Fred M. Jacobs, M.D., J.D., Commissioner,
New Jersey Department of Health and Senior Services
August 2007

Dear Dr. Jacobs,

Re: Establishment of Needle and Syringe Programs

I understand that the state of New Jersey is considering a needle and syringe “exchange” program. I am also advised that New Jersey is a liberal democratic society whose members for the most part believe in freedom of the individual to pursue “life, liberty and happiness”. This of course is wonderful! And also provides a useful opportunity to note that no drug addict enjoys real freedom while their will, their lives, their relationships and their resources are largely dedicated to the service and slavery of their chemical addiction. This would make your lovely part of the world an excellent place in which to pursue those liberties which should be the birthright of every human being.

To introduce myself I am a family physician in Australia, and have pursued a special interest in the treatment of addiction especially for heroin, but also other drugs of addiction for the last ten years. Health department figures indicated last year that in the years 2001-2006 I single handedly registered 11,000 of the 14,000 registrations for opiate detoxification in the state of Queensland. I have also attained one of the three largest numbers of naltrexone based rapid opiate detoxifications in the country of Australia with over 1,800 procedures performed including 600 naltrexone implants. This was done with only two overnight hospital admissions which is a world safety record. I have also submitted evidence to several Government committees and leaders on the subject of drug policy.

As the so-called “needle “exchange” programmes” make little effort to exchange syringes, and as actual exchange makes little difference to the operation or mission of the programs, it is probably more accurate to refer to them as needle and syringe distribution programs, or NSP’s. It is important that your community appreciate this because syringe disposal is a real problem with these facilities. It has been so in this country. Our lovely and world famous Bondi beach in Sydney is now said to be one of the best places in the country to get a needle stick injury, due to the many syringes hidden in the sand. Clean up patrols have operated in King’s Cross twice daily for years to clean up the extreme public nuisance of hundreds of used syringes left dangerously in the streets and side walks, to protect the public . This is a well recognized problem with NSP’s which is generally covered up while such programs are in the planning phase.

Epidemiological Evidence

Since the NSP experts readily resort to discussion of “evidence based treatments”, and since the community decision to fully implement this program has such far reaching implications both in terms of needle disposal bins in all public toilets and for the time and direction of public health policy in the management of addiction, it is very appropriate that careful consideration be given to the quality of evidence which is typically cited in support of NSP’s. In particular the evidence based literature waxes lyrical about “levels of [reliability of] evidence.”

Self-report data is widely used in the addiction literature but it has been shown many times to be highly flawed and unreliable, and to fails to correlate with more objective and hard signs of HIV rates. As was pointed out to you by Dr. Fred Payne’s letter, and as was noted in the Institute of Medicine Report on this subject, it is well recognized that most of the literature on the subject of needle exchange is based on self report. This would clearly make it the least reliable form of evidence by their own criteria. Actually one would have to wonder if the evidence based gurus would accept such data at all.

Secondly we are aware of the “ecological” studies where they repeatedly report many cities with and without NSP’s. The work of Dr. Kirsten Kall’s group from the University of Linkoping shows clearly that in such an epidemic the rate of rise of the epidemic is related to the population at risk. Epidemics it is argued have a natural life history with a rise, fall and usually stabilization levels. Depending where in the natural history of the epidemic one takes one’s samples one will get a different picture of the efficacy of the NSP’s. It is for this reason that showing either a rise or a fall in HIV incidence or prevalence after NSP introduction is irrelevant if one is not informed of the natural history of the epidemic, and unless one can adduce by other means the likely outcome in its absence. This is a severe criticism, and one which effectively invalidates the whole of this genre of studies. I am also assured by epidemiologists familiar with such matters, that such studies are given no weight in epidemiological circles for this reason. That they have been foisted upon the rest of the world and even mentioned in major UN reports shows the degree to which such sloppy unscientific methods have been adopted within such agencies.

