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Statins and ALS: Is There a Connection?

Tens of millions of people take statins every day. A decade ago a question was raised about statins and ALS. What have we learned over the last 10 years?
Statins and ALS: Is There a Connection?
Statins, Statin pills and a warning sign,

One of the most tragic diseases of mankind is amyotrophic lateral sclerosis (ALS). It is also known as Lou Gehrig’s disease. It is a mystery disease in that we do not know what causes it and we do not know how to cure it. Many people have asked whether there is an association between the use of statins and ALS.

What Is ALS?

Our muscles are controlled by nerves or neurons. To lift a pencil, kick a ball or step on the accelerator, our brain needs to send chemical messages to the motor neurons that control these voluntary muscles. If those nerve cells are damaged and die, we are diagnosed with motor neuron disease (MND).

Symptoms of ALS:

Symptoms of ALS often start with little things, like muscle weakness. There is incredible variability from one person to the next, so it can be challenging to describe a typical situation. Some people may find they start dropping things, like pens or coffee cups. Others may complain of poor hand-eye coordination. Many people develop difficulty walking, partly because legs and feet become weak and hard to control. Muscle cramps and uncontrollable muscle twitching in arms or legs (fasciculations) become noticeable.

Eventually, people with ALS find that their balance is affected and they may trip or fall easily. The voice is often affected. People develop slurred speech and/or swallowing problems. Family members frequently notice that the voice changes as the disease progresses.

As motor neurons continue to die, muscles become progressively weaker. Paralysis sets in and speech becomes increasingly challenging. Eating and drinking are especially difficult. The downward spiral takes a terrible toll on both patients and care givers.

Is There A Connection Between Statins and ALS?

Why would anyone ever consider that statin-type cholesterol-lowering drugs could be linked to ALS? As far as we can tell, the first published article on a possible linkage between statins and ALS was published in Drug Safety in 2007. The World Health Organization International Drug Monitoring group in Uppsala, Sweden detected a preliminary signal. It called this “ALS-like syndrome” and emphasized “the rarity of this possible association” with statins.

https://www.ncbi.nlm.nih.gov/pubmed/17536877

The following year the FDA published an intriguing article in the journal Pharmacoepidemiology and Drug Safety (online, Sept. 2008). It was titled “An Evaluation of a Data Mining Signal for Amyotrophic Lateral Sclerosis and Statins Detected in the FDA’s Spontaneous Adverse Event Reporting System.”

https://www.ncbi.nlm.nih.gov/pubmed/18821724

In the article the FDA staffers stated:

“Using techniques to data mine spontaneous-reported adverse event (AE) databases, we and others observed a disproportionate number of reports for ALS in association with statin use. Here we analyze data from post-marketing reports and clinical trials to gain a better understanding of the data mining signal for ALS and statins.”

The authors noted that of the 155,126 adverse events linked to statin use in 2006, 109 mentioned ALS, Lou Gehrig’s disease or motor neuron disease. The agency excluded 18 cases for various reasons. In its conclusions the staffers noted that they “found disproportionate reporting for ALS with statins when data mining the FDA’s AERS [adverse event reporting system].” These authors then went on to say that they doubted “the possibility that treatment with statins initiates this neurodegenerative disorder.”

Interestingly, the agency concluded this article with a caution:

“Nevertheless, given the expansive use of this class of drugs and the dire consequences of ALS, any degree of uncertainty justifies further investigation. To this end, there is an ongoing case-control study examining whether exposure to cholesterol-lowering drugs, including statins, increase the risk of developing ALS, or alter the disease progression of individuals with ALS (personal communication, Lorene M. Nelson, PhD).”

Beyond the FDA:

The same year that the FDA noted a statin-ALS signal, some neurologists published an article titled “Are Statin Medications Safe in Patients with ALS?” (It was published in the journal Amyotrophic Lateral Sclerosis, Aug. 2008). The authors concluded:

“This study has demonstrated a strong association between statin medications and an increased rate of functional decline and muscle cramping in patients with ALS. Although this association does not prove a causal relationship, it is prudent to exercise caution and discuss discontinuation or replacement of statin medications in patients with ALS.”

The FDA, Statins and ALS?

We have searched high and low for the case-control study the FDA referred to back in 2008. Perhaps we are just dense, but we have not been able to find any publication documenting a connection between statins and ALS or disproving this possibility.

Chinese researchers published a meta-analysis in 2013 in the journal Amyotrophic Lateral Sclerosis & Frontotemperal Dengeration (May, 2013). Out of 375 potentially relevant studies they could only locate three that could be analyzed. Their conclusion:

“No definite association was found between statin use and ALS incidence and progression. Current evidence is insufficient to draw definitive conclusions.”

On the one hand that seems very reassuring. On the other, it is a bit worrisome that after all these years we cannot draw definitive conclusions. The authors encourage further research on the question of an association between statins and ALS.

