Rethinking Statins: Inside the Fierce Debate Over Cholesterol and Heart Health

On clear winter mornings, Steve Kaplan hikes up a nearby ski hill in California at Lake Tahoe, before the resort opens to ski back down as the sun crests the Sierra Nevada mountains. Kaplan, 68, is active, eats well, practices yoga and has never been a smoker.

And yet, he has advanced heart disease. A few years ago, Kaplan’s doctor discovered that plaque was blocking blood flow through several major arteries in his heart, including the one nicknamed the “widowmaker” due to its frequent involvement in fatal heart attacks. Heart disease runs in his family, but Kaplan was still caught off guard.

“I was literally shocked, despite my family history, that I could have so much plaque,” he said.

The first cardiologist he saw recommended medication and warned he might need surgery, but Kaplan, who considers himself healthy, was not convinced. He sought a second opinion, then a third, fourth and fifth.

“The only thing they all had in common was they all said: you have to be on a statin,” Kaplan remembers. Statins are cholesterol-lowering medications thought to decrease heart disease risk by preventing plaque buildup.

“I was scared to death,” he said. So when the doctor prescribed the generic statin rosuvastatin (brand name Crestor), he started taking it immediately.

Cholesterol: The Risks of Too Little — and Too Much

Kaplan is one of roughly 90 million Americans — about 1 in 3 — taking a statin drug every day to manage cholesterol. Statins were introduced in the 1980s to treat people with high cholesterol, a risk factor for heart disease. However, in the decades since, researchers and clinicians have adopted a more comprehensive approach to metabolic and cardiovascular health. Some worry that the early emphasis on cholesterol and statins now distracts from other important risk factors, such as diet and lifestyle.

Cholesterol is a waxy type of fat produced by the liver and absorbed from food. It is critical for hormone production, cell membrane structure, and other essential functions, but it can also form plaques on artery walls that restrict blood flow. Even though cholesterol is essential to the body, in excess, it’s a risk factor for cardiovascular diseases.

“It is kind of a Goldilocks phenomenon: not enough [cholesterol] is not good; too much is also not good,” says Heather Ferris, M.D., P.hD., a clinician and endocrinologist at the University of Virginia.

The type of cholesterol doctors are most concerned about is low-density lipoprotein (LDL), a.k.a “bad” cholesterol. LDL transports cholesterol molecules from the liver through the body. High-density lipoprotein (HDL), the “good” cholesterol, carries cholesterol molecules back to the liver for digestion. Statins disrupt cholesterol production in the liver, where most of the body’s supply is produced. Decreasing cholesterol production frees up receptors to remove excess cholesterol from the bloodstream.

There are eight approved formulations of statin drugs, all of which work similarly but vary in their cholesterol-lowering capability or intensity. When Merck debuted the first statin drug, lovastatin, in the 1980s, it was hailed as a “treatment breakthrough” by the New York Times.

At the time, experts said statins would shape the future of medicine, and indeed they did, heralding a new era in drug development and prescribing practices.

Behind The Statin Wars: Conflicting Evidence and Industry Influence

Despite the initial fanfare, statins were contentious from the get-go. The same 1987 New York Times piece that praised the medication as a breakthrough also quotes Robert Levy, M.D., former director of the National Heart, Lung and Blood Institute, expressing concerns about overprescribing and side effects, which can include muscle aches, fatigue, headache, and digestive issues as well as increased diabetes risk and possible cognitive impairment.

When statins were first introduced, they were marketed as a treatment for familial hypercholesterolemia. This genetic condition predisposes people to high LDL cholesterol and heart disease from a very young age. Statins revolutionized treatment for individuals with this condition, and as pharmaceutical companies continued to roll out new versions through the 1990s and early 2000s, they slowly became applicable in other scenarios.

Some experts argue that the side effects are more serious than initially indicated, and the benefits may have been overstated to drive early sales. While statins remain widely recommended for treating familial hypercholesterolemia and existing heart disease, their use for primary prevention — reducing the risk of heart disease before it develops — is more controversial.

