A recent Cochrane review of the use of cholesterol-lowering statin drugs in primary prevention has sparked some controversy. The controversy is not so much over what the data says, but in what conclusions to draw from the data.
Statin drugs have been surrounded by controversy for a number of reasons. On the one hand they demonstrably lower cholesterol, and the evidence has shown that they also reduce the incidence of heart attacks and strokes. The data on whether or not they reduce mortality has been less clear, although this latest data actually supports that claim. However, statins have also been blockbuster drugs for pharmaceutical companies and this has spawned concerns (some might say paranoia) that drug companies are pushing billions of dollars worth of marginally effective drugs onto the public.
So are statins a savior or a scam? Life does not always provide nice clean answers to such simple dichotomies. The evidence clearly shows that statins work and are safe. However, pharmaceutical companies do like to present their data in the best light possible, and they need to be watched closely for this. The recent review does call them on some practices that might tend to exaggerate the utility of statins. Finally, the real question comes down to – where should we draw the line in terms of cost-benefit of a preventive measure like statins.
Let’s look as this recent review of the data to see what it actually shows.
Happy April Fool’s Day everyone. Here’s a cartoon that I made a few years back… Enjoy!
The Medical Letter, a highly respected source of reliable independent evaluations of drugs and therapeutics, has just published an evaluation of red yeast rice (Vol 51, Issue 1320, P 71-2, Sept 7, 2009). It has been widely promoted as a “natural” alternative to prescription medications for lowering blood LDL cholesterol levels. Studies have indeed shown that red yeast rice reduces LDL cholesterol levels and reduces the rate of major coronary events. The Medical Letter consultants concluded that it works, but they don’t recommend it. Why?
It’s Just Another Statin
When rice is fermented with the yeast Monascus purpureus, the resulting product contains numerous monacolins, which are naturally occurring HMG-CoA reductase inhibitors. One of these is identical to the prescription drug Mevacor (lovastatin). So it isn’t an alternative to prescription drugs, it’s just an alternative way of providing the same thing. (more…)
Triumph of the Heart, as its name does not suggest, is about science. The book’s author, Jie Jack Li, is a medicinal chemist who meticulously reviews the history relevant to the discovery of lipid-lowering drugs. He spares no details, even recounting the amusing quarrels and quirks of the scientists engaged in the “apocryphal showdowns” leading to the manufacture of cholesterol in a laboratory.
The personalities of the various scientists and Nobel laureates described in the book are highly entertaining. From beating one another with umbrellas, to insisting on wearing blue clothing only, to egos so large and unappealing as to empty an entire academic center of all its promising young recruits, one has the distinct impression that brilliance does not go hand-in-hand with grace.
That being said, each of these scientists did seem to share a common approach to research: carefully testing hypotheses, repeating peer study results to confirm them, and patiently exploring complex biochemical pathways over periods of decades. The physicians, physicists, and chemists showed an incredible ability to doggedly pursue answers to specific questions – understanding that the results might influence human health. But even more importantly, they were each willing to invest their careers in analysis that may never lead to anything more than a dead end. In fact, the book is full of examples of great ideas, developed over decades, that did not lead to a marketable drug. In some cases the research was halted due to lack of efficacy, in others political forces or personal whims influenced the course.
Over 26 million Americans are taking statin drugs. Some people think they should be available over-the-counter without a prescription, and it has even been facetiously suggested that they should be added to our drinking water. The protective effect of statins in cardiovascular disease and in high-risk patients with high cholesterol levels is well established. But what about people with no heart disease and normal cholesterol levels – can they benefit too?
The New England Journal of Medicine has pre-released an important new study on statins online prior to its planned publication date of November 20, 2008. It is certain to stir up a lot of controversy, and the International Network of Cholesterol Skeptics will not be happy, because it contradicts some of their favorite arguments. They have claimed that statins do more harm than good, that reducing cholesterol levels is harmful to health, that the benefits of statins and/or cholesterol lowering do not extend to women and the elderly, and that studies showing benefits of statins are meaningless because they do not show reduction of overall mortality. This study indicates otherwise. (more…)
I’m really tired of arguing about cholesterol, but I feel obliged to stand up once more to defend science-based medicine from unfair calumny.
Lewis Jones’s article “Cholesterol-shmesterol” in Skeptical Briefs (December 2007) included errors and misconceptions about cholesterol. It was a re-hash of the same kind of misinformation that is being spread by The International Network of Cholesterol Skeptics (THINCS) and that I addressed in an earlier post. THINCS would like us to believe that cholesterol has nothing to do with heart disease; that low cholesterol is harmful and high cholesterol is beneficial; and they demonize statins, even falsely claiming that they cause cancer.
I answered Jones with my own article “Cholesterol Clarifications” in the June 2008 issue of Skeptical Briefs. I said I agreed that cholesterol does not “cause” heart disease, that low-fat and low-cholesterol diets have been promoted way beyond the evidence and that statins are being over-prescribed. The public has a lot of misconceptions, but thoughtful science-based doctors agree that the evidence shows: (more…)
There is an organization that calls itself The International Network of Cholesterol Skeptics (THINCS). Its members “thinc” they are smarter than the average doctor. They “thinc” that cholesterol has nothing to do with cardiovascular disease and that we have been deluded into waging a “cholesterol campaign” for which the scientific evidence is non-existent. They say, “What we all oppose is that animal fat and high cholesterol play a role.” I find even the wording of this statement problematical: one does not usually hear scientists “opposing” matters of fact or non-fact. They go on to say, “The aim with this website is to inform our colleagues and the public that this idea is not supported by scientific evidence; in fact, for many years a huge number of scientific studies have directly contradicted it.”
They tell us about those contradicting studies; but they don’t tell us about the flaws in those studies, they misrepresent some of the results, and they don’t tell us about the many good studies that support the cholesterol/heart link. The issue is a complex one, and it is easy to find studies to support any claim. Good science is about weighing all the evidence pro and con before reaching a conclusion. As far as I can see, these folks have cherry-picked the literature to support an agenda. They seem to have a vendetta against statin drugs in particular.
The website solicits complaints of adverse effects from statin drugs. It features a petition to the WHO that you can sign requesting an investigation of statin side effects. It alleges that lowering cholesterol endangers the elderly. It provides “what the medical journals and newspapers won’t let you hear” – letters and papers that have been rejected for publication. It lists books, published papers and talks by its members. It solicits financial contributions to the cause.
This movement seems to have started with Uffe Ravnskov’s book The Cholesterol Myths, published in Swedish in 1991 and in English in 2000. That book has been severely criticized, for instance in The Skeptic’s Dictionary , where Bob Carroll points out some of the distortions and deceptive techniques found in the cholesterol skeptics’ arguments. A typical claim: “Cholesterol is highly protective against cancer, infection and atherosclerosis” and “high TC [total cholesterol] and LDL levels are beneficial at all ages.” These statements are not only false, they are potentially dangerous to the health of those who believe them. (more…)