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Statin Drugs & Connections to Lou Gehrig's Disease

A flurry of contradictory studies in recent years has stirred up serious concerns about a possible link between statins--drugs prescribed to lower cholesterol levels--and amyotrophic lateral sclerosis (ALS), better known as Lou Gehrig's disease. Such a relationship, if proved, would be devastating news to the millions of Americans and others around the world who are taking statin drugs to reduce their chances of developing serious cardiovascular conditions.

  1. Edwards Study

    • The most recent controversy about a possible link between statins and ALS was sparked by Ralph Edwards, M.D., director of the World Health Organization's (WHO) drug monitoring center, according to a report by Michael O'Riordan on the website of TheHeart.org. In the fall of 2006, Edwards noticed that a large number (roughly 23 percent) of a sample group of ALS patients also were taking statin drugs. Although it was not much proof, it was interesting enough to Edwards to prompt further study. He eventually decided to go public with his findings. "The Lancet" and "The British Medical Journal" declined to publish Edwards' article about the apparent link, which eventually was published in a smaller journal called "Drug Safety."

    Whirlwind of Controversy

    • Edwards' article did not claim that there was a definitive causal link between statin medications and ALS but did urge that patients taking these cholesterol-lowering drugs talk to their doctors if they began to experience severe neuromuscular symptoms. However, the article set off a whirlwind of controversy and was unsettling to the millions who take statin medications.

    FDA Sounds an All-Clear

    • Almost a year after Edwards' article raised the specter of a link between statins and ALS, the U.S. Food and Drug Administration (FDA) countered with assurances that no such relationship existed. The FDA based its conclusion on a review of 41 long-term controlled clinical trials, according to a report from Reuters. The review found that nine cases of ALS were diagnosed in a total of 64,000 people taking statins. In contrast, 10 cases of ALS were confirmed among 56,000 people taking placebos.

    Not So Fast

    • Although FDA's September 2008 report was welcome news to the millions of patients taking statins, the comfort they derived from the agency's seemingly definitive conclusion was to be relatively short-lived. In its August 2009 issue, Drug Safety published the "Statin Effects Study," the findings of the University of California, San Diego, which concluded that "statins (and other lipid-lowering drugs) may rarely be associated with ALS in vulnerable individuals in whom pro-oxidant effects of statins predominate."

    No Need for Panic

    • Clearly, the controversy about a possible statins-ALS link will continue, but the numbers that have come from the studies thus far published indicate that if there is any link at all, a relatively tiny number of patients appear to have been affected. When this is compared to the life-saving effects of statin medications among those at high risk for cardiovascular complications, the benefits of statins would appear to far outweigh any possible risk of ALS.

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