s New York Grand Rounds: ADHD and dependency; acupunture in addiction syndromes; ketamine in severe depression. | I2P: Information to Pharmacists - Archive
Publication Date 01/07/2014         Volume. 6 No. 6   
Information to Pharmacists


From the desk of the editor

Welcome to the July 2014 homepage edition of i2P (Information to Pharmacists) E-Magazine.
At the commencement of 2014 i2P focused on the need for the entire profession of pharmacy and its associated industry supports to undergo a renewal and regeneration.
We are now half-way through this year and it is quite apparent that pharmacy leaders do not yet have a cohesive and clear sense of direction.
Maybe the new initiative by Woolworths to deliver clinical service through young pharmacists and nurses may sharpen their focus.
If not, community pharmacy can look forward to losing a substantial and profitable market share of the clinical services market.
Who would you blame when that happens?
But I have to admit there is some effort, even though the results are but meagre.
In this edition of i2P we focus on the need for research about community pharmacy, the lack of activity from practicing pharmacists and when some research is delivered, a disconnect appears in its interpretation and implementation.

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Newsflash Updates for July 2014

Newsflash Updates

Regular weekly updates that supplement the regular monthly homepage edition of i2P. 
Access and click on the title links that are illustrated

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Feature Contribution

Woolworths Pharmacy - Getting One Stage Closer

Neil Johnston

It started with “tablet” computers deployed on shelves inside the retailer Coles, specifically to provide information to consumers relating to pain management and the sale of strong analgesics.
This development was reported in i2P under the title Coles Pharmacy Expansion and the Arid PGA Landscape”
In that article we reported that qualified information was a missing link that had come out of Coles market research as the reason to why it had not succeeded in dominating the pain market.
Of course, Woolworths was working on the same problem at the same time and had come up with a better solution - real people with good information.

Comments: 5

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Intensive Exposition without crossing over with a supermarket

Fiona Sartoretto Verna AIAPP

Editor's Note: The understanding of a pharmacy's presentation through the research that goes into the design of fixtures and fittings that highlight displays, is a never-ending component of pharmacy marketing.
Over the past decade, Australian pharmacy shop presentations have fallen behind in standards of excellence.
It does not take rocket science - you just have to open your eyes.
Recently, our two major supermarkets, Woolworths and Coles, have entered into the field of drug and condition information provision - right into the heartland of Australian Pharmacy.

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The sure way to drive business away

Gerald Quigley

I attended the Pregnancy, Baby and Children’s Expo in Brisbane recently.
What an eye and ear opening event that was!
Young Mums, mature Mums, partners of all ages, grandparents and friends……...many asking about health issues and seeking reassurances that they were doing the right thing.

Comments: 1

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‘Marketing Based Medicine’ – how bad is it?

Baz Bardoe

It should be the scandal of the century.
It potentially affects the health of almost everyone.
Healthcare providers and consumers alike should be up in arms. But apart from coverage in a few credible news sources the problem of ‘Marketing Based Medicine,’ as psychiatrist Dr Peter Parry terms it, hasn’t as yet generated the kind of universal outrage one might expect.

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Community Pharmacy Research - Are You Involved?

Mark Coleman

Government funding is always scarce and restricted.
If you are ever going to be a recipient of government funds you will need to fortify any application with evidence.
From a government perspective, this minimises risk.
I must admit that while I see evidence of research projects being managed by the PGA, I rarely see community pharmacists individually and actively engaged in the type of research that would further their own aims and objectives (and survival).

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Organisational Amnesia and the Lack of a Curator Inhibits Cultural Progress

Neil Johnston

Most of us leave a tremendous impact on pharmacies we work for (as proprietors, managers, contractors or employees)—in ways we’re not even aware of.
But organisational memories are often all too short, and without a central way to record that impact and capture the knowledge and individual contributions, they become lost to time.
It is ironic that technology has provided us with phenomenal tools for communication and connection, but much of it has also sped up our work lives and made knowledge and memory at work much more ephemeral.

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Academics on the payroll: the advertising you don't see

Staff Writer

This article was first published in The Conversation and was written by Wendy Lipworth, University of Sydney and Ian Kerridge, University of Sydney
In the endless drive to get people’s attention, advertising is going ‘native’, creeping in to places formerly reserved for editorial content. In this Native Advertising series we find out what it looks like, if readers can tell the difference, and more importantly, whether they care.
i2P has republished the article as it supports our own independent and ongoing investigations on how drug companies are involved in marketing-based medicine rather than evidence-based medicine.

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I’ve been thinking about admitting wrong.

