Updated: Jul 24
Editor’s Note: Amanda Pratt’s first contribution to our Pharmaceutical Inequalities series offers this insightful interview with Vincent Wartenweiler PharmD, an independent community pharmacist and Master’s student in Psychoactive Pharmaceutical Investigation at UW-Madison. Amanda (AP) and Vincent (VW) sat down on March 24, 2022 to discuss a qualitative project Vincent published in 2021 to determine perceptions of pharmacy stakeholders around opioid use disorder vaccines. In addition to providing a glimpse into a significant milestone for the history of alcohol, drugs and pharmacy–the development of substance use disorder vaccines–this interview sheds light on potential methodologies for understanding vaccine hesitancy. The Pharmaceutical Inequalities series is funded by the Holtz Center and the Evjue Foundation.
(RIGHT: Vincent Wartenweiler PharmD)
AP: How would an opioid use disorder vaccine work?
VW: In the simplest terms the vaccine works by programming the body to recognize and bind up a drug that is consumed, so that it doesn’t reach the brain. It doesn’t have any pharmacological action so while a traditional vaccine that’s used for communicable disease programs your body to recognize a germ, a virus, or a piece of a virus, the anti-opioid vaccines work by retraining the body to recognize a small molecule and then form an antibody complex around that molecule, which increases the size of the molecule.
AP: A 2016 Points blog post describes how the cocaine vaccine dAd5GNE combines a cold virus with a cocaine shaped molecule — is that also the case for opioid use disorder vaccines, where you’re attaching it to a cold virus?
VW: Yes, so the way most vaccine based therapeutics for substance use disorders work is through that kind of complexing. So you have a big protein like a tetanus toxin–which is another common one that is used in this sphere of vaccine development–it’s something that has already been in vaccinology and immunology that we know can be used to formulate these vaccines. And then it’s a matter of tweaking the end of it to be specific to the drug of interest.
AP: What is the benefit of these immunological approaches more broadly, as compared to something like methadone or suboxone treatment?
VW: The benefit I think of immediately is the length of action of the therapy. So with methadone, people are taking it every day. They’re going to a clinic to have it administered every day, and in a lot of cases things come up, people get busy, they miss appointments, they don’t want to go, and there are other adherence barriers to those types of daily treatments, whereas a vaccine is much more long-acting. Think of even just the flu vaccine–something we get once a year and we’re good to go–so that’s one advantage for sure. Another one is that the vaccine itself is not necessarily a desirable, usable, abusable product, whereas some of the medication assisted treatments that are out there can be abused and misused in ways that are dangerous to individuals and dangerous to public health..The other piece is that vaccines might provide an opportunity to target a different population. Whereas someone who is in the throes of substance use disorder might benefit more from a medication assisted treatment, someone who’s in the recovery process and has a different clinical course than someone who’s more acute might benefit more from a vaccine. So something that’s more a maintenance treatment, and more in the realm of overdose prevention as opposed to craving management.
AP: Related to these vaccines, I have read concerns of perhaps an overdose risk associated with folks who might try to do a lot more drugs to counteract the vaccine.
VW: That’s a very valid concern; opponents and critics of vaccine-based therapeutics often bring up the potential promotion of risky behavior. I don’t know that the risk would be all that different than someone who is using traditional therapies that are available right now. Regardless of treatment methods, to me there’s always going to be this issue of polysubstance abuse and it is a challenging area to tread, but that underscores why it’s so important to identify a target population that would most benefit from the vaccine-based therapeutics.
AP: Where are we in the process timeline-wise of bringing this to market? And do you have a sense of what the booster regiment would look like?
VW: Right now, there have been small clinical trials testing these vaccine-based products in humans, so we are to that phase for sure. It’s no longer just preclinical, it’s no longer just animal models. But, I think the clinical trials studying them have struggled to demonstrate efficacy, especially long term efficacy. So it could be that vaccine products for substance use disorder might require a more frequent booster regimen than something like the flu vaccine or the tetanus vaccine. With clinical cases of substance use disorder, there’s a huge variation in what it looks like in terms of severity and how long people are episodic and symptomatic and things like that, so I think there’s still kind of a mystery in discovering when the vaccine wears off, so to speak. That is something that is still very much being researched and we’re learning more about.
AP: I have also read that the neutralized drug perhaps stays in the body longer.
VW: That’s definitely something worth investigating, and something that I don’t know too much about other than given general physiology it would make sense that if the molecule’s larger–if it’s being complexed by antibodies which are proteins and very resilient in the body–it would make sense that it’s sticking around longer. But in that complexed form in the body it’s still not active at all, it’s just kind of floating around in the system. We don’t exactly know the implications of what these antibody bound drugs might do or may have on the system itself, so that’s still another area that’s important for the discovery process. The hope with the vaccine is that you would get it and then you would simply have antibodies and the only time that complexation comes into form is if there is a case of relapse or when the person ingests the drug. That’s when those questions of how long it stays in the body and what it’s actually doing emerge, and those answers will come out of more robust clinical trials.
