October 29, 2020

The Niche

Knoepfler lab stem cell blog

FDA warning letter

3 min read

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view. Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class …Read More

2 min read

We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on a personal level to need for medical innovation as a survivor of a very serious form of prostate cancer. I’m currently in long term remission 4+ years after surgery, …Read More

4 min read

What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what 23andMe has to offer in the way of personal genomics analysis. I thought of it as an experiment. I contacted them with my interest and background. We agreed to …Read More

2 min read

I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA. It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before? The JAMA ad sternly warned docs on the dangers of the use of foreign drugs. In fact it threatens potential criminal charges if providers enable patients to use foreign non-FDA approved …Read More