Here’s my core position: I support a patient’s access to his/her own stem cells (autologous use) for any use agreed to by the patient after proper informed consent which is not tainted by false or misleading advertising claims by the stem cell clinic. This post is about autologous use, not allogeneic, i.e., another person’s stem cells.
My philosophical/public policy/constitutional thinking is that people do/should have a right to determine what happens to their own bodies, so long as that right doesn’t endanger public health or safety, or impinge on another’s protected rights. I don’t see why someone else or some government agency should be able to stop me from using my body parts as I and a licensed physician see fit. If I want to waste my money or endanger myself with unproven and even potentially harmful treatments, I think I should be able to do so. People make foolish decisions which are actually harmful, like smoking and drinking to excess. It’s their right, self-destructive as it may be.
Further, my experience of being involved with stem cell clinics and keeping my ear to the ground in the field tells me that autologous stem cell transplants almost never causes serious problems, if the treatment is administered by a competent physicians.
I think the few highly publicized stem cell blindness cases at the Florida stem cell operation was an outlier based on some incredibly poor judgement on the part of the clinic operators. The other infamous clinic/defendant in the FDA’s injunction actions, the California stem cell treatment group was accused of using a deadly vaccine toxin which could cause harm. I don’t know much about that their use of toxins, but I know is was part of a protocol for stage 4 cancer patients. And what I haven’t heard or read about was any actual harm to patients receiving that treatment. In fact, third or fourth hand and I’ve heard that the results are good. If so, too bad they’re not making more of that. That’s what I’d be advising them to do, if that’s really the case. (And as some of you might recall, I’ve got some experience with this. See chapters 1, 2 and 4 of Galileo’s Lawyer. http://rickjaffeesq.com/galileos-lawyer/
My sense of the relative safety of these procedures was confirmed by a recent published report which did a google search of all reported stem cell adverse events. I wrote about that study. Here is the link:
Bottom line less that 40 reported serious adverse events, 11 or so deaths worldwide associated with stem cell treatment, one of which occurred in the U.S.
Of course, there could be and most likely have been serious adverse events not reported in the media, but still, the numbers of reported events seem to me incredible small based on the Knoepfler et al reported 700 plus stem cell clinics in the US alone.
(I am aware of the recent reporting of serious adverse events and harm caused by an allogeneic stem cell drug manufacturerer, but the regulation of allogeneic stem cell or other tissue based products do not implicate the same constitutional or public policy issues as do a person use of his/her own stem cells, or tissue. I don’t see why the FDA can’t or shouldn’t regulate these allogeneic products for non homologous, non approved use. And in fact it does, just not very effectively.)
All that being said,
recently I’ve been in contact with a couple of patients complaining they have been seriously harmed by a stem cell clinic.
I’m told that there are forty or more patients who experienced the same kind of injury resulting from stem cell treatments for Lyme disease. I’m not a doctor, but I have worked on a few Lyme cases for doctors, and it’s not obvious to this layman why stem cells alone would do any good for Lyme disease. And it’s possible that the harm is resulting may not be from negligent administration, but from the treatment itself causing MAST cell issues, exacerbating autoimmunity problems, and that would be a very bad thing for a Lyme patient.
The patients are starting to talk about a class action against the clinic (and hence the call to me). Supposedly, the FDA is looking into the clinic, and perhaps the state medical board. I think the FDA is too blunt of an instrument if there is demonstrable continuing actual harm. Rather, this should be initially and primarily a state board issue. I hear an investigation is underway, but if there are really several dozen patients who have been harmed, what the state board should do is start a summary suspension proceeding which stops the doctor administering the treatment immediately, pending a full board case.
The other disturbing aspect to this is that it could be that the physician isn’t even making the decisions in this case. The board needs to investigate that as well.
So even though I’m an advocate for private stem cell clinics which use autologous treatments, if you’re a Lyme patient contemplating any kind of stem cell treatment by a private stem cell clinic, here is my three-word advice: Don’t do it!
If you’ve taken the treatment and think you’ve been harmed, at least complain to your state board.
Rick Jaffe, Esq.