Should the FDA be Approving Useless No-Evidence Cholesterol-Lowering Drugs?

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Now, think back to the early 2000's when a nice little arthritis drug called Vioxx was withdrawn, inciting further investigation that led to the findings that Merck had known for 4 years of the deadly side-effects (heart attacks) that it's product caused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...

It gets even better when the drug reps give you their spiel. Two weeks ago, I had one from Pfizer visit the ward I'm in pushing the newest iteration of beta-blocker. I glanced at the "study" she was handing out and noticed that the data compared control groups for the new drug to a placebo, control groups for the old drug to a placebo, but never control groups for the new drug to control group for the old drug. When I asked her about this, she said she "wasn't sure why they didn't include that data", but that she would "bring it next time".

This is s standard statistical trick the pharmaceutical companies play, basically gaming the double-blind system, and is why I ALWAYS tell medical students to examine the research from independent labs yourself before prescribing a medication.

reply to post by VneZonyDostupa


Thanks for that tid-bit.

Unfortunately, a simple examination of a study may not be as revealing as one may hope as the prevalence of industry support tends to affect research integrity. Of course, this isn't always the case.

And you brought up a great point about pharmaceutical companies manipulating doctors for profits.

-Dev

[edit on 24-1-2010 by DevolutionEvolvd]

reply to post by DevolutionEvolvd


Oh, I have no doubt the pharmaceutical companies have their hands in a lot of research. Typically, though, if you see many larger universities producing positive research for a class of drugs, they're okay to use. Though, there is always some wiggle room as to whether or not they are more effective than their predecessors. Personally, I haven't found any need to use newer statins. Statins are statins, there is little to no reason to have a patient pay double for something that is functionally the same just to have a new name on the bottle.

reply to post by DevolutionEvolvd


No, they should not.

Yet more drugs. It is all about money - it is always about money, never about people.

This is why marijuana, a drug that can really help people in pain, is illegal.

Because if the people can grow their own, the drug companies do not want to know.

They are in each other's pockets - only money matters.

Maybe they will learn the hard way.

I find it remarkable that the negative stimulus of insulin has the same effect on HMG-CoA reductase as statins. The simple process of lowering insulin and increasing glucagon (done dietarily) will inhibit HMG-CoA, thereby reducing sereum LDL.

-Dev