Most evidence based on studies in men
The case for the widespread use of statins is extremely flimsy. The trials that provide the justification have been subject to detailed criticisms (1). In any event most of them were conducted before effective regulatory controls were introduced. As the work has been primarily with men, the case for using statins with women is based on the very dubious assumption that the impact will be exactly the same as in men. Clearly this is fallacious, not only because of biological differences but also because at any given age, the risks of developing heart disease are much smaller in women than in men.
A detailed critique of the evidence was published in 2004 (2). Here are the main points:
- Many of the clinical trials of lipid lowering treatments did not include women and others did not include adequate numbers of women to allow sex-specific analyses. Some of the trials that did report results in women reported aggregate events (eg. major coronary events), but did not report specific outcomes such as CHD death or nonfatal myocardial infarction (MI) separately.
- In the investigation, although over 1,000 were considered initially only 13 studies (represented by 23 articles) were found to be both eligible and to contain data stratified by sex for inclusion in the systematic review.
- The total number of women included in the trials was 17891, but almost two thirds were from 2 studies. Information on the ethnicity of participants was not provided in most trials.
- Duration of treatment ranged from 2.8 to 6.1 years and averaged 4.6 years. Six of the trials were classified as primary prevention and 8 were classified as secondary prevention (ie had previously been diagnosed with coronary CHD). However participants in most of the trials classified as primary prevention were at increased risk for CHD outcomes due to the presence of CHD risk factors.
It is my considered view that for anyone subjected to treatment with statins, the most important information is that on all-cause mortality (ACM). Obviously it is little comfort to learn that a reduction in deaths from a single cause, such as a heart attack, is accompanied by an increased risk of dying from another disease so that the life expectancy remains the same. Furthermore, the number of deaths is an objective value, while deaths from individual diseases are subjective or “soft” and therefore may be open to bias or manipulation.
With respect to primary prevention, the relative ratio (RR) for ACM was 0.95, which means a reduction of 5% in those treated with cholesterol lowering agents compared with the controls. This is very low and in any case is not statistically significant, which means that it could be due to chance. As far as deaths from CHD are concerned the RR was 1.07. Again this is very small and essentially means that there has been no demonstrable benefit.
For secondary prevention, there were only two trials which provided data and both of these used statins.
In one of these there were 25 deaths in 420 women (controls) and 27 deaths in 407 (Statin treated), which works out at an RR of 1.11. In the other there 78 deaths in the 760 women that acted as the controls and 74 in the 756 women treated with statins, which gives an RR of 0.95.
For CHD mortality there were results from three trials which all used statins to lower cholesterol.
In the controls there were 93 deaths reported for 1602 women but only 66 for 1588 women. This means that the RR is 0.74, a reduction of 26%.
What is revealed here is that the number of women on which the results are based is incredibly small. Even then there is not the slightest justification from these trials for the widespread usage of statins in women. Although this evaluation was conducted in 2004, I am not aware of any subsequent work to improve on the case in support of statin usage in women. Clearly, those who advocate the use of statins will make great play of the reduction deaths due to CHD. However when there is no genuine difference in the figures for ACM, the impact on CHD is of little consequence.
How should individuals respond?
Many people have great faith in the medical profession and have trepidation about raising objections to the advice given. Nevertheless it can be very important to consider and evaluate the available evidence. Ultimately each and every one of us has to face up to our own responsibilities. The hard realities of statins is that whatever way one looks at the evidence the benefit is very small. Is a reduction in death rate of 10% such a big deal? In practice it MAY mean that you live for another few months. But then again, it may not. Most people assume that when they take a drug it will have a definite impact within the near future. The brutal truth is that of all those treated, only a fraction will derive benefits. Even NICE accepts that 77 people would need to take statins for 3 years in order that ONE would benefit. When seen from the perspective of an individual, this probably comes as a great surprise. By the time the adverse side effects, which can be very nasty, are factored into the equation, it is doubtful if anyone would agree to statins if they are fully informed of these hard facts.
In fact, there is plenty of opposition to the existing policies on statins. In an article in the New York Times, by John Abramson and Rita Redberg in 2013, it was concluded that:
“…statins provide false reassurances that may discourage patients from taking the steps that actually reduce cardiovascular disease. According to the World Health Organization, 80 percent of cardiovascular disease is caused by smoking, lack of exercise, an unhealthy diet, and other lifestyle factors. Statins give the illusion of protection to many people, who would be much better served, for example, by simply walking an extra 10 minutes per day”(3).
So if you genuinely wish to improve your health and life expectancy, there are lots of simple lifestyle changes that can be made, which will be much more effective and avoid the risk of damaging side effects.