Attorney Richard Jaffe, who has been an advocate for clinics to have the right to sell and patient to buy unproven therapies such as the stem cells sold by clinics and unproven cancer therapies, just did a kind of shocking u-turn on a specific point.
Jaffe and I have very different philosophical views of the unproven stem cell clinic arena with him favoring less and me favoring much more FDA oversight. He may be most well known overall for having been the attorney for Stanislaw Burzynski.
What stopped me in my tracks a few days ago was a new blog post from Jaffe. In it, he lays out his opinion against a specific clinic firm, US Stem (Note that I found a past post discussed here by Jaffe on the recent FDA suits against US Stem & CSN to be useful). Not only that, but he also details specific, very strong steps the FDA could potentially use against the clinic.
This is a truly big deal.
It would almost be akin to me blogging right here on The Niche the turn-by-turn directions to a specific unproven stem cell clinic that I recommend patients go to right now. Well, maybe that’d be more of a shocker and would of course be negative rather than positive, but still, I think you get the point.
His post begins (emphasis his):
“I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action.
But I don’t.”
He goes on to write, “I am an advocate for a patient’s right to use his/her own stem cells, but that doesn’t mean that a clinic which continues to cause serious harm to patients has the right to keep injuring them.”
This passage also really stood out:
“In my opinion, US Stem Cells has done serious and irreparable harm to patients, and it needs to be stopped now, not in next few years, which seems like the FDA’s current time table. I don’t often agree with the big dog (aka Paul Knoepfler) but on this issue, I do.”
Next was a stunning section with this title, “How the Florida clinic can be stopped sooner rather than later.” Here Jaffe outlines things that could be done and things that could happen, including some he himself characterizes as “harsh”. You can go to his post to see what I mean in detail.
Jaffe also argues that the patient lawsuits will not be enough:
“One of the stem cell luminary thought leaders, Bernie Siegel mentioned to me his hope that the latest big malpractice case against US Stem Cells might shut the place down. I told him I didn’t think so.”
The bottom line?
My impression is that Jaffe still sees many other stem cell clinics’ practices as acceptable so no change there. Also, I expect he and I will continue to disagree mostly. However, someone with his philosophy taking this big step against a high-profile clinic firm was a gutsy move and could have some positive impact.
It seems to me that he doesn’t have an issue with the ‘theory’ but rather the injuries which are coming out of the clinic. I am not completely familiar with the issue at depth, but the statement above is relating the injury caused by the clinic, not the question of a patient’s right to have access to treatment.
I see this all the time in medicine. Physicians will have the ‘right’ to perform surgery, however, ‘their specific ability and choice’ of surgery is the problem. The surgery (spine fusion) including hardware has FDA approval, but the surgeon’s implementation and process become the problem.
I think Jaffe is simply saying that ‘not everything which is a Right… is right or well implemented’.