Rationing: flu leadership in short supply

The CDC and the National Immunization Program are getting serious about what to do in the event of a pandemic. It is neither too little, nor too late but could easily have been earlier and certainly could be better. What we have at the moment is just a part of a plan scheduled for release early next month. Announced this week were the proposed "priorities" (read, rationing) of any existing and effective influenza vaccine.

This last part is important, as at the moment there are no existing vaccines shown effective in protecting the population against a pandemic strain of influenza A/H5N1 ("bird flu"). Some vaccines are in the clinical testing stages in the US, Canada and Japan but their efficacy and doses are still being evaluated. Should a pandemic strain emerge there is no guarantee these experimental vaccines will be effective against them and the current production cycle is at least 6 months, and probably closer to a year for sufficient quantities.

In the interim the only therapeutic means would be antiviral agents like Tamiflu, Relenza, both neuraminidase inhibitors, or one of the older M2 blockers like amantadine or rimantadine. Some H5N1 strains are resistant to the latter drugs, although the extent of this resistance in any emergent strain is unclear and it is possible they might have some role to play in an outbreak situation. There is only enough Tamiflu currently in the US to protect or treat about 1% of the population. Good planning, huh?

In any event, the DHHS plan, allegedly in the works since 1993 and in draft form for a year, isn't very different than past parctice or at all innovative. It targets health care workers, some government officials and high risk groups first, followed by others, as supplies permit. And since H5N1 is a new serotype for human populations, it will likely require a booster shot, thus cutting any effective supply in half. Here is the scheme, as reported in USNews:

Group 1. The highest-priority group includes 9 million healthcare workers involved in direct patient care; 40,000 people who are making the vaccine and antiflu medicines; and some 37 million people who are at greatest risk if they get the flu, namely those over age 64 with a medical illness, younger people with two serious underlying medical conditions, pregnant women, and all household contacts of children under 6 months of age. Also in this top group are key government officials and specialized pandemic flu responders. [my emphasis]

Group 2. In the next tier are healthy seniors; younger people with one risky health condition; young children between 6 to 23 months old (the vaccine is not recommended for infants under 6 months); and workers in critical fields like public safety, utilities, emergency response, transportation, and telecommunication. This group is 68 million strong.

Group 3. The third priority is 500,000 people, including key government healthcare decision makers and those working in mortuary services.

Group 4. At the bottom are the remaining 179 million healthy people, 2 to 64 years old, not included in any other category.

The working group did not include nursing home residents, who typically get annual flu shots, among the highest-priority group. Instead, they advise vaccination of the nursing home healthcare workers and the prophylactic use of the antiviral drug oseltamavir (Tamiflu) in the advent of an outbreak.

The Federal Advisory Group making the recommendation also suggests only government financing would make this feasible and allow the control required to adhere to the rationing scheme. How likely the Bush administration and its friends in Big Pharma will go for this is questionable. We'll see. If the drug manufacturers see little likelihood they will be able to exploit the situation, they may be willing to let Bush do it, although whether he has the intelligence and the guts to do it is questionable (this would not be a conservative-base friendly approach).

Aside from these mundane questions, there are others. The low-profile CDC and the administration have taken on bird flu means the ethical and public health issues have not been publicly debated. While it is alleged that ethicists were involved, the public certainly has not been made aware of the issues. From the public health side, too, questions remain. Since the first in the population to sicken are usually school children, the strategy of immunizing them first has been suggested as an alternative. While school age children usually suffer least from flu, they may be the main vectors to the rest of the population. The discussions about the conventional strategy were not done in a public way (although perhaps technically the meetings were open and announced ahead of time), so I don't know to what extent these or other options were considered and debated.

The entire avian pandemic threat was foreseeable more than a year ago. Its relegation to the back burner is inexcusable. Now that it appears it may be right on top of us we are handed decisions that have already been made and which may, in the event, be moot anyway because the vaccine will be ineffective.

The failure of imagination, political will and leadership by public health authorities and the public health community, generally (of which I am part), is stunning.