Black and white photo of a line of dominoes toppling over

The (Possible) “Dark Side” of Gene Editing Technologies

By Shelly Simana

Gene editing technologies enable people to directly change their DNA sequence by adding, removing, or replacing DNA bases. Today, for the first time, as Jennifer Doudna and Samuel Sternberg announced in their book, A Crack in Creation: Gene Editing and the Unthinkable Power to Control Evolution, people “possess the ability to edit not only the DNA of every living human but also the DNA of future generations” (p. xvi). The emergence of new gene editing tools, such as CRISPR-Cas9prime editing, and dubbed SATI, has led to momentous advances in biotechnology as the new tools make gene editing faster, easier, less expensive, and more precise than ever before.

While gene editing technologies offer great promise, they may also introduce risks with far-reaching consequences. This post focuses on the possible “dark side” of gene editing technologies and addresses some threats that the technologies might pose to human lives. While nowadays some of those risks would be deemed “science fiction,” they should be in the back of our minds as we ponder the potential impact of gene editing technologies.

Gene Editing as a Weapon of Mass Destruction Read More

Surrealist black and white photograph of a person wearing a bowler hat and button down shirt. Ther person's face is obscured totally by a tiny cloud

DNA Phenotyping Experiment on Uighurs Raises Ethical Questions About Informed Consent

By Beatrice Brown

On December 3, The New York Times broke shocking news: China has been using the DNA of Uighurs, a Muslim minority group who have been facing increased persecution, to create an image of a person’s face using a process called DNA phenotyping. The Uighur men were living in Tumxuk (a city in the Xinjiang region), which The New York Times notes being described by Chinese state news media as “one of the gateways and major battlefields for Xinjiang’s security work.” The New York Times introduced many troubling ethical issues, including the potential for increased social surveillance and thus increased “state discrimination” of this vulnerable ethnic minority, but here, I wish to focus on the issue of informed consent.

Informed consent is essential to conducting ethical research. Premised on respecting the autonomy of participants, informed consent requires that participants understand the research that they are consenting to be involved in, including potential risks and benefits of the research. However, what exactly constitutes true, valid informed consent to research is a contentious issue. There are two concerns about the validity of the informed consent process in this DNA phenotyping experiment. Read More

A family of four, two parents and two children, walk down the beach together at sunset.

The (Ante-Mortem) Interest in Genetic Continuity

By Shelly Simana

Omri Shahar was killed in a car accident when he was 25 years old. At his death, Omri’s parents petitioned the Israeli family court for posthumous sperm retrieval. The request was approved yet, one year later, they submitted an additional request—to use the sperm to fertilize a donated egg, implant the embryo in a gestational carrier, and raise the child. The basis of their request was Omri’s interest in “genetic continuity.” This interest is about individuals’ desire to leave a “piece” of themselves in the world and maintain a chain of continuity. It is about perpetuating one’s genes to future generations as a liberal expression of personal identity and a communitarian expression of family heritage. Read More

Illustration of a senior woman walking with modern robot dog

Exploring Elder Care Robotics: Emotional Companion Robots

By Adriana Krasniansky

This article is the first post in a four-part series looking at robots being developed for aging care, as well as their ethical implications. In this first article, we explore the rise of emotional companion robots such as the now-famous Paro, which are designed to soothe and comfort. 

What are Emotional Companion Robots?

Emotional companion robots deliver on a very basic definition of the term “companionship:” they provide emotional soothing and a constant presence for users. Many emotional companion robots are modeled after animal-assisted therapy (AAT) pets, which are trained to calm and support individuals with Alzheimer’s, dementia, and cognitive impairments.

AAT in elder care can be challenging; animals risk injury to patients, trigger allergies, and require regular exercise (and bathroom breaks). Animals may also refuse to cooperate, which can further agitate patients. Emotional companion robots have similar demonstrated outcomes to AAT—reducing stress, improving mood, and stimulating conversation—without the logistical hang-ups of animal care.  Read More

An adult hold the hand of a child with an IV

Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late

By Beatrice Brown

In my last blog post, I reflected on the ethical issues relevant to a critical shortage of a widely used pediatric oncology drug, vincristine. The shortage occurred after one of two pharmaceutical companies producing the drug, Teva, withdrew from the market, and the other, Pfizer, was unable to keep up with the demand due to manufacturing delays. On November 13, Teva announced that they would resume production of vincristine. The announcement stressed that they have decided to re-introduce the product because of the anticipated lack of “reliable single supply in the near term.” They also seemed to shift the moral blame from their decision, stating that “When Teva removed vincristine from the market earlier in the year there was no indication at all of a possible shortage” and that they assumed that Pfizer, which supplied 97% of the market, could easily absorb the demand. Furthermore, Teva emphasized that before discontinuing a product, they “always evaluate the need” for it, noting the caveat that they usually do not know supply challenges that other manufactures may be facing. However, as noted by Forbes, there will be no “short-term impact on the ongoing shortage” as a result of Teva’s decision, as their new supply of vincristine will not be available until early in 2020.

I raised the question in my last blog post on the shortage of vincristine of whether pharmaceutical companies have a moral obligation to continue producing a critical drug, even if the decision is announced in advance. I argued that it would have been more ethically permissible for Teva to have reduced production over time, eventually halting production, in order to alleviate the issue of manufacturing delays that Pfizer subsequently faced. I would like to further explore this question in light of Teva’s recent decision to resume production. Read More

Eighth Annual Health Law Year in P/Review: Looking Back & Reaching Ahead

This post is part of our Eighth Annual Health Law Year in P/Review symposium. You can read all of the posts in the series here. Review the conference’s full agenda and register for the event on the Petrie-Flom Center’s website.

