under this rug…

Posted on Friday 28 March 2014

"My contacts tell me that a reliable source on the APA Board of Trustees informed members that the APA attorney has declared that there was no conflict of interest, effectively preempting any action by the Assembly."
Bernard Carroll – comment on not a peep…

I think it is likely true that the APA attorney declared that there was no conflict of interest in Dr. Kupfer’s actions detailed previously. While it’s hard to imagine what legal machinations the Attorney went through to come up with such an absurd conclusion, I’ve had my say about that multiple times. So for the moment, I want to talk about something else. Is a legal standard even appropriate to bring up in this case? We’re not talking about a person charged with a criminal offense going to trial or a civil suit alleging damages of one kind or another. And even in those situations, the opinion of a legal adviser isn’t the final word, it is only an opinion. Those verdicts comes from a Judge or a Jury.

In this case, the person under question is a high ranking official of the American Psychiatric Association tasked by the Board of Trustees to oversee a $25 M revision of the APA’s Diagnostic and Statistical Manual, a process over a decade in the making. The question is by what standard should such a person be judged. In the many debates about conflicts of interest over the life of the DSM-5 Revision process, the topic invariably revolved around the ties between DSM-5 Task Force members and the pharmaceutical industry – for example this point-counterpoint debate in the Psychiatric Times in 2009 involving Dr. Kupfer. The idea that a leader of the DSM-5 Task Force would be part of founding a company that produced screening instruments for things he was also supporting for inclusion in the manual never occurred to anyone. It was too outlandish to consider. But that’s what he did. And in an article about those tests in a peer reviewed journal, he omitted the required disclosure.

I presume that if we had the APA’s lawyer’s opinion, it would be something like: although the company was named, formed, incorporated in two states, professionally managed, and had a website, it had not yet officially launched its products, so technically that meant it wasn’t a conflict of interest. Something like that. That kind of technicality is well known to us from 20/20, or Mafia cases. This isn’t about such things. This is about medical ethics and integrity. And it’s not some Monica Lowensky dalliance – it’s in the direct line of duty. I can’t personally find a way to read this story as anything but profiteering. I gasped when I first heard it. Apparently the editor of JAMAPsychiatry did too, measured by the form of the published apology [Failure to Report Financial Disclosure Information]. I expect the members of the Board of Trustees at the APA gasped too [at least I hope so]. This wasn’t an ethical lapse. It was an active attempt to get away with something that went awry. No need to look at any rules to know that. Even if they had waited to incorporate their company until after the DSM-5 came out, or Kupfer had declared it along the way, it was still a misuse of his position for personal gain. There’s no piece of this caper that isn’t conduct unbecoming the chair of such an enterprise.

All of that is obvious. If it is indeed true that "the APA attorney has declared that there was no conflict of interest, effectively preempting any action by the Assembly," that does not mean that the APA Board of Trustees must remain silent, because that silence screams indifference or worse. They may be afraid of getting sued for slander by Dr. Kupfer, but they need to be even more frightened of their silence putting the finishing touches on the demise of an already heavily tarnished ethical reputation. They have to speak. There’s just no more room under this rug…
Mickey @ 7:37 PM
Filed under: politics
not a peep…

Posted on Friday 28 March 2014

I guess I can take down the crossed fingers about the Open Letter to the APA concerning the Affaire d’Kupfer [see credibility…]. The Board of Trustees met three weeks ago and there hasn’t been a peep that I know about. After all the questions about conflicts of interest among members of the DSM-5 Task Force and Dr. Kupfer’s defensive responses, for him to turn out to have a significant hidden conflict of interest himself is bad enough. But for the APA’s Board of Trustees to simply ignore that it even happened takes things over the top. I expect there will come a day when they will regret that decision. I sure do already.

In legal terms, the facts of the incident are uncontested. Dr. Gibbons, a statistician at the University of Chicago adapted a method of psychometric testing to measure anxiety and depression using NIMH Grant funding. The Clinical testing was done under contract with Dr. Kupfer’s department of psychiatry in Pittsburgh. The focus of the psychometric was an aspect of diagnosis being championed by Dr. Kupfer as DSM-5 Task Force chairman – "dimensions." They published an article about the test, hiding the fact that they had formed a company to market the test commercially. When this was discovered and they were confronted, they admitted their culpability publicly. Four of the five authors were directly affiliated with the DSM-5 Task Force, with Dr. Kupfer as the chair. It is simply not possible that this was anything but active deceit. Those are the facts.

When all of this was revealed, the Speaker of the Assembly of the APA was asked to report on the incident to the APA Board of Trustees. She concluded that they shouldn’t have done it, but that it did no damage and the fact that Dr. Kupfer was involved did not offer commercial advantage to their company [that is, of course, an absurd conclusion]. There was no comment in the report that addressed the why of it – why he/they did it. And to return to my letter above, she did not address the ethical issues raised by this whole episode.

The traditional medical ethic is that physicians should not even have the appearance, much less an actual conflict of interest. In recent times, that standard has been downgraded to an injunction to declare conflicts of interest publicly. I for one feel that is an unwise loosening of standards. But to have a clear conflict of interest and keep it hidden is to ignore even this depreciated standard. And for the APA itself to not even see this as something to act on in the case of an official in an important position of authority within the APA is to essentially say that they have no ethical policy at all.

I hope that’s not true, and that some commentary or action will be forthcoming. But so far, not a peep…
Mickey @ 12:00 AM
Filed under: politics
un·retraction watch…

Posted on Thursday 27 March 2014

That last reference is to a newer post on Retraction Watch. Speak, Memory [AKA When Psychiatry Battled the Devil] has been un·retracted now for a week, and has gotten its good share of comments at Psychiatric Times. Most addressed, incredulously, that such a thing happened and/or the motives of those involved. As in the historical story of the Salem Witch Trials  or the oft-mentioned story of the Emperor’s New Clothes, in retrospect, such things do seem incredible, particularly when they’re of such a magnitude.

