In this interview, conducted during ISCT 2020 Virtual (28-29 May), Aaron Levine, Associate Professor in the School of Public Policy at Georgia Tech (GA, USA), discusses the challenges of reacting to COVID-19 and protecting patients from unproven therapies.
What was the reason for the change in focus for the ISCT Presidential Task Force, from clinics offering unproven therapies to tissue banking facilities?
We wanted to structure the session to raise some newer issues that are coming up in the world in cell therapy. The talk I presented at ISCT 2020 discusses a form of cell banking that we, as members of the ISCT President Task Force, are calling speculative cell banking. There are firms that will bank your T-cells, for example, or cells from your child’s baby teeth in case, hypothetically, you need them in the future.
The real concern here is that whilst banking in itself is not problematic, we’re seeing a wave, maybe a small wave, maybe a larger wave, of firms offering cell banking in a way which is not really supported by the evidence. There certainly are some parallels to cord blood banking, which is a more established industry. However, we are seeing firms that are making promises to patients about what they can do with your cells, or what may be possible down the road, that we don’t think are in line with reality. We certainly think this speculative cell banking raises ethical questions, at least in some cases, given the marketing, patient expectations, and large fees being charged.
Often, very emotive language is used for a normally dry and scientific procedure. What is the impact of this on potential patients?
This is a really key issue. Clinics might say, “this is your one-time opportunity to bank this life saving therapy” even if you might not need it for another 50 years. There’s certainly a risk that patients will be drawn in by this slick marketing campaign – there’s a lot of promise in this area but there are lots of challenges to make it a reality.
When we think about how these firms are marketing cell banking, it needs to be made much clearer that it’s an experimental process, and they need to have a regulatory path in place for how the tissue will actually be used. An example that is getting a lot of attention is T-cell banking for the eventual production of CAR-T therapy. CAR-T therapy can be life-changing, and some indications and therapies do have FDA approval. However, this doesn’t mean a product from a third-party organization can simply slot into that approved pathway. The steps that need to be taken to isolate the T-cells and modify them for use in a CAR-T therapy are clearly laid out in the FDA filing and you can’t easily just use banked cells instead.
We saw a lot of parallels between this language and the language used by the clinics providing unproven therapies and this raised concerns. This is an opportunity to nudge cell banking practitioners into practices which are better for patients in the long term.
You recently helped develop an ISCT statement on the banking industry. What prompted this statement?
The statement was inspired by the observation that the marketing of several different cell banking services was problematic, in the claims they were making, in their marketing materials, in the way they were contacting patients or how they were actually planning to use the banked material, either scientifically or due to regulatory considerations.
One of the guiding principles here is that the community as a whole is stronger than any one person or any one organization. The statement was developed by members of the ISCT Presidential Task Force and then we worked with ISCT leadership to reach out to a host of other organizations to endorse it. The hope is that by doing so, the statement carries a little more weight in the community and with regulators.
Our hope is that as awareness of the issue grows, the number of signatories to the statement grows and this becomes a consensus within the field.
As a task force and a society, how can you react to emerging issues such as COVID-19 as quickly as the so-called ‘bad actors’ seeking to capitalize on them for their own gain?
This is a big challenge. There is huge value in developing COVID-19 therapeutics right now and we have started to hear about this at ISCT 2020. I hope we’ll continue to hear more about how the cell therapy community has risen to this challenge.
There’s also been a rise in companies making problematic claims about the efficacy of supplement-based products and other interventions against COVID-19. These events are very predictable: there is a huge market demand and group of players willing to take advantage of that to make a profit. We’ve seen this in stem cell therapies for over a decade but COVID-19 certainly puts pressure on bodies such as the ISCT and even more on regulatory bodies such as FDA to act quickly.
I do think that FDA has been more nimble than they have been in the past. In the US, there have been a number of FDA warning letters to organizations claiming to treat COVID-19 without appropriate safety and efficacy data. It’s fortunate there has been an ongoing enforcement push to wrap up the three-year grace period for cell therapy clinics to become compliant with FDA by filing investigational new drug applications (INDs) for their products and, by at least one measure, there was more FDA compliance action in April than the previous year.
It sounds very promising that FDA has learned from their experience regulating cell therapies in the past.
I think that’s right. I think that the industry and regulators have struggled to address unproven therapies over the years but working hard and working quickly to address these inappropriate COVID-19 claims is paying off. A lot of misinformation is still out there though.
How do you think the move to more virtual events, and more online availability of information, might affect the scenarios here?
The nature of traditional scientific conferences is they’re fairly closed off and expensive to attend. Online, there’s a lot of potential for public and patient education; it depends, of course, on how accessible the materials are and the cost of accessing them. However, I do think you’ll be able to reach a wider audience online than could make it to Paris for a conference.
At ISCT 2020, you closed your session on unproven therapies by asking what the appropriate role of the ISCT in this conversation. What might the role of the ISCT be?
There are really two questions there. With unproven cell therapies, we have taken a position where we are trying to educate the public as well as working closely with regulators to highlight the importance of appropriate safety and efficacy data to help inform their decisions. This is something the ISCT has been working towards for a number of years.
In the banking area, there is a different opportunity. There are a relatively small number of firms out there that are in the early stages of building their business models. My concern is that we’ll end up with a network of cell banks which are making lots of money but not offering meaningful benefits to patients. My hope, however, is that the ISCT will be able to engage these firms positively to work out how the industry can be structured in a way that works for patients over the long-term.
The opinions expressed in this interview are those of the interviewees and do not necessarily reflect the views of RegMedNet or Future Science Group.