AP: Can you talk a little bit about the exigence of the qualitative study you worked on around substance abuse disorder vaccination perceptions? Why is it important to do qualitative work in this area?
VW: An underpinning motivation of this research was to recognize what endgame stakeholders will be working with, and to understand their opinions and their motivations and how it compares to traditional therapies that they’re used to. What is similar and what’s different about these approaches to treatment for pharmacists, which is an area of research that’s not often talked about. In the drug development world we get a lead on a compound, we find something that we think will be useful and immediately delve into the development process, because it’s so involved and it’s so time consuming and expensive that we want to get through as much as possible. But when you’re focusing really hard on that development end of things you lose sight of the end goal. And oftentimes, promising products will make it to market but aren’t ever properly implemented or properly utilized in the way that it was initially conceived. So this project was one of the first of its kind to reverse engineer the drug development process to start from the end and move forward–that was the motivation for pursuing a more qualitative look at the subject.
AP: What did you find most interesting in doing that qualitative work?
VW: I would say I was a little bit surprised to see how favorable a lot of pharmacists thought this treatment modality would be. It’s good to see that across the board in pharmacy – students and practicing pharmacists as well – they see the value of the treatment approach and they can see that it will most likely be a helpful and beneficial thing. Another surprising thing is pharmacists and pharmacy students pretty much unanimously agreed that efficacy of the product–demonstrating that it works and it works well–was their number one concern.
AP: Has thinking about this question of vaccine perceptions while seeing in real time COVID-19 vaccine hesitancy and refusal changed the way you’re thinking about opioid use disorder vaccines or therapeutics?
VW: Yeah, the vaccine hesitancy surrounding the COVID vaccines and the media buzz about it did change my perception of opioid use disorder and vaccine-based therapeutics. With such widespread availability of the COVID vaccine, it begs the question of if it’s possible to immunize people against substance use disorder in the same way that we might give routine vaccinations for other illnesses. So that is an interesting question I’ve been thinking on, and the ethics are clearly fraught with a lot of different issues that are already being discussed and are already playing out. But it’s interesting to think we could potentially immunize addiction away.
AP: Have you considered a qualitative project, where you seek out perspectives of the general public, or even opioid users, on these vaccine therapeutics? I wonder if that might reflect some of that vaccine hesitancy in a way that isn’t captured by interviewing pharmacists.
VW: That makes a lot of sense and we definitely did consider it because while we were gathering research in the mid to late stages of the project was when COVID was ramping up, and when vaccine developments in that realm were also hitting the airwaves. So we definitely considered modifying the survey approach to be something that could be distributed to a broader population. Pharmacists were just a starting point, and there’s definitely a lot more research we could do in terms of other health professionals and the public in general, because their perspective and their opinions are very important to know.
AP: What sorts of takeaways from your research do you think would be most relevant for historians of drugs and alcohol?
VW: It’s a good question and one that I struggle to answer a little bit, but I think from a historical perspective it’ll be most interesting and most unique to compare the development of vaccines for infectious diseases with this new realm that is up and coming. Another thing that might be worth considering, especially with respect to autonomy and personal freedom is also the rise of the psychedelic medicine movement, because that is another area where autonomy and patient acceptability and hesitancy is a very gray area. So, obviously people’s perceptions are altered when they’re on psychedelic medications and they can lose sense of themselves, and I wonder what similar ways vaccine-based therapeutics may potentially infringe on autonomy. So how can we learn from what we know, and also from the body of evidence we’re trying to recover with archival research.
AP: Yes, you mentioning psychedelics makes me think of what I perceive as this very strong current of psychedelic exceptionalism where psychedelics are perceived as good all other drugs are bad–so I am also wondering about the stigma around (non-psychedelic) drug users and what vaccine-based therapeutics may or may not contribute in that arena.
VW: Yeah, drug use itself is interesting–not everyone that gets prescribed an opioid develops opioid use disorder, so there’s certainly something there to be said about inter individual variability and individual level of risk. It’s also worth bringing up environmental concerns; people with different socioeconomic statuses have different degrees of risk for developing substance use disorder. So that’s another area of qualitative investigation that’s happening.
Vincent Wartenweiler (he/him) is a PharmD graduate of the University of Wisconsin – Madison School of Pharmacy, independent community pharmacist, Master’s student in Psychoactive Pharmaceutical Investigation at UW-Madison, and Data Curator at the nonprofit online psychedelic prior art library Porta Sophia. His PharmD education focused on exploring the role of the pharmacist in clinical research and deepening his interest in psychiatric pharmacy.
Feature image credit: Dim Hou