SHE pod episode 8 Narcyz Ghinea_mixdown.mp3
SHE pod episode 8 Narcyz Ghinea_mixdown.mp3: Audio automatically transcribed by Sonix
SHE pod episode 8 Narcyz Ghinea_mixdown.mp3: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Kathryn MacKay:
Hello, everyone, and welcome to the SHE Research podcast. I'm your host, Kate MacKay.
Kathryn MacKay:
And I'm joined today by Narcyz Ghinea, who is here to talk to us about his paper, 'Australian Regulation of Autologous Human Cell and Tissue Products: Implications for Commercial Stem Cell Clinics', which is forthcoming in the Journal of Regenerative Medicine, I think? It's out! Excellent. Great. So, Narcyz, this is a co-authored paper?
Narcyz Ghinea:
Yes, it is.
Narcyz Ghinea:
So it's co-authored with Professor Cameron Stewart, who works at the Sydney School of Law here, and also Professor Megan Munsie, who's based in Melbourne University and works with Stem Cells Australia. And also there's Christopher Rudge, who's a legal scholar.
Narcyz Ghinea:
So, they... Basically their job was to keep me honest. I was the person who was mainly responsible for putting this paper together. But they, with their expertise, advised me and made sure that I had covered all the bases and had done the right thing...
Kathryn MacKay:
Ah great, cool.
Narcyz Ghinea:
...Because I don't have any legal training, so I needed that support.
Kathryn MacKay:
Interesting.
Kathryn MacKay:
So is this a legal paper, would you say?
Narcyz Ghinea:
From one perspective it is, it is a legal analysis of sorts.
Narcyz Ghinea:
But what I find interesting about it is, to me, I don't separate the legal from bioethical issues. I think they're so interrelated that every legal analysis, legislation, always have bioethical implications. And I think this paper does try to draw some of that out, perhaps not as much as I would have liked because of the focus of the paper. But perhaps we can discuss some of those bioethical implications during the podcast.
Kathryn MacKay:
Yeah. I guess to start us off then, in a nutshell, what is the paper about?
Narcyz Ghinea:
So basically this paper is about the regulation of stem cell therapies and in particular autologous stem cell therapies. Autologous means that they are stem cells, which have been derived from the person's own body.
Kathryn MacKay:
OK.
Narcyz Ghinea:
So let's say your doctor has extracted fat tissues from you, and has processed it in some way and then re-introduced it into your body. Those are autologous stem cells. So this paper is about those types of stem cells. And the concern was that prior to 2018, the Therapeutic Goods Administration and actually regulators all around the world took a very light approach to regulating these products. Basically, they didn't consider them therapeutic goods. Which meant that for all intents and purposes, doctors were pretty much free to use these products as they saw fit. And there were concerns raised around that, that, you know, all these stem cell clinics were popping up all over the place, providing these unproven therapies to the general public and also misleadingly advertising these these therapies. And so there was an outcry and, and actually the project, so this project was part of an Australian Research Council grant had a big influence in leading to these regulatory reforms.
Narcyz Ghinea:
And the idea was we need to take a stricter approach to regulating these products to protect the Australian public from unproven therapies, known evidence based medicine.
Kathryn MacKay:
Interesting. So the idea here is that there are legal ways to use autologous stem cells under the current regulations that are actually not well-backed up by research, or possibly very risky?
Narcyz Ghinea:
Well, that was the case previously. When it comes to regulating. I'll give you the example of off label drug prescribing, which was my previous research. What I have an interest in in off label drug prescribing is when doctors use an approved product in a non-approved way. So the product itself comes on the therapeutic goods regulation. When a doctor chooses to use that product in an unapproved way, that's part of their clinical judgment. That's regulated under a different system. So from one perspective, you could say they're experimenting, they're using an unapproved product outside of a clinical trial. From other perspective, you could say no, they're just applying their clinical judgment. So, in effect, what had happened previously was this practice was left in the realm of clinical judgment. The Therapeutic Goods Administration had nothing to do with it. So now basically what happened in twenty eighteen, the Therapeutic Goods Administration stepped up and said, no, we're now regulating these products.
Narcyz Ghinea:
And they took quite a strict approach actually, effectively, in what we discussed in this paper, made a lot of the services provided by stem cell clinics are no longer legal for them to provide, at least without further licensing.
Kathryn MacKay:
So what were the motivations for writing the paper? Motivated out of the kind of legal interest or out of the harm interest or maybe a bit of both?
Narcyz Ghinea:
Both. So it was first, the issues I had previously mentioned about the fact that these products were poorly regulated or perceived to be poorly regulated, leading to exploitation of the public. And then also the introduction of these new regulatory reforms, so part of the purpose of this paper was to say, well, what are the implications of these regulatory reforms? How might stem cell clinics react to these reforms? Are there further loopholes they might take advantage of, for instance, which we believe may be the case?
Kathryn MacKay:
Interesting. Yeah. So I am curious to know if there were any kind of challenges or barriers that you faced when you were writing the paper. I wonder, maybe more generally, if this is a challenging area to work in or to research on.
Narcyz Ghinea:
Not really, because this was not an empirical paper in the sense of actually going out and speaking to people and interviewing people. I assumed that would be an issue if that were the case. This was mainly a review of regulation which required me to basically understand the regulatory system, how it works, the different layers of regulation. So you have national regulation, you have state regulation and then the difference between legislation and regulation and the determinations and orders.
Narcyz Ghinea:
So I learned a lot about the hierarchy of laws and the hierarchy of...
Kathryn MacKay:
That sounds complicated.
Narcyz Ghinea:
It was complicated. And that's why I'm fortunate to have the support of Prof Cameron Stewart and Dr. Christopher Rudge, who are trained lawyers and they could help me out and make sure that I wasn't doing anything wrong.