By Prof. I. Glenn Cohen and Kaitlyn Dowling

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is excited to host the Eighth Annual Health Law Year in P/Review to be held at Harvard Law School December 6, 2019. This one-day conference is free and open to the public and will convene leading experts across health law policy, health sciences, technology, and ethics to discuss major developments in the field over the past year and invites them to contemplate what 2020 may hold. This year’s event will focus on developments in health information technology, the challenge of increasing health care coverage, immigration, the 2020 election, gene editing, and drug pricing, among other topic areas.

As we come to the end of another year in health law, the event will give us both a post-mortem on the biggest trends in 2019 and also some predictions on what’s to come in 2020.

Among the topics we will discuss: Read More

A sick child lies in a hospital bed. An IV pole is visible in the foreground

Ethical Reflections on the Recent Critical Shortage of Pediatric Cancer Drug

By Beatrice Brown

Recently, news broke that there is a critical shortage of vincristine, a drug that is integral for treating pediatric cancers. According to the Children’s Oncology Group, Pfizer communicated that they were experiencing a shortage of the drug due to a manufacturing delay. Pfizer is now the sole supplier of vincristine in the United States after the other supplier, Teva Pharmaceuticals, ceased production of the drug after making a “business decision.” Although the FDA announced that deliveries of the drug should resume in late October, it is predicted that there will still be a supply shortage until December or January.

Vincristine is “the single most widely used chemotherapeutic in childhood cancer,” according to Yoram Unguru, MD, a pediatric hematologist and oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland. Unguru stated, “Nearly every child with cancer in the U.S. will receive multiple doses of vincristine over the course of their treatment. For some children with cancer, vincristine comprises one half of all chemotherapy administered.”

The shortage is even more critical given that there is no other manufacturer that can pick up the slack. According to Unguru, the shortage was predictable once Teva halted production. Given that there is no substitute for vincristine, doctors are in a tough position. Thus, there are two ethical issues I wish to explore here: 1) the issue of resource allocation/drug rationing; and 2) the moral obligations of pharmaceutical companies to patients. I will take up each of these issues in turn. Read More

Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Challenging the Contours of the “Undue Burden” Standard in June Medical Services v. Gee: A Slippery Slope?

By Beatrice Brown

On October 4, the Supreme Court announced that it would hear June Medical Services v. Gee, in which a 2014 Louisiana law that requires abortion providers to have admitting privileges at a nearby hospital will be examined. The case is nearly identical to Whole Woman’s Health v. Hellerstedt, in which the Supreme Court held that a Texas law with a similar requirement for admitting privileges was unconstitutional according to the “undue burden” standard asserted in the landmark 1992 case Planned Parenthood v. Casey. According to the 5-3 ruling, such requirements for admitting privileges posed an undue burden on a woman’s constitutional right to abortion without also providing a significant health benefit to the woman.

As noted by many experts, the two cases are remarkably similar, with the key difference being the composition of the Supreme Court. In 2016, Justice Anthony Kennedy joined the four liberal judges in the majority opinion, whereas now, Justice Brett Kavanaugh will likely join the four other conservative justices. The uncertain factor, however, is that in February, Chief Justice John Roberts voted with the majority opinion to delay the Louisiana law from going into effect in light of ongoing litigation, despite voting against the majority in Whole Woman’s Health v. Hellerstedt about the constitutionality of this similar Texas law. As such, it is unclear if the Court will hold that the Louisiana law is constitutional – given that Justice Kavanaugh will likely vote for its constitutionality, the direction of the ruling hinges on whether Justice Roberts votes as he did in Whole Woman’s Health v. Hellerstedt or as he did in February. Read More

Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

Read More

Blurred image of a patient in critical condition in the ICU ward.

“An Act Improving Medical Decision Making:” An Argument in Favor of MA House Bill 3388 and Senate Bill 843

By Beatrice Brown

On September 10, 2019, the Joint Committee on Judiciary at the Massachusetts State House heard testimony regarding House Bill 3388 and Senate Bill 843, “An Act Improving Medical Decision Making.” The Massachusetts Medical Society (MMS) was among those testifying in favor of the act. As noted by MMS, Massachusetts is one of only five states in the U.S. that does not have a default surrogate consent statute for incapacitated patients without a health care proxy. The intent of a default surrogate consent statute is “to provide legal authority for health care decision-making through a non-judicial rule of law where no guardian or agent had been appointed.”

Without such a statute in place, this means that a patient who is incapacitated and has not declared a health care proxy must await treatment while a guardian is appointed by the courts. This may be a lengthy, time-consuming process that physically drains hospitals’ resources and emotionally drains families. By contrast, these default surrogate consent statutes establish a list of surrogates that can be appointed by physicians to make decisions in lieu of the incapacitated patient. For example, in the Massachusetts bills, the following persons are listed as candidates who may be appointed as surrogates: the person’s spouse, unless legally separated; the person’s adult child; the person’s parent; the person’s adult sibling; and any other adult who satisfies the requirement of subdivision seven of the bill which states, “The person’s surrogate shall be an adult who has exhibited special care and concern for the person, who is familiar with the person’s personal values, who is reasonably available, and who is willing to serve.” Read More