The incompetence, dissembling and lack of transparency at the Department of Health and Human Services (DHHS) is already well-established. But the degree to which the mess at HHS jeopardizes our health is only beginning to come to light. And it has nothing to do with Obamacare.
As we approach a busy holiday travel season, as cold weather grips much of the nation and as flu season gets into high gear, HHS is failing to make clear their intentions about when they'll green-light the manufacture of a vaccine for the particularly deadly H7N9 strain of avian flu from China.
H7N9 spread from chickens to humans in China this spring. It killed approximately a third of the people infected. So HHS was right to quickly partner with pharmaceutical firms to develop, test, and order some 20 million doses of vaccine to stockpile for those on the front lines, such as military and first responders. While the doses could be manufactured in record time, 60 days according to estimates, a supply must be in place (but not administered) before a pandemic starts.
While vaccines have been developed and tested, HHS refuses to give the go-ahead for pharmaceutical companies to begin making the vaccines, even though the money is already allocated. Earlier this month, two preliminary human studies, including one published in the New England Journal of Medicine, came out supporting the safety and efficacy of new vaccines developed by Novartis and Novavax. The HHS delay is mind-boggling, especially when one considers the warnings from the nation's top public health officials.
On April 19, 2013, Secretary Sebelius determined that the H7N9 avian flu represents "a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad." This threat of an emergency has not abated. The startling declaration is still in effect, according to an HHS spokeswoman.
And in September, Centers for Disease Control Director Dr. Thomas Frieden ratcheted up the sense of urgency by warning that "the only thing protecting us from a global pandemic right now is the fact that it doesn't yet spread from person to person...I can't predict if that's going to happen tomorrow, in 10 years or never."
And this week, a Taiwanese paper reported that "the risk of human transmission of the H7N9 strain of avian flu is expected to increase significantly over the next few months," according to He Jianfeng, head of the National Institute for Communicable Disease Control and Prevention in southern China's Guangdong province.
This is the same province where the government confirmed a three-year-old boy tested positive for H7N9 earlier in November.
The delay, according to HHS, is because it doesn't have enough data. A spokesman for HHS's assistant secretary for preparedness and response refused to say specifically what other studies are needed. The spokeswoman said additional studies should be coming out "very, very soon," but refused to even offer a window of dates when that may happen, nor would she give a deadline as to when HHS would move ahead with the vaccine order. We remain in an indefinite holding pattern as we head towards the heart of flu season.
How long will we wait? This most transparent administration in history won't tell us. But Dr. Robin Robinson, director of the federal Biomedical Advanced Research and Development Authority told Reuters this month that results on additional vaccines are not expected for four to six more months.
More data is always better than less data when time is not of the essence. But, especially given the increasingly sobering warnings from Secretary Sebelius, Director Frieden, and Chinese officials, the preference for waiting for more precise data must be balanced against the risk of waiting too long.
Since experts believe it would take 60 days to produce the 20 million doses HHS will eventually request, even if the order were placed today, vaccines wouldn't be available until the end of January. By then, if the virus spreads from human to human, as the CDC predicts could soon happen, we would be facing a pandemic not seen since 1918, when we also didn't have a vaccine at the ready. At the risk of sounding like avian little, we don't have time to wait.
Jeff Stier is a Senior Fellow at the National Center for Public Policy Research in Washington, D.C., and heads its Risk Analysis Division.