Lipitor, a cholesterol lowering statin drug, is the best selling medication of all time. One year 9 billion dollar’s worth was sold in the US alone. Now it is more like 7 billion per year (source: Los Angeles Times May 4, 2011) because a bunch of copy cat drugs were rolled out to hone in on such financial largesse. (Crestor, Zetia and Zocor to mention the brand names of 3 of the 6 other statins.) The point is, there is a lot of money involved in anything having to do with statins.
All the statin drugs lower cholesterol but in slightly different ways. The key to their success is buying into the theory that lowering cholesterol reduces heart disease.
Recently my friend, Basil sent me an e-mail, “There is a small but growing school of thought that rejects the high cholesterol-heart disease hypothesis. High cholesterol may not cause CVD (cardiovascular disease),” he wrote. “They were talking about it on that silly Dr. Oz show. You should write about that.”
Okay. I will though I will disclose that my temporarily crippled assistant, Tania, has been spending a lot of time recently deepening her relationship with Dr. Oz and she describes him more as “almost cute”.
An interesting study completed in 2006 on two popular statins, Vytorin (Simvastatin) and Zetia (Ezetimibe) changed the conversation about cholesterol lowering. Both drugs successfully lowered cholesterol however, the study (sponsored by the drugs’ manufacturers Merck and Schering-Plough) found the medications did not prevent heart attacks or other life-threatening events. There was actually no benefit from taking them. (See: The New York Times, Jan 14, 2008, “Drug has no benefit in trial, makers say”.) This four year long, multicenter trial of Simvastatin and Ezetimibe in Aortic Stenosis (SEAS), found the rate of congestive heart failure, stroke and cancer actually went UP when people took these two drugs together though in people who already had symptomatic aortic stenosis, ischemic events decreased (“Intensive Lipid Lowering with Simvastatin and Ezetimibe in Aortic Stenosis,” A.B. Rossebo, et al, NEJM, 2008, 359.)
Dr. Terje R. Pedersen, chairman of the SEAS trial summarized the findings by calling the drug combination “safe and well tolerated”. (http://www.internalmedicinenews.com/specialty-focus/cardiovascular-disease/single-article-page/major-cv-events-not-decreased-with-vytorin/033eb84c9a.html). Yeah, but they do not do help prevent disease and may, in point of fact, increase one’s chance of having a stroke or heart attack. Nobody will be surprised to hear that the study was misplaced for a couple of years. There is an ongoing investigation on how that could have happened. Do not expect results any time before hell freezes over.
Confusion and debate commenced and nothing changed. Both drugs still enjoy robust sales because the important point the manufacturers want doctors to remember is that the drugs lower cholesterol. Which brings us to Basil’s point. Maybe high cholesterol levels are not the risk factor for heart disease that they are believed to be.
The quiet truth is that the big difference between Zetia and the other statin drugs is that Zetia lacks anti-inflammation properties. All it does is lower blood cholesterol levels. Most of the other statins have mild anti-inflammatory properties. Mounting evidence suggests that high inflammation not high cholesterol may be what is increasing heart attack risk. It just happens that inflammation goes down as a secondary side effect of the cholesterol lowering process.
When you think about it, lowering inflammation as the mode of action makes much more sense than lowering cholesterol. For one thing, if lowering cholesterol is so important, why have heart attack rates barely dropped even though practically everyone you know over 50 takes a statin drug? Heart attacks and heart disease statistics have changed little since the massive and pervasive use of cholesterol lowering therapies.
The cover story for the May 2011 Harvard Heart Letter announced, “Gloomy forecast on heart disease”. The article goes on to say the American Heart Association predicts heart disease will increase 17% and heart failure and stroke will go up by 25% each over the next 20 years. They recommend avoiding tobacco, exercising, maintaining an ideal weight, managing stress and eating better. These are all life style choices that lower inflammation. Only one (healthy eating) might lower cholesterol.
Of course, lowering inflammation requires lots of work on your part while taking a statin drug only gives your wallet a work-out. I predict you will not hear much about the doubts surrounding the effectiveness of statin drugs until October. Actually, you do not need a Nostradamus level of psychic ability to predict that sometime this fall there will suddenly be many reports on how researchers now know it was not the cholesterol lowering properties of Lipitor that helped the heart but its mild anti-inflammatory properties. (We actually already know this.)
Why will this hot news story break in the fall? Because Lipitor goes off patent in November and the 7 billion dollar a year cash cow is about to become hamburger. Generic drug manufacturers will be able to crank out the thing at a tenth of the cost. Seniors on restricted incomes will finally be able to save lots of money on medication but what’s this? They no longer need their statins?
That’s right. I can see the headlines now, “New anti-inflammatory drug slashes heart attack rates.” I think they should call it, Inflamator.