Drug companies don't want to take on those costs because of the third problem with the flu vaccine business: it's a low-profit business and the demand for flu shots is "exceedingly fickle," said Poland, the Mayo clinic expert.
Sales of flu shots fluctuate from year to year based on people's perception of how bad a year's flu is going to be. Last year there were early reports of flu deaths and severe symptoms, so demand was strong and drug companies threw away only 4 million of the 87 million doses of conventional vaccine they made. This year the shortage seems to be fueling demand, prompting people who might not ordinarily get flu shots to try to get them, making the shortage worse.
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Regulatory costs, the two flu experts suggest, may be holding back development of better technologies for manufacturing flu vaccines that could have helped with this year's shortage.
Flu vaccine is manufactured with a time-consuming, half-century-old technology that grows the flu germs in fertilized eggs. By the time regulators discovered contamination at Chiron's plant in England, it was too late to crank up production elsewhere.
A MedImmune spokeswoman said the company starts its flu vaccine in California, ships it to England, where it is grown in eggs, then brings the material from the eggs back to a plant near Philadelphia to be turned into FluMist.
Other kinds of vaccines can be grown in tanks, which is much quicker. But if a drug company wanted to switch to that kind of technology for flu vaccine, Pavia said, federal regulations would treat the new version as if it were an entirely new drug, which would have to go through the lengthy Food and Drug Administration approval process before it could be sold. When profit margins are low and the market is fickle, there is no marketplace incentive for a company to develop a more efficient production method.
That issue might be tackled with tax incentives, says the Infectious Diseases Society, which began worrying about the vaccine market long before this year's shortage. There are already research and development tax credits, but Pavia suggests tax incentives that would be given to companies only when they bring a badly needed new product to market.
The Infectious Diseases Society also is lobbying to include vaccines in the Project Bioshield legislation passed this year to fight bioterrorism. The measure, which became law in July, provides incentives for developing drugs to treat or prevent ailments that could be spread by terrorists.
Another idea floating around Washington is to simply get rid of the free market for flu vaccine and do what Canada and many countries in Europe do -- have the government buy all the vaccine the nation needs. That is so contrary to the American approach to health care that the suggestion is pretty much dead on arrival.
Poland, of the Mayo Clinic, suggests a more limited role for government, which already buys about 20 percent of the flu vaccine for the military and federal health programs. (While the prevailing view is that Americans don't want the government dictating drug prices, the government does dictate what it pays for flu vaccine, demanding a price drugmakers say is unprofitable.)
Under the plan Poland recommends, the government would set a target for how much flu vaccine is needed and would pay market prices for the roughly 20 percent that it buys. Most vaccine -- say 70 percent of the market -- would be handled just the way it is now: the drug companies would sell it on their own. To guarantee an adequate supply, though, the government would promise to buy up to 10 percent of the output if it could not be sold and to pay a bonus price for it.
Poland argued -- persuasively to me -- that the government ought to treat vaccines as a national essential. We need jet planes to protect the nation's security, so we buy them. We need vaccines to protect the nation's health, so we buy them.
This approach isn't all that different from federal farm programs, which are intended to guarantee the nation an adequate food supply at reasonable prices while protecting the incomes of producers. If the government can buy milk or corn to stabilize the market, why not flu vaccine? If we can use tax dollars to subsidize growers of tobacco, which destroys people's health, why not use them to subsidize growers of flu vaccine to protect our health?
