TCS Daily

Bugs in the System for Treating the Flu Bug

By Sydney Smith - December 19, 2003 12:00 AM

It comes every year, as surely as the sun rises every morning and sets every evening. We know it. We expect it. Yet it often manages to take us by surprise. In 1918 it took the world by storm, aided and abetted by war-weary soldiers returning home around the world. In 1976, it threatened to be just as deadly, but fizzled out with a whimper, after proving less dangerous than the vaccine that was used to prevent it. It is the influenza. And this year is one of those years when it has taken us by surprise.

But should it have surprised us? It came earlier than usual, and hit the young harder than usual. There's been an unprecedented clamor for vaccine. And now, within a few short weeks of the flu's arrival, we have a shortage. But the only unpredictable link in that chain of events was the timing.

Every year the World Health Organization tracks the various strains of influenza virus that are
circulating around the world. And every winter, as the flu season draws to a close, a committee of infectious disease specialists meets to help the FDA decide which strain of flu will be the most likely visitor next season -- and thus which strain should be included in next season's vaccine.


Last March, when the committee met, there was significant disagreement about which strain to use. Dr. Peter Palese, chief of microbiology at New York's Mount Sinai Hospital, and according to another committee member, the "most knowledgeable about influenza viruses" on the committee, recommended including the Fujian strain of influenza A, a strain which had been making the rounds in Asia with increasing frequency. He was out-voted by other committee members because the Fujian strain could not be developed by current methods, which involve growing the virus in eggs. The only way to incorporate the Fujian strain was to grow it in canine kidney cells then transfer it to the eggs. But that method isn't FDA approved. In the end, the other committee members decided that it was better to stick with the approved method and use a strain that, though similar to the Fujian strain, would provide less protection -- and less risk.

That was in March. Now it's December, and the
Fujian strain accounts for seventy-five percent of the influenza cases in the United States. And although so far it hasn't been any deadlier than usual, it has been more widespread. And this, coupled with the depletion of vaccine stocks, has put many elderly and chronically ill people at risk of death. Which brings us to the next predictable link in the recent chain of events -- the depletion of the vaccine supply.

Normally, flu vaccines are given first to those who are at highest risk for complications from the flu -- the elderly, those with immunodeficiencies, or respiratory diseases, or heart disease, and then the left over supply is offered to the healthy and the young. But this year, the CDC recommended immunizing everyone from the start, regardless of risk. There would be plenty of vaccine this year, they assured us. And then, when the severity of the outbreak in the West became clear, CDC Director Dr. Julie Gerberding urged, "This is the time for Americans to really step up to the plate and get vaccinated against influenza," while Secretary of Health and Human Services Tommy Thompson assured us, "There is plenty of vaccine to meet demand."

Except there wasn't. Influenza vaccine production, like the production of any commercial product, is subject to the forces of the marketplace. Since the flu vaccine changes every year, manufacturers have to guess how many doses they'll be able to sell in any given year. Doctors have to guess how many they'll need to buy to meet patient demand. No one, not the manufacturer, not the doctor, wants to get stuck with excess inventory. It's too costly. This year, the two companies that still produce the vaccine made 83 million doses, which is roughly the number of doses they successfully sold last year. That's less than half the estimated number of elderly and chronically ill people who are most deserving of the flu shot, and a miniscule proportion of the total population. It's no surprise we were caught with a shortfall.

Mix the unbridled enthusiasm of public health officials with the market realities of vaccine production, and you have a recipe for disaster. It doesn't have to be this way. At the very least, the CDC could curb their enthusiasm and recognize that as long as supplies are limited, vaccine will need to be rationed. And although it's beyond the mission of the CDC to control vaccine production and supply, they should make themselves aware of the supply situation before making sweeping pronouncements and recommendations.

But supplies also don't have to be as limited as they are. Trial lawyers and poor reimbursement rates have made vaccine production the orphan of the pharmaceutical industry. Few companies are willing to invest in developing newer vaccine production technologies. Thus the dilemma of the FDA committee earlier this year. Only two companies currently make the influenza vaccine. If one, or heaven forbid both, decide to stop we would be in dire straights. Better reimbursement rates for vaccines could help alleviate some of these woes. So could tort reform. If we only had the will.


Sydney Smith is a family physician who has been in private practice since 1991. She is board certified by the American Board of Family Practice, and is a Fellow of the American Academy of Family Practice. She is the publisher of MedPundit.


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