The Drug Report
The Drug Report
Navigating Poor Ethics in Drug Research and Policy
What if the very strategies intended to reduce harm from drug use are actually endangering the very people they aim to protect? This episode of the Drug Report promises to tackle the complexities and controversies surrounding research into harm reduction in drug policy. With significant federal funding now backing harm reduction research, we stress the critical importance of reputable science in shaping effective policies. Hear our nuanced critique on the growing influence of drug normalization in policy-making, through revealing case studies like the Greater Harlem Coalition's experience with pro-drug Yale researchers.
But that’s not all. We dive into the murky waters of ethical concerns surrounding drug research, spotlighting the scandal involving Lykos (formerly MAPS) and its contentious clinical trials for psychedelic drugs. The Wall Street Journal's reports on unreported suicidal ideation among trial subjects raise alarming questions about participant safety and research ethics, echoing historical parallels with the tobacco industry. Finally, don't miss out on our exciting announcement about the TDR newsletter, brimming with insightful articles and a compelling editorial piece. Your feedback is invaluable to us, and we hope you find this episode as thought-provoking as we do.
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Speaker 1:Good morning everyone. This is Luke Nicferratis. I'm your host of the Drug Report podcast. Please check out our website, thedrugreportorg, where you can sign up for our twice-weekly newsletter giving you all the latest news and analysis of just everything going on in drug policy. And I would encourage you to do that today, because tomorrow we have an exclusive the Drug Review. That's our editorial section with original content from the Drug Report. We have an exclusive piece that we are going to be releasing tomorrow and you don't want to miss it. It's actually a really big deal. It's going to add a lot of clarity to some big drug policy news a few weeks ago. So make sure that you are subscribed so you can get that email to your inbox first thing tomorrow morning and before we get into the rest of this podcast. I also want to thank our two co-sponsoring organizations, that is, sam, smart Approaches to Marijuana at learnaboutsamorg, as well as FDPS, the Foundation for Drug Policy Solutions, which you can find at gooddrugpolicyorg.
Speaker 1:Well, today I want to talk about research, research in the field of drug policy, research specifically looking at this new trend line that we're seeing in drug policy, which is harm reduction. The idea that, while I think you know, obviously the well-intended version of harm reduction is while we are trying to get someone towards a life that is free from drugs and free from addiction, acknowledging that they are where they are in their addiction, and reducing the harm of that addiction, so things like naloxone, for example, so they don't die from an overdose, so they can get into recovery. I think those are things that most people agree with into recovery. I think those are things that most people agree with. Then there's the extreme forms of harm reduction, with what I think is a dystopian philosophy that there are always going to be people who use drugs in society and we just need to make them as safe and comfortable as possible as they are addicted, and the way to do that is to make their drug use safer with things like crack pipes and chapstick. I wish I was kidding For chapped lips, as they're using the crack pipes and smoke-free forms of drug use, etc. So ways to reduce the harm.
Speaker 1:And so we're seeing this trend towards harm reduction, whether it's extreme, whether it's more normal and directed towards recovery, and so this is a really relatively new phenomenon. Whether it's more normal and directed towards recovery, and so this is a really relatively new phenomenon. The Office of National Drug Control Policy, only in the last year, started dedicating substantial funds to this paradigm. It's a substantial paradigm shift to shift federal funds towards this. There's a lot of grants that are being made towards research and harm reduction, and so there's a lot of research happening on harm reduction and looking at these new interventions at least new for the United States and seeing if they're actually effective, if they actually do what they intend to do. And so obviously we at our organization, sam and FDPS, believe that we absolutely should follow the science and that the science leads us towards the truth, whether it's on marijuana's harms or other drugs harms, or on what policies are best in order to protect the public health. We need solid and reputable science and there's a lot of that out there.
Speaker 1:But, as we've seen, this growth of, first of all, harm reduction and a lot of the extreme forms of harm reduction are getting a lot of the press and narrative. These days. We have seen this push for also people to be at the table, driving the policy conversations, driving the research, even that have lived experience or maybe even are current users of these drugs, as if that is a requirement in order to have an objective and effective perspective on what research should be done or an effective perspective on what policies should be passed that these people should actually be using drugs. And it's a little bit crazy to think about, because I think we all intuitively understand that when you are intoxicated or when you are addicted, your ability to use your reason is impaired, and it's sad that I even have to say that today. But let's just remind ourselves that when someone is addicted, their ability to use reason is impaired. When someone is intoxicated, their ability to use reason is impaired. When someone is intoxicated, their ability to use reason is further impaired. They're not able to make sensible decisions, at least not consistently, not even in their own self-interest, let alone in the interest of the broader public, which is what we are supposed to be looking at when we're looking at policy. So we are in a period of time where lived experience which, by the way. Lived experience is absolutely important and people with lived experience need to have a seat at the table Absolutely, but there is an emphasis that's being placed on people who use drugs PWUDs, that they should be driving the research, and people who are normalizing the use of these substances are often the ones that are involved in the research.
