Need a Negative Vytorin Quote? Call Dr. Nissen

Anyone who has followed the Vytorin soap opera, from the troubled ENHANCE study to reports of cancer in the SEAS study, can recognize a pattern. Cardiologist Steven Nissen is certainly available to more than one media outlet for more than one derisive, highly quotable quote about the drug, the drug's studies, or the drug's comarketers (Merck and Schering-Plough).

That's not to say that Dr. Nissen isn't entitled to a scathing opinion...or two, or three, or more. However, the subtext of vitriol in these running opinions, as quoted by the media, suggests that Dr. Nissen's thoughts on anything related to Vytorin are informed by something more than dispassionate assessment—at least in my opinion.

For instance:

On the negative results of the simvastatin-controlled ENHANCE study in patients with heterozygous familial hypercholesterolemia (in which a substantial percentage of the carotid-ultrasound data were allegedly missing or of low quality).

To Alex Berenson of the NYT: "Shocking...This is as bad a result for the drug as anybody could have feared."

To CBS News: "My advice to physicians is not to use this drug Vytorin, nor to use Zetia [ezetimibe], as first-line agents any more. These should be really relegated to drugs of last resort, until we have some evidence that they produce a health-outcomes benefit...Right now, 5 years into this, with nearly 1 million prescriptions per week being written, there is no evidence that the drugs actually produce any benefit for patients."

To the Washington Post/HealthDay: "This wraps it up. That's all there is. There just isn't any evidence that adding ezetimibe to simvastain produces any advantage."

To Forbes: "This drug [Vytorin] doesn't work. Period. It just doesn't work."

On the FDA's approval of Vytorin, which was based on a statistically significant 20% lowering of LDL cholesterol, when compared with simvastatin alone. 

To Alex Berenson (again) of the NYT: "The FDA set the bar too low on the initial approval [of Vytorin]. It would have been a lot better if the agency had said, 'Show us that you do more than lower LDL a little bit; show us evidence of effectiveness.'"

On evidence of an increased cancer risk in the SEAS trial and lack thereof in the ongoing studies of SHARP and IMPROVE-IT (background post here).

To Dow Jones Newswires: "Even though they [SHARP and IMPROVE-IT] are shorter," they nearly reached a statistically significant link to cancer. "They definitely do not rule it out."

To Bloomberg: "There is clearly a signal for excess cancer and cancer mortality in SEAS. I do not believe that unblinding 2 incomplete trials to try to refute that signal is scientifically appropriate. The bottom line is we just don't know if ezetimibe is associated with an increased incidence of cancer or cancer mortality."

To Forbes: "What you're seeing here is the behavior of a company that is under siege by the failure to do the right studies. And they're trying to spin the results using media-relations strategies rather than the proper scientific approach...I think those studies [SHARP and IMPROVE-IT] should never have been unblinded. That's very regrettable."

But Dr. Nissen did provide at least one quotable caveat for patients who may act on medical information (or physicians' quotes) in the lay press.

To CBS News: "People should talk to their doctor. No one should stop taking medication because they hear a news report."

2006 photo of Steven Nissen testifying at the Hearing on Building a 21st Century FDA.