Indeed Dr. Alex Wodak, understood to be one of the primary authors of the relevant section of the 2006 UNAIDS report which eulogized NSP’s and the harm minimization addiction management paradigm, unequivocally stated in 1995 that formal proof of the methods of harm minimization would be impossible as it would not be possible to control in real life the many confounding factors which would be acting, and thereby prove that any particular intervention alone had been salient in controlling the target disorder .

Furthermore there is a clear conflict of interest by some of the leading proponents of NSP’s . Dr. Alex Wodak was for many years the President of the International Drug Law Reform Foundation and is the current president of the Australian Drug Reform Foundation which lobbies unceasingly for drug decriminalization. Dr. Don Jaralais in the USA is also understood to be of a similar ideology, and his advocacy for NSP’s is well known. I am of the understanding that such parallels could be made repeatedly for many of the most ardent advocates of NSP’s.

Dr. Payne’s letter mentions the very high rates of HIV in Vancouver at present despite the operation of an NSP, having risen from 1% to 35%. It was also shown long ago in Montréal that the HIV rate amongst NSP attendees was 2.5 times that amongst non-attendees (3.1 Vs. 7.9%) .

In terms of its control of other virus transmission NSP’s seem to substantially lack power. They failed to control Hepatitis B in Amsterdam , or Hepatitis C in Australia where rates of HCV carriage amongst IVDU who have been involved in the lifestyle for longer than six months exceed 80%.

Special Situations

Some situations are special and require special consideration. We are well aware that the apparent success of harm minimization techniques in this country is frequently cited overseas and in international fora as proof of principal of the efficacy of harm minimization epidemic management techniques. What is repeatedly overlooked in such discussions is our record rates of other infections such as Hepatitis B and C, and the venereally transmitted agents Herpes, Warts and Chlamydia. Indeed recently released data shows 30-100% growth in the last five years in Queensland in Gonorrhea, Hepatitis C, Chlamydia and Syphilis . Indeed it has been estimated that the Australian health care system has now to plan for over 100,000 liver transplants required for Hepatitis C alone in the next 20 years. One also notes that the outcome after transplantation for Hepatitis C is inferior to that for other infections due to the universal early graft re-infection which invariably occurs in the first few post-operative days, and the clash between anti-rejection immunosuppressive therapy and the anti-viral needs of fighting an aggressive viral infection in the context of the immuno-suppression and likely immuno-senescence induced by drug addiction, which is reversed to an unknown extent by abstinence.

In Australia our HIV rate amongst IVDU who do not share other risk factors is very low by international standards of the order of 1%. New cases of HIV nationally in all groups have risen from about 100 in 1991 to around 300 in 2005 . There appears to be significant variation in the estimates for the number of syringes distributed to addicts in this country with estimates varying from 20,000,000 to 200,000,000 – a level of inexactitude which in itself should give us pause. The former number was more than our total population at the time, and the latter number is substantially greater than the number of sheep here (which says a lot for a nation which for a long time was said to ride on the sheep’s back!) One important feature then facing the advocates of any NSP program is exactly how many syringes do they want to distribute? One for every man woman and child in the state?

However in the case of Australia we would do well to heed Wodak’s warnings about the inability to control for other confounders. From a modeling point of view the epidemic began in certain well known high risk groups. Its spread would then have been related to the population at risk, the activity of the various risk taking behaviours, and the intersection of these behaviors with the wider general community. Still today over half of all HIV infections in this country occur amongst men who have sex with men. It should also be added that the rate of IVDU in this group is 10-20 times higher than it is in the general community. Clearly then the spread of the disease into the wider community is related to the behaviour of this reservoir of infected people. One of the obvious confounding factors which has never been studied or quantified is what might be termed the homosexualization of the Australian culture with many laws, many bureaucracies, and schools of public health completely subsumed by the new ideology accompanying the public health impetus of the HIV epidemic. In that this likely instilled major good will in the primary target community, and is likely to have very positively influenced the relevant risk taking behaviours, it is clearly an intimate confound which confuses and likely dilutes any effects which might be attributable strictly to NSP’s.

Another important confounding factor was that Australia made treatment for HIV free to all patients who would have benefited from it from the outset of the epidemic. Assuming that the most at risk individuals were infected near the beginning of the epidemic, then those that survived their infection might reasonably be expected to have had a lower viral load for most of this time making them les infectious. This can be expected to have significantly slowed the rate of progression of the epidemic in this country.