And as in this case, it’s easy to decry what happened through a lens of history. But that doesn’t fully do justice to what happened back there. And it doesn’t address the related phenomena all around us. In our film industry, this is hot stuff – vampires, horror films, aliens – the list goes on and on. In the westerns of my youth, there were good guys and bad guys [often identifiable by hat color]. And this metaphor that can be counted on in crime shows, murder mysteries, science fiction, and the current vampire/zombie productions that populate our cable channels. Embodiments of evil are all around us in our entertainment world, our political wranglings, our wars and their rhetoric.

I saw only one of these identified cases, in consultation. It was a long time ago, but she didn’t strike me as a person who was coming to see me for help with something – she seemed more to be looking for someone to go crazy with her. I passed on the offer. I doubt that such an n=1 example in any way characterizes the patients who were part of this story. Many seem to be like the passive and shy Sybil, caught up in her therapist’s story, desperate for an attachment. Truthfully, I can’t even speculate about the range of patient therapist dyads or groups involved because of limited to no experience, but the phenomena is certainly familiar. There are two kinds of injunctions in this regard. The first, "Listen to your patients. Don’t discount their stories." On the other side is something like, "Don’t take everything at face value. Everyone is looking for a champion." Freud’s answer was "neutrality." Stay in the middle, equidistant from the various possibilities without  joining any particular side. That’s a lot easier to say than do sometimes.

I once made up something I called my rule for living, "Never accept an invitation to go crazy." It was only partially tongue in cheek. I was dead serious too. The offers are everywhere, particularly in the mental health field, and this story of the SRA craze is an example of what happens if you don’t live by it, if we don’t live by it. I won’t go into why I was moved to make up such a rule, but it has to do with being willing to take on patients who struggle with more primitive mechanisms for living. They are often heroic indications for therapy, and success is never guaranteed – but very rewarding if achieved. But the rule stuck with me. My family even had it made into a coffee cup and bumper sticker because I say it so often.

Richard Noll has brought up a huge topic with this story. All of us have seen couples who have gone crazy together. We know about the Salem Witch Trials, Hitler’s Nazis, Religious Cults, Political Extremism, etc. We all watch some version of the good guy/bad guy media. If you’re a therapist and you can’t recall going crazy with some patient, you haven’t really put your feet in the water. It’s only through a retrospective look at our own stories that we can gain the skills to even approach our impossible profession with integrity. One thing I learned along the way. Whenever I felt the pull [whatever that means], I insisted on a consultation with someone [not in my inner circle]. And I did a lot of those consultations myself. It’s amazing how much a third pair of eyes can see when the fog of such things is in play between two people or within a group, something like a historical review [an outside opinion]. Secrecy or a closed shop is a real breeding ground for craziness becoming institutionalized.

I think I figured out why this particular topic is so interesting to me – to me specifically. I think of it is an explanation for what happened in psychiatry at large. Right now, there are plenty of people who would put all psychiatrists as a group into the category of satanic cults – motivated only by greed or worse.  And because of the subjective nature of the topic, we are particularly vulnerable to such. I wince when people write, "psychiatry thinks…" or when someone comments as if I think fill in the blank because I’m a psychiatrist [as we all think the same wrong things]. But that’s not what I was referring to. Mainstream psychiatry itself has been largely focused on the evil biology that afflicts humanity, and on a quest to root it out – even though it remains elusively out of view, to be uncovered in the future. There are a lot of very thoughtful biological psychiatrists and neuroscientists who are interested in and pursuing the biological underpinnings of some of the mental illnesses, but they have been marginalized by a larger group of people caught up in a craze – abetted by industrial forces and sexy new technology. Were I myself one of those biological psychiatrists, I would be furious at being trivialized by association with the people caught up in the monomaniacal crusade.

Perhaps, by looking back at why so many mental health types and patients went crazy together in the SRA era [and they did], we might learn some things about how to approach them in the future. And it’s  not just by looking at the leaders that we will learn what we need to know. There are always such charismatic leaders around to follow. We would learn the most from the people in the audience who were captured by the craze, who accepted the invitation. Most of all, we need to know how to detect when there’s a mass hysteria or mass delusion in the making and bring it to the light of day when it is just getting started…
Mickey @ 3:25 PM
Filed under: politics
and take names…

Posted on Tuesday 25 March 2014

The Sunday Times
by George Arbuthnott and Jonathan Leake
23 March 2014

No, I didn’t make the print disappear. It faded behind a right pricey Sunday Times paywall. If there’s anything to the story, the whole thing ought to show up on the Internet sooner or later. And I’m curious what those early Prozac approval studies would show [if they exist anymore]. It’s hard to imagine it now, but in those days I believed what I read, at least for starters.

The first time I ever prescribed Prozac was to the first HIV positive person I’d ever met.  He was a professor at a nearby university who had developed a lymphoma. As he was gay, his doctor suggested a brand new test [HIV], and it was positive. I’d never even heard of the test, and knew little about AIDS. At a later point, he wanted to try that new drug, Prozac. I read what there was to read, and we gave it a shot. His report was that it helped, but said he wasn’t sure it was an antidepressant. He called it an "anti-broodant." He didn’t "brood" about his plight so much. When the sexual side effects came, I went to the books again. "Rare" is what it said. He said, "’Well done’ is more like it!" and ultimately decided to stop, reporting that he felt bad coming off of it, but the bad feelings cleared after a time. So with this first patient, I learned about the anti-OCD effects of the drug, the sexual side effects, and about the withdrawal. He died from his primary illness before the modern treatments for AIDS came along.

