As a practicing infectious disease physician, I become acutely aware, on occasion, of shortages of antibiotics or essential medical supplies, such as saline (salt water) solutions. For years, I’ve been concerned that the availability of these medicines should be regarded as a national security issue, but that issue appears to have received little attention.
Production line at plant manufacturing antibiotics. Photo by Stanislav KrasilnikovTASS via Getty… [+]
One problem I’ve encountered is that many pharmaceutical companies seem to hold where their plants are located as a closely held secret. In recent years, it has become clear that much of the outsourcing is to China and India, and in the U.S., to Puerto Rico.
Why is this occurring? Antibiotics are not as profitable to drug companies, as they are only taken for short courses. Pharma prefers drugs for chronic diseases, such as diabetes or hypertension, that need to be taken for years, or oncology drugs with their hefty profit margins. In fact, a number of companies have elected to stop developing and marketing antibiotics. As of 2008, the only big pharmaceuticals with active antibacterial discovery programs were GlaxoSmithKline, Novartis, AstraZeneca, Merck, and Pfizer. Bristol-Myers-Squibb stopped in 2006. In 2011, Pfizer ended antibiotic research at its main center.
Several factors contribute to the looming crisis in antibiotic availability and are nicely discussed in a new white paper from the nonprofit Access to Medicine Foundation. A major problem is the shortage of active pharmaceutical ingredients (APIs), often developed only in Asia. For example, piperacillin-tazobactam is a critically important antibiotic—and the global shortage occurred because of an explosion at a Chinese factory, the sole source. Manufacturing the combination antibiotic occurred primarily in India and Italy. Star anise, the source of the anti-influenza drug Tamiflu, is grown almost solely in China. When I looked into this problem in 2015, Levaquin’s active ingredient was made solely in Japan.