“I think our whole focus on cholesterol is misguided,” notes Rita Redberg, M.D., a cardiologist at the University of California, San Francisco. Blood cholesterol levels are just one part of cardiac risk, and this fixation on cholesterol leads to doctors writing more prescriptions instead of encouraging lifestyle changes, she adds.

Dr. Redberg has authored several academic articles showing that statins offer only modest benefits, if any, for people without preexisting cardiovascular disease.

In 2013, she brought that skepticism to a broader audience, co-authoring a New York Times op-ed with John Abramson, M.D., MSc, a family physician and lecturer at Harvard Medical School. Together, they urged caution against expanding statin prescriptions to millions of Americans with no history of heart disease.

That same year, Dr. Abramson published a separate analysis in the British Medical Journal — one of the world’s most reputable medical journals — claiming that the health benefits of statins have not been established for individuals with relatively healthy hearts, whose probability of developing cardiovascular disease is still low.

Judging by today’s prescribing rates, their warning appears to have been largely ignored.

Doctors evaluate heart disease risk by entering a person’s health metrics, such as total cholesterol and blood pressure, and medical history into a risk calculator that estimates their probability of developing cardiovascular disease in the next 10 years. Dr. Abramson’s argument stems from inconsistencies he observed in a meta-analysis published by The Cochrane Library, one of the largest medical data repositories.

In the 2011 meta-analysis, independent reviewers highlighted the lack of evidence for using statins to prevent heart disease. But just two years later, those same authors reversed course, claiming that the drug lowers the risk of having a heart attack or dying without adding any risks of side effects. This shift followed the release of new data from the Cholesterol Treatment Trialists (CTT), which Abramson and colleagues claimed were misleading, arguing that the CTT analysis used parameters that exaggerated the health benefits in the data while ignoring well-documented side effects.

Around the same time, Aseem Malhotra, M.D., a cardiologist at the Croydon University Hospital in London, published a brief statement in the BMJ calling cholesterol a “diversion” from other, more egregious risk factors, such as diets high in sugar.

One of Dr. Abramson and Dr. Malhotra’s most outspoken critics was Rory Collins, M.D., an epidemiologist at Oxford University who led the CTT. Dr. Collins defended the data and accused Drs. Abramson and Malhotra of spreading misinformation. Their work, he argued, showed “a deliberate intent to mislead the medical profession and the public despite the potential for harm to patients.”

Despite Dr. Collins writing numerous letters demanding that the papers be retracted, an independent panel of reviewers recommended against it. The decision was a win for Drs. Abramson and Malhotra, and an endorsement of their findings.

Additionally, while Dr. Collins’ team claimed they did not receive industry funding, 23 of the 24 trials providing their data were funded by industry sponsors.

Regardless of the spirited back and forth and concerns over possible financial motives, statin use more than doubled in the US between 2009 and 2019.

Statins for Everyone? How Guidelines Redefined ‘At Risk’

To explain the growing number of people taking statins for primary prevention, many point to the blood cholesterol treatment guidelines published by the American Heart Association (AHA) and the American College of Cardiology (ACC), which came out just after Dr. Abramson and Dr. Malhotra’s BMJ articles.

Previous guidelines set numerical thresholds for LDL, ranging from optimal to very high, and advised doctors to treat patients with a value in mind. The 2013 guidelines moved away from the “treat to target” approach and instead divided people into “statin benefit groups,” which recommended statins for anyone 40-75 without a history of cardiovascular disease whose risk score was higher than 7.5%.

The recommendations were met with immediate pushback.

Just weeks after the 2013 guidelines were released, a pair of Harvard Medical School doctors, Paul Ridker, M.D., MPH, and Nancy Cook, ScD, claimed that the AHA’s calculator overestimated risk by 75 to 150%, qualifying more than 45 million people with no prior heart disease for statin therapy in the U.S.

