Jeffrey N. Weiss, an American ophthalmologist, has been performing procedures that have not been approved by the Food and Drug Administration (FDA) for some time now. In fact, all he had to do was register his human trials with the US National Institutes of Health (which usually requires approval from the FDA).
He was able to bypass the approval process because the procedure he was performing on patients had nothing to do with drugs. When a new drug is introduced claiming potential benefits to patients, it must face a rigorous approval process, although the many harmful drugs which still make their way onto the market would seem to belie this fact.
Weiss has been extracting stem cells from the bone marrow of blind patients and injecting them into their retina and optic nerve. As a result, some of his previously blind patients have been regaining their eyesight. One of those patients is Vanna Belton from Baltimore, who recently underwent the procedure. The Baltimore Sun explains why Weiss’ actions have proved to be so controversial:
Weiss is not following the usual steps of clinical studies. Among other things, he didn’t test his treatment theories first on lab animals or using computer models, or randomize his trials by using either stem cells or placebos in study participants. He didn’t test the procedure for safety on a small group before moving to a larger trial.
He was able to avoid these steps because stem cells aren’t classified as a drug, which means that pharmaceutical companies can’t profit from the procedure. In order to use stem cells, they must be extracted from a patient’s body, undergoing very little processing. They are then always used on the same patient from whom they were extracted.
Weiss reports that 60 percent of 278 of his patients, who are blind as a result of of diseases like glaucoma and macular degeneration, have regained some of their sight following the procedure. He has even published a case study on his work in the journal Neural Regeneration Research.
The procedure takes approximately 5 hours. In the specific case mentioned in the study, stem cells were extracted from the bone marrow in the patient’s hip and then injected into various areas in each eye; as a result she gradually regained some of her sight
The only problem with this procedure is the fact that Weiss cannot explain how it actually works. But, as he explains, that shouldn’t be the only consideration:
We didn’t know how penicillin worked for many years, but it saved many lives in the meantime. It is hubris to think that something can’t work until you understand how it does. . . . It is more important what the patient sees, not what I see. (source)
Currently, there are several clinical studies in the US that are also investigating the potential of stem cell treatments.
We also recently published an article about a new bionic eye lens that’s currently in development which would give humans 3x/20/20 vision at any age.
A new bionic eye lens currently in development would give humans 3x 20/20 vision, at any age. The lens, named the Ocumetics Bionic Lens, was developed by Dr. Garth Webb, an optometrist in British Columbia who was looking for a way to optimize eyesight regardless of a person’s health or age. You can read more about that here.
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