Statins for women: a complete waste of time?
By Anthony Colpo, April 30, 2004.
Source: The Omnivore
According to NDS Health, a health-care information services company based in Atlanta, more than 110 million prescriptions were written for statin drugs in 2001. Needless to say, a good deal of these were for women. Because women who take statins are every bit as susceptible to the toxic side effects of these drugs as their male counterparts (if not more so) it is only fair to mention that clinical trials have not provided any convincing evidence that statin drugs will save even one single female life.
You read right; controlled randomized, clinical statin trials that have included female participants have failed to show any mortality benefit whatsoever for the fairer sex.
One of the earliest statin trials was the Scandinavian 4S study, the positive results of which helped catapult statin drugs to the forefront of mainstream coronary care. After 5.4 years, 12% of placebo patients had died, compared to only 8% of simvastatin users.
The study involved 4,444 participants. Of these, there were 407 women in the simvastatin group and 420 in the placebo group. Throughout the study, 91 women in the placebo group experienced a major coronary event, compared to only 59 in simvastatin group.(1) "So what's the problem?" you may be asking, "Isn't that what statins are supposed to do; lower the risk of coronary events?"
I'm sure I speak for most people when I say that I would like to avoid heart disease in order to live a longer life, not merely to experience the thrill of dying prematurely from some other horrible cause. Female readers who concur may be interested to know that in the 4S study, the lower rate of CHD incidents did not translate into an improved survival rate. In fact, 2 more women died in the simvastatin group than in the placebo group, a 12% relative risk increase.
In the ASCOT trial, which randomized 10,305 men and women aged 40-79 to either a placebo or Lipitor for 3.3 years, no overall mortality figures were reported for women. The primary endpoint, combined incidence of non-fatal heart attack and fatal coronary heart disease, was reported, and was slightly higher in the Lipitor women than in the placebo women, although the difference was reportedly not statistically significant (the researchers did not provide actual figures in their report).(2)
In a recent British Medical Journal article, U.K. practitioner Dr. Arnold J. Jenkins reports being overjoyed when he heard that the largest statin trial to date, the HPS study, showed clear benefits from the use of statins in women. However, after reading the study and finding the total mortality data for women missing, he contacted the researchers and was told that the total mortality benefit for women did not reach significance and therefore was not published.(3)
When reporting on the CARE trial, the authors gushed about the reduction in coronary events among the 576 women in the study. Eighty of the 290 women taking a placebo experienced a coronary event, compared to only 46 of those taking pravastatin. However, no overall mortality figures were reported for women. Overall mortality figures were given for the entire 4,159 study population, however. These showed that 180 people died in the pravastatin group, and 196 in the placebo group - a non-significant difference.
While they did not see fit to report overall female mortality, the CARE authors did report on cancer rates. Breast cancer occurred in only 1 patient in the placebo group compared to 12 in the pravastatin group. The one instance of breast cancer in the placebo group was a fatal case in a woman who had previously had breast cancer. Despite the repeated findings of carcinogencity from statins in animal studies, the authors dismissed the far higher incidence of breast cancer in the pravastatin group as an "anomaly".(4)
In the LIPID trial, 14% of the placebo women and 12% of the pravastatin-taking women experienced either coronary death or a non-fatal heart attack, a non-significant difference. Seperate overall mortality figures for women were not reported.(5)
If women are going to be asked to take drugs that, in addition to costing them their hard-earned money, have been shown to cause severe muscle pain and weakness, liver toxicity, cognitive impairment, and possibly cancer and heart failure, then they should be offered a pretty damn good reason for doing so.
Controlled, randomized clinical trials so far have provided no such reason whatsoever.
Before potentially dangerous drugs are recommended to a particular population, there should be convincing evidence that the potential benefits to that population will far outweigh the risks. However, the drug cartel long ago abandoned the strategy of marketing its wares only for those actually need them. The Pharmafia is now madly obsessed with expanding its market share anyway possible, to hell with the human consequences.
It is extremely sad to see that so much of the medical profession has become a willing participant in this disgusting endeavor, debasing itself to the level of being little more than a sales vehicle for prescription drug manufacturers.
References
1. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet, 1994. 344; 1383-1389.
2. Sever PS, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet, 2003 Apr 5;361(9364):1149-58.
3. Jenkins AJ. Might money spent on statins be better spent? BMJ, Oct 2003; 327: 933-b.
4. Sacks FM, et al. The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Cholesterol Levels. New England Journal of Medicine, Oct 3, 1996; 335 (14): 1001-1009.
5. The Long-Term Intervention with Pravastatin In ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. New England Journal of Medicine, 1998. Vol. 339: 1349-1357.
Anthony Colpo is an independent researcher and certified fitness consultant with 20 years' experience in the physical conditioning arena. To contact: contact@theomnivore.com
Disclaimer: This article is presented for information purposes only and is not intended as medical advice. Persons with medical conditions should institute dietary changes whilst being monitored by a competent medical practitioner.
Anthony Colpo 2004. Copyright information:
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