the game of thrones…

Posted on Tuesday 22 April 2014

Reuters
Apr 20, 2014

U.S. pharmaceutical giant Pfizer has approached British rival AstraZeneca to propose a 60 billion pound [$101 billion] takeover, the Sunday Times reported on Sunday. The paper said, citing senior investment bankers and industry sources, that informal conversations about a deal had taken place between the two firms but that no talks were currently under way after AstraZeneca resisted the approach. AstraZeneca is Britain’s second-biggest pharmaceuticals group with a current market valuation of around $80 billion, compared with Pfizer, which is valued at $193 billion, according to Thomson Reuters data…
New York Times
By MICHAEL J. DE LA MERCED and ANDREW POLLACK
April 21, 2014

The British drug company AstraZeneca said no to a tie-up with Pfizer, turning down the possibility of one of the biggest drug mergers in recent history. Whether such a deal would have made sense is another matter, because the British drug maker is trying to improve its fortunes on its own and Pfizer in the past has found that big acquisitions can sometimes prove more distracting than helpful.

In recent months, Pfizer made a number of informal takeover approaches to AstraZeneca, according to a person briefed on the matter who is not authorized to speak publicly about internal discussions. One of those tentative approaches valued the smaller pharmaceutical company at about £60 billion, or nearly $100 billion, according to The Sunday Times. At that level, the deal would be one of the biggest ever in the pharmaceutical industry, surpassing Pfizer’s $90 billion takeover of Warner-Lambert…
Reading this felt a lot like a new season of The Game of Thrones. Not so long ago, Pfizer’s Zoloft® was a chart topper in the antidepressant market, and AstraZeneca’s Seroquel® was the best selling of all pharmaceuticals in its day. Zoloft® was approved only through the efforts of FDA Official Paul Leber [zoloft: the approval III…]. Similarly, Seroquel® slid under the wire, and left unpublished its most definitive study [Study 15] that showed that it was decidedly inferior to Haldol [‘this cursed study’ – more about Seroquel…]. These drugs were giants in their day and the ads were everywhere – remember the Zoloft talking head that directly spoke of the drug correcting a "chemical imbalance." Now both companies are running out of patent for another class of drugs – Crestor and Lipitor – losing their places in the statin frenzy.

For these companies, the passage through the universe of CNS drugs was a lucrative but time limited season in their endless travels through the gamespace provided by our patent laws. The companies played on two simple themes – the SSRIs and the Clozaril derivatives. But in the day, it seemed like there was so much more happening. It was only as the cycles wound down that we heard all the talk about "me too" drugs. Part of that illusion of bigness was from all the activity generated by the indication sprawl and off-label prescribing.

While waves of pharmaceutical products have swept through many medical specialties [eg antihypertensives, antibiotics, statins, anticoagulants], I’m not aware of any that have had such a profound effect on a medical specialty as the psychopharmacologic agents had on psychiatry. The first wave in the 1950s is easily understood. The drugs treated things formerly untreatable by drugs, or much else. The second wave landed on a psychiatry struggling with redefining its medical identity in an age of Managed Care. House Psychiatry and House PHARMA formed an alliance that seemed forged in steel [that fit with House Managed Care perfectly]. They thrived for twenty years while the boundaries between them became increasingly indistinct.

This was hardly the symbiosis it seemed – more host and parasite. During those years, I might have thought that psychiatry was the host and PHARMA was the parasite – but I would have been dead wrong about that. PHARMA can live quite well on its own without psychiatry, but there’s been a question going the other way. Psychiatry actually rebuilt itself around the psychopharmacology of that period, and seemed dependent on there being a steady stream of new medications. When House PHARMA began their inevitable pull out of CNS drug development, there was a gasp of disbelief [APF Convenes Unique Pipeline Summit].
There are huge unmet clinical needs in mental disorders and addiction,” said Jeffrey Lieberman, M.D., incoming president-elect of APA and chair of psychiatry at Columbia University, who moderated the morning session. “There should be tremendous interest in this area, but there is not.
But as you can see from the articles up top, the Game of Thrones in PHARMA continues right along without bothering with psychiatry – merging and looking for new candidates for their end of the pipeline of drugs. Two former psychopharmacology giants moving along to other territories. I have come to believe that the powers that be in psychiatry were living as if PHARMA was duty bound to some kind of endless supply of new drugs because of the demand, as Dr. Lieberman implies – a loyalty that would persist. That was a very naive assumption. The pharmaceutical pipeline flows to all of medicine, and PHARMA goes where there’s a market and where they can find a product to sell. Nothing new in CNS, moving right along. In leaving psychopharmacology, they cut off a vital flow of funding that psychiatry had come to rely on in any number of ways. And psychiatry lost not only funding, but the myth of new drugs just around the corner that would be more effective – the myth I called future-think.

There was a time when I used to wonder why psychiatry was so vulnerable to the pharmaceutical industry. Why did so many KOLs race over to the dark side? Why did the specialty wrap itself almost exclusively around psychopharmacology practices? But I can feel the biases in all my answers so I’ll wait and buy the definitive history when it’s written. Another question: How does the big push for Collaborative Care fit into all of this? Surely it has something to do with responding to the exodus of PHARMA, but I’m not sure how it fits.

