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lockjaw
Top, a lockjaw sufferer, his face frozen into an agonized grimace.

Ready for some lockjaw?
There's no profit in the tetanus vaccine business, so a rare and hideous disease may soon strike more Americans.

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By Amy Standen

March 8, 2001 | Some vaccines work too well. If the tetanus vaccine weren't so effective, the sight of people suffering from lockjaw would be commonplace. And when the bottom of the tetanus vaccine supply dropped out, as it did in January, we might have been worried. Instead, we hardly noticed.

America takes about 25 million doses of tetanus vaccine per year, and until recently, there were two main sources for it: Wyeth-Ayerst -- a vaccine manufacturing subdivision of pharmaceutical giant American Home Products -- and the French manufacturer Aventis-Pasteur. (A third company, Glaxo Smith Kline, makes the infant diphtheria, tetanus and pertussis vaccine, DtaP, which is still widely available.)




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But Wyeth-Ayerst dropped out of the market, leaving the medical community with a situation one doctor described as "a real problem" and another as "frightening." A vaccination required by law in 47 states is now in the hands of only one major company -- Aventis. And for the next 11 months, the amount of time it'll take Aventis to get up to speed, there's a good chance that if you ask your doctor for a booster shot, you'll be told to wait until next year.

American schoolchildren receive vaccines for tetanus, as well as measles, mumps, rubella, polio, meningitis and chicken pox. Getting your shots is a ritual as basic to American childhood as the Sunday comics. And most Americans, if they think about these medicines at all, probably assume that the government manufactures them or controls their supply. But the government got out of the business long ago, turning it over to more efficient private companies. The problem is that the vaccine business offers very low profit margins -- in large part because of well-meaning but hopelessly outdated price controls -- and if private manufacturers decide they're not making enough money and decide to get out, there's nothing to stop them.

The result is a looming public health crisis -- the first manifestation of which appeared last month, when the four companies producing a strain of flu vaccine all fell victim to manufacturing problems, causing widespread shortages. Like the flu vaccine shortage, the Wyeth-Ayerst affair is a case study of what can go wrong -- and will continue to go wrong -- in the vaccine industry.

Wyeth-Ayerst, which has already faced major embarrassment in the marketing of the diet drug fen-phen and other drugs, abandoned its tetanus vaccine production not long after the Food and Drug Administration slapped a major fine on it and asked it to improve conditions in its manufacturing plants. Wyeth, answering to its stockholders like any other private company, said good riddance -- and as a result, lockjaw may be poised for a comeback.

"Every 10 years we need boosters because immunity begins to wane," says Dr. Larry Pickering, a pediatrician with the Centers for Disease Control and Prevention's vaccine program. "The organism is still in the environment and if you don't get those boosters, [and if you] are exposed to it, like in a cut, without a proper inoculant, people will begin to develop it, and we will start to see more cases."

About 45 people develop tetanus each year, with older patients, who are less likely to be up to date on their booster shots, making up the bulk of the cases. On Jan. 5, an Associated Press story described the case of an 80-year-old woman named Fern Turner who developed tetanus from an infected spider bite. Turner spent 53 days in an intensive care unit with muscle spasms and a locked jaw, but she lived. The mortality rate for elderly tetanus suffers is over 50 percent.

Pickering can't say how many cases of tetanus we can expect to see as a result of the shortage; no one can, which makes it hard to find an impending public health disaster to rally around. Dr. Yvonne Maldonado, a member of the National Vaccine Advisory Committee, comes a little closer, but not much: "We're pretty sure that we would have all these diseases if we didn't vaccinate, but we can't prove it. Science doesn't prove negatives."

Doctors can't say how much of a danger the tetanus vaccine shortage could be, but they can tell you that it points to a larger problem: The fewer sources we have for these crucial drugs, the more vulnerable the supply becomes and the more we put ourselves at risk for diseases most of us forgot existed.

. Next page | "If you have tetanus, you die"
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