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Saturday, August 30, 2014

The "nocebo effect", statins and Dr. Ben Goldacre

I just recently became aware of a study that came out in March of this year which concluded that statins, drugs like lipitor (atorvastatin) and zocor (simvastatin), which people take, increasingly, to lower their cholesterol and their risk of heart disease, have NO SIDE EFFECTS. Here is a paper which explains the study. It is not possible to link to the actual study in the European Journal of Preventive Cardiology because they want me to pay for it.

The paper says that, when comparing patients who took statins to ones who took an inactive pill, the side effects of both were about the same. That is called the "nocebo effect". Many people have heard about the "placebo effect" in which a sham treatment or sugar pill has a beneficial effect due, we think, to the fact that the subjects who receive it think it will work. Placebo, in Latin, means "I will please" and nocebo means "I will harm." So the researchers who wrote the paper about statins, after reviewing the data, found that patients who believed they would have side effects on statins did have side effects, whether or not they took the real drug. This is the nocebo effect. It implies that statins have no more side effects than sugar pills.

Now this would be really interesting if it were true. But it's not, so it's just really annoying. Patients who have received these drugs and physicians who prescribe them have noticed such a marked incidence of side effects, especially muscle weakness and pain, which resolve when the medicine is stopped, that any study questioning that finding is extremely suspect. When I heard about the article, I looked a bit further to see who had written it and what data they had looked at. I suspected that the study had been funded by pharmaceutical company lackeys using faulty data. It turns out I was only half right.

One of the major authors on the paper is a British physician named Ben Goldacre who is absolutely passionate about revealing the truth in scientific research and medicine, particularly in research done by unscrupulous pharmaceutical companies. He has founded a group, AllTrials to promote honesty in reporting the results of clinical trials of medications. He actively publishes articles aimed at lay audiences about ways in which drug companies use skewed data to mislead the public about the safety and effectiveness of their drugs. He has written a book Bad Pharma about how the pharmaceutical industry distorts the truth to get patients to use their products. He is passionate about it and appears to be an excellent human being.

So what happened? Why did this guy who seems to be such a voice for truth write this paper? He explains it all quite entertainingly and in much more detail than I will here in his column "Bad Science." What happened is that he used very incomplete data about side effects from studies that were mostly performed and designed with drug company support to show that statins were safe and effective. They didn't even ask about many of the side effects that patients frequently complain about and they didn't evaluate for muscle weakness in patients unless their muscle enzymes were 10 times normal or more, which is extremely rare. Dr. Goldacre attempted to write a disclaimer to the effect that he believed his data was inadequate, but the paper had gone to press. Oops. The news that statins have no side effects was on front pages of newspapers. There must have been champagne opened in the spacious offices of the companies that produce these medications.

So we still need good unbiased data on the true side effects of statins, and that will be pretty difficult to get at this date. Statins are so commonly used that finding a cohort of patients who have never used them to participate in a double blind study to evaluate their short and long term side effects will be tough. There are several statins on the market, with different incidence of side effects based on their chemistry, and each would need to be tested. Different categories of patients have different side effects, and the side effects vary based on dosage. Most patients who are willing to take statins are already on them, since physicians love to prescribe them. Patients who don't want to take them probably also don't want to take them in a double blind fashion for a long period of time. We will probably have to settle for a re-examination of data which was collected but not released, if anyone has the time or energy to find and scrutinize that.

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