Effect Measure

This week President Bush signed the Pandemic and All-Hazards Preparedness Act (S. 3678). It has generally gotten favorable reviews from public health professionals concerned with preparedness, including the Clinicians Biosecurity Network and The Trust for America’s Health. We’ve taken a look, too, and find much to like, but whether this will indeed be useful will depend on how it’s implemented. We have a few observations of our own, as well.

The law has four Titles, each dealing with a separate but related topic. Title I. pertains to ” National Preparedness and Response, Leadership, Organization, and Planning.” This is an important development because it consolidates federal public health and medical emergency preparedness and response activities within the Department of Health and Human Services (DHHS). For most public health and medical emergencies, the appropriate place to plan and manage them is with public health professionals. Prior to this there was much confusion whether the overall direction would rest within Homeland Security or HHS. This issue seems to have been settled by the stunning display of incompetence by Homeland Security. Who in their right mind would put them in charge of a pandemic? Apparently Congress got the message. The Assistant Secretary who will be in charge is a Presidential appointment but subject to confirmation. Under the Republican Congress of the last 6 years, this would have meant little, with cronyism and political considerations trumping expertise. Under a Democratic Congress we can hope for some responsible oversight. Hope, like pandemics, springs eternal. An interesting requirement is that planning must take account of “at risk individuals,” defined in the legislation to be “children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency, as determined by the Secretary.” The new Disaster Czar ill prepare and submit to Congress a strategy for national security every four years, starting in 2009.

Title II. allows the DHHS to institute a cooperative agreements program (essenially, a grant) with states, local public health and tribal entities. This is a good idea, but much will depend on how much money is allocated, what kinds of flexibility there will be and what the transaction costs are. There is a requirement for a 5 – 10% non-Federal match from the states or elsewhere. This is a pretty good deal, but it is still real money that most state health departments don’t have. Independent audits will be required. Thus what the “strings” are will be all important. If this money can’t be used for more general public health needs, we are likely to see continued erosion of public health infrastructure as personnel are reassigned to allowed activities at the same time state budgets are cut for others. There is also mention of “evidence based benchmarks” to measure progress. States will be required to have pandemic influenza plans and failure to meet the criteria for these plans will result in withholding of the grant funds. What are the criteria? We are supposed to know in 3 months, the deadline for the new Assistant Secretary (yet to be named) to develop and disseminate to each state the criteria for an effective state plan for responding to a pandemic. We’ll have to see how well this requirement takes account of the differences in scale, complexity and individual features of 50 states, numerous local health departments and many tribal authorities. Grants to support state and local public health are desperately needed, but so far federal efforts have been worse than a waste of money. They have seriously distorted public health priorities. I’m anxious that this will be more of the same. We’ll have to see. Title II. also requires the Secretary to establish a “near real-time electronic public health situational awareness capability.” I presume this means a surveillance system. Good luck. This is an extremely difficult problem. But we need one. So we’ll keep our fingers crossed.

An intriguing segment authorizes the secretary to “provide grants to states for tuition loan repayment to individuals who agree to serve for at least 2 years in state, local, or tribal health departments. The loan repayment program will support degree programs appropriate for serving in state, local, and tribal health departments.” (Clinicians Biosecurity Network). This is an extremely important initiative and could be a real boon to state and local public health. I hope this one gets priority and that money is appropriated to pay for it. I won’t hold my breath but I will try to be optimistic.

Title III. formerly transfers some functions previously at Homeland Security to DHHS, strengthens some existing activities and authorizes an increase in CDC’s Epidemic Intelligence Services by 20 more slots. It also requires the Secretary to make grants to hospitals and healthcare facilities to improve surge capacity and enhance community and hospital preparedness. That would be good, wouldn’t it. How they are going to do it is another matter. This doesn’t impress me very much. It’s handwaving.

Title IV. establishes Biomedical Advanced Research and Development Authority (BARDA). This title “integrates biodefense and emerging infectious disease requirements with…advanced research and development, strategic initiatives for innovation, and the procurement of [countermeasure and pandemic] products.” Lots of talk here about facilitating development of new medicines and vaccines, integrating the efforts of government, pharma, academia, promoting innovation, etc., etc. There will be a “Biodefense Medical Countermeasure Development Fund” to get stuff from the bench to the bedside, etc., etc. Even more than at other places in this legislation, the details of how this will be implemented are all important. There is a troubling provision here to exempt BARDA from certain Freedom of Information Act (FOIA) disclosure requirements when the Secretary deems it will endanger national security, or, as the law says it more generally, if the information “reveals significant and not otherwise publicly known vulnerabilities of existing medical or public health defenses.” This seems like a loophole to drive the truck that conceals adverse events to vaccines or drugs or other kinds of information that is dangerous or inconvenient for pharmaceutical companies or the government.

There are some good things here. It is still just enabling legislation and has no money attached to it and lots of blank spaces that need to be filled in. Getting the public health responses out of Homeland Security and into DHHS is a good move. For the rest, we’ll just have to wait and see. This administration has a poor track record.

If you want to read the law for yourself you can find it here (click on Text of Legislation, top of second column).


  1. #1 crfullmoon
    December 21, 2006

    “if the information “reveals significant
    and not otherwise publicly known
    vulnerabilities of existing medical or public health defenses.”

