Today’s discussion will focus on the comments made by Dr. Bruce Chabner, MD. Dr. Chabner is Director of Clinical Research for the Massachusetts General Hospital Cancer Center and he is also Professor of Medicine at Harvard Medical School. He is widely published, sits on a number of panels and committees focused on cancer, and in 2006 he received a presidential appointment to the National Cancer Advisory Board at the National Cancer Institute. Most importantly, Dr. Chabner cares for people touched by cancer.
Dr. Chabner noted a few of pieces of information that should be used as a backdrop. These shortages are almost exclusively for medications that are generic and have been used for many, many years. There are only a few (4 per Dr. Chabner’s count) generic manufacturers covering the needs of the U.S. marketplace. While our interest is primarily the impact to cancer care, these shortages reach beyond chemotherapy with Chabner noting 200 medications being affected in the past year. Finally, it has been noted that the majority of these medications are available in Europe and other countries at a price higher than in the U.S. which may provide the incentive for manufacturers to keep enough supply available to meet the need.
During his part of the conversation, Dr. Chabner pointed out a number of potential causes for the drug shortage. He included the generic pricing structure limits set by the Centers for Medicare and Medicaid Services (CMS), the decreasing price of generics as a driver of companies leave this market behind, the small profit margins on generics resulting in manufacturers not being able to update or repair facilities in a way that is ideal and also not allowing the company to have emergency plans in place (extra stock or an additional manufacturing line for example), and purchasing strategies and practices used by the organizations that sell and purchase these medications (buying at the lowest price instead of the most reliable supplier.
As for the Food and Drug Administration (FDA), Dr. Chabner noted a few points (before you jump, remember you will read about the FDA comments in 2 days!). First, there is a backlog of applications for additional generics sitting with the FDA and they simply don’t have enough people to process them all in a timelier manner. Second, he noted that the FDA has not encouraged major foreign manufacturers to enter the U.S. market. Finally, he pointed out that the administrative burden of the FDA is “significant”.
As a fine point, I have to say at I agree with most of these as a potential cause with the exception of the first. While CMS reimbursement may be a valid consideration for cancer care as a whole, this step in the financial chain affects the doctor and not the drug supply chain.
Of special interest is something called the gray market. It seems that there is a group (not clearly identified) who benefits from these shortages. These people secure excess stock of medication when available or through other means and sell it back into the market for an elevated price during times of shortage. A conversation on this could be an additional entry, but would include mentions of ethics and safety to name a few.
What are the implications of these shortages? Some patients may not immediately receive the drug deemed most appropriate for their care (although please note that for the most part, there may be other treatments that work equally). Sometimes the drugs that are substituted may cost more than the originally planned medication which is a particular concern for patients struggling to pay for care in the first place. Clinical trials are being impacted. In some cases, a lack of available drug resulted in a patient not being placed on a clinical trial but given another (albeit still a proven treatment) option. A key concern for the Cancer Support Community is the anxiety experience by a patient and their families when their first choice medication is not available to them.
Because so many of the proposed solutions overlap between experts, I will save those for a blog later in the series. So what are you, the reader who is potentially a person in need of a medication in short supply to do with this information you have just read? I would say nothing just yet. Use this as the opportunity to learn as much as you can about this issue, keeping reading our (and other) blog series and stay tuned for things you can do.
Tomorrow, we will explore a little deeper the economic pieces of this shortage through a review of the presentation by Dr. Sherry Glied, PhD from the U.S. Department of Health and Human Services.