needs looking into…

Posted on Monday 21 July 2014


Emil Kraepelin           Alois Alzheimer          Auguste Deter

In 1907, Alois Alzheimer working in the lab of Emil Kraepelin, presented the brain findings on his patient, Auguste Deter, a woman who had died after developing dementia at age 51. Besides general brain shrinkage, there were characteristic microscopic findings: plagues in the extracellular spaces and neurons with neuro·fibrillary tangles in the cytoplasm.

Plaques were known from cases of senile dementia, but the tangles were felt to be a unique finding in pre·senile dementia. Kraepelin immortalized his colleague after Alzheimer’s untimely death by using his name in his classification. When I was a medical student, I was taught that the term Alzheimer’s Disease was reserved for the pre·senile cases, but in recent times, that distinction has fallen by the wayside – so Alzheimer’s Disease is a progressive dementia with characteristic brain findings.

There are a number of neurodegenerative diseases with distinguishing features listed in the DSM-5: Alzheimer’s disease, Frontotemporal lobar degeneration, Lewy body disease, Vascular disease, Traumatic brain injury, Substance/medication use, HIV infection, Prion disease, Parkinson’s disease, Huntington’s disease, Another medical condition, Multiple etiologies, Unspecified. In the case of Alzheimer’s, the diagnostic feature has formerly only be seen at autopsy, though there are apparently scans and other tests becoming available for antemortem diagnosis. There is a rare form that runs in families with a genetic marker and the findings are seen in the dementia that can develop with Down’s Syndrome. Since there’s no sure diagnosis in life, the DSM-5 provides probable and possible variants.

The DSM-5 added yet another distinction – a syndromatic diagnostic pair: Major Neurocognitive Disorder and Mild Neurocognitive Disorder. So now there are four possible Alzheimer’s diagnoses:
    Major Neurocognitive Disorder, probable Alzheimer’s Disease
    Major Neurocognitive Disorder, possible Alzheimer’s Disease
    Mild Neurocognitive Disorder, probable Alzheimer’s Disease
    Mild Neurocognitive Disorder, possible Alzheimer’s Disease

I’ll spare you the various criteria. They’re as you imagine – Alzheimer’s and Alzheimer’s lite. Dr. Frances focused on this new distinction in his critique of the DSM-5 and when it was approved, he wrote:
APA approval of DSM-5 is a sad day for psychiatry.
Psychology Today: DSM5 in Distress
by Allen Frances MD
December 2, 2012

This is the saddest moment in my 45 year career of studying, practicing, and teaching psychiatry. The Board of Trustees of the American Psychiatric Association has given its final approval to a deeply flawed DSM 5 containing many changes that seem clearly unsafe and scientifically unsound. My best advice to clinicians, to the press, and to the general public – be skeptical and don’t follow DSM 5 blindly down a road likely to lead to massive over-diagnosis and harmful over-medication. Just ignore the ten changes that make no sense…
I felt sad too. I was as surprised as Dr. Frances that they never really engaged his [or anyone else's] campaign. They had agendas and they pressed ahead no matter what came along until they were forced to drop some of their more bizarre diagnostic changes.
The motives of the people working on DSM 5 have often been questioned. They have been accused of having a financial conflict of interest because some have [minimal] drug company ties and also because so many of the DSM 5 changes will enhance Pharma profits by adding to our already existing societal overdose of carelessly prescribed psychiatric medicine. But I know the people working on DSM 5 and know this charge to be both unfair and untrue. Indeed, they have made some very bad decisions, but they did so with pure hearts and not because they wanted to help the drug companies. Their’s is an intellectual, not financial, conflict of interest that results from the natural tendency of highly specialized experts to over value their pet ideas, to want to expand their own areas of research interest, and to be oblivious to the distortions that occur in translating DSM 5 to real life clinical practice…
That last paragraph is the place where I disagreed with Dr. Frances some. I wasn’t convinced that he was right. I’m still not. I think he was correct that the DSM-5 wasn’t composed of a gang of sociopaths. But I personally think that there was real industry influence in places in the Task Force, and one of those places I’m most suspicious about is the one I’m writing about right now – Alzheimer’s Disease.It was number 3. on his please ignore list:
[3] The everyday forgetting characteristic of old age will now be misdiagnosed as Minor Neurocognitive Disorder, creating a huge false positive population of people who are not at special risk for dementia. Since there is no effective treatment for this ‘condition’ [or for dementia], the label provides absolutely no benefit [while creating great anxiety] even for those at true risk for later developing dementia. It is a dead loss for the many who will be mislabeled.
We agree that adding Minor Neurocognitive Disorder gave us nothing except diagnostic sprawl and makes little sense [but it's unfortunately beginning to make more sense now]. When Cosgrove and Krimsky released their COI article in the lead up to the DSM-5 being approved is when my nose started twitching. I graphed their findings then:
PLoS Medicine
by Lisa Cosgrove and Sheldon Krimsky
March 13, 2012

