How rare drug made from group of Bay Area blood donors saves babies from botulism

SAN FRANCISCO (KGO) -- 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.

"I don't think anybody thought twice. They were just very enthusiastic about it," Shine said.

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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. But to make the formula work, Dr. Arnon needed antibodies against the toxin from the blood of volunteers who had immunity, like Shine.

"And so, Dr. Arnon turned to his colleagues and turned to those he knew who had been immunized against the toxin," said Jessica Khouri, M.D.

Dr. Khouri is a senior medical officer for California's Infant Botulism Treatment and Prevention Program. She says 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.

"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. Any of the circulating toxin that's being absorbed from the baby's intestinal tract. It does not reverse existing paralysis, but it stops or halts that toxin," Dr. Khouri said.

That success led to a clinical trial in California in the 1990s with babies suffering some of the same clinical signs as infants in the current ongoing Botulism outbreak, traced to contaminated baby formula. Signs of infant botulism include muscle weakness and paralysis and an attack on the peripheral nervous system. One family recently described the experience to ABC News.

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"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., is the Director of Infectious Diseases and Pediatrics at Stanford Medicine. She was also involved in the early clinical trials with Dr. Arnon that led to the approval of BabyBIG.

"So I worked with the families of the babies who had infant botulism and spoke to them and explained what was going on. And in the early days with the study, I explained to them why we were doing the study, and of course, they were really anxious to find anything that might work. So most of the babies, I can't remember anybody refusing to participate in the study," Dr. Maldonado said.

Stanford Blood Center recently completed blood plasma donation for a new batch of BabyBIG that's now being packaged for distribution. For Shine, it's part of an ongoing gift that so many have been happy to give.

"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," said Shine.

Shine is now over 70 and can no longer donate her blood. But even with the current outbreak, health officials say they have enough BabyBIG to last until next summer.

Head to the Infant Botulism Treatment and Prevention Program's website for more information.