By Duane Graveline, M.D., M.P.H.
For several years, I was persuaded that I was suffering from an ALS-like condition as a result of taking a statin drug, just as many had reported to me and others.
I made this connection due to the large number of reports sent to me and others of suspected amyotrophic lateral sclerosis (ALS) associated with the use of statin drugs. There was not the slightest doubt in my mind that the numbers of reports I had seen are far more than usually expected in a group the size of my reporting population.
One naturally wonders about this curious relationship with statin drugs and what the possible mechanism of action might be.
Neuroscientist, V. Meske, reported in the European Journal of Neuroscience a relevant study about the ability of statin drugs to cause neuronal degeneration. Statin drugs are designed to inhibit cholesterol synthesis (in the liver) by their effect on the mevalonate pathway.
It seems that a consequence of the inhibitory effect of statin drugs on the mevalonate pathway is the induction of abnormal tau protein phosphorylation. Tau protein phosphorylation goes on to form neurofibrillatory tangles, long known to be the prime suspect in causing the slowly progressive neuronal degeneration of Alzheimer's disease.
Sometimes this process is accompanied by beta amyloid deposition but more commonly not. Research scientists are now finding that this mechanism appears to be true for ALS and many other forms of neurodegenerative diseases as well. They have even coined a new word for this, the taupathies.
Statin associated taupathies or tauopathies may well be additional gross evidence of collateral damage to existing cellular chemistry that researchers were unable to predict when they originally created statins. All this from a class of drugs originally designed simply to inhibit the biosynthesis of cholesterol, which is a vital substance now proven to be largely irrelevant to the atherosclerotic process.
Since we were warned by the World Health Organization back in October 2007, researchers have confirmed the special tendency of neurodegenerative diseases such as ALS in statin users.
Reuters reported on 28 April 2008 that elevated lipid levels (also called hyperlipidemia and high cholesterol) appear to significantly improve survival in patients with ALS. Investigators have found that when patients with ALS have a hyperlipidemic profile, their survival is much better. Further confusing traditional medical philosophy, when their LDL cholesterol level is high and HDL low, their survival is the best — just the opposite of prevailing medical opinion.
Imagine, if you will, the effect on this type of person of a cardiologist or internist trying desperately to help them reach a "70" LDL cholesterol, using statin therapy. And further clouding this issue, many clinicians are unaware of this relationship of neuro-degenerative damage and statins.
My own awareness came in early 2007 when I noted many ALS/statin reports coming into my repository. Had clinicians been alerted to this combination of extreme fatigue and muscle weakness with or without muscle atrophy, they might have stopped the use of statins early in the course of toxic damage when possibility of remission may exist.
It was reported that in a study done at Hopital de la Pitie-Salpetriere, Paris, 286 healthy subjects were compared with 369 patients with ALS. ALS patients with relatively low LDL cholesterol had a 35 percent increased risk of death. The median survival in those with the higher cholesterols was 49.2 months compared with 36.7 months in those having the lower cholesterols, prompting the investigators to pose the question should they be using a high fat diet for ALS patients? Predictably, they cautioned to avoid using cholesterol lowering drugs — mainly statins.
ALS is an invariably fatal disorder of the nervous system. ALS is sometimes referred to as Lou Gehrig's disease, after the famous baseball player who died of it. According to Dr. Vincent Meininger of the research group, "The relationship between survival and lipids was previously shown in a mouse model of ALS, with the mice living longer when they are fed a high fat diet." Even today, more than 25 years after statins were first marketed, we are only scratching the surface of learning the true effects of this class of drugs on the body.
Sharing of Statin/ALS Experiences
The People's Pharmacy® website carries an unexpected goldmine of ALS incidence data in a page titled Statins and ALS-Like Syndrome.
Joe Graedon started this page in 2007. In it he has invited anyone struck down by statins with symptoms suggestive of ALS to comment on their status for the benefit of others.
Although the Graedons were aware of muscle problems as well as nerve issues (peripheral neuropathy) associated with statin drugs, they had not heard of ALS-like cases linked to these medications.
Then they received an email from a reader of their syndicated newspaper column: "I read with interest today's letter from a Lipitor taker. I believe Lipitor triggered my ALS, but had a hard time convincing anyone until this World Health Organization report came out."