Barring some major piece of serendipitous discovery, the Houses of PHARMA will carry on with their high stakes power play unaffected by our absence – psychiatry was just a phase they were going through. And House Psychiatry is entering a new period of trying to figure out what it is without them. I would doubt that the Drug Lords that have dominated our leadership since the 1980s will be of much use in that enterprise. And I’m not sure that the direction mapped out by Dr. Lieberman [in the comments…, The Role of Psychiatrists in the Brave New World of Health Care] offers us as much a template as he would like to think…
Mickey @ 10:28 PM
Filed under: politics
stuck in the middle…

Posted on Monday 21 April 2014

What should be done? Returning to the asylum system — which could be regarded as turning away from the goal of recovery — is not the answer.

As a late adolescent, there was something in the world I lived in that was wrong in an absolute sense. Once that dawned on me, I never had a moment of doubt – the segregation of races in the South where I lived was wrong. In those times, that was not an easy realization, but there was a comfort in knowing something without reservation. My closest friends to this day are others who had that same awareness early on and involved themselves in doing something about it. But that may have been the last time I was ever completely sure about anything.

When I came to psychiatry from internal medicine, my first rotation was an acute service at an urban charity hospital – the emergency receiving facility for in-town Atlanta. It was at the wrong end of the deinstitutionalization process when all of the outpatient resources left over from the Community Mental Health initiative were disappearing along with the evaporation of inpatient beds. It seemed as if the patients that I thought needed to be in the hospital didn’t want to be there; and the patients that I thought didn’t need hospitalization were lobbying to get admitted. The same thing was true of medications. It felt as if I was always positioned against the flow, and I was never "sure" about anything.

One thing I learned in those days was to listen to people who had been there in person. An apt analogy would be the  difference between civilians and veterans. There is an intrinsic impossibility in psychotic illnesses felt by both the afflicted and their caretakers that is a required ingredient in any cogent discussion of the topic. In my case, later I ran that same service for a year or so and then spent a decade directing the training program that staffed it and several others like it. The most important part of both jobs was helping the residents learn to make sensible decisions based on the individual patient in front of them, rather than becoming polarized in the confusion of chronic impossibility. I had seen that happen to two fellow residents [in different directions], both with disastrous results.

I have nothing but respect for those who stayed in public psychiatry where most psychotic mental illness is treated. It’s a very hard road. But even those with these more informed opinions vary widely when it comes to the inevitable conflict between patients’ rights and the need for treatment and/or restraint. In fact, it’s almost impossible to find any discussion that doesn’t turn the problem of psychosis towards one or the other of these priorities, often implying that the other party is ignoring the more important side of the equation. And that’s not meant as an indictment – it’s just in the nature of the problem as I see it. An observation: among people in the business, independent of what they might say in an armchair discussion, they are usually indistinguishable in how they approach a given clinical situation or case.

There are two psychiatrists from the public sector commenting here, Dr. Dawson [Real Psychiatry] and Sandy Steingard [Mad in America]. I would recommend following what both have to say. Their views and temperments differ, but they both speak from the trenches of experience and are the kinds of people we need to be listening to. Another reference you might want to look at is the article After Newtown by E. Fuller Torrey, the author of the report Dr. Insel was referring to in the last post [lamentations · long passed…] to fully digest his point of view. That brings me back to the quote from Dr. Insel I started with: "Returning to the asylum system — which could be regarded as turning away from the goal of recovery — is not the answer." I found that odd when I first read his post, but I passed over it because I had something else I wanted to say.

The dichotomy between the asylum system and the goal of recovery uses phrases that have too many layers of meaning for that simple sentence. The asylum of Philippe Pinel or Dorthea Dix was as sanctuary for the humane treatment of the severely mentally ill. The asylum of the 1940s was an overcrowded snake pit where the severely mentally ill were essentially warehoused to keep them out of sight – forgotten people. While it’s hard for me to imagine not having the goal of recovery for all patients, that has to be defined for any given person because it varies over the a wide spectrum of possibilities. In this instance, I’m talking about the people with chronic psychotic illness who live in our prisons because there’s no other place for them that they can manage, and many are there by their own hand for that very reason.

I said at the outset that the Civil Rights Movement may have been the last time I was ever sure of anything, but I’m thinking that’s not really right. I’m sure that putting chronic mental patients in prison isn’t right – certainly not as a standard operating procedure. And that’s not an invitation for rounds and rounds of the divisive and blaming arguments that always swirl around this topic. I’m old and have heard them all. When I was suggesting a Task Force, I wasn’t thinking of the usual suspects – the mental health policy wonks from either side of any number of fences. I was thinking of people who have spent their lives among these patients and have a sense of what might work and what won’t. I would include judges, their jailers, and the patients who could participate. In my view, the blaming and arguing that invariably arises has actually interfered with any progress in the humane care of these patients. I’m sure that there’s something we can do that’s much righter than what we’re doing right now, and we’re obviously not doing it yet. I should actually say some things, because these patients are as varied as the rest of us even in their disability, and we need flexability to meet that diversity. There are templates aplenty to guide us. We are at the bottom of the heap among the countries of the developed world in this area, and I expect they’d fall all over each other trying to help us do things better.

