November 02, 2005, 8:38 a.m.
Wrong Prescription
Jumping on avian vaccine spending won’t help matters.

By Gilbert L. Ross

President Bush unveiled the administration's new plan Tuesday in preparation for a possible onslaught of the dreaded "bird flu" pandemic in America. He and Health and Human Services Secretary Michael Leavitt seem to be bending over backward, allocating at least $1.2 billion for stockpiling millions of doses of new vaccine. But what are we going to get for that money?

Sadly, we're going to be getting warehouses full of a vaccine that will be as effective against a mutated pandemic bird-flu strain — if one ever shows up — as last year's human flu vaccine would be against next year's virus. That is to say, the new vaccine will be barely effective or worthless.

The latest reports of a new National Institutes of Health-researched vaccine against bird flu show that it evokes a weak antibody response to the current variant of the flu. Even a vigorous immune response is no guarantee that actual protection from disease would result — and the likelihood that a pandemic virus would be blocked by the current vaccine is slight. (One group recently got a huge grant to start producing a vaccine that has not even been tested.) The genetic drift that occurs annually makes a new vaccine necessary each year against the human flu epidemic; imagine the change in the bird flu virus that would enable it to become a human contagion — such a dramatic variance, called "shift," would disarm our current vaccine.

Similarly, stockpiling multimillion doses of current anti-virals (Tamiflu and Relenza), also at over a billion dollars, will prove much less effective than predicted: the older anti-virals rapidly became worthless as resistance developed to the prior strain of bird flu, due to massive overuse in the 1990s. By the time the pandemic strain reaches our shores, it is quite likely that our current pharmacopeia will be futile against the new bug. We need, instead, to devote our resources to researching and producing new anti-virals, which will effectively replace the ones that fall by the wayside.

Much of the new federal program is to be praised, indeed is long overdue. The current thrust against a hypothetical pandemic might actually end up saving the vaccine industry, by heightening liability protections for drug manufacturers. This would keep trial lawyers at bay, reducing costly lawsuits that discourage vaccine production.

There is nothing in the plan, however, about easing regulatory impediments, as by expediting vaccine licensing or expediting approval of novel technologies for vaccine production. (Can we really grow bird flu virus to make vaccine in bird eggs, as is the current flu-vaccine production method?) Current Food and Drug Administration mandates in this area would have to be sidestepped expeditiously if a global invasion of bird flu had to be slowed.

Finally, widespread threats of patent infringement, based on the WTO-TRIPS convention (which singled out pharmaceutical manufacturers for legalized patent-violation), need to be addressed immediately, to assure developers of new vaccines compensation for their efforts. Otherwise, drug makers will be reluctant to enter the fray.

All of these obstacles can be overcome with a more fluid partnership between the private and public sectors. This should entail:

enhanced surveillance of endemic bird-flu areas (addressed in the new government plan with an "international partnership") to detect dangerous changes in the current virus as early as possible;

financial outlays to encourage bird handlers and farmers in Southeast Asia to cooperate with public health authorities when flocks must be culled to stall the spread of the bird disease;

guarantees of support for R&D investments, especially for new technologies (e.g., cell cultures and molecular genetics for increased and faster production of new vaccines);

stockpiling of effective antiviral drugs, along with incentives for drug companies to develop new ones to protect us when, inevitably, viral resistance arises to Tamiflu and Relenza;

greasing the regulatory wheels to allow expedited licensing of new vaccines and technologies for a potential pandemic scenario;

dealing with the patent issues before the virus transforms into an imminent threat and panic sets in.

These are the relatively easy issues to overcome prior to getting a safe and effective vaccine in sufficient quantities. But we have been deluded into thinking that the "new" bird-flu vaccine will be the answer. It won't. It's just possible that the administration, bitten by justifiable criticism of its slow response to Katrina, is now leery of being seen as lagging in preparing for a pandemic and has entered the "Just do something/anything!" mode.

Vaccine research must proceed, no question about it. But squandering billions of dollars stockpiling useless vaccine is not the way to go. Overcoming the obstacles above will set the table for the real work: making an effective vaccine (and anti-virals) for the pandemic strain, if and when it arrives, and not becoming too attached to vaccines aimed against the wrong target — no matter how much they cost.

— Gilbert Ross, M.D., is medical and executive director of the American Council on Science and Health.

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