The Federal Trade Commission in the United States, has filed its first punitive action against two cell therapy companies. The Regenerative Medical Group and the Telehealth Medical Group offer therapy with stem cells derived from amniotic fluid for autism, cerebral palsy, various heart diseases and other serious diseases, despite no medical evidence that these kinds of cells are useful for treating these diseases.
The UNITED STATES DISTRICT COURT of California affirmed that the aforementioned companies “participated in deceptive and unfair acts or practices in the advertising, marketing, and sale of stem cell therapy to treat, cure, and mitigate various diseases and health conditions.” These companies also work with many insurance companies providers (see entire stipulated order of judgement HERE).
Our bioethical assesement
Why is it not the FDA that intervenes in these cases of clear medical fraud, and the commission that regulates the commercial legality? Since stem cells are not, strictly speaking, a “medicine”, companies – or their attorneys – argue that they can market their treatments without FDA authorization. While this argument may be solid from a legal point of view, it undoubtedly contravenes the most basic ethical norms.
It is also good news that the Federal Trade Commission has been able to detect these frauds, although in our opinion, this could be only the tip of the iceberg.