I wasn’t kidding when I said "I applaud Dr. Insel for reading that report and bringing up the problem." He may or may not be the person to assemble such a Task Force but he gets an A+ for speaking up. It was a surprise. And right now, we might be hard pressed to know who could muster a quorum of non-polarized right-thinking people to take a long look this problem. And that’s just the first of many stumbling blocks. But if we can land on the moon and build the Internet out of existing materials, surely we can tell the difference between "misfortune" and "crime" and create a viable approach to honoring that distinction…
Mickey @ 8:04 PM
Filed under: politics
in memory…

Posted on Monday 21 April 2014

Andy Lipscomb
the gentlest soul to ever pass our way
September 25, 1939 – April 21, 2014
Mickey @ 3:59 PM
Filed under: politics
lamentations · long passed…

Posted on Sunday 20 April 2014

Director’s Blog: NIMH
By Thomas Insel
April 11, 2014

… check out a new report  from the Treatment Advocacy Center on the treatment of people with serious mental illness. According to this report, there are now 10 times more people with serious mental illness in state prisons [207,000] and county jails [149,000] than there are in state mental hospitals [35,000]. The report includes a state-by-state assessment of treatment of people with mental illness in jails and prisons. In 44 of the 50 states, the largest single “mental institution” is a prison or jail…

How can this be possible? In the 1830’s Dorothea Dix revolutionized the care of people with mental illness by taking them out of jails and caring for them in asylums, later known as state hospitals. In the last 50 years, we have reversed this trend, resulting in a 90 percent reduction in public hospital beds for people with serious mental illness. While this reversal came about as the result of good intentions, it has resulted in unintended consequences. Many, but not all, people with serious mental illness can be treated effectively with the less restrictive care offered in outpatient settings. Sometimes patients with serious mental illness, just as with other serious medical illnesses, require hospitalization. In the absence of available public or private hospital beds, there are few options. Some patients are housed in emergency room holding areas; some return home, where family and friends struggle to provide care; and some—at considerable risk to themselves—become homeless. For those who do not realize they are ill and therefore resist treatment, or those whose behavior may be disruptive or aggressive, jails and prisons have become the de facto mental hospitals…

What should be done? Returning to the asylum system — which could be regarded as turning away from the goal of recovery — is not the answer. The new report suggests several remedies, including ensuring better treatment within the prison system, jail diversion programs, assisted outpatient treatment, and release planning. Surely our nation can do better than assigning the criminal justice system the responsibility for delivering care to the mentally ill. In an era of mental health parity and health care reform, how can we allow hundreds of thousands of people with a brain disorder to be treated in our justice system — if that can be called treatment — rather than our healthcare system? Abraham Lincoln, no stranger to serious mental illness, once lamented, “a tendency to melancholy… is a misfortune not a fault.” Our current system, if these new numbers are accurate, treats mental illness, for many, not as a misfortune but a crime, with little promise of recovery.
No, I’m not going to rale at Dr. Insel as I often have or chide him for finally getting around to noticing that our prisons are filled with chronic mental patients – or rant that this abysmal fact has been increasingly true since the deinstitutionalization reform movement in the second half of the last century. I’m not even going to point out that the criminalization of mental illness spans the Decade of the Brain or the age of Clinical Neuroscience.

And I’m not going let go with a primal scream that those 350,000 people are not Myths. Their commitment was as criminals. They are receiving medications whether they want them or not [or whether they need them or not]. And, by the way, the TAC doesn’t need any biomarkers to know who they are or to count them. The prison guards know. The other prisoners know. The judges that sent them there know. It’s just not that hard to tell.

And I’m not going to advocate more medications, or less, or pray for future medications, or long for old Asylums, or blame psychiatrists, or anyone else. But there is something worth saying here. The National Institute of Mental Health is our government Agency that is tasked with thinking about the mental health of the country, and this is a problem that actually belongs at the very top of that problem list. There are countries all over the world that do a much better job with this problem than we do. There are social scientists and psychiatrists and social workers and psychologists all over this country that specifically care passionately about this topic and these patients. So why doesn’t the National Institute of Mental Health have a Task Force to look at this problem rationally, to travel the world looking at solutions, to figure out a direction for us to be moving in.

This is more important than the RDoC, or Dr. Nemeroff’s neurobiology of trauma, or Dr. Gibbons CAT Screening tests, or Dr. Trivedi’s genetic tests to pick among light-weight antidepressants, or anything else on the NIMH agenda. I applaud Dr. Insel for reading that report and bringing up the problem, because he is perhaps uniquely positioned to assemble a cadre of people who could initiate doing something about it rather than just continuing to decry it. Let’s hope that it preys on his mind and spurs him into action. The time for lamentations has long passed…
Mickey @ 8:20 PM
Filed under: politics
other comments…

Posted on Saturday 19 April 2014

… My last thoughts after reading more of Dr. Lieberman’s quotes are, I’m convinced that integrated care is already a done deal; it is just a matter of time before it rolls out across the country. However, I am undecided if the APA leadership is reading the hand-writing on the wall and reacting to it or if they are already positioned in it and are trying to sell it to their membership, and peripherally the public, with the real sell to us coming from the media.

