I love this story because it shows how evidence-based medicine works, even in the face of corporate greed.
A while back I told you about a cholesterol study with negative results; that is, it failed to show a drug to be helpful. Intimately entwined with the study design was a potential conflict of interest on the part of the drug company, but science won out—data, after all, is data.
Then, few months ago, another set of (preliminary) cholesterol data was released by Merck and Schering-Plough, after much prodding, regarding their drugs Vytorin and Zetia.
Zetia has been quite popular. A certain number of patients do not tolerate “statin” cholesterol medicines, and are put on Zetia as an alternative. Zetia lowers cholesterol, but it has never been shown to improve important outcomes such as mortality, heart attack, stroke. That isn’t to say it might not do these things, it just hadn’t been studied. Statin cholesterol drugs have been studied, and have an excellent effect on outcomes.
Now, interesting new data is emerging. First, according to a study in the New England Journal of Medicine (NEJM) the companies’ marketing campaign appears to be working, at least in North America. Prescribing patterns have changed, with an increase in Zetia prescribing and in costs.
Second, at last week’s American College of Cardiology (ACC) meeting, more ENHANCE data were released, and consensus crystallized around experts in the field—there is no data to support the use of Zetia or Vytorin to improve important outcomes.
This is very interesting. It has been hypothesized for a number of years that statins do not simply lower cholesterol, but also prevent vascular events by other means, probably by reducing blood-vessel inflammation.
An important piece of information here is that medical science actually works. A hypothesis is formed (based on a scientific idea, and some economic interests), it is tested, and even if it fails, it adds to our knowledge. Huzzah for science! In this case, the use of Zetia will probably change significantly.
A counter example would perhaps be the mercury militia. Several recent studies added to the already conclusive database that thimerosal does not cause autism. Despite this, the wackos insist on looking for some other hidden connections between vaccines and autism, despite this having also been disproved.
A real scientist would say, “hey, I had a hypothesis, it didn’t pan out—I’ll move on to a new hypothesis.” Not so the wackos. They hold onto an idea whether or not there is any rational reason to do so.
Well, at least it gives me something to write about.
Kastelein, J.J., Akdim, F., Stroes, E.S., Zwinderman, A.H., Bots, M.L., Stalenhoef, A.F., Visseren, F.L., Sijbrands, E.J., Trip, M.D., Stein, E.A., Gaudet, D., Duivenvoorden, R., Veltri, E.P., Marais, A.D., de Groot, E. (2008). Simvastatin with or without Ezetimibe in Familial Hypercholesterolemia. New England Journal of Medicine, 358(14), 1431-1443. DOI: 10.1056/NEJMoa0800742
Jackevicius, C.A., Tu, J.V., Ross, J.S., Ko, D.T., Krumholz, H.M. (2008). Use of Ezetimibe in the United States and Canada. New England Journal of Medicine DOI: 10.1056/NEJMsa0801461