Medicine is like that: a case with a new disease, or a first encounter with an old one, or some new treatment. The only way to do it is to know that you don’t know something, then hit the books, or go to the literature, or talk to colleagues, or get a consultation, or make a referral. I claim that’s why we call it practice, and why we call the people we see patients. Medicine just can’t be mastered. But I think the psychiatric drugs of the 80s and 90s were my first encounter with a situation where those usual sources weren’t helpful. Of course there had been adverse effects that showed up with usage, but I can’t think of situations before where they were known, but not acknowledged. And I certainly never imagined instances where the academic resources would become an active part of the denial.
… As I was writing, there was a ping and an email with this…
PharmaTimes
by Kevin Grogan
March 24, 2014

The movement for more data transparency has been given a shot in the arm following a Sunday Times report which shows that the UK medicines regulator routinely destroys information on the licensing application files for drugs it has approved after 15 years. The newspaper’s piece documents the bid by Peter Gotzsche, co-founder of the Cochrane Collaboration, to get access to the data used to support marketing approval for Eli Lilly’s now off-patent antidepressant blockbuster Prozac [fluoxetine]. He approached the European Medicines Agency which referred him to the Medicines and Healthcare Products Regulatory Agency [MHRA] as the UK acted as the reference member state for Prozac approval.

However, the agency has shredded the vast majority of the clinical evidence it held on the treatment and the Prozac case is not an isolated one. Prof Gotzsche was told that “under MHRA record management policy, all application files and data for licences are held for 15 years". After this period, "files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest". The Sunday Times article noted that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings". Lilly retains the data and the MHRA "can order it to be submitted".

Ben Goldacre, co-founder of AllTrials, said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded". He added that "doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible". Dr Goldacre concluded by saying that "science progresses, and medicine improves, when we have many eyes on the data".

In response, an MHRA spokesperson told PharmaTimes that “we closely monitor the safety and efficacy of all medicines throughout the product lifecycle and we retain all key information relating to the agency’s assessment and decision-making processes". He added that "we use modern adverse drug reaction reporting systems and current research studies that better reflect clinical use and build on the original licensing data". He also stressed that the MHRA "has the legal power to require manufacturers of medicines to share safety, efficacy and clinical trial information from any time period so we can thoroughly investigate any issues".

Regarding the Prozac case specifically, the MHRA notes that it was "the first regulator to conduct a comprehensive safety review selective serotonin reuptake inhibitors [SSRIs] of the risks of suicidal behaviour and withdrawal reactions". It adds that "our overriding responsibility is to ensure that medicines work, and are acceptably safe. Our role is not to protect industry interests". The agency concludes by saying that "we are committed to greater transparency in our activities [and] we have already shown this by publishing the minutes of our advisory committees and Public Assessment Reports, detailing the processes and decisions made when licensing a drug and disclosing the evidence underpinning our decisions in areas of public concern."
so sooner, rather than later …
I don’t totally fault the MHRA [though in this day and time, there's no reason to throw away data ever with the availability of digital storage]. But I agree with Gotzsche and Goldacre, that this should never have been secret in the first place, and I hope Gotzsche goes after Lilly for that data.

What I was going to say above was that I want to know about all those early trials of the psychoactive drugs, and what they really showed. Every one of those studies is of "lasting historic interest." I’ve lived through a career without the traditional resources to learn from, including the academic department where I was a contributing member, a department chaired by Dr. Charles Nemeroff for twenty of the thirty years I’ve been a volunteer teacher – who sent me a letter every year thanking me for my service. During that time, almost everything I’ve learned about our medicines, I’ve learned from patients, particularly about the limited efficacy and the adverse effects. And it took a while to recognize that what I read in peer-reviewed journals was largely advertising pabulum.

It’s why I support the RIAT project [Restoring invisible and abandoned trials: a call for people to publish the findings]. That’s why I support AllTrials. I’d like to see critical analyses of all the drugs and trials that have come our way in the last twenty-seven years. Many of our critics point out that we [the physicians and psychiatrists] are the ones that wrote the prescriptions for every single pill taken, so I think we deserve to know definitively [whether we want to or not] what those clinical trials actually should have said – where those official guidelines and treatment algorithms actually came from. There is more than ample evidence that we were systematically deceived by the pharmaceutical industry and members of our own ranks who colluded with them and signed the articles that arose from those studies. That’s not to say that organized psychiatry and individual psychiatrists don’t also share in the blame.

People like to tease about Peter Gotzsche’s animated style, as he suffers fools lightly. But I have to agree with what David Healy said about that recently [Get Real: Peter Gøtzsche Responds]:
… History will recognize Peter as the man who, among other achievements, pried open the question of access to RCT data, forcing the European Medicines’ Agency to open up their files. His motivation to do this came in part from a discovery of how appallingly bad the state of affairs in psychiatry IS. How almost all trials on which the field depends are ghostwritten, all data withheld and all dissent suppressed. Whatever it is this is not science and there has to be a good chance it’s killing and disabling more people prematurely than it helps.

What you hear from Peter is a howl of horror. The rest of us have got so inured to the situation we can no longer see how bad it is. The Allied troops arriving at concentration camps must have reacted the same way, where many inmates had gotten used to the situation…
Sometimes we need somebody who is willing to kick ass and take names
Mickey @ 2:03 PM
Filed under: uncategorized
listening…

Posted on Monday 24 March 2014

 

I always feel an agita as March winds down. In the South, the trees and flowers begin to bloom in spite of periodic cold snaps. And for some of us, the antihistamines and daily checks on the pollen count come before the winter jackets move to the back of the closet. Then I remember why I feel flaky, and the memory actually helps, but always takes me by surprise. In 1968, it was a contentious time in Memphis where I lived – the garbage men went on strike. It was joined by the Civil Rights groups, and one Thursday in March, Dr. King came to town for a protest march which turned into a major riot – and we had martial law, curfews, gunfire was heard from my porch. Most of the violence before had come from white opposition to the Civil Rights Movement, but this one got started by the black militants who opposed MLK’s non-violent approach. However, once underway, everyone got in the act. It was the first march that King had lead that went so badly, and he vowed to return the following Thursday for another – it was to be a testimonial to non-violence.

