatment with antipsychotic agents." It was true. The other line, by the way, didn’t work, "In any case, weight gain over a 6-week period may or may not be clinically significant given that it may be a function of well-being resulting from improvement in psychosis." That was patent b-s at first glance. So I’m not sure that I would’ve realized what I now know – that Seroquel causes WEIGHT GAIN, not weight gain [and by the way again, there was no Trial 0015 to tell me that!].

The thing that haunts me about all of this is that as disgusted as I felt about the modern evidence-based medicine/DSM whichever turn in Psychiatry in 1997, I personally didn’t see all the corruption that now looks so obvious.  That’s one of the reasons I went back over the approval of Seroquel 14 years ago – to prove to myself how deceitful it really was. Back then, had I been on that F.D.A. panel, I may well have said, "No great shakes, but let’s give ’em a shot. If it’s no good, doctors won’t prescribe it and the patients won’t take it." If you had said, "But this is going to be one of the most prescribed and revenue generating drugs in history!"  I wouldn’t have had any idea what you were talking about. And I feel guilty even saying that.

Actually, that thought I think I might’ve thought ["No great shakes, but let’s give ’em a shot. If it’s no good, doctors won’t prescribe it and the patients won’t take it"] turned out to be right. The patients in Trial 0015 did just that – relapsed or stopped taking it. I too believe that Seroquel has a lower incidence of neurological side effects than the other drugs, but I don’t use it for the Schizophrenic patients [Advil has a lower incidence of EPS too, but I don’t use it in Schizophrenia either]. Seroquel doesn’t work well enough to get on my list. In cases where things aren’t desperate, I still try an Atypical first because of EPS/TD, but it often doesn’t get the job done. Seroquel isn’t the one I try. Risperdal is the only one I use because it’s the only one I’ve seen work with my own eyes.

It turns out that all approving Seroquel for Schizophrenia did was get it on the market and open up the doors for off-label use. Primary care Physicians don’t treat Schizophrenia, Psychotic [or profound] Depression, or even Mania. We do. And without outside influence, Seroquel would’ve died a quick death because it’s a weak sister, and because of the weight gain. Those billion dollar revenues come from office Psychiatrists who have drunk the Kool-ade and Primary Care Physicians. The F.D.A. thinks it has recurrently approved a drug to treat severe mental illnesses. What they’ve done is unleash a drug too soft to be usable for its intended patient population into circulation to fill the hole left by an increasing fear of the minor tranquillizers like Valium and its friends [I personally think that Seroquel is far more dangerous].

So, Seroquel was approved on a wish. What should have happened when it became clear that it had a big-time downside? Pull it from circulation. What about the indication creep? Psychiatrists have long used antipsychotics in manic patients or psychotically depressed patients during acute episodes. The F.D.A. didn’t need to be involved with that. We can figure that out all by ourselves. Those were marketing tricks that the F.D.A. should’ve declined. And Depression? Why would a lousy antipsychotic help depressed people? I don’t personally think it actually does any more than an anxiolytic or a sleeping pill might. Nobody’s thinking of submitting a sleeping pill for approval as an "add-on to antidepressants in MDD." That would be as absurd as the Seroquel indication is. I don’t fault the F.D.A. for approving the drug initially. I do question them for not pulling it when Trial 0015 came true. But I do damn the F.D.A. for approving the drug for other things that do nothing but validate off-label advertising and profiteering at the expense of our patients. They’re using F.D.A. approval as a gold-standard for their evidence-based medicine meme. Looking at those Clinical Trials we just reviewed, I didn’t see a whole lot of gold. In my opinion, that’s the place to start the reform movement. Every time I hear something like, "Now approved for augmentation of antidepressant monotherapy in treatment-resistant depression," I feel ashamed that I’m a Psychiatrist…
    February 14, 2011 | 9:31 PM

    Bravo –your last paragraph!! thank you, doctor!

    February 15, 2011 | 12:29 AM

    Thought you might be interested in this recently published study regarding Seroquel and it’s link to weight gain/diabetes…short term study with a limited subject pool…but significant findings?

    February 15, 2011 | 7:35 AM

    I just found your website. It’s like a breath of fresh air. I will continue to read with a glimmer of hope that things may change.

    February 15, 2011 | 8:05 AM

    The information I sent you regarding rDNA insulin reveals the same sort of marketing strategies and indication creep–only it occurred more than a decade earlier. It’s my personal bias that Eli Lilly was the trailblazer for this distorted practice of “discovering” a medicine, and then “discovering” the need.

    February 15, 2011 | 11:00 PM

    Can seroquel induce bipolar delusions? My daughter was being treated for ADHD with bipolar not ruled out it with it and adderall. After 2 hospitalizations they put her back on Depakote with risperdal.

    February 19, 2011 | 11:30 PM

    “…Nobody’s thinking of submitting a sleeping pill for approval as an “add-on to antidepressants in MDD…”

    Guess again:

    February 19, 2011 | 11:36 PM



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