Loosening regulations on stem cell therapies could hurt and help patients

scientific american stemcells

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis.

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 FDA to grant conditional approval to stem cell treatments without data from the big Phase 3 trials usually required before a drug hits the market. The bill has drawn the support of some stem cell companies, patient groups, and researchers, but a number of industry groups, scientists, and patient advocates have come out strongly in opposition.

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.

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“There’s this misperception about why these trial requirements exist,” said Dr. Aaron Kesselheim, an expert on regulatory issues. “Clinicians need data to guide their decision-making, and patients want treatments that work.”

Read full, original post: Drive to get more patients experimental stem cell treatments stirs concerns

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