Pharma is pretty funny sometimes. They have manufactured a 20 billion-dollar-a-year market on data that would normally get laughed out of a scientific conference in any other area of medicine. Now with major patents expiring on their statin cash cows, their next move to keep the gravy train rolling is called “combination therapies.” This means you take two drugs that have been around forever and put them in the same pill so you can call it something new, get a new FDA approval, and charge big bucks. This week the first big studies on combination therapies came out in the prestigious New England Journal of Medicine, and their comedic value didn’t disappoint. For our clinic, these results are important because they provide reassurance that the barely there effects of these drugs won’t be missed by patients when we have to stop them before a stem cell procedure.
You would think from all of the slick Madison Avenue marketing that these drugs are a modern miracle, saving lives left and right. You would be wrong. The absolute effects of these drugs in patients with known heart disease is a measly 1% reduction in the risk of dying from a heart attack. If you include patients who don’t have heart disease, the results get worse. However, the biggest market for pharma is people who aren’t sick, as this group vastly outnumbers those who have heart disease.
Cholesterol-lowering drugs are in a family of medications called “statins.” What’s the relationship between statins and stem cells? We’ve known for a long time that cholesterol-lowering drugs hurt adult stem cells, a fact recently confirmed through in vitro research. Hence, we routinely take our patients off of these drugs before a stem cell procedure. However, when we do that, sometimes we get flack from family doctors who think that these drugs are substantially reducing their patient’s risk of a heart attack or stroke. So if the ability of these drugs to lower heart disease and stroke risk is substantial, then we shouldn’t take patients off; if it’s tiny, we shouldn’t hesitate.
So let’s look at how well these new combination medications work. The two new studies tested Crestor alone in patients without known heart disease and then Crestor in combination with a blood-pressure-lowering drug in similar patients who had high blood pressure. These were massive studies with more than twelve thousand otherwise healthy patients each.
Before we begin, you should know that cholesterol drug makers love to publish reductions in “relative risk,” which means they take a percentage of a percentage to try and make the measly impacts of these drugs look big. Most physicians who read the drug brochures never look to see if these results are clinically meaningful—they just start prescribing. So we’ll focus our attention on how much the drugs reduced the absolute risk (the original percentage) of a fatal heart attack.
In these two new studies, much fanfare is spent on the fact that the drugs lowered cholesterol and blood pressure, which is meaningless unless they also significantly lowered the risk of dying, which is why these drugs are being prescribed. The fact that the study authors put this information up front is usually a “dead” giveaway that the data on reducing actual heart attacks and strokes is weak. How weak? One number stands out. If you take these side-effect-laden medications for more than five years, you can expect a lousy 0.3% reduction in your risk of dying from a heart attack! Huh? Who in their right mind would ever take these drugs for that type of effect? However, you can bet that AstraZeneca will only ever show prescribing physicians the relative risk reduction (the percentage of a percentage that magnifies this effect). However, even that number is a measly 11% reduction in risk!
The rest of the data is equally poor. By taking these two drugs for more than half a decade, you have a reduced risk of 0.4% for a nonfatal heart attack, 0.5% for a stroke, and 0.2% for heart failure! Most importantly your lowered risk of dying from anything is only 0.3%!! No matter how you cut it, these statistically significant reductions in dying from a heart attack, getting a stroke, or dying are clinically meaningless!
In no other area of medicine outside of the huge pharma biz of cholesterol and blood pressure drugs would this study be allowed to be published with the conclusion, “There was a significant reduction in the risk of cardiovascular events with the use of rosuvastatin (Crestor).” The really bad data at least would prompt the journal to demand that this statement be changed to something like this: “While there was a significant reduction in the risk of cardiovascular events with the use of rosuvastatin, the clinical significance of these reduced risks is questionable.”
While the sketchy results should prompt a scientific reappraisal of our use of cholesterol drugs, you can bet that instead they will be used to produce national guidelines that further expand the number of people who should be using this product. How could it be that pharma was even able to get an unsupported conclusion like this published in the New England Journal of Medicine? Look no further than a former editor of the New England Journal of Medicine, Marcia Angell, MD.
I’ve already discussed the fact that cholesterol-lowering drugs hurt adult stem cells. In addition, they can cause a serious disabling and even life-threatening muscle disease (my own aunt was hospitalized for this one). Finally, they can cause serious cognitive problems in older patients and other side effects.
The upshot? In any other area of medicine, effect sizes like these would be considered a good cocktail-party joke. Instead, in our pharma-funded world of heart disease and stroke prevention, they fuel national guidelines created by university professors on the pharma dole. Bottom line, the protective effects of these drugs are only slightly better than chance! Hence, taking patients without known heart disease off of these drugs is unlikely to change much with regard to heart disease or stroke risk!
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About the Author
Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…