The childhood cancer drug vincristine is expected to be back in stock starting in late October, but ... [+]
Deliveries of the vital childhood cancer drug vincristine, which is currently in very short supply across the U.S. should resume in late October, according to a new statement from the FDA. However, the drug is still predicted to be in short supply until at least December, indicating that the October deliveries will not solve the issue completely.
Pfizer is the sole manufacturer of the drug in the U.S. after Teva Pharmaceutical made a “business decision” to cease production in July and has been trying to scale up production after experiencing its own manufacturing issues.
Parents of children with cancer have been reacting with shock at the news with many wanting answers as to how this could have happened and when the issue will be resolved.
Although many of those affected are young children, teens and young adults with cancer are also frequently treated with the drug, such a this patient diagnosed at age 17:
A petition asking the White House to intervene has so far gathered over 3,000 signatures at the time of publishing this article, with many also asking how the shortage could have been allowed to happen in the first place.
The Children’s Oncology Group (COG), a National Cancer Institute supported member group of the National Clinical Trials Network, specializing in pediatric cancer clinical trials in the U.S. today issued a statement, providing an update and stating “a situation that requires rationing of drug is unacceptable,” but “welcoming the news that drug distribution should resume soon.”
The letter authored by Peter C. Adamson, M.D. Chair of the Children’s Oncology Group and Professor of Pediatrics & Pharmacology Perelman School of Medicine, University of Pennsylvania also proposes a “call to action,” to make sure a similar event does not happen again:
“While it is clear that the immediate concern and goal is to solve the issue surrounding vincristine, I believe the community should consider advocacy steps to help prevent future shortages of life-saving cancer drugs for children. In my view, as related efforts are developed for longer term, economic policy solutions, we need to focus on solutions for today’s children with cancer. In the upcoming days and weeks, I am hopeful we can arrive at focused action items for advocacy solutions that have the goal of guaranteeing cancer drug supplies for children in the United States. Proposals that could be enacted in a reasonable time frame for today’s children that merit consideration include but are not limited to (1) establishment and maintenance of a national stockpile of key cancer drugs used for the treatment of children with cancer and (2) US government purchasing contracts that provide a guaranteed buyer and may help stabilize a fragile market. There undoubtedly are other ideas to consider, and we are committed to working with the community and childhood cancer advocacy groups in galvanizing these efforts,” wrote Adamson.
These solutions are undoubtedly worth trying, but there may be some considerable issues to surmount before these solutions are viable.
“You can’t force a manufacturer to produce a particular drug against its other drugs, so this is a big problem,” said Sharona Hoffman, JD, professor of law and bioethics and co-director of the law-medicine center at Case Western Reserve University School of Law, Cleveland, Ohio, speaking to Cancer Therapy Advisor in April about recent research describing the danger of drug shortages for childhood cancer treatment. Hoffman in response to that research said stockpiles as a solution are “very difficult, expensive, and requires a lot of manpower.”
So, could the U.S. government intervene to ensure supply as suggested in the letter by the Children’s Oncology Group?
“The government can’t go in and dictate which drugs a company must produce. You can create lists — that’s fine — but taking that leap of asking the government to ensure supply is difficult. We have a free market; the government can’t force a business to make this or that drug,” said Hoffman to Cancer Therapy Advisor.
In the meantime it is still unclear as to how much of an impact the current shortage will have. Almost 16,000 children are diagnosed with cancer in the U.S. annually and many of them will be due to have doses of vincristine in the next few weeks.
Drug shortages are constantly ongoing in the U.S., but the shortage of this vital drug for children with acutely life-threatening illnesses has certainly been a reality check for many. Over a year ago, the American Medical Association declared the situation a “public health crisis” and the FDA announced a new strategy to try and prevent shortages. It would seem that after the events of this week, there is still a great deal that can be done better.
