The First International Conference On Heroin Maintenance: Commentator Panel, Martin Schechter

I would like to share with you an experience my colleagues and I have had over the past six months to a year. It reflects the relationship of science and ideology. What happened is that in a study we published about injection drug users in Vancouver, where there has been an explosive outbreak of HIV over the past two to three years, we reported that frequent attendees of the needle exchange had a higher HIV prevalence than infrequent attendees.

That result has been widely misinterpreted and misquoted, even in the House of Representatives and in your Senate and it was featured in the report that General McCaffrey submitted in the days before your federal government's decision to extend its ban on funding for needle exchange in the U.S.

We were visited by a team from the Office of National Drug Control Policy, and we spent more than an hour explaining, detail by detail, why and how these results were being misinterpreted. But in the end, it became clear to me that we were talking to people who were not interested in evidence in scientific terms, but rather, who were in the grips of an ideology.

I think that when I was asked to contemplate what a North American trial of heroin maintenance might look like, I realized that this is a trial that will be scrutinized to the same degree, and the scrutiny will occur in the context not purely of science but of ideology. Therefore, it is not business as usual. You cannot simply design a good clinical trial or a good randomized trial. The trial must be beyond all possible reproach. Because its opponents or its adversaries will use anything possible to undermine the evidence that is eventually presented.

Regarding the Swiss experiment, I want to congratulate them for the great step forward. It is, I think, a boost to everyone in the field. I personally find the evidence very compelling from the Swiss study. But, do I think a similar project in North America, which provided similar results would make the case here? The answer is no. The evidence from a Swiss style study, an observational study, I think would be undermined and attacked by opponents of heroin maintenance in North America.

I think we need to design and think about these trials as if we were in a chess game thinking three moves ahead. Often I teach students, when they're thinking about designing research or submitting a paper, to put themselves in the minds of their adversaries, which in their case are the reviewers. What are the reviewers going to say? Anticipate everything that they can pick apart. I believe in these kinds of heroin trials we have to do that as well but to the nth degree, because the methodology will be picked apart by those who are opposed to the idea.

Let me share with you some questions that occurred to me as I listened to this morning's presentations, anticipating what adversaries might say. So for the next minute, it's not me talking, but rather the voice of a future adversary of this type of research. They may say that you set these trials up to fail because the control group was given the very therapeutic modality they had previously failed on, namely methadone. In pharmaceutical clinical trial research, you cannot do that. Therefore, adversaries will say that use of the methadone control group, by being constituted of people who have previously failed methadone, stacked the deck against methadone in the trial. That's what they'll say.

Now, there may be very good reasons why such a group was used. You might say that this is the population we need to study. But it raises questions whether the control arm of these trials should receive simply methadone as usual. Perhaps, people should think about the control arm having some augmentation of current methadone therapy, since methadone has proven itself to have failed in the control group. I don't have the answer of what that might look like, but I think it needs to be considered.

I think the gentleman from the Netherlands mentioned this morning the fact that there are lots of psychosocial factors that are at work in these trials. I think adversaries will ask about the effect of going to a clinic three times a day in one arm compared to going less often in the other arm of the trial. There is, we know from numerous clinical trials, a benefit of simply going somewhere and being seen, and that's part of the psychosocial aspect of these trials. Maybe the control arm has to be better matched to the intervention.

There is the issue of durability of effect. If it is really the case that the goal of this therapy is to treat people only temporarily with heroin maintenance and get them back into methadone, which they have previously failed, then we must know that they do better this time on methadone than they did previously when they failed. Without that knowledge, this therapy will be viewed simply as a stalling tactic which may get people better for a while but then they will revert to where they were.

I didn't see any mention of blinded evaluation. I think adversaries will look for that. Obviously, we cannot necessarily do a double blind trial, but we can have the evaluators of these trials be blinded to which arm subjects were in. I think we would have to undertake validation of the data where it is self-reported and subjective. We should do so to degrees far greater than we might in normal clinical research because of the potential criticism that might fall there. And then there is the issue of losses to follow-up. I think we have to do exceptionally well in that area because otherwise, we leave ourselves open to criticism.

My remarks have stemmed from a research perspective and from the fact that heroin maintenance trials are not your simple pharmaceutical drug trials. The irony is that this field in which the methodology is so challenging, is precisely the area which will receive the greatest scrutiny.