The Latest Research:

A study published in the journal Muscle & Nerve (Aug. 2016) is quite interesting. The researchers are from the departments of neurosurgery and neurology at the Penn State College of Medicine in Hershey, PA. They introduce their investigation with these insights:

“The etiology [cause] of amyotrophic lateral sclerosis (ALS) remains unknown. Environmental and genetic factors are believed to modify ALS risk or disease progression. These include statins, which may accelerate ALS disease progression…

“There is increasing interest in the effects of statins on ALS risk, disease progression, and survival. In patients with ALS, statins may accelerate disease progression and increase the frequency and severity of muscle cramping. Analysis of results from 2 clinical trials suggests greater functional decline in women with ALS who take statins. However, other studies have shown no association between statins and ALS risk or survival…”

These investigators studied special mice that are susceptible to ALS. They found that “statins accelerate disease progression and decrease survival” in this mouse model.

What About Patients?

We started writing about Statins and Lou Gehrig’s disease in 2007. That was after the first article appeared in Drug Safety. In 2009 we wrote about “Statins and ALS-Like Syndrome.” Here is a link to that article:

 

At last count there were more than 600 comments associated with this article. Some are heartbreaking. Here are just a few of the many comments we have received over the years:

Jane in Ohio describes some worrisome symptoms:

“My husband is a vibrant, health-conscious man of 56. He eats fruit, vegetables, some meat and little junk food, if any. (Ice cream is his weakness.) He works out, lifts weights and hikes.

“He was put on Lipitor about 25 years ago. The doctors check blood work and he has a yearly physical. In the past six months he has started having muscle twitching in his neck and arm. He has leg cramps and back pain. His throat closes at times when he tries to swallow liquid. He chokes. His voice and speech and slurred. He feels healthy in every other way. They say it looks like ALS.”

Kevin shared this story about his mother:

“My mother took statin drugs for as long as I can remember. Although she was very much into fitness & followed her doctor’s regimen for diet, exercise & medicines, her cholesterol was never under 300.

“About four years ago she noticed that she would stumble on occasion & later developed ‘drop foot.’ Months later she was diagnosed with ALS. She died earlier this year at age 59, within 3 years of diagnosis.

“Through my own research about the disease, I had heard of a possible connection between statin drugs & ALS, but every doctor that I asked said there’s no evidence to support the connection. We’re in a sad state if we’re resting our hopes on the FDA to do something… And that’s a pretty powerful lobby drug companies have in Washington.”

Ann in St. Louis shared a chilling story:

“My mother took cholesterol-lowering drugs for years and
also died from ALS in August 2000. I had wondered about these drugs
being a cause of ALS and then about a year after her death, I read an
article that there may be a link between ALS and statins.

“Her symptoms started with severe leg pain which was so painful she had
to quit working. She fell and broke her hip in June 1995, recovered,
but had trouble walking and then fell and broke her ankle in April,
1997, and never was able to walk again and needed a wheelchair. The
disease was finally diagnosed in Nov. 1997 after much testing and a
muscle biopsy.

“This disease is hideous and I often wonder if mom would still be here
today if she would have stopped taking the statin drugs.”

The Bottom Line from the People’s Pharmacy:

What we hear from health professionals is that so many people are taking statins that it is hardly surprising that some of them would develop ALS. Not because of the statins but coincidental to the statins. That was seemingly the FDA’s position a decade ago. The agency pointed out that with so many people now on statins we should have seen a dramatic increase in ALS cases if there was a true connection. The FDA folks insist that has not happened. We hope they are right about that.

We found one article titled “The Epidemiology of ALS and the Role of Population-Based Registries.” published in Biochimica et Biophysica Acta (BBA) – Molecular Basis of Disease (Nov-Dec, 2006). In it the authors ask:

“Is the incidence of ALS increasing?
“There are several observations in the literature supporting the concept of an increasing incidence of ALS…”

Italian researchers report “an annual increase of approximately 2% throughout the 10-year [study] period.” Amyotrophic Lateral Sclerosis, online, July 6, 2011. There are other studies suggesting that there is a slight uptick in ALS cases (Neuroepidemiology, Aug. 2013).

Any Connection Between Statins and ALS Is Still Unclear:

ALS remains a relatively rare neurological disease. That said, we know that statins do affect both nerves and muscles in susceptible individuals. That is not in dispute. The latest animal research suggests that statins can have a negative impact on ALS mice. Whether some people are so vulnerable to this effect that they go on to develop an ALS-like syndrome remains unanswered.

We are the first to admit that it could all be a tempest in a teapot. But we surely would like to see some definitive research on this crucial topic. As the Penn State researchers point out, “New cholesterol management guidelines would increase the number of people eligible for statin therapy from 43 to 56 million.”

We encourage anyone with a story to share about statins and ALS to report it to the FDA’s MedWatch program. Because we are not always convinced that the FDA pays much attention to these reports, we also encourage you to share your story below in the comment section. We continue to pass these reports on to the FDA to encourage them to follow up on the case-control study they discussed in their 2007 article.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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