27 April 2014

15 years of client representation in New York.

15th Anniversary celebration of the New York VOCAL group (Voices of Community Advocates & Leaders in New York).
There was a true celebratory mood amongst those who attended and EVERYONE had interesting stories to tell and were most welcoming to this outsider from down-under.  Many photos of the evening have been posted on the VOCAL web site ... there were politicians, drug law reform advocates, treatment / research sectors joining the user group members (the latter funded by the former in a clever 'deal').  Ethan Nadelmann, Tony Newman, Marsha Rosenbaum, Ira Glasser and Gabriele Sayegh were present from the DPA while there were many other familiar faces, all delightful but don't ask me for names!  
On arriving at the venue there was incredible energy, enthusiasm and electricity in the magnificent 33rd floor penthouse in West 42nd Street next to the Port Authority bus terminal.  The brief walk from Times Square at rush hour was an education in itself as most days in New York tend to be. 
The presentations were to honor:
Each spoke well and it was an uplifting event for all.  In very different fields these honorees had each devoted time and energies on aspects of relieving suffering for those with addictions, viral infections and other consequences of under-privilege. 
I met up with dozens of people at the function and would estimate that about half were professionals and half user/client representatives.  Some of course were both.  Each seemed to have very interesting stories, deep insights and individual perspectives on the subjects.  By 9pm I was longing to meet somebody who was boring! 
Photos have been posted by an efficient organisation: https://www.flickr.com/photos/vocal-ny/sets/72157643893705294/
Written by Andrew Byrne ..
It might seem churlish to say the our Australian equivalents, NUAA and Family Drug Support (and VIVAIDS) were started 25 and 17 years ago respectively.  But considering all the barriers and difficulties that exist in a country of Puritan origin, it is a wonder that there is such a group at all.  I note the groups name is not really descriptive of their charter which started originally with housing for HIV sufferers. 

21 April 2014

"Is the War on Drugs Over?" New York panel discussion.

