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11/06/2017

Stem Cell Clinics & the FDA

When any business over-promises and under-delivers, it is well on its way to failure.   Does this principle also hold true in the world of stem-cells?  In the last few months the promise of stem cell treatment has met the reality of government oversight.

Does the government have the responsibility to rein in the larger-than-life claims of stem cell treatment clinics? In a letter dated August 24, 2017 to US Stem Cell of Sunrise, Florida, the FDA cited at least 14 failures relating to the facility’s compliance with federal regulations. It is a powerful letter that makes one wonder what is happening in some of these clinics throughout the country. US Stem Cell responded quickly, re-asserting their claim that they were simply treating consenting patients with their own cells and not subject to the same sorts of regulations that drug manufacturers are.

Is there a place for government oversight over stem cell clinics? At the very least, it could easily be argued that some of their claims are over-the-top and should be subject to false advertising laws.  Michael Joyce makes this point clearly.  He cites the concerns of stem cell researchers Paul Knoepfler and Jeanne Loring. Dr Loring puts it bluntly: “[Stem cell clinics] don’t want to talk to real scientists . . . Because 99 percent of them know they’re pulling the wool over people’s eyes. This is marketing, not science.”

Joyce makes an important point. There are real people with real physical problems who are turning to stem cell clinics as a last resort. If one buys a faulty product from the mall, one has the opportunity to return it for a refund. However, if one receives a faulty medical procedure, how can they be repaid for their loss? In these cases, shouldn’t stem cell clinics be held accountable for misleading the public?

The New York Times describes what happened to some unfortunate individuals who suffered at the hands of US Stem Cell: “The women had macular degeneration, an eye disease that causes vision loss, and they paid $5,000 each to receive stem-cell injections in 2015 . . . Staff members there used liposuction to suck fat out of the women’s bellies, and then extracted stem cells from the fat to inject into the women’s eyes.” They “suffered severe, permanent eye damage…”

Desperate people will try desperate things in order to receive desirable results. It is my opinion that the FDA is acting properly by providing at least a level of protection from those who would exploit the desperation of suffering people.

This entry was posted in Health Care, Stem Cells and tagged , , , . Posted by Neil Skjoldal. Bookmark the permalink.

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