They decided to post an ALS/statin drug statement inviting readers to report relevant experiences. Their invitation read: "If you have an experience you would like to report about statins in general or an ALS-like syndrome in particular, please write about it here. We will pass on your case report to the FDA."
The result was astonishing! Over the next three months many hundreds of case reports came in from which seventy two presented with the constellation of symptoms usually associated with ALS but the official diagnosis had not yet been made. I termed these, ALS-like. Additionally well over a hundred reports came in from people experiencing peripheral neuropathy, the other symptom complex reported by the WHO to appear in excess numbers worldwide in those on statins.
Given my personal experience, I now wonder how many of these ALS-like cases are in fact peripheral neuropathy.
I suspect a significant number, but testing would have to be done to confirm.
The following are a few of the personal experiences sent to me of ALS symptoms associated with statin use.
1.) My dad died on 6/1/06 at the age of 65 from a six-year battle with ALS. I said to my mom a million times that dad got ALS from taking Lipitor. When he was taking it he would wake up in the middle of the night from severe muscle pain and cramping. When he told his doctor about it, his doctor said, "Hey, I get aches and pains too, but that's life", then he doubled my father's dosage.
My dad finally was diagnosed with the ALS and kept taking the Lipitor because no one told him of any connection of his aches and pains and the Lipitor. He went from stumbling, to falling down, to walking with arm braces, to a walker, to a wheelchair, to total paralysis except for his hands. I watched him die from a disease that took away every bit of his pride and dignity because he needed help eating and going to the bathroom to being completely paralyzed and helpless. He was a proud, strong hard working carpenter and this disease turned him into a sobbing, completely petrified paralyzed person.
My dad worked for an "extremely" wealthy man who finally sent him to and paid for him to see one of the United States top neurologists after he was diagnosed. After seeing this doctor for a while I said to him that I thought my dad might have gotten ALS from taking Lipitor and the doctor said, "You see all of those folders behind me (there were hundreds)? He said, "Those are all cases that pharmaceutical companies have sent me of people who are in law suits because they think they got ALS from their cholesterol-lowering medications and they want me to read them all over and decide if I think that is the case or not." He said, "In your father's case, honestly I'm just not sure."
Well I know Lipitor gave my dad ALS no matter what anyone says. It took away my four small children's grandpa and memories they will never have with him. I just wish doctors would inform their patients before they prescribed them a medication of the side effects and risks of that medication so the patient could decide if they wanted to risk it or not. Maybe if someone told my dad this from the beginning he would have opted to lower his cholesterol in another way.
2.) The first neurologist gave Dad about an hour long electrode and needle test in arms and legs (we were in the room and watched) and provided us a medical/technical written report several full pages long to take to our second opinion. He was pretty sure it was ALS, but emphasized we needed to go to an ALS-specialized neurologist. Right now we are focused on his health and the battle against Lipitor.
3.) My neurologist has done a complete turn in his diagnosis. A few weeks ago he told me that he didn't think that my speech and swallowing problems were caused by Lipitor and that he thinks that I DO have ALS! Well, he calls my problems "atypical" ALS because I have deteriorated slowly. At this point in time I have had problems for almost three years. Currently, I can barely speak and my speech is pretty unintelligible. Further, I have such great difficulty in swallowing that I can only eat pureed food and I have lost a lot of weight. I am tired a lot, feeling weak and my breathing has declined somewhat. I have been off Statins for 2 1/2 years and that has not restored my vigor.
4.) I am a veterinary pathologist, that does a lot of neuropathology, and unfortunately, I am the patient with neurologic issues currently. I have been on Lipitor 40mg qd for 6 years (increased from 20 mg qd 2 years ago). Over the past 2 years, I have noticed increased weakness, extreme fatigue, shortness of breath, and very significant loss of muscle mass (postural muscles, laryngeal muscles, legs/arms, etc.). The loss of muscle mass in the lower legs has led to significant edema, which were the main clinical signs that my physicians were focusing on to try and explain. After some consideration, I became convinced that I had ALS. I have also experienced short-term memory loss, have trouble finding the right word, have trouble dictating my biopsy cases fluidly, and have significant depression. I have a referral with a neurologist tomorrow for an initial evaluation.
