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Statins: Real Deal or Rx Cash Cow?
By Gilbert Ross, M.D.
The New York Times Science section yesterday discussed the class of pharmaceuticals commonly called "statins." These drugs all reduce blood cholesterol levels, particularly the form of cholesterol called LDL, the "bad" cholesterol responsible for narrowing the arteries supplying blood to the heart and brain. Such cholesterol-containing deposits, known as atheroma, lead to heart attacks and strokes if not treated, either by drugs (such as statins) or interventions such as angioplasty or bypass surgery. Last week, the NIH's National Cholesterol Education Program (NCEP) revised its recommendations for treatment using statins, aiming for a significant lowering of LDL beyond the previous standard for high-risk patients -- a recommendation likely to lead to additional millions of Americans taking these drugs (users already number about 11 million).
Statins have been shown to lower LDL levels and, not surprisingly, also reduce the deadly results of high LDL levels -- heart attack and stroke -- in high-risk patients. Further, recent data indicates that statins (there are currently six on the market) may play a role in preventing or treating an array of other common and feared conditions, inlcuding Alzheimer's disease, multiple sclerosis, osteoporosis, and some types of cancer.
Wow! But wait. There are problems not apparent to the thousands of doctors who prescribe statins or to the millions of patients who stand to benefit from these drugs -- and perhaps if you were laboring under the impression that no drug should ever have any imaginable side effect or downside, no matter how beneficial the drug otherwise is, you'd be extremely grateful to have the alarm sounded over statins. Thank goodness, you'd say, that we have "consumer groups" who stand ready to come to the aid of the little people and point out problems. These problems include, according to no less an authority than Dr. Sidney Wolfe of the Naderite group Public Citizen, cases of liver function abnormalities, muscle damage, and kidney problems, possibly secondary to use of one or another statin. And the Center for Science in the Public Interest's (CSPI's) Michael Jacobson took the trouble to alert us to the fact that several of the NIH committee members who issued the new parameters for treatment had, at some time, received payments from one or more of the pharmaceutical companies that make statins (these companies include: Pfizer, AstraZeneca, Merck, Bristol-Myers Squibb, and Reliant).
Thank heavens for these astute watchdogs! How else would we know that statins are not 100% safe for everyone? But...isn't it true that there is no such thing as a drug that is completely safe? And didn't the FDA, the Federal drug agency that evaluates drug safety, go over thousands of patient profiles over the course of many years before allowing these drugs on the market? And don't the FDA and the drug makers continue to monitor the safety of drugs while they are in use? Of course -- indeed, one of the statin drugs, Baycol, was withdrawn a few years ago by its maker, Bayer, when unexpected toxicity was discovered.
Dr. Wolfe, who never met a drug he liked, fails to take into account that every drug has a risk-benefit ratio. He is anxious to produce figures for toxicities and adverse reactions but neglects the demoninator in the equation: How many folks are taking these medications without untoward effects -- i.e., reaping the significant benefits of statins? He will never tell us, but as the NIH notes: about 1% of people on statins develop elevated liver enzymes, and one out of one-thousand (0.1%) develop muscle pain or other symptoms, which almost always disappear when the drug is stopped. Deaths or permanent disabilities from statins are extremely rare. Contrast these figures to the toll of death from possibly preventable heart disease and strokes -- something like one million deaths annually -- not to mention the disability of those who survive.
And what about the taint of corruption implicit in the CSPI-Jacobson attacks on the integrity of the NIH/NCEP committee members? He was rightly given the back of the hand by the renowned cholesterol expert, Dr. James Cleeland, coordinator of the NCEP program, who asserted that the new cholesterol treatment advice was based on the science only. He added that the recommendations were also reviewed by eighty outside experts. "If you excluded all the people who have any financial connections to industry, you'd exclude all the people who are most expert," Dr. Cleeland said. Does Dr. Jacobson care about the actual benefits of statins for millions? He has decided that he is better qualified to advise the American public on this crucial issue than those who have devoted their careers to the subject (Dr. J's credential is in microbiology -- he has never treated a patient for anything).
So who should Americans listen to when it comes to treating heart disease and strokes -- "consumer groups" or experts on such treatment? Just ask your doctor!
Gilbert Ross, M.D., is Medical and Executive Director of the American Council on Science and Health. See also ACSH's booklet on Chemoprevention of Coronary Heart Disease and a related overview journal article by J. LaRosa, M.D.
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