Integrating Evidence-Based Practices Within Opioid Treatment
Sun 13th to Wed 16th April 2003
I was privileged to attend the AATOD conference in the Renaissance Washington DC Hotel along with many of our field's eclipsing luminaries. Over 1000 health workers came from all over the US and overseas. Much was said in the formal lectures and workshops, but face-to-face meetings with long-time, long-distance colleagues, in some cases for the first time, was a unique pleasure.
On the Saturday there were pre-conference courses on buprenorphine prescribing in office based practice and another for 'methadone advocates' (NAMA). On the Sunday afternoon, two further parallel 'strands' took place, one for local policy folk, the other involving overseas researchers and clinicians. The latter described experiences in a variety of settings in Switzerland, Italy, Israel, Bulgaria, Ukraine, Slovakia and Slovenia. Two additional American collaborations included talks of neonatal abstinence syndrome (Dr Loretta Finnegan) and high dose methadone prescribing (Dr M. Shinderman). The Canadians and Europeans at the meeting added a much needed bredth of experience. This conference which was pervaded by reaction to the uniquely American antagonism to logical drug policies. This includes regulations preventing doctors from treating their dependent patients in accordance with long-standing concordant research, mostly performed in this country.
On Monday morning we were addressed by Association President Mark Parrino, Washington D.C. Mayor Williams, D.C. Health Director James Buford, DEA Diversion Administrator Laura Nagel and SAMSA Officer Charles Curie. Surveys showed that 7% of Americans interviewed had used an illicit drug in the previous month and it was estimated that 16,000,000 were regular drug users. Surprisingly, this was not used as evidence that current policies fail to protect US families against drug problems. We were, however, reminded that 'treatment works', despite common mythology to the contrary. The virtues and proven benefits of intensive psychosocial supports for maintenance patients were extolled. The speakers quoted from the few good studies which confirm scientifically what Hippocrates described over 2000 years ago (additional services improve medical outcomes).
Parrino and his knowledgeable presenters dwelt on the 'crucial' role of these psychosocial supports. Indeed, as with diabetes and other conditions, such services can significantly improve numerous treatment outcome measures. But we know that even with minimal services, dependent folk can attain positive results in many or even most cases. Nobody would suggest denying such services if they were available, but equally, to deny methadone or other medication in adequate supervised doses, because of a lack of counselors, funding, real estate, etc, would be unacceptable in other fields. The latest moves on buprenorphine prescribing may redress some of the calcification in US policies which continue to deny simple and effective treatments to most American addicts who cannot realistically advocate on their own behalves.
The morning workshops included 'ethnic considerations', smoking cessation, 'harm reduction' integration, office based prescribing and benzo abuse. It was disappointing to me that the conference organisers did not have more practising clinicians among the 14 plenary speakers, most of whom were administrators.
I attended a workshop on a needle exchange information initiative in New York City's Bronx, given by Dr Jennifer McNeely of the Albert Einstein Medical School. She pointed out just how difficult it was to get simple practical information to patients. She had to deal with various levels of administration just to be able to pass on the contact details of 3 Bronx pharmacies selling clean needles and syringes under the new Sate legislation. It would seem that a graffito on the washroom door with the phone contacts would have had the same effect. However, by going through the correct channels, McNeely has wisely ensured that in other states with similar waivers clinics will now be able to do the same thing, thus reducing viral transmission and ultimately saving lives. This in turn may reduce the hysteria in this country over issues such as needle availability. 'Harm reduction' and needle services were under the conference heading of "hot topics". This is intriguing since each is just so uncontroversial as to be official government policy in numerous other countries.
In the Q&A session, I mentioned some details of the Sydney medically supervised injecting center where 69,000 injecting episodes occurred over 2 years with no deaths or other significant problems. One clinic manager from Pennsylvania said that she cannot even get minor changes to her clinic approved and was very pessimistic about a syringe program opening in her state. And a legal injecting room seemed light years away.
Other workshops covered cardiac rhythms in opioid users, Federal Regulation, counselors eduction, 'recovery', addiction nursing, residential care and community transfers. Another was "Administrative Withdrawal: Ethics, Implementation, and Alternatives". Apparently in various places across the country currently there are hundreds or even thousands of patients experiencing this callous indignity for reasons I could not comprehend, considering the this country's abundance of resources.
Next we had an interesting session on the introduction of buprenorphine into practice in the US. Dr Laura McNicholas gave a brief overview of the pharmacology and therapeutics, then Dr David Feillin related a number of trials of the sub-lingual combination drug including naloxone. Most of these trials involved supervised administration of the drug as distinct from the current waiver arrangements to dispense up to a month's supply at a time without supervision. Also, most of the extensive buprenorphine literature has been performed with pure buprenorphine, yet the recommendation is for American physicians to use mainly the combination product with naloxone. The claims that this is safe and effective in both treatment and avoiding diversion are not based on much scientific evidence. This shows that the drug can be abused by novice or occasional users and further, that the naloxone is absorbed up to 10% and has some clinical effects such as pupil changes. In the Q&A session mention was made of a twelve month Swedish/American study which compared buprenorphine maintenance with detox. The detox group had near zero retention rates at 2 months and, worryingly, 20% of the subjects had died. One must question the ethics of giving a virtual placebo treatment to half of such trial cases without some formal safety net.
On the Tuesday morning there were 4 papers delivered at the first plenary session. Before introducing Marc Gourevitch of the Bronx in New York City, Andrea Barthwell alluded to a concept I have always avoided: "conquering addiction". The term "brain disease" was also used in the plenaries, reflecting official policy edicts from the 1990s. The problem is that if drug addiction is a brain disease, then about 90% of us have it! I feel on safer ground calling drug dependency a 'condition'. Then, like dandruff, pregnancy, obesity or baldness, it is the sufferers who can decide if and when it becomes a 'disease' (and there were numerous user representatives present at the meeting). Dr Gourevitch spoke modestly and authoritatively about co-existing disorders in dependent patients.
