Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by […]
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »
State involvement in reining in predatory stem cell clinics has never been more important, which is why it’s such good news that the Medical Board of California has a task force in the works to investigate such firms. According to a new NBC7 report (linked to above) focusing both on this news and on their own investigation
Medical Board of California Task Force to Investigate Stem Cell Clinics Read More »
We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the
Several new investigations expose ‘snake oil’ stem cell clinics Read More »
Take our poll: what will be the fates of the stem cell clinic firms sued by the FDA one year from now in October 2019? To be clear, I am asking for your predictions, not what you hope will be the situation a year from now. U.S. Stem Cell, Inc. (USRM) and California Stem Cell
Polls on futures of stem cell clinics sued by FDA Read More »
I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin
Law firm blasts stem cell clinics in new ‘3 shocking facts’ video Read More »
I didn’t know until recently that the FDA has a blacklist, which is called the “FDA Debarment List”. You can check it out here. Should one or more particularly egregious unproven stem cell clinic operators should be on the list given their risk-taking with patients in the name of profit? There aren’t any on there
A real FDA blacklist: what is it, who’s on it, & should some stem cell clinics be? Read More »
The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally
10 questions on FDA suits targeting stem cell clinics Read More »
Even as some unproven, for-profit stem cell clinics promote themselves aggressively in many ways including now on TV, on the flip side lately we’ve seen more TV journalists covering questionable marketing by the clinics and negative patient outcomes. Today I saw that CBS This Morning, a national broadcast, had a fairly long TV segment on stem
TV Journalists Tackling Stem Cell Clinics Read More »
California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has
Update on state laws on stem cell clinics: California, Washington, & Florida Read More »