Speaker 1:And so why am I talking about this? Well, there's two case studies of why this is a really bad direction for the research. The idea that we should have objective research is not controversial in basically any other field of research, but let's look at what's been happening recently in the field of drug policy research. So there's two case studies I want to give you. The first case study is one that broke two weeks ago and that is with the Greater Harlem Coalition. So they're a very diverse group of people representing, obviously, the Greater Harlem area in New York City, of people representing, obviously, the greater Harlem area in New York City. They are trying to protect their communities from being overly saturated with drug-related response organizations and services.
Speaker 1:Okay, and so there was a pair of researchers from Yale, ryan McNeil, the director of harm reduction research at Yale School of Medicine, and his colleague, gina Bonilla, and they're conducting Zoom interviews with stakeholders in the area to look at. This is what they say. This is what the study says. Mcneil is working on a funded study and, by the way, nih has funded his work and funded the work, obviously, of these researchers before they're working on a funded study that started in 2022, it ends in 2027, looking at both fentanyl and polysubstance use, using drug combinations to increase or decrease the impact of the drug high or to experience the different effects produced by the combination and how those intersect with homelessness. The research plan is to pay and follow unhoused drug users in order to develop an understanding of their needs and how they're using services. So they propose to include the two researchers McNeil and Bonilla propose to include interviews that establish perspectives on service gaps, neighborhood dynamics and community priorities. So that led them to reach out to the Greater Harlem Coalition and so in this interview.
Speaker 1:So again, these two researchers they're working at the behest of Yale and they're funded research, looking at, basically, the efficacy of a number of the harm reduction efforts going on in the area, including, by the way, the fact that the drug injection site in New York is there in the Harlem area, and this group, the Greater Harlem Coalition is opposed to having the drug injection site, which again is a form of extreme harm reduction, basically saying you can use drugs safely if it's under supervision, which is crazy. You can never use drugs safely. They're dangerous, no matter which way you use them. But that's what this kind of philosophy is, is normalizing the use. So the Greater Harlem Coalition hasn't really taken a stance fully against injection sites, but the position that they communicated in this interview with these researchers, which was done on Zoom, done with an AI note taker, so take special note of that.
Speaker 1:We're getting to the point of this story here. They communicate that social services should be equitably distributed throughout New York City so all communities have local access to services and so neighborhoods of color don't continue this is their words on their website continue to suffer the effects of redlining by serving as a municipal or regional containment zone. And they noted the Greater Harlem Coalition noted the importance of working towards their goal of equity by locating small-scale addiction treatment programs throughout all New York neighborhoods. Okay, so I love this because basically what they're saying is sure, okay, if you want to do injection sites, if you want to have all of these forms of these extreme services, harm reduction, et cetera. Also, you know proven programs like addiction treatment et cetera, which all are needed. Sure, let's have those, but don't just focus them in communities of color, don't just focus them in Harlem, don't don't just put these places where you know, basically the NIMBYs don't want them. So putting them in Harlem, equitably distribute these throughout the city. Addiction is affecting the entire city. No-transcript.
Speaker 1:And it's so interesting that that's even controversial, because the whole idea is equitable access, expanding access, and yet that wasn't a good, this equity which is so popular today. Everyone wants to be in support of equity. It's so interesting the response that the researchers had. So they conclude the Zoom and the two researchers, ryan and Gina they didn't notice that the AI note taker, which is listening to their conversation on the Zoom, taking notes and then going to send those notes to all the participants, including the Harlem Coalition. Ok, so this is happening. They don't know it. So they conclude the Zoom and then the researchers begin to talk about you know how they thought the interview went, and so these are some of the just awful quotes from the researchers. Okay, so Gina says that dude sucked. That's a quote.