    Vulnerabilities such as, Even after all this warning time,
    if a pandemic influenza year starts up, We’re screwed?

    At least S.3678 actually used the “P” word in the title…
    (and there was much rejoicing: yay…)

    What’s this? (though, I think I’ve heard netizens discussing it before) “SEC. 203A. DEPLOYMENT READINESS.

    (a) Readiness Requirements for Commissioned Corps Officers-

    (1) IN GENERAL- The Secretary, with respect to members of the following Corps components, shall establish requirements, including training and medical examinations, to ensure the readiness of such components to respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State, and local levels:
    (A) Active duty Regular Corps.(B) Active Reserves.”…

    …”The Secretary may waive one or more of the requirements established under paragraph (1) for an individual who is not able to meet such requirements because of- -(i) a disability;(ii) a temporary medical condition; or (iii) any other extraordinary limitation as determined by the Secretary.”…

    …”except when such members are Commissioned Corps officers who entered into a contract with Secretary under section 338A or 338B after December 31, 2006 and when the Secretary determines that exercising the authority provided under section 214 or 216 with respect to any such officer to would not cause unreasonable
    disruption to health care services provided in the community in which such officer is providing health care services’.”…

    Where’s the BOYD section?

    (BOYD Flu: “Bring Out Your Dead” Flu – See what the brain comes up with; halfway between sleep and waking in the middle of the night?
    Public hears about bird flu, but they need to prep against boyd flu…)

  2. #2 M. Randolph Kruger
    December 21, 2006

    This new law still leaves a divided command though if bird flu hits. At the point that national security issues are breached as in ability of the infrastructure to perform in lieu of “health issues”, the DHS takes back over and may redirect any and all assets as they see fit after a Federal State of Emergency is declared. HHS will be responsible for the health side of things ONLY. The general response will be that of DHS and how they see things.

    Will they be able to handle it? Not a chance and only a divine intervention would and we know Revere’s position on that.

    So how much is it going to cost? 2 billion a year after next year for the next four years. Thats if they vote to fund it. Thats a big if Revere and the numbers just dont match up with what its needed. To completely fund everything it would take 80% of the GDP for the next 10 years and that would be best case scenario. About 6 trillion dollars for doctors, nurses, ventilators, maybe a vaccine. Again, the numbers just wont allow for the support of the country in any other thing. 6 billion for this is like a rain drop in a metal bucket. It makes a lot of noise but its just one drop. It also is one of those carrot government programs. We will pay for you to do this if you will do that for us. Kind of like student loans.

    I disagree with Revere on the “oversight” by Democrats, its going to be business as usual and they will have to raise taxes tremendously just to overhaul and create the bureacracy in HHS. Kiss that 6 billion goodbye and fast. Wont change a thing. They are even directing that the VA hospitals be overturned if pandemic comes for public use. Ever been to the VA to get anything done? Waiting list now thats about two years long. Going to tank the veterans again. You there with the Agent Orange, you’re outta here got a bird flu patient thats going to die anyway. That is based on current rates, but at least they get a bed. Better to stay home.

    We could hope that this new law really meant something but it really doesnt. If we had a vaccine or dumped 6 billion in research to get it, we likely could. National disasters like Katrina dont happen often and this “noise” in Congress is just that. So HHS isnt really in charge of anything other than the health side of it and thats only if DHS decides they are. Another fluff law to make it look like they are doing something about bird flu. It gives them cover when it happens.

  3. #3 crfullmoon
    December 22, 2006

    (MRK the only time I set foot in a VA hospital, they didn’t call back with a bed
    until the vet had been on the wrong side of the grass for a month.)

    Fluff laws may not provide government “cover” pandemic&post- not as you sometimes use the word, right, MKR?

    What if Congress and Governors started getting,
    “You and your staffers weren’t even expecting my phone call to be about H5N1/pandemic influenza year unpreparedness at the local level;
    what are you going to do when instead of me,
    you get the word that pandemic has broken out??
    Better start talking to the public now and telling them they were supposed to be preparing and how to start. (Why didn’t they have public forums on pandemic influenza years?; the most important issue hanging over our heads?” -what an election year-)
    phone calls from the electorate more fequently…

    Plans on paper (and orders for antiviral$, vent$ and vaxe$) are for naught,
    if the public isn’t told in time so they can be ready
    to try and not be part of the problem -or tell tptb which parts of the plans are unworkable, since there seems to be a lot of panic/denial/avoidance on their parts- someone – who outranks them- needs to whistleblow the wishful thinking.

    Feds and state knew a very long time ago there wasn’t enough help to go around;
    at least they could have helped tell the public since it seem to literally be the last thing the local health officials of government want to tell the people (whose taxes pay their paychecks).
    That federal website (and the WHO’s “nine things”) does no good if the families, business employees, parents of school childrens, churchgoers, community organizations,
    don’t know it’s there, and
    don’t know what the scientists are afraid an H5N1 pandemic influenza year could be like. (Telling the public they might have a take a few “snow days” is disgusting. Public knows what a snow day is and it’s not what the honchos have in mind.)
    Public is going to be outraged if the learn for themselves; not only will too many skilled people be lost to have a Recovery, the surviving people may lose all trust in the previous authorities and institutions.

  4. #4 M. Randolph Kruger
    December 22, 2006


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