Back when I first read this, I got it that the two most compromised workgroups were Sleep and Neurocognitive Disorders, but when I went back and looked today at the actual graph in the study, the Neurocognitive Disorders were the most changed from the DSM-IV. It looked to me like somebody had stacked the deck this time around.
And when I went back and looked at my forest plot of the results of the DSM-5 Field Trials, there was something really not quite right about those Mild Neurocognitive Disorder results:
And here’s a snippet from their table [see footnote]:
I didn’t spend all that time looking back at these things for no reason. All of a sudden, Alzheimer’s is quite the rage these days, more on the financial front pages than in our journals [yet] – but it’s where the action is right now. I’m obviously concerned that adding Mild Neurocognitive Disorder was a pre-emptive strike aimed at expanding the market for some future treatments. If they get any of the drugs in development approved, no matter how weak the effect size, people with Mild Neurocognitive Disorder are going to be clammoring to take it, whether it’s approved for Alzheimer’s lite or not, whether it’s known if Alzheimer’s lite is a precursor of Alzheimer’s proper or not. And some of the strategies are going to be dangerous biologics [like monoclonal antibodies to beta-amyloid], and will likely cost a fortune. So I’ve run out of room in this post for much more than speculation, but I think some information on the R&D going on in this area will be coming soon. Don’t get me wrong, if they can find a real way to halt the progression of Alzheimer’s Disease, more power to them. But I’m wary that this is an area that’s vulnerable to exploitation, and this target population is among our most vulnerable [and exploited] already. So this is a topic that needs looking into…
Mickey @ 6:05 PM
Filed under: politics
one of the predators…

Posted on Monday 21 July 2014

New York Times
By ANEMONA HARTOCOLLIS
July 15, 2014
Healthcare Renewal
by Roy Poses
July 17, 2014

Dr Herbert Pardes was once one of the best paid CEOs of a US non-profit hospital system. A new New York Times article reported that the hospital system continued to pay him millions after his retirement… In 2009, we first discussed the compensation given to Dr Herbert Pardes, the CEO of New York – Presbyterian Healthcare System, which appeared to make him one of the best paid, if not the best paid non-profit hospital system CEO in the US. His total compensation for 2008 was $9.8 million, according to the NY Post. While his compensation was lower in 2007, approximately $5.1 million, 9 other executives made over $1 million, and the 10 together made over $26 million. This amount was approximately 20% of the system’s total surplus, and 1% of its total budget. The Times reported that since then, Dr Padres continued to do very well financially,
    Dr. Pardes’s compensation has consistently been among the highest of any New York hospital C.E.O. His compensation in 2011, his last year as chief executive, was $4.1 million, including base pay of $1.7 million and a bonus of $1.8 million.
According to the Times, after Dr Pardes retired in 2011,
    The next year, Dr. Pardes earned $5.6 million, which included $1 million in base salary, a $1.8 million bonus for his final year as chief executive and more than $2 million in deferred compensation, according to hospital tax records. That exceeded the amount earned by Dr. Pardes’s successor, Dr. Steven Corwin, who made $3.6 million that year. Three years after retirement, Dr. Pardes is still employed by the hospital as the executive vice chairman of its board of trustees, a position that compensation experts say is rare in the nonprofit world,…
So the year after Dr Pardes retired, he made as much from what most people might have thought was his former employer as he did in 2007 as CEO, when he was one of the best paid non-profit CEOs in the country, and more than he made in 2011, the year of his retirement…
Herb Pardes From Wikipedia

Herbert Pardes [born c. 1932] is an American physician, psychiatrist, and the Executive Vice Chairman of NewYork–Presbyterian Hospital. He was previously president of Presbyterian Hospital; a few years after its merger with New York Hospital he became CEO of the combined entity, which was named NewYork–Presbyterian Hospital. He is a national figure in psychiatry and academic medicine. Prior to his retirement at New York Presbyterian, Pardes in 2008 was receiving compensation in excess of nine million dollars annually while CEO at the hospital along with other benefits.

Education and career
Dr. Pardes received his Bachelor of Science degree summa cum laude from Rutgers University in 1956 and his medical degree from the State University of New York-Downstate Medical Center in Brooklyn in 1960. From 1978 to 1984, he was director of the National Institute of Mental Health [NIMH], where he strengthened the Institute’s research program and emphasized the need to increase research support for psychiatry. From 1989 he was president of American Psychiatric Association [APA]. He is a former Dean of the Columbia University College of Physicians and Surgeons. Before becoming dean, Pardes was chair of Columbia’s Department of Psychiatry, where he remains a professor…
I don’t know Dr. Pardes or much about his contributions to medicine/psychiatry, except that he’s held all the prestigious positions there are to hold over the course of his career. And I don’t have much to say about the NewYork–Presbyterian Hospital being willing to pay him those absurd amounts of money. He may be a great fund-raiser and/or administrator, but what they’re buying is at least in part, his prestige. My only comment is about his willingness to accept that kind of compensation.

In his commentary about the New York Times article, Dr. Poses goes through the various rationalizations for Pardes being paid that obscene amount of money. They’re in his blog post. I want to skip all of that. That money has to come from somewhere and the only possibility is the pockets of the patients or their insurance carriers. Oh by the way, NewYork–Presbyterian is a not-for-profit hospital system. By accepting that salary, he’s making the statement that medicine is a business first and foremost, part of the system we now have that contributes to the wealth inequity in our country, that contributes to the ridiculous rising cost of healthcare, that contributes to the feeding frenzy of the hospital corporations, the pharmaceutical and medical equipment industries, and the insurance/managed care goliaths.

