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Ready for some lockjaw? | 1, 2, 3


Tetanus is one of those diseases whose onset is marked by symptoms so mild they're almost sinister: fatigue, soreness, irritability. A few days later, when the patient notices a stiffness around the jaw, and a labored breathing, it's often too late. As swallowing becomes difficult, the mouth fuses shut while the rest of the body is racked with muscle spasms so severe that a patient can break his or her bones.

You don't quickly forget photos of tetanus patients, their faces frozen into something that would look like a smirk -- eyebrows raised, the corners of the mouth turned up into a smile -- if it didn't give off the distinct impression of a physical prison; tetanus patients look, literally, trapped in their own faces. Later, their bodies become fortresses too; tetanus stiffens the entire body into positions you wouldn't want to spend five minutes in. One photo shows a man bent backward into a crescent moon shape; another has a child's arms bent up at the elbows, like a boxer getting ready to punch, but immobile. The people in these photos look scared.




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Dr. William Muraskin, author of "The Politics of International Health" and assistant chairman of graduate studies at Queens College, says, "If you have tetanus, you die." He's exaggerating, but not by a lot: In developed nations, about two-thirds of those infected with tetanus die, with those who catch the illness quickly more likely to survive. Recovery for tetanus can take months, during which time the patient is treated with a medical arsenal that's almost as scary as the disease itself: muscle relaxants, or medically induced temporary paralysis, weeks spent isolated in dark, silent rooms intended to reduce stimulation to the nervous system.

Tetanus is scary, but when you're a pharmaceutical company, it's the vaccine business that causes nightmares. In 1999, Wyeth-Ayerst caused a stir when it had to withdraw its rotavirus vaccine from the market, after an intense ad campaign and widespread usage. Rotavirus, a diarrhea-like sickness common among young children, is potentially deadly, but so, it turned out, was the vaccine, which caused bowel obstructions in dozens of children. The incident was particularly embarrassing to the FDA, which had approved the drug only a year before, officially recommended it to all children in the United States and then proceeded to vaccinate (according to a New York Times article on the withdrawal) 1 million 2-, 4- and 6-month-olds. Add to that the well-publicized recall of Wyeth-Ayerst's notorious diet drug, fen-phen (which was found to cause heart problems and cost the company $3.7 billion in damages), and you have a company justifiably wary of vaccine scandals.

The company doesn't cite earlier problems with its decision to drop the tetanus vaccine. Wyeth-Ayerst spokesman Doug Petkus won't say much beyond "We periodically evaluate our portfolio to see how we can better and more efficiently allocate our resources."

But Wyeth-Ayerst's announcement of its decision came just seven months after Justice Department officials entered the Wyeth-Ayerst warehouse in Venore, Tenn., on orders from the FDA to seize thousands of wrapped, ready-to-go syringes of tetanus/diphtheria vaccine and other drugs.

Such seizures are not uncommon, and in this case, the move came after a series of FDA warnings to Wyeth-Ayerst regarding the company's production of tetanus vaccines and other drugs. The paperwork around this event is a fax-machine hazard -- blurry, 25-page documents blotted with ink spots to cover classified information -- but it's possible to make out the FDA's charge. It wasn't Wyeth-Ayerst's vaccines that were found to be at fault, it was the packaging.

"Vials [found at Wyeth-Ayerst's manufacturing plant in Marietta, Pa.] had defects ranging from a slight 'nicking' to a complete 'chipping' around vial rim surfaces that present a potentially critical defect which cannot be unsuspected out following filling and capping."

FDA documents suggest that the company had been warned in the past about possible sanitation issues. However, Petkus, who spoke on behalf of the company at the time of the seizure, says that the FDA's complaints "referred in many cases to paperwork" and that beyond that, well, we'll have to ask the FDA. "Seizure is a process the FDA has at its disposal," he said, three times, "to indicate FDA is serious about its inspections." When asked about this seizure, and about the charges that vials containing the tetanus vaccine weren't meeting FDA standards, Petkus said, "That's not my recollection." Possibly, he suggested, the FDA seizures were a "symbolic gesture" of the agency's determination to be stringent with recently upgraded regulations.

Whether the FDA got what it came for is another question.

. Next page | There's no money in getting rid of disease altogether
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