The Precautionary Principle (PP) refers to risk avoidance when future consequences are uncertain or potentially dangerous. In other words, better safe than sorry. PP is used by many organizations and nations such as the United Nations (UN) and the European Union (EU). Some in the scientific field support this framework, while other see this as a hindrance to progress.
PP is a way to avoid our mistakes in the past. These mistakes includes the case of Diethylstilbestrol (DES; expanded on “Heritable Consequences”), a drug prescribed to women in the mid 20th century to reduce risk of miscarriage. Years later, it has been observed to increase the risk of breast cancer, and raise the chances of infertility to their offspring. Another incidence involves Thalidomide, which was given to prevent nausea in pregnant women (same time period). Severe birth defects were observed in the offspring of mothers who took thalidomide. These incidents have contributed to the stringent regulation of the FDA. After all, this is the mission of the FDA: “protecting and promoting the health of the American people, using science for regulatory decision-making.” Could mitochondrial replacement have some unforeseen consequences that will make it seem like a mistake in the future? Should the FDA prevent this procedure for the unknown possible long-term effects? Indeed, there is substantial risk involved with this procedure.
Some risks pay off, however. The field of effective vaccination originated from risky trials. Edward Jenner experimented on the small pox vaccination by inoculating an eight-year old boy with live cowpox, and as a result has saved millions of lives. Immunizations have eradicated many diseases, or at least reduce the incidence of many pathological and infective diseases. If the PP framework was implemented then, would widespread vaccination still have been implemented worldwide?
This framework causes ambivalence with procedures such as mitochondrial replacement. Science may be the only key to solving issues such as mitochondrial disease, so further investigation is simply necessary. At the same time, there is a fine line that may turn science from beneficial to detrimental. Thus, tough decisions are expected of policy-making bodies such as the FDA in the US and HFEA in the UK. These decisions may be context-dependent. Nevertheless, people’s voices should be heard by participating in voting.
Difference in the use of the precautionary principle could explain why the UK and the US are in vastly different stages of the approval of mitochondrial replacement as a prevention method for mitochondrial disease.
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