Independent of his contributions and/or prestige, he took the same oath I did at the end of medical school, Primum non nocere – "First, Do no harm." By accepting that amount of compensation, he plants himself firmly among those forces that are skies-and-away the most harmful elements in healthcare today. He’s become one of the predators [just like the KOLs we talk about] – a "bought doctor." It makes perfect sense that I read about this in a blog called Healthcare Renewal
Mickey @ 6:00 AM
Filed under: politics
our own eyes…

Posted on Sunday 20 July 2014

In the first post about the Lu et al study, I mentioned the CDC 1979-2007 suicide data [see a madness to our method…]. But in its origin…, my post had a broken link to the CDC YRBS [Youth Risk Behavior Study] in the Rapid Response by Barber et al. That was an unfortunate omission as it’s a center ring piece of information. First, here’s the CDC Suicide data [1979-2007]:
Here’s my graphing of the YRBS data [1991-2011]:
The Youth Risk Behavior Surveillance System [YRBSS] was  actually new for me. It’s an every other year survey querying dangerous behaviors in kids 16-19. It looks pretty solid to me and I was glad to find it. Take a look. It certainly doesn’t confirm the findings of Lu et al [in fact, most things don't].

I honestly don’t believe that the black box warnings lead to an increase in either suicides or suicide attempts based on scientific grounds, some of which are shown here. But that’s not what fuels my writing about this. What keeps me writing is what I do believe, not what I don’t believe. I’ve seen two completed suicides from SSRIs that I’m sure about. Thankfully, neither was a patient of mine, but I was privy to enough information to be unquestioning about what happened. I may fill this blog with graphs and population statistics, but as a clinician, I’m a one-person-at-a-time doctor. And people like me are at a loss because I can’t or won’t report why I can say that with such conviction. I also believe in Akathisia of the kind that’s described in patient reports, books, on RxISK, in blogs etc. I believe it because I’ve seen it personally in its very loud forms. I can’t or won’t report the stories that lead to that conviction either, so I can only say that I have no doubts. I think the black box warning is correct – the truth:

 

If someone actually did a non-jury rigged study that said that the black box warning is wrong, I wouldn’t change a single thing in the way I personally do things. David Healy says why best when he talks about getting doctors to "doubt our own eyes." See Akathisia once, a dramatic change in personality and the aggression that comes with the drug, that then disappears when the drug is withdrawn, and you’re on alert. See it the second time and that’s enough for this old man. It might as well be an epidemic. And given the fact that I’m an infrequent prescriber, that I’ve seen it often enough makes it real for me. I would bet it’s even under-reported because the patients stop that drug and don’t go back to see that doctor. I’ve prescribed SSRIs to adolescents and young adults infrequently, and only when I’ve said my spiel and am comfortable that I and competent others can keep close tabs. I can’t imagine anything ever changing that. There have been some successes, some failures, and much indifference. So I’m glad the black box warning slowed down the accelerating rate of prescribing – even in an HMO. And what I’ve seen with my eyes trumps epidemiology on large datasets.
Mickey @ 10:27 PM
Filed under: politics
retire the side…

Posted on Sunday 20 July 2014

I will admit that it’s hard for me to write about this particular recurrent topic without sarcasm [I'll give it a shot, but will likely fail]. The topic is an NIMH Study called EMBARC [Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression] being conducted by Madhukar Trivedi [NIMH Project Number: 1U01MH092221-01] [ClinicalTrials.gov Identifier: NCT01407094]. This is part of a series of studies that date back to the TMAP program in the 1990s:
TMAP [Texas Medical Algorithm Project] was a program that began a push to medicate by algorithm. It was used by industry to get public funded systems to use in-patent medications rather than generics of equal effectiveness – and died a painful death when exposed by whistle-blower Allen Jones. But the idea of creating algorithms for treatment lived on in STAR*D with TMAP veterans John Rush and Madhukar Trivedi from UT Southwestern in charge. It was a complex scheme that had algorithms for sequencing antidepressants in an attempt to enhance the effectiveness of medicating depression. It was a $35 M NIMH project that generated hundreds of papers [now largely forgotten for good reason] and uninterpretable results. Dr. Trivedi had an NIMH Project of his own, supplying a computer program for clinicians to use picking treatments [IMPACTS], but that study was never completed because the clinicians wouldn’t use the computers [cost $2.7 M]. Failing at sequencing and computerizing, their next NIMH funded study tried various combinations of antidepressants [CO-MED]. It was a negative study.

In the first decade of this century, there was a preoccupation with the idea that more efficacy could be extracted from these antidepressants. By the end of the decade, sequencing, augmenting, and combining had each failed to produce the dreamed of enhancement, and so for a time, researchers had a love affair with "personalized medicine" – coming up with some test that would predict response to one or the other antidepressants. It would seem like sequencing and combining would’ve answered that question, but apparently not. At the time, it was thought that genotyping would be the key [but anything would've done]. The Australian Brain Trainer, Evian Gordon, gathered one group of KOLs and began the iSPOT study. And Dr. Trevidi was funded for an NIMH study, EMBARC, to look for biomarkers that predicted drug response. His study started with Placebo, Citalopram [Celexa®], and Bupropion XL [Welbutrin XL®], but the Citalopram was replaced for unknown reasons with Sertraline [Zoloft®] not long after the study began. It was funded from September 30, 2010 through June 30, 2014. The NIMH web site has the following data available for funds allotted:

That comes to $9,199,613 so far. The overall cost to the NIMH for the four funded studies in the figure above [STAR*D, IMPACTS, CO-MED, and EMBARC] exceeds $50 M. Some time back, I had added a note to my calendar that EMBARC ended on June 30, 2014. My prediction was that it would not be completed – based on Dr. Trivedi’s poor track record and my own conviction that it wouldn’t show anything of any value just based on reading the protocol. While that cynical prediction remains an open question, the study should now be completed and yet it is still listed as "recruiting."

