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Drug Helps Babies Fight Deadly Botulism

'BIG-IV' offers new hope against a rare killer, researchers say

WEDNESDAY, Feb. 1, 2006 (HealthDay News) -- Babies threatened with a rare but potentially lethal botulism infection now have an effective new treatment option.

The medication, human botulism immune globulin (BIG-IV), can shorten a baby's average hospital stay for botulism by about three weeks and save about $88,600 in hospital charges per infant, a new study finds.

Before BIG-IV, "there was no specific treatment in the past, only supportive treatment. Doctors could provide breathing support with respirators and feeding support with stomach tubes, but babies fight the disease off on their own," explained study author Dr. Stephen Arnon, chief of the Infant Botulism Treatment and Prevention Program for the California Department of Health Services.

Now, there's "a fully-licensed, safe and effective treatment for this rare, but life-threatening paralytic disease," he said.

His team's study appears in the Feb. 2 issue of the New England Journal of Medicine.

Botulism is an uncommon infection. In fact, the disease is so rare that it has garnered orphan status from the U.S. Food and Drug Administration. Orphan diseases are those that affect fewer than 200,000 people each year. The FDA passed a law in 1982 allowing manufacturers of drugs that treat orphan diseases to conduct smaller clinical trials, though the drugs must still go through the standard development process and drug makers must prove the safety and efficacy of their drugs.

Botulism definitely falls into this category, Arnon said. "Infant botulism is really an orphan-orphan disease, because it typically hospitalizes only 80 to 110 babies a year," he said.

The only known preventable source of infant botulism, according to Arnon, is honey. Botulism spores are found in dust and soil. They are also found in honey in very small amounts. For that reason, babies under 1 year of age should never be given honey. Adults can usually fend off botulism spores in honey because of "good" bacteria found in the intestines that prevent it from proliferating.

However, honey probably still accounts for less than 10 percent of babies hospitalized with botulism, the study authors said, with most babies probably inhaling botulism spores from contaminated dust or dirt.

"The disease results from swallowing the spores of a common bacterium," Arnon said. "Some babies have the bad luck of swallowing the spores at a moment in their life when their intestine is vulnerable to colonization. Other babies swallow the spores, but have enough favorable bacteria to keep the spores from germinating."

From a group of 180 infants believed to have the disease, Arnon and his colleagues were able to enroll 122 infants with suspected (and later lab-confirmed) botulism in their study. Fifty-nine received treatment with BIG-IV, and 63 received a placebo. The average age of the babies was 105 days old for the placebo group, and 131 days old for the treatment group.

The drug was well-tolerated by the babies, and the results were dramatic.

The average hospital stay was 5.7 weeks for non-treated babies and 2.6 weeks for babies who received BIG-IV. Time in the intensive care unit dropped from an average of five weeks to 1.8 weeks for the babies who received the treatment. Babies who were given BIG-IV had fewer adverse events and were able to spend less time on mechanical ventilation or tube-feeding.

"With the new treatment, more than 20 patient years of hospital stays were avoided and more than $34 million was saved," Arnon said.

Arnon added that it's important to remember that "this progress couldn't have been made without the willingness of the parents of these babies to enroll them in these randomized and open-label clinical trials."

Dr. Stanford Shulman, chief of infectious diseases at Children's Memorial Hospital in Chicago, said the one drawback to this medication may be its cost, which is significant.

However, he added that this study "shows the benefit that justifies the need for something that expensive. If you can significantly shorten the stay in intensive care or the time a baby needs to be intubated, or you can clearly show that patients with this disease who were treated with BIG-IV do well and get better faster, then you figure out a way to pay for it."

More information

For more information about botulism, visit the U.S. Centers for Disease Control and Prevention.

SOURCES: Stephen Arnon, M.D., chief, Infant Botulism Treatment and Prevention Program, California Department of Health Services, Richmond, Calif.; Stanford Shulman, M.D., professor, pediatrics, Feinberg School of Medicine at Northwestern University, chief, division of infectious diseases, Children's Memorial Hospital, and president-elect, Pediatrics Infectious Disease Society, Chicago; Feb. 2, 2006, New England Journal of Medicine
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