E. coli outbreaks fuel federal action

Mark A. DeSorbo

WASHINGTON, DC—Outbreaks of the deadly E. coli 0157:H7 strand in Milwaukee and Northeast Ohio in late July and August riggered the U.S. Department of Agriculture (USDA) to crack down on contaminated meat and prompted the Food and Drug Administration (FDA) to authorize drug maker Synsorb Biotech Inc. (Calgary, Alberta) to provide emergency doses of experimental treatments.

The USDA crackdown comes on the heels of the Ohio outbreak that afflicted 26 people in five counties and is expected to yield new testing requirements in beef plants for the 0157:H7 strand as well as a ban on the sale of meat from animals in which excessive drug residue has been found.

Following the Milwaukee outbreak that claimed the life of a 3-year-old girl and infected 42 people, Synsorb Biotech was authorized by the FDA to provide doses of its Synsorb Pk, an experimental E. coli treatment.

Health officials say hygiene and sanitary precautions before eating and preparing food are key to preventing the spread of food-borne viruses and bacteria.
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Advocacy groups such as Consumer’s Union contend that livestock producers are giving excessive amounts of hormones, antibiotics and other drugs to their animals. There is also a longstanding concern among scientists that harmful bacteria develop resistance to antibiotics when exposed to drugs in animals, becoming more of a threat to humans.

Under USDA rules, meat packers can throw out part of an animal that has tested for drug residue, typically the liver and kidney, and sell the rest. Animals are tested for more than 50 different drug compounds, including a variety of antibiotics.

The FDA, however, has not set tolerances in meat for most drugs. While violation rates are low, less than two percent or 12,400 of 6.2 million cattle in 1997, the intent of a new
policy, according to the USDA, is to bring agency procedures in line with FDA policy.

A new USDA policy may require the entire
carcass to be destroyed. The USDA reports that the policy would apply to all livestock, primarily dairy cows, the source of 40 percent of the nation’s hamburger meat.

The federal crackdown comes on the heels of reports that people in five Ohio counties, ranging from 1- to 84-years-old, were stricken with the E. coli virus that health officials say may have manifested at the Medina County Fair. Many of the victims attended the event, leading health investigators to focus on
animals, animal feces or food vendors.

“We are still trying to pinpoint the exposure source,” says Jay Carey, a spokesperson for the Ohio Department of Health in Columbus. “We are conducting epidemiological studies and genetic fingerprinting. We don’t know if the cases are from the same source.”

The source of the Milwaukee incident, however, stems from a Sizzler Steakhouse in the Wisconsin city, health officials say.

A 3-year-old girl died and 42 people, 25 of whom were children between the ages of 1 and 15, were infected. That’s when the FDA authorized Synsorb Pk to be administered at Children’s Hospital of Wisconsin, under the direction of Dr. Kelly Hendrickson, a pediatric infectious disease specialist.

“We did enroll one patient on the Synsorb program, and soon after, fortunately, our outbreak ended,” Dr. Hendrickson says. “We are thankful to Synsorb and the FDA for bringing this medicine to our community. In outbreak situations like this, it is heartbreaking to watch patients, especially children, suffer without being able to offer any treatment.”

While there are no approved drugs for combating verotoxigenic E. coli infections, Synsorb was released under the FDA’s Investigational New Drug provisions. According to Synsorb Biotech, the drug is designed to prevent serious complications and infections associated with E. coli. When administered within 48 hours of symptoms, the product reduces the progression to Hemolytic Uremic Syndrome (HUS), a severe and sometimes fatal kidney disease, by 59 percent in children, according to data in a third analysis phase.
Inhibiting the spread of E. coli, however, comes down to hygiene, says Carey, of the Ohio Health Department. People need to wash their hands after touching an animal or before eating and preparing food.

“In 1998, we had 128 cases. In 1999, there were 262 cases. As of [August 22], we’ve had 103 cases,” Carey adds. “Is it alarming? Yes, but I don’t want to be an alarmist. The best way to combat this is with good hygiene.”


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