“Unscrupulous.” “Deceptive.” “Corrupt.” “Dishonest.” “Motivated by greed.”
Tough words from new FDA Commissioner Scott Gottlieb last week to describe stem cell clinics that have popped up around the country and, according to the agency, peddle unapproved, unproven, and even dangerous regenerative medicine products.
Although small in number, these outfits’ “dangerously dubious” products and “hollow claims” will make it harder for legitimate products to emerge, Gottlieb said in a statement announcing a crackdown on dodgy clinics. Bloomberg News’ Anna Edney covered the FDA’s announcement, and stem cell policy experts chimed in in my follow-up for Bloomberg BNA.
Gottlieb, sworn in May 11, said these clinics exploit the high hopes researchers have for stem cell therapies and regenerative medicine in order to prey upon patients often desperate for relief from serious conditions. Stem cells could be used to treat cancer, Parkinson’s disease, diabetes, and other diseases.
Observers told Bloomberg BNA the FDA’s clampdown is crucial.
“These clinics should have to prove that their therapies are safe and effective before they’re allowed to sell them to patients,” said Sean Morrison, chair of the International Society for Stem Cell Research’s policy committee and its former president. “In many cases, they are making claims that are not even plausible about what they’re able to cure. People don’t even really know what they’re injecting.”
Morrison said Americans used to travel outside the country seeking out untested stem cell therapies, but with lax enforcement, fishy clinics have proliferated in the U.S. as well. Some countries, such as China and Germany, have tightened up their controls, he said, and he’s glad to see the U.S. doing so as well.
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