According to the Wall Street Journal (March 3, 2014), Lipitor brought in roughly $13 billion for Pfizer in 2006. That was during the drug’s heyday. This cholesterol-lowering statin-type medication made only $2.6 billion in 2013. The precipitous decline can be attributed to generic competition.

Insurance companies encourage people to buy low-cost generic drugs. A month’s worth of Lipitor (20 mg) can run over $200. At a big-box discount pharmacy chain like Costco, generic atorvastatin would cost under $16 for the same amount. It is little wonder that most insurance programs refuse to pay for the brand name.

Not surprisingly, Pfizer would like to recoup some of its lost revenue. One option is to try to take brand name Lipitor over the counter. Financial experts estimate that this strategy could bring in another billion dollars a year for the company. That’s not nearly as much as during Lipitor’s golden age, but it’s not chicken feed. Any billion-dollar drug is considered a huge best seller within the pharmaceutical industry.

Pfizer is spending serious money to determine whether consumers can self-medicate with Lipitor without a doctor’s supervision. A clinical trial involving 1,200 subjects will recruit subjects at dozens of pharmacies. The patients will be allowed to order their own blood cholesterol tests so they can monitor progress. If Pfizer is successful in this study, it will presumably apply to the FDA for approval to market OTC Lipitor.

The Wall Street Journal article offers the following company justification:

“Pfizer says an over-the-counter Lipitor would help close a ‘treatment gap’ for people at risk of heart attacks and strokes who don’t currently take a statin.” In theory this would save money in the long run by getting more people on statins and “warding off costly health problems down the line.” A top Pfizer representative told the Wall Street Journal: “It’s our responsibility to demonstrate patients can safely and effectively use these products.”

We have serious concerns about this initiative. For one thing, it is not at all obvious that otherwise healthy people really benefit from taking statins. Just because cholesterol is elevated above some arbitrary number does not mean that a statin will prolong life or even prevent a heart attack for a significant number of people. An intriguing article in the BMJ (Oct. 22, 2013) titled “Should people at low risk of cardiovascular disease take a statin?” describes the situation this way:

“In other words, 140 low risk people must be treated with statins for five years to prevent one major coronary event or stroke, without any reduction in all-cause mortality. The five year absolute reduction in myocardial infarction and stroke for the lowest risk patients (< 5% risk over the next five years) was 0.6%. This means that 167 such people needed to be treated with a statin for five years to prevent one hard cardiovascular event.”

The distinguished researchers who authored this paper go on to point out that statins don’t save lives in patients who have not been diagnosed with heart disease. (That’s what it means when they say “without any reduction in all-cause mortality.”) They also point out that muscle problems are under-reported in clinical trials and that exercise fitness can be compromised by statin therapy. They also point out that statins may increase blood glucose levels and push some susceptible patients over the edge into type 2 diabetes. Their “bottom line” conclusions:

“Statin therapy in low risk people does not reduce all cause mortality or serious illness and has about an 18% risk of causing side effects that range from minor and reversible to serious and irreversible. Broadening the recommendations in cholesterol lowering guidelines to include statin therapy for low risk individuals will unnecessarily increase the incidence of adverse effects without providing overall health benefit.

“From a pharmacoeconomic perspective, expanding generic statin therapy to millions of low risk patients would add drug costs of up to $1/day or more per person for no net health benefit.”

For the purposes of this discussion, “low risk” means people who have not had a heart attack, stroke, stent or a diagnosis of coronary artery disease. These are people who may have a modestly elevated cholesterol level. In fact, the American Heart Association and the American College of Cardiology have gone on record discouraging physicians and patients from the old idea of trying to bring cholesterol levels down to a specific number such as under 100 for LDL cholesterol. Their new guidelines say that only people with an LDL number over 190 need treatment with a statin on that basis alone.

Instead, they encourage people to work with their doctors to assess their overall cardiovascular risk by using the CV Risk Calculator. This tool does not even ask about your LDL cholesterol number. Instead, it calls for information on sex, age, race (only two categories, African-American and other), total cholesterol, HDL cholesterol and a yes-or-no for diabetes, blood pressure medication and smoking.

