PHARMA

This 2016 debate features arguments for and against the use of statins in primary prevention.

For the past 170 years, there have been two main competing ideas about what causes cardiovascular disease. One of them, the cholesterol or lipid hypothesis, has come to dominate. The alternative hypothesis has had different names over the years — e.g., the encrustation hypothesis, thrombogenic hypothesis, and response to injury hypothesis. In the first article in this four-part series, Dr. Malcolm Kendrick explains this alternative hypothesis, outlines its brief history, and proposes why it may have fallen out of favor.

This trial indicates metformin suppresses gains in strength and muscle mass associated with resistance training in elderly patients. Its results support previous research suggesting the drug suppresses the benefits of resistance training in multiple populations. In patients who do not require immediate improvements in glycemic control, metformin’s suppression of exercise-induced muscle strength and size gains could increase risk of disability and mortality. These risks may provide an argument for not prescribing metformin to elderly patients. In diabetic and prediabetic patients, it is worth considering non-pharmaceutical treatments that lead to improved glycemic control without reducing the benefits of exercise.

Dr. David Diamond, a Ph.D. in biology and neuroscientist with 40 years of experience, speaks about cholesterol science and the various forms of deception apparent in research on cholesterol-lowering statins. Diamond developed an interest in cholesterol and statins in 1999 after being diagnosed with familial hypertriglyceridemia, a genetic anomaly that causes triglyceride levels in the blood to become elevated, leading to additional health complications such as obesity. After realizing that the dietary and pharmaceutical recommendations he was given were all wrong, Diamond began to investigate the sources of the misinformation. In this presentation, he shares how his discoveries conflict with received wisdom about cholesterol and statins and explains how and why we have been deceived by companies that seek to profit from our ignorance.

This 2019 review analyzed randomized controlled trials testing the effect of one or more dietary factors on heart disease incidence, heart disease mortality, or overall mortality. It found that nearly all common dietary patterns and supplements fail to reduce cardiovascular risk or overall mortality. Notably, no diet focused on modifying the amount or type of fat in the diet had any significant impact on overall mortality, cardiovascular mortality, or cardiovascular risk.

Dr. Maryanne Demasi worked as a journalist and producer for the Australian Broadcasting Corporation (ABC) for 11 years. In 2013, she produced a two-part series called “Heart of the Matter,” which challenged the role of cholesterol in heart disease and addressed the overprescription of statin drugs. The series received excellent ratings and was praised by ABC management for being “superbly presented” and “provocative.” Over time, however, reception became less favorable. Demasi attributes the shift to the media storm stirred by those with vested interests in statins. Here, she shares her story and explains why the fallout is indicative of a “crisis of democracy” in the sciences.

Dr. Malcolm Kendrick discusses recent concerns in the medical community regarding the potential for bias in clinical research on statin therapy. He reviews the various reasons statin trials may be unreliable, including selective publication of results and strategic shifting of trial endpoints during ongoing studies. Despite the apparent evidence-based support of statin therapy and measures taken in the 1990s and early 2000s to mitigate bias, Kendrick urges doctors to proceed with caution when recommending the drugs. Echoing another review from 2015, Kendrick claims “a complete reassessment [of their efficacy and safety] is mandatory.”

Statins are the most widely prescribed class of drugs in the world and thought to be beneficial for reducing cardiovascular events and relatively risk-free. Dr. Malcolm Kendrick approaches such ideas with skepticism, here reviewing the research behind such claims and sharing the sleight-of-hand tactics used to promulgate them. While much of the data related to statin studies remains hidden from independent researchers, Kendrick finds that available data has been framed in misleading ways. Reviews of studies that tout statins’ effects on mortality reveal statistically insignificant outcomes and leave open the possibility that adverse events could offset statins’ very minuscule benefits.

The authors of this 2016 review find compelling early mechanistic evidence that insulin and IGF-1 suppression may have anti-cancer effects. They also find substantial evidence to suggest diets that reduce insulin and IGF-1 levels reduce tumor progression in rats; human evidence, however, is preliminary.

Statins inhibit the synthesis of cholesterol and decrease levels of low-density lipoproteins, which many believe are atherogenic. Since their development in 1987, statins have become the single most prescribed class of drugs in medicine, and well over 100 million people worldwide take them daily. Here, Dr. Malcolm Kendrick discusses some of the controversies surrounding the popular drugs and explains the evidence that suggests their benefits may be overstated and their adverse effects significantly underestimated.

"Marcia Angell of Harvard Medical School and the author of 'The Truth About the Drug Companies' talks with EconTalk host Russ Roberts about the impact of pharmaceutical companies on academic research, clinical trials and the political process. Angell argues that the large pharmaceutical companies produce little or no innovation and use their political power to exploit consumers and taxpayers."

In a follow-up to Marcia Angell's analysis of “The Illusions of Psychiatry,” four critics in the field respond to her assessment of psychiatric drugs and the influence of the pharmaceutical industry. Angell responds, reiterating her claim that publication bias clouds the psychiatric drug literature. Two papers by Erick Turner corroborate Angell’s claim.

In this two-part series published in The New York Review of Books under the titles “The Epidemic of Mental Illness: Why?” and “The Illusions of Psychiatry,” Marcia Angell summarizes three books that strongly criticize the pharmaceutical treatment of psychiatric disorders, and particularly the role the pharmaceutical industry has played in shaping public and medical perception of them.