About false conclusions and a diet revolution

September 2011

Shuffle the cards and the reader will believe you!

Misleading papers about the benefits of statin treatment published by research groups from prestigious universities are countless. Here is an example.

In 2003 the results from a large, multinational statin trial named ASCOTT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm) including 10,305 patients, half of whom had received statin treatment. All of them had three risk factors, but none of them had had a heart attack. The trial was planned to continue for five years, but was stopped already after 3.3 years because of its “large reduction in major cardiovascular events”. Fatal and non-fatal myocardial infarction was reduced by 36 %, seemingly an impressive figure.

However, the absolute figures were 1.93 % “heart events” in the statin group against 3 % in the untreated control group, thus a difference of only 1.07%. The figure 36% is correct, however, because 1.07 is the difference between 3 and 1.93, and 1.07 is 36 % of 3.The difference in mortality was even lower. 3.6 % died in the statin group against 4.1 % among the untreated. You could also say that the chance of being alive after 3.3 years without statin treatment is 95.9 %, but if you take a statin drug every day you can increase your chance to 96.4 %.

You have to consider the risk of adverse effects, however. In the statin group 3.8 % either got diabetes, renal failure or life-threatening heart arrhythmia, against 3.2 % among the untreated. None of these adverse effects had increased with statistical significance, but perhaps they would, had the trial continued for the planned five years. Nothing was said about other adverse effects, although there are many reports about muscle damage, impotency, cancer, bad memory or temper, to mention just a few, and some of them have been reported in much larger number. More about that in my previous newsletter.

Now to the amazing news. Eight years after the discontinuation of the trial the outcome of the British participants was analysed. To their surprise the researchers found that among those who had been on statin treatment eight years before, fewer had died from an infectious or respiratory disease compared with the untreated control individuals. Only 1.6% of those, who had been on statin treatment, had died from these diseases against 2.44% among the untreated.

The authors were excited, and the news were spread to many newspapers and professional websites; for instance Science Daily, Daily Mail, Pulse, Netdoctor and The Heart to mention a few.

The authors had a number of reservations. But what they didn’t consider was the fact that the number of statin-treated individuals after these eight years was almost the same in the two groups. To cite the authors:

“…there was substantial drop-in and drop-out of statin therapy among those originally randomized to placebo and atorvastatin, respectively. Consequently, at the closure of BPLA (the follow-up analysis; my comment), of those originally assigned atorvastatin, 63% were still taking it, and of those originally assigned placebo, 56% were taking atorvastatin.”

The crucial question is of course the following: Why did the original treatment group stop taking statins? Could the reason be unpleasant adverse effects? And isn´t it possible that some of those who started statin treatment during these eight years had not yet decided to stop because of unpleasant symptoms? If so, no conclusions can be drawn from these findings. That cholesterol-lowering should prevent infectious diseases is also highly unlikely, because the lipoproteins protect against all kinds of infectious diseases, an issue that I have described in detail in my books.

More brave journalists

Now to the good news. Skepticism against the cholesterol campaign is growing. A few days ago medical journalist Lois Roger published a critical article about this issue entitled Big Fat Lies in the Sunday Times. Unfortunately it is not available without paying, but somebody has sent it to a website named Active Low-Carber Forums

Another eloquent journalist and researcher is Roy Moynihan. In the August 15 issue of BMJ he published a new, critical paper entitled “Surrogates under scrutiny: fallible correlations, fatal consequences”. Those who have read my books are of course familiar with the issue. Here are a few quotations for those who haven´t, as it is not available for nonsubscribers:

According to the 2010 Institute of Medicine report, although the methods used to determine blood cholesterol are reliable and reproducible, they do not directly measure LDL cholesterol and so have “limitations.” In addition, though LDL cholesterol is “hypothesised” to have a causal role in the atherosclerotic disease process, it has “not been conclusively proven.” And…lowering LDL cholesterol “does not always correlate with improved patient outcome.”The report points out there are over 200 coronary risk factors, and that cholesterol, while currently considered by many to be a valuable biomarker for heart disease, is only one of “multiple determinants” and “numerous other mediators.

…The benefits of long term preventive therapies like cholesterol lowering drugs are usually portrayed as relative reductions in risk, but when the risks are considered in absolute terms, a different picture emerges. For example, based on a Cochrane review of trials for primary prevention, there has been recent enthusiasm that for people without a history of heart disease statins can reduce premature deaths by 17%, coronary heart disease by 28%, strokes by 22%, and revascularisation by 34%. Yet a close reading of the tables from that systematic review suggests the estimated absolute risk reductions with around four to five years of drug taking are 0.5% for death, 1.9% for coronary heart disease, 0.5% for stroke, and 0.7% for revascularisation.
…A major rethink of the role of surrogates in medicine is timely. Routinely approving and prescribing therapies on the basis of their effects on someone’s numbers, rather than their health, is increasingly seen as irresponsible and dangerous. And even when evidence suggests clinical benefits of popular “preventive” medicines for those at lower risks, a rational assessment reveals many people must be treated to prevent one adverse event, so most users gain no direct benefit despite years of treatment.