April 4, Vanderbilt Hall, Law School, NYU. "Is the War on Drugs Over?" A Panel Discussion on the Drug War's Effects on Human Rights and US Policies.
Three panel members (the fourth cancelled in unfortunate but almost humorous circumstances) were very actively chaired by Mattathias Schwartz. 
Kathleen Frydl is an award-winning historian of US policies.  Her most recent book, Drug Wars in America 1940-1973, was hailed by SUNY Professor Paul Gootenberg as "the most compelling scholarly book to date written on America's post-war transition to punitive domestic drug policy". 
Hamilton Morris is a research chemist and an expert on synthetic and psychedelic drug and contributes to Harper's and is science editor at Vice, where he hosts "Hamilton's Pharmacopeia", a video series. 
Cesar Gaviraia served as President of Colombia from 1990 to 1994 and Secretary General of the Organisation of American States from 1994 to 2004.  He is a member of the Global Commission on Drug Policy, which has advocated a shift towards de-criminalization, harm reduction, and demandside anti-drug programs. 
Michael Botticelli is Acting Director of the White House Office of National Drug Control Policy, also know as the office of the drug czar.  He previously served as Director of the Bureau of Substance Abuse Services for the State of Massachusetts. [cancelled and no substitute available]
Vice drug czar Mr Michael Botticelli was missing in action having apparently had an underling call the moderator earlier to cancel.  We were told an amusing description of the chain of events.  Moderator Mr Swartz asked if another drug office person might fill in and when that was declined, even the staffer, who seemed to be very knowledgeable about the subject himself, was asked if he would like to attend and represent the Government.  No go.  
This chain of events is hardly surprising in the current climate where popular opinion and science are diametrically opposed to long-time official Washington policy.  One of the pertinent comments of the evening was a question as to how one might get members of a prohibitionist orientated administration into the same room as the activists, doctors and public health experts.  My answer from Australian experience would be to wait until a member of one of the high profile families is affected by drugs or, even more likely, affected adversely by current drugs policy in America. 
The moderator was highly effective young journalist Mattathias Schwartz who writes on national security and state power for The New Yorker, the London Review of Books, and other publications.  "A Mission Gone Wrong," his most recent New Yorker story, gives a history of the drug war as waged abroad.  [A rather long-winded but fascinating article available on http://www.newyorker.com/reporting/2014/01/06/140106fa_fact_schwartz?currentPage=all  ]
This meeting was one of the most enlightening I have been to in some time.  It was held in the beautiful and high-tech Vanderbilt lecture hall at NYU Law School near Washington Square.  Three eminent speakers and an on-side (the side of reason) moderator were unanimous in agreeing that the drug war was not yet over, although signs were present that an end might be in sight, at least for some aspects of that long, expensive and unproductive conflict/noble experiment. 
Mr Schwartz asked ex-President Gavaria if he would still condone his governments pursuit and assassination of Pablo Escobar in 1993.  Schwartz repeated his proposition that Escobar might have just been replaced by another king-pin anyway and asked if it was therefore right to go ahead with his killing.  Gavaria had no hesitation is saying that as a fugitive and acting against the countrys rule of law that of course action had to be taken against him.  However, the ex-President followed up by saying that the breaking of the Escobar cartel made little if any difference to the flow of drugs northwards which continues to this day unabated.  Mr Gavaria emphasised that only measures which affect demand in the consumer countries can have any meaningful effect on this. 
El ex-Presidente then spoke at length about numerous issues, belabouring and berating journalists and politicians especially for their lack of attention to drug related matters.  He described modern journalism as the art of the unusual, (making quite a lot of sense to my mind).  He said that nobody wanted to hear about public health statistics but anecdotes, even those contrary to trends, are more likely to be published prominently than small changes elsewhere which might save hundreds of lives.  He gave an example of legalisation of cannabis in which a teenager has a car accident and kills a family while intoxicated even though the main game of crime, corruption and medical consequences are far more significant to the country. 
He then told us that one of the worst consequences of being placed on schedule one meant effectively that scientific research on that drug was effectively prevented as the drugs could only be obtained in exceptional circumstances with enormous paperwork and safeguards.  Hamilton mentioned that this was a disaster, especially for LSD and numerous other drugs which had shown promise in certain diverse medical and clinical fields, migraine being just one he mentioned.
Morris Hamilton then mentioned that just one day before the seminar, naloxone had been approved by the FDA for public dispensing.  An off-label nasal formulation of the opioid reversal agent has been widely circulated already in some states.  ‘Evzio’ will be marketed by Kaleo but it is not clear who will pay  the estimated $200 for each unit - which will include audible instructions once the unit is opened, rather like a defibrillator.  http://www.bostonglobe.com/lifestyle/health-wellness/2014/04/03/fda-approves-user-friendly-device-reverse-opioid-drug-overdoses/aPUzTAmmY0uMGQn3PwMR7H/story.html
In addition, we were given some intriguing information about the leglisation of all synthetic cannabinoids in New Zealand, contrary to trends elsewhere to continue banning anything which appeared to be popular (see http://www.huffingtonpost.com/2013/08/02/new-zealand-drug-law_n_3696809.html  )
Other panellists pointed out the fallacy of banning a relatively safe drug like cannabis when legal alternatives may turn out to be far more dangerous and are only or largely used because of prohibition of the progenitor.  Spice, bath salts and other designer drugs were mentioned. 
More than once the Presidente made a statement which was highly controversial with the other panellists and some audience members: All drugs are bad.  He defended this, but after much goading, finally admitted that it was just necessary politically to make such statements.  Yet others pointed out that all drugs could be bad and all drugs could be good and it was the set and setting which made the difference.  It was Paracelsus who wrote (in Latin) that the difference between a poison and a drug was just the dose.  That might apply to homeopathy as well. 
Ms Frydl made the point that she was agnostic about good and bad with drugs.  When it comes to what should be more strongly regulated she said that such decisions should be based on evidence of actual harms, and the consequences of regulation.  So often it was said that the bans were more harmful than the drug itself.  She mentioned work of the DPA and the legalization issues and an audience member pointed out that DPA supremo Ethan Nadelmann was present in the room.  He had in fact just been in New Zealand giving a keynote address to a conference partly devoted to the new synthetic drug laws. 
It was pointed out that prohibition did sometimes work as with methaqualone and some analgesics.  Yet the flat balloon analogy was used by El Presidente that if you restrict one popular drug then another will take its place very quickly, sometimes with disastrous consequences.  One panel member said that recent changes in availability of prescribed opioids in places like Vermont had cause them to be largely replaced with street heroin which in turn had been associated with very high numbers of overdoses … every one preventable.  Vermont has one single methadone program which is totally inadequate for a state which has a rural population and long distances for most residents to reach such a facility.  Fortunately buprenorphine is available for some who can afford it. 
In question time I made a comment about the lamentable reluctance of Americans to allow their doctors to prescribe methadone and of their pharmacists to supervise its administration.  Ms Frydl interjected that methadone is always available in clinics in this country (a rather pusillanimous sentiment considering waiting lists and high costs to consumers).  I was surprised but touched that the Colombian ex-President said that some of the most sensible comments and arguments he had heard had come from Australian physicians (probably including Dr Alex Wodak who often speaks common sense at international forums on the subject). 
We were told that one major factor in the repeal of alcohol prohibition in America was the fear of the general population that they would be subjected to income tax, something which only affected the very rich in that era.  Legalising alcohol again would ensure a flow of excise funds to government to use for schools, hospitals, etc.  I had never heard of this before, always assuming that it was the mothers of America’ who were campaigning against the occurrence of truancy and drunken school children who were the main force against the prohibition of the 1920s.  Maybe it was both. 
Very brief and incomplete summary of this informative talkfest - written by Andrew Byrne ..

