Want to eat all of the McDonald’s cheeseburgers, fries and shakes you want without increasing your risk of heart attack? Why not pick up a statin capsule when you stop by the condiment bar to put ketchup on that burger?

This may sound like a spoof commercial for Lipitor or a skit on Saturday Night Live, but it’s actually the recommendation made by the authors of a recent study published in The American Journal of Cardiology. The authors, who are from the Imperial College in London and funded by the British Heart Association, write; “Fast food outlets already offer free condiments to supplement meals. A free statin-containing accompaniment would offer cardiovascular benefits, opposite to the effects of equally available salt, sugar, and high-fat condiments.”

In their study, the researchers set out to evaluate the available evidence that fast-food statins would be an effective prevention strategy. They looked at seven randomized controlled trials including 42,848 patients and found that; “The risk reduction associated with the daily consumption of most statins, with the exception of pravastatin, is more powerful than the risk increase caused by the daily extra fat intake associated with a 7-oz hamburger (Quarter Pounder®) with cheese and a small milkshake.” “In conclusion, statin therapy can neutralize the cardiovascular risk caused by harmful diet choices.”

 
The idea is to use statins as “primary prevention” for heart disease, especially for people who have not “had contact with the health care system;” presumably including those who have no risk factors. The authors say data is still “inconclusive” that reducing dietary saturated fat can significantly lower serum cholesterol levels and, in turn, lower an individual’s risk for heart attack. Primary prevention may be made more effective, they say, by including pharmacotherapy (i.e. statins). Do they have any concern about the side-effects of these drugs? “[T]he documented safety record of statins is substantially better than that of fast foods,” write the authors.

The researchers make it clear that they are not trying to promote unhealthy food consumption; “We emphasize that in no way are we encouraging individuals to eat unhealthily by coaxing them into the belief that a simple pill is a panacea for all risks.” But isn’t that just what they’re getting at?

Such a strategy—offering a statin with every fast-food meal—will do nothing to promote healthy eating. It would be like if bars offered heavy drinkers a drug they can take with their cocktails to prevent liver damage or hangovers. There’s really little downside then to excessive drinking (beyond the risk of making an ass of yourself or getting in a car wreck.) In reality, to prevent some alcoholics from drinking, doctors prescribe Antabuse (disulfiram); a drug that causes highly unpleasant side-effects (headache, vomiting, blurred vision, etc.) when it mixes with alcohol. In that vein of thought, perhaps Quarter Pounder-eaters should instead be given Orlistat, the diet drug that prevents the body from absorbing fat and can lead to unpleasant side-effects like diarrhea and “oily” stools. Now that might keep them away from fast food for a while.

The American Journal of Cardiology article ends with the request “that the MacStatin concept not be rejected on the grounds of condoning unhealthy diets, any more than seatbelts should be rejected on the grounds of an appearance of condoning speeding. Indeed, it is providing a free opportunity for someone who has already decided to eat unhealthily, and may well already be rejecting medical advice for a healthier lifestyle, to remain alive for longer than they might otherwise.”

I don’t think we need to reject the MacStatin concept just because it condones unhealthy diets: There are plenty of other reasons why the idea is lame-brained. How about the fact that children and people taking contra-indicated medications could scoop up their fast-food statin just as easily as those at risk for heart disease? Or that regular use of statins is associated with side-effects including muscle pain, headache and cognitive problems?

At the moment, the MacStatin concept is a no-go in the U.S. as statins are only available by prescription. But in the UK a low-dose version (10mg) of simvastatin is already available over the counter at pharmacies without a prescription. It’s also cheap—at about 5-pence (pennies in the US) a single dose is comparable to the cost of a package of ketchup, according to Dr. Darrel Francis, one of the article’s authors.

There have been efforts to make low-dose statins available OTC in the US as well, but for now, the FDA has rejected the concept three times since 2000 on the reasonable concern that too many people who don’t need the drugs would take them. In a study of  almost 1,500 potential customers, researchers found that one-quarter of people who wanted the pill did not have a high enough risk of heart disease to qualify, meaning they would face unnecessary side effects. They also found that 30% of people with serious heart disease expressed interest in using the OTC statin, even though the dosage would be too low to be effective and they would not be under a doctor's care.

Recently pharmaceutical companies have pushed to get statins approved by the FDA for use in millions more Americans—including for use in children and also in adults who do not have high cholesterol, diabetes or other standard indications that they are at risk of heart attack. (See Maggie’s post on this subject for more background on the overuse of statins.)

An estimated 20 million Americans currently take statins; it’s only a matter of time before the pharmaceutical lobby convinces us that these pills are actually benign “risk-reduction supplements”–a phrase actually used by Dr. Francis in an interview. Getting a dose at McDonalds sounds far-fetched now, but who knows? Given enough pressure from drug companies, health officials might start adding them to our drinking water, along with the fluoride.