Steve Nissen goes 0 for 2

An FDA advisory panel has ''unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis, on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users,'' Dow Jones Newswires linkurl:reported;http://online.wsj.com/article/SB118174200915533871.html yesterday. That means it's at least the second time in under a year that Steven Nissen has been wrong about the promise of new drugs. Nissen, of course, is the well-known Cleveland Clinic ca

By | June 14, 2007

An FDA advisory panel has ''unanimously rejected Acomplia, a weight-loss drug from Sanofi-Aventis, on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users,'' Dow Jones Newswires linkurl:reported;http://online.wsj.com/article/SB118174200915533871.html yesterday. That means it's at least the second time in under a year that Steven Nissen has been wrong about the promise of new drugs. Nissen, of course, is the well-known Cleveland Clinic cardiologist whose efforts were largely responsible for toppling Vioxx, and he just co-authored a linkurl:NEJM study;http://content.nejm.org/cgi/content/full/NEJMoa072761 raising serious doubts about Avandia. Nissen had something to do with the Acomplia trials, too. In October, I moderated a linkurl:panel;http://www.healthjournalism.org/secondarypage-details.php?id=51 at a regional meeting of the Association of Health Care Journalists in Cleveland. Nissen was among the four panelists. I asked them all in advance to bring story ideas to the panel, since this was a group of journalists. Nissen brought two: Acomplia, which he said was a clever scientific idea and held real promise, and CETP inhibitors such as Pfizer's torcetrapib, data on which he said would be hitting his desk in about six weeks. The idea behind Acomplia is to block the receptors that make you hungry when you smoke marijuana -- not just when you're smoking pot, but all the time, as a weight loss strategy. CETP inhibitors, as you'll recall, are designed to raise HDL levels -- a sort of holy grail of the pharmaceutical industry, which has thus far only been able to come up with drugs that raise LDL. He was quite excited about both drugs, and was involved in trials of both at the time, which he disclosed. That was Friday, October 27. On Monday, October 30, Dow Jones reported that Pfizer had announced that torcetrapib raised blood pressure in patients taking it. That's a bad side effect in patients who, because they have low HDL levels, are by definition already at risk for heart attacks. Tuesday morning, the New York Times website ran linkurl:a story;http://www.nytimes.com/2006/11/01/business/01pfizer.html quoting Nissen saying ''the increase was clinically meaningful and would raise the hurdles for the drug?s approval.'' Pfizer stopped the trials of torcetrapib in early December. And now, it turns out, Nissen's optimism on Acomplia was similarly misplaced. The FDA had given Sanofi-Aventis an linkurl:approvable letter;http://pipeline.corante.com/archives/2006/02/20/rimonabant_bangs_into_something.php for Acomplia in February 2006. Such letters often lay out concerns the FDA needs to see addressed before approving a drug, but the company hasn?t made the letter public, so I don't know whether Nissen ever saw it, or knew about the concerns. I certainly appreciate that new data can change someone's opinion. In fact, I applaud Nissen for not being too rigid when it came to torcetrapib. But I think it's worth noting the record of someone whose pronouncements on drugs are so linkurl:often held up;http://online.wsj.com/article/SB113979871583172131.html?mod=health_hs_pharmaceuticals_biotech by drug industry critics and that make media headlines.

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