A wise observation. It looks as if they’ve worked out a pretty detailed system:

These concerns notwithstanding, we must collectively make a leap of faith and be prepared to make changes on the ground in the way that we as psychiatrists practice medicine. But this might be focused on specialty mental health care for the most complex patients, while primary care providers increasingly may conduct the first line of mental health screening and provide basic care. It is likely that the relationship between primary care providers and psychiatrists will expand exponentially with brief phone and “curbside” consultations replacing many of the more formal referrals for consultation.

Many psychiatrists will become leaders of multidisciplinary mental health teams providing coordinated services and, in some cases, may be located within large primary care practices. Conversely, we can expect to see primary care providers move into settings such as community mental health clinics to better provide general health care to severe and persistently mentally ill patients [SPMI].

A possible variant of this is that some psychiatrists and allied mental health providers will assume some basic primary health care responsibilities for SPMI patients or may even become their principal caregivers in collaboration with primary care providers. There is an increasing emphasis on addressing health behaviors such as diet, smoking cessation, and exercise as the understanding of the link between mental health and other health behaviors has deepened. Psychiatrists are finding they need to counsel their patients on these issues and even provide more basic medical screening and care to patients or in consultation with primary care providers. Some psychiatrists are even taking refresher courses in primary care to be able to better address this patient need.

To reiterate, multidisciplinary mental health teams will also become more common within hospitals and local health systems. To meet the anticipated demand from more patients while reducing costs, psychiatrists as the team leaders will provide less direct care [again, focusing their direct care efforts on complex, high-risk cases] and more supervision of care, while monitoring and tracking patient progress and increasing their consultative role with other specialists.
The changes suggested here pick up from the Community Mental Health Initiatives of the 1960s  when the State Hospital collapsed. The glue that they intended to hold that system together was Thorazine [and friends]. The thought was that medication would stabilize the patients they are now calling severe and persistently mentally ill patients [SPMI]. We know that story now. It was never fully implemented and naive in its predictions of the power of medications. As Robert Whitaker has pointed out to us all, the reliance on neuroleptic medications persists to the present with these patients. But it also failed in that the ancillary services were never close to what was needed, so many SPMI patients live in our prisons – by default. If what he describes in paragraph two above can do anything for these patients, more power to him – but cost containment is what killed the last attempt, so anyone alive back then is appropriately wary that it will never be appropriately funded.

That the system he’s proposing will ever fund what most people reading and commenting on this blog would like to see happen for less severe illness is a dream probably gone with the wind, so more important right now is to look at the Lieberman System of Collaborative Care for fatal flaws. As anyone alert and awake knows, the Managed Care system in place has relegated psychiatrists to the role of medication doctors focusing on symptoms. That has been true for some time, and psychiatry, particularly APA psychiatry, has essentially become a psychopharmacology specialty with what many of us consider an outrageous expansion in drug treatment. Let me remind you of the SAMHSA report I posted recently [a graph…]:

My concern in both the SPMI and the Collaborative Care models Lieberman is proposing is that the legacy of the Age of Psychopharmacology will be directly incorporated into both arms of the Lieberman System and perhaps even expand. This kind of medical model thinking for psychiatry is the stuff of managed care, perhaps its only stuff, and I’m reading the model as pure managed care. Likewise, the upper ranks of organized and academic psychiatry are largely people who have known little else, so the dangers of overmedication are multiplied. Finally, the notion of primary care physicians delivering even more of the mental health care is a further force for overmedication. So even if the pharmaceutical industry has abandoned CNS drugs, their golden years will be perpetuated and institutionalized in a healthcare system even without their "ask your doctor…" ads on television.

Psycritic’s post about Collaborative Care [On Integrated Mental Health Care] is excellent. In taking about worst case scenarios, he mentions a comment from Sandy Steingard that was on this blog last month that made us all shudder:
I was at a conference where a psychiatrist enthusiastically described her experience with collaborative care. Every morning, the treatment team would get together [the “huddle”]. She gave an example of why this was so helpful. One day, someone mentioned that someone’s PHQ-9 had gone up by a few points [this is a nine item screening for depression]. The presenter said something like, ”So we agreed to increase the fluoxetine from 20 to 40 mg and we were all set to go!”
At the risk of being a broken record, these developments even heighten the importance of full transparency about clinical trials and adverse effects covering all drugs currently still in use – in this case from Prozac forward [1987+]. If this is the service that’s going to be provided, it’s going to rely heavily on these existing medications. The efficacy and adverse effect information remains heavily skewed by this last twenty-five years of marketing department distortion. I would even think that new, longer clinical trials of heavily used drugs long out of patent might well be in order. I expect that some astute bean counter in managed care land has already figured out that as the drugs in the above graph go generic, their costs are going to take a dive.

