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Why Do Statins Remain Controversial?

The statin wars have been raging for decades. How can statins remain controversial after so many years? A doctor takes us to task on statins!
Why Do Statins Remain Controversial?
Atorvastatin active ingredient in drug as international nonproprietary name of active pharmaceutical substance concept photo. Packaging with label “Atorvastatin medication”

When the first statin drug was approved, we were cautiously optimistic. Lovastatin (Mevacor) was introduced in 1987. Four years later, we published a book titled Graedons’ Best Medicine (Bantam © 1991). We wrote that Mevacor was highly effective at lowering LDL cholesterol. But we did note that “Mevacor may actually increase one important risk factor for atherosclerosis called Lp(a).” Fast forward 30 years. Why in the world would lovastatin, atorvastatin, simvastatin and other statins remain controversial more than three decades later?

Statins Rule!

After 34 years, you might imagine that people would be bored with statins. That does not seem to be the case, however. Statins remain controversial in part because they dominate the pharmaceutical marketplace.

Statins are among the most prescribed pharmaceuticals on the planet. The last time we checked, atorvastatin (Lipitor) was taken by over 21 million Americans. Add in other statins and you end up with well over 200 million statin prescriptions dispensed annually. If there are 30 pills in a bottle (and many prescriptions are now sold with 90 pills), you would end up with a mind-boggling number of swallowed pills: 6,510,000,000. That’s over 6 billion in the US alone.

Statins have made a ton of money for the pharmaceutical industry. Some pundits have placed total statin sales at 1 trillion dollars. That is a number that is hard to comprehend. 

Many Doctors Don’t Think Statins Remain Controversial:

A physician recently wrote to chastise us:

“I write about your article, Can Statins Cause Transient Global Amnesia? I agree with your remarks except the first part. To begin your piece, you wrote:

“‘Statins remain controversial.’ Then you say: ‘Most physicians insist they protect the heart.’

“Taken together, these remarks will cause many people to believe that statins are inappropriately prescribed by doctors and that they are not really beneficial. That contradicts the guidelines of all orthodox American medical groups. Those who deny the value of statins for the population as a whole do not represent the standard view.

“Physicians do not ‘insist’ that statins protect the heart. Evidence proves that they protect the heart and other organs too.

“You do your readers a disservice by casting unwarranted doubt on this valuable class of drug. Mountains of solid medical research from all over the globe show the very favorable risk/benefit ratio of these drugs.

“There are some controversial issues associated with statins. (1) What side effects do they cause? (2) Are there some groups where the risk/benefit ratio does not favor their use?

“Any drug can cause side effects. I believe that statins cause cognitive changes in some people (as you argued), along with other undesirable side effects. Some people cannot tolerate statins, but the vast majority can use statins without problems. If statins make you sick, you should work with your doctor to change the medicine.

“The main point for your readers is this: For the millions of Americans who meet the guideline criteria, the benefits far outweigh the risks.”

The Statin Wars and Statistics:

We appreciate this physician’s perspective. It is the mainstream view of most cardiologists. Guidelines encourage physicians to prescribe statins to almost every man over the age of 64 and every woman over 70. That is regardless of risk factors. 

Statins remain controversial because of questions about side effects and the balance of benefit to risk. Many people assume that statins represent a magic bullet against heart disease, heart attacks and premature death. They may conclude that if their LDL cholesterol levels remain low, even if they eat burgers, fries and milkshakes, they have nothing to worry about.  And many physicians assume that side effects are minor or nonexistent for most people.

People don’t always understand the absolute benefit of statins. For example, a Lipitor ad many years ago stated enthusiastically that this drug (atorvastatin) lowered the risk of heart attacks by 36 percent. That was a relative risk, though.

The manufacturer put an asterisk beside that number, which led to an explanation of the absolute risk:

“That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

The way we interpret this, only one person in 100 over the course of the five-year study actually prevented a heart attack by taking Lipitor. In this study, no lives were saved.