9 April 2014

Noble attempt to tease out role of dose supervision in OTP.

Holland R, Maskrey V, Swift L, Notley C, Robinson A, Nagar J, Gale T, Kouimtsidis C. Treatment retention, drug use and social functioning outcomes in those receiving 3 months versus 1 month of supervised opioid maintenance treatment. Results from the Super C randomized controlled trial. Addiction 2014 109;4:596-604 
Summary: Dose supervision is the last frontier of our OTP evidence base.  All seem agreed with early supervised induction doses yet there are very different views on the use of unsupervised (take-home/take-away) doses and when these can safely be introduced.  The UK has commonly used unsupervised methadone while America and France introduced unsupervised buprenorphine despite virtually no research on these protocols (Fudala used supervision for most of his trial).   This second attempt should not deter these authors from trying again, perhaps using some international input. 
Dear Colleagues, 
These authors assessed 627 patients entering opioid maintenance treatment of whom 32% were deemed to need daily, supervised doses and 5% were deemed to need (or deserve?) unsupervised dosing.  Another ~15% were excluded for other reasons, leaving 298 subjects who were randomised to 3 months daily supervised dosing or daily dose collection with self administration, at the clinician's discretion after the first month of daily supervised dosing.  The primary outcome was retention at 3 months which showed no significant difference (74% in the un-supervised group versus 60%).  By 6 months the retention was within 1% for the two groups, approximately 55% a finding which is in keeping with other reports (Bell 2006).   Nor were any differences found in illicit opioid use. 
Some trends here seemed to run contrary to a pilot study in Scotland by the same first author yet these differences are not addressed directly although another study from Italy is quoted as being consistent in some respects.  It would be a spurious to conclude that no significant difference proves supervision is unnecessary until or unless a larger and more rigorous study were conducted. 
Unfortunately, like much research from the UK (notably the NTORS study) this trial provides little information for clinicians giving opioid maintenance.  The authors take a form of treatment which is used around the world (supervised daily initiation) and then compare it with a home-grown practice of daily attendance for dispensed doses to take home for unsupervised consumption.   This protocol also prevents a valid comparison with other studies comparing varying numbers of dispensed doses each week (see Rhoades et al. who examined 2 versus 5 dispensed doses weekly on two dose levels). 
The authors state that supervised dispensing is more costly than non-supervised, without any references.  Our own experience is that it is cheaper, simpler and faster to give a supervised dose at the counter than to make up a bottle, seal it with a child resistant lid, label it and place it into a suitable bag for the patient to take away.  They state further that the practice of supervised consumption implies a lack of trust yet there is a trend for supervised consumption of medication in many other fields of medicine, mostly with positive outcomes (eg. malaria, TB, HIV, vaccinations, STD, UTI).  The question of trust might equally well be posed in the reverse: can the patient trust the doctor to prescribe in the most effective manner?  Unsupervised treatment is simply not evidence-based in the addiction area.  
Some parts of the UK have poor quality maintenance treatments: very little methadone was supervised and doses were often grossly inadequate (mean 37mg daily in 1999 according to J. Strang and Sheridan).  It should therefore be of no surprise that there is a vigorous market locally for illicit opioid including methadone (more than one third of these subjects reported the use of illicit methadone on entering treatment).  Furthermore OTP in the UK has a poor image it would appear. 
This study by Holland et al. excluded fully half the possible subjects based on whether the clinician believed the patient did or did not need supervised dosing, the very subject which the researchers are trying to test.  It makes rather a mess of the thesis being examined yet this subject is serious and worthy of debating and research which has been sorely lacking to date. 
The authors point out that the data were collected by existing staff which may introduce a favour bias.  Many UK clinicians defend unsupervised treatment yet there is still no controlled research to demonstrate its safety and effectiveness (and much to indicate that opioid maintenance in the UK is a disaster with the government effectively trying to ban all but reduction treatment programs if my reading is correct).  I believe that as with Rhoades work, the effort should be to carefully examine the use of extended take-home protocols and examine the numerous outcome measures.  Of course one cannot perform a double blind trial of two such physically different interventions. 