That is a bad combination, great methodological challenges that will face great scrutiny. If there is one point to my remarks, it is that this is not science as usual. This is science in the context of ideology. Because of that, the research has to be done beyond all possible reproach. Thank you.

Selected questions and answers:

CRAIG BOLAK: Thank you. My name is [CRAIG BOLAK?] from Amsterdam from the Municipal Health Service, I'm a psychiatrist. And I wanted to comment on what Dr. Schechter has said about the necessity to have extremely thorough scientific research.

I am in the board of the Drug Policy Foundation, and we had an interview with a delegation of the International Narcotics Control Board (INCB) when they visited the Netherlands in April. They criticized the Netherlands for starting this research without waiting, you know, for the objective or independent evaluation of the Swiss research by WHO.

First of all, you can say that [UNINTEL] the independence of this evaluation is really at question. But another thing is that their attitude is not scientific. It would be -- the normal attitude would have been, say, this is quite interesting research and the results are promising, so the United Nations should have been interested in this. And I think that we have to get down to such a basic attitude to see that what they do is wrong and that they're not interested in having any better [research].

What then happened was that the delegation of INCB started to make remarks about the Swiss research that I think could be called slanderous. They not only said that it was not real research it was more a kind of a demonstration but they also said that it, at some point, was misleading and the facts were wrongly -- I don't know the name for -- well, as if it was kind of a fraud the way it was presented. And this was really done by the official representatives of INCB coming to visit our country.

MARTIN SCHECHTER, MD, PHD: I certainly agree. Of course, it's not fair. But then, I think it's just a reflection of the fact that when you want to contest the prevailing ideology, the hurdles are far greater than when people want to continue it. That goes back to Galileo. I think the best way to counter that is to live with it. We have to have evidence so unassailable that it passes what one of my professors used to call the traumatic intraocular test, which means it'll hit you between the eyes. The evidence must be clear and compelling, because when you have that, you are on much higher ground. But I agree with you.

ALAN R. FLEISCHMAN, MD: Dr. Wodak?

ALEXANDER WODAK, MD:I used to sit on a committee with a very wonderful chairman who influenced me a great deal, and he used to listen to my passionate interjections on one subject or another. And when I'd finally pause for breath, he'd say, the trouble with what you've said, Alex, is that it's just based on logic and rationality. [LAUGHTER]

And we have to keep on reminding ourselves that in this field of illicit drugs that what we are dealing with is not based on logic and rationality thus logic and rationality are not going to overcome it. And so I disagree with the position that Martin was arguing for earlier.

Because if you become super-defensive in your design of research, in fact, it's not going to overcome the problems that you're setting out to achieve. Look what's happened with the history of needle exchange research, that as soon as better data was produced, the authorities raised the bar even higher. And when that level of research was achieved, then the bar got raised even further. And there is no amount of data that is going to shift the minds of some people. Because their position is not based on logic and rationality, it's based on fantasy and denial. And you can't beat fantasy and denial with data.

So I would suggest to you that the quality to aim at in research on heroin prescription should be the quality of good research in medicine generally. It should be as good as rheumatology research or cancer research or AIDS research. You shouldn't pretend that you can achieve even better research than that, because I don't think there's been a single research project that's ever been published that hasn't had some kind of problem with it. Problems are inevitable, and we shouldn't pretend otherwise.

RON BRIN: I was born in Williamsburg, Brooklyn, and what we're dealing with are human rights violation, it's clearly about global violations of human rights. Also the most important issue is that trade issues and economic issues are overwhelming any other issues. And in terms of science, experts at the national level here in this country admit, off the record, privately, that science is being totally decimated in the name of control. And it's not the United Nations Drug Control Program anymore, it's the vision of narcotics and crime. Those agencies have been folded together.

So clearly, the only way people are going to get any assistance for addiction problem, at least in the unit, they're going to have to be in jail or in prison, and this policy is being spread worldwide because we've got the money to make policy, just shame the hell out of everyone who keeps getting the help that they need.

MARTIN SCHECHTER, MD, PHD: I have just a quick comment. I think Alex and I probably are going to agree to disagree. It may be a reflection of different ways people approach decision making in Australia versus North America. I didn't mean to imply that if we had excellent research, that would sway political leaders in and of itself. What I do know is that if you have research that can be undermined in their briefing notes, then you cannot sway them. So that's the point I'm making. Solid research in and of itself is not going to do the trick. But if it's undermined, I think you're in great trouble with decision-makers in North America.