In Psycritic’s post, he mentioned a situation from his experience in a Collaborative Care setting that will surely become endemic:

I thought that the vast majority of patients I saw would have benefited from psychotherapy, yet very few of the clinics employed therapists, and none had access to more intensive treatments like dialectical behavior therapy. Even in the clinics that did have therapists [usually LCSWs], they were usually full and could not readily see new referrals. Because of the therapist shortage, I often ended up prescribing a medication by default. And of course, other forms of integrated care may be much more compromised than what I experienced. For example, managed care organizations seem to focus much more on cost containment, screening using rating scales, and then using medications to get those numbers down.
So back to where we started and the "done deal" – it’s unclear to me why the APA would actually be promoting this model other than that they feel the alternative is extinction, at least third party extinction. I find the notion that psychiatrists are going to close their offices and join group medical practices to fit this template extremely unlikely, but who knows…
Mickey @ 6:12 PM
Filed under: politics
in the comments…

Posted on Friday 18 April 2014

Comments from three psychiatrists to the last post: three wishes… – all focused on the APA push for Collaborative Care [AKA Integrative Care].
I don’t think the APA’s initiative on collaborative care has anything to do with getting other doctors to see psychiatrists as real doctors. Psychiatrists who practice like real doctors are seen as real doctors without PR fluff form the APA. The emphasis on collaborative care by the APA is a function of their political ineffectiveness in supporting the current practice environment and it is also the way oligarchies function. Once managed care friendly contingents get a hold inside of the organization and "cost effectiveness" and "evidence-based" become buzzwords the resulting corporate approach is predictable. If Ioannidis has taught anything – it should be that anyone can come up with the evidence they want and there is ample evidence for that.
George Dawson, MD, DFAPA
Regarding the APA’s push for "integrative care" and more specifically about having psychiatrists embedded in internal medicine/primary care practices as the Brave New World. I was chewing the fat with my suite partner in my private practice, who is an excellent psychiatrist doing mainly medication management and consultation for psychologists and social workers. He’s a good guy with 35+ years of experience. After discussing Kupfer’s COI issues and the use of "computerized adaptive testing" for depression and anxiety, he shrugged and offered: "It won’t go anywhere. The Internal Medicine docs hate us" [meaning psychiatrists]. I laughed. APA at work for you! Not!
Just saw this article by Jeffrey Lieberman today on integrated care. Some real gems in there, including this:
    There is a historic and exciting opportunity for psychiatrists to influence the future of medical care and occupy our rightful position in the field of medicine.
"Occupy our rightful position." Doesn’t that smack of insecurity and wanting a more "medical" identity for our profession? What do you think, Dr. Dawson?


If you read this blog much, you will recognize that I have
recycled this image from other posts on Insel’s campaign
for Clinical Neuroscience.  It was originally an old Soviet
propaganda poster.

And then comes APA President, Jeffrey Lieberman, in the PsychiatricNews [The Role of Psychiatrists in the Brave New World of Health Care]. I’m not going to try to summarize or paraphrase what he has to say. It’s there for you to read for yourself ["Yes, he really does say "Brave New World"].

My original specialty was Internal Medicine, something I enjoyed  doing, and I think I’ll put on my Internist hat to respond. Dr. Dawson is right on the money here. This is all some kind of garbled system theory talk that reads like a power-point presentation from a Managed Care or governmental think tank meeting where they use the word impact as a verb, where evidence-based and cost-effective are synonyms, and where if there’s a doctor in the room, it’s not a practicing physician.

As an internist, I didn’t hate all psychiatrists, only some psychiatrists. The ones I liked were the ones that did their jobs. They saw the patient, and took care of the problem that I couldn’t handle myself. You could tell that because the patient either disappeared into their care, or when they came back, gave a report like, "We’re working on it." That’s what doctors want from a referral. Internal Medicine really is frequently algorhythmic – psychiatry as I understand it, not so much. The proof is readily apparent in the last twenty years of psychiatry giving the straight medical model the old college try, a bust in my book. Internists, primary care physicians, medical physicians in general spend their life with algorithms and guidelines. If mental illness could be approached that way, back in the day, I would have simply learned the rules just like I learned them for diabetes or heart disease. But I could see that there was something else, and I saw how a decent psychiatrist could approach those patients in a very different way, and do the job I couldn’t do.

I don’t hear any medical physicians, or any psychiatrists, or any psychologists, or any social workers, or any patients clamoring for Collaborative Care. Tom’s partner in the second comment sounds to me like he has a reasonable take on what the internists of the world might say if they read Jeffrey Lieberman’s piece. He’s creating a whole new profession based on the vision from a third party way of thinking about medicine that will surely go absolutely nowhere. So why are he and Dr. Summergrad [new APA president] talking it up so much? As Psycriyic pointed out, that’s what the whole theme of this year’s APA is really all about:

The APA seems to see its role as finding a way to redefine psychiatry to make it fit, and isn’t having much luck. Maybe that’s not their job…
 
