David Kessler’s expert report is as damaging as Rothman’s from the earlier Texas Trial. Here’s just a paragraph from an Excerpta Medica document presented to Janssen in 2003:
The original article [Abstract below] doesn’t mention Tim Coffey anywhere. This list of articles are the influential articles that launched Risperdal’s wide use. Note that the Aman article was the version 1 that later became Biederman’s Bipolar Child article in version 2. Excerpta Medica was essentially Janssen’s ghost-writing factory [among other things]:
Risperidone in the treatment of schizophrenia
by Marder SR and Meibach RC
American Journal of Psychiatry. 1994 151[6]:825-35.
OBJECTIVE: The purpose of this study was to investigate the safety and efficacy of risperidone in the treatment of schizophrenic patients and determine its optimal dose.
METHOD: This double-blind study included 388 schizophrenic patients drawn from 20 sites in the United States. Patients were randomly assigned to 8 weeks’ treatment with placebo, one of four doses of risperidone [2, 6, 10, or 16 mg], or 20 mg of haloperidol daily.
RESULTS: Clinical improvement [20% reduction in total scores on the Positive and Negative Syndrome Scale for Schizophrenia] at the study end point was shown by 35% of the patients receiving 2 mg of risperidone, 57% receiving 6 mg, 40% receiving 10 mg, and 51% receiving 16 mg; and by 30% receiving haloperidol and 22% receiving placebo. Statistically significant differences in clinical improvement were found between 6 and 16 mg of risperidone versus placebo and versus haloperidol. Positive symptom scores were significantly lower after 6, 10, and 16 mg of risperidone and 20 mg of haloperidol than placebo; negative symptom scores, however, were reduced significantly, compared with placebo, only after 6 and 16 mg of risperidone. The incidence of extra-pyramidal side effects [measured by the Extrapyramidal Symptom Rating Scale] was significantly higher in patients treated with 16 mg of risperidone or 20 mg of haloperidol than placebo. The results indicate that the optimal daily dose of risperidone for most schizophrenic patients in this study was 6 mg; this dose was as effective as 16 mg, and the incidence of extrapyramidal symptoms in patients receiving 6 mg of risperidone was no higher than that in patients receiving placebo.
CONCLUSIONS: Risperidone is a safe antipsychotic that is effective against both the positive and negative symptoms of schizophrenia.
We’re so used to this stuff we forget how devious it really is. I vaguely recall reading this article one day at lunch in my office. I doubt that I even knew it was industry financed and at that time, I’m sure that I didn’t know it was ghost-written, because I didn’t know such things happened in our peer-reviewed literature. I thought Marder and Meibach were two researchers who were telling me about a new drug on the market. I think I commented something like "Looks like they’ve finally got a neuroleptic that isn’t so toxic, something people can actually take." In those days, I saw the American Journal of Psychiatry as the most reliable of sources. And when you’re a doctor, since the drugs you learned about in medical school or later in residency are soon ancient history, you have required CME [Continuing Medical Education] to make sure you stay up to speed. And like a good neighbor, Excerpta Medica was there:
And this isn’t so very comforting either:
I don’t want to be overly self-referential here, but the chump in this story is yours truly. And it’s me that Excerpta Medica is flooding:
And so to my favorite literary reference from Joseph Heller’s Catch-22. Yossarian is a gunner in a World War II bomber and is talking about the anti-aircraft fire when he’s on a bombing run:
Yossarian: Those bastards are trying to kill me.
Milo Minderbinder: No one is trying to kill you sweetheart. Now eat your dessert like a good boy.
Yossarian: Oh yeah? Then why are they shooting at me Milo?
Dobbs: They’re shooting at everyone Yossarian.
Yossarian: And what difference does that make?
Dobbs: Look Yossarian, suppose, I mean just suppose everyone thought the same way you do.
Yossarian: Then I’d be a damn fool to think any different.
Milo Minderbinder: No one is trying to kill you sweetheart. Now eat your dessert like a good boy.
Yossarian: Oh yeah? Then why are they shooting at me Milo?
Dobbs: They’re shooting at everyone Yossarian.
Yossarian: And what difference does that make?
Dobbs: Look Yossarian, suppose, I mean just suppose everyone thought the same way you do.
Yossarian: Then I’d be a damn fool to think any different.
More to the point, they were shooting at you too. They stepped out of their role as a vendor in the world of medicine, and found a way to infiltrate the role of the director of medical care – a way to manipulate both me and you, and for a time, we fell for it. Many still are falling for it…
And here’s one for the road:
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