Mark Neuenschwander

Editor's Note: This is an early article by Mark Neuenschwander we have republished after the soul-searching surrounding a recent Australian dispensing error involving methotrexate.
Hmm. There’s more than one way you could take that, huh? Like Someday when I get around to it (I’m not sure) I may admit that I was wrong about something. Actually, I’ve been thinking about the concept of admitting wrong. So don’t get your hopes up. No juicy confessions this month except that I wish it were easier for me to admit when I have been wrong or made a mistake.
Brian Goldman, an ER physician from Toronto, is host of the award-winning White Coat, Black Art on CBC Radio and slated to deliver the keynote at The unSUMMIT for Bedside Barcoding in Anaheim this May. His TED lecture, entitled, “Doctors make mistakes. Can we talk about it?” had already been viewed by 386,072 others before I watched it last week.

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Dispensing errors – a ripple effect of damage

Kay Dunkley - BPharm, Grad Dip Hosp Pharm, Grad Dip Health Admin, MPS, MSHPA

Most readers will be aware of recent publicity relating to dispensing errors and in particular to deaths caused by methotrexate being incorrectly packed in dose administration aids.
The Pharmacy Board of Australia (PBA), in its Communique of 13 June 2014, described a methotrexate packing error leading to the death of a patient and noted “extra vigilance is required to be exercised by pharmacists with these drugs”.
This same case was reported by A Current Affair (ACA) in its program on Friday 20 June

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Take a vacation from your vocation

Harvey Mackay

Have you ever had one of those days when all you could think was, “Gosh, do I need a vacation.”
Of course you have – because all work and no play aren’t good for anyone.
A vacation doesn’t have to be two weeks on a tropical island, or even a long weekend at the beach. 
A vacation just means taking a break from your everyday activities. 
A change of pace. 
It doesn’t matter where.
Everyone needs a vacation to rejuvenate mentally and physically. 
But did you also know that you can help boost our economy by taking some days off? 
Call it your personal stimulus package.

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Explainer: what is peer review?

Staff Writer

This article was first published in the Conversation. It caught our eye because "peer review" it is one of the standards for evidence-based medicines that has also been corrupted by global pharma.
The article is republished by i2P as part of its ongoing investigation into scientific fraud and was writtenby Andre Spicer, City University London and Thomas Roulet, University of Oxford
We’ve all heard the phrase “peer review” as giving credence to research and scholarly papers, but what does it actually mean?
How does it work?
Peer review is one of the gold standards of science. It’s a process where scientists (“peers”) evaluate the quality of other scientists' work. By doing this, they aim to ensure the work is rigorous, coherent, uses past research and adds to what we already knew.
Most scientific journals, conferences and grant applications have some sort of peer review system. In most cases it is “double blind” peer review. This means evaluators do not know the author(s), and the author(s) do not know the identity of the evaluators.
The intention behind this system is to ensure evaluation is not biased.
The more prestigious the journal, conference, or grant, the more demanding will be the review process, and the more likely the rejection. This prestige is why these papers tend to be more read and more cited.

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Dentists from the dark side?

Loretta Marron OAM BSc

While dining out with an elderly friend, I noticed that he kept his false tooth plate in his shirt pocket. He had recently had seven amalgam-filled teeth removed, because he believed that their toxins were making him sick; but his new plate was uncomfortable. He had been treated by an 'holistic dentist'. Claiming to offer a "safe and healthier alternative" to conventional dentistry, are they committed to our overall health and wellbeing or are they promoting unjustified fear, unnecessarily extracting teeth and wasting our money?

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Planning for Profit in 2015 – Your key to Business Success

Chris Foster

We are now entering a new financial year and it’s a great time to reflect on last year and highlight those things that went well and those that may have impacted negatively in the pursuit of your goals.
It's also a great to spend some time re-evaluating your personal and business short, medium and long term goals in the light of events over the last year.
The achievement of your goals will in many cases be dependent on setting and aspiring to specific financial targets. It's important that recognise that many of your personal goals will require you to generate sufficient business profits to fund those aspirations

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Attracting and Retaining Great People

Barry Urquhart

Welcome to the new financial year in Australia.
For many in business the past year has been described as a challenging period.
Adjectives are a key feature of the English language.  In the business lexicon their use can be, and often is evocative and stimulate creative images.  But they can also contribute to inexact, emotional perceptions.
Throughout the financial pages of newspapers and business magazines adjectives abound.
References to “hot” money draw attention and comment.  The recent wave of funds from Chinese investors, keen to remove their wealth from the jurisdiction and control of government regulations is creating a potential property bubble in Australia.