5.) I came across your website while doing some research concerning the side effects of cholesterol medication. My mom has been taking cholesterol medication for 15 years now. Recently the past couple months she has been showing signs of ALS. These symptoms include muscle weakening in the arms, tingling, twitching, slurred speech, fatigue, neck aches, and an overall mood change. She went to see a couple different doctors and they have taken her off her medication. One of the doctors told her that she has ALS. I am not convinced that she has ALS. I still have a strong feeling that this has something to do with her cholesterol medication. She has always watched her diet and before all these major symptoms occurred, she was working out really hard. We are in serious need for some answers. I am so worried about my mom. She is only 48 years old and her spirits are so low.
6.) Hello, I was on Lipitor for three years; complained of hand and stomach cramps to my doctor and stayed on the drug; finally went to see a neurologist who promptly diagnosed me with ALS and gave me three to nine months to live. My sense is that Lipitor affects the myelin sheath.
7.) I have a scheduled appt. with a neurologist. I found out my Creatinine Kinase was 386 on March 31, 2005 and was taken off Lipitor. I asked for my old records and found that it was at 237 in February of 2004 and was taking Lipitor for 14 months (20mg per day). With all the research I have done, I feel this was the cause, however, my doctor said he does not know what is wrong with me. Since January 2004, MS was ruled out but I have lost fine motor skills and walk unsteady. Have weakness and loss of muscle in hands. I fell down the stairs last week. I work a physical job, need my income and I am only 55 yrs old.
8.) My mom has been on cholesterol medication for almost 15 years. She is only 48 years old. The medicine she has been on ranged from all different types of statin drugs, the last being Zocor and then a switch to Vytorin. She has always suffered from stomach problems and then the last couple years she has noticed muscle weakening in her hands and cramping. After vigorously exercising recently, the problems seemed to get worse. There is not much muscle left in her hands and she finds that her arms are very weak. Her muscles are easily tired and after a recent EMG she has noticed twitching throughout her body. She also seems to have slurring in her speech and difficulty writing. Basically the doctors are leaning towards ALS.
I just have a hard time believing that this is the answer. Could it be possible that these really are side effects from the Statin Drugs?? Supposedly her EMG results were not great and the last doctor she saw seemed to think it was ALS. She has been off the statin drugs for 2 months now. Her symptoms are not any worse; they have pretty much stayed the same. I am so worried about her, but refuse to believe that she has a life threatening disease. I'm just trying to get my mom back.
9.) I have a preliminary diagnosis of ALS. I am a 57 year-old male and have been on Simvistatin (Zocor) for 12+ years at 60mg a day. I am a medically retired pilot. Last Thanksgiving I thought at first I had had a stroke but over time I realized that this was no stroke as muscle weakness and movement were getting worse. A CT scan ruled out stroke so they sent me to a neurologist and he has made the preliminary diagnosis. I have an MRI, EMG and Nerve velocity test coming up. I have stopped taking Zocor (gradually) and it seems that symptoms have leveled off. Maybe wishful thinking but they are definitely not progressing at the rate they were. I am not getting any better at this time but not getting worse as far as I can see.
10.) I am a 48 year-old woman. I have been on various statin drugs for 13 years. I have been on Zocor the most. About 2 years ago, the Dr. put me on Zocor and Zetia 20/10 mg. After a while, I started getting muscle cramps in my hands, legs, neck, and abdomen. I complained to the Dr. about it but he said to try and tolerate it because my numbers were so good. About a year ago, he switched me to Vytorin. After about a month or two, I noticed that my hands were getting weak---I had difficulty with buttons and zippers and tying. Upon starting the Vytorin, I also started a vigorous exercise routine of running 4 miles 3 to 4 times a week and doing a boot camp routine. I then I noticed I had trouble doing lateral lifts with my right arm. I thought I had a weight lifting injury and then I thought I had carpal tunnel.
Went to see my Dr. who noticed I had muscle atrophy between my thumb and index finger on my right hand. Thank God I'm left-handed. He sent me to a neurologist who did all the tests, MRI, EMG, nerve, etc. After the EMG, I started twitching all over. I couldn't even sleep. The neuro said I was probably in the early stages of ALS.
I have been off Statins for about 4 mos now. I haven't gotten any worse for which I am grateful. Whenever I overdo physically, I pay for it. On my last visit to the neuro, he was surprised at how strong I still am. He still thinks I am in the early stages of ALS but then added that he wouldn't "bet the farm on it". This comment gave me hope.
Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor
Updated May 2016