Switching Cholesterol Drugs to Over-the-Counter Could Prevent 250,000 Coronary Events
Lipid-lowering statins have been life-savers for many years now. They are so well understood that many now believe that they should be sold over-the-counter (OTC), that is, without a physician’s prescription. The proposal is certainly controversial. After all, how do you know you have high cholesterol without a physician telling you? It’s not like you are coughing or sneezing and just trot off to the pharmacy to get some cough suppressant or antihistamine or whatever you need.
Nevertheless, many medicines we consume OTC — even children’s Advil — were once available by prescription only. There is no doubt that when a medicine switches from prescription to OTC that more people will take it. New research by Christopher Stomberg and colleagues suggests that switching statins to OTC would reduce the number of coronary events by a quarter million annually. Manufacturers would like to switch their statins, but the FDA is not allowing it.
Let me open a bag of worms…
Why does the FDA have the power to decide whether a drug is available by prescription or OTC? The FDA regulates drugs’ “safety and efficacy”, but that does not necessarily include how they are distributed. This power was not granted to the FDA until 1951, via the Humphrey-Durham amendment, half a century after the FDA was birthed. How the drug is distributed to patients is a matter of professional judgment. Physicians and pharmacists are regulated by state boards. What if the power to decide whether a drug was dispensed by prescription or OTC was determined by states?
What do you think would happen?
“Let me open a bag of worms…”
This is quite a large bag of worms you are opening. However, I don’t see how switching statins to OTC prevents coronary events. Checking cholesterol is based on blood tests, it is not an ailment like a headache. You shouldn’t take a statin drug if you “think” your cholesterol is high. Without physician supervision, it is dangerous to take this med.
Also, it isn’t like cost is a barrier to obtain the medication. The generics are readily available by prescription and relatively cheap.
If we make a statin OTC, do we make atenolol for high blood pressure OTC? Or metformin for type 2 diabetes? It is easier to check for high blood pressure and high blood sugar than cholesterol. If it treated something that could be monitored at any moment, it would make sense to become OTC.
I agree. Why would there be any reason for someone to assume they have high cholesterol or take statins OTC. You concede this point, John. And, this study concedes that those that do have coronary events have them because they don’t get diagnosed.
Letting states determine drug status would be interesting. Would it also provide incentives for individuals to cross state lines to obtain a particular medication? And would their be repercussions for this, like for medical marijuana?
You bring up a good point Buddy. Yes, that could happen, but so what? Should people not be left alone to make their health choices?
I think we should be too. Buddy’s point goes well with the unintended consequences of differing interstate taxes and other policies. But yes, we Americans are fully capable of making our own decisions with respect to which drugs we should be able to obtain OTC. In fact, we should have far greater autonomy over just about every aspect of our medical care. As long as not other people are hurt the government ought not interfere with the availability of such drugs.
I, for one, am always in favor of having states and local decision-makers implement such policies. In broad terms, this debate is basically about whether or not people are allowed to make their own healthcare decisions. For example, I could have a headache, and take too much Advil or take it in an incorrect manner. However, that is MY responsibility, and not the government’s.
Merck tried to get Mavacor approved for OTC sales on three separate occasions. It was rebuffed in each case. By contrast, Zocor has been available Over-the counter in Britain for a decade now. I haven’t seen any media stories about how people are dying like flies.
That’s because people are not nearly as ignorant as their government purports them to be Devon. After all, we make all kinds of choices all by ourselves, ranging from what foods to eat, what type of vehicle to drive, to hundreds of others each and every day. But, leave it to the FDA to Bloomberg us with potentially life-saving OTC drugs.
Very true, Steve. Federal agencies and politicians have tried time and again to impose a nanny state, implementing their limited beliefs regarding our capability to run our lives. This is another case of that. The FDA has slowed or stopped countless drugs that could have benefitted millions of Americans since its inception, and they are the supposed patient “advocates.”