I was an Intern and spent several days in the ER of the City Hospital treating casualties. Memphis was a wreck by then – garbage collecting at the curbs; people afraid to go out at night; racial tension at a fever pitch; soldiers on the streets; trees and flowers beginning to bloom. The next Thursday, we awoke to 14 inches of snow, and the march was postponed for a week. By the afternoon, the snow melted and the garbage spread down the streets as the runoff headed for the clogged drains. Over the next week, the tension continued to build. You all know what happened then – Martin Luther King was assassinated in the early evening on the eve of the march.

On the day it happened, I had been temporarily promoted and was acting as admitting resident because they had over-scheduled vacations. After dinner, my wife called and told me the news and took off for her brother’s house in a safer part of town. Then came a page to me that the ambulance was headed our way and I was to meet it. Anticipating the headlines, "Intern masquerading as Resident blows it in ER," I mobilized every doctor in the hospital to the ER. As it turned out, MLK was taken to another hospital on the way where a friend pronounced him dead. Then all hell broke loose. I’ve never been to war, but I call those next several days my Viet Nam. The ER was immediately filled with gun-shot people. Except for the wheels of the gurneys, it was silent as more wounded than I could imagine streamed in the doors. The cops were terrified. The patients were terrified. So were we. The floors were slippery with the blood that pored from the gunshot wounds. It went on for days.

I think about those days when people talk about the fog of war. My memories are seen through a vasoline covered lens and I rarely think of it except, like this morning, when I see an early Redbud, feel an unexplained emotional discomfort, and then I remember. I always feel like I’m being melodramatic when I talk about it, but it was real drama – at least as close as I ever get. When we finally went home three days later, we could hear  periodic gunshots, and tank convoys still rolled down our street. We were both committed to and involved in the Civil Rights Movement, but we were so caught up in the surround, and what was happening, that it would be a while before we could even think about the implications of that assassination. My friends who were in Viet Nam said the same thing coming home – they didn’t think about the why of that war while they were in it, only about managing the chaos of the days they were in.

These are not pleasant memories, but every year at about this time, I find myself telling this story to someone, or writing about it. I don’t think there’s a reason exactly. We all have memories of times like that – unpleasant stories, yet ones told repeatedly throughout life. I’ve come to believe that those experiences are a major part of the persons we’ve become, and even though the words can’t really convey the experience, the telling is vital to knowing who we are. Narrative, itself, is a psychotherapy. Thanks for listening…

Mickey @ 4:29 PM
Filed under: politics
all by itself…

Posted on Sunday 23 March 2014

When I saw this, being a chronic follower of Dr. Nemeroff’s doings, I clicked on the link. It’s a topic he talks about a lot. There was no Abstract or Article posted on this side of a paywall…
by Charles B. Nemeroff and Elisabeth Binder
Journal of the American Academy of Child & Adolescent Psychiatry, 2014 53:395-397.
but there was this:
Disclosure:
  • Dr. Nemeroff has received research/grant support from the National Institutes of Health (NIH).
  • He has served as a consultant to Xhale, Takeda, SK Pharma, Shire, Roche, Eli Lilly and Co., Allergan, Mitsubishi Tanabe Pharma, Development America, Taisho Pharmaceutical Inc., and Lundbeck.
  • He has held stock in CeNeRx BioPharma, PharmaNeuroBoost, Revaax Pharma, Xhale, Celgene, and Seattle Genetics. He has served on the advisory boards of American Foundation for Suicide Prevention (AFSP), CeNeRx BioPharma, National Alliance for Research on Schizophrenia and Depression (NARSAD), Xhale, PharmaNeuroBoost, Anxiety Disorders Association of America (ADAA), and Skyland Trail.
  • He has served on the Board of Directors of AFSP, NovaDel, Skyland Trail, Gratitude America, and ADAA.
  • He has received income sources or equity from PharmaNeuroBoost, CeNeRx BioPharma, NovaDel Pharma, Reevax Pharma, American Psychiatric Publishing, and Xhale.
  • He holds patents in Method and devices for transdermal delivery of lithium (US 6,375,990B1) and Method of assessing antidepressant drug therapy via transport inhibition of monoamine neurotransmitters by ex vivo assay (US 7,148,027B2).
  • He has received honoraria from the Florida Council for Community Mental Health, the Las Vegas Psychiatric Society, the World Psychiatric Association, the Saudi Psychiatric Association, the Kenes MP Asia, the American Physician Institute for Advanced Professional Studies, Asociacion de Psiquiatras de la Region de Bayamon, Florida Partners in Crisis, Global Technology Community, LLC, the International Society of Psychoneuroendocrinology, CPO Hanser Service, 1er Congreso de la Sociedad Internacional de Trastornos Bipolares, Venezuela, APA/Egyptian Psychiatric Association, YPO Partners Forum, Lieber Institute, Inc., Nevada Psychiatric Association, the University of New Mexico, World Congress of Biological Psychiatry, the University of Texas Medical Branch Galveston Grand Rounds, the Volkswagen Foundation/Herrenhausen Conference, Rush University Grand Rounds, 5th International Cardio Event 2013, CCM International Saudi Arabia/APA Meetings, CME Outfitters, CINP World Congress, the Medical University of South Carolina, Harvard Medical School/Psychopharmacology: A Master Class, the Florida Psychiatric Association, the International Society for Bipolar Disorders, 16th Annual Laura Evans Memorial Breast Cancer Symposium, Delaware State University, the University of North Carolina, New York University, NARSAD/the Brain and Behavior Research Foundation, the American Foundation for Suicide Prevention, the University of Chicago, King’s College, Beth Israel Deaconess, Wright State University, the University of Texas Medical Branch, Physicians Practice Group, Augusta, GA, Londocor Event Management – South African Biological Psychiatry Congress Education SPA, Psychiatric Foundation of North Carolina, Colombian Psychiatric Association Meeting, the Anxiety and Depression Association of America, Scuola Superiore di Neuroscienze – Neuroscience School of Advanced Studies, American Psychiatric Publishing, 20th National Congress on Child Maltreatment, Bogota, Colombia, Lundbeck, Max Planck Institute, Medical Education Speaker Network, and Guarant International.
  • He has received royalties from the American Psychiatric Association, John Wiley and Sons, Inc., The Authors Registry, Elsevier, Oxford University Press, and Cambridge University Press.
  • He has served as an expert witness and/or legal advice consultant to Edward Health Services Corporation, Penn and Seaborn, LLC, Schochor, Federico, and Staton, PA, Great Northern Insurance Agency, Douberly and Cicero, Sotolongo, PA, and Kirby Johnson, PC.
I can’t think of anything to say that it doesn’t say all by itself…
Mickey @ 11:37 PM
Filed under: politics
not define it…

Posted on Saturday 22 March 2014

PsychiatricNews
by Carolyn Rodriguez, M.D., PH.D.; Jonathan Amiel, M.D.; and Jeffrey Lieberman, M.D.
March 20, 2014

The beginning of a psychiatrist’s career after residency or fellowship is an exciting, but daunting, time. Whatever career path he or she is pursuing—clinical practice, academics, public sector, or industry—the transition from trainee to professional is critically important and often stressful. There is the challenge of having primary responsibility for one’s own patients. The desire to become comfortable in a new work environment and with new colleagues. The understanding that no matter how thorough our training has been, there remain difficult situations that arise in practice, testing our knowledge and mettle. APA well understands the need to support psychiatrists at this stage of their development and even has a special name for them: early career psychiatrists [ECPs]. Every psychiatrist and member of APA has faced this juncture in their careers. Consequently, we recently reviewed APA membership survey data to learn what special needs and services applied to this important constituency of our profession.

We were surprised to see that while resident-fellow members saw value and were pleased with APA membership, many weren’t continuing their membership as they entered the field and the professional workforce. We wondered whether this may be due to the fact that, in a changing and challenging environment, we may too often focus on the challenge of the moment over our longer term professional needs and enrichment. This problem was particularly concerning since APA membership is especially helpful early in one’s career for educational and mentoring resources. And more importantly, young members strengthen APA and shape the Association now and for the future.

To examine this issue, we co-chaired a work group of ECP members and two senior APA advisors to find out what APA was — and wasn’t — doing to support the needs of psychiatrists just starting in the field and what could be done better. Based on the work group’s recommendations, APA, with the full support of the Board of Trustees, is focused on making sure that the needs of psychiatrists just starting their careers are optimally addressed…
Conflict of Interest Statement: One’s view of recent history at large is irreconcilably bound to one’s own personal experience. And the study of history often involves a critical review of what the people of the time said about the period under the microscope. I had been an Early Career Physician already in the field of Internal Medicine. For me, being an Early Career Psychiatrist was the second time around. And what a time to enter the fray – in the middle of what is now called "the crisis of the 1970s". To say psychiatry was changing is beyond an understatement.

In some ways, I was lucky. I was torn between two compelling interests – the hard science of medicine and the human experience of illness. I had already had my identity crisis before arriving in psychiatry training and made my choice, so I was running on my own motor towards the latter. I had no idea that psychiatry itself was about to go the other way, and during my Early Career Psychiatrist days, it did. But I didn’t. And again, I was lucky. I was able to have a rewarding career doing what I chose to do, even though it was isolated from mainstream of psychiatry. I have a thought about what Dr. Lieberman et al are saying in this article, but it’s idiosyncratic, biased by my own path.

Cultivating the Next Generation Of Psychiatrists: People talk about the neoKraepelinians [Robins and Guze etc.] or the DSM-IIIs Robert Spitzer as the movers and shakers of the changes in psychiatry in 1980, but that credit really belongs to Mel Sabshin, the Medical Director of the American Psychiatric Association from 1974 to 1997. His book, Changing American Psychiatry: A Personal Perspective, tells the story from his front line perspective. He was a strong and beloved leader who did what he set out to do – change American Psychiatry.  I didn’t even know he existed at the time. The APA under Sabshin took the reins of the direction of psychiatry and lead the radical changes we all already know about, some of which were positive and long needed, some of which were either ill-considered or had inadvertent negative consequences.

The above article is really about the APA’s continued waning membership roles, and why young psychiatrists see APA membership as superfluous. I wasn’t so young when I let my APA membership expire. At that time, the APA was leading psychiatry in a particular biomedical direction that had little to do with my life and practice. In contrast, I didn’t see the APA taking leadership at all in areas that were of interest to me, but rather following Managed Care and PHARMA who were shaping and redefining psychiatry in their own image. So the APA was more than superfluous. It was a negative force that I couldn’t do anything about, but I sure wasn’t interested in supporting.

The way the story’s told, psychiatry needed a Melvin Sabshin to consolidate power to motivate change, and that may well have been absolutely true. I wasn’t around for that so I don’t really know the answer. But there were some unaddressed consequences that linger. The first was that the APA hadn’t read Bion’s books about groups and became lethal – extruding the psychoanalysts and the psychologically minded almost en mass [exception: Aaron Beck's CBT], actually assigning us to the status of scapegoats. That attitude unfortunately bled over into the APA’s relationship with the other mental health professions. So people like me didn’t actually withdraw from the APA, we were marginalized. But more importantly, the APA under Sabshin consolidated and centralized the power, and never gave it back. History is filled with similar stories – a strong leadership that brings off a coup d’etat as a reform movement, creating the environment for a future oligarchy in the process. Sometimes, that’s the only way to get the job done [by revolution], but the wise know that a subsequent restoration of balance is essential.

