Investigators race of find the cause of botulism contamination in ByHeart infant formula

By Brenda Goodman, CNN

(CNN) — Rose Dexter was just a month old in August when she developed constipation, gas and tummy discomfort, symptoms that her pediatrician chalked up to normal baby development.

“Looking back at the photos, she was losing weight. She looked sick,” said her dad, Stephen Dexter. “And the entire time during the decline, Mom had been saying something was wrong.”

That something turned out to be infant botulism, a condition caused by the spores of a bacteria that was growing in her gut, producing a toxin considered to be the most powerful in the world. It was poisoning her nerves and gradually paralyzing her.

Rose is one of at least 31 infants who have developed botulism after consuming powdered formula from the company ByHeart.

The California Department of Health conducted tests of an opened can of formula that had been fed to an infant, and those tests found Clostridium botulinum, the bacteria that makes the toxin, spurring a nationwide recall of certain batches. Days later, the recall expanded to all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products. Last week, an independent company hired by the manufacturer also found the bacteria in unopened cans of formula.

The number of illnesses in this outbreak may rise as officials reopen investigations into cases of infant botulism from earlier in the year.

Already, it is “certainly the largest foodborne illness outbreak that I’ve heard of in 32 years due to infant formula,” said attorney Bill Marler, who specializes in litigating food poisoning cases and is representing the Dexters and two other families in lawsuits against ByHeart. “This outbreak has me very worried.”

Dr. Steve Abrams, a neonatologist and expert on pediatric nutrition at the University of Texas at Austin, says he also doesn’t remember ever seeing this many patients sickened by baby formula.

“This is an insane level of patients, babies affected. I think you’d have to go back very far to find this many babies affected by a disease state from contaminated formula,” he said.

Despite growing numbers of illnesses, he’s worried that people aren’t aware of the recall or the severity of the outbreak.

“We have these disturbing reports of 10 days after the recall, people are going into stores and still find cans of ByHeart,” Abrams said last week. “This recall is testing some real untested waters that we haven’t seen before.”

ByHeart would not comment on pending litigation, but the company said in a statement that it is “doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve.”

Although ByHeart said November 11 that it had recalled all its infant formula, the FDA said last week that it has received reports that some of the product is still on store shelves in multiple states, including at major chain stores like Wal-Mart, Target, Kroger and Sprouts. It has also been sold through online marketplaces, including to some customers overseas.

“Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall,” the FDA said.

Marler said that it’s a retailer’s responsibility to remove recalled product from the shelves and that it’s not clear why the word hasn’t gotten out to all stores.

Searching for the source

It’s also not clear how the formula – which is made with organic whole milk from grass-fed cows and advertises itself to health-conscious consumers as a “patented protein blend that’s as close to human breast milk as possible” – became contaminated.

ByHeart said Wednesday that it is working with the FDA to examine “every facet of our process – from ingredient-sourcing to our manufacturing process and facilities, packaging, transportation, everything.”

Botulinum is a unique problem in food poisoning. Adults get sick from ingesting the toxin that’s made by the bacteria, often by eating improperly canned food. Babies, whose guts aren’t yet fully developed, fall ill after ingesting the spores of the bacteria, which then colonize their guts and begin producing the toxin.

“If you think about seeds, like plant seeds, spores are like the same version, only produced by bacteria,” said Dr. Kristin Schill, a food microbiologist at the University of Wisconsin-Madison’s Food Research Institute. “They package their DNA and kind of like a protein shell, like a seed, that prevents them from being killed in harsh environments.”

Spores can survive pasteurization, the heat treatment that destroys other types of pathogens in milk.

ByHeart formula uses whole milk powder as an ingredient, as well as whey and other dairy ingredients.

“Any of those ingredients really could be a source of spores. There could be an accumulation of spores on the equipment, I don’t know,” said Schill, who previously worked as a research microbiologist for the US Food and Drug Administration.

Schill said botulinum spores have been found in milk powder in the past, though at very low concentrations. A case of infant botulism linked to powdered infant formula was published in a medical journal in 2005.

It will be critical to find out how high the concentrations of spores are in the formula that’s been tested, Schill said, and those levels may help point investigators in the right direction.

The only treatment for infant botulism

Stephen Dexter said he bought the first can of ByHeart formula for Rose after they got home from the hospital and his wife, Yurany, had trouble making enough breast milk.

“It was kind of a desperate move,” he said. He wasn’t sure what to get and went to a natural grocery chain, “assuming they would have some alternative selections.”

