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Statins, one of the most commonly prescribed and bestselling drugs in history, have shaped Western society’s approach to treating heart disease.
By: Vance Voetberg
Statins, one of history’s most commonly prescribed and bestselling drugs, have shaped Western society’s approach to treating heart disease.
Akira Endo, a Japanese-born biochemist, discovered statins from mold. His research garnered the attention of pharmaceutical companies, aiming to find a compound that could effectively lower cholesterol—the assumed cause of heart disease. Merck ultimately obtained samples of the drug and was “astonished at the potency,” recalled by Mr. Endo in his review, spurring the pharmaceutical company to develop its own statin.
In 1987, the U.S. Food and Drug Administration (FDA) approved Merck’s lovastatin, the first commercial statin.
At the same time, questions began to accumulate about this wonder drug.
Statin Benefits: Same Coin, Different Sides
Statins are regarded as life-saving medications because they reduce the risk of heart attacks and strokes, as asserted by numerous studies investigating their safety and efficacy. In these studies, a statistical analysis model called relative risk reduction is often employed to demonstrate drug efficacy.
This model, however, can be misleading, according to Dr. Malcolm Kendrick, a Scottish-based physician who published multiple reviews on cardiovascular disease and statins in academic journals. “It’s a way of hyping benefits,” Dr. Kendrick said.
Suppose there are two groups of 100 people, with the first group taking an experimental pill theorized to prevent heart attacks and the second group taking a placebo. During a trial time of two years, the first group only experienced one heart attack, while the second group recorded two.
Statistically, the experimental pill appears to be insignificant in its cardiovascular protection. But when the relative risk reduction is applied, the pill shows a 50 percent efficacy in decreasing heart disease compared to placebo, given that there was one fewer heart attack in the treated group.
This inflation of data receives raving media coverage. Reporting the results of a large 2008 study, The New York Times noted that the risk of heart attack was “more than cut in half” by statins. The study evaluated AstraZeneca’s rosuvastatin (Crestor) on 17,802 people without high cholesterol, finding about a 50 percent relative risk reduction of heart attack in the statin group.
Another study, commonly cited to exemplify statins’ robust protective effects, is a large trial investigating Pfizer’s atorvastatin (Lipitor), called ASCOT-LLA. In this case, statins were 36 percent more protective than the placebo.
However, the absolute risk reduction for both studies was approximately 1 percent.
As opposed to relative risk reduction, assessing the efficacy of a drug is more accurately interpreted by using absolute risk reduction, said Dr. Kendrick.
In a 2022 investigative report published in JAMA Internal Medicine, researchers from different countries reviewed 21 clinical studies on statins. They averaged a relative risk factor reduction of all-cause mortality by 9 percent and for heart attacks by 29 percent. The absolute risk reduction, however, was 0.8 percent and 1.3 percent, respectively. The researchers noted that the absolute benefits of statins were “modest” and “should be communicated to patients as part of informed clinical decision-making.”
There is a big difference between these two types of data, and the data a study chooses to present could influence how people perceive the efficacy of statins, wrote Dr. T. Grant Phillips in a letter published in American Family Physician.
The Close Financial Ties
Who is behind the studies proving statins’ ostensible benefits? It’s a crucial question to ask, according to Dr. John Abramson, lecturer emeritus of health care policy at Harvard Medical School.
“Virtually all of the major clinical trials of statins were funded by the manufacturers—when the drugs were still on patent,” he said.
In a 2015 investigative meta-analysis published in The Journal of American Cardiology, researchers reviewed all phase 2 and 3 clinical trials in a decade. They found that nearly 80 percent of the trials had a conflict of interest, and almost 60 percent involved over half of the authors. Of these studies, 54 had favorable outcomes, and only 12 had unfavorable results.
The financial ties allowed the manufacturers to design the studies and select patients most likely to benefit from and not be harmed by statin therapy. These ties also allowed the manufacturers to not compare the benefit of statin therapy to the benefit of adopting healthy lifestyle habits and not to ask prospectively about side effects, Dr. Abramson explained.
Furthermore, the peer reviewers of medical journals who review these papers “do not have access to the actual data from the trials and must trust the usually manufacturer-supervised or reviewed manuscript as an accurate and complete summary of the trial results,” he added.
In 2013, in conjunction with the American College of Cardiology (ACC), the American Heart Association (AHA) updated its cholesterol guidelines, significantly broadening the criteria for determining which patients would benefit from statin therapy.
Previous cholesterol guidelines targeted the prevention of coronary heart disease, whereas the 2013 guidelines further expanded the focus to stroke and peripheral arterial disease. As a result, the number of individuals who used statins increased by 149 percent from 2013 to 2019, reaching 92 million.
Dr. Robert DuBroff, a cardiologist and retired professor at the University of New Mexico School of Medicine, reported multiple conflicts of interest with cholesterol guidelines’ framers, including the 2013 guideline, in the Quarterly Journal of Medicine (QMJ). The guidelines’ authors also failed to include multiple studies that conflicted with their recommendations, which is evidence of confirmation bias, he said.
Doctors seeking to prevent coronary heart disease by lowering cholesterol are confronted by “a bewildering array of drugs, guidelines, indications, warnings and contraindications,” wrote Dr. DuBroff. “They expect these opinions to be comprehensive, balanced, unbiased and unsullied by financial conflicts. Unfortunately, these examples illustrate that some expert opinions fall short of these standards.”
The AHA accept “millions of dollars from Big Pharma, Big Food, and medical device companies,” explained Dr. Barbara Roberts, director of the Women’s Cardiac Center at The Miriam Hospital in Providence, Rhode Island, and associate clinical professor of medicine at the Alpert Medical School of Brown University. In 2022, the AHA received nearly $34 million from pharmaceutical companies—including multiple statin manufacturers, according to 2021–2022 financial reports.
In response to the Epoch Times’ request, the AHA stated that it has strict policies to prevent these relationships from influencing science. “Most of our revenue—nearly 80 percent—comes from sources other than corporations,” the AHA wrote. Regarding the guidelines, it said, “The majority of the writing committee experts [have] no relevant relationships with industry.”
Downplaying the Side Effects
Pharmaceutical companies also seek to “downplay or deny” the significance of statins’ side effects, according to Dr. Beatrice Golomb, a medical professor and statin researcher at the University of California San Diego School of Medicine. In the 2008 and ASCOT-LLA studies involving Pfizer and AstraZeneca drugs mentioned earlier, for example, researchers reported no noticeable difference in adverse effects between the groups that received statins and placebo.
Neither company has responded to The Epoch Time’s requests for comment.
Another industry-funded meta-analysis of 19 statin trials with declared conflicts of interest found that statins only rarely “cause substantial muscle damage.”
Some independent studies, however, show significant differences.
The most common and noticeable side effects are muscle-related problems, with one report noting that 51 percent of statin users experience muscle pain, while a 2022 study showed between 70 percent and 80 percent of users experience it.
Many doctors are familiar with patients reporting muscle-related problems while taking statins but misinterpret study evidence and presume the symptoms are unrelated, “telling patients that the symptoms are merely psychological, due to age, stress, or other factors,” Dr. Golomb said.