Dr Leonard Seeff was ill and at short notice Dr Larry Brown spoke well on the difficult subject of HIV in dependent patients. Dr George Woody then dealt with non drug related symptoms in dependent patients. He quoted DSM IV and even later definitions of the various presentations (mentioning that the DSM V was due out in 2010!). Symptoms from a number of pre-treatment surveys found high rates of anxiety, phobic disorders, ASPD, auditory hallucinations, etc. We were also told that just as drug users suffer from a wide variety of psychiatric disorders, equally, up to 50% of mental patients can present with co-existing substance abuse problems. When the primary condition is treated the other symptoms will resolve spontaneously in a proportion of cases. We were told that two weeks was a good interval in new methadone patients to reassess such problems which may need specific interventions such as antidepressants. It would appear that MMT can improve depression, anxiety and in some cases paranoid symptoms. It has long been believed that opioids have some anti-psychotic properties.
Regarding hepatitis and HIV infections, "prevention is better than cure" is an old maxim which was apparently NOT emphasised. Needle availability was an unpardonable omission in these plenaries. It is disappointing when respected scientific experts fail to say what needs to be said. Needle availability prevents viral disease transmission and does NOT encourage drug use. Several US states have introduced 'waivers' against the bans on pharmacies selling injecting equipment (see workshop above).
After the morning plenaries there were workshops on a variety of issues: dual diagnosis, homelessness, pregnant patients. In a well attended session, Dr Peter DeMaria spoke about 'Optimizing methadone doses'. He used a number of case histories to show that dose manipulation, splitting, increases, etc can turn around a 'failure' in treatment. One case history was a MMT patient who had used heroin continuously for 12 months in treatment while on 120mg daily. While it was helpful to examine the methadone level and a dose increase, it might also be questioned why the patient was treated for twelve months in this clearly unstable state, and all the attendant risks (but better late than never!).
DeMaria also took us back to the basic pharmacology of methadone to explain withdrawal symptoms with a helpful graph of methadone levels over 48 hours and thus two doses. He reminded us of the words of Sir William Osler: "Listen to the patient, he's telling you what's wrong with him". [I seem to recall that Osler continued: "... and if you listen hard enough he may also tell you the treatment"].
DeMaria stated that daily doses of 80 to 120mg are adequate for about three quarters of patients, but that others, some with aberrant metabolism need extra, split doses or alternative drug or non-drug treatments. Drug interactions were covered in detail, including phenytoin, fluvoxamine, antiretrovirals (three of them only), anti-fit meds etc. It was gratifying that the hall was packed with attentive clinicians from all over the US since one major consistent finding of surveys of clinics is inadequate dose levels across the board (this also occurs in Australia, Great Britain and elsewhere). Then we had mention of the stereoisomers of methadone and cytochrome metabolism ... rather too complex and speculative for us front-line workers perhaps, unlike the rest of this practical presentation.
Another session, by researcher and editorialist Stewart Leavitt, was entitled "Can Addiction Research be Trusted?" He helped us with just how to assess the clinical significance of particular studies from the anecdotal ('n=1') to RCT to the hallowed 'metanalysis'. But he warned that some such studies may be "gigo" (garbage in, garbage out) since overall conclusions are only as reliable as the data they are based on. Leavitt also gave us a timely lesson on the two common ways of interpreting studies over time (1) ITT or 'intention to treat' and (2) PP 'per protocol' (analysis of only those who finish the intervention). Both have pros and cons depending on the proportion of drop outs. He introduced the terms "PLUS-cebo" (for positive effects) and "NOCI-bo" (harm causing) for the more usual term for 'dummy' treatments which do often have apparent effects in trial subjects.
Leavitt then shattered the illusion of the "Farmington consensus" (which may not be a 'consensus' at all) that all research associated with 'inappropriate' sponsorship should be rejected for publication. This ban, largely aimed at tobacco and alcohol sponsorship, could also be levelled at drug companies, health authorities, policing interest, drug cartels, etc. Dr Leavitt pointed out that all research is biased by the nature of the authors, their background, ethnicity, funding, etc. Thus it is the reader who should look at what is disclosed regarding possibly conflicts of interest, who is writing/funding the research and then decide for themselves its 'rigour' and/or relevance for their practices. 'Publication bias' was also covered in which studies which have positive outcomes are more likely to be completed and published. Laura McNicholas MD from Philadelphia VA questioned some details from the floor concerning research samples - which were clarified. Extensive references and comprehensive handouts were given on a number of clinical and ethical matters of interest and the declaration that Leavitt's service is sponsored by a manufacturer of methadone and naltrexone.
The Tuesday evening dinner included 13 awards in honour of Vincent P. Dole and Marie Nyswander who together pioneered methadone treatment. While I have no objection to credit being recognised when it is due, Washington DC is hardly the place for accolades over drug treatment or policy in the centre of these continuing epidemics (addition, HIV, hepatitis C). Hence to avoid any ill feeling, I avoided this part of the proceedings and retired back to my lodgings early to gather my thoughts. It had been a marvellous three days meeting up with dozens of colleagues from all over the US as well as further afield.
I have great admiration for all these dedicated and hard working front-line professionals, some of whom operate in situations of poor funding, dangerous work environments and limited scope for professional advancement. Even simple advocacy can be hazardous in America. But one remains in hope of improvements, and that conferences like this might seed some such positive moves.
The above is not intended to be a comprehensive summary of the conference which also had 22 diverse poster displays and many other workshops, plenaries and 'round table' discussions I could not get to.