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On Tuesday I posted about Wyeth/Solvay's subtle bifeprunox advertisement masquerading as a CME activity in Psychiatric Times. Their karma has caught up with them, as the FDA just rejected their application for approval of the new antipsychotic.
According to reports, FDA was unimpressed with two acute-treatment controlled studies, both of which showed that bifeprunox performed more poorly than existing atypicals. You can read a review of these efficacy trials here. One study compared bifeprunox 20 mg/day with risperidone 6 mg/day. After 6 weeks, bifeprunox lowered PANSS scores by 11.3, wherease risperidone posted a more robust symptom reduction of 15.6 (statistical significance was not reported). In a second study, bifeprunox with slammed even more harshly by Zyprexa (olanzapine). Also a 6-week study, bifeprunox 20 mg/day yielded a PANSS improvement of 13.8 vs. Zyprexa 15 mg/day's 22.0. In that trial, only Zyprexa significantly separated from placebo.
As a psychiatrist, I'm not too disappointed, because bifeprunox is essentially a me-too version of Abilify (aripiprazole). Like Abilify, bifeprunox is a partial dopamine receptor agonist, meaning that it can either block or stimulate dopamine receptors. Thus, bifeprunox appears to be a less effective version of Abilify (though no head to head trials have been reported). We don't need it.
The supplement to the latest issue of Psychiatric Times is yet another variation on the use of CME to promote products. Entitled "Reaching New Heights in the Management of Schizophrenia: Current and Emerging Therapies," it is supported by Solvay and Wyeth Pharmaceuticals. It is based on an industry-sponsored symposium given at the 2006 U.S. Psychiatric Congress, and you can view a video of that symposium here.
If you casually read through this article, which is designated for 1.5 AMA PRA Category 1 Credits, you get the sense that it doesn't endorse the use of any particular antipsychotic. In fact, the first part of the article reviews the confusing array of recent studies, with names like the CAFE studies, the CATIE trials, and the CUTLASS trial, and seems to conclude that it's hard to draw any firm conclusions. Next, there's a robust section on "Safety and Tolerability," focusing on the metabolic disadvantages of Zyprexa and Seroquel, but also touching on the prolactin-raising disadvantage of Risperdal, and the EPS liabilities of first generation antipsychotics.
If there is any obvious conclusion here, it is that current treatments have a lot of problems, and that we desperately need something new. Well, just prior to the conclusion there is a section entitled "New Drugs in the Pipeline." And the first non-approved drug mentioned is bifeprunox, which is a me-too knock off of Abilify. Bifeprunox is manufactured by Solvay and will be marketed in the U.S. by Wyeth (read about it here). These are the two companies that paid for the production of this article.
Thus, the promotional logic of this "educational" activity is as follows:
1. Recent studies of antipsychotics yield conflicting findings, and there is no clear winner.
2. There are safety problems with all existing antipsychotics.
3. We need a new medication.
4. That new medication is bifeprunox.
I suggest that the article be slightly re-titled, "Reaching New Heights in the Management of Psychiatic Prescribing: Pre-Release Flimflammery."
On Tuesday I posted about Wyeth/Solvay's subtle bifeprunox advertisement masquerading as a CME activity in Psychiatric Times. Their karma has caught up with them, as the FDA just rejected their application for approval of the new antipsychotic.
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