Yet another story about a drug maker getting into trouble for its off-label marketing practices for a psychiatric medication, this time to children and teens. The drugs? Lexapro and its older sibling, Celexa. The manufacturer of them? Forest Laboratories. The New York Times has the story:
In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.
From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.
Ooops! Can’t do that, and of course, drug executives know you can’t do that. So the only question remaining is whether the executives knew what the Justice Department is claiming, and if they have the evidence, well, guess what…
The real interesting story is how we continue to learn about these transgressions by pharmaceutical companies. It’s not through great investigative skills on the part of the government, it’s because employees of the companies charged keep bringing these problems to the government’s attention! If it weren’t for such individuals stepping up and blowing the whistle, it’s likely the transgressions would never see the light of day. Kudos to folks who take such a brave step forward.
But here’s the bizzaro part — one arm of the government has known since 2002 that Celexa had negative findings. Guess which arm?
In 2002, Forest submitted results from Dr. Wagner’s study, which were positive, and those from the Lundbeck study, which were negative, to the F.D.A.
Based on the Lundbeck findings, regulators rejected pediatric approval for Celexa, finding that the report was “a clearly negative study that provides no support for the efficacy of citalopram” in children. The agency, however, did not disclose the study’s results because Forest had submitted them confidentially.[…]
In court papers, prosecutors said that the existence of the Lundbeck study first came to public light when The New York Times published an article about it. Three days after that article was published in June 2004, Forest acknowledged the study as well as an another, earlier trial that also failed to show any benefits of Lexapro as a depression treatment for children.
So even though the U.S. Food and Drug Administration knew in 2002, it took another two years before this information came to the public light. And not because of the government bringing it to light, but because of investigative reporting on the part of the media.
There is no clearer indication that the FDA is terribly broken than by looking at this example. The FDA is supposed to be protecting the public from such behaviors, and instead — because of a confidentiality agreement it apparently was beholden to — it kept this valuable information private. Just truly astounding.
Read the full article: Lexapro Maker Forest Is Accused of Fraud.