Fourier was a large human clinical trial that assessed whether the injectable drug, evolocumab, brand name Repatha, reduces cardiovascular events in people already taking a statin cholesterol drug. The clinical trial reported a 59% reduction in LDL cholesterol (92 mg/dl reduced to 30 mg/dl), resulting in a 1.5% reduction in cardiovascular events over three years. (The investigators reported this as a 15% reduction in events using the same logic that a reduction of 2 heart attacks for every 100 people that is reduced to 1 heart attack for every 100 people is a reduction of 50%, a wild statistical exaggeration, a trick called “relative risk.” But that’s how Pharma works: efficacy is so lousy that you use statistical tricks to impress.) Take a look at the disclosures of potential conflicts of interests from the investigators performing the study for the company, Amgen: They received money from numerous sources, both as grants as well as direct payment for conducting the study. You can’t help but conclude that the investigators and the pharmaceutical company are one and the same. For all practical purposes, the drug company conducted the study, tabulated results, interpreted findings such as cause of death, and analyzed the data.
Interestingly, another group called the Restoring Invisible and Abandoned Trials (RIAT), a watchdog group that reviews the accuracy of clinical studies, independently re-analyzed the Fourier data and reported “significant inconsistencies and misreporting” in the study. Specifically, they reclassified a large number of deaths of undetermined cause as sudden cardiac deaths. With this reanalysis, administration of evolocumab increased cardiovascular events and deaths. The original investigators have countered these assertions, arguing that many of these deaths were indeed not cardiovascular.
Regardless of who is right, we can come to some definitive conclusions in view of this and numerous other studies asking similar questions:
- Dramatic reduction of cholesterol to as low as LDL of 30 mg/dl minimally reduces cardiovascular events, if at all, and may increase deaths from other causes
- Cardiovascular events continue at a high rate in participants receiving treatment and those receiving placebo despite ongoing statin drug therapy. For example, in the original Fourier dataset, of the 13,784 participants receiving evolocumab with mean LDL cholesterols of 30 mg/dl, there were 1,344 events, many fatal. Even in the original data, there were more cardiovascular deaths on the drug vs. placebo (251 vs. 240).
In other words, the focus on cholesterol, cholesterol, cholesterol yields little advantage in reducing cardiovascular events. Even in the best case scenario in which we accept the original investigators’ conclusions, they resort to statistical sleight-of-hand to exaggerate the outcomes. Worst case scenario, financial motivations colored the performance and interpretation of the data and, not only was the drug ineffective, but harmful, as measured in excess deaths.
Fourier is among the latest developments in the world of cholesterol that illustrates how ineffective and pointless reducing cholesterol values can be. Literally hundreds of billions of dollars have been spent by the pharmaceutical industry to prop up this enormously profitable enterprise while providing little to no benefit to the public. After all, more than 80 million Americans now take statin cholesterol drugs that have resulted in virtually no meaningful reduction in cardiovascular events, while hospitals continue to expand their multi-million dollar cardiovascular centers to keep their primary revenue source, procedures for cardiovascular disease, busy and profitable.
As I have often pointed out, the real tragedy of wearing blinders to everything but cholesterol is that the real causes of heart disease are unaddressed. No wonder people taking statin drugs, Repatha, or other methods to reduce cholesterol continue to have heart attacks and die. The real causes of heart disease? In a nutshell:
- Increased blood levels of VLDL particles due to liver de novo lipogenesis
- Increased blood levels of small LDL particles—validated now in 55 clinical trials
- Glycation—Glycated small LDL particles are especially lethal
- Insulin resistance—that triggers inflammation
- Inflammation—that worsens insulin resistance
- Endotoxemia—especially if SIBO is present
- Vitamin D deficiency
- Magnesium deficiency
- Thyroid dysfunction, iodine deficiency
This list may seem daunting at first. But take each item one-by-one, as we do in all my programs, and we witness virtually zero cardiovascular events.
Thank you another excellent article. Your voice is most welcome in this confusing crazy world of sick care.