Mickey @ 2:10 PM
Filed under: politics
three wishes…

Posted on Thursday 17 April 2014

It’s been over a hundred years since Freud suggested that our wishes can color the workings of what he called the mental apparatus. Think what you will about the old guy, but he was onto something with that wish thing. Here are three personal examples:
  1. In my last post [reason enough…], I interpreted the theme of this year’s APA meeting [Changing the Practice and  Perception of Psychiatry] as some recognition that psychiatry’s reputation is in the tank. But, alas, Psycritic gently informed me that I’d missed the boat:
      I don’t want to a total downer, but when the APA says “changing the practice and perception of psychiatry,” with the “practice” part they are referring to increasing use of evidenced-based treatments and integrated care, and the “perception” part is wanting the public, other doctors, and med students to see psychiatrists as “real doctors” and scientists. Alas, it has nothing to do with the the reasons for change that most of us reading this website believe are important.
    Alas indeed! I could perhaps blame the pollen count, but that’s not the only time that my wishes have overwhelmed my rational thinking recently. To wit:
  2. In early March [before the Spring pollen came], the APA published a preliminary schedule for this year’s meeting. Looking through it, I ran across this:
    That was about a month after Dr. Kupfer’s Conflict of Interest with this company became clear. I thought maybe this had been put together before and they might need alerting, so I wrote the program chairs:
      Drs. Muskin and Carter,
      I’m a retired Psychiatrist and Psychoanalyst who blogs as 1boringoldman. Looking over the preliminary APA Annual Meeting Program, I ran across this:
      [above graphic]
      The presenters are shareholders in a commercial venture [Adaptive Testing Technologies] marketing these very CAT tests. The details are well documented:
      Is it really appropriate for them to be presenting their products in an educational forum like this? Did they declare this obvious Conflict of Interest to your program committee? Don’t we have enough Conflict of Interest problems already?
    And was answered the same day:
      All presenters disclosed.
      Thank you for your message, I will consider the matter closed.
      Philip R. Muskin,MD
    And sure enough, when the definitive program was published, the disclosures [and symposium] were there:


    [reformatted to fit screen]


    [reformatted to fit screen]

    So it’s listed as NIMH Research [Gibbons grant to develop his tests]. It’s disclosed as a coming commercial product. But at the APA convention, it’s a session. How that’s anything but a huge conflict of interest and using the APA meeting to roll out a new commercial product disguised as an educational symposium is beyond my understanding. But back to the wish it was a clerical error – no cigar there.
  3. The third wish interfering with my judgement should be obvious. I apparently still wish the APA would stand up and firmly acknowledge the problems and make some kind of ethical stand about COI, or just about anything else. So I keep acting as if that’s possible. But I’m afraid that’s the most irrational wish of all. They’re not going to do that. They didn’t do it through the DSM-5 process, or at the time of the Grassley investigations, or any time since or in-between. And my continued attempts to view the American Psychiatric Association as anything but a big part of the problem is going to have to accede to Freud’s Reality Principle – and fade away.
I guess Psycritic‘s right, the APA plans to barrel ahead with "increasing use of evidenced-based treatments and integrated care" and to get "other doctors … to see psychiatrists as ‘real doctors’.” It’s hard for me to see how moving ahead without addressing the tsunami of the academic·pharmaceutical fusion and its attendant conflicts of interest and scientific misbehavior is going to achieve those goals. But what I do see is that my wish for some kind of coming clean and reappraisal emanating from the APA is a just fanciful dream I had…
Mickey @ 9:00 AM
Filed under: politics
reason enough…

Posted on Wednesday 16 April 2014

In the comments to [what really matters…], Dr. Carroll mentioned a post on the Danny Carlat Blog back in August 2010 about the Dan Markingson case, actually two posts ["Making a Killing": New Carl Elliott Article in Mother Jones, Was the CAFE study manipulated by AstraZeneca? Maybe Not.]. Both of these posts, and particularly the comments to the second give a pretty full version of the story. In an article in the Pioneer Press in May 2008 [Patient's suicide raises questions], the attempt to file a suit against the Institutional Review Board was described as follows:
A judge ruled in February that as a state agency, the university and its IRB are immune from the lawsuit. The legal ruling didn’t allow questions to be explored about who’s ultimately responsible for the safety of research subjects and whether the university did everything reasonable to protect Markingson from harm. According to the U’s human subjects protection guide, the IRB’s first charge is "to protect human subjects involved in research at the university from inappropriate risk"…

The lawsuit by Markingson’s mother, Mary Weiss, alleged that the IRB’s trust was misplaced in the so-called CAFE study, led by Dr. Stephen Olson, a U psychiatrist. A central allegation was whether Olson had too much power over Markingson, and too many conflicts that obscured his clinical judgment. Olson recruited Markingson into the study at the same time he served as Markingson’s treating doctor and advised a Dakota County judge on whether Markingson should be committed to a psychiatric hospital.

Had the IRB followed its own guidelines, it would have discouraged Olson from recruiting his own patient. The IRB Web site states that "doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion"…
While it’s an obvious point, Dan Markingson’s suicide was ten years ago. One might ask why people won’t just let it go – let the "sleeping dog lie" and move on? The drug companies have run out of tricks and currently aren’t even looking at the CNS drug market. Why continue to cover this same ground over and over? Dan Markingson’s suicide? Paxil Study 329? the case of Rebecca Riley? Ghost-writing? Guest authorship? TMAP? the ways that clinical trials have been mispresented? the complicity and/or collusion of way too many academic psychiatrists?

In some ways, the way the University of Minnesota has tried to deal with the Markingson case [refusing to let it to see the light of day, denying all allegations, trying to limit any investigation to the present corrections] turns out to be a microcosm of how American Psychiatry is dealing with the overall problem of corruption in the ranks in the specialty. If you look at the APA Convention program for next month’s meeting, none of these unpleasant and shameful topics made it to the program. Yet the theme for the meeting addresses them:

So we’re interested in Changing The Practice and Perception of Psychiatry, but we’re not mentioning why it needs to be changed? Like the President of the University of Minnesota, the APA is saying "look at us now, not then." For that matter, the pharmaceutical industry is doing something similar. They’re finally giving in to Data Transparency but presenting it as a magnanimous act rather than a position they’ve been forced to occupy.

