Jessica Flanigan proposes to permit individuals to purchase any drug directly from the pharmaceutical manufacturer without gatekeeping by physicians, pharmacists, or government (i.e. FDA) regulation. She posits that individuals are rational creatures, and with sufficient information, they can make their own informed choices. I hold that such a position is nearsighted and dangerous. The current dual system of pharmaceuticals—over-the-counter (OTC) and prescription—recognizes that some drugs create a harm not just to the individual but also to others that necessitates a paternalistic approach.
According to the World Self-Medication Industry, self-medication is “the treatment of common health problems with medicines especially designed and labeled for use without medical supervision and approved as safe and effective for such use.” In the nineteenth century, self-medication was the only way that one could find medications in the United States. Many of these were peddled by snake oil salesman and commonly contained opiate derivatives and marijuana. Even prescribed elixirs led to addiction and some overdose deaths. Few of these medications were effective at treating ailments. In 1906, Congress passed the Federal Drug & Food Act which established the federal government’s obligation to ensure that drugs were safe, effective, and advertised accurately.
In 1968, Bruce Brennan, an FDA attorney, argued that self-medication “has grown from the demand in our society that the individual be able to determine for himself what he wishes to do in managing subjective manifestation of physical disorders.” He further said that a right to self-medicate was based on the idea that “the individual should fight his own battles.” Of course, no right is without limit when its exercise can harm others. By 1978, an article written by pharmacists suggested that there are some medications about which people need guidance or they are subject to abuse. In all of philosophy, law, and history, there is no right to self-medicate. Neither is there a mention in the list of inalienable rights laid out in the U.S. Declaration of Independence or Constitution.
The United STates already has a system of self-medication for certain drugs. For example, I used to need a prescription from my physician to purchase an allergy pill or an acid reflux drug. After years of widespread use, these drugs proved themselves to be safe and effective, eliminating the need for a gatekeeper. Drugs that achieve over-the-counter status have a track record of not interacting with many common medications, of not having problematic side effects, and can be easily taken by an untrained person.
For other drugs, we have paternalism—under which someone who knows more than you acts to keep you safe. Consider that I do not wake up in the morning and test my water for lead and arsenic before brushing my teeth. I do not test my air for sulfur and ozone. I do not pave my own road to get to work. I do not have to test the produce I buy for the presence of bacteria or fungi. To be frank, I would not know how—I lack the knowledge, the skills, and the means. However, there are experts upon whom I rely upon to make sure that all of these things are safe and available. As Brennan said, “In our free society, government is established to do only those things that individuals cannot do alone.” To do any of this safety surveillance on my own would require expertise in chemistry and biology, having a laboratory in my home, knowing the appropriate tests and how to read them, and having the hours necessary to undertake these tasks. Realistically, we must rely on others who have the expertise and means to make sure that publicly available goods are safe and effective.
Flanigan’s proposal relies on the notion of informed consent. There are two components to informed consent: 1) informational and 2) volitional. In the first, I need to know the risks, benefits, and alternatives. In the second, a competent, capacitated, rational decisionmaker, absent of coercion or influence, makes a decision. The standard here is not simply that knowledge is passed to me in a document or a Google search, but rather that I have an understanding of it—not just reciting a list of side effects but knowing the effect on physiology and lived experience. Without standardized, rigorous clinical testing, no one can have knowledge of the risks or benefits. A new drug must be tested on thousands of people (phase three testing) to know this information. I could not conceivably test each potential drug on my own subject pool of a thousand people, nor should I trust a wiki written by a bunch of lay people self-experimenting with a compound. Given the complaints by pharmaceutical companies about the expense of clinical testing, pharma manufacturers are unlikely to undertake the same rigorous testing the FDA now requires if it were made optional.
There are many dangers to full self-medication. Studies show that choosing drugs and dosages requires knowledge of dosing, timing, and side effects which untrained people do not have. Among the dangers are incorrect self-diagnosis, incorrect choice of therapy that harms one’s health, not knowing dangers of mixing drugs with ones you are already taking, lack of knowledge of contraindications, not knowing that the same substance can be sold under different names (increasing risk of overdosing), not recognizing adverse reactions, not correctly administering, using for too long or for too short a period of time, developing dependence, and not knowing that chemicals in food can affect the actions of a drug. In addition, a person may not know the source or quality of the medication: a problem that has been raised in other studies. Still others may be susceptible to becoming dependent and addicted, especially if they have a mood disorder or existing addiction which he or she may not recognize.
The second component of informed consent is that your choices are voluntary. Marketing goes back to selling snake oil when we are encouraged to take the word of the manufacturer absent proof. Studies show that physicians are strongly influenced by pharmaceutical marketing: If a drug rep visits a physician to talk about a company’s drug, the physicians will prescribe that company’s drugs at higher levels for several months. If physicians who are highly trained in the science and clinical use of medication are so influenced by advertising, how will someone without the benefit of at least seven years of post-college education be able to escape the coercive effect of advertising?