I doubt seriously that there’s anyone on the planet waiting to have a biomarker test to decide between Zoloft® and Welbutrin XL® for a depressed patient, particularly with a ~$10 M price-tag. TMAP was a scam; STAR*D was a bust; IMPACTS never even got off the ground. CO-MED flat-lined. Can EMBARC live up to that record? [I warned you I couldn't contain the sarcasm]. It’s stories like this that account for my negativity about Dr. Insel’s NIMH. These people have been funded for a series of ill-conceived, badly designed, and poorly executed studies one after another for a decade and a half to the tune of $50 M. There’s just no need for that. STAR*D produced hundreds of forgettable papers, but never even really reported on what the study proposed to find out. Insel’s NIMH famously selects the directions for research rather than selecting from among the creativity of researchers own proposals. They chase things like personalized medicine, algorithmic medicine, measurement based medicine, translational medicine, RDoC, etc. – fads that come and goand genomics, proteonomics, neuroimaging, connectomics – shiny objects that have appeared in view. And the same people get funded over and over, like the examples mentioned above, independent of their track records.

These attempts to turn clinical psychiatry into algorithms for medications driven by symptoms, often gathered by questionnaires, have yielded nothing. Worse, they trivialize both the human experience of patients and the practitioners’ efforts to help them. Let’s hope that the chart up there has finally run out of iterations and we can retire the side…
Mickey @ 8:00 AM
Filed under: politics
on its extended sabbatical…

Posted on Saturday 19 July 2014

I woke up Thursday morning to an email alerting me to the fact that my blog had disappeared. I tried it and saw:

Was it something I said? The nice technician in Utah [who knew it was in Utah?] said not-to-worry. It had been moved to a new server [?] and the domain pointer hadn’t been ‘hooked up.’ The department that looks into such matters didn’t open until 10:00 AM EST. Oh by the way, after it’s hooked up. it’ll take several days "for global DNS propagation."

I had an uncanny and uncomfortable feeling that the blog was gone for good in spite of the technician’s reassurances, and I thought through its ten year history as I rocked on the porch waiting for the sun to come up. It didn’t take me very long in that mode to understand the why of my "uncanny" feeling. My daughter had set up the blog as 3oldmen.com when I retired in 2003. The other two "old men" were lifelong friends who had retired to the same place I did. They didn’t write much on it. So when my own posts turned serious, she joked sarcastically, "I should change the name to 1boringoldman.com!" I actually liked the sound of that, so we did change it. Those two friends both died within a week of each other at the end of April [in memory…]. So my "uncanny" feeling when the blog disappeared this morning wasn’t so hard to figure out after all – just another example of the realization of finality that grief brings [displaced onto a bunch of magnetic ones and zeros somewhere in Utah].

I actually should’ve realized that almost immediately. There have been so many reminders of them in the recent weeks. The original bond among the three of us was as veterans of the Civil Rights years in the South, the two of them more than I [see, for example Look out Lord, here comes Al Clayton]. This week, PBS’ The American Experience had two pieces on the year 1964, 50 years later. That was "Mississippi Freedom Summer," my first year in medical school in Memphis. Watching the documentary brought floods of my own memories from those days, and with them came the memories of the two of them. I actually met them ten years later in Atlanta – 1974. They had weathered the 1960s in Nashville in the thick of things. So we all had plenty of stories to tell, and became fast friends in the telling.

It hadn’t fully occurred to me that my zeal in writing about what happened in psychiatry had something to do with the Civil Rights days. But sitting on my porch with a wandering mind that morning brought the parallels immediately to the front burner. I had grown up in what might be called an enlightened Southern household. Racism wasn’t tolerated, but quietly not tolerated. All of that changed for me on September 16, 1963, a few days before I was to leave for medical school in Memphis. I read in the paper about a church bombing in Birmingham the day before that killed four little girls. I guess in today’s parlance, I was ‘radicalized’ at that moment. Then I didn’t know what was happening, and it was only in retrospect that I realized how much that article changed the trajectory of my life, who my friends were, and how I saw the world. The same thing happened in October 2008 when I read about Senator Grassley’s investigation of Dr. Charles Nemeroff, chairman of the department of psychiatry at Emory University where I was on the clinical faculty. I had left an academic career there some twenty-five years before when psychiatry changed so dramatically after the coming of the DSM-III and the neoKraepelinians. Wherever things were going back then wasn’t where I was headed, and I exited stage left [by mutual agreement]. By 2008, I was five years retired from a private practice in Atlanta to these mountains near where I grew up to think about other things. But reading about Nemeroff’s misadventures with industry had the same impact that the bombing had back when I was young. In both cases, there was something I knew on the edge of my mind, but I didn’t quite know I knew. But it didn’t take too much of a pin prick to know it all over the place. I had ignored Nemeroff as a self promoter, but hadn’t keyed in to his industry connections, his challenged morality, or his power [or how many others there were around like him].

About that same time, I started working some in a little clinic and realized what seemingly outrageous medication regimens were being prescribed. I had no idea that polypharmacy had become the name of the game. I had been a psychotherapist using not very much medication. It seemed that everyone was Bipolar and had a chemical imbalance. In rural Appalachia? Chemical Imbalance? Bipolar? I bought some contemporary psychopharmacology books and couldn’t even finish reading them – gibberish. I’d practiced in a cocoon and missed a revolution it seems, and the more I saw of it the gladder I was to have missed it. That reminded me of those days in the sixties when I woke up and saw the world I’d grown up in a very different, much darker way. I felt guilty back then for what I hadn’t really seen clearly. I also feel guilty about what happened in psychiatry in the twenty-five years between 1983 when I left academia and 2008 when Senator Grassley blew his whistle – the years when I was in a self-styled exile. I guess you can feel as guilty for not looking as you can for seeing but not doing anything.