Leading cardiologists have been feuding about the relevance of the CV Risk Calculator, suggesting that it overestimates risk and is likely to lead to overprescribing of statins. Regardless of what you may think about the new approach to assessing a need for statin therapy, it is clear that the point of the exercise is to have a thoughtful conversation with your health care provider about your overall heart risk and the best strategies for improving your odds. Nowhere in the new guidelines is there a suggestion that patients should be self-medicating with statins without medical consultation.

The Dark Side of Statins

We have been roundly chastised for suggesting that statins have a dark side. Some cardiologists used to suggest that statins are so safe they might as well be put in salt shakers or added to the water supply. We disagree. Here is just a smattering of the thousands of reports of statin side effects that people have sent us over the years:

“I am now over a year out from my last 10mg Lipitor. I feel like I am back to normal, but in the last few weeks my symptoms are recurring, albeit milder and more intermittent than when I first quit:

  • severe, transient lateral hip pain getting up from tying my shoes
  • intermittent general muscle aches
  • difficulty walking up stairs

“This is all very discouraging. I was hoping to get back to skiing in the woods and then regular bike rides once the snow melts. Has anyone else experienced this sort of prolonged reaction?” Amelia, March 3, 2014,


“I started taking Lipitor because of high blood pressure and slightly elevated cholesterol.  Within 4 months, I was using a cane because of sudden onset of severe hip and knee pain.  I spoke with my cardiologist, and he said the problem was not from Lipitor.  But the pain was so bad, I decided to go to an orthopedic doctor.

“After x-rays, the ortho doc also told me the pain was not from Lipitor.  He said the most likely source of my problem was my back.  I knew he was wrong; it was not from my back.  So, I took myself off Lipitor.

“Within two weeks the most severe pain was gone and I was walking without a cane.  I continue to have hip and knee pain after one year of being off Lipitor, especially at night.  I refuse to try any other drug for my cholesterol – it is only 129, which is the same as it was when I started this nightmare.” C.V.M. Feb. 21, 2014


“Several years ago, I was put on 20 mg of Lipitor because of high cholesterol. After a few years my arm muscles were too weak and painful to lift a gallon of milk from the fridge. When I learned about similar problems others had had with statins, I stopped taking the Lipitor and the weakness and pain stopped.” Enid, Feb. 8, 2014


“I was prescribed Lipitor at age 45 when it first came out (in the mid-80s) and thought I had no side effects until I started getting high ALT [liver enzyme] levels (37) and borderline diabetic glucose levels in my regular blood tests. I don’t feel those side effects.

“The big problem is that I’ve been fighting very painful peripheral neuropathy in my feet that started shortly after I started Lipitor. At the time, neuropathy was not listed as an official side effect, so I never made the connection until recently. It has kept me squirming awake at night with burning pain and numbness in my feet all these years. If I had known that painful possibility, I might not have started any statin.” P.M., Jan. 31, 2013


“I started taking Lipitor in Oct 2012. By March 2013 the peripheral neuropathy, fatigue, muscle cramps, shooting pains, hot flashes and memory loss were frightful. The symptoms would get worse at night, till exhaustion just knocked me on my butt. I was 46 and got real old very quick.

“My doctor said my cholesterol was around 250 because of my hypothyroidism and put me on Lipitor. (I was already feeling crappy before taking Lipitor, probably because of my thyroid problem.) The doctor just blew me off and that didn’t change when I told him about the Lipitor side effects. He did say to stop taking Lipitor and referred me to a neurologist and later to a podiatrist. They could not find a problem with my feet. I would be on my feet most of the day and I could barely walk up the stairs at work. It got so bad driving home that when I put my feet on the pedals it felt like being stabbed with a knife. My quality of life has suffered due to Lipitor!” S.D., Jan. 6, 2014


People who have experienced a heart attack or have diagnosed heart disease can benefit from statins, but they should be under medical supervision. Moving Lipitor over the counter so people can take it just to lower their cholesterol numbers seems scary to us. What do you think? Share your own experience and your thoughts about this idea. 

