The statins – drugs for the superstitious

In a recent Danish paper published in European Heart Journal the authors claimed, that negative statin-related news stories decrease statin persistence and increase myocardial infarction and cardiovascular mortality. It was based on the fact, that early statin discontinuation by some of more than 800,000 Danish statin-treated people was associated with the number of negative statin-related news stories published in the media between 1995 and 2010., and that 1.1% more of those with early statin discontinuation had died after 10 years of follow-up compared with those who continued.

A more reasonable explanation is that the statin-treated individuals learned that their many unpleasant symptoms were caused by the statins, because most adverse effects do not appear immediately. Very often they develop several weeks or months after the start of the treatment. As the side effects of almost all drugs appear immediately, neither the “patient” or the doctor realize that the late statin side effects are caused by the drug. The muscular problems, the mental disturbances and the decrease of sexual potency, the most common side effects, are therefore seen as a result of increasing age.

An interesting observation is that the heart mortality difference of 1.1% is what those who continued their treatment won after 10 years of treatment. This is much less than reported from the statin trials. In the first statin trial 4S for instance, the difference between the statin and then placebo group as regards heart mortality was 2.5% after about five years of treatment. Not very impressive, but more than four times as much as in this paper.

Furthermore, there was not a word about total mortality in the paper. The only reason for excluding this information is of course, that either there was no difference, or that those, who stopped statin treatment lived longer than those who continued. It was not possible either for a Canada Free Press journalist to get this information from Børge Nordestgaard, one of the authors and head of the department, where the study was performed. He just answered the following: We probably could have looked at all-cause mortality. What I thought would have meaning for people that are interested in this field was myocardial infarction and cardiovascular death. Those are the two major endpoints that you look for when trying to prevent cardiovascular disease.

Isn´t the main interest of people on preventive medicine to prolong their life?

In an interview in the Danish newspaper Politiken, Nordestgaard declared that people, who stop their statin treatment have a 26% increased risk of a heart attack and 18% higher risk to die from a cardiovascular disease compared with those, who continue the treatment.

What explains his misleading words may be that he has strong economical links to the drug industry. In the section Conflicts of interest you can read the following: B.G.N. has received consultancy fees and/or lecture honoraries from Astra Zeneca, Pfizer, Merck, Amgen, Sanofi, Regeneron, Omthera, Dezima, ISIS Pharmaceuticals, Aegerion, Fresenius, B. Braun, Kaneka, Lilly, Kowa, and Denka Seiden.

Much evidence has shown that there is little benefit from statin treatment, if any at all. In my previous newsletter for instance, I told you about the Danish study, where the authors had calculated how may years you are able to prolong your life by statin treatment. What they found was that on average you can only prolong it by a few days.

Recently a research group from Italy, the UK and Sweden published a study in BMJ Open about the trends of statin use and heart mortality between 2000 and 2012 in 12 European countries. In all of the countries statin treatment had increased and heart mortality had decreased, apparently a support of statin treatment. However, there was no association between the degree of statin increase and the degree of mortality lowering between the countries. In Germany, for instance, statin treatment had increased by 54% during these years and heart mortality had decreased by 85%, whereas in Portugal statin treatment had increased by102%, whereas heart disease had decreased by only 41%.

The fact is, that heart mortality started to decrease already in the early seventies, long time before the introduction of the statins, and the decrease continued in the same rate after the start of statin treatment. This is one of the strongest argument against its alleged benefit. If statin treatment was able to lower heart mortality, the rate should of course have been even larger after its introduction in the early nineties, but this not the case.

And there is more evidence that statin treatment is useless. Four years ago, Staffan Nilsson and his coworkers at the University of Linköping published a study of acute myocardial infarction and statin use in Sweden. They compared the use of statins with the incidence and mortality of this disease in all the municipalities between 1998 and 2002 and found the same association as in the studies mentioned above. However, there was no association within each community. In some of them both statin use and mortality increased; in other communities both of them decreased.

Obviously we cannot claim that the decline of heart mortality in most of the world is caused by the increased use of statins; there must be other reasons. Some of them are probably the decreasing number of smokers and better treatment of heart disease. When I was a young doctor in the sixties for instance, the standard treatment of an acute heart attack was six weeks bed rest, which resulted in many cases of venous thrombosis, and venous thrombi may loosen and go to the pulmonary arteries and kill the patient. Today patients with acute myocardial infarction are mobilized as soon as they are able to walk.

As I have told you before, the directors of the statin trial do not allow access to the primary data. This has raised much criticism and a campaign, backed by the British Queen´s former doctor Sir Richard Thompson calling for urgent public enquiry into drugs firms’ ‘murky’ practices. You can read more about that in in Daily Mail and in Sunday Express.

In 2005 new, stricter regulations were introduced in the conduct and publication of randomized controlled trials. Since then the results of all statin trials have been minimal compared with those published before 2005. You can read more about that in a paper published in Expert Review of Clinical Pharmacology by Professor Harumi Okuyama and his co-authors; in a paper in Journal of Controversies in Biomechanical Research by Michel de Lorgeril and Mikael Rabaeus, and in Sunday Express. The authors of the two scientific journals are no amateurs; most of them are members of THINCS and de Lorgeril was the first who demonstrated the benefits of the Mediterranean diet.

In my view the cholesterol campaign is the greatest medical scandal in modern time. In the early sixties there were about 8000 active doctors in Sweden. Today there are more than 40,000 and we need more although the number of inhabitants has increased from eight to nine millions only. How come? Could the reason be that almost a million Swedes are on statin treatment and that such treatment has many serious side effects, most of which are unknown to most doctors?