Should Lipitor (Atorvastatin) Be Sold Over The Counter Without Medical Supervision?

According to the Wall Street Journal (March 2, 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.

Losing Money 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.

Would Over the Counter Sales Recoup Those Losses?

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.

Here’s the Rationale:

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.”

Our Take on OTC Lipitor:

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.

Using the Risk Calculator:

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 purchased over the counter without medical consultation.

For a more up-to-date perspective on the risk calculator and the pros and cons of statins, you may wish to listen to our one-hour interview including two divergent perspectives on statin drugs. It is Show 1044: The Truth about Statins and Heart Disease.

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.