What happens if we mix stem cells with populism?
From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to patients looking for hope and also to some companies looking for profits. Stem cell populism poses serious questions and risks too.
What exactly is “populism”? The Internet defines it these ways:
“support for the concerns of ordinary people.
the quality of appealing to or being aimed at ordinary people.”
In what we might call a stem cell populism worldview, stem cells should be available to the everyday folks across the U.S. and the world. It’s a simplistic notion today since for the most part, stem cell therapies haven’t yet been proven safe and effective other than in a few narrow cases such as bone marrow/hematopoietic transplants. Would wider availability of stem cells right now help people or potentially be more likely to hurt them (health-wise and economically)?
At this point, the former is much more likely and there would be concrete harms. To be clear, at some point with future proven stem cells therapies, I believe that such safe and effective treatments should be widely available and not at an exorbitant cost (insurance coverage of stem cells is and will continue to be an important area to discuss including related to cost as well), but that’s not the stem cell populism of 2018.
Some direct-to-consumer stem cell firms that market unproven and non-FDA approved stem cell “treatments” invoke a kind of stem cell populism to draw customers in the door. Certain clinics repeat catch phrases essentially as advertising like “you should be able to use your own cells however you want” and “you have a right to your cells.” In fact, as I’ve written in the past (see, “Our bodies, not our cells?”), our rights to our own biologic materials including our cells are much more limited than most people think.
Often times once a clinic or hospital has your cells, it is unclear who has ownership. More broadly, we don’t have a universal right to use biological products made from our bodies in any way we want. Such a right does not exist in any federal law that I know of nor in the Constitution, etc. So, no, there isn’t a clear inherent right to use (or even own) one’s stem cells that I know of, and that’s especially true if the stem cells have been turned into a drug product by processing or by use in a way unrelated to the intrinsic nature of the tissue from which the cells were isolated (non-homologous use).
Stem cell populism is also related to the Right-To-Try movement, which seeks much broader patient access to unproven drug products than is currently available in most cases, but some promoters of Right-To-Try comes off as being anti-FDA as well. For example, the current Right-To-Try legislation at the federal level has some provisions that would interfere with the FDA’s ability to oversee this arena. It’s also important to note that the FDA already has an expanded access (aka “compassionate use”) program that is streamlined and approves nearly 100% of applications with relatively much less paperwork and time required than in the past.
Notably, from a practical perspective for stem cells, I’m not aware of the various state level Right-To-Try laws having led to proven beneficial outcomes and they are almost never utilized. For some groups like the Goldwater Institute, it’s reasonable to ask the question the following: could Right-To-Try and perhaps also stem cell populism of a sort be more of a philosophical or ideological goal than anything else?
My hope is that in the next 10 years we’ll have a half dozen or so approved, proven new stem cell therapies. If that hopeful vision becomes a reality, again I also hope (and will work to make it a reality if what way I can via advocacy) that they are not so expensive as to fail to be widely available to patients in need. But I believe that the stem cell populism of today isn’t going to help people. Instead it is more likely to make profits for various firms or be used as a political device. In that sense now, it is often a bubble instead of a real thing that can help people.
Some might argue that one type of stem cell populism is already the reality today with ubiquitous stem cell clinics operating across the U.S. and the world without governmental approvals. Are they right?
Note: the idea of stem cell populism came up on Twitter last year, which is what sparked this post, but I can’t find the original twitter conversation.