The REGROW Act has attracted both support and criticism, including on this blog, for the changes it would mandate in the way the FDA regulates stem cell products.
More specifically it would greatly reduce regulation of experimental stem cell products. I believe that would be dangerous to patients and to the stem cell field more generally.
REGROW Act excludes pluripotent stem cells
One additional important issue about REGROW that oddly hasn’t been talked about very much is that it would only apply to adult stem cells. So if the fans of REGROW had their way, the U.S. would end up with a regulatory system that gives adult stem cells a relative free pass.
Agree w/ @Pontifex– life-saving regenerative therapies should be available for people living w/ disease. #REGROWAct https://t.co/TWYOxmZ2JM
— Mark Kirk (@SenatorKirk) May 2, 2016
Why was REGROW written like this?
I wonder if in part (see yesterday’s tweet above from Senator Mark Kirk, the prime driver of REGROW that cites both the Act and the Pope) it is based on religious beliefs? I tweeted back to Senator Kirk asking why the bill doesn’t include embryonic stem cells and IPSC. We’ll see if he responds.
More practically speaking, probably REGROW’s creators felt it would have a better chance of passing and garnering support from fellow Republicans (and yes, I know it has some Democratic support too) if it was only on adult stem cells. But I believe that some of those pushing REGROW likely themselves are opposed to embryonic stem cell research.
Some will certainly argue that pluripotent stem cell therapies are going to be riskier so that is why they were excluded, but I’m not convinced that makes solid sense if we are talking about stem cell products already having INDs and successfully passed through Phase I/II.
Interestingly, in Japan the regulatory changes so often cited by REGROW as a model to follow and also by the Bipartisan Policy Center report backers as such a great thing, do include embryonic stem cells and IPS cells in the new regulatory framework. Some cherry picking then with REGROW?
Why are you people so obsessed with using murdered children to further your research? Embryonic stem cell research, even before the Federal Government stopped funding it, was going nowhere. Adult stem cells have proven far more viable. And, regardless, if you’re the type of person who is ok with murdering another human being to try to find a cure for diseases, then I don’t want you or anyone like you anywhere near me… what kind of decision will you make if you’re allowed to decide whether someone slaughters me or not? After all, it’s “for the good of ________”, right?
I believe it is because the companies with adult stem cell technologies are able to produce products for the market in the very near future. hiPSC treatments are further behind although I believe they will be more valuable. When investors can invest in hiPSC tech they will have to change the regulations again to avoid losing money to other countries. My fear is that if the adult stem cell tech companies fail because clinical testing is carried out too early or the potential of adult stem cell therapies is exaggerated it will affect future investment into hiPSC therapies.
Paul,
You’re correct. As you probably knew before you mentioned it, there isn’t much out there in terms of meta-studies of successful international treatments in peer-reviewed journals. Journals are usually on the research side, not on the clinical treatment side. But, given hoards of US investors are taking their money abroad because there is a plethora of market research to guide them, based upon outcomes/successes. It’s not good science, to be sure. I am comfortable with my position, though, as inductive as it seems. If markets from other countries were open to global outcomes research, I think it would be great though.
@Doug – “…patients are receiving effective treatments abroad, to the disadvantage of the U.S. economy”
Are you recapitulating the marketing from REGROW advocates or can you point me to actual peer-reviewed, independent assessments of the effectivity of treatments received abroad? If you have some data to back up your claims please do share.
I have asked many times for this source evidence, including direct letters to the offices of senators and agencies involved, so far with no success.
REGROW is a non-starter for me, because it specifically limits itself to adult stem cells. We need embryonic, we need SCNT. Patient advocates and scientists have fought too many years for research freedoms to let anything “for adult stem cells only” slip through. It has not been publicly challenged (although I believe ISSCR has posted against it–not sure) because it does not appear to have much chance. But if it does pick up steam, I believe there will be many who will fight it.
Thanks for the comment, Don.
Paul
Paul, have you any experience with the following company:
http://www.copdri.com/
They are using stem cells derived from fat, and I thought scientific studies consider such cells iffy.
And I’ve thoroughly enjoyed your conference posts…thank you!!
Paul,
I agree that iPSC’s and embryo-derived stem cells are not specifically mentioned by name; however, their pathway is described by classifying them as a more-than manipulated allogenic cell products. The requirements are more stringent because the innovation is newer than autologous adult stem cells, which have been clinically used internationally now for about 10 years.
It seems to me the REGROW Act is also designed for other than scientific research purposes. It’s designed to foster innovation and retain U.S. investment in domestic biotech. Both the practice and the patients are receiving effective treatments abroad, to the disadvantage of the U.S. economy, to be sure.
Thirdly, the REGROW Act is about access. Let’s not forget that those who are living (or surviving) from chronic or other serious diseases deserve access to therapies that are largely regarded as safe, world-wide, and which may ameliorate much suffering.
Stepping up our social and regulatory policies to accommodate safety, innovation, investment and receive suffering is not a race to be won, but a symphony to be played.
UC is amazing in its work, and will no doubt take a commanding lead in emerging therapies, but we shouldn’t anymore let better be the enemy of perfect.
Doug Oliver
I so agree!
I await the day when someone mixes a few chemicals with a skin cell or an adult stem cell and out pops an embryonic stem cell. Then, let the politico-religious gyrations begin!