Category: Beatrice Brown

An adult hold the hand of a child with an IV

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

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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

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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?

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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 protestor holding a hot pink sign that reads "I Stand with Planned Parenthood"

Trump’s Title X Gag Rule: An Ethical Conundrum for Planned Parenthood

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By Beatrice Brown

On August 19, Planned Parenthood announced that they would be leaving the Title X family planning program due to the Trump Administration’s new prohibition that restricts those who receive Title X funds from providing or referring patients for abortion. This restriction on Title X funding has unsurprisingly been met with a lot of criticism, namely, that it interferes with a woman’s constitutional right to abortion. This can be seen as a partial victory for those who have been attempting to defund Planned Parenthood for years, an organization that, despite others’ characterizations, is fundamentally committed to providing all women access to quality health care and is not solely an abortion provider.

As a result of this gag rule, Planned Parenthood has faced a huge ethical dilemma: Do they continue to accept Title X funding to assist low-income women with everyday health care, such as yearly routine wellness visits, or do they reject this funding and both 1) take a stand on a woman’s constitutional right to abortion and 2) continue to provide a service (or retain the right to refer patients to a service) that is crucial to women’s health? Planned Parenthood has chosen the latter, and I think that Planned Parenthood’s difficult choice is justified.

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