We must also consider that Flanigan’s perspective requires a rational decisionmaker. Although we like to think that we are rational, most of are not, and even fewer patients are, which is one reason why free market approaches to health care have failed. A sick person needs prompt help, not an opportunity to consider options, costs, benefits, and risks. Rationality is compromised by the influence of others, and we are often unaware of it. While most doctors are influenced by marketing, when asked, doctors say that other physicians are influenced, but that they personally are not. Lack of awareness of the effect that others have on us is dangerous. The gatekeeper helps to mitigate this effect.
One can argue that by self-medicating, a person agrees to undertake all of these potential problems and accepts the consequences. However, as even the libertarian John Stuart Mill argued, when one’s actions pose a potential harm to others then the government is obligated to step in. If one becomes addicted to a drug, as was common in the 1800s, that action could cause harm to one’s family and co-workers. The price might be paid for others (e.g. drugged drivers killing others in a crash). Taking something as seemingly innocuous as antibiotics can have a strong negative effect on others: Not completing a full dose of treatment because you feel better, or treating yourself with the wrong drugs, leads to antimicrobial resistance, meaning that such drugs can be ineffective against future infections and endanger others’ lives.
The reason why people choose self-medication is cost, not lack of access to medical care or convenience. This finding suggests the solution might be cost-control rather than removing patient protection. While liberty is a good thing, all rights and freedoms have their limits—usually when their practice infringes upon other people. For the moment, our society is best served by our dual system of pharmaceutical distribution: drugs with long proven records of safety and ease-of-use are sold over the counter, and all others are available through our partners in health—physicians and pharmacists.
Bennadi, Darshana. 2013. Self-medication: A current challenge. J Basic Clin Pharm 5 (1):19-23. doi:10.4103/0976-0105.128253.
Brennan, Bruce J. 1968. The Right to Self-Medication-A Continuing Conflict Between Congressional and Agency Policy. Food Drug Cosm LJ 23:487-.
Chimonas, Susan, Nicholas J. DeVito, and David J. Rothman. 2017. Bringing Transparency to Medicine: Exploring Physician’s Views and Experiences of the Sunshint Act. . American Journal of Bioethics 17 (6):4-18. doi:10.1080/15265161.2017.1313334.
Collier, Roger. 2009. Rapidly rising clinical trial costs worry researchers. CMAJ 180 (3):277-278.
FDA. 2009. Federal Food and Drugs Act of 1906 Public Law 59-384. 34 STAT. 768. Washington DC: Food and Drug Administration. https://www.fda.gov/Regulatoryinformation/LawsEnforcedbyFDA/ucm148690.htm. Accessed July 7 2007.
Iserson, K. V., R. J. Cerfolio, and R. M. Sade. 2007. Politely refuse the pen and note pad: gifts from industry to physicians harm patients. Ann Thorac Surg 84 (4):1077-1084. doi:10.1016/j.athoracsur.2007.06.032.
Lazareck, Samuel, Jennifer Robinson, Rosa M. Crum, Ramin Mojtabai, Jitender Sareen, and James M. Bolton. 2012. A Longitudinal Investigation of the Roleof Self-Medication in the Development of Comorbid Mood and Drug Use Disorders. J Clin Psychiatry 73 (5):e588-593. doi:10.4088/JCP.11n0 7345.
McGuire, Ryan. 2011. Per Patient Clinical Trial Costs Rise 70% in Three Years. Cutting Edge Information. https://www.cuttingedgeinfo.com/2011/per-patient-clinical-trial-costs/. Accessed July 10, 2017.
Mill, John Stuart. 2002. On Liberty. Mineola, New York: Dover Publications.
Schafheutle, E. I., J. A. Cantrill, M. Nicholson, and P. R. Noyce. 1996. Insights into the Choice Between Self-Medication and a Doctor’s Prescription: A Study of Hay Fever Sufferers. International Journal of Pharmacy Practice 4 (3):156-161. doi:10.111/j.2042-7174.1996.tb00859.x.
Weil, Gilbert H. 1965. The Natural Right of Self-Medication. Annals of the New York Academy of Sciences 120 (July):985-989. doi:10.1111j.1749-6632.tb56737.x.
World Health Organization. 2000. General Policy Issues: The benefits and risks of self-medication. WHO Drug Information 14 (1):1-2.
WSMI. n.d. What is self-medication? Nyon, Switzerland: World Self-Medication Industry. http://www.wsmi.org/about-self-care-and-self-medication/what-is-self-medication/. Accessed July 7 2017.