Sweden is an important case in point which must be mentioned in any intelligent discussion of the NSP movement. Sweden has very limited methadone treatment availability, until recently no NSP activity, and no legal “shooting galleries” and a very low rate of HIV in IVDU. Hence the methods of harm minimization cannot strictly be said to be required for HIV control. Clearly HIV control can occur in a very effective manner in the absence of the model harm minimalist strategies.

The situation in prisons, or penitentiaries, is a special one and well worth at least some specific consideration. I was privileged to give evidence to the Inquiry into the Impact of Illicit Drug Use on Families before the Federal House of Representatives of the Australian Parliament on 3rd April 2007 . During that interview I stated that “my blood ran cold at the thought of 500 inmates all sharing the same syringe barrel” as was recounted to me by one of my HIV positive patients. However typical harm minimalist solutions such as methadone, syringe distribution and bleach use have been found to be impractical in the prison environment, and in this country have triggered strikes and industrial disputes by the prison warders due to the creation of unsafe workplaces. Since making those comments to the committee I have considered what might best be done about this appalling situation. One approach follows below (see “Other Treatment Modalities”).

In essence it is my belief that where the crime for which a person is committed is referable to opiate drugs, the standard of care will become naltrexone implant insertion on admission to the jail (after appropriate detoxification procedures), naltrexone implant maintenance during incarceration, and naltrexone implant prior to discharge to prevent the overdose which so often accompanies discharge (and the ritualistic “get a whack, get a woman” routine which is invariably followed). Indeed in Perth patients discharged from the prison are taken by volunteer escort from the prison gates to the clinic for implantation before the whole destructive cycle can re-commence. This seems the most sensible, responsible and compassionate management of this problem.

Other Treatment Modalities

Naltrexone was fist synthesized in the USA 1963 at Endo laboratory by Matossian acting under Blumberg’s instruction . Naltrexone implants and depot preparations have recently received a lot of attention from the international addiction management literature, and have been commercially introduced in the USA. American developed depot injections typically last 3-4 weeks. A preparation recently developed in this country lasts typically 4-6 months. The results of the first formal clinical trial conducted in Perth will soon be announced, probably in a leading medical journal such as JAMA or New England Medical Journal. They have been extensively used in this clinic where we have inserted over 600 USA (Wedgewood) and Australian (Perth “Go Medical”) implants. I was asked by the Preventative and Community Medicine Committee of the Queensland Faculty of the Royal Australian College of General Practitioners to evaluate naltrexone medicine including the Perth naltrexone program in 1998, and since 2001 I have been involved with the development in Perth of their naltrexone implant.

Unofficially the abstinence rate in terms of not returning to dependent heroin use at five months was well in excess of 50% in a study which set new standards international medical literature for patient follow-up. Only 11% of the 70- patients were lost to follow-up compared to over 90% in a similar (larger) study conducted in leading centres in the USA reported by Hollister in 1977 for NIDA at the NIH . Naltrexone is also a widely recognized and used technique for reducing problem drinking in alcoholics. It has also been used for gambling addiction, with positive results on some occasions. Moreover other results reported from the Perth clinic indicate that naltrexone is likely to have a controlling effect on other chemical addiction such as benzodiazepines, cannabis and stimulants such as amphetamines.

It is my personal view that they are excellent and will soon revolutionize the treatment of opiate addiction. Opiate dependence of course is the most addictive and refractory of all drug addictions, and the possibility of gaining control of such patients in a drug free context, as opposed to the usual medical model involving the indefinite maintenance of addiction, must be one of the most exciting opportunities ever to be offered to physicians in addiction medicine.

Another medical agent which has shown enormous promise in the control of multiple addictions is the cannabinoid antagonist rimonabant (“Accomplia”; SR141716A) which has been used with success against opiate, tobacco, alcohol, amphetamine food and cocaine addictions. This drug has attracted attention from NIDA and is undergoing further testing. I am not sure what its regulatory status is in the USA. It was available in eight European nations when I enquired with the pharmaceutical company (Sanofi-Synthelabo) about four months ago. The drug is still under patent, so this impedes its being re-formulated into an implant or depot preparation.