But the point of this post came after all those thoughts. By this time, the sun was up and my dogs were clammoring for breakfast. I had figured out in the recent days after my friends died that they had given me back something I’d lost in those Memphis years [along with being great friends]. Memphis was a hard place to be of the Civil Rights persuasion in the 1960s. There weren’t so many of us that were white. The garbage strike, the King assassination, a less well known hospital strike that shut down my training program, tanks and soldiers in the streets, sniper shots in the night. There was a racial divide in those days as wide as the Mississippi that runs through the town. When we left for Europe in 1971 [drafted into the Air Force], I wouldn’t have bet on our returning to the South. But three years later, I picked Atlanta for a psychiatry residency from among many other [actually better] choices. It felt like something I was supposed to do, but the remnants of those darker days were still hanging like storm clouds. Almost immediately, I met Al and Andy, like-minded Southerners who introduced me to many more. They’d made their peace with all that had happened and literally gave me back the South. I didn’t feel like a stranger in my own land anymore [because I wasn't]. And the parallel to the present is very clear to me now. Through this blog, I’ve connected with any number of new friends that I may never meet in person, but that doesn’t too much matter. They’ve helped me reconnect with a psychiatry that I understand, even though we come from diverse ideological backgrounds, places, and even countries. I just don’t feel like an exile anymore [because I'm not]. I guess it felt like I’d lost that connection too when I saw that message up there.

Not a bad bit of front porch grief work for a morning when my blog went on its extended sabbatical…
Mickey @ 5:43 PM
Filed under: politics
ta dah!

Posted on Saturday 19 July 2014

Mickey @ 3:55 PM
Filed under: politics
its origin…

Posted on Tuesday 15 July 2014

by Catherine W Barber, Matthew Miller, and Deborah Azrael
British Medical Journal 2014 348:g359.

In the spirit of Lu et al’s [1] warning not to sound alarms about antidepressant use prematurely, we used readily available national data to investigate whether youth suicide attempts in the U.S. increased after 2003 and 2004—the years in which the FDA issued warnings about antidepressant safety. Attempts did not increase. Lu et al’s opposite finding probably has more to do with the unusual proxy they used [one they said was validated by a paper that two of us — MM and CB — co-authored] [see a madness to our method – a new introduction…] than with an actual change in suicidal behavior among youth. We briefly summarize here five readily available, online data sources that provide more direct and valid measures of youth suicidal behavior, and we discuss problems with the proxy that Lu’s study used.

The CDC’s Youth Risk Behavior Survey [YRBS] is a pencil-and-paper questionnaire filled out by high school students [3]. There was no increase in self-reported suicide attempts from 2003 to 2005 according to the YRBS [see Figure 1]; in fact, there was a decline in suicidal thoughts, plans, and medically-treated attempts from the late ‘90s through 2009 [with some increases in more recent years]. Two databases that estimate national hospital visit rates based on a sample of hospitals also saw no increase in youth self-harm following 2004. The first is the Health Care Utilization Project’s [HCUP] online database [4], which shows no increase in inpatient discharges for intentional self-harm diagnoses [E950-E959] among those ages 17 and under. The CDC’s WISQARS-Nonfatal database [5] also shows no increase in emergency department care for self-harm in this age group [although numbers jump around from year to year]. Both HCUP and WISQARS-Nonfatal are estimates based on a national sample of hospitals and thus subject to sampling error. California’s EPIC website, on the other hand, presents a census of inpatient discharges for the entire state [6]. There, too, no increases in self-harm hospitalization rates among children, adolescents, and young adults were observed following the FDA warnings. Finally, and most consequently, according to official mortality data available on the CDC WISQARS-Fatal website [5], the suicide rate among youth was largely flat 2000-2010, with an increase in 2011.

Lu’s study findings are roundly unsupported by national data. While the national and California data sources have limitations, each is a more direct indicator of intentional self-harm than the data Lu et al used. Lu et al used poisonings by psychotropics [ICD-9 code 969] as a proxy for suicide attempts in claims data from 11 health plans, in spite of the fact that the code covers both intentional and unintentional poisonings. Our paper, which is the sole reference to their claim that code 969 is a “validated” proxy for suicide attempts, in fact shows that in the U.S. National Inpatient Sample the code has a sensitivity of just 40% [i.e., it misses 60% of discharges coded to intentional self-harm] and a positive predictive value of 67% [i.e., a third of the discharges it captures are not intentional self-harm].

