basketball on court

Sports Medicine in the Era of COVID-19

By Brian Feeley and William Levine

The world of sports and sports medicine offers a valuable window into understanding key developments in the COVID-19 pandemic and the broader health and equity issues at play.

Sports medicine, the practice of keeping athletes of all abilities in their peak through a combination of surgery, rehabilitation, and medications, has grown exponentially in the past few decades, with a concomitant rise in the popularity of professional and recreational sports.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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Several vaping devices on a table

E-Cigarette Laws that Work for Everyone

By Daniel Aaron

The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.

The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.

Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?

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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

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

Photograph of a gavel and three open books

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

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Back view of a little boy wearing a backpack walking to school

Zeroing In on “Zero Tolerance” School Discipline Laws

By Alexandra Hess

Exclusionary school discipline (ESD) policies, also known as Zero Tolerance policies, enforce disciplinary measures like suspension, expulsion, or law enforcement referral to address particular student behaviors.

Though it began as part of the Gun-Free Schools Act of 1994, which mandated one-year expulsion for possessing a firearm at school, ESD became more widely adopted over time. Now, the policies apply nationwide to a broad range of behaviors — from damaging property and fighting, to possessing a cell phone or tobacco, as well as behaviors described by subjective terms often undefined in the law, like willful defiance, obscenity, or profanity. Read More

A baby getting vaccinated by a doctor wearing gloves.

The Rockland Ban: The Next Step in the Battle Against Measles

Rockland County, New York’s Executive, Ed Day, issued an emergency declaration last month, banning unvaccinated children from public places. Although this seems like a drastic step, it is the culmination of extensive efforts to stem a large outbreak created by anti-vaccine misinformation. It is also in line with principles of public health.

For months, Rockland county in New York has been battling a large measles outbreak. As of April 2, 2019, the outbreak reached 158 cases. The vast majority of cases – 86 percent – were in minors under the age of 18, and over 50 percent are under six years old. Only 3.8 percent of the victims are fully vaccinated (3.8 percent received two doses of the Measles, Mumps, Rubella vaccine, MMR). And 82.8 percent of cases are known to be unvaccinated. Many of the cases are concentrated in Orthodox Jewish neighborhoods.

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close up of the back of a baby's head while breastfeeding

Toxic Breastmilk: When Substance Abuse Relapse Means Death for Baby

Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk.  According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.

Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.

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baby held in mother's hands in lap

US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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