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Lead poisoning can permanently damage the developing brain, causing behavior and attention problems. For 35 years, Children's has used a drug called D-penicillamine to bring children's lead levels down. But it's never been FDA-approved for children, and its noxious, rotten-egg smell and taste have limited its use. So Michael Shannon, MD, MPH, a Children's toxicologist, worked with Rhode Island-based Tedor Pharma Inc. to develop a grape-flavored version that kids would actually take.
You would think that drug companies would line up to conduct clinical trials and get FDA approval. Not so, says Shannon. Ironically, lead screening and abatement efforts have made lead poisoning an "orphan" disease. Just five years ago, one million U.S. children had lead poisoning; today the number is around 300,000—too low to attract drug-company investment.
So Shannon teamed up with Boston-based venture capitalist Roger Kitterman, who formed a virtual company, Bezoloven (Bulgarian for "lead-free"), and raised seed money from angel investors. This has enabled Shannon to obtain a grant from the FDA and launch a small clinical trial in children with moderate blood-lead elevations.
Shannon, who's helped care for some 5,000 children with lead poisoning, is delighted. "We've succeeded in many cases," he says, "but we're sure we can do better."
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