Category: Student Fellows

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

Beatrice Brown Leave a comment

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

Beatrice Brown 1 Comment

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

Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Opioid Claims for Fetal Opioid Exposure Alarm Pregnancy Advocates

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By Alexa Richardson

Lawyers calling themselves the “Opioid Justice Team” are pushing forward in their mission to certify babies exposed to opioids in utero, as well as “all women in the United States capable of becoming pregnant,” as distinct classes in the multi-district opioid litigation now unfolding in federal court in Ohio. Last week, lawyers filed an amended complaint on behalf of the legal guardians of individuals diagnosed with neonatal abstinence syndrome (NAS), and a list of “experts” with the court. Their claims misrepresent the science regarding fetal exposure to opioids and position fetal rights in opposition to those of pregnant people. National Advocates for Pregnant Women (NAPW) has issued a statement and fact sheet denouncing the claims.

In a series of court filings, sweeping claims about the impact of prescription opioid exposure on fetuses are being made. The lawyers falsely claim “[a]nything a pregnant woman ingests or breathes is transmitted to her baby by the placenta” and that “[i]n-utero opioid exposure leaves most children with physical, social, educational disabilities that require constant and regular interventions. Most of these disabilities are considered permanent.” In actuality, the American College of Obstetricians and Gynecologists states that the available data show “no significant differences” in long-term outcomes for individuals exposed to opioids in utero versus those who are not. The Centers for Disease Control (CDC) finds there may be early childhood impacts on cognitive or developmental abilities from prenatal opioid exposure. However, available studies struggle to separate the physical effects from environmental and social variables. There is not enough data to conclude whether any long-term consequences of fetal opioid exposure exist, the CDC finds.

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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?

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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

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

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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

Photograph of a woman lying in a hospital bed holding her newborn wrapped in a blanket

Where Are the Legal Protections for People Mistreated in Childbirth?

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By Alexa Richardson

A new study indicates that 28.1% of women birthing in U.S. hospitals experienced mistreatment by providers during labor, with rates even higher for women of color. The multi-stakeholder study, convened in response to World Health Organization efforts to track maternal mistreatment, included more than 2,000 participants, and defined mistreatment as including one or more occurrences of: loss of autonomy; being shouted at, scolded, or threatened; or being ignored, refused, or receiving no response to requests for help. The study newly highlights the lack of legal protections available to for pregnant and birthing people who experience these kinds of mistreatment by providers.

Campaigns like Exposing the Silence have chronicled the outpouring of people’s harrowing birth stories, riddled with abuse and violations of consent. In one typical account, a user named Chastity explained:

I had a room full of student doctors, an OB I never met come in and forcibly give me extremely painful cervical exams while I screamed for them to stop and tried to get away. They had a nurse come and hold me down. There was at least 10 students practicing on me. I was a teen mom and my partner hadn’t gotten off work yet so I was all alone.

Another user named Abriana recounted:

As I was pushing, I got on my side and it was then that I started to feel pain much different from labor pains. I asked, ‘What is going on?’ The nurse replied, ‘I am doing a perineal rub.’ I immediately said, ‘Please stop doing that. You are hurting me.’ The nurse argued, ‘It will help you’ and didn’t move. I asked her again to please stop. I then yelled, while pushing, ‘Get your hands out of me!’ The nurse continued.

The traditional modes of seeking legal recourse have little to offer those who experience these kinds of mistreatment.

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Court Upholds Manslaughter Charge of Pregnant Mother For Death of Her Baby

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By Alexa Richardson

A woman whose hours-old baby was dying admitted to her care providers that she had abused prescription and over-the-counter medications shortly before the birth. This summer, in United States v. Flute, 929 F.3d 584 (2019), the Eighth Circuit held that she could be charged with federal manslaughter for the death of her baby. While some states have charged pregnant people with manslaughter for drug use during pregnancy, Flute marks the first time that federal prosecutors have brought such charges. The decision, which reversed the district court decision dismissing the charge, opens the door for pregnant people to be criminally charged for a wide range of prenatal conduct — should it result in the baby’s death after birth — such as driving recklessly, receiving chemotherapy treatment during pregnancy, failing to obtain adequate prenatal care, or declining a medical recommendation.

Samantha Flute, an American Indian woman, gave birth at a Sisseton, South Dakota hospital on August 19, 2016. She told the medical staff that she had ingested Lorazepam, hydrocodone (possibly laced with cocaine), and cough syrup before coming to the hospital. Four hours after birth, Baby Boy Flute died. The autopsy revealed a full-term baby with no anatomical cause of death, and the pathologist determined the death to be the result of drug toxicity from the substances ingested prenatally by Flute.

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A doctor from neck down wearing white coat, holding clipboard in one hand and bowl of fruit in the other.

Medically Tailored Meals and the Reverberating Impact of Public Demonstration Projects

Alexandra Slessarev Leave a comment

Recent headlines highlighted a $40 million investment by a range of Blue Cross Blue Shield companies in Solera Health, a start-up focused on improving chronic disease management. Solera Health will use the investment to scale up its wellness programs, which seek to improve social determinants of health for patients.

One of Solera’s initiatives focuses on providing medically tailored meals to beneficiaries. The concept behind medically tailored meals is simple. Patients with diabetes, congestive heart failure, and other chronic illnesses can be treated only to a limited extent in doctor’s offices. By extending services like meal provision to beneficiaries—thus improving their long-term health—insurers can potentially avoid paying for more costly interventions down the line. Read More

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The FDA’s NEST Initiative and Women’s Health

Alexandra Slessarev Leave a comment

The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.

The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime. Read More

A yellow dentist chair, in an empty dental office.

Barriers to Dental Care Abound for Individuals with Developmental Disabilities

Alexandra Slessarev Leave a comment

In early May, a New York Times article profiled the N.Y.U. College of Dentistry’s Oral Health Center for People with Disabilities. As the Times article describes, the new facility establishes an important point of service for people with developmental disabilities in New York City. It also creates a much-needed pipeline for dentists skilled in treating this special population. Read More