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Updating Your Values - Extending Your Culture

Neil Johnston

Pharmacy culture is dormant.
Being comprised of values, unless each value is continually addressed, updated or deleted, entire organisations can stagnate (or entire professions such as the pharmacy profession).
Good values offer a strong sense of security, knowing that if you operate within the boundaries of your values, you will succeed in your endeavours.

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Evidence-based medicine is broken. Why we need data and technology to fix it

Staff Writer

The following article is reprinted from The Conversation and forms up part of our library collection on evidence-based medicines.
At i2P we also believe that the current model of evidence is so fractured it will never be able to be repaired.
All that can happen is that health professionals should independently test and verify through their own investigations what evidence exists to prescribe a medicine of any potency.
Health professionals that have patients (such as pharmacists) are ideally placed to observe and record the efficacy for medicines.
All else should confine their criticisms to their evidence of the actual evidence published.
If there are holes in it then share that evidence with the rest of the world.
Otherwise, do not be in such a hurry to criticise professions that have good experience and judgement to make a good choice on behalf of their patients, simply because good evidence has not caught up with reality.

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Laropiprant is the Bad One; Niacin is/was/will always be the Good One

Staff Writer

Orthomolecular Medicine News Service, July 25, 2014
Laropiprant is the Bad One; Niacin is/was/will always be the Good One
by W. Todd Penberthy, PhD

(OMNS July 25, 2014) Niacin has been used for over 60 years in tens of thousands of patients with tremendously favorable therapeutic benefit (Carlson 2005).
In the first-person NY Times best seller, "8 Weeks to a Cure for Cholesterol," the author describes his journey from being a walking heart attack time bomb to a becoming a healthy individual.
He hails high-dose niacin as the one treatment that did more to correct his poor lipid profile than any other (Kowalski 2001).

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Culture Drive & Pharmacy Renewal

Neil Johnston

Deep within all of us we have a core set of values and beliefs that create the standards of behaviour that we align with when we set a particular direction in life.
Directions may change many times over a lifetime, but with life experiences and maturity values may increase in number or gain greater depth.
All of this is embraced under one word – “culture”.
When a business is born it will only develop if it has a sound culture, and the values that comprise that culture are initially inherent in the business founder.
A sound business culture equates to a successful business and that success is often expressed in the term “goodwill” which can be eventually translated to a dollar value.

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ReWalk™ Personal Exoskeleton System Cleared by FDA for Home Use

Staff Writer

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk.
ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

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Pharmacy 2014 - Pharmacy Management Conference

Neil Johnston

The brave new world of health and wellness is not the enemy of Pharmacy, it is its champion.
Australian futurist, Morris Miselowski, one of the world's leading business visionaries, will present the Opening Keynote address on Pharmacy's Future in the new Health and Wellness Landscape at 2.00pm on Wednesday July 30.
Morris believes the key to better health care could already be in your pocket, with doctors soon set to prescribe iPhone apps, instead of pills.
Technology will revolutionise the health industry - a paradigm shift from healthcare to personal wellness.
Health and wellness applications on smartphones are already big news, and are dramatically changing the way we manage our personal health and everyday wellness.

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Generation and Application of Community Pharmacy Research

Neil Johnston

Editor’s Note: We have had a number of articles in this issue relating to pharmacy research.
The PGA has conducted a number of research initiatives over the years, including one recently reported in Pharmacy News that resulted from an analysis of the QCPP Patient Questionnaire.
Pharmacy Guild president, George Tambassis, appears to have authored the article following, and there also appears to be a disconnect between the survey report and its target audience illustrated by one of the respondent comments published.
I have asked Mark Coleman to follow through, elaborate and comment:

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New York Grand Rounds: ADHD and dependency; acupunture in addiction syndromes; ketamine in severe depression.

Dr Andrew Byrne & Associates

articles by this author...

A Harm-Minimisation Research Perspective: Dr Byrne (and his associates) advocate for better policies which are proven to reduce risks for drug users and the general community, under a framework in parallel with Australia’s official policy of harm minimisation.

Wednesday, 2nd May 2012 10.30am Addiction Grand Rounds, Bellevue Hospital Center, 1st Avenue @ 26th St, Manhattan, NYC. 
I was privileged to hear three registrars at Bellevue Hospital in Manhattan discuss literature reviews on three interesting topics. 

* Dr Erin Zerbo spoke on ‘ADHD and Co-Morbid Substance Abuse’
* Dr Crystal Tholany dealt with ‘Acupuncture in dependency practice’
* Dr Joseph Kwon addressed ‘Ketamine for Treatment of Depression’

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1. ADHD & Co: Dr Zerbo.