By their estimates, 40-50% of people now eligible for statin therapy qualified only because the risk calculator was flawed.

Still, leadership at the AHA and ACC defended their guidelines, calling them an improvement to the previous recommendations, which accounted only for LDL cholesterol but ignored other factors.

In 2018, the AHA and ACC revised their cholesterol guidelines once again. The updates placed renewed responsibility on doctors to stay current, emphasizing not just a patient’s risk of heart disease, but also incorporating target LDL cholesterol levels (100 mg/dL or lower) and additional risk factors such as family history and metabolic conditions.

The updated guidelines also reference alternative cholesterol-lowering medications for those who do not tolerate statins well. With the new guidelines comes an updated cardiac risk calculator —basically the same one criticized for grossly overestimating risk.

But the true benefits of statins remain subject to debate.

In 2016, an independent panel of government-funded researchers analyzed data on more than 70,000 patients with elevated risk of cardiovascular disease (including those with high cholesterol, hypertension, and/or diabetes) and found that statins lowered the absolute risk of stroke by 0.38% (or 38 in 10,000) and heart attack by 0.81% (or 81 in 10,000), regardless of sex, age, or cardiovascular risk. The risk of dying from a cardiac event was just 0.2% (or 20 in 10,000) lower in people on statins.

This analysis seems to support Dr. Redberg’s argument that the benefit of statins for low-risk individuals may have been overblown. For reference, blood pressure medication can reduce the absolute risk of any cardiovascular disease-related event by 4.3% in high-risk patients.

Weighing the Risks: Side Effects of Statins

The argument against statins is not limited to debating their efficacy. Some clinicians joke that statins are so ubiquitous we might as well put them in drinking water, a turn of phrase that suggests that they are also risk-free.

But like any drug, statins can produce side effects, which include muscle aches, an increase in blood sugar level, and possible cognitive decline. The frequency of these effects varies. Statin-related muscle symptoms affect about 5 to 10 out of every 100 users, while roughly 4 in 1,000 people who take statins for four years or longer may develop diabetes as a result of taking statins.

“Patients think they’re all going to be helped immediately by taking a statin, and I don’t think we’re explaining the actual risks and benefits well enough,” notes Dr. Redberg.

Muscle Symptoms

Statin-associated muscle symptoms are one of the most common side effects and can present as muscle cramping, aching, and stiffness. These observations are based on association, making it difficult to prove a causal link, given that most studies only look at associations. For some people, muscular symptoms may discourage them from engaging in basic physical activity, which is critical to heart health.

“If you take a drug, and it causes muscle weakening so bad that you can’t climb the stairs or go for a walk, that’s having the exact opposite effect that it should have,” said Alan Cassels, MPA, an independent drug policy researcher at the University of Victoria, Canada.

Diabetes Risk

In 2012, the FDA issued a warning stating that statins can also increase a person’s risk of developing diabetes, citing several studies showing that statins were associated with high blood sugar, a hallmark of diabetes. This warning prompted cautionary updates to statin drug safety labeling, notifying physicians and patients of the potential adverse effects.

One trial reported a 27% increase in diabetes risk for people taking rosuvastatin for two years. Another large-scale analysis of close to 100,000 people found that statins were associated with a 9% increase in risk of developing diabetes after four years.

According to a study in post-menopausal women, also cited by the FDA, this effect is independent of dosage and type of statin, suggesting that any statin at any dose may increase diabetes risk after three years.

Although statins have been linked to increased insulin resistance and production, which can lead to elevated blood sugar, the relationship between statins and diabetes is still not entirely clear.

“There’s a small increased risk of developing diabetes in the general population,” says Dr. Ferris. “But diabetes is manageable,” she adds, and in her view, the potential rise in blood sugar is “inconsequential” when weighed against the risk of a heart attack.

Dr. Ferris also notes that most of her patients have already been diagnosed with both diabetes and heart disease, which makes treatment decisions more clear-cut.

