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Drug Shortages in the 21st Century: Recent History of a Mystery

Date: March 6, 2014
Time: 6:00 PM - 7:30 PM

Refreshments at 5:30 p.m.

Speaker(s):

Jacalyn Duffin, MD, FRCP(C), PhD, FRSC

Location: The New York Academy of Medicine, 1216 Fifth Avenue at 103rd Street, New York, NY 10029


Temporary shortages of prescription drugs are not new. In 2008, however, patients and pharmacies across North America began reporting more severe shortages affecting more numerous drugs: some injectables; some pills; all older, cheaper, off-patent remedies, called “generics.” By 2010, the problem ballooned to crisis proportions for certain conditions. Cancer patients went without chemotherapy and anti-nausea agents. Children with epilepsy could not find anticonvulsants. Anesthetics, anti-depressants, painkillers, and anti-Parkinson drugs disappeared, sometimes for weeks, sometimes months.

Pharmacists suggested more expensive, brand-name products as substitutes. Shortages are now reported in Africa, Australia, Europe, South America, and Asia. India is facing a lack of anti-tuberculosis drugs and anti-malarials for children. The U.S. Food and Drug Administration (FDA) tracked missing drugs, and in October 2011 President Obama issued an executive order requiring manufacturers to provide six months notice of shortages, or face heavy penalties.

Using media reports, scientific articles, interviews, government documents, and the evidence of previous shortages from as early as World War II, this paper will trace the history of the current drug shortage crisis. It will also delve deeper into the pharmaceutical past to identify potential causes. Some causes entail scant raw materials and business decisions about their uses. Some affect products with short shelf life. Some result from the long-standing division between the so-called, research-based pharmaceuticals and generic companies. Some stem from lower prices set by Medicare and the anti-trust behavior of large Group Purchasing Organizations. Following the global economic crisis of 2008-9, lax manufacturing standards led the FDA to issue more warnings requiring factory improvements that, in turn, provoked more slowdowns. In June 2012, a congressional committee blamed the FDA.

Curiously, governments have been loath to tackle the problem by exposing its root causes; none are mapping its extent. Media reaction to each acute shortage silo’s them by disease or region; interest wanes when “nobody dies.” In June 2012, bioethicists at Emory U hosted an international conference to determine ways to cope with unavailable drugs. But proposals to mitigate the consequences do not address the causes, which remain a mystery.  The paper closes with health policy implications of this historical research.

About the Speaker(s)

Jacalyn Duffin, MD (Toronto), FRCP(C), PhD (Sorbonne), FRSC, a hematologist and historian, occupies the Hannah Chair of the History of Medicine at Queen’s University, Kingston, Ontario, Canada. A former President of both the American Association for the History of Medicine and the Canadian Society for the History of Medicine, she is author of eight books and holds several awards for research, writing, teaching, and service. Her most recent book is Medical Saints: Cosmas and Damian in a Postmodern World (Oxford U Press, May 2013). A revised and expanded second edition of her popular textbook for medical students appeared in 2010: History of Medicine a Scandalously Short Introduction (U Toronto Press). Her current clinical activity is in breast cancer, and she participates in an award-winning research project on music, memory, and dementia. She is founding webmaster of www.canadadrugshortage.com, a site for information about the current drug shortage.

 

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