The First International Conference On Heroin Maintenance: Commentator Panel, Alex Wodak

I was next in the queue. God asked me 'what are you doing?' I said that I was going to a meeting in New York to discuss prescribing heroin in the United States. God said to me, 'heroin prescribing in the United States will not occur in your lifetime'. Then God paused, scratched his head and said, 'come to think of it, I don't think there's going to be heroin prescribing in my lifetime either'.

I came to New York city in 1987 and spent a good while here looking at how the United States was responding to the problem of HIV infection among injecting drug users. I heard Dr. Benny Prim, who is present at this conference, discuss HIV spread among African-American people through injecting drug use at a conference at Columbia University. I also spent an evening in a shooting gallery in Williamsburg, Brooklyn. This is not something many tourists do. Probably few American citizens who are not drug users have seen the inside of a shooting gallery. I learned an enormous amount from that evening and it is one of the reasons I am here in New York today.

I was so appalled by the horror of that experience that I decided that one of the things I would do when I got back to Australia is make sure that the conditions of a US style shooting gallery are never replicated in my own country. One of the conclusions I drew from that evening is that it is just not possible to stop some people using some drugs some of the time. And if some people use drugs, surely they are better off getting sterile drugs of known concentration prescribed by a doctor than getting dirty drugs of unknown concentration provided by criminals.

At the end of the day, this is and always will be the central question about heroin prescribing. I am grateful to the US government for allowing me to see these conditions. It was really this experience in Williamsburg, Brooklyn, that led me to make the recommendation to a Parliamentary committee back in Australia that heroin prescription should be studied scientifically. The other consideration for me which also prompted my recommendation was the succession of official inquiries into illicit drugs in Australia which have drawn attention to the lack of data upon which to base sound policy. In the absence of adequate data, unfortunately, very ineffective and very problematic policies have been adopted and once implemented these have become very difficult to change.

Another impetus for making the recommendation to study heroin prescription was the concern that HIV infection would still somehow break out among injecting drug users in Australia. So far that has not happened. But heroin prescription seemed worth testing as another potential weapon. A fourth reason was a desire to enhance drug treatment. The arguments for evaluating heroin prescription seem as compelling now as they did then. If anything, the reasons for evaluating heroin prescription have grown even stronger over time.

The most persuasive argument is that drug users do much better when in treatment than when out of treatment. The community also does much better when drug users are in treatment than when they are out of treatment. Drug users vote with their mouths or veins or legs for treatments and the treatments they choose overwhelmingly are based on pharmacological approaches.

The gold standard pharmacological treatment for heroin users today is methadone. I suspect that will always be the case. But methadone does not attract all heroin users and it does not benefit all who enrol. Expanding effective treatment options, especially the pharmacological options, is a paramount need in many communities.

Any doctor dealing with a chronic, complex medical problem would always prefer to choose from a range of effective treatment options. But for this condition of heroin dependence, because of the constraints imposed upon health professionals, we can only prescribe one pharmacological agent, methadone. Very recently, the range has been expanded in some countries to also include leva-alpha-acetyl-methadol (LAAM) and buprenorphine.

In the marketplace, the drug of preference is still unquestionably heroin. What we need to know is whether the prescription of heroin by doctors is better than the distribution of heroin by a criminal monopoly. The arguments for evaluating heroin prescription boil down to: firstly, a desire to enhance treatment of drug users , and secondly, to help resolve the policy impasse.

There is inevitably a drug policy aspect to this question. Many have commented on this. With the passage of time, confidence in law enforcement as the mainstay of society's response to illicit drugs is rapidly declining in most parts of the world. Heroin prescription is sensible contingency planning for a further deterioration in confidence in illicit drug law enforcement.

This loss of confidence in illicit drug law enforcement is happening in the United States and it is also happening in my country. And it is certainly happening in many other countries. As confidence in law enforcement declines, it is inevitable that people will look to treatment enhancement as the most likely way that we can deal effectively with the problem of illicit drugs in our communities. Illicit drugs do not seem like they will simply melt away.

