Q&A: Bioethicist Leigh Turner on the worrisome boom in unregulated stem cell clinics
By Megan Molteni,
STAT
| 11. 08. 2021
In 2016, the Food and Drug Administration put the emerging stem cell cottage industry on notice. At the time, a few hundred clinics were peddling experimental stem cell therapies costing between $2,000 and $25,000 for conditions ranging from chronic pain to autism to multiple sclerosis without solid scientific evidence that they worked. Federal regulators asserted that the stem cells being sold — usually taken from a patient’s body and slightly processed before being re-injected — were drugs, and therefore required a rigorous approval process.
After contentious public hearings, the agency offered a sort of compromise. For three years, starting in November of 2017, regulators would exercise “enforcement discretion.” In other words, mostly look the other way. The idea was to give the stem cell clinic operators time to convince the agency their products were safe and effective before the crackdown came. The alternative would be to shut down or move abroad.
But according to a new analysis, the period of enforcement discretion led to a boom in the unauthorized stem cell business. “Embedded in that plan was...
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Bioethics needs an update
The National Research Act is now 50 years old. It was signed into law on July 12, 1974, as a direct response to publicity about the 1932 “Tuskegee Study of Untreated Syphilis in the Negro Male.” The Hastings Bioethics Forum celebrated its anniversary with an...
Image courtesy National Human Genome Research Institute
The U.S. Food and Drug Administration (FDA) is supposed to encourage effective medical advances while also ensuring that patients and research subjects are protected. This dual mandate demands tricky judgment calls that are made more difficult by outside pressures of several kinds, political, judicial, and especially commercial. This April story at Bloomberg examines one deeply troubling pattern of regulatory capture:
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