Speaker 1:And this person and she also said it's interesting that his solution is for us to talk to the community. She says they just want these people dead. And the website says Gina's speculating on the Harlem residents' thoughts Because they don't want all the services only concentrated in Harlem, where the communities of color are. They want them equitably distributed throughout the city. That, in their mind, is oh, you just want these people dead Because you don't want some of these extreme services that they're also looking at. And so they speculate again on the views of the subject. Ryan says that obviously means arresting people, which he probably wants. So they're saying, basically, if you don't want an injection site in your community, that means you obviously just want to arrest people with an addiction. So it's kind of this false dichotomy we so frequently talk about. They also said and this is the final quote I'll read to you this is what Ryan said Again, he is the lead investigator for the University School of Medicine Yale.
Speaker 1:This is a quote. Let's try to get some more interviews with people who suck. I want to find someone who can give enough rope to hang themselves with. So these are the researchers that we have entrusted that are being funded to the tune of millions of dollars to assess whether or not these new, novel harm reduction interventions work like injection sites. Certainly in the future it'll be the safe supply, the quote-unquote safe supply, the drugs that are, you know, in their pure forms, not tainted with fentanyl, so to speak. So they're supposedly safer? Obviously not true. But you know, these are the researchers we're going to entrust to study the outcomes and they so clearly have so much bias that they see those who disagree with them as just wanting to kill or lock away people who have addiction. It's nuts. It's nuts. They think these interviewees suck.
Speaker 1:And yet these are the folks who are going to be publishing research from Yale that then are going to be cited by the American Medical Association, then are going to be cited by the American Society of Addiction Medicine, by other major medical institutions, as saying this is evidence-based, this intervention injection sites, for example that is an evidence-based intervention. They're going to base that assertion off of evidence from researchers like this and we can't trust them. They are clearly doing this research with the end in mind that these interventions work, that people who don't think they work are literally basically murderers, just want people to die in the streets, which is just insane. They're not looking at this with a nuanced perspective. They're not going into these research studies with an open mind of what the result is going to be, and I'll tell you what folks. You can stack any kind of research any which way you want it to get the outcome you want, and I think we hopefully all understand that by now. So they speculated about their interviewees' opinions about things they didn't ask about, showing a preconceived bias. Again, these are all huge no-nos in the field of research, in the field of academics, completely huge no-nos. And so, by the way, I mean the reason why we know all this information is because all the notes on everything they said were sent out to all the attendees, including the Greater Harlem Coalition, after the conclusion of their Zoom interview. So that's how we have all this information. You can check out their website at thegreat Harlem coalition dot. Nyc to see all this for yourself. But their unprofessional conduct was on full display. It was fully noted by this AI note taker. So the research has zero integrity. I mean it is a giant ethical breach that this research is being done by folks with such a strong level of bias. And you know we still live in a country where the expectation is that research is done without bias. So that's case study number one of what we're seeing in this trend of harm reduction research.
Speaker 1:Now let's go to case study number two. So there's a huge write-up in the Wall Street Journal looking at this company that used to be called MAPS. It's now called Lycos. They have been pushing and boosting psychedelics as supposed medicine for decades. Their founder is somebody who's been accused of a whole litany of crimes and issues sexual assault. He's obviously a user of these substances, supposedly for medicinal purposes, but clearly just an enthusiast, and so that was his company, maps. He changed the company's name to Lycos in an attempt to do a PR makeover so they could get products actually legitimized by the FDA and approved by the FDA and basically join the ranks of big pharma, even though they're still running their company in exactly the same kind of crazy way. We'll get into that in a second. So MAPS's new name is Lycos. They are psychedelics enthusiasts. They have been doing drug trials of their psychedelics products psilocybin, for example, and ecstasy and others to try to get them approved by the FDA.
Speaker 1:And so, for those of you who listened to this podcast a few weeks ago, we talked about the fact that Lycos' products were not up to snuff. Excuse me, their clinical trials were not up to snuff, that there were allegations against the way the company was conducting their trials and ultimately, an FDA panel rejected their psilocybin drug for approval. Now, obviously, the FDA can still there's going to be a broader, more official FDA review of their trials, in which case their products could be approved. I think it's highly unlikely, though, given this new news. So in the Wall Street Journal today, they talked about their ecstasy drug and how researchers for Lycos I think that's a loose term, but we'll run with what they're being called Researchers for Lycos failed to report suicidal ideation, suicidal thoughts, among their trial subjects for this ecstasy drug trial.