What is the current status of this field of research? It has already been demonstrated, even at this early stage, that heroin treatment is feasible. We know that heroin treatment is probably safe. Nothing disastrous seems to happen when heroin is prescribed. There are several decades of experience from England to testify to the feasibility and safety.

Do we know that heroin treatment is effective? I think we have to still keep an open mind on the question of effectiveness. The same criteria of proof adopted for effectiveness of HIV combination therapies or anti-tuberculous chemotherapy or hypertension treatment should apply to evaluation of heroin prescription. We need several well-designed studies before coming to any definitive conclusion. At the moment, we only have one large observational study and a few other smaller studies which are of great interest.

More studies are needed before any conclusions can safely be made about effectiveness. It is premature to decide now whether heroin prescription is (or is not) cost effective. On the other hand, looking at the results of the Swiss trial, there is no innovation that comes to mind over the last 25 years which has been as promising in the entire illicit prevention and treatment field. That is a different question from deciding conclusively whether heroin prescription is effective, safe and cost effective.

I would like to pay a tribute to some of the great pioneers in this field. I am very pleased that Dr. John Marks is at this conference. John has made an outstanding contribution to this area and has been ahead of many of us. No one can really diminish his very important contribution.

In 1987, I travelled to a number of countries to investigate responses to HIV infection among injecting drug users. I visited John Marks in Liverpool and met two of his patients. It was an extraordinary experience for me. I recall vividly talking to John's patients. They looked like human beings. They talked like human beings. One of them was employed and the other was a university student. Both were prescribed heroin by John.

It was an extraordinary experience to see that they did not have horns. They were just normal, ordinary folk. It was a very banal experience. I can strongly recommend it. We will see in a video soon which is a version of the same experience I had when a patient prescribed heroin describes his life.

I would also like to pay a particular tribute to Dr. Gabriele Bammer for the outstanding way in which she conducted the heroin feasibility study in Australia. It is difficult to really convey the impact that her study has had. This was largely because of the extraordinary way she handled it.

A couple of points about the Australian experience are worth thinking about. As Ms. Bronwyn Barnard has just mentioned, up until the 1950's Australian doctors were able to prescribe heroin quite legally. That continued up until 1953. Australia had a very small heroin problem at that time. Perhaps that was because of heroin prescribing. It is not possible to be certain.

But in 1953, pressure from the World Health Organisation (WHO) was applied to Australia to stop heroin prescription. Many suspect that the reason WHO put pressure on Australia was because of pressure on WHO from the United States. This has never been established.

The second point about the Australian experience was that the longer the heroin trial was under consideration, the stronger the arguments for doing the trial appeared and the weaker the arguments for not doing a trial seemed.

The trial had very little public support in the beginning. In the days leading up to the all important national meeting of Health and Police Ministers in July 1997, as Gabriele Bammer has mmentioned, the trial was publicly supported by police commissioners, directors of public prosecution and the leaders of the legal and medical professions. The vote at that national meeting was six in favour of the heroin trial and three against. (The Ministers voted in pairs). Less than three weeks later, Federal Cabinet over turned that decision.

Opinion leaders were overwhelmingly in favour of the trial. When the Prime Minister instigated the abandonment of the trial in August 1997, there was overwhelming condemnation of the Prime Minister from many influential people as well as ordinary people in the street who had supported the trial.

Another lesson from the Australian experience that has also been demonstrated in the United States is the very important role that science can play in developing social policy, especially in areas where the political framework has not been able to devise effective solutions. I would like to emphasise how the construction of Gabriele's research project really enabled this element to be shown very clearly. Gabriele's project design could readily be applied to many other fields where we grapple with effective solutions.

We can conclude from the Australian experience that where policy shuts off research and freedom of thought, societies are doomed to perpetuate failure. That is a very important finding. We have also learned from the heroin trial experience that we must always evaluate innovative interventions.

