T Nation

Maybe SOME Good News from the FDA


This will be a reality someday, maybe not in the U.S. but somewhere in the world.


Hi Zep,

I suppose it depends on what you mean by “now.” For example:

Cellular enhancer for expressing genes in undifferentiated stem cells
US4959313A, granted 25Sep1990;

Methods and compositions for the optimization of human hematopoietic progenitor cell cultures
US5399493A, granted 21Mar1995;

Methods and compositions for isolation and growth of kidney tubule stem cells, in vitro kidney tubulogenesis and ex vivo construction of renal tubules
US5429938A, granted 4Jul1995.

So, again, I’m curious as to where you are reading Big Pharma can’t patent their efforts within this aspect of medicine?

Pfizer’s Stem Cell Research Policy: For more than a decade, Pfizer has been using animal or adult stem cells in its laboratories to help screen new compounds and identify safer and more effective medicines.

Merck: Together with the scientific community, we believe that research using stem cells has the potential to help identify medicines, therapies and vaccines that will treat, cure or prevent diseases and alleviate the suffering of patients with significant unmet medical needs…We have been conducting research into the biology of stem cells for more than a decade.

Roche: At Roche we are utilizing the enormous potential of human stem cells to test potential new drugs in vitro…At Roche, we are also investing effort in developing tri-dimensional culture systems for stem-cell derived stem cells, which would allow access to tissue models that are closer to an operating organ.

GSK:We have been involved in cell and gene therapy since 2010, working with Fondazione Telethon and the Ospedale San Raffaele, acting through their joint San Raffaele Telethon Institute for Gene Therapy (SR-TIGET), a world-leading research centre for stem cell gene therapy in Italy. SR-TIGET has been a pioneer in bringing gene therapy from preclinical studies to research in patients.

Do you think it’s strange that they are throwing so much time, money, and personnel into an endeavor they feel can’t be monetized?


Did you know…?

Did you know that there are a shit ton of diseases or conditions that simply can not be “cured”?

Treatments to suppress symptoms improve quality of life, plain and simple.

You can’t just cure some things. Tell me- How do you “fix” or cure someones immune system?

Lay out a step by step for us that has been clinically proven to work for anything from general dust allergies to some of the more nefarious types of arthritis, just to name a few.


Well, this thread has gone exactly as expected…


Hi Zep,

[quote=“Zeppelin795, post:58, topic:224450”]
This is evidenced by the people who actually travel outside the U.S. to have this therapy administered.[/quote]

I’d actually like you to talk a little more about this, if you don’t mind.

For reference: Roche is based in Basel, Switzerland. Sanofi is based in Paris, France. Pfizer is U.S.-based, but do you know where Viagra and Maraviroc research efforts were spearheaded? AstraZeneca is based out of Cambridge, England. GSK is out of London, and while Merck & co. is American, they employ tens of thousands of employs in 120 countries worldwide.

These companies combine for an annual revenue of ~$234 billion dollars. Big Pharma broke 1 TRILLION in revenue in 2014.

With that much money and influence, why do they allow any country to permit stem cell treatments?

What are these countries people travel to for this therapy, and why are their regulatory authorities beyond Big Pharma’s grasp?


I think Zep is conflating our current scientific ignorance with greed. Big Pharma doesn’t have the cure for cancer locked up in a room somewhere.

I’m curious as to his thoughts on Zepatier, one of Big Pharma’s most recent “symptom relief” drugs to hit the market.


If it can be monetized then it will become a reality. In the meantime the public has to go overseas to receive this treatment.



If it is multiplied the FDA considers it a drug. Gee wonder who was behind that decision?


Helping repair immune systems is one of the things stem cells accomplish. If the drugs Big Pharma come up with don’t work as well as stem cell therapy, why isn’t stem cell treatment a standard od care?

Treatments to suppress symptoms improve quality of life, plain and simple.


So improving quality of life is not something experienced by many who elect to take the drugs being pushed by the medical community.


Big Pharma is not monolithic and doesn’t have the same influence in other countries as it does in their host country.

I think Peyton Manning went to Germany.

Plenty of Americans went to Panama to The Stem Cell Institute in Panama City.


The Stem Cell Institute(Panama City, Panama)has been having great success with RA and Osteoarthritis.


Hi Zep,

Thanks for the article. All due respect, I don’t think you’re entirely correct on how the FDA evaluates this technology. I’d recommend 21CFR1271.3 for a review of their definitions (e.g., minimal manipulation).

I don’t know who was behind that decision, but I did note that it was upheld by a US District Court.


Hi Zep,

Appreciate the additional posts. To be frank, I think we’re just talking past each other at this point.

My experience in the industry is with both sponsor and CRO, in monitoring and study management. If you’d like to discuss phase II/III execution, industry practices, or anything else not related to nonspecific industry/regulatory collusion, then I’m happy to continue. Otherwise, I’m going to cut our discussion loose after this post, since I don’t feel this specific topic is a productive use of my shitposting efforts.

Happy New Year.


You’ve been far more than fair and civil. In fact, very pleasant and informative posts. I am afraid it’s fallen on deaf ears, as so many things do with conspiracy theorists.

Zep often practices a form of psychological projection whereby he likes to accuse others of being “blinded by ideology”. It is an archetypal speck vs. log in the eye situation.


I’m not trying to be down on the U.S. medical system but the profit motive CAN create some perverse incentives. And I’m not the only one who thinks that From The Stem Cell of America their FAQ http://stemcellofamerica.com/documents/stem-cell-of-america-faqs.pdf I ought to be having a conversation with them in the next few days. Anything you would like me to ask them?


It is not a conspiracy theory. Just the way the system works. Profits before everything.


This is why (most) doctors take medical ethics so seriously. For (most of) us, it’s pt well-being before everything.


Yep. I’ve had some in depth conversations on this with a friend of mine. It really isn’t anything like what Zep describes.

This whole idea he has that it’s some kind of patients in->corpses out monetary extraction process is actually what I would consider insane, based on distilled ignorance and misinformation.


Hi Zep,

[quote=“Zeppelin795, post:75, topic:224450”]
I ought to be having a conversation with them in the next few days. Anything you would like me to ask them?[/quote]

Not particularly. I think you’re attentive enough to the field that you’ve got enough questions of your own, so I’d only encourage you to read the following article about the company’s founder:


and then watch the following report:

I’m sure that you already know that a search of Stem Cell of America site with the word “cure” only provides 4 results: one titled “A Possible ‘Cure’ for Aids,” and 3 testimonials, none of which involve the patient actually being cured.

The only question I would have for them is how they can sleep at night.


Hi Zep,

For real, though, I think it’s unfortunate that your experiences with the healthcare industry in our country have left you so jaded. Although Big Pharma is a business like any other, with good days and bad, I’ve found my colleagues to be some of the most kindhearted and conscientious folks around, all things considered. At the study level, we take the rights, safety, and well-being of trial participants extremely seriously.

If you are contacting those people for a consult, I hope you continue to do your due diligence before writing any checks or offering any veins. If not for the field of research, at least with regards to that specific company. I mean that sincerely.