More on Cholesterol Lowering Drugs:
Are They Worth The Risk?
Anti-cholesterol drugs are moving towards the top of the most widely prescribed drugs in the country list. Doctors love feeling useful, and when they write a prescription for cholesterol lowering drugs after a paltry effort at life style modification has failed, they truly believe they are helping their patient. Most everyone is aware that the acceptable range for cholesterol has been steadily falling over the years. Soon, everyone in the country will be a candidate for this medication. Hmm, I wonder if the National Cholesterol Education Program might have anything to do with the drug companies’ bottom line? Oh well, just a wild thought. But what I wanted to do this week is review the evidence on which orthodox practitioners base the super-aggressive marketing and prescription of this class of pharmaceutical.

A basic premise is that statistically 20% of patients with coronary disease will have a heart attack in the next 10 years. Even though most patients survive these events, it does appear to be true that statins reduce the risk of death from these events. But by how much? Not much. The CARE trial showed a reduction in cardiac patients’ 5 year mortality risk from 5.7% to 4.6%, while the WOSCOPS trial using healthy adults showed mortality reduction from 1.6 to 1.2%. Not too much to get excited about there.

Of course to really assess the risk/benefit ratio of these drugs you would need to know what other unwanted ill effects might they be having, and to what extent might they INCREASE mortality from other conditions like cancer, for example. Patients have died from this class of drugs’ side effects (e.g. Baycol was pulled from the market after multiple deaths), and many patients have experienced muscle disease and dysfunction. There is also real concern that overly aggressive lowering of cholesterol with these medications (I have seen some patients on the drugs whose cholesterol level was 120!) may interfere with normal sex hormone production, and possibly predispose to cancer (this is a proven fact in lab animals). The EXCEL trial was intended to document total mortality statistics in statin treated patients, but unfortunately just about the time (less than 1 year) that a borderline significant INCREASE in overall mortality was found, the study was stopped. Also, in the Heart Protection study at Oxford, which showed slight benefits from statin drugs, cumulative overall mortality statistics were never published despite multiple requests to the authors to do so, and specific funding to publish such data. The authors said it would be “inappropriate” to publish the data this way! This reminded me of my recent review of the breast cancer literature, and the amazing fact that despite multiplied thousands of patients treated with radiation, no statistics on side effects are available! However there have been several other studies that seem to question the value of cholesterol lowering drugs. Here they are:

Honolulu 2001: This was a twenty year study of elderly patients undergoing cholesterol lowering therapy. It found an excess in overall mortality in individuals with low cholesterol readings, and the longer the cholesterol was kept low, the greater the risk of death.

MIRACL 2001: 3086 cardiac patients received aggressive doses of Lipitor in the 16 week period immediately following a heart attack. There was no reduction in death rate, reinfarction rate (a second heart attack), or need for CPR. Its only effect was to reduce early rehospitalizations because of renewed anginal chest pain.

ALLHAT 2002: This 10,000 patient trial is the largest ever. It compared mortality between patients treated with and without (basic life style change only) Lipitor. Although 28% of the drug treated group versus only 11% in the life style group experienced a significant reduction in LDL cholesterol, the mortality rates from any cause and from heart attack were identical in each group at 3 and 6 years follow-up.

PROSPER 2002: This studied Pravastatin use in elderly patients that had and did not have a history of coronary disease. Pravastatin did not reduce total myocardial infarction or total stroke in the primary prevention population (no prior history) but did so in the other group. However, total mortality and total serious adverse events were unchanged by pravastatin as compared to the placebo group, and those in the treatment group had increased cancer. No lives were saved.

J-LIT 2002: 47,294 patients were treated with the same dose of simvastatin. Patients were grouped by different degrees of LDL reductions. There was no correlation between the amount of LDL lowering and death rate at five years. Those with LDL cholesterol lower than 80 had a death rate of just over 3.5 at five years; those whose LDL was over 200 had a death rate of just over 3.5 at five years.

No study has shown a significant reduction in mortality in women treated with statins. None-the-less in February 2004, the medical journal Circulation published an article in which more than 20 organizations endorsed cardiovascular disease prevention guidelines for women with several mentions of "preferably a statin.”.

Those studies pretty much speak for themselves, don’t they? And out of this scientific data the marketing departments of the big drug companies have done a masterful but wicked job of creating a feeding frenzy over their almost useless pharmaceuticals. So what shall we take away from this weeks’ newsletter? High cholesterol may be a problem, but it is not one which should be addressed with current statin drugs. These drugs should simply not be prescribed to healthy individuals who do not have documented coronary disease. The benefits do not out-weigh the risks. In coronary patients, overall survival benefits have not yet been proven although there is a very slight decrease in mortality from cardiac events. There are any number of dietary (limit refined carbohydrates), nutritional (Vitamin E, garlic, Vitamin C), or natural medicine interventions (chelation therapy) that will with complete safety dramatically and more effectively reduce the risk of cardiovascular mortality. As far as the cholesterol level itself, elevation is indeed not a sign of good health, but typically it says more about the patient’s overall metabolism than it does about his cardiovascular risk. And in the scheme of things, there are far more important indicators of coronary risk than the serum cholesterol that should occupy our attention. We routinely test for all of them (see prior issues for a list) here at Caring Medical. The problem is there are no drugs out for any of those risk factors, and they are best solved with nutrition. That’s why you never hear anything about them. For example, no drug company has the incentive for setting up and funding a National Lipoprotein (a) Education Program, because only ascorbic acid can bring that risk factor under control. Cholesterol lowering drugs are good….for the pharmaceutical companies, but of little or even negative value to the patients and to our expensive, unwieldy, and biased third party carriers that pay for them. My advice is don’t entrust your health to prescription medications. Accept the fact that you will have to cooperate with your doctor and change some things to improve your health, but you can get the job done without contributing to drug company profits while putting your own health in jeopardy in other ways. And we can help you.