If there is any criticism that should be levelled at the international medical community, it is the failure in Britain from 1926 up until now to conduct solid, rigorous evaluation of the British experience in the form of scientific trials. Whenever we depart from conventional approaches to medical problems, we must always rigorously evaluate what we do.

I conclude by saying about heroin prescribing, in the words of your former President, you have nothing to fear but fear itself. We should be ready to evaluate heroin prescription without further ado.

The next segment of the program is a video made by Mr. Gary Sutton, who appears in it and who presents a drug user's perspective of what it is like to be prescribed heroin. As he explains, he has been previously been a patient of Dr. John Marks. I would also like to acknowledge the important role of Andrea Morgan-Ethaemou [check?] who is in the audience today. Andrea helped to make this video.

GARY SUTTON: Hello, my name is Gary Sutton, I'm 37 years old. I've been a heroin addict since I was 19. With three periods of remission during that time. I'm currently prescribed 400 milligrams of diamorphine IV daily, having been rather drastically reduced by a change of prescriber from 700 milligrams daily. Therefore, I apologize if I seem to be struggling today.

Heroin has played an extremely central part in my life over the last decade and, for the best part of two decades now. I feel that my choices aren't quite so much can I get off drugs and live an abstinent life or can I not? I feel that my choices are, do I get a legal source of drugs or do I get an illegal source of drugs.

Now, I've tried other opioids or opiates. In fact, I was on methadone for four or five years. I've been on heroin now, legal heroin for just on three years and it's made a colossal difference to my life, the quality of my life, and the scope of possibilities thar I'm able to countenance.

One of the problems that all addicts encounter in general and in virtually everything they do is that they are essentially chained to their drug of choice or to whichever drug they are prescribed by their clinician. I feel the advantage that I've got from being prescribed heroin is that I feel far more clearheaded than I did previously.

I feel that I have an active sex life. There's a pretty good paper by [CICERO?], I think, I can't remember, I think it's out of San Francisco, Cicero and colleagues on libido and control of methadone and a heroin group, which if none of you know it, I suggest you look it up. That's made a big difference to me. I think it's, you know, sex is very important form of self-expression and I think you lose quite a lot when we lose the ability to make love and to form relationships.

Now, we do have a small problem with using any opiate -- I'm talking about making relationships -- because you have an up side and you have a down side, And the down side is that, to me, heroin is an antidepressant medication. It's not something that -- any longer that I take to be cool or chic or because my peer group take it or because as a mystique, and I want to be rebellious.

And if you were to push me on the reasons why I take heroin or started taking it and found it impossible to stop, I don't think I will be able to tell you. However, it's got to the position where that is now as far as I'm concerned, I either am supplied a clean, unadulterated pharmaceutical source of heroin or I am forced to the black market with the rather unsavory side effects of having to hang out with gangsters to get incredible and legally unobtainable sums of money, not to be able to kick down any type of itinerary that would lead anyone to employ me because I simply wouldn't be reliable enough because the type of people that you deal with simply aren't reliable enough.

And it has given me this equilibrium I mentionedr which has, to a greater or lesser extent, enabled me to lead a relatively normal life. It won't be completely normal because, by using opiates, I think you probably cut out the peaks of sensation or emotion that you feel. But you cut out the troughs at the same time.

And for a lot of people, and this, as I said, there are different reasons for different people, I feel I'm able to live without that. Personally, I'm quite proud of what I've achieved over the last four or five years, and I'm extremely grateful, particularly to Dr. John Marks who gave me the chance to do something with my life when I really felt that, previously, that I was going nowhere. Thank you.

ALEXANDER WODAK, MD: okay?

ALAN R. FLEISCHMAN, MD: We invite you to the microphones for comments or questions, and perhaps we can begin with any comments by members of the panel of one another? Let's go to this microphone. If you'd identify yourself, please.

ALLAN CLEAR: Hi, from the Harm Reduction Coalition. I think it's great that we have this conference here. It's a visionary exercise in many ways to see what the science is from around the world and I think if we pursue this 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. He used to listen to my passionate interjections on one subject or another. When I would finally pause for breath, he would say, 'the trouble with what you have said, Alex, is that it is only based on logic and rationality'.

