Study 113? 245? ERI? Still in the shadows…

Posted on Tuesday 7 June 2011

As with all the psychopharmacology blockbusters in the last twenty-five years, Risperdal [Janssen, Johnson & Johnson, Ortho-McNeil Janssen] was marketed deceptively. In the South Carolina penalty settlement the Judge noted that they had evidence that the manufacturer knew that Risperdal was associated with metabolic side-effects of some magnitude:

I can find no evidence of the studies mentioned above ["RIS USA-113 & 275 & ERI"] even now – they are presumably in the discovery material used in the trial but it’s not posted. Then, when instructed to send a "Dear Doctor" letter about those side effects in 2003, they sent out an advertisement instead:

They are appealing a $257 M settlement in Louisiana and are likely to appeal this $327 M settlement in South Carolina. Meanwhile, they are in negotiations with the Federal Government over a potential $1 B fine for off label-marketing. In November, they go to trial in Texas for an even more damning suit than any of these mentioned so far – manipulating the State by essentially bribing State and University officials to approve their drug for its Medicaid and other public medication programs, and then proselytizing the program to other States:

The period in which they had data confirming the metabolic problems and kept the studies hidden is colored in [1999-2009] and the place where they sent the non-warning "Dear Doctor" letter is marked [2003]. How hard is it to guess at their motives for secrecy, for defying the FDA? And how hard is it now to figure out why they were willing to risk losing these suits? Pocket-change…

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