Innovative Medical Advances Save Lives of Infants

For former Bay Area biochemist Nancy Shine, Ph.D., cards and thank-you notes from grateful families are a reminder of a life-saving project that's rescued countless infants with botulism. It's an antitoxin developed from the blood plasma she and a unique group of volunteers donated.

Unique, because they were among the few in the country already immunized against botulism because of their potentially dangerous lab work. Shine said, "I don't think anybody thought twice. They were just very enthusiastic about it." The antitoxin for infant botulism was the brainchild of a Bay Area doctor, the late Stephen Arnon, M.D., working for the California Department of Public Health more than four decades ago.

The treatment is now known as BabyBIG, for human botulism immune globulin. To make the formula work, Dr. Arnon needed antibodies against the toxin from the blood of volunteers who had immunity, like Shine.

Jessica Khouri, M.D., a senior medical officer for California's Infant Botulism Treatment and Prevention Program, explained that donation and making the medicine involve separating out and concentrating the antibodies in the plasma, so the BabyBIG treatment contains the valuable antibodies against the toxin.

Dr. Khouri said, "BabyBIG, as an antitoxin, is going to stop any effect of the toxin once BabyBIG is administered. So, it's neutralizing that toxin as soon as it's administered in the baby's bloodstream." A clinical trial in California in the 1990s with babies suffering similar clinical signs as infants in the current ongoing botulism outbreak, traced to contaminated baby formula, led to the success of this treatment.

Symptoms of infant botulism include muscle weakness and paralysis. One family described the experience to ABC News, stating, "And you know, just in my gut, it was like, yeah, we need to take her. Her gag reflex was not intact.

It's like it becomes paralyzed," said Hanna Everett, whose daughter was recently diagnosed with botulism during the outbreak. Bonnie Maldonado, M.D., the Director of Infectious Diseases and Pediatrics at Stanford Medicine, was involved in the early clinical trials with Dr.

Arnon that led to the approval of BabyBIG. Dr. Maldonado recalled, "So I worked with the families of the babies who had infant botulism and spoke to them and explained what was going on." She noted that most families were very anxious to find anything that might work and that, "I can't remember anybody refusing to participate in the study." The Stanford Blood Center recently completed blood plasma donation for a new batch of BabyBIG that's now being packaged for distribution.

Shine stated, "You know, so grateful that I was, like, in the right place at the right time and that we were in contact with people who were developing the product. And, it's like the highlight of my career." Shine, now over 70, can no longer donate her blood, but health officials state they have enough BabyBIG to last until next summer.

For more information, visit the Infant Botulism Treatment and Prevention Program's website.