We learned that ADHD was extremely prevalent, affecting 6-9% of children with ½ to 2/3 of cases persisting into adulthood, making ~4.4% of US adult population (~8 million victims).

Since 10-30% of adults have substance use disorder (SUD) there is a very large overlap of these groups. This was shown starkly in The National Comorbidity Survey Replication (n=3000) where prevalence of ADHD in those with a SUD was 11% while in those without SUD it was only 4%. The same survey showed that SUD was present in 15% of those respondents with ADHD but only 5.5% of those not having the ADHD. Four other studies (each 100-300 subjects) showed a high prevalence (10-24%) of DSM diagnosed ADHD in those with alcohol, cocaine and opioid dependency.

This information puts ADHD clearly in the scope of dependency health workers although on the other hand almost 90% of ADHD subjects have no substance use disorder (SUD) at all. It was emphasised by Dr Zerbo that as well as having a more severe and more prolonged course, ADHD subjects with addiction are also less likely to fit in with existing treatments despite such treatments being known to be just as effective in this population group.

I was interested to learn that those with ADHD are likely to use the same spectrum of drugs as others with drug use disorders and no ADHD. However, the drug use is often from a younger age and is more severe with more co-morbid psychiatric and behavioural disturbances.

The criteria for diagnosis of ADHD included six symptoms of inattention, hyperactivity or impulsivity for more than 6 months, dating from before 7 years of age, in two or more settings involving clear impairment and in the absence of other psychiatric reasons for the symptoms. In adults one would expect: low frustration tolerance, chronic conflicts with peers and authorities, stubbornness and impulsivity (which are major obstacles for treatment).

Treatment using stimulants, antidepressants, noradrenergic agents, etc can be very effective for ADHD symptoms but rarely does anything for the SUD directly. Hence opiate maintenance or other pharmacotherapy for SUD should be used just as insulin might be used if the patient were diabetic. Dr Zerbo has made the point that appropriate and early treatment of the ADHD will ensure lower drop-out rates from treatment, including opiate maintenance where this is necessary.

A case history given raises issues of polypharmacy as a complex in-patient from the Bellevue Hospital ward was discharged after stabilisation with the following medications: methadone 120mg daily, dextroamphetamine 60mg daily (slow release), gabapentin 300mg tds, hydroxyzine 25mg nocte (sedating antihistamine) and valproic acid 500mg bd. I was told by staff that such cases are not uncommon but reminded that Bellevue tends to attract some of the more difficult cases, being a tertiary referral centre.

A colleague from California tells me that it can be a regulatory nightmare getting permission to prescribe opiate maintenance along with stimulants even though there is obviously a group of patients who need both drugs. He said that only in the Veterans Administration setting was it possible to give comprehensive care in his experience.

Conclusions given by Dr Zerbo:

1. Patients with ADHD are at higher risk for SUD, and have a more severe and prolonged course if they develop SUD.

2. ADHD symptoms can be a significant barrier to effective SUD treatment.

3. Pharmacological treatments for ADHD are effective in patients with SUD; they have not been found to be addictive or to worsen the SUD (even while active).

4. ADHD is often under-prioritized, which can lead to greater morbidity for these patients and a longer time to remission.

My own conclusion is that we must be under-treating some of our dependency patients unless we have a proportion (at least 5% probably) taking prescribed stimulants. If we are not comfortable with that then we are not comfortable with evidence based medicine. I am not proud to say that we only have had three or four such cases in our practice in Sydney over the past decade. The regulatory hurdles are immense.

For more information on this subject: http://dependencyseminars.blogspot.com.au/2008/07/adult-adhd-substance-use-disorders-dr.php4

2. Dr Crystal Tholany spoke next about acupuncture in the treatment of dependency and withdrawal syndromes.

We were given a description of acupuncture and some proposed mechanisms for its apparent effectiveness in various medical settings. We were given the historical context for following thousands of years’ of use in China, its introduction into American medicine and especially in the treatment addiction and withdrawals and the several studies that have been published. There were connections through Japan, Hong Kong and the Bronx. All eyes were on whether it was better than placebo. Many modern settings use electronic as well or instead of mechanical stimulation to the fine needles inserted into the body.

It was found that acupuncture could lessen withdrawal symptoms dramatically. However, this was not evidence based and the effect wore off quickly once the acupuncture was ceased.

Trials show no change in symptoms after treatment stops but some changes remained in PET scans and pathology with several proposed mechanisms.

