- The Washington Times - Sunday, January 2, 2005

During the winter of 1918-19, only months after the end of World War I, much of the world was ravaged again, this time by the “Spanish flu” that killed an estimated 40 million to 50 million people. Normal societal functions, including commerce, education and government services, were virtually shut down in many places.

We know now this pandemic strain of influenza was so destructive not because it was particularly infectious, but because it had an unusually high mortality rate. Experts are virtually certain another flu pandemic will eventually occur, either naturally or as a result of laboratory strains developed as bioterror weapons. Unless we take appropriate countermeasures, international travel by recently infected, contagious individuals could make our global village even more vulnerable than it was nearly a century ago. The consequences to public health, and to world business, could be devastating.

Such an outbreak could, in theory, be controlled by vaccination and antiviral drugs, but current vaccine production methods and stockpiles of antiviral medications are woefully inadequate for a genuine emergency.

The limits of current methodology slow response to constantly appearing new flu virus variants. Decisions about the viral strains to be included in each season’s flu vaccine must be made during the previous winter, and the viruses are then grown in millions of chicken eggs. Some companies try to grow the viruses in cultured cells, but even so it would be difficult to respond quickly to a new pandemic strain.

What we really need is a quantum leap in technology: use of gene-splicing techniques to make so-called “subunit” flu vaccines. Used for two decades to produce Hepatitis B vaccine, this approach involves splicing a single gene from the virus into either bacteria or yeast. These organisms then become mini-factories for synthesizing the viral gene product, which, after isolation and purification, is used as the vaccine.

Early attempts to adapt this approach to flu vaccine have been unsuccessful; more research is needed. Researchers also are trying to devise vaccines that make the immune system target viral components highly conserved across all strains of flu.

In the meantime, anti-flu drugs — which should also be effective against all variants of the virus — provide an essential complement to vaccines. Assuming each flu victim would infect two to four more, researchers estimate giving antiviral medicines prophylactically to 50-75 percent of the population would prevent a pandemic like that of 1918.

Vaccination to prevent viral and bacterial diseases is modern medicine’s most cost-effective intervention. Although their social value is high, vaccines’ economic value to pharmaceutical companies is low because of their minimal return on investment and the manufacturers’ exposure to legal liability.

The underlying problem is government policies that discourage companies from investing aggressively in new vaccines, and that have failed to stockpile antiviral drugs.

The major purchaser of most vaccines, the Centers for Disease Control and Prevention, extracts huge discounts from manufacturers. Arbitrary and excessive regulation also blocks progress. As a result, innovation has suffered and vaccine producers have abandoned the field in droves, leaving only four major manufacturers and a few dozen products. There are only two producers of injectable flu vaccine for the U.S. market.

To correct these broad deficiencies, and to stop an evolving flu pandemic in its tracks, the government must take a number of steps: increase funding for basic research on subunit vaccines (which are safer and cheaper and should have shorter development times than conventional ones) and other novel approaches; and stockpile anti-flu medicines. The CDC must stop demanding discounts that discourage manufacturers, and regulators should pursue “reciprocity” agreements on approvals so vaccines and antiviral drugs licensed in certain foreign countries can be marketed in the United States.

In the longer term, Congress could take other measures to improve the climate for vaccine-makers, such as offering tax breaks to offset research and development costs; requiring that health-insurance providers cover immunizations without deductibles; and stipulating that once the Food and Drug Administration approves a vaccine, the government will compensate victims of side effects.

These measures collectively constitute a health insurance policy we can’t do without.

Henry I. Miller is a fellow at the Hoover Institution and Competitive Enterprise Institute and the author of “The Frankenfood Myth.” From 1989-1993 he headed the Food and Drug Administration’s Office of Biotechnology. David Longtin is a free-lance writer specializing in science and technology.

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