Posted in Capers, Disease Prevention, FDA, Government Regulations, Patient Safety, Policy Issues, Protocols, Uncategorized

Stem cell clinics co-opt clinicaltrials.gov to push unproven therapies – STAT

When a judge ruled last week that the FDA could stop the work of U.S. Stem Cell, the firm’s trials remained on clinicaltrials.gov; the postings were no longer actively enlisting patients, but they didn’t mention that the company’s injections had blinded at least four people, either.

Nor did a listing of a completed study sponsored by Cell Surgical Network include any indication that the FDA is seeking an injunction against that company, too.

Nor did the five entriesfrom StemGenex say anywhere that regulators had found the clinic’s marketing to be illegal in 2018.

What worries bioethicists and biologists is not just the crossing of governmental wires. It’s also these companies’ co-opting of a taxpayer-funded database to market therapies without proof of safety or regulatory review. To let such dubious vendors post on a federal website, the critics say, is to lend them an air of legitimacy they don’t deserve.

https://www.statnews.com/2019/06/11/stem-cell-clinics-clinical-trials-dot-gov/

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A primary care physician by training, my passion is researching and writing about the importance restoring patient centered care, supporting independent private physicians, promoting free-market solutions and seeking sustainable fiscal policy in healthcare.

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