A picture of a patient’s eye one week after receiving stem cell injections from U.S. Stem Cell in 2015 shows widespread retinal hemorrhages. The patient’s doctor said the patient was in pain and later suffered significant loss of vision.
But the FDA’s slow response has permitted U.S. Stem Cell to continue operating four years after those first reports of blindness. Although the company stopped injecting its fat-derived treatments into eyes after the patients sued, it continues to sell the therapy to people with spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
FDA officials declined to discuss the lawsuit, or respond to critics who say the agency should have sought a temporary restraining order to shut down U.S. Stem Cell years ago. Former FDA officials said that such orders are extraordinarily difficult to obtain, and that the agency is wary that a loss in court could undermine its ability to regulate the industry.
In a long interview at her company’s main clinic in Weston, Fla., an hour north of Miami, Comella accused the FDA of overstepping its authority — which, she said, does not extend to any of her treatments. She said that adverse events are rare, and that doctors trained by U.S. Stem Cell have provided relief to more than 10,000 people, many of them suffering from intractable conditions.
In 2014, Comella formed the Academy of Regenerative Practices, an advocacy group that has set up a legal-defense fund for clinics under government scrutiny. The group has accused the FDA of squelching innovation and denying patients with incurable diseases access to potentially lifesaving treatments.
Last year in Tallahassee, Comella successfully lobbied state legislators to kill a measure that would have required stem cell clinics to register with the Florida Health Department, submit to annual inspections and have a physician on staff. In addition to treating patients, U.S. Stem Cell has long played a major role in the industry’s growth. The company has trained more than 700 doctors — for a fee of $7,500 in person or $2,500 online — and sells clinical equipment, Comella said, helping many American clinics get their start.
It's pointless resisting stem cell research. It's going to happen regardless if the US is involved in it or not. If the US isn't then it'll simply be left behind in that field.
Business Business Latest News, Business Business Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Source: NBCNews - 🏆 10. / 86 Read more »