Atypicals Are Lousy For Schizophrenia, Bipolar Disorder

As I mentioned on Friday, the British press was alive with news of a study in the Archives of General Psychiatry in which British researchers claim that there is fundamentally no difference in patient outcomes between patients with schizophrenia who took either a first-generation antipsychotic or a second-generation antipsychotic (the atypicals). Why the Brit press just caught on to all of this when the study was published 7 weeks ago is beyond me. Not that the American media has done such a grand job with reporting this study.

I need to caution that I have not seen the paper in full yet (anyone want to send it to me?), so it is difficult for me to know exactly how they measured quality of life for patients and so on. But from the abstract and press accounts of the study (also here), it is clear to me that even the researchers were surprised by this outcome. In fact, they went back and ran their data again just to be sure.

I am not entirely sure which second-generation meds were used, but I know that Seroquel was among them (sulpiride was the first-generation drug used). This is now the third study in about a year to knockdown the prevailing orthodoxy that atypicals reduce symptoms better than first-generation antipsychotics and that the atypicals are so kinder and gentler with the side effects. I have discussed the CATIE study here and here.

All of these studies combined raise serious questions. Here are a few:

Why do pharma companies continue to charge anywhere from 8 to 20 times as much for atypicals as they do for older antipsychotics? Because they can and no one will question them on it.

Why do doctors continue to insist, in the face of compelling data, that atypicals are great? Because they can and no one will question them on it.

Why did NAMI National put out a press release and organize a teleconference for reporters soon after this Archives of General Psychiatry study called the status of atypicals into account? Because they can and no one will question them on it. And, NAMI National gets a lot of money each year from pharma companies. Any connection?

Why have these same atypicals suddenly become frontline treatments in treating bipolar disorder, despite a profound lack of independent evidence showing that these meds are good for schizophrenics and that those poor folks can barely tolerate taking them? Why would they suddenly become so "good" for bipolars? Hell, they don't even reduce re-hospitalization rates compared to only taking a mood stabilizer. Bipolars don't particularly fancy these meds, either, as I pointed out last year.

Why are we now giving them to children? Why are their parents going along for the ride?

Why has this gone down with such little public questioning or accountability among federal regulators, mental health advocates, the entire psychiatric profession and the media?

Why is there so much silence on this matter?

Well, fuck this silence. It's time for bullshit to be called on using atypicals in schizophrenia and bipolar disorder and all the other maladies of the mind and soul that the pharma companies want them to be used for. Bullshit. There I said it. (Actually, I've been saying it for over a year, for example in this post and in this long-winded article I wrote in my former employer's paper.)

Here, the head of the British research team, Shon Lewis, offers some thoughts to the BBC:

"Despite modern prescribing patterns, second-generation anti-psychotics are not the great breakthrough they were once thought to be--and certainly may not justify their 10-times higher price tag."

Change that "may" to "can." Still, Lewis gets points for honesty.

British advocacy groups are taking the same stance NAMI National took in October. From the BBC:

"Marjorie Wallace, chief executive of the mental health charity SANE, warned it would be wrong to limit accessibility to news anti-psychotics. 'What we hope is that the study will flag up the importance of patients being able to look at the risks and benefits of different drugs, matched to their own biochemistry, and that it will encourage the pharmaceutical companies in their current research to develop third-generation medications'."

Um, whatever. NAMI National's medical director, Ken Duckworth, said this back then:

"General findings cannot be substituted for specific choices made in treating individuals with schizophrenia. One size does not fit all. It is critical that the study's limitations be recognized."

Why do groups like NAMI never recognize the limitations of pharma-funded studies that are used to justify using atypicals and licensing in the first place? Why is it that in many of those studies, you'll find huge dropout rates among participants and that for those who stick out the entire study that only about half the patients see any real benefit? Sounds pretty limited to me.

And why aren't the NAMIs of the world bothered by the fact that in the US 90 percent of the antipsychotics prescribed are atypicals? Who does this group really represent?

In October, NAMI National criticized the British study for not being useful in American medical circles because:

"The British study relies heavily on an older drug, sulpiride that has never been approved by the Food & Drug Administration (FDA) and is unavailable in the United States."

At the time, I let that assessment slip, but now it bugs me. Why? Because sulpiride is off-patent, so why would any pharma comapny go to the expense of getting it licensed in the States? And, because sulpiride is a kissing cousin of other antipsychotics like amisulpride. For all I know, it's like Haldol, too.

But, then, there's plenty of truth evasion going on outthere. A reporter at The Guardian called AstraZeneca for comment on the British study. Here's what the reporter got:

"A spokesman for AstraZeneca, which manufactures the second generation drug quetiapine, said the study did not measure the effectiveness of individual drugs and that quality of life in schizophrenic patients was difficult to measure."

Quality of life is hard to measure? Oh, please. That's about as bad as last year when, soon after the CATIE study came out, a couple of researchers at Eli Lilly published a paper claiming that the patients were at fault for not taking their Zyprexa properly. (Sadly, I cannot find that Eli Lilly paper at the moment. But I will. :))

So I wonder if this chap at AZ could go check his calendar, find an afternoon when he's free, and then go fuck himself.

God knows that first generation antipsychotics are nasty drugs, chock-full of zombieism-inducing side-effects. I am not against using atypicals and I am not in favor of restricting their access to patients, provided that said patient actually benefits from the drug. I am against the American public being ripped off for their cost. And, I am decidedly against their use as a long-term maintenance medication in bipolar disorder. I have noted before that I have no problem using them to address short-term crises. But using them day-in, day-out for years and years is without justification, in children, teens and adults.

I think this British study is a huge wake-up call for patients, doctors, the media and advocates. Are they listening? (OK, the New York Times seems to be waking up.)

Posted by Philip Dawdy at November 27, 2006 12:38 AM
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