Journal Articles Can Easily Mislead Doctors About Statin (or any) Drug Safety

Doctors don’t go to medical school to become expert at interpreting statistics. Yet most of the articles that tell us how safe drugs might be rely on complex statistical analyses that go far beyond what I learned in my one credit course on Statistics for Medical Practitioners. For the most part, doctors have to take the word of the statisticians on whether a drug has a given benefit or harm.

An example is a recent Lancet review article has been hailed as the “definitive” summary of the potential risks versus potential harms of statin drugs. The authors conclude that most of the side effects we’ve thought statins had are actually nonexistent. They predict just 2 adverse events per 15 cases of heart attack or stroke prevented, and make rather strong statements about doctors not prescribing statins often enough.

A couple of folks I respect have pointed out that the authors have long served as apologists for the statin industry. In my video critique of the Lancet article I discuss Malcolm Kendrick, and HealthInsightUK.

This article is continued below...(scroll down)

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My concern about this particular article is that, as far as being the last word on risk versus harm, it’s seriously flawed by failure to include ALL the common side effects in the analysis. Some side effects simply weren’t discussed, like heart failure. But most side effects were dismissed based on the results of randomized controlled trials. However,  a little-known stage of most such trials called the “run-in” or “wash out” period, can be used to screen out massive numbers of study subjects. I believe that this little trick is often used to sway the results in favor of a given drug.

View my video critique of the Lancet article here, and let me know what you think. Do you believe doctors should also consider the potential harms from statin side effects that I review in the video, do you think they are irrelevant like the Lancet article claims?

Prefer to Read? Here’s the Full Text

The Lancet’s November 2016 edition contains a 30-page review article calling for doctors to stop worrying and start loving their statins. The article’s abstract is also massive, which sometimes means that the author is using it to editorialize, not to summarize, as is the case here.

The gist of the abstract is that some doctors are irrationally fearful of side effects, and this irrational fear is putting their patients in danger. The conclusion of the abstract lays it on pretty thick: “The heart attacks or strokes that may occur if statin therapy is stopped unnecessarily can be devastating.”

This review attracted criticism from a number of doctors and writers who I respect, and I’m going to summarize their concerns before I add a few of my own.

The data are kept secret

The first is from Health Insight UK, a site whose mission is to create a discussion forum for professionals who are critical of current approaches to preventing and treating chronic disease. The article points out something I’m embarrassed to say. I didn’t realize that when a pharmaceutical company foots the bill, all the research data can be kept secret. In other words, we’re forced to take the word of the authors.

Wow. I wasn’t sure I could believe that, so I had to Google it. I found that yes, indeed, study results are considered confidential. Although the NIH just recently said that when they’re paying for it, the data can’t be kept secret or the NIH won’t pay for the next study.

A career defending statins

The next critique is from a man I’ve known for over a decade, Dr. Malcolm Kendrick, a GP working in the UK. Dr. Kendrick points out that the Lancet article’s author has made a career out of working for the drug companies. Whenever an article critical of statins is published, Sir Rory Collins rushes in to defend statin use. He seems to come as close as he can to accusing those who don’t use statins as often as he thinks they should be used of being uncaring and perhaps even medically irresponsible.

Most side effects were left out of the math

My take on this article is that it’s also flawed by the failure to consider all of the side effects of statins in its analysis of how many will be helped versus how many will be harmed. Thanks to Health Insight UK, who does some math the author should have done, we can better understand that the numbers proposed in the article are 2% harm versus 15% help. But those numbers are a result of including only three of the possible side effects of statins.

Other established side effects should have been included in his analysis, but they weren’t, because the so-called randomized controlled trials cited in the article did not find evidence of several important side effects.

How run-in periods hide side effects

However, I’m not convinced all the articles cited are as randomized as they claim to be. Here’s why. In one of the trials cited in the Lancet article, a full one-third of participants dropped out of the trial during its run-in period. We don’t get any information as to why. But it’s very possible that after starting the drug, a side effect developed.

In other words, a run-in period is an opportunity to effectively screen out those people who experience side effects. In my view, any study that has a run-in period is of no value in determining the potential for a drug to cause a side effect. But most randomized controlled drug trials do have run-in periods, and doctors don’t realize that it means people with side effects can be screened out.

This is just one trick statisticians can use to take control of the conversation around benefits and harms of drugs and drown out concerns doctors may have based on basic understanding of science like biochemistry.

The side effects the Lancet left out

For example, the brain is composed of 15% cholesterol, and some statins impair the brain’s ability to manufacture this essential chemical. That’s why perhaps the most important kind of side effect excluded from the Lancet article is cognitive effects, which I see in my friends taking statins as well as my patients who have gotten prescriptions from other specialists. Because the symptoms come on so gradually, most people don’t make the connection to the drug. And as long as the symptoms stay mild, we’ll assume they’re simply experiencing normal aging.

Other important side effects that were not built into the mathematical analysis include liver damage, which is why you need blood testing done before you can start statins. About 1 in 10,000 people suffer kidney damage that’s serious enough to land them in the hospital. And we’re not even looking for less serious damage, but this article concludes that we should.

Muscle damage is discussed in the article, and we’re starting to understand why statins actively disrupt the process of normal muscle maintenance and promote atrophy. So that means there’s another side effect not considered by the Lancet: the weakness that results from muscle atrophy.

And the heart is a muscle. So it’s not surprising, given the known risk of muscle damage from statins, that heart failure is a potential side effect. What did surprise me when I read this article is that the authors suggest it’s actually a good thing that statins weaken heart muscle.

Low cholesterol levels have long been associated with increased risk of cancer. And for certain groups of people, like those over 70 or those with prior cancer, starting statins is more likely to trigger cancer development.

The last common complication of statin therapy I’ll mention is infection. One study evaluated risk of infection while in the hospital after a stroke. Pneumonia and bladder infections are the most common reasons for extended ICU time and death after a stroke, and those on statins are seven times more likely to experience one of these.

A “placebo-controlled” claim that doesn’t hold up

Now, let’s return to the Lancet article. I would like to bring attention to one statement in particular. Regarding the side effect of muscle pain, the authors say that placebo-controlled trials have shown definitively that almost all of the symptomatic adverse events aren’t actually caused by statins, because people on placebo get them just as often.

That would be a worthy point if it had in fact been shown definitively. But in the body of the article, they only cite a grand total of two such trials. Hardly definitive.

What is more outrageous is that the group of people supposedly getting placebo, hence “placebo-controlled,” were in reality also getting injections of an experimental cholesterol-lowering drug, a PCSK9 inhibitor. So the claim that this was a placebo-controlled trial would seem outright false, although admittedly the study description is remarkably unclear.

Read past the abstract!

You can imagine that a busy doctor who reads just the abstract, which sings the praises of statins and overtly recommends that doctors should be prescribing them more often, would be left with the impression that the case for more widespread statin use has been settled. Those doctors who actually read the entire article, and have been able to compare its contents against all the other articles they’ve also actually read in their entirety, would come to a very different conclusion.

In my view, statins are only useful for people who are unwilling to change the habits that damage their lipoproteins.

For more information, see my other articles on statins.