In America over the past ten years a national guideline (not evidence based in my view) has allowed many patients to take 4 weeks supply of methadone (one supervised dose plus 27 take-home bottles) even after a relatively short period of documented stability.  Yet I could find no published research on this noble experiment apart from the very old monthly maintenance trial at Beth Israel, New York (Novick et al.) which mostly had positive results. 
Holland et al. discuss an apparently significant finding in their data whereby unsupervised patients seem to be involved in less crime.  However, they to not canvass the possibility that those receiving unsupervised methadone may have less financial pressure if selling a proportion of their medication.  When I contacted the authors I was told this was a possibility despite denials of diversion in patient questionnaires.  The mean daily dose (sent to my kindly by the first author) at 58mg is in fact less than the minimum effective dose for the majority of patients as quoted by Strangs group at 60mg daily.  They advised 60-120mg daily for most opiate dependent patients.  The dose level of buprenorphine was much the same as elsewhere at 10.5mg daily (for which I thank Dr Holland).  Vincent Dole, whose group originally devised methadone maintenance treatment in New York, stated that with appropriate treatment illicit opiate use should be eliminated in 90% of dependent individuals.  But this requires sufficient psychosocial support, adequate doses and some degree of supervision. 
The elephant in the room on this subject, not addressed by these authors, is public perception.  It is far easier to justify a program which supervises methadone doses for a population who, by definition, have lost some control over their drug use.  As these authors state at the start of their article: Supervision ensures that patients take their medication as prescribed and prevents illicit drug diversion [sic]. Daily supervised treatment (often with one take-home dose for Sunday) is the proven standard for treatment induction, as long as there is no contraindication (homelessness, actively using family members, current psychosis, acute concurrent alcoholism, etc where even Sunday supervision is advised where possible). 
As in other fields of medicine all decisions should be reviewed in light of the patients response to treatment, in this case, judged by attendance, self-report, physical examination of veins, pupils, etc and urine or blood testing.  Most patients can be successfully treated by second or third daily attendance within the first year in our experience (meaning 3 to 5 take-home doses weekly).  Increased supervision occasionally has to be reintroduced if the clinician and or the patient finds their control is again being lost.  Others can move to less frequent attendance before leaving treatment after sufficient time on reducing dose schedules when this is tolerated. 
Another canard is prison entry.  For an inmate on supervised treatment a dose, any dose level can confidently be administered on receipt of written confirmation of last-dose and ID information from the community pharmacy or clinic.  For non-supervised patients however, prison medical staff are obliged to follow induction protocols in the case of a patient who might not be taking all of their daily doses.  In such a case even a single dose could be fatal (~70mg is considered a lethal dose in non-dependent adults where the average dose on most well run programs is higher than this). 
Comments by Andrew Byrne ..
Declaration of potential conflict of interest: Dr Byrnes clinic charges a fee for supervising the administration of methadone and buprenorphine. 
Holland R, Matheson C, Anthony G, Roberts K, Priyardarshi S, Macrae A, Whitelaw E, Appavoo S, Bond C. A pilot randomised controlled trial of brief versus twice weekly versus standard supervised consumption in patients on opiate maintenance treatment. D&A Rev 2012 6:483-91
Strang J, Sheridan J, Hunt C, Kerr B, Gerada C, Pringle M. The prescribing of methadone and other opioids to addicts: national survey of GPs in England and Wales. Brit J General Practice 2005 55;515: 444-451
Rhoades HM, Creson D, Elk R, Schmitz J, Grabowski J.  Retention, HIV Risk, and Illicit Drug Use during Treatment: Methadone Dose and Visit Frequency. 1998 Am J Public Health 88:34-39
Novick DM, Joseph H, Salsitz EA, Kalin MF, Keefe JB, Miller EL, Richman BL. Outcomes of Treatment of Socially Rehabilitated Methadone Maintenance Patients in Physician's Offices (Medical Maintenance). J Gen Intern Med. 1994 9:127-30
Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, Collins J, Raisch D, Casadonte P, Goldsmith RJ, Ling W, Malkerneker U, McNicholas L, Renner J, Stine S, Tusel D. Office-Based Treatment of Opiate Addiction with a Sublingual-Tablet Formulation of Buprenorphine and Naloxone. NEJM (2003) 349:949-958
Drug Misuse and Dependence - Guidelines on Clinical Management. (1999) HMSO Department of Health. Working Group Chair: Strang J.