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 and logic and rationality is not really going to overcome our problems. Therefore I disagree with the position that Martin was arguing for earlier.

Because if you become overly defensive in the design of research, in fact, it is not going to overcome the problems that you are setting out to achieve. It is worth remembering the history of needle exchange research. As soon as better data was produced, the authorities raised the bar even higher. When that level of research was achieved, then the bar got raised even further. There is no amount of data which is going to shift the minds of some people. This is because their position is not based on logic and rationality, it is fundamentally based on fantasy and denial. Fantasy and denial cannot be beaten with data.

Therefore I suggest 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. We should not pretend that we can achieve even better research than that. I doubt that there has been a single research project that has ever been published that has not had some kind of problems with it. Problems are inevitable, and we should not pretend otherwise.

ALAN R. FLEISCHMAN, MD: Let's go on to the comment here. Please identify yourself.

PAUL CHERISHORE: From the Harm Reduction Coalition and the North American -- I hope that the research here will anticipate how these programs will look in the real world because I think the biggest failure of drug treatment as it is the way the consumer is treated by these programs. And unless changes are made, I don't think that the outcomes are going to be so much different in heroin maintenance programs as they are in methadone programs.

I think a lot of that comes from the abstinence only starting point and basically drug users are treated as people who are doing bad things, they're naughty children, and programs are basically taking a parental role in correcting their behavior. And I just wonder how heroin maintenance programs would address the failure of methadone treatment as it is today, because I think that that is the root problem of methadone, in that drug users are basically asked to admit they're doing bad things.

ALAN R. FLEISCHMAN, MD: Dr. Wodak?

ALEXANDER WODAK, MD: Let me describe for you what our experience was. This question came up at the National Centre for Epidemiology and Population Health (NCEPH) at the Australian National University (where Gabriele works). The Director of NCEPH, Professor Bob Douglas, convened a meeting of about 20 people.

ALEXANDER WODAK, MD: It may be interesting for you as an audience to know that these people ranged from government officials, NCEPH researchers, and also police. But there were also some drug users. And one of the questions that came up was why should we do a study on a heroin prescription when we have not even got decent methadone clinics?

At that time in the Australian Capital Territory, roughly equivalent to the District Of Colombia, the methadone clinics were a national disgrace. I made a prediction that I was very confident that as soon as we started talking about heroin prescription, the authorities would make damn sure that the methadone clinics were improved, and they would do that to try and forestall the arguments for heroin prescription. I predicted that they would increase the numbers on methadone and that they would improve the quality of the methadone program.

And as soon as I made that argument, I remember that Professor Douglas said, well, he changed from being fairly neutral about the whole question to becoming really quite interested. My perception is that the quality of the programs did improve. The number of people on methadone certainly increased dramatically from about that time.

So the short answer to your question is I think that if you start talking about heroin prescription in the United States, there will be a rapid expansion of methadone clinics and an improvement of their quality.

ANDREA DEMIMORDON: Hi, my name's Andrea Demimordon I'm from the U.K. And first of all, I'd like to applaud the courage of people in this country wholve sponsored this conference, because if I was a drug user living in this country -- I don't know how people put up with it and stay sane. But anyway, they do. And so I really, really want to say thank you for that, speaking as an advocate. And also to Bronwyn, and it's all right to cry.

Now, my comment. I was just interested in what Gabriele Bammer was saying -- Bammer? About whether we have heroin prescribed within a prohibitionist or not framework. And I guess really I just want to totally, totally support, you know, what Allen Clear was saying from the Harm Reduction Coalition which is that, you know, as far as we're concerned, AIDS has killed many of our people, hepatitis is killing many of our people, the sense of urgency for us is getting overwhelming.

We don't have time to wait for governments. The U.N. has blocked all the people that have come from all over the world to speak about drug policy reform, has actually blocked us out of their building. They clearly do not want to hear, they are clearly gangsters. So I think within prohibition, I, you know, whatever I believe about it -- yes, I believe the laws might change, but I think we must do this within what we have at the moment. And I just want to really encourage people with that and not to get sidetracked.

