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Please write a one to one and half page paper explaining why you agree or disagree with the situation. Make sure to support your decision based on the ethical principles we have discussed in class and the legal discussions we have had in class about such things as patient confidentiality, mandatory reporting, informed consent before an experiment. Any other ideas you may want to include are also fine. The case study is attached.

How Should Physicians Respond When They Learn Patients Are Using Unapproved Gene Editing Interventions?

Abstract
Hundreds of gene therapies are currently in various stages of research and development. A subset of these involve gene editing technologies such as CRISPR. In this hypothetical case, a patient with chronic pain has initiated a CRISPR-based intervention obtained from a clinic in the Cayman Islands. His physician doubts it is approved by the US Food and Drug Administration and worries about its safety. The case presents ethical questions about potential violations of US regulations regarding the sale of products intended to affect human health, patients? lack of understanding about risks of unproven drugs, and suboptimal support for and management of patients with chronic pain. We discuss how physicians should address these questions.

Case
Dr T is surprised to see a patient, Mr J, at the gym. For years, chronic pain has kept Mr J away from most physical activity. Not having seen Mr J for a couple of years, Dr T asks how he?s doing and learns that Mr J had been using a recently developed clustered regularly interspaced short palindromic repeats (CRISPR) tool designed to permanently modulate inflammation. Mr J explains that he ordered this intervention from an American clinic in the Cayman Islands, reports improved sleep and capacity to exercise, and notes heartburn as the only side effect. Dr T suspects this CRISPR application is not approved by the US Food and Drug Administration (FDA) and asks Mr J to schedule an appointment for follow-up. Dr T?s view is that direct-to-consumer CRISPR tools should remain prescription only, since peer-reviewed clinical evidence in support of this CRISPR application is minimal. She?s concerned that Mr J?s use of it is too risky and wonders whether she should both gather more information from Mr J to help him and report the case to the FDA.

Commentary
A patient has obtained?likely via an internet-mediated mail order?a CRISPR gene editing product from ?an American clinic in the Cayman Islands.? Presumably, the intervention was not prescribed by another physician but was advertised and marketed by the entity providing the so-called therapy ?designed to permanently modulate inflammation.? Although this case is hypothetical, it does bear similarity to events that have actually happened.

Reducing the burden of pain has been identified as a significant public health challenge that must be addressed to stem the ongoing opioid crisis.

Similar Cases

In October 2017, a biohacker livestreamed himself self-administering a CRISPR- based experimental intervention for muscle enhancement.1 That year, another man recorded himself self-injecting an experimental gene therapy supplied by a Singaporean company; he hoped the investigational agent would stimulate his immune response to HIV.2, 3 This company?s late chief executive officer also recorded himself using an investigational gene therapy?this one intended to treat herpes simplex virus.4 He catalogued the company?s experimental gene therapies in a Facebook post, noting that they would be made available to the public.4 In another case, a scientist affiliated with both an academic institution and a company administered an investigational herpes vaccine to people in both the United States and St. Kitts, without approval from the FDA, St. Kitts regulatory authorities, or local institutional review boards.5, 6
One might dismiss these and similar cases as of small public health concern, but these u nproven products could harm those who use or consume them. There is additional concern, albeit small, that these products could pose risks to people who do not actually take them. For example, Germany banned all imports from a California-based company that sells DNA reagents and gene editing kits because some if its products were contaminated with pathogenic bacteria.2
The hypothetical case, as well as the real ones, prompts questions about proper roles of government in regulating drugs and biological interventions, the health and media literacy of the public, and how patients might respond when a health care system does not or cannot meet their needs. The case also highlights ethical obligations of clinicians to (1) communicate with patients and provide appropriate care, (2) report potential violations of US regulations regarding sale of products intended to affect human health, (3) educate patients about risks of unproven drugs in the context of the FDA?s mission to protect public health, and (4) optimally support patients with chronic pain.

Caring for the Patient
Dr T is right to ask Mr J to schedule an appointment, especially since he is experiencing heartburn, which he seems to attribute to the CRISPR product. Other more serious conditions, such as angina, can mimic heartburn pain. Since she suspects the product Mr J used is not FDA approved, its safety profile is uncertain. Although side effects will likely be product specific, clinical concerns about gene editing products include possible infection, immunologic reactions, and unanticipated molecular and cellular effects.7 Dr T will want to get an updated health history from Mr J. She will also want to check his vital signs and order tests to check for possible intervention-associated toxicity. Because Mr J might not realize why she wants him to come in, Dr T should communicate her concerns to Mr J before she leaves the gym.

Duty to Report
The FDA is tasked with protecting public health by ensuring the safety and efficacy of human drugs, biological products, and devices. According to the agency, sale of gene- editing products or kits intended for self-administration is illegal.8 Companies, institutions, or individuals who want to do clinical research on experimental gene editing products in the United States must first submit an investigational new drug

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