Statins or not? Red meat or not?

May 2013

Is the Cochrane Collaboration still reliable?

Doctors and researchers have great confidence in the Cochrane Collaboration. It is a non-profit organization consisting of a group of over 28,000 volunteers in more than 100 countries and said to be independent. The group conducts systematic reviews of randomized controlled trials of health-care interventions, which it publishes in the Cochrane Library.

Hitherto no statin trial has succeeded in prolonging the life of healthy people whose only “disease” is high cholesterol, or who have risk factors for heart disease, but who have never had any heart problem. As mentioned in one of my previous newsletters Cochrane Collaboration published an analysis of these trials in 2011. When all results were taken together they found a minimal risk reduction. However, their conclusion was, that “only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.

But in a recent Cochrane report about the same issue, the authors conclude that Reductions in all-cause mortality, major vascular events and revascularisations were found with no excess of adverse events among people without evidence of CVD treated with statins.

How come they have changed their mind, you may ask. Because the minimal benefit in the second review was a little better. Let us take a look at the figures.

The first Cochrane analysis included about 28,000 “patients”. In the control group 3.06 % had died; in the treatment group only 2.58%; a difference of 0.48 % You can also say, that without statins your chance to be alive after a few years without treatment is 96.9 %, but if you take a statin drug every day, you can increase your chance to 97.4 %.

In the new analysis, that included about 48,000 “patients”, the result was a little better. In the control group 5.17 % had died; in the treatment group only 4,41 %; a difference of 0.76 %. You can also say, that without statins your chance to be alive after a few years without treatment is 94.8 %, but if you take a statin every day you can increase your chance to 95.6.

These small effects were even exaggerated, because in both analyses, the authors had excluded EXCEL, the first trial performed on healthy people. It included more than 8000 people, but it was stopped after 48 weeks, because, as Merck explained to me in a letter, they were only interested to know, if the “patients” tolerated their drug, which they did.

The trial included three treatment groups, and the mortality in these groups were 0.5 %; in the control group only 0.2 %. This is not mentioned in the abstract; you have to calculate it yourself from figures given in the text.

The reason for excluding EXCEL was that they only accepted trials with a length of at least one year, and as mentioned EXCEL was stopped after 48 weeks.

Without the data from EXCEL the new analysis seems to have shown a benefit because, as the authors wrote, there was no excess of adverse events. Obviously they had forgotten what they wrote in their previous report: There was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease.

And they were right. In my newsletters and in my books I have given many examples of the fraudulent way the industry-sponsored trial directors have downplayed the adverse effects from statin treatment. Let me just mention that at least 20 % get muscular problems, just as many become impotent, at least 4 % get diabetes, about 1 % cataract, and an unknown number polyneuropathy or mental disturbances such as memory loss, depression, sleep disturbances and aggressive behaviour. Duane Graveline has also written about this issue, and you can read about the influence of low cholesterol on brain function here.

Most serious is the risk of cancer. Together with Kilmer McCully and Paul Rosch, two of our most respected members of THINCS, I have given detailed arguments in a paper for the view, that statin treatment, or rather low cholesterol, is carcinogenic.

More about red meat

For several years we have been told that red meat causes both cancer and cardiovascular disease. However, most studies of this issue have calculated the outcome for intake of red meat and processed meat taken together in their calculations, and as I told in a previous newsletter there were serious errors in the few studies that found unprocessed read meat to be unhealthy.

Recently Sabine Rohrman and 46 co-authors published the results from EPIC (European Prospective Investigation into Cancer and Nutrition), a large dietary study conducted in 23 centers in 10 European countries.

The authors organized interviews of 448,568 men and women about their habitual diet habits during the previous year; and in most countries an extensive self-administered dietary questionnaire was used as well. After that the participants were followed for 12-13 years. After correcting for confounders they found that intake of red meat is harmless; not unexpected it is the intake of processed food that may be harmful.