Have you ever had a really bad day?
I’m not talking about a gloomy Monday or a stub your toe kind of day.
I mean more like all on the same day your dog died, you rear ended a cop, and you accidentally flushed your wife’s wedding ring down the toilet.
March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA.
Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is CEO of a stem cell company called IntelliCell Biosciences of NY, NY. It is a stem cell-related cosmetic clinic that some celebrities fancy. The FDA says in its letter that it has issues with IntelliCell, in fact at least 16 issues.
What’s going on here?
Intellicell is part of an exploding stem cell cosmetics industry (see my posts ‘From Boobs To Baldness‘ and ‘From Boobs to Baldness 2.0) growing even faster than stem cell sports medicine (discussed here), which itself is expanding rapidly.
You name the ailment, they’ll treat you with “stem cells”. What “stem cells” means is unclear most of the time, but usually refers to autologous transplants of adipose stem cells that are loosely called by clinics “MSCs” or mesenchymal stem cells.
Do these treatments work and are they safe? Some folks including celebrities say “yes”, while many other people including some mainstream stem cell scientists say “no”. In short, it is such a new field that we do not have all the answers yet.
Two specialties of doctors are in particular diving in head (or should I say ‘face lift’) first into this arena, plastic surgeons and dermatologists, such as Dr. Victor.
Dr. Victor has reportedly “de-aged” numerous celebrities including Fergie (not the singer, but the ex-Royal) to great fanfare.
The FDA letter (see image below left of just the first page) outlined at least 16 specific items of concern with IntelliCell that require action.
The list of FDA action items is long and contains many significant issues of concern ranging from “failure to ensure appropriate laboratory testing” to “failure to have written procedures” to prevent bacterial contamination to “failure to establish written record of major equipment cleaning”.
The list goes on and on.
The FDA ends its letter with the following warning to Victor:
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.
What’s the take home message from all this?
For you stem cell doctors at the various clinics out there reading this blog and I know you do, the FDA is serious, docs. You have to follow their rules and do what they say. Getting an FDA warning letter never looks good, but if you do not address the issues they raise in their letters then they are likely to make you even more unhappy with their subsequent actions.
For patients, caution is the key word. There are many stem cell clinics out there and how each one is doing in terms of following FDA regulations varies dramatically so you should exercise a high level of caution and consult your own personal physician. I highly recommend first talking with a primary care or family medicine doc.
Generally speaking, often times stem cell clinics, in terms of the real science or lack thereof supporting their procedures and products, look a lot worse than their pictures (websites) on the Internet.