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  1. KWilson
    Reply

    Glad I found this site. I suffer from high cholesterol that runs in my family. My regular doc doesn’t prescribe statins regularly. Have discussed it over the years and he said, “as long as you are not a smoker, I think you are fine.”
    Went to the diet doc in the same clinic and he thought I needed to be on generic Lipitor 10 mg. Took for two weeks, even split them in half each night, and I found myself with burning feet, muscle fasciculations (which have subsided a bit since I’ve taken myself off of it) and muscle cramps, worse in my left leg. I have been off of the drug for 12 weeks and hope that I will fully recover. No muscle weakness thank God!
    I am a mother of two and 48 years old. Scary symptoms!!

  2. ariferahman
    Reply

    Regardless of what you may think about the new approach to assessing a need for statin therapy, it is clear that the point of the exercise is to have a thoughtful conversation with your health care provider about your overall heart risk and the best strategies for improving your odds. Nowhere in the new guidelines is there a suggestion that patients should be self-medicating with statins without medical consultation.

  3. crandreww
    Reply

    @Jo..I am so sorry to hear of your statin ill effect. Ask your doctor if he or she knows the FACT that Statins have never been shown to be effective in reducing the risk of death in people with no history of heart disease. No study of statins on this “primary prevention population” has ever shown reduced mortality in healthy men and women with only an elevated serum cholesterol level and no known coronary heart disease. (CMAJ. 2005 Nov 8;173(10):1207; author reply 1210.) Also The only statin study dealing exclusively with seniors, the PROSPER trial, found that pravastatin did reduce the incidence of coronary mortality (death from heart disease). However, this decrease was almost entirely negated by a corresponding increase in cancer deaths. As a result, overall mortality between the pravastatin and placebo groups after 3.2 years was nearly identical.
    Again, I am sorry to hear of your statin problems, and send prayers for a full recovery.

  4. Jo M
    Reply

    I took myself off atorvastatin 10 days ago after I got much worse with my back and shoulder. I had horrible cramping, muscle weakness and all that goes with it. The pain is not getting any better. What can I expect? I am 81.
    People’s Pharmacy response: People vary quite a bit in their recovery time. We would hope you would be better in six weeks.

  5. I.Wickes
    Reply

    There should be a class action lawsuit due to hiding the results of the clinical trials which caused damage to ones liver, muscles and contributing to type 2 diabetics. All doctors that said to ignore these symptoms when the information was available to them should also be included.

  6. Ruth M.
    Reply

    It shouldn’t be sold with or without a prescription!!!!

  7. Mary
    Reply

    A few years ago my physician put me on Niaspan, prescription strength. Flushing was body wide so I talked to him about stopping.
    High HDL on the Niaspan put total cholesterol above recommended on lab tests. What a conundrum when a supposedly beneficial cholesterol puts one over the line.
    I also asked him NOT to prescribe a statin drug. He didn’t either.
    Personally, I will never take any statin drug.
    If you haven’t experienced side effects from your statin, be grateful.
    Or maybe your doctor is denying your various problems are statin related, so do more research and decide what to do.