Because in a way for me, you know, in the frontline, if we're talking about saving lives and that's our primary goal, then we need to just implement harm reduction and continue to do that at as good and at a speed, and there is money out there, so please, know that. Thank you.

ALAN R. FLEISCHMAN, MD: Identify yourself.

MARK SCHINDERMAN: [MARK SCHINDERMAN?], Center for Addictive Problems, Chicago. Response no axis I disorders in general in Europe and in America is associated with this rather high dose group and that such a person described never would have been exposed to adequate dosage of methadone. However, there are patients who need other agonists than methadone to function normally. So both things are true. what he mentioned may be either a case of someone who has a peculiar and idiosyncratic positive response or someone who had never really been exposed to adequate methadone treatment.

ALAN R. FLEISCHMAN, MD: Thank you, thank you. These will be our last three comments. If we can keep them brief, because weld like to get to the break out sessions.

DONALD GROVE: Yeah, first of all, I see no reason why she shouldn't --

ALAN R. FLEISCHMAN, MD: Please identify yourself.

DONALD GROVE: My name is [DONALD GROVE?], Lower East Side Needle Exchange, Beth Israel medical Center, Church Ladies for Choice. First, I see no reason why -- I mean, I'm a little surprised by the question. As though people shouldn't shoot up and act like middle class housewives. A lot of middle class housewives shoot up and then act like middle class housewives.

But two questionst both -- I'd like to follow up on the question I asked this morning because it didn't quite get answered about bio-availability of the heroin and how that relates to whether people wind up using other drugs. That if people aren't metabolising enough heroin because they aren't getting or whatever do they wind up using other substances. The other question is --

ALAN R. FLEISCHMAN, MD: We understand, the second question.

DONALD GROVE: -- no really, that here in New York City, we don't have the luxury of worrying about whether heroin maintenance is going to reduce HIV seroprevalence, we already have outrageous HIV seroprevalence, and I want to know what sort of study is done along with heroin maintenance to support AIDS medications which the people in heroin maintenance may be doing. Where are the clinical trials which demonstrate how protease inhibitors or AZT or opportunistic infection treatments relate to heroin maintenance, to methadone maintenance, any of those things?

ALAN R. FLEISCHMAN, MD: Panelists? Comment? Dr. Wodak?

ALEXANDER WODAK, MD: Well, I know that in the 1,146 people who entered the Swiss trial and who were followed for 18 months, there were three new HIV infections and four new hepatitis B and five new hepatitis C infections. So, from a consideration of prevention of blood borne virus infection, the trial worked well.

In terms of the interactions with the antiretroviral treatments, I think we have to remember that medical research takes time and we have to do generations of research. The first generation is to see whether the treatment is safe and then whether it is effective and then we need to see who it is effective for and then we need to see how to maximise benefits and minimise any side effects. In that later research, we start looking around for the interactions. And it's really too early in this field to start asking those questions.

ALAN R. FLEISCHMANI MD: Bioavailability, any thoughts on bioavailability? No. Okay, let's go over here.

TOM PATE: Namels [TOM PATE?], I'm from San Antonio, I have over 30 years working with methadone and addiction, and remain terribly frustrated at the state of methadone treatment programs in the U.S. today in terms of access to care. We have about 130,000 slots for upwards to a million addicts.

A lot of the motivation which I support toward establishing heroin trials in the United States is based on the failures of traditional methadone care and I would caution the group to keep in mind that perhaps we should link to these efforts the idea of optimising and insuring that all the patients are receiving optimum care in terms of dose and frequency of dose and appropriate supportive services in conditions that are not disruptive to any form of normal life. Then we may be able to diminish the numbers that might be looking for this treatment. But I think they will be there. And as a physician, I would like to have all the potential tools at my disposal, including heroin, hydrocodone, methadone, LAAM, buprenorphine, whatever else may come along.