I know of no situation in the history of medicine that matches what happened in psychiatry in these last twenty plus years. Fundamental medical values like trust and honesty were repeatedly pushed aside. How can we now ask people to change their perceptions, if we’re not even honest enough to acknowledge why they have them? The reason to keep bringing up things like Dan Markingson’s suicide is because they happened – that’s reason enough. In medicine, sometimes we learn from the living, but often-times, we learn the most from the last autopsy.
Mickey @ 8:00 AM
Filed under: politics
what really matters…

Posted on Tuesday 15 April 2014

University of Minnesota
Medical School News
by Sarah Hansen
04/15/2013

S. Charles Schulz, M.D., head of the Department of Psychiatry, will receive the esteemed Stanley Dean Award for Research in Schizophrenia in 2014. For more than 50 years, The American College of Psychiatrists [ACP] has issued this award to “a group or individual that has made a major contribution to the treatment of schizophrenic disorders.” The award will be presented at the next annual meeting of the ACP in February 2014. As part of the award ceremony, Schulz has also been asked to present a brief lecture on his work.

Schulz is the founder of the Schizophrenia Program at the Medical College of Virginia and, previous to his coming to the University of Minnesota, was the Medical Director of the Schizophrenia Module at University of Pittsburgh. He has contributed to the National Plan on Schizophrenia Research and with his colleague Dr. Carol Tamminga, started the International Congress on Schizophrenia Research. Schulz was featured as an expert in the 2011 Academic Health Center informational video The Value of Academic Medicine: Confronting Psychiatric Illness. Watch to see him discuss relevant psychiatric issues including schizophrenia.

hat tip to altostrata…   
I don’t know much about Dr. Charles Schultz and his research on Schizophrenia, but we all know that he and Dr. Stephen Olson were co-investigators for the Minnesota arm of the CAFE study, a Clinical Trial funded by Astra-Zeneca to compare maintenance antipsychotics in first-break Schizophrenia. We also know the Dan Markingson was inappropriately recruited and included in this study, and killed himself some six months into the one year trial [see Fear and Loathing in Bioethics].

The outcome variable in the study was voluntary continuation of medications. Patients with a diagnosis of Schizophrenia regularly stop their medications. The CATIE and CAFE studies hypothesized that the side effect profiles of the drugs were a major factor in the poor adherence rates, thus the outcome variable. In truth, side effect profiles are only one of many factors involved in this complex issue, and the naive notion that these drugs are the solution to the problem of Schizophrenia for either patients or society has long passed. But those larger questions aside, in this case there was ample evidence of fundamental research misconduct. Dan Markingson’s adherence to medication was not a function of side effects – it was legal repercussions. His semi-freedom to live outside an institution was predicated on staying on the medication.

There is another underlying assumption in such studies. The "non-compliance" is viewed as a paradox. Here is a medication that can rid the patient of psychotic thinking and symptoms, yet they stop taking it. How-come is that? While it’s another naive question, in Dan’s case, there’s none of the usual evidence that it helped him in any way. We’ve not seen a detailed case report [if there is one], but the observations of his mother and the staff at the Halfway House don’t confirm that it was helping. He was seclusive, grandiose, remaining in his private world that we don’t know about. If anything, the outside view suggests continued psychotic processes. The point being, there’s no concrete evidence that suggests that he responded to the medication in the first place.

A research program that condones or allows that kind of recruitment and inclusion deserves thorough investigation, and perhaps shutting down. The University wants to limit the investigation they have been forced into to remain limited to the program now – not what happened then. That allows Dr. Olson to continue to aver that they did "nothing wrong" and Dr. Schultz to make tapes like the one above selling that academic programs [his academic program] as the right places to do clinical trials. That should be true, but in this case, it wasn’t. This was not research misconduct lite – this was the real deal and what has been happening is, by any measure, a cover-up extraordinaire.

There’s another part to this story that isn’t the stuff of courtrooms or investigations. Dan Markingson was an Object, not an encountered person – a Subject. He was a Schizophrenia Object for the study. He was a Dangerous Person Object for the courts. He was a young adult taken out of the course of his life by a show-stopping illness we’ve known since the dawn of time. There’s no guarantee that he could have been helped, but if that had been possible [and it often is], it would require that the Subject Dan Markingson be encountered. Anyone who has ever worked with these patients knows that with such cases, that’s not always easy, and sometimes impossible. But in this case, it doesn’t seem that anyone gave it a shot. They didn’t even seem to register how sick he remained during the six plus months he was in their care.

