That's the question that senior staff writer for the
Journal of the American Medical
Association (JAMA) Mike Mitka is asking:
Should the FDA be approving drugs (especially those that represent new classes of medications) that satisfy established surrogate markers without
demanding immediate postmarketing studies to prove clinical effectiveness? Why are physicians continuing to prescribe a drug whose clinical
effectiveness has yet to be shown? And why are not more patients receiving niacin, with its proven effectiveness as an adjunct therapy to
statins?
About time, right?
This release was preceded and likely instigated by the release of a
study in the New
England Journal of Medicine (NEJM):
Conclusions This comparative-effectiveness trial shows that the use of extended-release niacin causes a significant regression of carotid
intima–media thickness when combined with a statin and that niacin is superior to ezetimibe.
In fact, atherosclerosis increased in the ezetimibe group.
Now, if that's not enough for you, take note that there were two other studies published in 2008 conclusively demonstrating that ezetimibe has no
effect on atherosclerosis or heart attacks, despite lowering LDL-cholesterol. Found
here and
here.
You might be wondering what
ezetimibe is.... Well, Ezetimibe is a drug used to control cholesterol
levels when statins alone can't do the job. It's also known as
Zetia
Now, think back to the early 2000's when a nice little arthritis drug called
Vioxx was
withdrawn, inciting further investigation that led to the findings that Merck had known for 4 years of the deadly side-effects (heart attacks) that
it's product caused and yet still kept it on the market. Remember?
Well, Zetia happens to be a Merck product!
No big deal, right?
.....Until you consider the fact that the FDA approved Zetia (Ezetimibe) in 2002, merely 3 years before the first large outcome clinical trials began,
the results of which will be available in 2015.
There are so many problems here...
It's great that writers in these medical journals are starting to get it. They're realizing that simply lowering cholesterol or lowering LDL isn't
good enough. Great news.
My questions, however, are:
1) Why the hell is a drug that has been shown to be ineffective in clincal trials (especially compared to a vitamin) still being prescribed?
2) Why the hell is MERCK (given it's history), or any pharma company, given the green light on drugs
before conclusive trials are
conducted?
-Dev
Other Sources:
blog.cholesterol-and-health.com...
www.cholesterol-and-health.com...
www.drugs.com...