Drugs' Other Side-Effects

By Konnoth, Craig J. | Iowa Law Review, November 2019 | Go to article overview

Drugs' Other Side-Effects


Konnoth, Craig J., Iowa Law Review


I. Introduction

Drugs produce side-effects-that is, unintended, incidental, consequences of ingesting the drug.1 Benadryl causes drowsiness;2 Zoloft causes nausea;3 Warfarin might result in internal bleeding.4 Sometimes such side-effects are serious enough for the Food & Drug Administration ("FDA") to deny approval of the drug.5 And the public hears of the side-effects of some drugs only after they are approved, marketed, and even prescribed.

Sometimes these side-effects are positive. NyQuil is frequently used as a sleep medication because it produces drowsiness.6 Manufacturers might even market these desirable side-effects.7 But most of the time, side-effects are negative, causing discomfort, danger, and even death. These side-effects have in common one important feature: they all involve physiological reactions to the chemical effects of the drug. Government agencies have been equipped to deal with these physiological effects-their experts can identify side-effects through the pre-approval clinical trials and post-approval drug surveillance, and their legal powers permit them to withhold or withdraw approval of drugs that have dangerous effects.8

But drugs can produce other kinds of effects that go far beyond chemical and physiological reactions. The birth control pill gave women autonomy that they never had before.9 More recently, pre-exposure prophylaxis ("PrEP") has proven to prevent HIV transmission. This allows individuals to engage in intercourse without the fear of contracting HIV and may reduce the stigma that HIV positive individuals have suffered.10

Some may argue that these are, in fact, the main purpose of drugs. The point of wellness isn't to have a body that functions optimally. Rather, its good lies in the other goals wellness allows us to pursue: autonomy, human connection, and happiness. Drugs are marketed with the promise of joy and productivity, rather than for producing health for its own sake.

But putting that issue to one side, my central point is that the introduction of drugs onto the market can have additional non-physical negative effects that are, most decidedly, unintended. Some argue that PrEP has led to increased promiscuity and a decline in condom usage.11 The introduction of high cost drugs in the Hepatitis C context has siphoned resources away from other areas. Another drug, BiDil, which was famously understood to target heart conditions specifically for African-Americans was criticized for reifying racial categories.12 These non-physiological effects can range from unintended changes in the behavior of individuals to broader effects on third parties or society as a whole.

However, the literature has a gap, in that it fails to abstract and analyze these problems-and the FDA's engagement (or non-engagement) with them-more generally. At base, my claim is, that as a systematic matter the FDA regulates only (1) direct effects of the drug (2) on the person who takes it (3) because of its physiological effects. The harms that are not considered systematically are therefore (1) indirect effects, such as risk compensation behavior, or (2) effects on third parties or society, that is, those who have not taken the drug, or (3) effects that are non-physiological in nature, such as racial effects.13 This Article concedes that the FDA should continue to focus primarily on direct, physiological, and first person side-effects, and might save its most onerous regulation for those contexts. However, I also claim that the FDA should take into account these "other" side-effects more systematically, and engage in some consideration and possible regulation, usually less onerous, based on them.

This is not to say that these effects are never, or even rarely, considered. In many cases, as I describe below, the FDA will take some of these harms into account. But the FDA does not explain why it does not consider these effects in some contexts and not others, or with respect to some drugs or not others. …

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