On both coasts, campaigns are building to get desperate patients faster access to stem cell treatments — in some cases, before they are proven to work. And that is making some scientists nervous.
In Washington, a US senator recently introduced a bill that would allow the Food and Drug Administration to grant conditional approval to stem cell treatments without data from the big Phase 3 trials usually required before a drug hits the market. In California, meanwhile, the state stem cell agency is enlisting patients to back an aggressive push to speed up the federal regulatory process for stem cell therapies.
Proponents say an accelerated regulatory process will help patients, but a chorus of critics warn that faster approvals could undermine the FDA’s authority to ensure that only rigorously tested therapies make it to market. They point to the hundreds of largely unregulated “stem cell clinics” hawking unproven treatments for everything from autism to heart failure and warn that hucksters will be emboldened if FDA regulations on the stem cell field are relaxed.
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