Kathryn MacKay:
Yeah. Yeah. So what's the main kind of bottom line of this paper?
Narcyz Ghinea:
The main bottom line, I think, is effectively what the Australian regulatory reforms around autologous human stem cells have done is made stem cell clinics obsolete. I mean, they just can't. Well, they just can't do what they were doing. I mean, they the description which the regulation uses is there are three categories which the regulators have established; in the first category are excluded products. The second category is exempted products. And the third category are fully regulated products. So if stem cells are going to be used within a hospital, then they're considered excluded. The TGA wants nothing to do with that. They assume that within the hospital setting, there's enough governance structures in place to ensure the safety and potential that patients are being exploited, that they're being treated appropriately.
Kathryn MacKay:
Can I ask a question just on that? So that means that things that are excluded here, that simply means that they're covered by some other piece of legislation.
Narcyz Ghinea:
Yes. Some other governance structure. Exactly.
Kathryn MacKay:
So something we'll be making sure that they're safe and effective.
Narcyz Ghinea:
Exactly.
Kathryn MacKay:
OK.
Narcyz Ghinea:
Now, stem cell clinics, which operates as private businesses, effectively, they can continue to use exempted products. Now exempted products are those which the TGA calls minimally manipulated and for homologous use. So basically by minimal manipulation. It's talking about the manufacturing process. So these cells cannot be manufactured in a way which may change their nature. So you might actually change the properties of these cells, which could have unpredictable consequences to the patient and for homologous use means that the tissues and cells basically have to be used in the same way that the body naturally uses. So, for instance, if I extract fats from your body, and I inject it into your lips, I'll give you more plump lips - well that's a function that that actually plays in a human body. That's homologous use. But if I take fat cells and inject it into your joints. Now I'm using fat cells for a purpose they are not actually used for in the body. So that would be a non homologous use. So basically, if you look at the details of how these things are defined, what stem cell clinics have been offering up until these regulatory reforms came into play would not qualify as an exempt product, which would mean if they want to continue providing those services, they either have to partner with a hospital, become a hospital, or they would have to get their products fully regulated and go through the normal process, as you would for any other medicine, go to the TGA, make an application, get the product registered. So, in effect, yes, it was actually really interesting and quite, in my view, I think they took quite a strict approach towards stem cell clinics. Enforcement is a different issue.
Kathryn MacKay:
And this paper is an analysis paper, really, of the regulations and stuff. But as an ethicist, I really feel compelled to ask you if you think that this is better. Like, if you think that the fact that the stem cell clinics aren't able to operate the way they did before, does that represent an improvement?
Narcyz Ghinea:
I think so, yeah. And I haven't thought about it deeply enough to give a definite opinion, but I definitely think so. I mean, there was, there appeared to clearly be a profit motive behind a lot of these stem cell clinics. Basically, if we can provide these services and people are willing to take them and as long as we're, they seem to be relatively safe, as long as we're not harming anybody - and they're expensive, these treatments are not cheap. You know, they can be considered exploitative. And then also they are harmed. I mean, even when it comes to products that could be deemed relatively safe to undergo, stem cell therapy requires, you know, liposuction for instance, and there can be complications associated with that. And actually, one of the, I think it was twenty eighteen, twenty seventeen, there was a death from complications of liposuction. So there are always risks when it comes to these things. So are the risks warranted, given that these products are unproven and the evidence base is quite poor? Probably not. So I think what this regulation has done, well, it's either forced clinics to go and get the evidence and get the product registered or make sure that these products are being used within a setting where the motivations and interests are not commercial or less commercial. Let's say in a hospital setting.
Kathryn MacKay:
I guess it's time for us to wrap up already.
Narcyz Ghinea:
Really?
Kathryn MacKay:
Yeah. But I wonder if there's anything that you want to leave the listeners with - any kind of takeaway message or maybe where you're going with this research.
Narcyz Ghinea:
So my main interest here really is the fact that the regulatory systems that we have in place, in my view, are quite outdated. You know, they were developed in the 1960s, mainly in response to the thalidomide tragedy. And medical technology has progressed, you know... Medicines aren't just these things you push out of a blister pack anymore and swallow with a glass of water, or a product you pull off the shelf and implant in somebody, you know. I think what's really interesting about autologous stem cell therapies is it's not just the product. It's also a procedure. It's also a manufacturing process. And all of these things are lumped into one. You know, it's not like the product is being manufactured in a factory. And I'm getting this packet at the end of the process and I just have to take the medicine. No, there's a procedure involved to extract the cells, have the manufactur it in-house.
Kathryn MacKay:
Yeah.
Narcyz Ghinea:
And then I have to reinjected and reintroduce it into your body. Where does that fall into, you know, in terms of classifying things as products or devices or. Or medical practice. So to me, it made sense. I mean, I understand why the TGA didn't want to get involved in regulating these products initially. But I think what this highlights is the fact that regulators need to adapt in the 21st century to all of these new medical technologies that are entering the market, and which hybrid technologies, codependent technologies, these types of human cell and tissue products. We need to rethink what regulation in the 21st century looks like. So that's what I'm really interested in, and that's where my research is heading - in that direction.
Kathryn MacKay:
Cool. Well, thanks so much for joining me on the podcast. That was really interesting.
Narcyz Ghinea:
Thank you.
Kathryn MacKay:
And anybody who's interested in reading the paper can take a look at the link at the bottom of this episode's notes. Thanks so much for joining me on the SHE podcast. If you're interested in hearing more, you can find us on Spotify or Anchor, or wherever else you get your podcasts of quality. Thanks for listening. Bye.
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