He looked for the most expensive formula, figuring that would be higher quality. ByHeart sells for about $40 a can. “It said all the things I was looking for. It said all the things that I thought I would not want, as it had a bunch of ‘no’s’ on there, which seemed good to me, and so I purchased that,” he said.

Rose did well on the formula, Dexter said, until she didn’t.

After a few weeks of subtle changes, he tried to wake Rose one day for a normal feeding, but she wouldn’t wake up. It was “the moment of ‘Oh, we gotta go.’ … That’s when we took her to the to the emergency room.”

“She couldn’t move her arms or her legs,” Yurany Dexter said. The doctors tried to gently lift Rose’s head and shoulders to see whether she could hold them up, and she couldn’t.

They did blood tests and then used a needle to collect the clear fluid that surrounds the spinal cord and the brain. Doctors told the baby’s parents that they suspected muscular dystrophy or botulism.

Infant botulism “happens a little bit from the top of your head down. So you first might notice droopy eyelids or some parents notice, like, their infant’s expressions are not as expressive,” said Dr. Erica Pan, a pediatrician who is the state public health officer with the California Department of Health. “It’s a slow progression.”

That makes the early symptoms hard to spot. Each year in the United States, fewer than 200 infants develop this type of botulism, and as long as they are diagnosed in time — the condition can be fatal if it paralyzes their lungs — the cases all eventually come to the California Department of Public Health, which has an Infant Botulism Treatment and Prevention Program.

The program is the legacy of Dr. Stephen Arnon, chief of the Infant Botulism Treatment and Prevention Program at the California health department, who dedicated his life to finding a treatment for infantile botulism.

That treatment is called BabyBIG, for botulism immune globulin. It’s made from the plasma – the clear part of the blood – of donors who’ve been vaccinated against botulism. It’s the only treatment available in the world for the condition.

It’s also an orphan drug, meaning it’s not profitable for pharmaceutical companies to make. The process is expensive and there’s not a large market for it. So the California Department of Public Health makes it.

It’s still very expensive, costing nearly $70,000 per treatment. But it’s so effective that it cuts the time a baby may have to spend in the hospital by an average of three and a half weeks, meaning it easily saves more money than it costs.

The California health department says it has treated nearly 2,200 infants with BabyBIG since it was approved by the FDA in 2003. From August 1 through November 19, it said 107 infants nationwide have received BabyBIG treatment.

The doctors gave Rose a dose of BabyBIG partly on faith: They didn’t have confirmation that she had botulism when they treated her. But soon after she got it, her condition began to improve. Stool testing finally confirmed botulism just a few weeks ago.

‘I feel like it was a nightmare’

The California infant botulism program does a thorough case investigation for each patient. They ask about exposure to dust or honey, which can be another source of the spores. They also ask about what formula the child uses.

“Often, we just don’t find a source,” Pan said.

Starting in August, Pan said, the agency began to get more calls than usual to the infant botulism hotline. In taking the case histories, they learned that about half the babies were formula-fed, and about half of those had consumed ByHeart. That was a red flag since ByHeart accounts for only about 1% of all formula sales nationwide.

“It’s a much, much higher proportion than you would expect, and that’s what raised the alert,” she added.

The state contacted the US Centers for Disease Control and Prevention to its findings and issued a nationwide alert November 8, when just two specific lots of the formula were recalled.

The Dexters had no idea that the formula they were feeding their daughter might have been the source of her illness. They continued to give it to her even after she got home from the hospital.

Then they got a call asking whether they’d fed Rose from either of two specific lots of the ByHeart formula. Stephen, who repairs pianos for a living, had kept all the cans to store the parts he uses. “None of my numbers match the recalled numbers,” he said, but they stopped giving the formula to Rose. Additional products were recalled on November 11.

After weeks of panic and worry about their daughter, they were relieved she was back home and getting better. But the recall has stirred all those emotions up again.

“I feel like it was a nightmare, all the things that happened for us,” said Yurany, who still regrets that she wasn’t able to breastfeed.

“You just keep getting more and more angry, just kind of reflecting and going, how did this happen?” Stephen said.

Rose is recovering. She continues to see a gastroenterologist every few months to make sure her gut is healing.

For now, investigators are racing to find the exact cause of the infections before more babies get sick.

“I hope we can find the source of the outbreak to prevent future infant botulism outbreaks,” Schill said. “It is heartbreaking that such a vulnerable population can be subjected to a horrible disease.”

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