  8. Marie
    Reply

    No, statin should be sold OTC. I, personally, think that there are lots of people who shouldn´t take statins at all.
    Statin side effects can be terrible and I wish people would tell their stories.
    In 2004, my mother (84 at the time) complained about muscle weakness, cramps and aches in her legs. She also had sleeping problems. Because of this I started to look for information about her medications (Zocor and Toprol). It didn’t take long before I realised that she could be suffering from side effects of Zocor (=simvastatin). Eventually, she stopped, and improved.
    In 2005, my mother and I met a friend of my sister (=M) and had a chat. She told us that she had pains in different parts of her body. I said, jokingly, I hope you are not taking any statin such as Zocor or Lipitor (=atorvastatin). She did – she was taking Zocor for prevention.
    I told her that she could be suffering from side effects, suggested that she read the package insert carefully. I promised to send some information.
    Then I didn’t hear anything and the years passed by (we live in different towns). The other day, I run into her and she told me her story.
    The pains had become worse. Particularly, in her back and hips. She was told that she had some disc problem and had surgery. She didn’t improve. M thought it was due to poor healing after the operation.
    She visited a pain clinic. They did all kinds of tests. She was given cortisone injections and tried different pain medications including opioids and morphine, but nothing helped.
    The staff was nice. They used to phone and ask how she was doing (but they never thought about drug-induced pains). She could hardly stand and walk. Had to use a walker.
    One day, her husband went to the pharmacy to pick up a refill. They didn’t have any Zocor at hand (delivery problems) and because of this M went without medication for some time. She started to improve, to her great surprise.
    She phoned the health clinic and spoke to a female doctor. She asked if she could take a break from the medication to see what would happen and the doctor agreed.
    M improved, little by little, and eventually she could stand and walk without the walker. The nerve pains also disappeared in spite of what the staff at the pain clinic had told her.
    I asked M – how did you feel after all this – didn’t you get angry? She said – no, the prescribing doctor was such a nice man, he listened and really cared and besides he took Zocor himself. Therefore I trusted him and the medication, but the last time that I saw him, I didn’t want to burden him with my problems because he was more sick than I and eventually he had to close his practice.

  9. Carol J.
    Reply

    NEVER. There is enough self-medicating going on.
    My husband has incurred more than half of the negative side effects of having been prescribed statins over the past 16 years. He takes it no more now that I have learned that this was the cause, I believe, of his difficulties. NO more. I contacted his doctor when I determined that my husband would be better off with out it. The physician checked test results and agreed that the medication could be discontinued.
    I can not imagine someone electing to take this medication without supervision. For with supervision one can run into many problems.

  10. mb
    Reply

    big problem what do people do who have genetically inherited high cholesterol and triglycerides-with family history of heart disease and immediate family member died young from blocked arteries-of course they were smokers!

  11. EW
    Reply

    Leg muscle weakness developed after 4 years on Lipitor. My own research indicated this could be a statin reaction. Discussing this with my pharmacist who confirmed my research. I quit taking the statin immediately.
    My doctor told me I would never tolerate another statin. She was correct, even Red Yeast rice produced the same effect immediately. The muscle weakness gradually dissipated and after 5 years, I have no leg muscle weakness.

  12. crandreww
    Reply

    @ Patrick Hickey Percentage of people taking statins and percentage of ill effects is irrelevant. I think the point is that when a provider places a patient on a new Drug, the provider is obligated to disclose the actual risks versus benefits. I was a Critical Care RN for 12 years, went to countless statin seminars, listened to several drug reps tout the benefits of these poisons, but never in my wildest imagination was I ever made aware that this drug could actually cause my Mitochondrial DNA to Mutate, nor was I made aware that by blocking Acetyl Co A Reductase, the statin would also block every other VITAL element in the mevolonate pathway, such as CoQ10 (Ubiquinol) which every cell in our hearts NEED to produce energy, nor was I aware that the Neuropathy I developed was even a remote side effect. I am now almost 11 years post statin induced Neuropathy, Neuronal Apoptosis (brain cell death), I will likely never work again, in any capacity due to the unreported, unpublished side effects of these drugs. @ Mary Wessinger I am sorry to hear of your statin induced problems with your family. Just keep helping to get the word out! These drugs are VERY DANGEROUS and in Some instances, Deadly.

  13. K.T.
    Reply

    Took statins for several months during which, my muscles became weaker. Doc said my liver enzymes were not elevated and that statins were not the cause. Continued on them as prescribed until one morning, I experienced leg muscle weakness accompanied by such intolerable pain that I could not walk.
    I discontinued the statins on my own and after several days slowly began to regain some strength in my legs. Doctor suggested I try another brand. I refused to ever take statins again. Because of this experience (and the warnings on other meds), I am petrified of any prescription medicine.

  14. Mary Wessinger, RN, MN., B.C.
    Reply

    I totally agree,I am also a nurse and have seen these bad side effects in my husband and family, and friends. This drug is dangerous and the people who know the physiology of how the brain functions, muscle function KNOW that cholesterol is necessary and needed for optimal brain, muscle, and endocrine function. SHAME on the physicians and pharm industry who push these harmful medications on people to “help” patients. The only thing is does is to “fatten” their bottom line.