Cognitive Impairment

Cognitive side effects are more difficult to quantify, as research findings on their prevalence remain mixed and inconclusive: Although statins may be associated with cognitive impairment, it’s not certain that they cause it. Some studies even showed that statins may reduce the risk of Alzheimer’s disease and dementia.

The 2012 FDA warning also cautioned statin users about cognitive side effects, such as memory loss and confusion. In one survey of 170 individuals, 75% reported experiencing cognitive side effects, “probably or definitely related to statin,” while other studies reported no cognitive decline after a three-year follow-up.

Current guidelines for statin use put forth by the US Preventive Services Task Force, an independent, volunteer panel of experts, note that statins may or may not benefit adults over 75 years old with no history of heart disease, citing insufficient data on the benefits and potential harms to this population.

Other ‘Debilitating’ Side Effects

While additional side effects like headaches, sleep disturbances, digestive, liver and kidney issues have also been reported, studies supporting these claims are limited.

Despite the lack of consistency in data on side effects from statins, anecdotal evidence suggests that adverse reactions do occur and can be debilitating.

Dr. Redberg reports seeing patients who describe trouble walking, stomach issues and brain fog after starting a statin. And when they stopped taking them, their symptoms tended to dissipate.

Although the incidence of side effects varies, one survey of more than 10,000 people found that more than half who had stopped taking statins had done so due to the side effects.

Prevention, Not Perfection: When A Statin Prescription Might Make Sense

Despite his skepticism, Kaplan has opted to continue taking a very low dose of statins to manage his cholesterol. “However many cardiologists there are in the world,” he says, “they can’t all be in cahoots.”

No matter how tenuous and contentious the link between cholesterol and cardiovascular disease is, there are still plenty of doctors who prescribe statins for primary prevention.

Although medical practice guidelines have set certain thresholds for cholesterol, what constitutes a healthy level varies from person to person.

Despite what seems to be a black-and-white description of healthy cholesterol levels, “we don’t know what ‘normal’ LDL cholesterol is,” said Vijay Nambi, M.D., a preventive cardiologist at Baylor College of Medicine. “The question is whether we want to treat it or not.”

The clinical definition of desirable LDL cholesterol continues to evolve, notes Dr. Nambi. The takeaway is that cholesterol is a risk factor for heart diseases, and treatment decisions should be guided by other underlying risks as well, he adds.

It is worth noting that the link between LDL cholesterol levels and plaque progression varies from person to person. A 2022 study in Denmark involving 20,000 people found that almost half of the participants did not have plaque, but the percentage of high-cholesterol subjects with plaque was only 64%, compared with 56% in the lowest cholesterol cohort, suggesting a weak link between LDL cholesterol and plaque accumulation.

Even so, prolonged exposure to high LDL cholesterol is thought to accelerate atherosclerosis, or plaque buildup, which increases cardiovascular disease risk.

By 30, most men and women would have accumulated some plaque in their arteries. Atherosclerosis is a “lifetime achievement award,” Dr. Nambi says. “If you live long enough, you’re going to get it.”

Because these fatty deposits worsen with age, keeping cholesterol in check is considered an effective strategy for mitigating risk.

Whether or not someone decides to take a statin, it’s important to note that the drugs don’t “fix” high cholesterol, which can be genetic or diet-related. Once someone stops taking a statin, their cholesterol will likely rebound. Lifestyle changes are important for cardiovascular health and produce a more prolonged effect, but the effects on cholesterol are smaller, says Dr. Nambi.

Dr. Ferris agrees. Diet and lifestyle changes are “better for people in the long run,” she notes. But dieting may be difficult, and cholesterol-lowering medications can help people reach otherwise unattainable goals, she continues.

Starting statins early for eligible people could prolong their healthy years, but it’s difficult to recommend treatment for something that hasn’t become a problem yet, Dr. Nambi acknowledges.

