This American Life: Use Only as Directed

            In this podcast, reporters analyze the history of Tylenol and its active ingredient: Acetaminophen. Though invented in the fifties, Tylenol became most popular in the seventies due to its lack of side effects when compared with competitors. Specifically following the 80s “Aspirin Wars” Tylenol fought in advertising to become known as the safest pain medication, , even though studies published since 1975 showed that Acetaminophen is seriously linked to liver failure. As more and more “accidental overdoses” were reported, calculations began to estimate that the difference between a safe and potentially deadly dose could be as little as an extra 2 extra-strength Tylenol pills a day over the recommended dosage. This problem is further compounded by the resistance of the McNeil’s companies’ resistance to address root issues, such as labeling of proper warnings of Acetaminophen usage, and the FDA’s reluctance to pass restrictions on the company. (Glass, 2013).

The issues the This American Life podcast brings up raises concerns over the ways in which pharmaceuticals act as businesses and how these effects general safety of medication. Due to the financial motivation to produce medicine with few side effects and good outcomes, some companies may feel the need to skew statistical reporting. This is partially examined in Chapter nine of Stegenga’s book: Care and Cure, which focuses on the statistics of medical reports and the extent to which data can be skewed based on the way the results are presented. It asks the question as to how this data can be applied to real life and the necessity of an impartial analysis (Stegenga, 2018). In an ideal world, every study would be conducted with as little bias as possible, but this article credits many of the “studies” that found Tylenol to be the safest drug, as being funded by the McNeil’s own company. McNeil argued in the court cases surrounding accidental overdoses that these trial studies were able to make this conclusion as the company possessed information that the governmentally funded trials run by the CDC did not. They pushed the idea that the lack of certain (unspecified) information led to a drastic overestimate of the number of accidental deaths, and even argued that most of these overdoses could be attributed to suicide (Glass, 2013). Stegenga’s article shows the possibility of such an occurrence, especially if the sample of cases used by the CDC were not truly representative of the population. But though it can never be said with complete certainty that the numbers released by the CDC on Acetaminophen are accurate, the greater possibility that the percentage of accidental overdoses are even near the rate reported is extremely troubling. It brings into question exactly what information should be required to be displayed on warning labels, to enable consumers to make decisions based on informed consent.

Without the proper wording and information properly displayed, the consumer of the product does not have the proper information to choose whether to use the good. A research article, Millum and Bromwich, clarifies this scenario through defining different perceptions of informed consent as well as what should be required for a subject to give informed consent. They argue that in order to fully assent to treatment, patients must understand “(1) that [they are] giving consent; (2) how to exercise [their] right to give or refuse consent; and (3) to what [they are] being asked to consent” (Millum & Bromwich, 2021). In the absence of a proper warning label patients cannot give informed consent to treatment using the medication due to the third requirement, under which it is necessary that the patient understands the risks of taking the medication. Thus, the sole way in which the company can ethically disperse medicine is if they oblige the CDC’s recommendation of the warning label’s wording. Though by the time the podcast was published the McNeil Company had already placed a proper warning label on their product, it took them forty years after the CDC’s report highly recommended the change for them to do so (Glass, 2013).

According to the podcast, a large reason behind this decision was the impact that such a statement would have on the public view of Tylenol. If the media picked up a story on the potential risk of liver failure while taking the advertised “safest pain medication on the market”, there would likely be grave implications for the company’s future. It became apparent that others recognized this to be true as well, as a competing brand once tried to use the CDC’s findings in an ad against taking Tylenol (Glass, 2013). The power displayed by this single ad shows how much weight news media carries, especially in the present day. It is often the main source, if not the only source, of information, for the general public. What they chose to focus on in a report or story has the potential power to sway or inform the nation. If the medical community was able to establish a good relationship with news media, the nation could be one step closer to closing the expertise gap between physicians and patients. This would allow for more cohesive communication and trust between the two, as well as limit unnecessary case numbers in overcrowded emergency rooms.

In application to the Tylenol controversy, when listening to this podcast the average public reader might begin to question their own use of over-the-counter medication, especially those that contain acetaminophen. If they chose to continue taking the medication, they will be able to do so, well informed of potential risks and benefits to taking acetaminophen products. This could lead to a dramatic decrease in accidental overdosing on over-the-counter drugs. In addition, listening to the risks of just one medication could open conversation between patients and doctors about other prescriptions, and conclude with the patient being able to fulfill requirements for the use of informed consent. Thus, the media, which in this instance exacerbated issues with pharmaceutical company disclosure, also poses the ability to change the gap of information between doctors and patients.

Sources

Glass, I. (Host). (2013, September 20). Use Only as Directed (No. 505) [Audio podcast episode]. In This American Life. Serial Productions. https://www.thisamericanlife.org/505/use-only-as-directed

Millum, J., & Bromwich, D. (2021). Informed consent: What must be disclosed and what must be understood? American Journal of Bioethics, 21(5), 46–58. https://doi.org/10.1080/15265161.2020.1863511

Stegenga, J. (2018). Care & cure: An Introduction to Philosophy of Medicine. University of Chicago Press.