Bioethics in Practice: FDA Restrictions: How Strict Should They Be?
In May 2012, Mayor Michael R. Bloomberg proposed the “Sugary Drinks Portion Cap Rule” in an attempt to ban sweetened drinks larger than 16 ounces in New York City. Bloomberg reasoned that it was necessary to remove the sweet “hazard” from public consumers. Although the regulation was eventually repealed in June 2014, it prompts the following ethical question: How involved should the government be in protecting people from health-related risks?
The Food and Drug Administration (FDA) requires a tobacco seller to have the following warning on a pack of cigarettes: “Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.” Yet despite these warnings, approximately 15.5 percent of adults smoke, according to a 2016 poll conducted by the Centers for Disease Control and Prevention (CDC). From an ethical perspective, it seems that the FDA believes it is acceptable to sell cigarettes, as long as they display a warning for buyers to see. It is possible that, ideally, the FDA thinks that people should not buy cigarettes, but if people want to exercise their right to harm themselves, the FDA wants to make sure that people are informed.
When is it right to continue to sell a dangerous product with a warning, and when does it become necessary to completely outlaw the product? The United States was founded on the ideal of providing liberty to its citizens. Preventing access to drugs, even dangerous ones, could be infringing on that liberty. After all, even suicide is legal in the United States. If people have a right to end their own lives, they should certainly have a right to purchase drugs with high risk.
One could argue that each person should be able to decide everything for his or herself without governmental restriction. By this argument, the FDA should simply require that all risks be listed on the label of a product, leaving the consumer to evaluate the risks on his or her own. By the same token, a person who is in a dire health situation could easily gain access to a potential cure, even if it were a risky one. A sick patient with no feasible recovery plan may prefer to take the risks that come with a clinical trial. One can claim that the FDA should simply work as an informative agency to document and record the risks of all available treatments.
On the other hand, one may argue that it is immature and dangerous to allow unsafe drugs to be released to consumers. To allow unregulated drugs to be sold in stores is to remove the comfort and trust that American citizens have when they enter a drug store. Currently, a person does not necessarily need to be concerned for his life when he buys an Advil. In a world with lax regulations, it is possible that people could accidentally harm themselves.
From a Jewish ethical perspective, this question may fall under of the domain of Vayikra (Leviticus) 19:14: “Do not place a stumbling block in front of a blind man.” The Talmud in Tractate Avodah Zarah 6b explains that this pasuk is not limited by its literal meaning. The pasuk also implies that one may not intentionally help someone perform a sin. Rabbi Shlomo Yitzchaki (Rashi) explains that the pasuk also hints to the prohibition to give intentional bad advice. If selling an unstable product can be defined as bad advice or a transgression of some Jewish commandment, then the sale may be prohibited according to traditional Jewish Law.
Smoking, it seems, does not pose a lethal-enough risk for the FDA to completely outlaw it. Traditional Jewish ethics may not agree with this American legal practice. According to many Jewish authorities, smoking is prohibited under Jewish law because it presents a serious health risk. If smoking can be classified as a sin (because of the detrimental health effects), then according to the Talmud, selling cigarettes can possibly fall under the category of “placing a stumbling block in front of a blind man.” Unlike the FDA’s solution to give a warning, Jewish ethics may claim that you are still helping someone transgress a commandment to take care of one’s health. Theoretically, then, Jewish ethics would be at odds with the FDA when it comes to cigarettes.
This question also can also apply to clinical trials. On its website, the FDA states, “Recently, unethical behavior on the part of some researchers has shaken the public trust and prompted the federal government to establish regulations and guidelines for clinical research to protect participants from unreasonable risks.” This unethical behavior includes unsafe procedures performed on, or medications administered to, patients in clinical trials. Here too, one may wonder whether providing a warning to the patient is enough action to call a potentially unsafe clinical trial “ethical.”
On the one hand, one can argue that a patient who has no other option to survive might as well increase their chances of survival and participate in a knowingly risky trial. Yet, one can imagine that without regulation, it is possible that an unregulated clinical trial could be misrepresented to the patient, or maybe not fully understood by the clinicians themselves, leading to potential harm to the patient.
The guidelines for regulating health-related remedies present an ethical dilemma which requires more analysis than one short newspaper article to be resolved, but is nevertheless worth considering. The FDA must find a balance between keeping people safe, while also giving them access to potential innovative cures to difficult illnesses. From a Jewish perspective, it seems that a seller needs to figure out if providing the treatment could be labeled as “bad advice,” which may bring us back to the same issue as the FDA. Without an absolute answer, it seems that this issue needs to be judged on a case-by-case basis.
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