I was reading the business section of my Metro paper this morning and noticed that Johnson & Johnson was subpoenaed in Boston, San Francisco, and Philly. According to the Associated Press, it is in relation to “sales and marketing of three drugs.” The drugs? Risperdal, Topamax and Natrecor. Risperdal is used for schizophrenia and bipolar mania, Topamax is an epilepsy drug (if not approved for bipolar use, probably used off-label for that purpose), and Natrecor is used for patients with heart disease.
The latest subpoenas seek information about the corporate supervision and oversight of J&J’s Janssen, Ortho-McNeil and Scios subsidiaries, which sell the drugs, J&J said.
J&J posted Risperdal sales of $4.18 billion last year, an 18 per cent increase from 2005. In November 2005, Janssen received a subpoena from the U.S. Attorney’s Office in Philadelphia seeking information about Risperdal marketing and adverse reactions to the drug.
Topamax sales were $2.03 billion last year, a 21 per cent increase from 2005. Ortho-McNeil received a subpoena from the U.S. Attorney’s Office in Boston in December 2003 seeking documents relating to the drug’s marketing, including alleged “off-label” marketing, J&J said in the SEC filing. Doctors often prescribe drugs for uses not described on U.S. Food and Drug Administration-approved labels, but pharmaceutical companies cannot market products for off-label usage.
Do we have another Zyprexa case on our hands?
Between the Risperdal investigations, the Zyprexa lawsuits, the Seroquel lawsuits, BMS’s recent mysterious settlement with the US Attorney in New Jersey (it’s not clear if that was related to Abilify, but I bet it was), plus the pending Congressional investigation of Zyprexa and Seroquel, it looks like the wonder drugs are in a world of trouble. In my adult life, I cannot recall a class of drugs that have ended up in such a pickle before. Nor have I seen such a class of drugs that were once touted as cures turn into such duds. The whole thing is just weird.
The wonder drugs are probably in trouble, but they won’t get pulled off the market and I doubt they’ll get more coverage than how the situation affects the company’s stocks. (This is one area where I’d like to be wrong.) But I agree with Dawdy’s assessment that a class of drugs have never been more criticized than atypicals. There have been individual instances of investigations within a class of drugs, but not a whole slew of them. What leads companies to shady practices in this area when it comes to mental health? Perhaps it’s because the drugs have not been conclusively proven to be the savior they are touted as. Or maybe it’s because the hypotheses – that’s really what the explanations of how these drugs work are – have enough of an effect from clinical trials to market and make a substantial profit. I’d venture to say that psych drugs are the only class of drugs that are marketed based on hypothesis only and not conclusive evidence.
Read more at Furious Seasons.