Rethinking Statins: Tailoring Treatment to the Patient

The apparent lack of consensus amongst doctors regarding statins drives many people to seek advice on social media.

After Steve Kaplan started taking statins, he discovered a group on Facebook called “STATINS – the silent killer!” with more than 30,000 members. Post after post details questions and concerns about statins.

Although the page is “full of zealots,” Kaplan says, he sees merit in some of the claims. After joining the group, he devoured more than a dozen books on heart health. He now takes just 5 milligrams of a statin daily, even though his cardiologist suggested 40 milligrams.

Kaplan is also vigilant about his health data. “A cardiologist might say that’s like representing yourself at a trial,” he said, but he feels more comfortable being in control.

Many of the questions feeding this controversy stem from a lack of clarity around the true role cholesterol plays in health and longevity, said Nick Norwitz, Ph.D., a health influencer and medical student at Harvard University with a doctorate in metabolism from Oxford University.

“I think sometimes in medicine, we don’t always communicate the full picture,” he says.

In 2024, Norwitz published an attention-grabbing case study suggesting that eating Oreo cookies daily for two weeks lowered his cholesterol more effectively than statins. He notes that his cholesterol levels rose several years earlier after adopting a ketogenic diet, which replaces high-carbohydrate foods like bread with high-fat options such as meat and eggs.

The purpose of a ketogenic diet is to burn fat instead of sugar, inducing a state called ketosis, which can elevate cholesterol. For people whose cholesterol spikes in response to their ketogenic diet, Norwitz isn’t convinced that cholesterol is a reliable health metric.

His cookie experiment was meant to “put a spotlight on the physiology of why cholesterol goes up,” he says. With just one participant, his methods lacked rigor and should not be interpreted as medical advice. Still, “It draws an interesting tension out,” he says. “You have a ‘bad’ intervention for what is perceived to be a good outcome.”

His experiment teed up a larger study published on April 7, 2025. Norwitz and colleagues investigated the link between high cholesterol and plaque in other people on ketogenic diets with high cholesterol.

The study tracked 100 people who had been on a ketogenic diet for two years before enrolling and had experienced at least a 50% increase in their cholesterol after starting the diet.

The results were surprising. Individuals with high cholesterol and no plaque did not have more plaque at the end of the year-long study, but those with existing plaque did. Norwitz and his team concluded that in this population, plaque is a more significant risk factor than high cholesterol.

“I think that one of the major takeaways from this research is that the narrative that’s often put forth is overly simplified,” notes Norwitz, who claims it is the first time LDL cholesterol has been isolated as a variable, and the results suggest that cholesterol alone is not the problem.

So why, then, do so many doctors recommend lowering cholesterol levels with a statin to improve heart health?

Bret Scher, M.D., a cardiologist and lipidologist in San Diego with ties to the ketogenic diet study, said the explanation is layered. The calculators that spit out cardiovascular risk, used to determine statin eligibility, are imperfect, he says. Plus, doctors and patients are inundated with advertisements touting the benefits of statins.

Statins “absolutely have a role” for treating people with cardiovascular disease. But “they’re not the end-all and be-all treatment,” says Dr. Scher.

“We like to polarize things and say statins are great, or statins are evil,” he adds. When in fact, the utility of statin drugs varies between individuals.

Like Dr. Redberg, he recommends considering LDL in the context of metabolic health. The ketogenic diet study findings reveal that cholesterol levels alone do not define a person’s health and might not predict their heart disease risk, he adds

“You just want to make sure you’re not getting the knee-jerk statin prescription,” continues Dr. Scher. Health metrics, including cholesterol, are personal, and, he says, “we can’t treat everybody the same.”

Disclosures

Vijay Nambi, M.D., is an investor at Insera Therapeutics, a company that develops catheters for treating blood clots. He has completed a research project that received funding support from Roche. He was also a site investigator for a study sponsored by Ionis Pharmaceuticals. None of these were related to statins.