Three women in Florida were permanently blinded by an unregulated, experimental medical procedure that was listed on ClinicalTrials.gov; an official government website run by the National Institutes of Health (NIH).
The women, ages 72, 78, and 88, who were seeking treatment for macular degeneration, paid $5,000 each for the stem-cell procedure that caused them to become permanently blind.
Confirmation that the experimental procedure was the cause of the blindness in the Florida women was reported in the New England Journal of Medicine on March 16, 2017.
We evaluated three patients in whom severe bilateral visual loss developed after they received intravitreal injections of autologous adipose tissue–derived “stem cells” at one such clinic in the United States. In these three patients, the last documented visual acuity on the Snellen eye chart before the injection ranged from 20/30 to 20/200. The patients’ severe visual loss after the injection was associated with ocular hypertension, hemorrhagic retinopathy, vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment, or lens dislocation. After 1 year, the patients’ visual acuity ranged from 20/200 to no light perception.
Axios reports that the NIH has a disclaimer on ClinicalTrials.gov., that says, “Listing of a study on this site does not reflect endorsement by the National Institutes of Health.”
However, posting a disclaimer does not necessarily make it clear that an experimental medical procedure is not government approved. Furthermore, the fact that the women paid for the treatment raises questions about whether the facility is using an official government website to make money off of unsuspecting people who are desperate for cures to serious illnesses.
From the Washington Post,
Of special concern, said Jeffrey Goldberg, professor of ophthalmology at the Stanford University School of Medicine and one of the authors of the report, was the clinic’s ability to list its study on a comprehensive database of clinical trials called ClinicalTrials.gov, which is run by the National Institutes of Health. At least one of the patients — and maybe more — believed that she was taking part in a government-sanctioned study, he said.
Goldberg called the incident a “wake-up call across the spectrum” — for patients, physicians and government regulators. “Surely,” he said, “it’s an opportunity for the FDA to increase patient safety for these unapproved clinical trials.”
But in the Trump era, ‘regulation’ has become a dirty word, which means problems like this are more likely to get worse, rather than better.
As the Washington Post report further notes, “Many clinic operators oppose FDA regulation.”
The Trump administration’s anti-regulation attitude creates a more dangerous environment for all Americans. With the continuing ‘deconstructing’ of federal consumer protections, and public health and safety laws, exploiting the vulnerable appears to be among the more tragic caveats of making America ‘great’ again.
Image: Florida Gov. Rick Scott via Facebook screen grab
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