It’s been almost a month since the FDA’s two day hearing on the draft guidance documents on autologous stem cells. Here is the short version of what happened:
The stem cell research industry, meaning the basic scientists and academic physicians employed at big institutions, and their acronym organizations like the draft guidances. They agree with the FDA that non-homologous, (roughly meaning therapeutic as opposed to replacement) autologous (i.e. my) stem cells (or any kind of autologous tissue or “HCT/P’s”) should only be available in clinical trials until the FDA grants marketing approval for some use. (What happens after approval, in terms of off-label use, is anyone’s guess).
Those institutional players cited four cases of harm to patients. Three were at one clinic where a non-physician injected stem cells into the eyes of the patients which resulted in loss of vision. The other case was someone who took stem cell tourism to the extreme, continent-hopping and injecting every manner of autologous and allogenic stem cells for his degenerative condition.
Testifying on the other side were clinicians providing non-homologous, autologous stem cell treatments to patients. These clinicians have treated or spoke about the tens of thousands of patients who have received various forms of therapeutic HCT/P treatment under the soon-to-be extinct practice of medicine exception (21 CFR 1271.15).
And then there were the HCT/P patients, many with life threatening, incurable or life altering conditions. They all testified in support of Americans having access to their own HCT/P’s in the U.S. It was heart wrenching and uplifting to hear their stories. I couldn’t begin to do justice to their plight and the power of their words, so I won’t try.
But, if there’s one thing I’ve learned about dealing the FDA on access to treatment issues, it’s that the government doesn’t really care about actual patients or even future patients, due to its deep concern about PUBLIC HEALTH and THE SAFETY OF THE PUBLIC, which are sort of like Platonic ideals, and which have only the faintest connection to actual patients and reality.
Powerful as it was, I don’t think the testimony of these patients will change the FDA’s mind on the core issue of a person’s access to his/her own body parts.
There were over six thousand public comments submitted to the FDA after the hearing. However, that’s orders of magnitude too small to make an impact on the FDA.
So after pondering the hearings, I feel like what Roy Scheider felt and expressed when he finally saw JAWS up close: “We’re gonna need a bigger boat.”
Between the media, which has been harpooning all these unregulated stem cell clinics, and the stem cell research industry’s greenlighting the draft guidance documents, we’re gonna need a bigger boat.
The bigger boat has to be a vehicle to reach a lot more people, like many tens of millions. Social media itself can’t do it.
To me, the obvious solution is a documentary. I’ve recently seen Vaxxed. These guys are now on a bus tour all across America. The documentary and the tour is having an impact, and that’s in spite of the fact that Andy Wakefield is a very controversial fellow who has been excoriated in the media.
I was involved in a couple of the documentaries about Dr. Stanislaw Burzynski. He’s also a very controversial fellow and gets a great deal of negative press. Nonetheless, the director/producer made a deal with the cable companies which resulted in the Burzynski documentary being available to something like 40 million cable viewers. Now those are the kind of numbers I’m talking about!
I think the right kind of documentary focusing on the patients and not having a polarizing protagonist could avoid some of the special challenges facing the producers of the two aforementioned documentaries. If done right, it could spark the interest of tens of millions who themselves or their family members are dealing with serious unresolvable medical conditions.
I have to believe that in the stem cell patient community there are media insiders, power players, and even celebs who support access to these treatments and would be willing to help. I also have the feeling that the money to make it happen would show-up.
The stem cell clinical community needs a game changer.
You know what they say: “Go big or go home.”
Rick Jaffe, Esq.
More about the FDA stem cell hearings at: