got any thoughts?…

Posted on Monday 8 June 2015

So first there was the New England Journal of Medicine series by Jeffrey Drazen and Lisa Rosenbaum suggesting a relaxation of the restrictions on industry affiliated experts writing editorial or review articles in the NEJM.  Then came strong rebuttals in the British Medical Journal from both sides of the pond [UK: Elizabeth Loder, Catherine Brizzell, and Fiona Godlee][US: Robert Steinbrook, Jerome Kassirer, and Marcia Angell]. Now, Lancet Editor, Richard Horton, weighs in. :
by Richard Horton
Lancet. 2015 385:2238.

It’s hard to recall now, but there was a time in medicine’s recent past when interactions between physicians and the pharmaceutical industry were seen as positively virtuous. During medical school [a long time ago, 1980–86, at the University of Birmingham], most of our general medicine teaching was organised by the Department of Pharmacology and Therapeutics, led by the inspirational Martin Kendall. In weekly “roadshows”, 180 students would discuss clinical scenarios from a pharmacological perspective. Martin Kendall would lead the class through vignettes of patient management. He would do so by testing the students on stage, a ritual we all endured and enjoyed in equal part. An appreciation of, and respect for, the contribution of the pharmaceutical industry to clinical medicine was embedded in our training, and I think most of us felt better prepared for the practical aspects of subsequent ward work as a result. This mutuality extended to research. In 1985, I spent 3 months working at the Astra Laboratories in Mölndal, near Gothenburg, Sweden. At that time, the great Swedish cardiovascular physiologist, Björn Folkow, was at the University of Gothenburg. It was accepted [and encouraged] that senior faculty in Folkow’s department, together with post-docs and PhD students, would move seamlessly between university and industry. This symbiosis is hard to comprehend today. The conflict between those who see industry as an enemy to the values of medicine and those who see great possibilities from collaboration is exemplified by the recent argument between two great general medical journals, The New England Journal of Medicine and The BMJ.
I was in medical school even earlier [1963-1967], and I saw no split between Medicine and the Pharmaceutical Industry, having had something of the same experience as Horton. When I first started writing about the corruption in what I now think of as the «academic·industrial complex», I repeatedly said that I had only become aware of it after my retirement, around the time of Senator Grassley’s investigation [2008]. But then I read so many critics saying that we [psychiatrists] knew, or should have known, but were in denial, or that we were making lame excuses for some kind of passive collusion. So I stopped saying it. It had begun to sound like excuse making or an attempt to disavow responsibility even to me.

The changes in 1980 had a dramatic effect on my life. But after the dust settled, I think I had a Solomon-like view of things. It just wasn’t "a time for" my likes or the likes of me. Things were good in my world and my drifting away from mainstream psychiatry was more because it was irrelevant than anything else. My cluelessness was genuine. More than that, I hadn’t even considered the possibility of a corrupt «academic·industrial complex». That’s all the more remarkable considering I was on the faculty at Emory University, teaching in a Psychoanalytic Institute that was part of the Department of Psychiatry, whose chairman was Charlie Nemeroff, now seen as the poster-child for the «academic·industrial complex». The office where I practiced was minutes from the office I had when I was on the full time faculty – literally around a couple of corners.
Writing in The BMJ this week, two former Editors-in-Chief of the NEJM, Jerry Kassirer and Marcia Angell, call three recent NEJM articles [by the journal’s national correspondent, Lisa Rosenbaum] and an editorial [by the journal’s current Editor-in-Chief, Jeff Drazen], “A seriously flawed and inflammatory attack” on financial, largely pharmaceutical and device manufacturer, conflicts of interest. “We find it sad”, they write, “that the medical journal that first called attention to the problem of financial conflicts of interest among physicians would now backtrack so dramatically, and indulge in ad hominem attacks on those who disagree”. They accuse the NEJM of downplaying the importance of conflicts of interest in medicine. They allege the journal has “little understanding of the meaning of the term”. They call Lisa Rosenbaum’s three essays “rambling”, “fanciful”, and “data-free”. They also attack Drazen, their successor, for weakening the NEJM‘s conflict of interest policy. In an accompanying editorial, the BMJ‘s Editor-in-Chief, Fiona Godlee, together with the journal’s heads of research and education, notes that they are “deeply troubled” by Drazen’s “possible retreat from policies that prevent experts with relevant commercial ties from authoring commentary or review articles”. “We don’t find much to agree with in NEJM‘s anecdotal analysis…It is a mistake by NEJM to suggest that rigorous standards should be revisited.” There have been few such sharp rebukes by one journal editor against another. What led to this surprising assault?
Here’s where Horton loses me. I may have been naive about the «academic·industrial complex» before 2008, but it was sure easy to catch up. There was no surprising assault, just a reaction to a preposterous series in the New England Journal of Medicine. Has Horton been in suspended animation? One is tempted to think he’s being ingenuous here.
Lisa Rosenbaum posed a series of questions that have upset those who believe in the inimical influence of industry in medicine. For example, Rosenbaum asked whether it was reasonable to conclude that a physician with industry ties is motivated by a desire for financial gain? To what extent are reactions to industry influenced by reason or emotion? Why do we not take non-financial conflicts as seriously as financial entanglements? What unanticipated negative consequences might accrue from a hunt for wrongdoing? Why are the benefits of industry–academic collaborations persistently ignored? It would seem within the spirit of scientific inquiry to pose questions that challenge received orthodoxies. Rosenbaum accepts that gifts to doctors can have unacceptable influence. She agrees that past wrongdoings should not be excused. She believes that oversight of industry should not be eliminated. And she discusses evidence that industry-sponsored studies are more likely to be positive. Therefore, I don’t agree with the NEJM‘s critics that the Rosenbaum papers represent a reversal of policy by the NEJM. But while I don’t agree with these critics, I do think that the BMJ‘s analysis should be welcomed. A clear division of opinion in this argument helpfully clarifies both positions. The truth is likely to lie somewhere between these extremes. It’s time we found it.
I’ll be honest. I don’t even follow what Horton is saying. Of course it’s a reversal of policy. They even say it in their series [see Understanding Bias — The Case for Careful Study].  And I don’t know where his middle ground "somewhere between these extremes" would be. This post has been sitting on this screen all day while I went about doing this-and-that, and every time I glance over it, it makes me a little madder. Are he and Drazen pals? Or was he looking to not cross either set of colleagues? I wondered what policy the Lancet had but couldn’t find anything that made things clear. Anybody else got any thoughts?
Mickey @ 10:41 PM

not just “no”…

Posted on Sunday 7 June 2015

By the beginning of 2011, I was finally catching on to the extent of the the problem with the Psychopharmacology literature. I had written a sarcastic post about inventing a computer to generate Clinical Trials mixing every drug with every condition [NIMH·receptalator] and I got a comment from someone in Texas pointing out that such a computer program was already proposed. It was a paper by Madhukar Trivedi at UT Southwestern. He had written a computer program to implement an algorithm driven treatment of Major Depressive Disorder on an NIMH grant. The paper was talking about his attempted Clinical Trial [IMPACT] to test the algorithm. He’d had to abandon the Trial, because the clinic doctors wouldn’t use the computer unless Dr. Trivedi was there looking at them. In the paper, he was speculating about why they wouldn’t use it [strange bit of psychologizing for a biological psychiatrist, I thought]. Then I looked at his COI declaration [see evidence-based medicine I…]  and my jaw fell to the floor. That’s when I started blogging consistently about the pharmaceutical invasion of psychiatry. I’d never seen anything like that before.

I had found that five year grant for IMPACT [MH064062] which had been paid out at a total of $3.3 M [which seemed like a lot for a study that never happened]. Working backwards got me to STAR*D. While it had >100 articles, they never published the results of the Primary Outcome Variables – just some secondary rating scales [see a thirty-five million dollar misunderstanding…]. Yes, it cost $35 M in all and essentially told us very little about treatment. Moving further back in time, I ended up at TMAP, with Trividi in c harge of nthe Mood Disorder Algorithms. And that opened up learning about the biggest industry/psychiatry scam of them all, TMAP – getting in-patent drugs into the State formularies was a gold rush for PHARMA. Somewhere back around 2008, John Rush left UT for the Duke Program in Singapore. At that time, Trivedi inherited all the NIMH Projects at UT. He finished up CO-MED, a negative study involving combining antidepressants. Then he got a NIMH Grant for a project of his own [EMBARC] to look for biomarkers that discriminated between Zoloft or Wellbutrin responders – a personalized medicine quest of dubious value at best. The NIMH has paid out $9+ M so far, the grant cycle has elapsed, and yet it’s currently listed as still recruiting on ClinicalTrials.gov. Altogether, I’d say the four NIMH studies [STAR*D, IMPACT, CO-MED, and EMBARC] came to well over $50 M total.

As you can see, it’s become something of a hobby of mine, following Dr. Trivedi’s projects since that first one in 2011. He’s very adroit at getting NIMH funding, though he’s less adept at finishing the projects. He actually completed CO-MED as advertised. Other than that, STAR*D, IMPACT, and EMBARC never got published as the completed research they were funded to be, though there were plenty enough papers generated by STAR*D for a small library. And TMAP just quietly faded away after almost bankrupting the Texas Mental Health budget [bailed out by Governor George Bush prior to leaving for Washington]. In Dr. Trivedi’s defense, the gross corruption and PHARMA collusion exposed had to do with the Atypical Antipsychotics rather than with Dr. Trivedi’s Antidepressant algorithms, though I don’t know that the Antidepressant part of TMAP received a thorough vetting.

But I never thought my hobby of following Trivedi’s projects would lead to this recent punch line:
UTSouthwestern Medical Center: Newsroom
May 18, 2015

DALLAS – Dr. Madhukar Trivedi, Director of the Center for Depression Research and Clinical Care at UT Southwestern Medical Center and an internationally recognized expert in depression and mood disorders, is receiving the 2015 American Psychiatric Association Award for Research, the Association’s most significant award for research. First awarded in 1949 as The Hofheimer Prize, the award is given in recognition of a single distinguished contribution, body of work, or lifetime contribution that has had a major impact on the field and/or altered the practice of psychiatry, according to the American Psychiatric Foundation, which identifies the awardees. Dr. Trivedi, Professor of Psychiatry and Chief of the Division of Mood Disorders at UT Southwestern, will present an honorary lecture May 18 at the APA Annual Meeting in Toronto…

click on the graphic for the meeting guide
see page 105
Dr. Trivedi previously served as one of the Principal Investigators of the Sequenced Treatment Alternatives to Relieve Depression [STAR*D] study, which at the time was the largest and longest study on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. Dr. Trivedi also helped author innovative treatment guidelines called the Texas Medication Algorithm Project [TMAP], a set of comprehensive management tools for doctors treating severely mentally ill patients within Texas’ publicly funded mental health care system.

He also served as Principal Investigator for NIMH grants examining treatment for chronic depression, identifying specific signaling proteins found in blood cells that may predict whether a depressive person will respond better to workouts or medications, a computerized decision support system for depression, and one using specific antidepressant combinations to increase remission rates by treating a broader spectrum of depressed patients and by capitalizing on additive pharmacological effects…
[Obviously, this narrative differs from my version]. I feel like a tabloid writer this week after the series on Dr. Wagner’s election as AACAP President and now Dr. Trivedi’s award. But there was something that happened in the world of psychopharmacology in the last twenty-five years that was unprecedented in my experience in medicine – maybe anybody’s experience. And while there are moves to set things straight, they’re still in their infancy. So here’s what I encountered on my first exposure to Dr. Trivedi’s work back 5 years ago [see evidence-based medicine I…]:
    Competing interests

    Madhukar H. Trivedi, M.D. has been a consultant for Abbott Laboratories, Inc.; Akzo (Organon Pharmaceuticals Inc.); AstraZeneca; Bayer; Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Fabre-Kramer Pharmaceuticals, Inc. Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica Products, LP; Johnson & Johnson PRD; Eli Lilly & Company; Meade Johnson; Neuronetics; Parke-Davis Pharmaceuticals, Inc.; Pfizer, Inc.; Pharmacia &; Upjohn; Sepracor; Solvay Pharmaceuticals, Inc.; VantagePoint; and Wyeth-Ayerst Laboratories.

    He has served on speakers bureaus for Abdi Brahim; Akzo (Organon Pharmaceuticals Inc.); Bristol-Myers Squibb Company; Cephalon, Inc.; Cyberonics, Inc.; Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica Products, LP; Eli Lilly & Company; Pharmacia &; Upjohn; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories.

    He has also received grant support from Bristol-Myers Squibb Company; Cephalon, Inc.; Corcept Therapeutics, Inc.; Cyberonics, Inc.; Eli Lilly & Company; Forest Pharmaceuticals; GlaxoSmithKline; Janssen Pharmaceutica; Merck; National Institute of Mental Health; National Alliance for Research in Schizophrenia and Depression; Novartis; Pfizer Inc.; Pharmacia &; Upjohn; Predix Pharmaceuticals; Solvay Pharmaceuticals, Inc.; and Wyeth-Ayerst Laboratories.

The study chart above is all government funded research aiming to making direct recommendations to clinicians about how they should treat patients using Guidelines and Algorithms. It is not possible for someone with that level of Conflict of Interest to make unbiased recommendations. In my estimation, no-one with those competing interests should have ever received NIMH grant support in the first place.

At the  Mayflower Conference, on Personalized Medicine in October 2009, Dr Trivedi said: “… clinicians have to decide on treatments and therefore the best goal, interim goal at least, we may want to understand the pathophysiology better and I’m not against that, but I think we have to help clinicians decide on one versus the other treatment." I disagree. The body of that work aims to tell clinicians what choices to make rather that give them the accurate efficacy, safety, and pathophysiologic information to make these decisions in concert with their patients. After reading that first article, I made this sketch:

 

Using a structured interview or questionnaire and a DSM-whichever, a computer algorithm informed by [industry funded and managed] clinical trials spits out treatments and tweaks things along the way. This whole line of thinking mimics that graphic. The only clinicians involved are the ones that create the computer’s algorithms [with COI loading like the above] and never meet the patients. So not just "no" – but "hell no!". Practicing physicians don’t need recipes of questionable validity from compromised academics. We need accurate scientific information to allow us to do our jobs…
Mickey @ 3:01 PM

wars, and rumors of wars…

Posted on Friday 5 June 2015

The Battle of Agincourt: Hundred Years War

The Hundred Year War started during the ravages of the Black Death and ending when the heroism and martyrdom of Joan of Arc inspired the resurgence that ultimately closed that chapter of history:
    "Bubonic plague and warfare reduced population numbers throughout Europe during this period. France lost half its population during the Hundred Years’ War. Normandy lost three-quarters of its population, and Paris two-thirds. The population of England was reduced by 20 to 33 percent due to plague in the same period."   Wikipedia
Hundred Year WarAnybody recall what it was about? I remembered the Black Death, Joan of Arc, the introduction of the longbow in the Battle of Agincourt. As for what it was about? England v France, Kings and things – that’s about all I could remember. One thing I never knew, the distinct cultural identities of France and England, including languages, were formed and consolidated during that conflict. Apparently a good war is a powerful organizer of national unity and cultural identity.

War of RosesOne of my memories from early childhood was of standing in our front yard when everyone had gone crazy. People were beating on pans and shooting guns, laughing and hugging each other – my parents included. My mother noticed I was frightened, crying I think. She said something like, "Don’t worry. We’re happy. The War is over! [WWII]. But that made things worse, because I didn’t know that "War" was something that was ever "over". Where would it go? I thought war was just a part of life [actually, I think I might have been right about that at age 4]. Oh, by the way, the War of Roses started a few years after the end of the Hundred Years War.

The thing that got me on this topic [conflicts that don’t seem to end] was thinking about all the discord lately around the questions of using maintenance antipsychotic medication in Schizophrenia and the long term use of psychiatric medications in general. I remembered similar debates from forty years ago. And I thought about how much professional identity had [and has] to do with where people stand on this issue. all of which relates to the recent Maudsley Debate… «Does long term use of psychiatric drugs cause more harm than good?» [speaking of British Wars].

The Maudsley Debate didn’t do a much for me. The Yes camp had Sami Timimi, a British child psychiatrist with the Critical Psychiatric Network and Peter Gøtzsche of the Nordic Cochrane Group and author of Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare. On the No side, we had Allan Young, Mood Disorders researcher at Kings College, London with heavy industry ties and John Crace, who writes for The Guardian and spoke as a patient. The audience was on the Yes side both before, [during,] and after the debate. The moderator did her best trying to hold the speakers and questioners to the topic [but her best wasn’t enough with such a polarized issue].

I knew what each of them was going to say [as will you]. And I didn’t like the question. My mind kept saying things like "For whom?" "Which Patient?" "Which drug? in Which Patient? For What?" I expect that in a world of indiscriminate or rampant overprescribing, I might go for a Yes. But I don’t do indiscriminate or rampant overprescribing, so I’d be a No. But the audience at this debate might think otherwise and lump me in one or the other bad guy camp. etc. etc. I don’t like the question. But I think I might spend some time thinking about why, and blogging about that [at a later time] rather than responding to the question on the table [at a later time].

Like the British Wars of antiquity, this one looks as if it may go on and on without resolution for a very long time…
Mickey @ 5:42 PM

the Maudsley Debate…

Posted on Friday 5 June 2015


The Maudsley

The Maudsley Debates occur three times a year. The debate last month was on the topic «Does long term use of psychiatric drugs cause more harm than good?». Since it’s mentioned in the recent commentary so frequently, I thought I’d post the video and some of the comments from the BMJ for those who haven’t followed it. Locating the pieces can get tedious. My comments will come later:

Mickey @ 11:12 AM

the answers to those questions…

Posted on Thursday 4 June 2015

In deeply troubling…, I started in 2001 with the publication of the Paxil Study 329 paper looking at Karen Dineen Wagner’s history, but perhaps I should’ve started a couple of years earlier with the now infamous TMAP project. And then there was an appearance at a SmithKline Beechum Neuroscience Division meeting that bears mentioning…


TMAP/TCMAP

Perhaps the biggest pharmaceutical scam to date was TMAP [Texas Medical Algorithm Project]. Before it was stopped, it had nearly bankrupted the Texas Mental Health system, had spread to 17 other States, and was on its way to Washington. It should make us all shudder when we hear the word "Guidelines." It was shepherded into being by John Rush and Madhukar Trivedi in Dallas. Basically, they controlled guidelines for the huge Mental Health system in Texas. It had a child piece [TCMAP] and Karen Dineen Wagner and Graham Emslie  were both involved in setting the Algorithms. The TMAP program was exposed in 2004 largely through the work of one man, Allen Jones, an Inspector for the Pennsylvania OIG [who was fired for his work] but who never gave up. Below is just a snippet from a report he published on the Internet in 2004 with the bare bones of Dr. Wagner’s involvement [A more complete version about her goes from pages 10-14, and tells quite a story]:
In 1997-98, TMAP, with pharmaceutical industry funding, began working on the Texas  Children’s Medication Algorithm Project [TCMAP]. An "Expert Consensus" panel was assembled to determine which drugs would be best for the treatment of mental and emotional problems in children and adolescents. The panel consisted almost exclusively of persons already involved in TMAP or associated with TMAP officials. A survey was not necessary. These persons simply met and decided that the identical drugs being used on adults should also be used on children. There were no studies or clinical trial results whatsoever to support this consensus…

One of the members of the children’s "expert consensus panel" was Graham J. Emslie,M.D., Professor and Chair, Division of Child and Adolescent Psychiatry. University of Texas Southwestern Medical Center, [a TMAP site] and Director. Bob Smith Center for Research in Pediatric Psychiatry, Dallas, TX…

The panel also included Dr. Karen Dineen Wagner

In 1998, without any published trial data and based on the "consensus opinion" of Emslie, Wagner and others, TCMAP began widespread usage of these SSRIs and other drugs on children within the Texas state Juvenile Justice system and state Foster Care System…

Between 1998 and 2003, state doctors following the TCMAP guidelines routinely and regularly prescribed these antidepressant drugs to children in accordance with the TCMAP algorithm requirements…
After the first year, they published periodic updates in the JAACAP:
by CARROLL W. HUGHES, GRAHAM J. EMSLIE, M. LYNN CRISMON, KAREN DINEEN WAGNER, BORIS BIRMAHER, BARBARA GELLER, STEVEN R. PLISZKA, NEAL D. RYAN, MICHAEL STROBER, MADHUKAR H. TRIVED, MARCIA G. TOPRAC, ANDREW SEDILLO, MARIA E. LLANA, MOLLY LOPEZ, A. JOHN RUSH, AND THE TEXAS CONSENSUS CONFERENCE PANEL ON MEDICATION TREATMENT OF CHILDHOOD MAJOR DEPRESSIVE DISORDER
Journal of the American Academy of Child and Adolescent Psychiatry, 1999 38[11]:1442-1454.

The consensus panel agreed on categorizing 3 levels of "data" hierarchically in formulating stages and differential branching of the treatment algorithm. Level A data consist of both child and adult randomized controlled clinical trials, level B data consist of open trials and retrospective analyses, and level C data are based on case reports and panel consensus as to recommended current clinical practices. Level A takes precedence over level B, and B over C…
The recommended monotherapy antidepressant for stage 1 are SSRIs [fluoxetine, paroxetine, or sertraline]. [Fluvoxamine and citalopram may be added to the list at a future date with additional research and experience]…
SSRIs are deemed first-line treatments because of supporting efficacy data for fluoxetine in children and adolescents and paroxetine in adolescents [level A], open trials of sertraline [level B], and clinical experience [level C]. Information extrapolated from adults further supports the initial use of SSRIs given the minimal need for dosage titration [level A in adults and level C in children/adolescents] and favorable side effect profiles [levels A and C]…
Only fluoxetine was a published paper [paroxetine was an abstract of Study 329 posted at the 1998 APA]. There was a consensus meeting recorded in 1998, with no details [wayback machine].

With the coming of Jones’ whistle blower suit and the mounting awareness of adverse effects that lead to the Black Box Warning, TCMAP just disappeared. TCMAP was never adjudicated, and the only specific TMAP suit I know of was the settlement in Allen Jones and the State of Texas v. J&J.


Paxil in Pediatric Depression and «The Launch»

We all know about the famous Paxil Study 329, published in July 2001 in the JAACAP with 24 authors [Karen Dineen Wagner among them]. The Acute phase of Study 329 ran from 04/1994 until 03/1997 [blind broken]. In October 1998, this internal memo went out:

The draft of the paper came from ghost writer Sally Laden to First Author Martin Keller in February 1999, and by August 1999, he had submitted the paper to the JAMA. It was turned down there in November 1999. In December 1999 and again April 2000, there were emails saying that they were rethinking it, planning to go for the AJP. But in June 2000  [?], it was at the JAACAP where it was accepted in January 2001 and published in their July 2001 issue.

So what does all this have to do with Dr. Wagner? Back in Early December 1999, she was the main event for a SmithKline Beecham meeting in San Francisco – the Neuroscience Division. Here’s their Newsletter [December 9, 1999] about the meeting [Nulli Secundussecond to none]. They were launching Paxil for adolescents:
"As many of you know, SB is preparing an indication for adolescent depression for Paxil next year! SB’s clinical study demonstrating the success of Paxil in treating depression among adolescents will be published in a peer reviewed journal during first quarter 2000…"

"Dr. Wagner said the window of opportunity is before SB. Several other competing SSRls and other compounds have studies ongoing. But Paxil and Prozac are the only two SSRIs that have any published data to date and many physicians have already found success in treating adolescent patients with Paxil…"

"The paroxetine study measured treatment of adolescent depression. It is the largest study to date, involving 275 adolescents at 12 sites for eight weeks. In the study, one of three treatments was possible: imipramine, paroxetine, or placebo. Results:
    • 66% of paroxetine group improved
    • 52% imipramine improved
    • 48% of placebo improved."
"As a result of this large study," Dr. Wagner said, "We can say that paroxetine has both efficacy and safety data for treating depression in adolescents."

At the time she gave this presentation, that first paragraph  simply wasn’t true. SB had long before decided not to go for an indication for Paxil in adolescents. The paper had just been rejected by the JAMA – with no publication in sight. The JAMA reviewers pointed to the low HAM-D cut-off, the effect of supportive care, the high Placebo response, the small or absent differences in rating scales, the significant incidence of Serious Side Effects with Paroxetine, and the inappropriate dosing of Imipramine. For that matter. I have no clue where those results came from, not from the paper or the CSR.


A look at the work of one medical school researcher, Dr. Karen Dineen Wagner, shows the challenges and possible pitfalls such research can entail. For example, from 1998 to 2001, university records show, Dr. Wagner was one of several academic researchers participating in more than a dozen industry-financed pediatric trials of antidepressants and other types of drugs. While some of the results were published, many were not. 

I ran across this 2004 article from the New York Times by Barry Meier [Contracts Keep Drug Research Out of Reach]. An excellent article, it prominently mentions Dr. Wagner and reminds us that this was the heyday of industry-funded Clinical Trials and that Dr. Wagner was one of a handful of Academic Child Psychiatrists who were involved with almost every study published – people who were and who remain prominent figures in the American Academy of Child and Adolescent Psychiatry, the organization Dr. Wagner was just elected to lead.

This is hard for me to personally understand. Dr. Wagner has essentially made her career advocating the use of psychophatmacologic agents in the treatment of children – having covered the gamut of conditions, drugs, and worked with many of the front-running drug companies who make and profit from these drugs. Surely the broad membership of the AACAP knows that, and knows about the dark side of her work – ghost-writing, financial COI, withheld negative studies, TMAP, training sessions for PHARMA. At a time when such things are moving closer and closer to the front burner, why would the AACAP membership choose her as President? Are her colleagues unaware of her history? Is that possible? Is this a sign that her position represents the consensus of the members? For that matter, why would she even run for that office instead of lowering her profile? It’s similar to the questions asked when people like Drs. Alan Schatzberg or Jeffrey Lieberman have been elected to the APA Presidency.

I don’t know the answers to those questions…
Mickey @ 10:36 PM

the real editors speak out…

Posted on Wednesday 3 June 2015

by Robert Steinbrook, Jerome P Kassirer, and Marcia Angell
British Medical Journal. 2015 350:h2942

A series of articles in the New England Journal of Medicine has questioned whether the conflict of interest movement has gone too far in its campaign to stop the drug industry influencing the medical profession. Here, three former senior NEJM editors respond with dismay

A seriously flawed and inflammatory attack on conflict of interest policies and regulations appeared recently in a most unexpected location: the venerable and trusted New England Journal of Medicine [NEJM]. In a series of rambling articles, one of the journal’s national correspondents, Lisa Rosenbaum, supported by the editor in chief, Jeffrey Drazen, tried to rationalise financial conflicts of interest in the medical profession. As former senior editors of the NEJM, we find it sad that the medical journal that first called attention to the problem of financial conflicts of interest among physicians would now backtrack so dramatically and indulge in personal attacks on those who disagree.

Physicians and the public rely on journals as unbiased and independent sources of information and to provide leadership to improve trust in medicine and the medical literature. Yet financial conflicts of interest have repeatedly eroded the credibility of both the medical profession and journals. As the Institute of Medicine explained in its 2009 report, a conflict of interest is “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” The key issue is that “a conflict of interest exists whether or not a particular individual or institution is actually influenced by the secondary interest.” The report drew heavily on a 1993 NEJM article by Dennis Thompson, not cited by Rosenbaum, which made clear that the rules “do not assume that most physicians or researchers let financial gain influence their judgment. They assume only that it is often difficult if not impossible to distinguish cases in which financial gain does have improper influence from those in which it does not.”

The NEJM has now sought to reinterpret and downplay the importance of conflicts of interest in medicine by publishing articles that show little understanding of the meaning of the term. The concern is not whether physicians and researchers who receive industry money have been bought by the drug companies, as Drazen writes, or whether members of guideline panels or advisory committees to the US Food and Drug Administration with ties to industry make recommendations that are motivated by a desire for financial gain, as Rosenbaum writes. The essential issue is that it is impossible for editors and readers to know one way or the other.

Judges are expected to recuse themselves from hearing a case in which there are concerns that they could benefit financially from the outcome. Journalists are expected not to write stories on topics in which they have a financial conflict of interest. The problem, obviously, is that their objectivity might be compromised, either consciously or unconsciously, and there would be no easy way to know whether it had been. Yet Rosenbaum and Drazen seem to think it is insulting to physicians and medical researchers to suggest that their judgment can be affected in the same way. Doctors might wish it were otherwise, but none of us is immune to human nature.

Straw men
Rosenbaum’s language is colorful, but her arguments for the purported harms of conflict of interest policies and regulations are fanciful and data-free. No one is proposing that “we prevent the dissemination of expertise, thwart productive collaborations, or dissuade patients from taking effective drugs,” or allow “true experts to be replaced?on advisory panels, as authors of reviews and commentaries, in other capacities of authority by people whose key asset is being conflict-free.” Where is the evidence of “a loud chorus of shaming,” or “a stifling of honest discourse,” or that “the license to trample the credibility of physicians with industry ties has silenced debate?” Silliness and fear mongering about straw men are masquerading as scholarly analysis.

In 2014, under the Open Payments program [the Physician Payment Sunshine Act which is part of the Affordable Care Act], the Centers for Medicare and Medicaid Services in the United States published 4.45 million financial transactions from healthcare industries to physicians and teaching hospitals over just the last five months of 2013; the total value was nearly $3.7bn [£2.4bn; €3.4bn]. When full data for 2014 are reported later in 2015, the amounts may well exceed $9bn. Drug and device companies are investor owned businesses that are required to maximize profits by any legal means. These companies are not charities, so they expect to get something in return for all the largesse; the evidence is that they do, and it is naive to explain the situation otherwise.

Put simply, financial conflicts of interest in medicine are not beneficial, despite strained attempts to justify them and to make a virtue of self interest. Unmistakably, collaborations between academia and industry can speed medical progress and benefit patients. Such partnerships, however, can flourish with far less money in aggregate flowing from drug and device manufacturers to physicians and their institutions, and without the web of other lucrative ties between industry and physicians that lack a clear scientific or medical purpose. There are few reasons for physicians and other investigators to have financial associations with industry other than research support and bona fide consulting related to specific research programs and projects. Physicians who develop products and hold patents or receive royalties should not evaluate the product. Other types of payments, such as speakers’ and other personal fees, payments to be ghost authors of review articles, and ill defined consulting arrangements, distort physicians’ work and undermine our independence, as has been repeatedly documented. And there are no excuses for outright gifts, such as meals, travel, lodging expenses, and entertainment.

Editorial responsibility
In 1984, the late Arnold S Relman, then the NEJM’s editor in chief, instituted the first conflict of interest policy at any major medical journal.10 The policy required authors of research papers to disclose all financial ties they had to health industries, and if the ties were deemed significant they were published. In 1990, Relman extended the policy to prohibit authors of editorials and review articles from having any financial interest in a company [or its competitor] that was discussed in the article, since these types of manuscripts do not contain primary data but rely exclusively on the authors’ judgment in citing and interpreting the literature.11 As Relman’s successors, two of us [JPK and MA] continued these policies. We found that it was sometimes difficult, but nearly always possible, to find outstanding authors with the needed expertise and without a conflict of interest to write editorials and review articles. In 2002, however, after Drazen succeeded Angell, the policy was weakened, so that it only applied to authors with “any significant financial interest in a company [or its competitor] that makes a product discussed in the article.” To its credit, The BMJ has taken the opposite approach and implemented a zero tolerance policy on educational articles by authors with industry ties.

The privilege to serve as an editor of a major medical journal is accompanied by the responsibility to provide leadership on the critical issues that define the profession. How medicine responds to conflicts of interest and earns the trust of the larger society in which we exist is one such issue. In 1990, it was a bad idea for authors of editorials, review articles, and other opinion articles in medical journals to have financial conflicts of interest. A quarter of a century later, it is a very bad idea. The articles by Rosenbaum and the supportive editorial by Drazen could presage a further weakening of the conflict of interest policy at the NEJM, or they could serve as a wake-up call for all medical journals and the profession. It is time to move forward, not backward.
by Elizabeth Loder, Catherine Brizzell, and Fiona Godlee
British Medical Journal. 2015 350:h2957

The New England Journal of Medicine goes on an ill advised journey
Public trust in the pharmaceutical and biotechnology industry is low. Many practising physicians share that mistrust and are inclined to discount the results of otherwise sound studies that are industry funded. There are good historical reasons to be sceptical. But has suspicion degenerated, as some have charged, into “mindless demonisation?” The New England Journal of Medicine [NEJM] seems to think so. It has published a series of commentaries and an editorial suggesting there have been serious negative consequences of strict, “oversimplified” conflict of interest and disclosure policies, including the development of a “hostile climate” and “loss of trust.” Editor in chief, Jeffrey Drazen, says the “divide” between academic researchers and industry is not in the best interests of the public because “true improvement can come only through collaboration.”

A close reading of Drazen’s editorial suggests he is having second thoughts about policies put in place by many journals—including The BMJ—that make it “harder and harder for people who have received industry payments or items of financial value to write editorials or review articles … Having received industry money, the argument goes, even an acknowledged world expert can no longer provide untainted advice.” These policies, he says, came about “largely because of a few widely publicized episodes of unacceptable behavior.” He urges revisiting of the reasons that “medical journal editors remain concerned about authors with pharma and biotech associations.”

We are deeply troubled by a possible retreat from policies that prevent experts with relevant commercial ties from authoring commentary or review articles. The pharmaceutical and biotechnology industries may well be our medical saviours, but that is not a good reason to return to past practices. Such policies were not motivated solely by a few events, as Drazen asserts, but by recognition of extensive, systemic problems. These problems are far from solved, including internationally, as shown by recent events in India and China.

Checks and balances remain important
We agree that people with industry affiliations may be capable of expressing impartial views about matters affecting the commercial interests with which they are associated. Journal readers and editors, however, have no reliable way of identifying which industry affiliated views are disinterested and which are inappropriately influenced by commercial considerations, particularly in subtle ways. Bias is not always overt or easily detected. Authors with industry ties may be likely to approach a topic from a perspective shaped by their associations, so that their views will reflect industry assumptions, priorities, and preferences. The existence of academic and non-financial conflicts of interest does not reduce the need to be wary about conflicts that arise out of the powerful economic incentives associated with industry connections.

In our view, no one has such superior knowledge that he or she is the only one qualified to write an article on a subject. Checks and balances are important in any system. In the case of medical evidence, they should be based on the assumption that it is a mistake to combine evidence production and appraisal functions in a single person or group. Some academics must work closely with industry to develop and commercialise new medical treatments, but they should not also author editorials, reviews, or guidelines that appraise them. These are different professional responsibilities, and they clash.

The stakes are high. Editorials, reviews, and guidelines legitimise medical knowledge and shape clinical practice. Society needs a group of people who can evaluate medical evidence completely free of the appearance of commercial taint. One goal of The BMJ’s zero tolerance policy on education pieces by authors with industry ties was to offer unconflicted authors “prominence and visibility.” The success or failure of this policy can be evaluated only after the distinction between these different responsibilities—developing treatments or evaluating their place in practice—has been established long enough to influence the career choices of young doctors.

Disclosure does not solve the problem of bias and might make it worse. Advisers who disclose conflicts may subsequently feel more comfortable giving biased advice, a phenomenon called moral licence. Those who receive advice from a biased adviser often do not discount it sufficiently. Finally, “requiring disclosure is much easier than changing the status quo … I’d rather tell you I’m on the gravy train than get off it.”

We don’t find much to agree with in NEJM’s anecdotal analysis, but we do agree that criticism of the pharmaceutical and biotechnology industry is often reflexive and unfair. In fact, industry leads academia in complying with trial registration and reporting requirements. Many companies have embraced the open data movement. These are good things, but improvements in obvious problems should not be a pretext for regressive change. Instead, we should encourage all medical journals to separate the functions of evidence generation from those of appraisal. Policies that prevent experts with commercial ties from participating in evidence evaluation institutionalise this protection instead of making it optional. They are an important safeguard against bias and a defence against the perception of a “trial-journal pipeline” in which “companies treat trials and journals as marketing vehicles.” We agree with Steinbrook and colleagues that journal editors have a responsibility to lead on this issue and that “financial conflicts of interest in medicine are not beneficial.” It is a mistake by NEJM to suggest that rigorous standards should be revisited. To do so would undermine the trustworthiness of medical journals and be a disservice to clinical practice and patient safety.
see also excellent coverage on HealthNewsReview:
Mickey @ 9:13 AM

deeply troubling…

Posted on Tuesday 2 June 2015

This afternoon, I found out that Karen Dineen Wagner had been elected President of the American Academy of Child and Adolescent Psychiatry. She will be President Elect [2015-2017], President [2017-2019], and Past President [2019-2021] – all three being positions of active leadership in that organization. I find her nomination and subsequent election hard to fathom. She has been in the center of every Child and Adolescent Psychiatry scandal on recent record:
Paradoxically, Karen Wagner and some of her co-authors in these studies were later on the ACNP [American College of Neuropsychopharmacology] Task Force convened to report on these questions after the Black Box Warning was added by the FDA in 2004:
She made Senator Grassley’s list of psychiatrists found to have failed to report personal pharmaceutical income to their universities by law:
She is the Child and Adolescent columnist for the Psychiatric Times:
  • 2006-2015: Articles promoting antidepressants in MDD, stimulants in ADHD, antipsychotics in childhood Bipolar Disorder, and opposing the FDA Black Box Warning. List of the 27 articles.
This listing is by no means comprehensive, but it does frame the central themes of her tenure as Marie B. Gale Centennial Professor and Vice Chair in the department of psychiatry and behavioral sciences and Director of Child and Adolescent Psychiatry at the University of Texas Medical Branch at Galveston. Dr. Wagner’s positions on Child and Adolescent treatment are widely known throughout and beyond the membership of the American Academy of Child and Adolescent Psychiatry. So by electing her to lead them, in one form or another, the AACAP has chosen its path into the future – a path I find deeply troubling…
Mickey @ 10:36 PM

a note…

Posted on Tuesday 2 June 2015

I just closed the comments on the talk that matters… because a tit-for-tat was about to break out. I removed both comments, because that seemed fair. I’ve decided that that’s the only way to deal with such things. It keeps others from commenting for me to close things, but looking back over what happens when one of those things get going, the discussion invariably stops anyway and people join in the conflict. That’s not to say I’m going to censor negative opinion, or negative comments directed towards me [unless they get monotonous]. I can even live with conflict among commenters. But the first hint of contemptuous, sarcastic, uncivil banter and I’m afraid that this is going to be my response. I’ve tried everything else I know. If my belief that that kind of thing shouldn’t be here is idiosyncratic to me – as Popeye says, "I am what I am."

If waring parties want to duke it out, if both send me emails at 1boringoldman@gmail.com and agree, I’ll send along your email addresses to each other and you can fight it out in private. I’ll even publish a one-time summary comment if both agree on its content about how it came out. I kind of hope you take me up on this last part. Maybe we can bury some hatchets…
Mickey @ 3:58 PM

everything is fine now?

Posted on Tuesday 2 June 2015

It seems to me that President Kaler at the University of Minnesota thinks if he words things just right, people will believe what he says. So he says the same things over and over in a slightly different way and then seems surprised that we all don’t say, "Oh, I see, everything is fine now" and leave him alone.
And it is, with an action plan on ethics in research that has the potential to be a national model.
Minnesota StarTribune
by Eric W. Kaler
May 30, 2015

Difficult ethical issues are inherent in medical research, especially clinical trials involving human subjects. Research holds the promise of finding lifesaving treatments, but it sometimes depends on the participation of vulnerable patients suffering from serious illnesses. We at the University of Minnesota take seriously our responsibility to patients participating in clinical studies, and our critics are wrong when they assert that we have turned a blind eye to our ethical obligations [“Medical research: Honor code still needs strengthening,” a May 27 commentary by U Prof. Carl Elliott].

Let me be clear about Dan Markingson’s 2004 death by suicide, which is at the center of much of this conversation. The events have been the subject of many proceedings, including two reviews by the U.S. Food and Drug Administration [2005 and 2015], a lawsuit in Hennepin County District Court [2008], complaints to the Minnesota Board of Medical Practice against two doctors [2009 and 2010], and a review by the legislative auditor [2015].

As the legislative auditor concluded, we can never know if Markingson’s tragic death was the result of a clinical study conducted at 26 sites, including the University of Minnesota. However, it is clear we could have done better in our response to the concerns raised about these events. I have apologized to Dan Markingson’s mother, to a legislative committee and at public forums…
In this attempt to deny responsibility, the question is teleported to the clinical study. While the clinical study itself was nothing to write home about, what’s on the table isn’t the clinical study. The Protocol is clear, patients who didn’t respond were to be withdrawn. So a grossly psychotic patient with lethal delusions and disorganized thinking was in full view, not responding to the study medication, and nobody noticed, in spite of being confronted about that by Dan’s mother repeatedly [see making sense…]. Dan wasn’t studied clinically.
To their credit, our university faculty wanted further assurance that our current program was at the highest levels of ethics and science, and in December 2013 the Faculty Senate requested an independent external evaluation of our human subjects protection program…
At the  time, the limiting of the investigation to the current program and not the Markingson case per se was Kaler’s idea, not the Senate’s [see the following brief posts with links on Carl Elliot’s Fear and Loathing in Bioethics blog from December 2013]:
Meanwhile, back to President Kaler’s counterpoint. As with many of his statements, Kaler says essentially that everything is fine now and that Carl Elliot et al should be satisfied and move on:
Critics are important voices, but there comes a point at which criticism of past actions stops being a catalyst for reform and, instead, becomes a barrier to necessary change in the future. We can’t change the past, but with vigilance, dedication and integrity, we will move forward. I promise all Minnesotans, our faculty and students, and our future patients and their families that the University of Minnesota’s human subjects research program will soon be a model for other universities.
Other U·of·M Administrative types are accusing Carl of sticking on this issue as résumé padding and book selling COI, this criticism documented by a U·of·M colleague blogging on The Periodic Table [see For the Record: U·of·M faculty member of Academic Freedom and Tenure Committee Steps Over Line?  and  For the Record: More foolishness from a member of #umn Academic Freedom and Tenure Committee]. Neither passion nor perseverance are conflicts of interest in my book – they’re expressions of interest of the best kind.

Dan Markingson was in the hospital for around six months in 2003/2004. Mary Weiss, his mother, was told that everything is fine now – and it wasn’t. Mary Weiss, Mike Howard, Carl Elliot, Leigh Turner, and all investigators have been repeatedly told that everything is fine now in the decade since – and it wasn’t. So why should they listen to President Kaler’s tired message that everything is fine now? Let’s hope they don’t…
Mickey @ 2:52 PM

the talk that matters…

Posted on Monday 1 June 2015

NIMH: Director’s Blog
by Tom Insel
May 15, 2015

…It’s true that most of the neuroscience and genomics findings are not yet actionable for psychiatry. No one doubts that the brain is the organ of affect and behavior, but no one can point to a biomarker that is essential for clinical practice. In the short-run, we may do much more to bend the curve on suicide mortality by changing public policy [such as through restricting access to means] rather than finding a biomarker for suicidality. But in the long-run, and we need a long-run strategy, policy will hit a wall and we will need better diagnostics and therapeutics. That is where this new initiative can make a difference. The research of 2015 suggests that the clinician of 2025 and certainly the clinician of 2035 will need to know about cortical dynamics, neural networks, and genomic variation. Those entering the field today will need to know how to think about the brain and how to critique brain science. By changing the training of the next generation, we not only prepare for the future, we create it.
Genomic Biomarker for Suicidality Found!

Independent Georgia researcher, 1boringoldman, working closely with the CDCwebsite discovers clear evidence of…
[No, I haven’t gotten any calls from the Karolinska Institutet in Stockholm yet, but hope springs eternal. Should I perhaps add waiting room screening for the Y Chromosome?].

