Dying to Be Fresh and Clean? Toxicants in Personal Care Products, the Impact on Cancer Risk, and Epigenetic Damage

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how the current risk-based regulatory system enables manufacturers to market products containing toxicants that cause preventable cancer while promising product safety. In addition to increasing cancer risk, EDCs have the potential to induce both epigenetic marks and transgenerational epigenetic damage, increasing the risk of cancer and widespread adverse health consequences for future generations never exposed to the toxicant. This Article asserts that we have an ethical duty to enact precautionary regulations governing cosmetics that would protect the integrity of the human genome against preventable, environmentally mediated damag

Emerging Governance of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence and Policy Outcomes

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the first nation to legally authorize “cautious use” of this experimental procedure and it appears the United States will soon also permit clinical investigation of MRT under the purview of the FDA. This article evaluates the coherence between the scientific evidence assessing safety and efficacy of MRT, describes potential risks, investigates the medical rationale, and analyzes the driving motivation behind policymaking in the United States

Manipulating the Prescription Drug Market: Spiking Prices, Inducing Demand, and Costs to the Public

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to$500. Critics called the price hike “outrageous, “brutal” and “corrupt.” Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case – and other similar cases involving generic drugs and insulin – highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United States outpatient spending on prescription drugs totaled $369.7 billion. Despite massive expenditures, the United States ranks below comparable countries on health outcomes. This article traces the reasons for high medication prices; describes two key lawsuits alleging patterns of anticompetitive pricing, collusion, and fraud; and analyzes how corporate practices contribute to unnecessary and harmful healthcare costs through the pharmacological imperative. Industry practices described in this article reflect a pattern of organizational business ethics that contravenes market guardrails through both alleged and admitted dishonesty and illegal conduct. This article proposes solutions that will improve patient health, reduce healthcare costs, and uphold market fairness by reforming the expectations of corporate conduct

A proposal for comprehensive biobank research laws to promote translational medicine in Indiana

Predictive Health Ethics Research (PredictER), funded by a grant from the Richard M. Fairbanks Foundation, Inc. Indianapolis

Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberation about altering the genes of future generations