The APA didn’t do that, and continued to hold the reins tightly – going on to became a power base for a biomedical ideology that seems primarily allied with the forces of industry. In the last decade, the ideologically driven APA attempted to "do it again" by using the revision of the Diagnostic Manual to further change psychiatry to fit a particular view just as Sabshin and Spitzer had done [but with a different agenda]. But the "second coming" fell very flat. Even the title of this article contains the problem – Cultivating the Next Generation Of Psychiatrists. It implies a centrality that exists primarily in the minds of the APA leadership, but apparently not in the minds of the majority of psychiatrists or its newest arrivals. A professional organization is meant to represent and serve that profession as a whole, not define or even cultivate it…
Mickey @ 11:25 AM
Filed under: politics
phrases…

Posted on Saturday 22 March 2014

NIH Director’s Blog
by Dr. Francis Collins
February 4, 2014

It would seem like there’s never been a better time for drug development. Recent advances in genomics, proteomics, imaging, and other technologies have led to the discovery of more than a thousand risk factors for common diseases—biological changes that ought to hold promise as targets for drugs…
It would appear that the terms genomics, proteomics, and imaging ought to be combined into a single phrase, because we usually hear them together. For that matter, we could throw in recent advances in into a unitary shorthand for recent·advances·in·genomics·proteomics·and·imaging. I thought the phrase was limited to psychiatry/neuroscience, but from the above in appears to be a medicine-wide term to introduce research initiatives that lead us into a brighter future [how the recent·advances·in·genomics·proteomics·and·imaging triad relates specifically to drug development isn't exactly clear to me, but I don't want to be too picky].

There are some other stock phrases that come to mind: unmet·clinical·need and global·burden·of·disease. Both of these are used routinely in reports of clinical trials or in pleas for more research funding for some particular project. The latter was almost guaranteed to be in the introduction to the ghost written clinical trial reports that were so popular during the last several decades, the age of psychopharmacology. And unmet·clinical·need is all purpose – can either go in an article to introduce a new drug that’s being hawked as an advance or later when discussing how that last drug wasn’t really very good and we need to find a new one [it's actually hard to think of a medical situation or grant proposal where you couldn't throw in an unmet·clinical·need].

And even though it’s only a single word, translation fits into this lexicon because it can be shorthand for so many things. It’s usage overflows its specific meaning these days, but it was intended to mean moving basic science research into something that directly helped patients [it's also hard to think of a medical situation or grant proposal where you couldn't throw in a translation metaphor or two]. There’s another newer term that goes in here as well, but I’ll talk about it later – recent·exits·by·companies·from·psychiatry.
Science
by Steven Hyman
March 14, 2014

Last month, the battle against four major diseases received some good news. The U.S. National Institutes of Health [NIH] and 10 of the world’s largest pharmaceutical companies decided that instead of working ineffectively in silos, they would work together to discover therapies for Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, and lupus. This initiative — the Accelerating Medicines Partnership [AMP] — recognizes that progress toward new therapies for common chronic diseases increasingly requires large-scale collaborative efforts that range from the need to grapple with heterogeneous polygenic disease phenotypes to the validation of biomarkers in large populations. What is disappointing is that, at least for the time being, the consortium dropped schizophrenia from its list, despite vast unmet medical need and substantial, albeit still recent, scientific advances. Was schizophrenia deemed too risky to pursue? If innovative partnerships such as the AMP are not willing to take on common and serious but otherwise neglected disorders such as schizophrenia, then the scientific community will have to find new ways of pooling intellectual and financial resources to address them…
So now we can combine my shorthand with Dr. Hyman’s longhand:

unmet·clinical·need and global·burden·of·disease
Schizophrenia is a severe and disabling brain disorder that also creates enormous costs and challenges for caregivers and for society. Antipsychotic drugs that partially treat hallucinations and delusions were discovered in the early 1950s but have serious side effects and leave entirely untreated schizophrenia’s characteristic cognitive impairments and “negative” symptoms such as blunting of emotion, loss of motivation, and impoverishment of thought and speech. The past six decades have witnessed many commercially successful antipsychotic drugs, but no new mechanisms of action and no gains in efficacy since the early 1960s. Cognitive behavioral therapies show promise, but even when combined with current medications, individuals with schizophrenia live with profound limitations resulting from diminished control over thought, emotion, and behavior. Many pharmaceutical companies have exited psychiatry in recent years because of high failure rates in clinical trials, only rudimentary understanding of disease mechanisms, and the lack of treatment biomarkers. Under these circumstances, patients and families would have scant hope for the arrival of better drug treatments….
recent·advances·in·genomics·proteomics·and·imaging
Much about this grim scientific picture has changed in the past 5 years. New genomic technologies, combined with global collaborations to identify study participants and collect samples, have permitted the identification of a large and rapidly growing number of alleles associated with schizophrenia, bipolar disorder, and autism. Molecular pathways involved in neuronal function are emerging from the data and are beginning to suggest drug targets. Animal and in vitro models in which to investigate hundreds of gene variants of small effect remain works in progress. However, promising tools have emerged here too. For molecular and cellular analyses, stem cell technologies make possible the generation of human neurons in vitro. When combined with remarkable new genome engineering tools, these approaches permit the study of individual risk alleles, multiple alleles in molecular pathways, and the correction of risk alleles in neurons derived from patient samples. Studies at neural circuit levels are yet more challenging, but one can even envision transgenic nonhuman primate disease models with the genome engineering tools at hand. Proposals to the AMP have focused on advancing the genetic analysis of schizophrenia; improving in vitro human neuronal models to study disease-associated alleles; and a project to identify biomarkers, modeled on the early stages of the successful Alzheimer’s Disease Neuroimaging Initiative.
And now we can add in our very·important·new·phrase:

recent·exits·by·companies·from·psychiatry
Perhaps recent exits by companies from psychiatry made schizophrenia too great a reach for the AMP, despite continued strong support from NIH leadership. It is precisely when new knowledge opens challenging but real possibilities to make major advances in health that partnerships such as the AMP seem most warranted. The scientific community, including industry, academia, patient groups, and government, must find ways of sharing financial risk while developing effective and well-governed partnerships. Otherwise, important basic science investments will go untranslated while patients and society continue to bear painful and costly burdens.
Steven Hyman has been an influential figure in the development of American biomedical psychiatry. From 1996 through 2001 he was Director of the NIMH where he initiated the large drug trials [CATIE, STAR*D, etc], genetic and neuroscience research, and helped fund the early DSM-5 revision effort. In 2002 he became Provost of Harvard University, but continued his involvement with the DSM-5 and the ICD focusing on the inclusion of neuroscience and genetics. In 2011, he became the Director of the heavily endowed Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard that focuses on genetics and neuroscience research in psychiatry. He has been an active advocate of the NIMH RDoC project. The article above might best be viewed as an extension of a number of articles he’s written since moving to the Stanley Center:
by Hyman SE.
Science Translational Medicine. 2012 4[155]:155.

