Last week, an FDA advisory panel recommended a number of significant changes regarding the sale and marketing of products that contain acetaminophen, which is the active ingredient in the popular over-the-counter painkiller Tylenol. Three of their recommendations are especially significant.
First, they advised that Vicodin and Percocet be discontinued as prescription pain-relieving drugs. They also suggested that both the maximum daily dosage listed on bottles of acetaminophen, and the size of the largest bottles available for purchase, be reduced. Their hope is that these changes will prevent several thousand deaths and tens of thousands of E.R. visits that result every year from an overdose of acetaminophen.
The astute reader will notice that the justification for this recommendation is the prevention of harms caused by the improper use of a generally safe medication. Some may find this objectionable, on the grounds that this justification is paternalistic. Paternalism is the view that sometimes, the government can ban or restrict certain substances or activities in order to protect people from self-inflicted harm.
Prohibitions on illegal drugs are sometimes thought to be paternalistic, and a common reply from someone who is generally opposed to paternalism might be that this new restriction is unjustified because it is paternalistic.
This is not a sufficient reply, but it is a good place to start for analysis. Citing paternalism isn’t enough, by itself, to undo the logic of this recommended restriction. After all, we sometimes think paternalism is a good idea.
We don’t allow people to shoot heroin just because they want to do so, even if they aren’t hurting anyone else. We also think it’s a good idea to closely monitor the mentally ill to prevent them from hurting themselves. In the workplace, especially if one works around dangerous equipment, certain behaviors are prohibited precisely because they are dangerous to those who engage in them. We seem to think that sometimes, paternalism is a good thing.
The question is whether restricting the availability of acetaminophen is the right kind of paternalism. Three questions need to be answered here. First, we need to know what benefits are being lost by this restriction. Second, we need to ask ourselves whether the harm being prevented justifies the benefits that are being lost. Finally, we need to consider how effective these measures will actually be in preventing the harms that they are intended to alleviate.
Let’s first consider what benefits are being lost. Acetaminophen is a very cheap pain reliever and fever reducer, so it is widely available to most people. Further, Vicodin and Percocet, which are being suggested for ban because they contain acetaminophen, are two of the most effective prescription pain relievers available. Acetaminophen is also not an anti-inflammatory, which means persons with allergies to this class of medicines can take it for pain. Finally, it is one of few pain medications that can be taken even by very small children. By restricting access to acetaminophen, we are reducing the availability of three very good pain medications, as well as a fever reducer that can be used by people of all ages.
The seriousness of the harm being prevented is the next relevant consideration for our analysis. It is certainly true that a great number of people become seriously ill and even die as a result of taking too much acetaminophen. It is also true that acetaminophen, when taken in large quantities, can cause long-term damage to the liver.
However, in both cases we are talking about harms caused by the misuse of acetaminophen, rather than the appropriate use of acetaminophen. Whether acetaminophen ought to be restricted when used appropriately is not the issue. The question is whether access for appropriate use causes or contributes to inappropriate use, and also whether the harms of inappropriate use justify limiting access to acetaminophen for appropriate use. The fact that the harms at issue are caused by poor choices, lack of education, and bad judgment by users is what makes this a question about paternalism.
Finally, whenever a legal ban or restriction is under consideration, it’s worth thinking about whether the proposed measures will have the desired effect. It is on this point that the FDA advisory panel’s proposal fails.
First, acetaminophen is already sold with a warning label advising that no more than 4,000 milligrams be taken in a 24-hour period. If people are already failing to follow a more lenient standard, it’s difficult to see how making the maximum daily dosage lower would have any measureable effect on use patterns.
Next, by banning Vicodin and Percocet because they contain acetaminophen, you are arguably encouraging people to take even more acetaminophen, as they now lack an inexpensive, effective opiate painkiller. Other prescription painkillers are either much too strong for a lot of pain, such as Oxycontin, or not terribly effective, like ibuprofen in 1000-milligram tablets. If taking 15 tablets of Tylenol is the only viable option remaining for one’s pain control, that’s probably what people are going to do.
Finally, reducing the size of the largest bottles available for purchase will have no effect whatsoever on consumption unless we also prohibit the purchase of multiple smaller bottles, and keep track of how often people buy acetaminophen. This is the current system for purchasing products that contain pseudoephedrine. Acetaminophen may have dangerous side effects at high doses, but it is not on par with the main ingredient in methamphetamine, and to treat it as such would be unjustifiably costly and time-consuming, not to mention a gross invasion of personal privacy.
Our intuitive response to the FDA advisory panel’s recommendations was to reject them as bad policy, and our analysis suggests that this intuition is probably right. Even if acetaminophen’s harms did justify restricting access for appropriate usage, the suggestions made by the panel for achieving this end are not likely to work. At best, this reasonable goal is being poorly implemented. At worst, it is a dangerous policy with the potential to bring about even more severe consequences than it seeks to prevent.
About the Author
Elijah Weber is a graduate student at Bowling Green State University. He holds a Master's degree in philosophy from Colorado State University, and Bachelor’s degrees in sociology and philosophy from Chapman University. He currently lives in Ann Arbor, Michigan with his wife Laura, his son Brandon, and two cats.