Thursday, June 09, 2005

HERE WE GO AGAIN

Here we go again. The US Food and Drug Administration (FDA) says that Crestor is safe, yet new research from Tufts-New England Medical Center shows that it has more than twice the number of adverse incidents, including kidney damage, than other leading statins. Sounds like deja vu in the aftermath of the recent NSAID problems. With sales of Crestor topping $1 billion in the 12 months ending March 31, 2005, and sales of all statins estimated to be around $20 billion in 2004, this may be just the tip of the iceberg with regard to the tough decisions millions of Americans must face in managing their cholesterol. I spoke with Jay Cohen, MD, author of What You Must Know About Statin Drugs & Their Natural Alternatives, about the implications of this latest research. One of the core issues for Dr. Cohen is the overprescribing of excessively powerful medications. Crestor is far more potent than its competitors, and far more potent than necessary for most people with elevated cholesterol. The milder statins are strong enough to lower cholesterol to recommended levels in the vast majority of people -- few need as powerful a drug as Crestor, with its increased risk of side effects. It was obvious from the day Crestor went on to the market that this drug had problems, says Dr. Cohen. He has been consistently questioning its safety on his Web site, www.medicationsense.com, and observes that this is yet another example of how poor the system is at recognizing a dangerous drug before it causes harm. In the Tufts study, published in the May edition of the American Heart Association's journal Circulation, researchers compared statistics of adverse reactions reported by doctors to the FDA specific to Crestor as well as for three other statins -- Lipitor (atorvastatin), Pravachol (pravastatin) and Zocor (simvastatin). Based on the analysis, researchers found...
*The rate of adverse events per million prescriptions was 28 for Crestor, 13 for Zocor, 4.3 for Lipitor and 3.5 for Pravachol. Adverse events that researchers specifically examined in the study were muscle and kidney damage.
*There were six deaths per million people taking Crestor, as compared with three per million with Zocor, two per million with Lipitor and one per million with Pravachol.
Frighteningly, the Tufts study comes on the heels of an FDA statement reaffirming Crestor's approval, following repeated questions about its safety profile. In November 2004, FDA researcher David Graham, MD, MPH, sounded the alarm about Crestor, complaining to a congressional committee that it was unsafe. Soon after, contending that its risks of potentially life-threatening side effects were too high, the consumer watchdog group Public Citizen's Health Research Group petitioned the FDA to withdraw Crestor from the market.
Yet in March, the FDA concluded that the risks of serious side effects from Crestor were no greater than those of rival statins Lipitor, Pravachol and Zocor, and refused Public Citizen's request. Given the FDA's poor track record over the past year -- from antidepressants in teens to COX-2 inhibitors to NSAIDs -- it's not surprising that the organization is dragging its heels on Crestor... but Public Citizen predicts that Crestor will ultimately be banned. While Crestor is being aggressively promoted as the most powerful statin, Dr. Cohen says the key is to use the least potent drug at the lowest possible dose that controls your cholesterol. Keep in mind, too, that not everyone needs a statin -- there are natural alternatives. Many people can control cholesterol with regular exercise and a healthy diet (eating more fruits, vegetables, soy and fish and consuming less saturated fat), observes Dr. Cohen. In an upcoming article, I will outline Dr. Cohen's recommendations for natural, safer cholesterol-lowering alternatives, including garlic, guggulipid, niacin, omega-3 fatty acids, plant sterols, policosanol, red yeast rice and soy. If it turns out that you do need a statin to get your cholesterol down, Dr. Cohen says to work with your doctor to determine the lowest dose of the least potent -- and therefore least side-effect-prone -- medicine to lower it to recommended ranges. Statin drugs that are less powerful than Crestor -- including Mevacor (lovastatin), Lescol (fluvastatin) and Pravachol -- are strong enough for most people and cause fewer side effects. If these prove insufficient, Lipitor or Zocor usually does the trick. All these drugs have far better track records for safety than Crestor, emphasizes Dr. Cohen. All statins work the same way and potentially have the same side effects. This means that while lower doses of milder statins are less likely to cause side effects, you must always be on the lookout and sensitive to changes in your body. Do you suddenly have muscle aches or difficulty concentrating? Don't automatically chalk these up to exercise or aging -- they could be caused by statin use. Report all possible side effects to your doctor and talk about adjusting medications and/or dosages to eliminate them. If your doctor won't discuss side effects or dosages with you or tries to send you off with a free sample of Crestor, find yourself a new doctor. The fact is, our bodies need a certain amount of cholesterol, and many experts remain unconvinced that cholesterol plays such a significant role in cardiovascular disease after all. According to Daily Health News contributing editor Andrew L. Rubman, ND, "The latest information on heart disease shows limited causation between cholesterol and coronary vascular disease. It is difficult for me to understand why these drugs are used to the degree that they are but for a medical system that focuses on symptom-suppressing drugs. The solution to the cholesterol problem usually lies in helping the gastrointestinal tract and liver to function better, which allows the body to better self-regulate." Both the statin story and the FDA fiascoes seem far from over. Only time will tell what happens as pressure mounts on Crestor's embattled manufacturer, AstraZeneca. With the publication of this new study, Public Citizen has already renewed its call for Crestor's ban. Stay tuned as I continue to bring you the latest news on statins and natural alternatives.

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