There are also some unconvincing but interesting animal studies. In some intriguing para-placebo studies groups were randomised to receive either “sham” acupuncture of the real thing. This was the closest one might get to a RCT, showing that in addiction cases no differences were shown for symptoms yet some changes were noted on MRI scan findings. In fibromyalgia cases, however, there were some significant improvements in those receiving the true acupuncture under the blindfold.

So, like AA, therapeutic communities, ten-day detoxification and numerous other respected interventions, acupuncture remains a folk treatment and non-evidence based to date. After centuries of use it should not be dismissed but likewise it should not be recommended in place of known effective treatments regarding serious outcome measures including morbidity and mortality. Because this treatment has only been used quite recently in addiction it warrants further investigation, according to Dr Tholany. Naturally it must never be advised in preference to proven treatments like opiate maintenance but in those refusing such treatments and consenting to non-evidence based approaches it may a valid alternative.

3. Dr Joseph Kwon spoke about ketamine for treatment of depression.

Dr Kwon was the third of three senior registrars at Bellevue to deliver a brief paper at their Grand Rounds to which I was invited. Dr Kwon had performed a literature search and presented some history, pharmacology and made the case for this option to be investigated further and possibly used now under close supervision for treatment resistant cases of suicidal depression.

The reason this subject was broached was the recent focus on suicide prevention and the delayed onset of most current forms of treatment for depression. There was also a group of treatment resistant individuals who failed to respond to either antidepressants or ECT. These included both endogenous depression and those with histories of bipolar disorder.

The drug’s effect is largely on inhibiting the glutamate system and a Wikipedia page indicates that it shares this property with nitrous oxide, alcohol, methadone, propoxyphene, tramadol, PCP, ibogaine and numerous other substances.

There are groups interested in this subject at Mt Sinai Hospital in New York as well as Bethesda Maryland and in the Netherlands (there was also a paper from New Zealand I noted). Numerous publications of small trials were cited to justify further work and even to use this treatment off-label in certain severe cases at the present time. There has been at least one RCT in an add-on trial with other observational studies being reported, largely very positive in their outcomes with low rates of side effects.

We were told by Dr Kwon that research had shown depression to be associated with increased glutamate in the occipital cortex and reduced levels in the anterior cingulate gyrus. Animal experiments with stressed mice showed better coping with shock when pre-treated with ketamine as also seen with other antidepressants (at least that was the inference).

We were informed that ketamine is fifth on a relatively long WHO list of ‘essential drugs’ for medical purposes.

A small number of invivo human trials were cited: infusions in emergency room situation were very effective apparently as promptly reversing many signs and symptoms of depression on validated scales. In cases of suicidality this type of intervention could clearly be life saving if used appropriately.

Small doses of ketamine (1mg/kg) were shown to improve postoperative depression (and also pain in depressed patients). Another three trials were mentioned involving single or repeated infusions, one with placebo control. No patient developed psychotic symptoms (schizophrenic patients were excluded).

Like morphine and other prescription drugs, it is also used as a mind altering drug recreationally. Taken at rave parties, for example, it seems to cause more dissociative symptoms than the much more popular MDMA. I was informed that it has become one of the most popular recreational drugs in Hong Kong in recent years.

I understand that some Australian centres use ketamine for acute analgesia in patients who are taking buprenorphine (presumably due to resistance to morphine from the antagonist properties of the maintenance drug). According to a colleague in London it could also be useful in those taking naltrexone. I note that ketamine is available in Australia as a parenteral anaesthetic/analgesic under the trade name Ketalar, available in vials for injection of 200mg per 2ml liquid. Product information states that doses must be titrated individually but that 150mg injected intravenously can cause ten minutes of surgical anaesthesia.

It is the writer’s view that ketamine could do with a ‘White Knight’ like Reckitt Benckiser which developed buprenorphine as a treatment for opioid dependence. As an old drug, ketamine is of little interest to drug companies in its present state. However, with some manipulation and focussed research a new patented version could be part of the way to both profits and improved treatment options. With the benefits promised by Dr Kwon’s presentation I would buy stocks in any company working in this direction.

As well as Dr Marc Galanter, head of department, and addiction psychiatrist Dr Phoebus Dhrymes, veteran dependency advocate Charles Winick was in the small audience at Bellevue for this morning session. As it happened, Winick gave a talk I attended at Columbia University the following week outlining some parallel issues with fundamental research on rehabilitation which, like acupuncture and AA, is not easily amenable to controlled trials although some have been attempted with positive outcomes. Yet another coincidence was that we were both due for appointments at the Drug Policy Alliance later that day - let’s share a cab! “Only in New York!” There were more stories on request of security in New York hospitals and other institutions these days … food in New York … ‘coffee’ in New York … and more.

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