CALL TO ACTION- Don't let SB 535 survive the committee vote
Human Experimental Treatment Centers Are Not Wanted in Montana
Although there are now a total of four amendments on SB 535, the bill is still quite troubling. Many people are under the impression that these human experiment centers will continue with ongoing clinical trials with the goal of eventual FDA approval for new experimental treatments. I have confirmed with Senator Bogner that this is not the case. There is no plan at this time to advance the approval process, only to continue to offer experimental treatments which have only passed phase I, meaning that it has been administered to 20-100 healthy, paid volunteers with the goal of determining what the maximum dose is without reaching unacceptable side effects. There is no goal of determining if the treatment is effective. That typically happens in Phase II, which as I said, will not be occurring in these centers. That also means that the centers will not be required to submit the data outcomes to the FDA. This was confirmed by Mr. Livingston, the CEO and Founder of Alliance for Longevity Institute (A4LI.org), who was the prominent proponent for the bill, along with others from the Longevity sector.
There are thousands of ongoing clinical trials in the US, but Mr. Livingston spoke repeatedly about experimental treatments in the "longevity sector," particularly during the Senate committee hearing. This is a newer research area and where many of us get squirmy. The use of human embryonic stem cells (hESC) and the act of modifying one's genes, such as what is done using CRISPR are common in longevity medicine, despite the assurances of Mr. Livingston in the hearing.
Two articles summarize our concerns:
This article from the Cleveland Clinic describes gene editing and CRISPR technology: https://health.clevelandclinic.org/crispr-gene-editing. "While gene-editing is already in use, CRISPR is still in the clinical trials phase," Dr Chan says. "It's used all the time in research laboratories and industries, and many clinical trials are testing CRISPR in the setting of genetic diseases and cancer." Dr Chan also explains in the article, "With any type of CRISPR therapy, there's a risk of getting off-target effects or unexpected side effects. Whenever you're altering something as fundamental as DNA, you just don't know what might happen. There's always a chance for the unexpected. You can potentially have effects on your DNA that were not intended."
Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update - https://www.cell.com/cell-stem-cell/fulltext/S1934-5909(24)00445-4. This article highlights the growing use of human embryonic stem cells (hESC) clinically, and are particularly helpful for conditions like age-related conditions such as macular degeneration and neurodegenerative diseases like Parkinson's. Despite potential improvement in certain conditions, ethical concerns surrounding the use and destruction of embryos continue to spark debate.
The inherent risks of using experimental treatments which have only passed phase I clinical trials are too great for these centers to be utilized in Montana. There is a reason that there are no other centers like this in the USA. These treatments need to be administered under the normal umbrellas of institutional review boards (IRB), ethic committees and FDA oversight, with the goal of enhancing human subject protection. We are all for medical freedom and "right to try," but we are also to respect God’s creation and the dignity of life as He created it. As with most progress, there is a slippery slope with this type of manipulation. Just looking at this headline, “Startup aims to make lab-grown human eggs, transforming options for creating families,” should get us right on the phone calling these committee members to vote this bill down.
Thank you for taking action to kill SB 535.