Campylobacter Food Poisoning : Vaccine

by Food and Drug Administration (FDA)

(Page 2 of 2)

Because of the concern over antibiotic resistance, FDA is considering whether, before it reviews a new animal drug for approval, manufacturers must assess the likelihood that use of a certain drug in food animals will transfer resistance and create a public health problem. In addition, new procedures for monitoring antibiotic use and resistance after approval also are being considered.

"FDA believes a new regulatory framework is needed to address resistance concerns raised by the food animal use of antibiotics," says Goodman, who also serves as a deputy medical director for FDA.

The Animal Health Institute, a national trade association representing manufacturers of animal health products, says it also is concerned about the possibility of antibiotic use in food animals causing resistant bacteria to develop. But the organization believes that the requirements FDA is proposing may have "unintended negative consequences on animal health ... and risk sending unhealthy animals into the food chain."

Hollinger says, "At this time we are not taking action toward withdrawal of these products from the market. We have asked the sponsors of poultry fluoroquinolone products to provide data that would describe the prevalence of resistance in poultry flocks and identify possible actions to prevent the emergence of disease in treated flocks."

Calling it a "farm to plate" approach, Hollinger says that the Campylobacter problem can be addressed "at any number of points" along the food chain. "They all need to be reviewed and evaluated for new methods to deal with the problems."

USDA's Stern says he believes the poultry industry is "trying very hard" to move toward enhanced food safety for economic as well as safety benefits. For example, he explains, a company could use extensive microbiological criteria to ensure safety as a marketing tool. Just as consumers are willing to pay more for "gourmet" coffees or specialty food items, an increasingly health-conscious consumer could be wooed by a health emphasis when it comes to safer poultry products, he says.

Vaccine on the Horizon

A team of Navy, Army, and drug industry researchers is also moving ahead in the development of a prototype vaccine for Campylobacter. The vaccine has shown promise in animal models and currently is undergoing clinical trials.

Capt. Louis A. Bourgeois, director of the enteric diseases program at the Naval Medical Research Center in Bethesda, Md., says the Navy has been involved in Campylobacter research since the early 1980s.

"Historically, the military has had longstanding diarrheal problems with troops deploying overseas," he explains. "Campylobacter was an emerging pathogen in the early '80s, and by the mid-1980s, we began doing more directed studies towards a vaccine development."

Bourgeois and his fellow researchers say an approved vaccine is likely "several years away" but they remain optimistic. Bourgeois says private companies are interested in a vaccine due to its possible application in "traveler's diarrhea," a common ailment.

"We know from animal model work that we can protect animals against Campylobacter colonization," says colleague Daniel Scott, M.D., deputy director of the Navy's enteric diseases program. "We have also gained an increasing amount of knowledge in the clinical and preclinical development of this product, especially in terms of what happens with the actual infection. We are already seeing some evidence that term protection can occur, which allows for a lot of optimism."

The Consumer's Role

While researchers, regulatory agencies, and scientists grapple with Campylobacter, what can you do to protect yourself?

"Consumers go to the supermarket thinking everything [there] is clean, and that is just not true," says Donald H. Burr, Ph.D., a research microbiologist in FDA's Center for Food Safety and Applied Nutrition. "People can't assume that anymore. Consumers have a responsibility in food safety."

Those responsibilities include prompt refrigeration, thorough cooking, avoiding cross-contamination, and washing hands and surfaces often. In addition:

• Don't let raw foods such as uncooked poultry touch other food, since bacteria can spread.
• Thaw raw poultry on a bottom shelf in the refrigerator so that blood or juices don't drip onto other foods.
• Do not reuse marinades from raw meat or poultry.
• Never put cooked poultry or meat back on the plate that held the raw product.
• Wash your hands frequently, especially after handling raw meat and poultry.
• Wash kitchen surfaces and cutting boards often, especially after they have come in contact with raw meat or poultry.

Link To Guillain-Barré

Campylobacter is not the only thing that triggers Guillain-Barré syndrome, but it is now recognized as one of the disorder's major forerunners. Guillain-Barré, which also may follow a viral illness, is an autoimmune attack on the peripheral nerves that can cause weakness and paralysis. Annually, about two people per 100,000 contract the syndrome.

"We also know that many patients who have [campylobacteriosis] seem to have a more severe form of Guillain-Barré," Leshner says.

Guillain-Barré can be difficult to diagnose in its early stages, although Leshner says clinicians often suspect anyone with "acute weakness" as having the disorder. It's usually diagnosed via clinical observation, spinal fluid analysis, and electromyogram (EMG) tests, which analyze electrical activity in muscles.

"With mild cases, probably no more is needed other than supportive care. But if the person is unable to walk or has breathing problems, more dramatic treatments may be needed," Leshner says. "A small percentage of people have residual disabilities, and these people have the form linked to Campylobacter."

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.