WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

303 Creative, Transgender Rights, and the Ongoing Culture Wars

By Michael R. Ulrich

The Supreme Court’s ruling in 303 Creative LLC v. Elenis suggests a willingness to ignore the rights and health implications for minority populations under the guise of protecting against theoretical harms. The decision is a crucial blow to strides made in achieving gay rights, and may bolster other attacks on LGBTQ+ rights. As laws that restrict the rights of transgender people in the U.S. face challenges in court, the legal, public health, medical, and bioethics communities have an essential role to play both in properly framing the legal issue, as well as explaining what is truly at stake in these cases to minimize the chances of similarly harmful rulings for the transgender community moving forward.

Read More

Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

Read More

rendering of luminous DNA with gene being removed with forceps.

Mainstreaming Reproductive Genetic Innovation

By Myrisha S. Lewis

Despite religious and ethical objections, assisted reproductive technology (ART), including in vitro fertilization and egg freezing, manages to flourish in the United States, with some states and companies even creating regimes for its insurance coverage. However, reproductive genetic innovation — a term I use to refer to the combination of assisted reproduction with genetic modification or substitution — has yet to receive the same acceptance. Examples of reproductive genetic innovation include mitochondrial transfer, cytoplasmic transfer, and germline gene editing.

Moreover, while many scientists, regulators, and members of the public have called for societal discourse or consensus related to individual reproductive genetic innovation techniques, these calls rarely include an explanation as to how these discourses would be conducted. In a recent article, Normalizing Reproductive Genetic Innovation, I offer four potential avenues for structuring a societal discourse in the U.S. on the topic.

Read More

U.S. Capitol Building at Night

Is Preemption the Cure for Healthcare Federalism’s Restrictions on Medication Abortion?

This post is an adaptation of an article published in the Harvard Social Impact Review.

By Allison M. Whelan

On June 24, 2022, the U.S. Supreme Court issued its decision in Dobbs v. Jackson Women’s Health Organization, overruling almost fifty years of precedent established by Roe v. Wade and reaffirmed by Planned Parenthood v. Casey. The tragic consequences of Dobbs are many, and all require urgent attention.

Post-Dobbs, states have complete control over the regulation of abortion, including medication abortion. Now more than ever, a person’s access to abortion and other essential reproductive health care services depends on their state of residence and whether they have the means to travel to a state that protects access to abortion care. As a result, the question of whether states can restrict or ban pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) is now top of mind for lawyers, scholars, policymakers, and the public

The consequences that result from state bans and restrictions on medication abortion reverberate across the U.S. healthcare system, representing just one example of “healthcare federalism” — the division of power between the federal and state governments in the regulation of health care.

Read More

LISBON, PORTUGAL - 7 NOVEMBER 2017: Dr. Oz, heart surgeon & television personality speaks at the Web Summit, Lisbon.

The Dr. Oz Paradox

By Claudia E. Haupt

Why does the law sanction giving bad advice to one patient, while it permits giving bad advice to millions of YouTube or television viewers, which may result in significant physical harm?

We might call this the “Dr. Oz paradox.” Dr. Mehmet Oz, the Republican candidate in Pennsylvania’s U.S. Senate race, is a famous television personality as well as a licensed physician. But, according to one study, half of his publicly disseminated medical advice is wrong. Yet, his sizable audience may very well follow it anyway, and perhaps suffer harm as a result. Such bad advice, which could get any doctor in legal trouble if disseminated to their patients, may be given to the public at large without fear of sanction. The consequences of this sharp doctrinal distinction can be quite jarring.

Read More

Concept: An ounce of prevention is worth a pound of cure.

The Paradoxical Legal Treatment of Preventive Medicine

By Doron Dorfman

Preventive medicine is a tool used by individual patients, primary care physicians, and governmental agencies to preempt illnesses rather than to treat them after they have arisen. Despite this salubrious aim, stigma, shame, and fear often are attached to the use of preventative care.

The stigma around preventive medicine can arise from the tendency to view such measures as a proxy for risky or otherwise socially marginalized behavior or lifestyle. Why would someone use a preventative measure if they are not at high risk as a consequence of their own choices?

Consider, for example, what I call “sexually charged” preventative health measures like the human papillomavirus vaccine or Pre-Exposure Prophylaxis (PrEP). PrEP is a highly effective daily drug regimen that prevents HIV infection, which has become specifically popular with gay and bisexual men.

As I discuss in a forthcoming paper, PrEP has been viewed by policymakers and health care professionals as a “license for promiscuity” due to the fear of risk compensation, meaning the adjustment of risky behavior by those who take PrEP to potentially have sex with more partners and with no condoms. Such views are reflected in Kelley v. Becerra, a case pending before the U.S. District Court of the Northern District of Texas, where plaintiffs wish to purchase insurance that excludes coverage for PrEP and contraception, to which they object to on religious and moral grounds.

Read More

Concept illustration of DNA and genes.

The Civil Rights Challenge to Gene Patenting

By Jorge L. Contreras

In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.

In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”

Read More

Bill of Health - Globe and vaccine, covid vaccine

Promoting Vaccine Equity

By Ana Santos Rutschman

The COVID-19 pandemic has brought into sharp relief longstanding equity problems surrounding the allocation of newly developed vaccines against emerging pathogens.

In my upcoming book, Vaccines as Technology: Innovation, Barriers, and the Public Health, I examine these problems and look into possible solutions to incrementally build more equitable frameworks of access to vaccines targeting emerging pathogens. These solutions focus on ensuring that vaccines are made available affordably to the populations that need them the most according to public health parameters.

Read More

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Toward a Broader Telehealth Licensing Scheme

By Fazal Khan

Evidence generated during the first year the COVID-19 pandemic has called into question the need for many of the telehealth restrictions that were in effect prior to the pandemic.

The question many policymakers are asking now is: which of the telehealth regulatory waivers enacted during the pandemic should become permanent?

My forthcoming article proposes that the federal government use its spending power to incentivize states to adopt a de facto national telehealth licensing scheme through state-based mutual recognition of licensing and scope of practice reforms through a Medicaid program funding “bonus.”

Read More

UN United Nations general assembly building with world flags flying in front - First Avenue, New York City, NY, USA

Legal Capacity and Persons with Disabilities’ Struggle to Reclaim Control over Their Lives

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By Matthew S. Smith & Michael Ashley Stein

Persons with disabilities face an ongoing struggle to reclaim power and control over their lives.

The United Nations Convention on the Rights of Persons with Disabilities (CRPD) is an important tool in this struggle.

In mental health care settings, the CRPD has challenged states and practitioners to reject coercive forms of care orchestrated by substitute decision-makers — be they clinicians, family members, or court appointees — in favor of modalities that preserve and privilege individuals’ direct control over their care.

Read More