As an Internist, I never heard the term "biomarkers" or any of its synonyms. And yet they were part of everyday medical life. They were the tests we ordered to make or confirm diagnoses; the parameters we followed to monitor treatment; and the screening tests we collected to detect risk or early signs of disease. In Psychiatry, there weren’t any. Biomarkers were the thing that we didn’t have. Actually, by the time I showed up, we did have a couple in Melancholic Depression, Dr. Carroll’s Dexamethasone Suppression Test and Dr. Kupfer’s REM Sleep Latency studies. As is often also the case in physical medicine, neither was pathognomonic. But they stacked up well against many of our medical colleagues’ biological tests – particularly in combination. Then, in the most peculiar of moves, we discarded the diagnosis they marked [Melancholic Depression], and that was that for our brief biomarker years [until, of course, my recent breakthrough above!]. So we rely on the more subjective rating scales like the HAM-D or the PANSS.

Psychiatry’s greatest internal critic, Thomas Szasz, actually fueled the modern psychiatric obsession with biomarkers. Szasz argued that Mental Illness was a false construct – a Myth.
    "To be a true disease, the entity must first, somehow be capable of being approached, measured, or tested in scientific fashion. Second, to be confirmed as a disease, a condition must demonstrate pathology at the cellular or molecular level."
In spite of the fact that even the diseases in medicine long antedated the biomarkers that they became associated with, the body psychiatric seemed to accept Szasz’s argument as a gold standard. The neoKraepelinians made one of their tenets negating Szasz, but then in another set about the business of searching for biomarkers Szasz’s definition required:
    5. There are discrete mental illnesses. They are not myths, and there are many of them.
    6. The focus of psychiatric physicians should be on the biological aspects of illness.
And Robert Spitzer’s claim of the DSM-III being "Atheoretical" …
    Undoubtedly, with time, some of the disorders of unknown etiology will be found to have specific biological etiologies, others to have specific psychological causes, and still others to result mainly from a particular interplay of psychological, social, and biological factors…
… was soon forgotten in the biomedical transformation of psychiatry that followed him. So we now have the paradox of certain modern biopsychiatrists who speak of Mental Illness broadly as Brain Disease [as in biological] insisting on validation by biomarkers [as Szasz – and now Insel et al] but there aren’t any. For them, the search for biomarkers becomes, first and foremost, a quest for legitimacy. To add to the parodox, they also assume something like the universality of biomarkers [as in Tom Insel’s fantasy of a biomarker for suicidality or Nemeroff’s even more fanciful biomarker for PTSD]. And then there’s Insel’s newest scheme [RDoC], as in bring the diagnoses to the biomarker, rather than the other way around.

Okay. You win. I don’t think my Suicide Biomarker is a breakthrough. And I don’t think Thomas Szasz was a very nice man [he thought a lot of the patients were Malingerers who didn’t want to take responsibility for their lives]. I don’t think Insel is a clinician. And I kind of think the NNCI is forced at best. I watched one of their videos about talking to the patient using neuroscience talk. An obviously competent resident was illustrating talking to a anxious young woman who had a Heroin Relapse when her boyfriend broke up with her. He started with a [downloadable] brain picture and explained about the brain parts involved in "a circuit" [the Ventral Tegmental Area, the Nucleus Accumbens, the Orbital Frontal Cortex, the Prefrontal Cortex, the Amygdala, and the Hippocampus which he referred to as V+N, O, P, A, and H respectively] explaining each one’s part in the relapse and where and how different modalities of treatment worked, making an analogy to a car [the typing part is mine]. She got to take the completed diagram home as a reminder [click image to enlarge].

I liked the resident, and thought he did a reasonably credible job in his presentation. But I hardly think it prepared residents for the coming decades, and it came too close to the dumbed-down-ness of those "chemical imbalance" explanations of yore. This was part of the accompanying case presentation:
Today, she presents to your outpatient clinic feeling anxious and demanding that you prescribe alprazolam to her because she has heard that it helps with feeling nervous. A urine drug screen is performed in the clinic and returns positive for heroin. The resident confronts her with the results, and she breaks down crying about how she recently broke up with her boyfriend, happened to drive by her former drug dealer’s home and relapsed. She expresses to the resident how guilty she feels about using again after working so hard to stay clean for 5 years. 
You can watch the video here. He made the point that explaining things this way helped him to not shame the patient [a good point]. But I sure wish he’d mentioned the part in red and commented on it. If she actually makes it to that NA meeting, they’ll do that for sure with laughter and rolling eyes. I know that because I played this video for an addict in long term recovery whose reaction was pretty negative ["No addict is going to listen to all of that!"]. But I’m not here to judge.

"If you’re not here to judge, 1boringoldman, why are you here?" said the voice from the corner of the room. It’s because I’m an old training director, and while I agree that we learn from watching others, we also learn by watching ourselves. I wanted to ask Chris [the resident in the video] what he thought. Do we know enough to really say those things about the brain? Did the brain "prop" help? Will this young lady feel talked down to? Will she feel heard? Does this much bio take us away from the psycho·social? An alternative…
    "One thing any addict whose gotten clean knows is that the Heroin solution to pain is seared deep into the brain for all times. It’s like a reflex, whether it has been 5 days or 5 years. The only tools you’ve got in the face of that reflex is what you’ve learned in your mind and what others can do to help you. So when you heard yourself saying that you "happened to drive by [your] former drug dealer’s home," you were already in deep do-do. Did you really believe that? You needed to be driving by your nearest NA meeting, or a Sponsor’s house, or here. Did that occur to you? I have a feeling that with 5 years clean, you know all of that. Here’s what we can do about the relapse, «blah, blah, blah». But maybe right now, the thing we really ought to talk about is the breakup with this boyfriend. You’ve been in a whole lot of hurt, and it obviously threw you for quite a loop. So you just said the hell with it and did something really pretty self-destructive. Tell me about all of that…"
I’m well aware that Chris is making a training video to show how one might use neuroscience metaphors in explaining things to a patient, and that his natural behavior in real life might have been quite different. But my point remains. The NNCI proposes to "help residents incorporate relevant neuroscience into their own emerging clinical ‘voice’." That’s okay with me, when appropriate. This young woman isn’t in need of knowing how her brain works, or how treatment for her Heroin relapse works. She’s needs someone who addresses her obviously painful life crisis and who finds out if her relapse was a suicidal equivalent. And I expect that I might have that same objection to many such clinical vignettes, that the brain talk might well get in the way of the talk that matters.
Mickey @ 6:40 PM