Drug discovery is at a near standstill for treating psychiatric disorders such as schizophrenia, bipolar disorder, depression, and common forms of autism. Despite high prevalence and unmet medical need, major pharmaceutical companies are de-emphasizing or exiting psychiatry, thus removing significant capacity from efforts to discover new medicines. In this Commentary, I develop a view of what has gone wrong scientifically and ask what can be done to address this parlous situation…
The Dana Foundation: Cerebrum
By Steven E. Hyman
April 02, 2013
PsychiatricNews
From the President
by Steven Hyman, M.D. and Jeffrey Lieberman, M.D.
October 17, 2013
by Steven E. Hyman
Neuropsychopharmacology Reviews. 2014 39:220–229.
First, my apologies for the length of this post, but I wanted to gather all of this in one place so we could think about the whole picture. So back to the phrases

the·revolution: A lot of meanings here. One is the burst of discovery in the 1950s of medications that were effective in psychiatric conditions [lithium, antipsychotics, antidepressants, anxiolytics]. Another revolution was the coming of the neoKraepelinians and Robert Spitzer’s DSM-III in 1980. I think by the time Hyman arrived at the NINH, he might think of his tenure there as a revolution of sorts. By then, multiple classes of psychoactive drugs were flowing from the pharmaceutical pipeline at a steady rate. It was the decade of the brain, and the NIMH was front and center. Acadedemia and industry were collaborating [above and below the table]. And Hyman’s NIMH set out on a bold path to test the emerging drugs in mega clinical trials. During those years, the human genome project was completed and psychiatric genomics was becoming quite the rage. There was a feeling that the biological basis of psychiatry was just around the corner, and Hyman’s NIMH joined with the American Psychiatric Association to fund a series of symposia to plan for the next revolution, a biomedical DSM-V/5.

the·crisis: Another phrase with multiple meanings. After Hyman left the NIMH, his replacement, Tom Insel, came from a large academic/industry translational program and carried the banner of biomedical psychiatry, adding his psychiatry·as·clinical·neuroscience phrase to the base well laid by Hyman. But then came the crises. First there were a series of disillusionments as the misadventures of prominent academic psychiatrists became increasingly apparent, along with the exposure of widespread research misdemeanors in industry funded clinical trials. That culminated in Senator Grassley’s investugation of a number of high ranking psychiatrists for financial hanky-panky. Then came the legal suits exposing unmentioned adverse effects, accompanied by the release of documents that showed epidemic ghost-writing, the antics of the KOLs, the jury-rigged analyses of drug trials, and the deceitful marketing practices of PHARMA. And then there was another big crisis, the collapse of the grandiose wishes for the DSM-5 and its other foibles. But none of these are the crisis Hyman is talking about.

He’s referring to the recent·exits·by·companies·from·psychiatry that came in the summer of 2011, around the time Hyman left the Provost job for the Stanley Center – returning to the game, so to speak. The phrase I picked is Hyman’s, and it’s telling. Not recent·exits·by·companies·from·CNS·drug·development. He says recent·exits·by·companies·from·psychiatry. And I think that’s how it felt to the NIMH, to the APA, and to Steven Hyman – like they’d been abandoned by an essential ally.


So what Dr. Hyman, and Dr. Insel, and Dr. Lieberman and others at the APA say is that because of the unmet·clinical·need, the global·burden·of·disease, and the recent·advances·in·genomics·proteomics·and·imaging, this is the perfect moment to sustain the·revolution and develop new biomedical psychiatric treatments that are just·around·the·corner. But there’s the·crisis of the recent·exits·by·companies·from·psychiatry that has to be dealt with. Solutions include the NIMH et al taking on the task of drug development and compensating for the failed DSM-5 outing by creating a new diagnostic system [the RDoC] more amenable to biomedical techniques and research. Another big part of the solution is luring PHARMA back into the quest by collaboration that shares their risks in the enterprise:
"The scientific community, including industry, academia, patient groups, and government, must find ways of sharing financial risk while developing effective and well-governed partnerships."
So it’s little wonder that Dr. Hyman is disappointed to be left out of the Accelerating Medicines Partnership. It’s the kind of thing he hopes will solve the·crisis.

There’s certainly another way to look at these phrases. It’s in all the papers. In the last thirty years, psychiatry has largely equated itself with drug treatment and colluded with the PHARMA advertisement that radically inflates efficacy and downplays risk. Psychiatry has largely taken the position that all mental illness is brain disease. Over the last thirty years of this monocular biomedical psychiatry, there has developed of a huge academic·pharmaceutical complex that has functioned like a symbiosis – operating on the the capital provided by PHARMA in return for lots of things. So the recent·exits·by·companies·from·psychiatry threatens this complex with financial collapse. This second view takes into account the scientific and financial misbehavior of PHARMA and the KOLs in psychiatry. It offers a more accurate view of the medications available. And it knows that PHARMA sees the recent·advances·in·genomics·proteomics·and·imaging as offering little that’s to their advantage – likewise seeing unmet·clinical·need as well as the global·burden·of·disease for what they really are, rhetorical gimmicks. PHARMA [and the rest of the world] also knows that just·around·the·corner is a fantasy that has run out of legs.

