There is an increasing understanding among medical researchers that statin treatment of healthy people with high cholesterol, so-called primary prevention, is without any benefit. The first trial that only included healthy people was WOSCOPS, the outcome of which was published un 1993. Since then millions of healthy people with high cholesterol have been treated with statins because its results were highly exaggerated. In the summary of the paper for example you can read that the number, who have died after five years treatment was 22 % lower among the treated than the untreated.
This figure, the relative risk reduction, is misleading, to put it mildly. As 106 of 3302 participants (3.2%) died in the treatment group and 135 of 3293 participants (4.1%) died in the control group after five years treatment, the absolute risk reduction was only 0.9 percentage points. You could also say that to prolong the life of one individual during five years, you have to treat 114 healthy people. The difference of 0.9% (4.1-3.2) was not even statistically significant, which means that it could have been a coincidence.
However, as the difference of 0.9% is 22% of 4.1 (the number of deaths among the untreated), the authors used that figure, the relative risk reduction, instead.
Recently a 20-year-follow-up study of the participants in the WOSCOPS trial was published. Here the authors claimed that their analysis had provided “robust evidence” for the short and long-term benefits of lowering LDL-cholesterol (the “bad” one) in healthy men; in particular among those with high LDL-cholesterol. For instance, during these twenty years all causes of mortality were lowered by up to 28% and with statistical significance.
They had of course, as almost all authors of the statin trials do, calculated the relative risk. The absolute risk reduction was only a few percentage points, and in most types of mortality without statistical significance.
But to find the relevant figures in that study is difficult, because its design is utterly complicated, Together with a supplement the paper consists of more than 60 pages filled with dozens of complicated figures and tables including thousands of statistical calculations; an effective method to prevent readers to continue after having read the abstract.
Hitherto many reports about the follow-up study have been published all over the world in various newspapers or on scientific websites, and with optimistic comments. In Telegraph for insyace (“Millions of people in their 20s and 30s should be offered statins”), in The Times (“Statins Cut Heart Deaths by 28%”) and in Daily Mail (“Statins DO work”). You can read more about that in Justin Smith´s newsletter. (Justin is one of the few medical journalists who have realized that the cholesterol campaign is the greatest medical scandal in modern time He has just started a campaign – Dont let STATINS break your heart).
Obviously none of the many optimistic reporters of the follow-up study have understood the difference between relative and absolute risk. And there was even a more serious error.
To evaluate the possible benefit of a drug in a trial it is necessary to compare two groups of participants. One of the groups receive the drug under investigation; the other group receive a placebo; a pill without any effect. And when it is time for evaluation of the result, you must of course know to which group the participants belong and whether they have taken the drug. The latter is of particular importance if you are studying the effect of a statin drug, because due to its many unpleasant side effects, many patients stop the treatment. This has been documented in a Canadian study including more than 140,000 elderly patients. Two years after they had been prescribed the statin drug, more than half of them had discontinued the treatment
But the authors of the follow-up study have ignored these elementary preconditions. On page 4 in the supplement you can read that…
Following the final randomised trial visit, pravastatin and placebo were withdrawn and patients returned to their primary care physicians. At 5 years after the completion of the randomised trial 38.7% and 35.2% of patients originally allocated to pravastatin and placebo arms, respectively, were taking statins. No later data on the proportion of individuals taking statin therapy were available for the subsequent years of follow-up,
Thus, the authors did not know whether the participants had been on statin treatment or not during the follow-up period. There is no “robust evidence”. The paper is simply an attempt to fool the medical world.
But of course, the authors are well paid by the drug industry. With one exception (the main author) all of them have several financial conflicts with Big Pharma. One of them has been supported financially by 21 various drug companies.
The reason why fewer had died among those with the highest LDL-cholesterol is hardly due to statin treatment, because, as we have documented in a recent study, elderly people with the highest LDL-cholesterol live the longest; even longer than those on statin treatment. The reason is most likely that LDL partake in the immune system by inactivating all kinds of bacteria and virus.
Evidently, no one seems to have observed the authors´ deliberately misleading information. Together with ten international experts I therefore sent a short comment to British Medical Journal, and Professor David Diamond sent a more detailed comment together with Dr. Malcolm Kendrick and Dr. Luca Mascitelli, all of whom are members of THINCS.
Those of you who have read my previous newsletters know that statin treatment is just as ineffective when used by patients who ave suffered from heart disease or stroke (secondary prevention) , and many researchers have also realized that. But as long as the “experts” do not change their mind, nothing will happen, and the health of millions of people on statin treatment all over the world is in danger.