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What Should Happen if a Stem Cell Clinic Harms Many Patients?

What Should Happen if a Stem Cell Clinic Harms Many Patients?

Here’s my core position: I support a patient’s access to his/her own stem cells 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.

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:
https://wp.me/p7pwQD-fd

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 Knoefpler et al reported 700 plus stem cell clinics in the US alone.

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, 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.
www.rickjaffe.com
rickjaffeesquire@gmail.com

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

vaccineimage
The elimination of the PBE (personal belief exemption) via SB 277 has put a lot of pressure on vaccine concerned California pediatricians to write medical exemptions for the children of vaccine concerned parents. The recently dismissed San Diego federal anti-SB 277 lawsuit showed that at least one school board is collecting information about the docs who write these medical exemptions and will forward the information to the medical board for prosecution.

Based on some non-binding legislative history, and some personal discussions with legislators, the vaccine concerned community was hoping that the medical board could not or would not assert jurisdiction over docs who write these exemptions. That seemed completely unrealistic to me based on my experience dealing with medical boards. These guys just don’t give up jurisdiction on their licensees’ conduct.

In case you had any doubts, the board has made it official in its recent executive summary. Here is its position which couldn’t be clearer:
“The passage of two legislative bills increased the Board’s authority to investigate allegations of misconduct. * * *
In addition, SB 277 (Pan and Allen, Chapter 35) effective January 1, 2016, deleted the personal belief exemption from the existing immunization requirements. The Board will investigate any complaints in which a physician may not be following the standard of care in these two new areas.”
(From page 6: http://www.mbc.ca.gov/Publications/Annual_Reports/annual_report_2015-2016.pdf)

So there you have it. It’s basically open season on docs who write full vaccine exemptions, because according the pediatrician groups and the CDC, there are almost no medically justifiable reasons to excuse a child from all childhood vaccinations.

So what can be done about it? In the very short term, nothing really. Many pediatricians will probably be wary of writing medical exemptions.

Still, here are a couple hints. If your child had some prior vaccinations and had a serious adverse event associated with (not necessarily provably caused by) a prior vaccine, you may be able to obtain an exemption from the right doc, which decision would be literature supported. Make sure you bring documentary proof of the prior adverse event(s). The doc will need it for his records. Prior auto immune problems in the child or family members? That might help as well. Again, bring documentation. Help your pediatrician make the case and help him document the exemption. That’s the best protection for you and your doc. Admittedly, right now there is no medical board authority indicating that this would justify or exculpate a doc who writes an exemption on this basis, but I hope to change that within the next six months, in connection with my work on the current medical board case I’m working on, so stay tuned.

Next, an obvious mid-term solution is to amend SB 277 by making medical exemption decisions unreviewable by the medical board. As stated, there is some legislative history indicating that SB 277 was not intended to have the medical board second-guess the decisions of docs who write these medical exemptions. Realistically, passing such an amendment is a long-shot, but it’s time, energy and money better spent that filing another frivolous SB 277 constitutional challenge. (By the way, whatever happened to the dismissed San Diego federal lawsuit which was supposed to be refiled October 1st?) My suggestion: start working your legislators to get some feedback on whether it’s a possibility. If it is, that’s where the community should put its efforts and money.

Finally, there’s a soon-to-be publicly announced group of vaccine concerned docs, which is open to the public. It’s called Physicians for Informed Consent.

Check out their Facebook page at https://www.facebook.com/search/top/?q=physicians%20for%20informed%20consent.

Here is their web site. www.physiciansforinformedconsent.org

These folks have done more good for the vaccine concerned community even before they’ve officially started than all the lawsuits combined, but I can’t talk about that now. Go to their Facebook page, sign up and support them. They have and will continue to make a difference.

Rick Jaffe, Esq.
Rickjaffeesquire@gmail.com