…The magic of numbers may help corporate profits and professional pride, but at what cost to the health of ordinary people who mistake a numerical benefit for a genuine one? Surely it’s time to ask if there might be a healthier new model for medicine based on far less harmful and costly ways to try to reduce human suffering.”

A Swedish revolution

In Sweden there is an increasing understanding that meat, eggs and dairy products have nothing to do with atherosclerosis or heart disease. The story began the year 2005. Lars Erik Litsfeldt, a Swedish lawyer contacted me to tell me about his success with a lowcarb, high fat (LCHF) diet. A few years earlier he was an overweight diabetic with heart problems, but after a few days on the LCHF diet his blood sugar became normal and he could stop his medication, and a few months later, his body weight was back to normal. Our discussions about fat and cholesterol inspired him to wrote a book “Fettskrämd” (Scared by fat).

The same year a book was published by Sten Sture Skaldeman, a journalist, who had almost halved his body weight (141 kg; 311 lb) by eating a LCHF diet. He had followed the usual dietary recommendations in vain; his body weight increased more and more. When he got diabetes and heart failure he realised that his life could end very soon and he therefore decided to eat the food he enjoyed the most, eg. fat food. To his surprise he noted that week after week he lost weight and all his ailments disappeared.

However, what really created attention was what happened to Annika Dahlquist, a general practitioner in Northern Sweden. When she experienced the same benefit on herself from this diet, she started recommending it to her patients as well. Two local dieticians accused her for misconduct and reported her to The National Board of Health and Welfare (Socialstyrelsen), and her chief prohibited her from giving dietary advice. However, two years later The National Board acquitted Annika; although her dietary advice went contrary to the official guidelines, as they wrote, they were supported by science.

Annika wrote a book herself, which became a blockbuster. Today every Swede knows Annika Dahlquiost and her message. She has appeared in several television shows and she has given numerous lectures for lay people all over the country She has been followed by another general practitioner, Andreas Eenfeldt, who has written a blockbuster book as well and started an LCHF blog that has become the largest health blog in Sweden.

Together with eight colleagues I have backed up the LCHF movement by criticizing The National Food Administration for giving unhealthy dietary advices, both in the newspapers and in the Swedish medical press. Here is an excerpt from my book “Ignore the Awkward!” about one of our papers, published in Dagens Medicin, a popular medical newspaper:

“Recently, the Swedish Food Administration published a list of seventy-two studies, which they claimed were in support of their warnings. Together with eleven colleagues I scrutinized the list and what we found was the following: Eleven studies did not concern saturated fat at all.

Sixteen studies were indeed about saturated fat, but they were not in support.

Three reviews had ignored all contradictory studies.

Eleven studies gave partially or doubtful support.

Eight studies were reviews of experiments, where the treatment included not only a ‘healthy’ diet, but was combined with weight reduction, smoking cessation and physical exercise. So how did they know whether the small effect was due to less saturated fat or to something else? Furthermore, all of them had excluded several trials with a negative outcome.

Twenty-one studies were about surrogate outcomes. In most of the studies the authors claimed that saturated fat raises cholesterol. We should note that high cholesterol is not a disease.

Twelve studies were listed because they had shown that people on a diet, which included a high proportion of saturated fat and little carbohydrates, reacted more slowly to insulin than normally. From that observation, the authors claimed that saturated fat causes diabetes, but decreased insulin sensitivity is a normal reaction. When you cut the intake of carbohydrates radically, your metabolism is changed to spare blood glucose and it works by reducing your insulin sensitivity. That saturated fat produces diabetes is also contradicted by several experiments on patients with early or manifest type 2 diabetes. They have shown, that a diet with much saturated fat and little carbohydrates normalises the level of blood sugar and insulin and many of the patients are able to stop their medication.

Another contradiction is, that for many years the consumption of saturated fat has decreased in many countries, while during the same time period we have seen a steady increase in the incidence of type 2 diabetes.”

I assume that you are curious to know how the Swedish Food Administration responded to our criticism. They did respond, but we couldn’t find an answer to our questions about saturated fat. Indeed, we could not even find the term saturated fat in their text. Instead you could read statements such as:

Our dietary guidelines are based on science… they are a synthesis of thousands of studies… they are based on the WHO guidelines.

According to a recent poll almost 25% of the Swedish population has changes their dietary habits in the LCHF direction and in today´s local newspaper you could read that there is lack of butter in all districts in Sweden.