We all know that there are many people on this planet who genuinely see the recent·exits·by·companies·from·psychiatry as the beginnings of a solution rather than the·crisis
Mickey @ 12:44 AM
Filed under: politics
champagne around…

Posted on Friday 21 March 2014

Associated Press
By CHUCK BARTELS
Mar 20, 2014

The Arkansas Supreme Court on Thursday overturned a $1.2 billion judgment against Johnson & Johnson in a lawsuit challenging the drugmaker’s marketing of the antipsychotic drug Risperdal. The court ruled that the state improperly sued under a law that applies to health care facilities, not pharmaceutical companies. The ruling comes in an appeal of lawsuit filed by Arkansas against the drugmaker and subsidiary Janssen Pharmaceuticals. The state says the companies didn’t properly communicate the drug’s risks and marketed it for off-label use, calling the practices fraudulent. Johnson & Johnson said there was no fraud and Arkansas’ Medicaid program wasn’t harmed…
In a separate action brought by the U.S. Department of Justice, Johnson & Johnson agreed in November to pay more than $2.2 billion to federal and state governments and in penalties to resolve criminal and civil allegations that the company promoted powerful psychiatric drugs, including Risperdal, for unapproved uses in children, seniors and disabled patients. The agreement was the third-largest settlement with a drug maker in U.S. history.
Johnson & Johnson and Janssen are also awaiting a ruling by the South Carolina Supreme Court, where the companies have an appeal pending of a $327 million judgment in a similar case. A $330 million verdict against both companies in Louisiana was overturned in January.
hat tip to pharmagossip…
Matters legal and their vicissitudes are well beyond my skill set. But I think I get the music here. After their settlement in Texas, J&J lost a number of similar suits – Louisiana, South Carolina, Arkansas. Having sat through the Texas trial, it’s hard for me to imagine how they could win. The off-label marketing, hiding side effects, giving out perks, etc. It was just rampant. I think they settled in Texas because they could tell [as could everyone in the courtroom] that if they let the trial proceed, they stood the chance of getting massacred. But in the other suits, they went to the end – losing the verdicts. Now, they’re neutralizing their losses one at a time on technicalities.

It will be champagne around in New Jersey at headquarters. Another bullet dodged by the hard [well paid] work by their lawyers. I reckon there have been many other champagne celebrations about Risperdal® in the past – pulling off TMAP, buying Omnicare’s business, Excerpta Medica’s flooding the medical literature, turning Biederman by funding a Harvard Center and cashing in on his Bipolar Child epidemic. The $ 2.2 B settlement with the feds was a set-back, but well within their cost of doing business budget. The Risperdal® roll-out was a big success for its leader Alex Gorsky, who is now CEO of the whole company. He turned a schizophrenia drug into an all-purpose blockbuster many times over. And he couldn’t have done it without the help of skillful lawyers and marketers. Well, that’s not the whole story.

He also couldn’t have done it without the doctors who participated in creating the guidelines, and the treatment algorithms, and signed on to the articles, and acted as traveling speakers, and even wrote the prescriptions…
Mickey @ 8:30 AM
Filed under: politics
the unforgetting…

Posted on Wednesday 19 March 2014

In case you haven’t noticed, there’s been something of a bruhaha over the publication of Richard Noll’s article, When Psychiatry Battled the Devil, in the Psychiatric Times. It appeared in early December on-line, then disappeared a week later without a trace. It’s the story of the epidemic of acronymed cases of SRA [Satanic Ritual Abuse], the FMS [the false memory syndrome], MPD [multiple personality disorder], and DID [Dissociative Identity Disorder] that appeared in the late 1980s and faded in the mid 1990s – to be forgotten except for the people [still] imprisoned in its wake. Richard Noll, then a young psychologist, was involved and wrote this article reminding us of what happened. He points out that this whole episode is never mentioned, long forgotten, and asks why? He ends with:
Are we ready now to reopen a discussion on this moral panic? Will both clinicians and historians of psychiatry be willing to be on record? Shall we continue to silence memory, or allow it to speak?
I read it during its week in the sunlight, and thought it was fascinating, including the why? at the end. It hasn’t come up in my mind in decades, and I thought a lot about that. I flagged it to write about, but by the time I got back to it, it was gone. I thought I’d written down the wrong URL, but soon learned that it had been pulled from the Psychiatric Times‘ web site. If you don’t know the story, here are some recent references from here and there:
Well. It’s back! Psychiatric Times republished it on-line today. It has a new name. Instead of When Psychiatry Battled the Devil [on Gary Greenberg's site][also Academia.edu], it’s now under Richard’s original title, Speak Memory [at Psychiatric Times]. It’s introduced with:
Editorial Note: In light of the responses we have received regarding this article by Richard Noll, PhD, that was posted on our website on December 6, 2013, the article has been reposted with a modification. Additionally, we are posting responses from certain of the individuals mentioned in the article in order to leave analysis of the article up to our readers. We have also requested a response from the author regarding those comments and if Dr. Noll wishes to comment, we will also post that.
I didn’t go line by line, but the "reposted with a modification" seems to refer to omitting …
New APA work groups for the preparation of DSM-IV were formed. Not surprisingly, none of the former members of the DSM-III-R Advisory Committee on Dissociate Disorders was invited to be on the work group for the dissociative disorders.
from the beginning of the second paragraph in the last section [The fade out into forgetfulness]. The article is packaged with three commentaries from the people mentioned in the article. The article is around 2700 words. The commentaries add up to about 5300 words and are pretty dismissive. But reading them, it’s easy to imagine why the Psychiatric Times had its hands full with this article. Richard ends asking if the people involved back then were ready to speak. I’m not sure they were ready, but speak they did! I’ve been so interested in the story about the story [the retraction] that I’m going to sign off, and step back, and reread the article. I want to think about Richard’s original question and specifically my own forgetting like he suggested in the beginning, now three months ago…
Mickey @ 6:14 PM
Filed under: politics