Could the blinding of three women at a stem cell clinic have been prevented by better oversight or was the clinic acting outside of the scope of oversight by its institutional review board (IRB)?
More broadly, when is an IRB conducting proper oversight and how do we know? When on the other hand is it not being careful enough or even outright enabling risky behavior by those selling non-FDA-approved, experimental stem cell “treatments”?
It can be hard to really be sure. What makes this area particularly muddled is that most of what IRBs do is confidential. We in the stem cell community are as a result left with a bunch of questions in general and about specific cases such as the blinding of these women.
When things go wrong and patients have bad outcomes how much is the responsibility of an IRB versus the stem cell clinics doing the actual experiments? Stem cell clinics often point to their IRB-approved status as some kind of merit badge, but how much does that approval mean? My goal in today’s post is to tackle that last question.
Over at BuzzFeed reporter Peter Aldhous has been following the story of the three women who were blinded by experimental offerings of US Stem Cell, Inc. In Aldhous’ new article he focuses more on US Stem Cell’s IRB. This IRB was run by an organization called the International Cellular Medicine Society (ICMS), which in theory was responsible for overseeing work of US Stem Cell.
There are a host of questions about what happened leading to the women losing their vision and what if any role the ICMS IRB had in overseeing the experiments on these patients. Did US Stem Cell wander outside the scope of ICMS IRB oversight in this case? Could the ICMS IRB have done a better job? If the ICMS IRB did its job well here, I still wonder how they can help to prevent more bad outcomes like this from happening? Presumably the ICMS IRB is overseeing work by many other stem cell clinics as well. How much risk is there at those places? If a business doesn’t follow its IRB’s rules, what happens then? It’s hard to find answers to questions like these.
More specifically in the recent blinding case there also seems to be uncertainty about why US Stem Cell injected the fat stem cells into both of each patient’s eyes and whether ICMS OK’d that or not. ICMS flat-out says “no”:
“The International Cellular Medicine Society (ICMS) Institutional Review Board (IRB) did not approve the bilateral treatment techniques or practitioners utilized by US Stem Cell / Bioheart that resulted in the three cases of blinding complications that was described in the New England Journal of Medicine, Brief Report, published March 16, 2017.”
I don’t know for sure, but I would tend to believe that the ICMS IRB did not approve the bilateral injections. The ICMS statement also makes some other reasonable points such as that the approved “trial” with US Stem Cell injection of stem cells into the patients’ eyes apparently never officially began and then was withdrawn. ICMS also points out that in other ways the stem cell experiments on the patients that actually took place were apparently outside the context of the approved trial and did not follow the approved guidelines. So in a sense it is possible that what US Stem Cell did with these patients was technically not the subject of oversight by the ICMS IRB.
Still I have some concerns about the ICMS IRB itself.
The mission of the ICMS IRB is unusual in some ways in my view. ICMS has a policy statement for physicians that seems focused on freeing up the doctors to experiment as near the end it says the following: “No other group has done more to protect a physician’s right to practice stem cell and regenerative medicine.” By contrast, if you read the FDA’s IRB page the focus of an IRB must be on protecting patients rather than protecting doctors’ freedom to conduct for-profit, experimental, non-FDA approved stem cell medicine.
Aldhous also points to more issues with the ICMS IRB such as it having a number of members who have their own stem cell clinic businesses selling non-FDA approved interventions. According to the BuzzFeed piece, some of the IRB members have in addition had concerning issues with regulatory bodies. Also notable is the fact that a few years back the ICMS IRB received a critical inspection report from the FDA.
Since the FDA more generally is tasked with overseeing IRBs themselves too and not just stem cell clinics, we can hope that the agency is overseeing stem cell clinic IRBs as well, but with no activity in this area for years I wonder what’s up with the FDA and stem cell-related IRBs. It’s one of those “who’s watching the watchers” situations.
Another vision “trial” of sorts called SCOTS has been controversial as well with no FDA approvals and some patients who participated in SCOTS have alleged that they were blinded by stem cell offerings there too. It’s not 100% clear who the SCOTS IRB provider is, but it might be ICMS as well as the SCOTS clinicaltrials.gov listing includes a trial identifier ICMS-2013-0019 that suggests as much. I’m going to try to get clarification on this.
If more broadly the ICMS IRB is now trying to move in a positive, more rigorous direction then it has a lot of work to do with potentially dubious stuff that it has approved in past years it seems and with for-profit entities still claiming ICMS IRB approval when what these folks may now be doing was actually not specifically approved by the ICMS IRB.
Stem cell clinics love to advertise their “IRB approval” as though it is some kind of regulatory good housekeeping seal of approval, but how much weight should be given to that? Today’s bottom line unfortunately is that IRB approval of experimental for-profit stem cell clinic offerings that lack FDA approval may in some cases mean very little on its own.
For you patients out there considering stem cell treatments don’t just accept “IRB approval” from a stem cell clinic as meaning everything will be OK and that the work has been subject to rigorous oversight already. Probe deeper with common sense questions including about which IRB is involved and that IRB’s track record, Google the IRB and see what you find, ask the clinic if the IRB approved exactly what they are now doing, and err on the side of caution overall.