On balance, the evidence shows no increase in suicidal behavior among young people following the drop in antidepressant prescribing. It is important that we get this right because the safety of young people is at stake. Lu et al’s paper sounding the alarm that attempts increased was extensively covered in the media. Their advice that the media should be more circumspect when covering dire warnings about antidepressant prescribing applies as well to their own paper.
I know I tend to perseverate on things I find outrageous…
  1. a madness to our method…
  2. are you listening?…
  3. another campaign?…
  4. read me him…
  5. a madness to our method – a new introduction…
  6. return to a madness in our method
  7. all databases are not created equal…
… and that Lu et al article is obviously the one on my front burner right now. But the Rapid Response article above stands out. It’s from the Harvard School of Public Health and was written by the authors of the study [Patrick et al] where Lu et al claimed to have gotten their "validated" proxy – poisoning by psychotropic agents. They call foul like the rest of us, but it carries more weight because they’re the ones that got "fouled."
    Our paper, which is the sole reference to their claim that code 969 is a “validated” proxy for suicide attempts, in fact shows that in the U.S. National Inpatient Sample the code has a sensitivity of just 40% [i.e., it misses 60% of discharges coded to intentional self-harm] and a positive predictive value of 67% [i.e., a third of the discharges it captures are not intentional self-harm]. 
The problem is that the damage has already been done with the extensive and immediate press blasts about this article [see another campaign?…]. We’ve seen that with many of the previous "anti-Black-Box" articles [see are you listening?…].This one was in all the syndicated news services. I found this one particularly disturbing – straight from the new APA President, Paul Summergrad:
I doubt that my fervor with blog posts or even all the very well framed BMJ Rapid Response replies will hold a candle to the impact of the immediate press alerts posted all over the country or the tweet to the APA President’s followers. One can’t help but wonder how these things get coordinated. The article was "Published 18 June 2014," and the press blitz was on the same day. It was even on WebMD the day it was published in the BMJ. That same thing happened with other "anti-Black-Box" articles – notably the ones by Dr. Robert Gibbons [see smell a campaign…]. His media blitz was in high gear even before the second article that gave the source of his data was published [and Gibbons was commenting on this current article on, you-guessed-it, June 18th]. There’s obviously a "pipeline" for getting the word out. It would make a good project for some young investigative reporter to flesh out this pipline and locate its origin…
Mickey @ 10:59 AM
Filed under: politics
where I came in…

Posted on Sunday 13 July 2014

I work in a fairly unusual charity clinic, one that only has one paid employee – a Director. The place is teeming with volunteers, most of us with grey [or little] hair – many living in retirement communities nearby. The doctors who started the clinic had an amazing vision, so we have a pharmacy stocked with donated samples and some purchased medications. And there’s a group that is skilled in getting patients with individual medical needs their medications through the indigent programs of the drug companies. In addition, this group helps patients seen elsewhere [mental health centers] get in-patent medication. Another group arranges for patients with specialty needs to be seen by doctors in the community where possible [by begging], or set up tests that we can’t do [like EEGs or MRIs] elsewhere [also by begging]. Their skills in getting people taken care of are remarkable. Some of the local docs volunteer too [eg a diabetic clinic].

I saw a woman Friday who has been followed in a State contracted Mental Health Clinic in a nearby town. She developed a psychotic illness in her mid-fifties with agitation and persecutory delusions. She was hospitalized with a diagnosis of "Schizophrenia" and treated with Geodon® [Ziprasidone], an Atypical Antipsychotic, which she has taken continuously for six years. She saw me at the request of our pharmacy staff for an "administrative" matter. Our pharmacy has been able to supply her with the medication through an indigent program, but is no longer going to be able to do that. She has a nine month’s supply, but they can get no more. So she came to see me to find an alternative. She’d thought about Risperdal®. In the original hospitalization, they had tried Seroquel® [she made an it-made-me-sick face as she said it]. She had taken 60 mg daily since being hospitalized, but the dose had recently been lowered [at her request] to 40 mg. She still had some "60′s," and was "taking them up" before going to "40s." She said she could never afford to buy it herself at "$300/a month" at the pharmacy. Her husband had died in the recent past and she lives alone. She said with a grin that if I picked "too high a dose," she’d know it ["I've got the Internet"] and wouldn’t take it. I admired her spirit [putting me in my place, not knowing I was already there].

 

If it were just an "administrative" matter, it wouldn’t be a big problem. The local pharmacies are as helpful as the local doctors and our volunteers. The reason we can’t get it for her anymore is that the patent on Geodon® ran out, and along with it, the indigent program shut down. The Generics are now available and with the discounts and the good will of our local druggists deferring their profit, it could be purchased for $55/month. It is likely that I could get the pharmacy at our clinic to get it for her with discretionary funds at that price. But it’s not just an "administrative matter." First, "Schizophrenia" with a first episode in her mid-fifties? Sounds odd to me. And she’s had no symptoms since that hospitalization. So was the diagnosis "Schizophrenia?" I don’t know that but have my doubts. When I saw her, the focus was on her meager finances, as well as staying on a lowest possible dose. She also mentioned that she had tried going off of it altogether, but couldn’t sleep without it. She seems to have been followed as if lifelong-medication were the standard treatment, and we’re not thinking that anymore – at least I’m not. But that’s not the whole story.

She has early Tardive Dyskinesia [TD]. It’s subtle, but it’s noticable if you know what it is – fingers, a little in the face. So from my point of view, the imperative at this point is to begin to taper her off of the medication altogether. She was the last patient of the busy day and the clinic and pharmacy staff had all left. So I encouraged her to go ahead and go down to the 40 mg dose, reassuring her that we would take care of all the administrative matters. There are domain issues as she’s not really our patient and if we’re going to taper her, I’ll need to get some lower dose capsules. But those kind of "administrative" matters are do-able. I’m obviously mentioning the case here in relation to the recent discussions of the treatment of psychosis and the medications used.


In my first medical life, I was a Clinical Immunologist, which meant treating diseases of unknown etiology [like Rheumatoid Arthritis, Systemic Lupus Erythematosis, etc] and it was the early days of organ transplants. We used some mighty toxic drugs in those days – steroids, anti-inflammatories, immunosupressives, antineoplastics – poisons. The consequences were potentially dire, but the alternatives were even worse. Getting people off the medications was always part of starting them. Toxic drugs like those could often be used safely short term, but were long term nightmares. Every case was a rock and a hard place. That’s just how it was. That’s still kind of true in that field, though they have a lot wider [and safer] range of drugs to choose from these days – but the risk/benefit ratio remains a constant watchword [just listen to those mumbled warnings at the end of the t.v. ads].

