Last Thursday, HHS Secretary Kathleen Sebelius brought an all-star cast of government leaders in medical research issues together to announce how the department intended to invest $2 billion to improve how the government and private industry developed medical countermeasures for pandemic flu outbreaks. But first, she had to sensationalize the issue so that the reporters would know that this was really serious stuff.
Our greatest responsibility in government is keeping the American people safe, and to uphold that responsibility, we’ve always had a powerful military that can guard against conventional threats. But increasingly, the range of dangers we face is widening to include biological, chemical, nuclear, and radiological hazards. Today, we really don’t know where our next public health crisis can come from. It could be a dirty bomb set off in a subway car. It could be a naturally-occurring “super bug” that is resistant to all treatments. It could be a biological weapon we’ve never seen before assembled from the building blocks of life by a terrorist in a lab.
It could be an asteroid the size of Texas or a 350-foot monster come out of the depths of the ocean. Honestly, do we need all this melodrama to justify spending $2 billion on improving how the US government obtains medical countermeasures for public health emergencies? Obviously, we do. We must have no expertise or policy analysts who can calmly and accurately review the past century of how the federal government responds to natural disease outbreaks or the relatively few bioterrorist incidents. But I digress. The point of this conference was to announce how the government would pay pharmaceutical firms to work in a government-owned facility to improve the speed (but maintain the efficacy and safety) of vaccines for pandemic flu outbreaks.
Among other things, the effort would provide $822 million for upgrades to speed up production of pandemic flu vaccine. Another large block, $678 million, would be used to set up at least one private facility that would work under government contract with small companies to manufacture new products, develop new manufacturing processes and help produce vaccines during periods of peak demand.
There are a number of interesting points here, first of all that the government is not proposing to produce the vaccines itself. Under what it calls a "public-private partnership," the government will provide a facility and funding to a private firm (or firms) so that they can produce the vaccines. The government will just "manage" the process and "encourage" the private firm, thus getting around the traditional reluctance of Big Pharma to invest in low profit, high risk research and development of new vaccines. Along with this partnership, the government wants to speed up the FDA's review and processing of new, experimental drugs.
Dr. Tony Fauci (NIAID) was asked what the difference was between this project and how BARDA provides funds to pharmaceutical firms for medical countermeasures under Project BioShield. He trotted out a story that BARDA focuses on helping companies get a specific product through the regulatory system, whereas this new process focuses on investing in the company's viability. Viva la difference. What no one wanted to say was "Project BioShield was a bust, but Congress won't let us disestablish it, despite its repeated failure to develop new medical countermeasures for CBRN terrorism."
In general, I'm not against this proposal. It makes sense for the US government to invest in a vaccine facility and to improve FDA regulatory processes as long as the general public expects the government to protect it from natural-occuring endemic diseases. Big Pharma doesn't want to play, and working with foreign producers is difficult and time-consuming. But we really don't need to hype the message with the "gloom and doom" terrorist aspect. Saving some of the thousands of Americans who die every year from the flu ought to be enough reason. And it should be noted that none of this effort will directly result in any new medical countermeasures for CBRN terrorism.
UPDATE: I did want to add something about the failure of the "invisible hand of the market" and the failure of Big Government to address the policy aspects of public health and its decision to just throw money at the problem, but this post was getting long enough.
"Saving some of the thousands of Americans who die every year from the flu ought to be enough reason."
And therein is the problem with "throwing" money at the "pandemic" will-o-wisp!
More people die from seasonal flu than died from the H1N1 virus...the numbers are there...and yet what got more attention?
The seasonal flu which everyone gets...or the H1N1 flu that a few people got, and because of poor medical attention, died of.
But I will say this much...the H1N1 flu vaccine...$$$$$BOOYAAAHHH$$$$$
Yeah baby, guess who made a killing off of that one!
Thats right baby, big pharma...they are so in on it!
Get a little scaredy of a virus, hype it, and then sell the vaccine for it...everybody has a wish list to live another day longer, and with the fear hype...oh yeah, H1N1 vaccine is like printing your own money.
Posted by: sheerahkahn | 23 August 2010 at 11:37 AM