By Margaret A. Hamburg, M.D.
When there is a multi-state outbreak of illnesses, what federal agencies are doing in response is often the focus of attention. All too often, the dedicated efforts of countless other public servants at the state, county, and local levels aren’t acknowledged as much.
As we all strive to resolve the tragic outbreak of fungal meningitis tied to contaminated steroid injections, I want to recognize the invaluable role of our colleagues across the country. These frontline public health officials at all levels of government work alongside the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) every day, and even more closely in times of crises.
State, county, and local health officials are often the first to hear about a problem and begin investigating. In this deadly outbreak of fungal meningitis, the alarm was first sounded by the Tennessee Department of Health. Tennessee has been one of the hardest hit in this outbreak. The Tennessee health department was told by a clinician on Sept. 18, 2012, about a patient with culture-confirmed Aspergillus meningitis
By Sept. 27, Tennessee public health officials, in collaboration with the CDC and the North Carolina Department of Health and Human Services, had identified eight additional patients with similar meningitis symptoms, but lab results were not showing a clear cause. With persistence, shoe-leather epidemiology and amazing laboratory efforts, state and federal public health officials worked quickly to narrow down the common exposure of these patients. They ultimately identified a steroid solution compounded at the New England Compounding Center (NECC) in Framingham, Mass., as the likely source of the outbreak. Conclusive evidence of fungal contamination was confirmed on Oct. 3, when FDA identified fungus in sealed NECC vials. CDC and state laboratories later pinpointed the fungus, Exserohilum rostratum, in both patients and also in unopened vials of the steroid solution.
The FDA has been working closely with the CDC and public health officials in Massachusetts and other states to investigate the scope and cause of the outbreak. In fact, both agencies have been working hand-in-hand with our colleagues in every state affected by this outbreak.
The demanding task of tracking down the thousands of people who were potentially exposed to medications from one of three implicated lots of contaminated NECC medication has involved state, county and local health officials, the CDC and health care providers. So far almost all—97 percent—of the patients exposed to the original three implicated lots have been contacted. Now, FDA is urging healthcare providers to follow-up with patients who were administered any NECC injectable product that was shipped on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
More legwork is being performed by local, county and federal epidemiologists who are interviewing patients to collect key data about their experience while state public health officials are pitching in to help FDA ensure that the recall of NECC products is carried out in a timely and effective way, with no NECC products remaining in distribution.
Nearly every day our counterparts in the states play a role in helping the FDA fulfill its mission of keeping Americans safe and healthy. We work together, across state lines and levels of government, whether the issue is foodborne illness, drug safety or other concerns. Frankly, we are immensely grateful for their expertise, professionalism and commitment to the people of their states and beyond.
In the face of this current tragedy, we are all working hard—together—to fully contain the health risks associated with this outbreak as quickly as possible to protect patients and the nation’s medical drug supply.
Margaret A. Hamburg, M.D., is the commissioner of the Food and Drug Administration.