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.

First, such a shortage poses a huge ethical problem for pediatric oncologists: what is the most ethical way to ration this important drug? I think what makes this particular case even more pressing is that the drug is used for pediatrics – vincristine is used in fewer than 3% of adult cancers. Given that children are a vulnerable population, we have an even stronger moral obligation to protect them.

How are we to decide who among this vulnerable population receives care? There is no easy answer, especially given a physician’s fiduciary duty of care to their patients. Rationing requires that a physician fulfill this fiduciary duty to some of their patients but not to others, and this seems even more problematic in the case of pediatrics – simply put, the physician must act in the best interests of one child at the expense of the best interests of another.

One way to ration the drug, and likely the most common way to do so, would be on the basis of need: those patients in greatest need of the drug have the highest priority. Likely, in the case of vincristine, this would mean treating those who are actively receiving chemotherapy and not yet in remission, and skipping doses for those receiving the drug to keep them in remission (such as Laura Brewer’s 5-year-old son, Titus). Obviously, this is an extremely problematic result since a missed dose may mean that the child’s cancer could reoccur. Again, there is no perfect way to ration these drugs, and ethically problematic decisions have to be made in the face of such a shortage.

Second, do pharmaceutical companies have a moral obligation to continue producing a critical drug? Teva halted production for “business reasons,” but as one of only two companies producing vincristine, did they have a moral obligation to continue production? And if so, is the obligation strengthened by virtue of the drug being for pediatrics? I believe that a full halt of production was unwarranted, even if the decision was announced in advance.

Given that Teva was one of only two companies manufacturing the drug, the more ethically permissible way of pulling out of the market would have been to reduce production over time until eventually halting production. This would have allowed Pfizer to slowly increase their production, potentially alleviating the issue of manufacturing delays and thus avoiding the critical shortage issue. Given that such a strategy could have avoided these potentially dire consequences for patients, I believe that Teva had a moral obligation to slowly pull out of the market rather than completely halting production, an obligation that is strengthened given the fact that the drug is used almost solely in pediatrics.

Hopefully, the shortage is alleviated in a timely manner and there are no further manufacturing delays. However, steps need to be taken in the future to prevent such critical shortages from occurring in the first place – pediatric oncologists should never have to deliver the news to their patients that the drug that will treat their cancer is currently in short supply.