Saturday, March 28, 2009

More Ambiguous News for Vytorin/Zetia, and Cancer Incidence Rates. . . .

Marilyn Mann, over at Gooznews has a very careful, cogent review of the latest FDA-reported adverse events SEAS (my error here corrected, by Marilyn Mann's comment below -- do read it, as well) data study -- published in the April issue of the Journal of Clinical Lipidology (by authors, BTW, who report receiving speaking fees and honoraria from Schering-Plough and Merck -- huge surprise, that!), this Saturday afternoon -- do go read it all, but here is a "money" quote:

. . . .it is difficult to see how any particular case of cancer could be definitively connected to ezetimibe even if it turns out that ezetimibe causes cancer or increases the risk of cancer death. Bottom line: if you are worried about the cancer signal in SEAS, this study is unlikely to provide you any comfort. . . . .

Indeed. I am not sure a down-shifted cancer incidence rate is really a "selling point" -- for a cholesterol drug.


Anonymous said...

They're basically saying we'll pull the tobacco litigation defense again.

So what if it causes cancer.

Just try suing. You've got to show that your particular cancer was due to our drug and wouldn't have arisen anyway, or is due to some other cause. We'll fight you over every nickel until after you're dead and buried.

We've done the cost benefit analysis and you'll never hurt us enough to stop killing people. Why just look at Vioxx we sold over $10 billion and only paid $4.8 billion. It was worth it.

Marilyn Mann said...


Thanks for linking to my post. This study was not an analysis of SEAS data, but an analysis of adverse event reports to the FDA. The researchers compared the number of reports of cancer linked with ezetimibe (Zetia) or ezetimibe/simvastatin (Vytorin) with the number linked with three statin drugs. The results did not support the idea that ezetimibe increases cancer incidence.
However, adverse event reports are usually not a very reliable way of determining whether or to what extent a drug causes a particular side effect. This is especially true in the case of a common diagnosis such as cancer.
Picture a 60-year-old woman newly diagnosed with breast cancer, who happens to be taking Vytorin. Will she or her doctor conclude that the Vytorin caused her cancer? Not very likely, since breast cancer is a very common diagnosis in post-menopausal women. In addition, this is not a case where you can stop the medication and observe whether the side effect goes away.

I agree with the commenter that if and when people who have developed cancer while on ezetimibe start suing MSP (or their estate sues, in the case of people who have died), one of MSP's arguments will be that there is no proof that ezetimibe caused that person's cancer, or increased their risk of dying of the cancer. Of course, currently MSP does not concede that ezetimibe increases the risk of cancer or cancer death at all.

As pointed out by the commenter, a similar argument was made with respect to rofecoxib (Vioxx) and heart attacks.


Anonymous said...

FYI -- one and all:

The Sunday NYT has good piece on research showing that statins reduce risk of blood clots, and some updated JUPITER data analysis -- out of the ACC.

Marilyn Mann said...

We're having technical difficulties over at Gooznews. Posts keep disappearing. At the moment, what you get when you click on the link in Condor's post is the draft I sent Merrill, not the final version.

condor said...

I think I fixed the link -- it now anchors to "the Gooz's article perma location" -- now on the front page.

Thanks, as always, Marilyn!