  15. Judy
    Reply

    I started on Lipitor 10 mg. in June 2013. My cholesterol levels went down dramatically but were not that high to begin with and I do not have any health problems other than taking Synthroid for many years. A month after taking Lipitor my elbows began to be painful for no reason. I then had muscle pain in the calf of my leg and in my fingers I’d never had before. My doctor sent me for an x-ray of my elbows and then to an orthopedic specialist. By then I had stopped taking the Lipitor on my own. No reason for the pain was ever found. It has taken until now for my elbow pain to subside but there is still soreness. Never again!

  16. crandreww
    Reply

    Why should Wall Street be dictating what doctors do for patients? Oh thats right, our healcare is a for profit BUSINESS… Sickening…the whole notion of cholesterol causation is based SOLELY on CHECKBOOK SCIENCE! Most prescribers are not aware of the very real and permanent effects ALL STATINS can potentially do. Jeck they are not even aware of the very low percentage of absolute risk reductions… Pharma needs to stop peddling directly to consumers. Scaring you on the nightly news, and then bald faced lying about the very real risks, and MINIMAL BENEFITS. Funny, I got this email from Peoples Pharmacy, just after I finished reading an article slamming statins http://www.express.co.uk/news/health/462607/Health-chief-slams-statins-Millions-face-terrible-side-effects-as-prescription-escalates#.UxU20HurYxM.facebook
    In this article, http://www.express.co.uk/news/health/462943/Millions-more-need-statins-according-to-experts-but-GPs-fight-plans#Comment_form The survey of 511 GPs also found that 55 per cent would not take statins themselves or recommend a relative to, based on the new risk score. I think that should speak volumes.

  17. sandyw
    Reply

    After reading the book Grain Brain by David Perlmutter, I am extremely opposed to statins being made available over the counter. As a former RN who worked with Holistic doctors and studied homeopathy, I realize that drug companies and doctors affiliated with them, usually only have their bottom line in mind… millions to be made by keeping the general population on drugs. We are suffering brain problems because of statins in addition to other medical problems as previously listed. Please keep up the great job of enlightening the general population on medical dangers.

  18. DB
    Reply

    My Husband had to stop taking Statin drugs in 2012 He was off work most of the year, His muscles were breaking down, He had to have surgery on his arm and then his a large muscle tore in his leg just doing normal everyday tasks. I believe he would be in a wheelchair today if he had not stopped the drugs. He treats himself now with Herbs!!!!! So proud of Him!!!!!

  19. Patrick Hickey
    Reply

    I NEVER see you publish data on the % of people taking satins, vs the % that experience problems.

  20. Carole
    Reply

    I was completely unaware that Lipitor could cause elevated liver enzymes. My last tests showed alkaline phosphatase to be 190. That shows a gradual elevation over the last 5 years. Every test has been done to find the cause, but none has been found.
    I intend to take myself off this drug, and have already dropped to 3 days a week. I hope the muscle damage is not permanent. I have also had a steady increase in my blood glucose levels. I watch my diet and exercise. I hope it is not too late to reverse the damage.

  21. WM
    Reply

    I was on Lipitor for 8 years then switched to a generic version. I have never had any side affects.

  22. Barb G.
    Reply

    My own opinion it should not be sold over the counter. When I found out the damage that Statin’s can do to a persons liver I refused to continue taking the drug that my doctor prescribed. I only had borderline high cholesterol. I told my Dr. that I would control it with diet which is what I have done. I only took the drug for about two weeks so I wasn’t on it long enough to cause any damage.
    I went to a semi-vegetarian diet cutting out all junk food, along with beef and no pork. I eat chicken which has the fat removed along with turkey breast, no fat, using a slow cooker. All my veggies are frozen which I steam. Cut down on all foods that comes from animals.
    Cut your salt intake to 1500 mg per day. Stay away from processed meats. Look on the back of packages of meats for the fat and sodium content. If the public would do what I have done not only would you begin to lose the lbs you will feel better.

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