I’ve always been fascinated by how much microorganisms have altered world history through the ages — from the "black death" and smallpox that swept through Europe in the Middle Ages, killing millions, to the numbers of individuals, great and small, rich and poor, like Byron, the Bronte sisters, and apparently one of my grandmothers, who succumbed to "consumption,” or tuberculosis, as we now know it. For me, a career as a microbiologist just came naturally.
As recently as the early 20th century, young children often failed to survive their first year, succumbing to infectious diseases like diphtheria, measles, whooping cough, and numerous enteric microorganisms. Thousands died of yellow fever building the Panama Canal. Polio was a debilitating disease during the middle part of the century, and Malaria still kills millions in the developing world.
In the mid 1990s, I was already working to develop diagnostic tests for infectious diseases like hepatitis when the human immunodeficiency virus (HIV) was linked to the immunodeficiency syndrome, now known as AIDS. A diagnosis of infection by this virus was considered a death sentence. I was involved directly with the development of the first test used to screen blood donations for the presence of HIV and I spoke regularly to schools, medical students, and professional organizations here and abroad on the disease and how to prevent infection. This experience led naturally to my involvement during the past decade with the post 9/11 anthrax attacks, the 2003 SARS epidemic, and the 2009 H1N1 influenza pandemic.
During the influenza pandemic of 2009, the FDA Task Force, including my Division, was able to very quickly clear, approve, and license the products that were needed. Working with the Centers for Disease Control and Prevention, we authorized a diagnostic test for the 2009 H1N1 influenza virus within 4 days of their call telling us this was "no ordinary bug." During the following year, we authorized 18 additional tests once it became clear that the public health labs could not cope with the surge in requests for testing. It was an extremely satisfying experience to be a member of this extraordinary Division/Office/Center/FDA/HHS team and to feel we had made a significant contribution with our public health response to the pandemic.
Today we know that no one agency can be responsible for preparing and protecting the Nation for a CBRN event or emerging infectious disease threat. Interagency collaboration in development and review of MCM diagnostics is a case in point. FDA is working side by side with colleagues at the Centers for Disease Control and Prevention, the National Institutes of Health, the DoD, and others in support of MCM diagnostics development. One of our key priorities is to facilitate the development of multiplex diagnostic tests, ushering in a new era in the diagnosis of infectious diseases. We have a common mission. Although much work remains, the support we have received through the MCMi is helping us achieve our goal.