Time is racing against politics which is racing against time.
Yesterday the Senate finally confirmed the appointment of Kathleen Sebelius as HHS Secretary and she resigned her post as governor of Kansas. Given the unfolding events from last week around the Swine Flu outbreak, this cannot have happened fast enough. The Administration had indicated that it was doing fine on matters related to the flu outbreak in spite of the fact that some key health appointments remain open - HHS, FDA, CDC and the Surgeon General - to name a few. Wait, no, to name them all.... Come on folks, this is important.
Two days ago, the World Health Organization raised the pandemic flu alert from phase 3 to phase 4 - which is mostly ministerial. But the numbers and the scope of infections continues to climb, with CDC reporting as of April 28, 64 cases in the U.S. among 5 states and WHO reporting cases in a total of 7 countries - numbers which represent laboratory confirmations - numbers which undoubtedly under-represent the true number of infections. The Obama Administration has asked for $1.5 billion to combat the burgeoning situation - if there is no one in charge of health, where is that figure coming from?
In Mexico City, there is an escalating presence and consequence to the outbreak. Public facilities such as libraries, museums and schools were closed. Then restaurants, except for take-out, were also closed. Airline passengers are being screened for their temperature. Garish scenes of citizens wearing breathing masks abound. Social distancing, as a mechanism for containing the spread of the virus, is happening. But given the rapid spread of this flu, social distancing and masks are insufficient to contain the virus. In fact, the virus is beyond being contained at this point.
The FDA has authorized the emergency use of flu medications and diagnostic testing in response to the outbreak. But it is going to take more than that. Right now, public health is kind of throwing everything it has to mitigate damage from the virus, but pretty soon, we may start shooting blanks. The FDA is going to have to do a lot more.
That is because there is no vaccine. A vaccine takes time - first someone has to ask for it; then government in a time of need has to drive it; then someone has to discover it; then someone has to manufacture it in hundreds of millions of doses - and someone has to pay for all that. It wall all take many, many months.
The influenza pandemic that was so lethal in 1918-1919 appeared first briefly, disappeared for several months, and then roared back with a vengeance infecting hundreds of millions of people and killing tens of millions. There is no way to know if this flu virus will act in a similar way. But with summer in the northern hemisphere, the spread of the virus could subside. But by the fall, which is much more friendly to transmission of flu, we may have isolated the virus and deduced it's characteristics and maybe even identified a vaccine. But would we be able to manufacture and distribute the dosages necessary to thwart a lethal pandemic? I might be wrong, but I say probably not.
That means we can no longer afford empty chairs. Even when these people get into their positions, one cannot expect them to steer their respective ships instantly - it takes time. It also takes time to get the rest of them in their chairs. Time is something we may not have in abudance. So it is incumbent upon the Senate and on the Administration to fill the chairs still waiting for occupants. Now that Sebelius is here - great. Give us someone at FDA and CDC and in the Surgeon General's Office. There is a lot of work waiting to be done and many lives may depend on it.
PhRMA applauds the Finance Committee’s endorsement of Kathleen Sebelius and we are pleased that the Senate as a whole quickly followed its lead. Clearly, achieving meaningful healthcare reform will be difficult, making it imperative for Sebelius to be confirmed as HHS Secretary in a timely manner.
It’s equally important for Congress to act rapidly to put a full-time Commissioner in place to head the Food and Drug Administration (FDA). Consumers count on the FDA to help assure the safety and efficacy of a myriad of products – including the life-saving anti-virals contained within the Strategic National Stockpile, which could be deployed in the event of an influenza pandemic.
Now, more than ever, Americans look to our nation’s healthcare leaders for steady, science-driven decision making and we call on the full Senate to expedite the FDA Commissioner’s confirmation vote.
Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson
Posted by: Ken Johnson | April 29, 2009 at 11:02 AM