I think that mentality came with me when I came to psychiatry. In Rheumatology, I’d learned the concept that every single pill was a therapeutic trial, and we saw people frequently to see how the endless trials were going. Coming to psychiatry and encountering the neuroleptics of the 1970s was no different to me. Acute psychosis was a show-stopper and antipsychotics "worked," but the medications long-term were toxic [as in Tardive Dyskinesia as one example]. It felt familiar to me – just another rock and a hard place as a part of a medical life [those double binds I was talking about in part one: the bind…]. I was fortunate in having teachers who taught that these were symptomatic medications and they were in the lowest-effective-dose-drug-holiday-when-possible mindset of the day. Most of the people who pushed the notion that our job was insuring endless medication compliance or using depot injections were not psychiatrists, but rather administrative types trying to keep people out of harms way [and out of the hospitals]. By temperment, I might have fallen into the no medication set, but by experience following some of these patients long term, I am planted in judicious-use-of-medications-and-supportive-psychotherapy where I will likely stay. Like in Rheumatology, I use the medications when I have to, and aim for less or none when I can – another rock and a hard place as a part of a medical life.

So I agree with Robert Whitaker’s campaign against medications-for-life, though the anti-medication-altogether meme seems ill-informed to me. When the Atypical Antipsychotics were introduced, it was hoped that they were not going to cause the long-term neurological problems, but that turned out to be untrue as in this case. I personally think this patient has been ill-advised in that the medicine has been continued for six years – an older patient [more prone to Tardive Dyskinesia] with no apparent attempt to get her off [even though she is asymptomatic]. I’ve seen patients like this who have tried to stop it themselves, but had symptoms that interfered [like insomnia] and so they continued it. I would suspect in this case that those symptoms may well have been from withdrawal and might’ve been managed by a slow tapering and help with safer medications for sleep if needed, but that’s not what happened. In addition, TD can sometime worsen when the medication is withdrawn [another rock and a hard place]. Sometimes it goes away with stopping the medications – sometimes it doesn’t.

There are a number of forces perpetuating the medications-for-life idea. Our KOLs certainly haven’t been much of a help in alerting people to the adverse events. The drug companies made money from the number of pills sold so medications-for-life is not something they would discourage. Rather, they’ve actively minimized adverse events. Families, doctors, law enforcement officers, and staff who live in the revolving door world get very burned out by the patients who stop their medications on discharge and keep showing up every few months with recurrent psychosis. Insurance companies, families, and public mental health centers aren’t keen on the costs of repeated hospitalizations so they tend to advocate for staying on medications. Back in the day, when one or another of the psychiatry residents was showing signs of that kind of frustration, getting angry when patients stopped their medications, I often suggested that they try a dose themselves one free weekend. Some took me up on that, and slept the weekend away. One said he felt like "a tree." The point is that the patients are between a rock and a hard place too. Antipsychotics are no fun to take.


This is the first case of Tardive Dyskinesia I’ve seen in a long time. I’ve not practiced in a situation where I would see it a lot, but I’m still surprised at how little I’ve seen. The case reminded me that that this is where I came in forty years ago. The drugs were different then [first generation], more toxic, but the music was the same – the same rocks and hard places, the same impossibilities. Then, we worried about the mental patients confined to State Hospitals. Now, we worry about those in State Prisons. The opinions about neuroleptics was similarly polarized though the divisions cut along somewhat different lines – more within specialty groups in 1974 rather than between them now.

More to the point, what are the differences between 1974 and 2014? the differences between those first generation antipsychotics and the Atypical Antipsychotics of the modern era? Well, underneath all the drug company propaganda, there’s some actual data:


[C.A.T.I.E.]


[European Schizophrenia Study]

And also this from that European Schizophrenia Study:

 

At least in the area of neurologic Adverse Effects, there’s been some demonstrable progress.

I’ve always thought it ironic that many KOLs [specifically Dr. Lieberman] stick to the line that medication compliance is a key, even using the term "neuroprotection" [see Neuroprotection: A New Strategy in the Treatment of Schizophrenia] [for the record, I don't believe that Lilly-funded CME roundtable]. The irony is apparent in the discontinuation rate in Dr. Lieberman’s own NIMH C.A.T.I.E. study above, and in other studies like this one from the VA hospitals:

The medication-for-life [or at least for a long time] recommendation has been repeatedly voted down by the patients themselves. I have been unable to find any studies to the contrary. Back in 2011 when I was collecting these graphs, Dr. Carroll made an observation that relates to some of our more recent discussions:
    Upon eyeballing the attrition curves you displayed above, it looks like the median time to discontinuation [50% attrition] was 3-5 months in this Veterans population receiving usual clinical care. In CATIE, it was 3-6 months except for olanzapine. In the European study it was 14 months for one drug and the other agents never reached 50% attrition. What might be the magic ingredient that the Europeans possess? Was it more intensive case management?

That’s certainly what I think, and hope for with the coming changes in parity, or the RAISE program, or its SAMHSA extensions – that it will allow these patients more face time. In the patients I’ve followed over the years, case management has been much more than about medication compliance. It has been about using the least amount of medication possible and learning with the patient how to live with the illness as it is manifested in their specific case. As I said, by temperment, I’d love to be in a medication free world and I read all the Open Dialog studies with great interest. But the lives of the patients trump my temperment, and so I live with the rocks and hard places and the double binds along with them – I worry when they’re on medications and I worry when they’re not. Such is my lot just like it was in Rheumatology. I personally think that if there’s something -for-life, it’s not meds, it’s periodic contact no matter how infrequent with someone who knows the case and can jump into action when it’s needed [In a crisis, I can do a hell of a lot better job with patients I already know than otherwise].

