I am a tuberculosis doctor. My patients and I inhabit a world of TB medications, diagnostic technology and public-health investigations. Together we have celebrated many triumphs over this deadly, but curable, disease.
The problem we are now facing, however, is so threatening that it will take a concerted national effort to prevail. I am talking about the shortage of tuberculosis drugs.
Last December, the Centers for Disease Control and Prevention reported that U.S. supplies of isoniazid, the most important drug in the treatment of TB, were critically low. A national survey of health departments in January reported that 79 percent of responding jurisdictions were having trouble getting the drug.
In California, where tuberculosis cases are the highest in the nation, we have struggled to keep the drug available. Physicians are now being advised by the CDC to ration their isoniazid supplies. As the TB controller for my county’s public-health department, I have to choose which patients get their potentially life-saving medications, and which ones don’t. Alternative regimens without isoniazid exist, but they can be more toxic, longer in duration and more expensive.
Isoniazid is just the latest -- albeit the most essential - - drug to be added to the growing list of unavailable or critically low TB medications in the U.S. Many of the other drugs we have relied on -- including kanamycin, amikacin and capreomycin -- have been difficult to obtain for more than a year.
California is ground zero for TB in the U.S. With 2.3 million Californians infected with M. tuberculosis, we have the most TB disease, the most TB deaths and the greatest number of the most feared form: multidrug-resistant TB. We aren’t exactly chanting “We’re No. 1.” In this emerging era of drug shortages, we are becoming desperate.
How desperate are we?
Desperate enough to turn for help to the Global Drug Facility, a part of the World Health Organization that ensures universal access to TB drugs for even the most impoverished countries. Kenya, India, the Philippines and Uganda (to name only a few) all rely on the facility for an uninterrupted supply of vital TB medications. The Global Drug Facility is funded partly by the U.S. I sat beside many other TB doctors from around the U.S. when we met with a GDF representative recently, and we all agreed: Asking the GDF for emergency help had to be considered. And last week, in an article about the nationwide isoniazid shortage in the Morbidity and Mortality Weekly Report, the Centers for Disease Control and Prevention agreed.
How is it that the wealthiest country on Earth could be forced to resort to a Third World solution to treat a disease as dangerous as TB?
To make things worse, we have received reports from pharmacies that isoniazid prices may skyrocket soon. Currently, a 30-pill batch of 100-milligram tablets costs $35.51. The notices, linked to one of the three isoniazid manufacturers, informed pharmacies that the price would rise to $1,309.94. That is a whopping 3,589 percent increase. (It hasn’t happened yet, possibly due to vocal protests -- and the promise of industry shaming -- by TB doctors.)
Price-gouging isn’t unprecedented in the pharmaceutical industry. In October 2011, President Barack Obama issued Executive Order 13588 in response to such behavior. The order states that “some participants in the market may use shortages as opportunities to hoard scarce drugs or charge exorbitant prices.” The order directs the Food and Drug Administration to notify the Justice Department of any suspicious pricing. I think anyone would agree that a 3,589 percent increase qualifies as “exorbitant.” Unfortunately, the FDA directly contradicts Order 13588 by stating on its website, “Pricing issues are not within the purview of the FDA.”
This shortage will have dire health consequences for the U.S. We are going to see marked increases in TB across the nation -- a tragic step backward for public health.
The three U.S suppliers of isoniazid are Teva Pharmaceuticals USA, Sandoz Inc. and VersaPharm Inc. Teva and Sandoz blame the problem on shortages of the drug’s active ingredient and on shipment delays. VersaPharm recently notified public-health officials that it is canceling all orders for isoniazid because tests have shown that the purity of its product falls outside FDA specifications. (The company is working to correct this by 2014.) Because no federal law mandates that pharmaceutical companies produce sufficient amounts of essential medications, public health is at the mercy of pharmaceutical executives’ decisions. This is a broken system.
So what is the solution?
First, the FDA and CDC should construct a list of essential public-health medications, such as those that treat TB. No such list exists. Next, President Obama should issue an executive order requiring that pharmaceutical manufacturers report any anticipated shortage of medications on the list six months in advance. Such an order, had it been in place, could have prevented much of our recent scrambling.
TB doctors have been reduced to begging drugmakers not to push up their prices; asking pharmacies to send a few more isoniazid pills; and now pleading with the World Health Organization for aid from the Global Drug Facility. When it comes to treating a disease as contagious and deadly as tuberculosis, we can’t succeed as beggars. We must have a more reliable system for delivering the medicines our patients need.
(Charity Thoman is a deputy health officer for the Santa Barbara County Public Health Department and oversees county HIV and tuberculosis clinics. The opinions expressed are her own.)
To contact the writer of this article: Charity Thoman at Charity.Thoman@sbcphd.org
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