We hear a lot about the dangers of an increasing number of rogue stem cell clinics, but another critical trend has flown more under the radar: direct marketing of stem cells to doctors.
This is big business and arguably one of the biggest threats to patients. In some ways it is a black market right here in the U.S.
When I think of direct marketing, what pops in my heads are images of ads or little samples of products that show up in the mail.
For doctors generally, maybe direct marketing is of flyers or free pill samples, and so forth. However stem cell direct marketing to doctors can in fact involve actual living stem cells that hucksters are trying, sometimes successfully, to convince doctors to inject into patients.
Last week at the World Stem Cell Summit 2012, a doctor during a talk said a guy showed up at his office and literally said he had stem cells in his pocket, a sample if you will, to sell the doc on using them in the future on his patients.
It’s like the guy on the street corner in NYC who lifts up his sleeve, which is ringed with a dozen watches, or opens his trench coat and says with a grin “wanna buy a watch?” except in this case if even a few docs buy the “black market” stem cells, patients will be put at serious risk.
Wanna buy a stem cell? Have I got the one for you and cheap! You can make millions off of patients using these, doc!
In the same way that there is a black market for body parts (see book at right below ), I think a black market in stem cells is emerging as well.
What are these stem cells? According to experts, they can be almost anything. Sheep cells are popular. Human amnio or placental cells. Human umbilical cord stem cells. No cells at all (just buffer). Human adipose MSCs. Where do they come from? Who knows. Are these “vendors” licensed to sell stem cells? That is highly unlikely in most cases.
Another dangerous form of direct marketing in the stem cell field that is exploding right now for mainly autologous transplants is of kits for stem cell purification. This is really big business according to several stem cell docs that I’ve talked to recently. One stem cell doc in the business of doing transplants, complained to me about the problem of the kits because they enable essentially untrained docs to get into the stem cell business and put patients at great risk. It is unclear how well the kits work and if their use would, from an FDA perspective, cross that important line over to more than minimal manipulation depending on the ingredients and how the kits are used by often untrained clinic employees.
Besides enabling untrained doctors, one of the most dangerous aspects of the stem cell “black market” more generally is just how difficult it will be for any regulatory agency to control it.