Statins, Stem Cells, and Fatigue
Statins stem cells and fatigue I’m sure at first seem like an unrelated group of words, but read on and it will begin to make sense…
I have a history of heart disease in my family, so like many physicians and patients, I was initially entranced by the messaging of Statin drugs. Basically, the concept seems simple. If you have high cholesterol, that’s bad, so you need to get it lower. Statin drugs like Lipitor and Crestor can lower your cholesterol, that’s good. If you pay attention to the claims on TV advertising, it seems we all have a ticking time bomb that we’re trying to ignore and that any minute it could explode and leave our sorry remains all over the place. But is this message real, or Madison Avenue? Are Statin drugs the modern wonder pill helping us all access the elusive fountain of youth or are they hurting more people than they help? A story this week brings up the debate again, this time showing that Statin drugs cause fatigue. This is on top of a laundry list of issues brought up about these drugs including memory issues and muscle pain. In addition, the entire drug class can cause a severe and sometimes deadly muscle allergy known as eosinophilic myositis. We’ve gotten so used to Statins causing widespread pain that we often ask first about whether a patient with these symptoms is on a Statin drug, before pursuing further work-up. The same article referenced above discusses that Statins may harm the mitochondria of certain patients (the batteries inside every cell that give it energy). We’ve certainly seen Statins adversely impact stem cells in culture. When we stop that Statin drug and then re culture the patient, everything seems fine. In addition, what’s the absolute benefit of taking Statin drugs? It’s very tiny. Most studies show an absolute risk reduction of dying of a heart attack of a few percent over 5 years. The problem is that you and your doctor would have little interest in these drugs if you were told about this measly little benefit, so the drug manufacturer quotes the “relative risk reduction”. As an example, if the risk of dying from a heart attack was 3% over 5 years and the group taking the Statin drug had a heart attack death rate of 2%, that minuscule reduction in absolute risk can now be quoted as a whopping 1/3 reduction in “relative risk”. This issue was brought out by a Businessweek artcile in 2008:
“The second crucial point is hiding in plain sight in Pfizer’s own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”
Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.
Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.
A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out.
Plus, there are reasons to believe the overall benefit for many patients is even less than what the NNT score of 100 suggests. That NNT was determined in an industry-sponsored trial using carefully selected patients with multiple risk factors, which include high blood pressure or smoking. In contrast, the only large clinical trial funded by the government, rather than companies, found no statistically significant benefit at all. And because clinical trials themselves suffer from potential biases, results claiming small benefits are always uncertain, says Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill and a longtime drug industry critic. “Anything over an NNT of 50 is worse than a lottery ticket; there may be no winners,” he argues. Several recent scientific papers peg the NNT for statins at 250 and up for lower-risk patients, even if they take it for five years or more. “What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? How many would take that?” asks drug industry critic Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles.”
In addition, you may also want to read an e-mail I sent to my family on the issue of the benefits of Lipitor versus Chocolate:
“OK, this has to be an only in America set of stories. Last night I read a NYT article about how the FDA recently approved Crestor (cholesterol drug) for use by average every day people. For Cholesterol lowering drugs, usually the absolute difference in the number of heart attacks between the groups (sugar pill vs. cholesterol drug) when taken for long periods is about 1%. That means that after 3 years, 1% less people in the cholesterol drug group will have had a heart attack. These are in people with known heart disease, not folks who are otherwise healthy with known risk factors. Now nobody would buy the stuff if they advertised a 1% difference, so the FDA allows them to advertise their relative change. Since it’s 3% of people having heart attacks in one group and 2% in the other, they can advertise a whopping 33% reduction in relative risk.
Last night, I came across the story below where FDA has just allowed Crestor to be used in normal healthy people, despite only a 0.2% difference in heart attacks and strokes between the groups (after two years of taking this stuff). You might ask yourself how? Well, big pharma is up to it’s old tricks. Since the number of heart attacks was 0.37% in the Crestor group and 0.17% in the sugar pill group, they can advertise a whopping 50% reduction in risk of a heart attack! Now since about 5% of the people taking Crestor will have a significant side effect and 1% will be seriously injured by the stuff, why on earth did these numbers make sense to the agency? This is also the same drug that was recently cited as increasing the chance of getting diabetes by 7%!
Ok, now heres the really funny part. This morning a German study was published that you can get about the same relative risk reduction in heart attacks by eating Chocolate! (40%) So which will it be, Crestor or Chocolate? At least nobody I know of has died of a serious muscle disorder from taking Chocolate, but the margins are much slimmer on Chocolate (which by the way never got FDA approval), it’s doubtful that drug reps will show up at your doctor’s office extolling the virtues of chocolate.
The upshot? Statins don’t work well to protect patients from heart attacks. They have serious side effects and we’re convinced those side effects extend all the way down to the cellular level. Get some dark Chocolate, clean up the sugar in your diet, don’t smoke and work out hard-you’ll be better off than being heavy and on Statin drugs!