Statins Remain Controversial Because Some Cardiologists Disagree with Their Colleagues:

An analysis by three cardiologists in the journal BMJ Evidence-Based Medicine (Aug. 3, 2020) concluded:

“This analysis highlights the discordance between a well-researched clinical guideline written by experts and empirical evidence gleaned from dozens of clinical trials of cholesterol reduction. It further underscores the ongoing debate about lowering cholesterol in general and the use of statins in particular. In this analysis over three-quarters of the cholesterol lowering trials reported no mortality benefit and nearly half reported no cardiovascular benefit at all.”

Did you understand that conclusion? “No mortality benefit” means no lives were prolonged or saved in the majority of clinical trials. We suspect that comes as a shock to most physicians. The idea that well-conducted clinical statin trials did not always lead to longer life seems like heresy. And that is why statins remain controversial.

But Wait…There’s More!

JAMA Internal Medicine is a highly reputable, peer-reviewed journal. An analysis of data from a study called SPRINT (Systolic Blood Pressure Intervention Trial) offered some intriguing conclusions (JAMA Internal Medicine, April, 2018): 

“Participants in the SPRINT trial 65 or 70 years or older without diagnosed CVD who were taking statins at baseline had no significant differences in primary outcomes compared with those not taking statins with or without adjustment for nonrandom statin use.

“We still do not have sufficient numbers of primary prevention trials to make strong recommendations about statins in intermediate-risk populations (6%-12% 10-year risk), at least on the basis of survival. Yet even in this relatively high-risk older adult population (22%-25% 10-year risk), significant reductions in cardiovascular events were not found.”

You can read more about the guidelines and why statins remain controversial at this link

Should Everyone Over 65 Take a Statin to Prevent a Heart Attack?
Statins can help prevent a second heart attack in middle-aged people. What about older people? Will a statin prevent a heart attack in the first place?

We know that many cardiologists believe 1) that statins prevent heart attacks and strokes and save many lives annually and 2) that statins have few, if any side effects. We have no doubt that such drugs do save lives. How many remains controversial. And when it comes to statin side effects, that too remains highly controversial.

We close this article with an editorial from Rita Redberg, MD, MSc. She is a highly regarded cardiologist at the University of California, San Francisco Medical Center. She is also Editor-in-Chief of JAMA Internal Medicine. She is as mainstream as they get.

Dr. Redberg and a colleague offered this perspective (JAMA Internal Medicine, Jan. 2017): 

“Using the current data, the decision aid shows that of 100 people who take a statin for 5 years, only 2 of 100 will avoid a myocardial infarction [heart attack], and 98 of the 100 will not experience any benefit. There will be no mortality benefit for any of the 100 people taking the medicine every day for 5 years. At the same time, 5 to 20 of the 100 will experience muscle aches, weakness, fatigue, cognitive dysfunction, and increased risk of diabetes.”

You can read more about Dr. Redberg and the Statin Wars at this link

Do Doctors Hate Stories of Statin Side Effects?
Have you ever experienced statin side effects? Some cardiologists think stories of statin side effects are fake medical news or worse, fear mongering.

Why Do Statins Remain Controversial?

The physician who contacted us believes that:

“For the millions of Americans who meet the guideline criteria, the benefits [of statins] far outweigh the risks.”

That is doubtless the mainstream medical view. We always recommend that people with heart disease and those at high risk should follow their doctors’ guidance, which may well include statins.

We recognize that many patients do not experience statin side effects. But we have heard from thousands of readers about irreversible muscle damage, cognitive impairment and other serious complications. So, statin side effects should not taken lightly.

Statins do remain controversial even after three decades. We fear the statin wars at not over. Read more about other risk factors and dietary strategies to reduce risks in our eGuide to Cholesterol Control & Heart Health

What Do You Think?

Please share your experience with statins. If you have tolerated the drugs well, let us know. If you have experienced statin side effects, please share your story in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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