So there are two issues in this story: an egregious and concrete violation of research ethics that was likely a factor in Dan’s suicide; and an absence of an essential something that’s hard to measure, but when it’s missing, it’s too loud to ignore. It’s too late for Dan and his mother. But the case deserves a full hearing and investigation because of its bearing on future research at this center and elsewhere. But, secondly, it deserves a full hearing at large because of what was missing. There are countless future medical workers who need the case of Dan Markingson in the back of their minds throughout their subsequent careers to remind them of what really matters about what they do. There is certainly no call for a celebrity award anywhere in this story…
Mickey @ 12:05 PM
Filed under: politics
their oyster to harvest…

Posted on Monday 14 April 2014

I threw this slide in as an afterthought to your nose is growing longer…, but it has stayed with me since then. It’s from PhARMA-2014, their annual meeting going on this week, in the Chart Pack. The various charts follow three themes: the hard road of PhARMA; what good people PhARMA people are; and some new strategies to increase sales. The subtext says:
Revisions to clinical guidelines based on the latest research have resulted in appropriate increases in the use of medicines in recent years.
I question whether these things are so appropriate. These are all ways to increase drug sales: larger populations, polypharmacy, longer on-meds duration. I found "longer continuation of treatment for depression" particularly offensive. So we can infer that the modern guidelines and recommendations we keep hearing about are prime PhARMA targets [as in TMAP], and they’ve been busy bees behind the scenes.

As long as I’m at it, the next chart in the pack has a rather ominous background message:

Mr. Rand says that we doctors are witholding guideline recommended medications and not following up closely enough to be sure the medications are being taken. They’re saying that doctors aren’t over-prescribing, they’re underprescribing and not following up to be sure that the patients are being compliant. I would say that Mr. Rand must’ve gone into some eldercare facilities and practices other than the ones I’ve been around.  I’ve always said that a good retirement career would be to visit nursing homes and start decreasing and discontinuing medications right and left. But more on point, for PhRMA to be making these recommendations is the height of Conflict of Interest in action. But all of that is just an introduction to this next article, Be warned, it’s so heavily spun that it’s hard at first to know what they’re talking about.
eye for pharma
By Zuzanna Fimi?ska
Apr 11, 2014

The 21st century pharma company is no longer solely a provider of molecules. To survive in the new reality, the industry must change its mindset and offer services, putting the customer at the center of their activities. In an uncertain climate, big pharma must understand its customers and deliver what they really need: value beyond the pill. While many companies have begun to do this in earnest, others hesitate and question whether patient services are warranted or appropriate. However, it is increasingly apparent that the industry has a role to play in patient support, and that much is at stake for the industry itself.

The importance of treatment adherence

According to the World Health Organization [WHO[ improving adherence would have a greater impact on health than any potential discovery in medicine. Even if the pharmaceutical industry one day discovered the much wished for “cure for cancer,” it is likely that it won’t be taken properly [oral anti-cancer therapies currently run about 60% adherence].

In addition to being potentially lethal, non-adherence is expensive. While there may have been a tendency in the past to assume that not taking prescribed medicines provided some degree of savings, the U.S. Congressional Budget Office (CBO), which serves as an independent, official scorekeeper of the fiscal impact of federal policy and proposed legislation, changed its stance on medication adherence in 2002, recognizing that the evidence of a direct connection between medication use and healthcare spending was sufficient to “score” a medical cost offset in its budgetary forecast. The CBO’s budget forecasting now assumes that medication adherence can lead to reductions in doctor visits and hospitalizations, and impact the rise of healthcare costs.
That’s the flavor of things, so I’ll skip to the end where he gets around to talking about the point of all of this:
Change in paradigm

According to eyeforpharma’s "The Importance of Patient Services" Whitepaper, the estimated impact from non-adherence ranges from $30 billion a year to $560 billion a year, although it must be pointed out that patients who do not adhere to a given treatment often end up on a different treatment, so the higher figures are undoubtedly not representative of the impact on the industry as a whole. This is not lost on the pharmaceutical executives. In 2011, business intelligence firm Cutting Edge Information conducted a survey of 18 drug companies. The study concluded that 25% of overall sales were diminished by patient adherence, while 31% of revenue can be preserved by patient support efforts. Nevertheless, offering patient-support services is often met with skepticism and fear. “People in pharma are scared,” said Isler. “Everyone agrees that the traditional model is broken, but nobody really knows the answer,” he admitted.

Entering into a dialogue with customers requires a shift in organizational structure. Companies need the right people with the right skill set, including experience in services and with customer interaction. “Pharma are mostly scientists and physicians, who are happy in their labs, but not talking to customers. It’s not natural for pharma to be a customer-focused industry, but now we need to be there, talking to our customers, instead of being this prescriptive black box that tells them what is good for them,” Isler concluded.

The days when pharma could safely build their business on a molecule are now gone and efforts must be made to ensure a shift in thinking necessary for the industry to remain relevant. To achieve this, companies need to overcome fears that have so far been crippling the revolution of pharma.
I find all of this both infuriating and discouraging. PHARMA has done enough damage, at least in my specialty of psychiatry for the current millennium already. So here from multiple directions we hear marketing schemes involving:
  • expanding target populations by lowering threshholds
  • encouraging polypharmacy
  • staying on medications longer
  • following guideline recommendations fully
  • following up patients to insure medication compliance
  • PHARMA getting into the business of dealing with patients and theiradherence
None of these things are any of their business, and while I don’t actually know what "crippling the revolution of pharma" means, they speak as if Medicine is their oyster to harvest. In the last thirty years, they’ve swept through psychiatry like West Virginia Strip-Miners, and one wonders if the landscape will ever return. But we are not alone. and it’s hard to see anything about what’s happening here as self-limiting…
Mickey @ 10:27 PM
Filed under: politics