The combination of naltrexone and rimonabant has yet to be tested but would appear to show obvious promise, and it would be a priority in a rational testing program to investigate this further.

Future Research Directions

Many studies show increased evidence of drug use in young people.

All senior authorities in the world agree that there is far too little resources put towards investigating the toxicological effects of addictive drugs in general, and in adolescents in particular.

If we are ever going to do more than shut the door after the horse has bolted, clearly the issue of the true toxicity of addiction must be much better investigated, and the results of such studies broadcast far and wide to our young people, to de-glamourize the dreadfully seductive marketing program to which the rock music and popular culture misleadingly subjects them. If we are ever going to contain the monster of rampant destructive drug use in our younger people, then their dangers must be better emphasized.

Given the obvious multi-system damage of long term chemical addiction which is immediately apparently to even the untrained observer, one can only conclude which a Science which espouses the relative benignity of addiction must be grossly and egregariously deficient.

I have formulated a detailed plan by which such a strategy can be put in place, based around the accumulated ageing changes evident in the skin, teeth, hair, blood vessels, bones, immune system, stem cells and brains of addicts. It invites international collaboration and multi-system multilevel cooperation and the application of state of the art techniques to classical clinical problems. That however, is another story.

CONCLUSION

In summary NSP’s incur great social cost and are clearly part of the problem rather than part of the solution. Their scientific literature is remarkable for its lack of compelling evidence and methodological rigor, not to mention the prominence of adverse findings, when properly adjudicated. Rather the global penetration of NSP’s is an indicator of the strength of the marketing strategy of the ideology they enshrine. They are in any case about to be phased out like old dinosaurs by the cutting edge technologies which are moving ever closer to being a real market alternative, particularly the revolutionary long lasting Australian naltrexone implant.

I have been advised that now methadone is worth $150/week to dispensing hospitals in Federal hospital subsidies. As some of the most famous institutions in the USA have 10,000 – 20,000 patients enrolled on it, this income source forms a major stream of hospital funding. As such it is not likely to be disrupted. What the management of the Australian HIV epidemic does teach us is that it is best to get on and treat the HIV infection as soon as medically appropriate. In addiction medicine we have up until now largely done the reverse, for there we have deliberately continued indefinitely maintenance treatment designed to not to confront the addicted physiology, but rather to postpone indefinitely the definitive redress of that medical condition. The Australian success with HIV management tends to rather emphasize the reverse approach. This is the therapeutic route suggested by naltrexone implant maintenance. In all the discussion we would appear to have forgotten that in the early 1960’s New York was in urgent need of a treatment for addicted GI’s returning home from Vietnam. Methadone as the only medical solution then available was adopted and quickly came to command tremendous official support to the point where it became in time, the established industry. We have now a far more exciting opportunity to launch naltrexone implants and other new treatments in a similar and innovative manner. In would be my sincere hope that nations can move speedily to deliver proven and safe medical treatments to vulnerable populations without incurring undue, unnecessary and officious regulatory obstruction.

This would appear to be the visionary, drug free and health enhancing approach. As these concepts are more widely understood it is hoped that regulators and administrators will cooperate to mobilize international best medical practice on behalf of those with whose care they have been entrusted. I would invite the legislators of New Jersey to work with us on these issues of major cultural importance.

Yours Sincerely,

A. Stuart Reece, MBBS (Hons.), FRCS (Ed.), FRCS (Glas.), MD, FRACGP.
Family Physician, Highgate Hill Brisbane,
Senior Lecturer, Medical School, University of Queensland,
Fellow, Drug Watch International,
Fellow, Drug Free Australia,
Member, Society for Neuroscience,
Member, International Cannabinoid Research Society,
Attendee, College of the Problems of Drug Dependence Conferences 2002-2006.
Awardee, National Institute of Drug Abuse, International, 2003, 2004, 2006.