Speaker 1:So I mean that is a huge omission huge omission that they did not report that finding among their subjects, and that's a huge issue for people who are taking ecstasy with a lot of trauma. And what's really sad is a lot of the people who you'll read in this article, a lot of people who are experiencing this, are people who are victims of prior victims of sexual assault, and so the idea that they could relive this while taking this substance and then potentially have worse outcomes suicidal thoughts and other awful outcomes is a really scary thing. We need to be very careful, as we're going through these trials, in looking at what the impact could be on victims of trauma, so they underreported this effect, as well as other adverse effects, in this trial. So, yet again, lycos is selectively stacking the books of their research. So they're not really a legitimate company. I mean, they're being run by somebody who uses these drugs. A whole bunch of people in the company probably do. They have rebranded, but they certainly have not changed their pattern of behavior, and so their results highlighted obviously the positive findings minimize the negative findings several ethical violations in terms of their selection of clinicians, in terms of their reporting I mean, I could go through the list. You can read this in the article in the Wall Street Journal today. It's just unbelievable. And so they didn't pay attention to, among many things, participant safety, and so that is another big concern. There were multiple allegations throughout this process that people were being assaulted by the clinicians that were doing the research. So we haven't had any of these substantiated yet, but that's going to be working itself out in the days and months to come. So, once again, lycos, psychedelics, ryan and Gina Yale, researchers looking at harm reduction interventions and drug policy interventions in general, research bias People coming into these studies with a preconception of how they should work out and what the results should be.
Speaker 1:And once again, science is science. Truth is truth. You can't create your own truth. The truth is the truth. Right, we know that. But people can set these studies up to get the outcome that they want. And if we have people going into the research hoping for a certain outcome, you better believe that they will find a way to make the research fit their narrative, and any interpretation of results that don't fit their narrative will then be spun back into their narrative. That's just how this works.
Speaker 1:We've seen this time and again across many other industries and research areas and, speaking of industry, that's one of the things we have to think about. We know that in the history of big tobacco, they paid researchers to get the research that they wanted. That confused the public. It sent an opposing message to the science-based studies that were saying tobacco and nicotine were harmful and addictive, that smoking was causing cancer. They were paying for studies that said the opposite, that casted doubt upon this and that gave them a runway of decades to hurt and addict a lot of people.
Speaker 1:So we know industries do this. They've done it in the past. It's a very, very profitable ploy. Do this. They've done it in the past. It's a very, very profitable ploy, and so we should be very concerned by A the bias that's amongst a lot of the researchers right now in drug policy looking at these new and innovative approaches as well, as we should be wondering who benefits financially, what profit incentives are there at play? What industries may be looking to influence this? Because you need to look no further than just over the northern border of the United States and Canada, where they are contending with even much more extreme harm reduction in the form of safe supplies.
Speaker 1:I mentioned before quote unquote the safe supply of literal opioids to sustain people's addiction, and what they found is there are people, obviously, who's producing and providing this supply? There are companies that are doing that. There are people who are in league with those companies who are then writing the rules as to how safe supply should work, who are then advocating and saying that it should remain in place even though it's not working, even though Vancouver, the place with the most of all these extreme harm reduction policies, has the worst rate of opioid overdose deaths in the world or, excuse me, in this whole continent. So, again, thinking about the profit, incentives and the motivations of those who would be wanting to influence. This adds a whole other layer of concern to this discussion. So you know, wrapping this up very concerned.
Speaker 1:We are very concerned about the trend of biased research using bogus protocols, clearly going into studies with a preconceived notion about how they should end up and what the results should be. We should be tackling these harm reduction interventions and the way we tackle any other intervention in drug policy, which is that we should have objective research being done that does not have objective research being done that does not have a predetermined outcome that tells us whether or not these interventions work. And, yes, it's not completely devoid of values. The core value and this is what FTPS has constantly said is meet people where they are, but do not leave them there. The core value has to be getting folks into a life of long-term recovery. Meeting them where they're at, but getting them and pushing them towards recovery, and that's what we really need the research to help us understand is do any of these interventions help us get any closer to a society that is more free from drugs tomorrow than it is today?
Speaker 1:So I hope you found this useful. Check out these articles Again. They will be in our TDR newsletter tomorrow, along with the extremely exciting original editorial piece from a guest author that we are excited to share as well. Thank you, leave us a review. Five stars, please. We would really appreciate that. That goes a long way. Have a great rest of your week.