So what is different for me from those ancient times? I now have no qualms about tapering or stopping medication and seeing what happens. I am aware of the frequency of withdrawal symptoms, something I didn’t even know about back then – so I plan for them. I realize that a lot of patients like this lady I saw Friday continue to take the neuroleptic medications for symptoms better dealt with with other, safer drugs [like Benzodiazepines for sleep or anxiety]. And I’ve learned to have an eagle eye for TD and the metabolic syndromes. And with cases like the lady that started this ramble, I question the diagnosis of a chronic illness based on one discrete episode in middle age. But the main difference for me now is a comfort with these patients and what are called "negative symptoms." I see them as primary – a relative cognitive impairment that makes for certain difficulties in living – things that one can actually help with over time in ways other than medications.
Mickey @ 1:58 PM
Filed under: politics
the manual…

Posted on Friday 11 July 2014

Back in early May, I was looking into the NIMH ARA funded RAISE study [Recovery After an Initial Schizophrenia Episode], an as yet incompleted program being used as a template for a Congressionally mandated SAMHSA block grant allocation of funds to treat these patients:
One component of this RAISE program was something called Individualized Resiliency Training [IRT], basically designed to teach these patients adaptive skills – to be "resilient": 
I got a bit diverted by a comment by Sandra Steingard who brought up a fascinating program from the days right after Thorazine was introduced for the treatment of Schizophrenia in the mid 1950s called The Vermont Longitudinal Study of Persons With Severe Mental Illness done by Dr. George Brooks and his staff. The patients who were unable to leave the State Hospital after being treated with the newly introduced Thorazine then underwent an extensive psychosocial rehab program – something along the lines of the therapeutic community model. The combination of medication and this additional treatment was successful in getting these medication-only-treatment-failure cases out of the hospital, and had good results for the long haul. That’s the subject of these three posts:
I’m still wandering around with this topic. This post adds a 1963 paper to the mix written by two prominent psychiatrists of the time – one British [as in Max Hamilton of the Hamilton Depression Rating Scale] and the other from Australia, Anthony Hordern. As you recall. 1963 was the year of the Community Mental Health Act that established public mental health centers in the US as a part of the "deinstitutionalization" process already underway. Enthusiasm for the neuroleptics was high in the US in 1963. These authors had a somewhat different take on things [I included my purloined not-very-good OCR copy because I think it's worth a read if you have any interest in this topic]:
by ANTHONY HORDERN and MAX HAMILTON
The British Journal of Psychiatry. 1963 109:500-509.

The advent of the phenothiazines as a treatment for chronic schizophrenics has been enthusiastically hailed as a great advance, but the history of medicine teaches that the enthusiasm with which a new treatment is greeted is not necessarily a measure of its efficacy, and this is as true of psychiatry as of other branches of medicine. In general, the results obtained with the phenothiazines have not bettered the results of those pioneers who introduced "moral treatment" over a century ago. The present-day equivalent of "moral treatment" has also achieved good results, and its supporters are not over-enthusiastic about the value of the phenothiazines. This review has attempted to bring some sort of order in the conflicting reports and an examination of the work done to combine these two forms of treatment has shown that their role is not yet established. Many more investigations will have to be made to establish the value, indications, and inter-relationship of the various treatments available for the mental hospital chronic patient.
By the time I came along [1974], "deinstitutionalization" was something of a done deal. The megalithics State Hospitals had emptied out and closed their doors. Central State was replaced by a Regional Hospital System in Georgia, but beds were disappearing at what seemed like an alarming rate. So it was the Era of the Revolving Door. Patients were admitted to the hospital and back out in a matter of days. It was called "Stabilization" which essentially relied on neuroleptic medications. The hospitals were brief custodial medication units. There were an increasing number of "street people" – many with chronic psychotic illness – and there was a migration of these patients to the urban centers, often given a bus ticket by the rural sheriffs to get them out of the small towns. The system that relied essentially on medication and brief custodial hospitalization sure didn’t look very effective to me. It wasn’t pretty, and was a striking contrast to the formal lectures about community treatment given to students in training. I personally never saw an effort like that described in the Vermont study, or like some of those "moral treatments" mentioned in the Hordern and Hamilton Drugs and "Moral Treatment" article. I just saw Drugs and More Drugs.

While the RAISE study and the recent plan to implement something like it in the States through dedicated Block Grants even before the RAISE results are in seems more rushed and driven by the availability of funding than one might like, that’s the way things work in the real world. The ARA stimulus money becomes available – jump on it. The SAMHSA Block Grant money comes along – grab it. In this world, you take advantage of any breaks that come your way. The thing that worries me isn’t that, it’s specific – it’s the Individualized Resiliency Training [IRT] aspect of the program. I had my say about that earlier [from on IRT, some comments…]:
    Speaking of honesty, again  with this, of all groups, "honesty is the  best  only policy." For example, on page 181 under Summary Points for – What is psychosis?, the manual includes:
    • Scientists believe psychosis is caused by a chemical imbalance in the brain.
    • Both stress and biology contribute to psychotic symptoms.
    • Biological factors contribute to this chemical imbalance in the brain.
    I doubt the authors really know that, or even believe it. I expect the motive in putting it there is to simplify things for the patient. But there’s nothing we know about Schizophrenia that’s "dumb." The Manual is filled with pseudo-expertise and, as Dr. Bracken rightly says, "It is much better to start with doubt, with questions, with openness." And when he says "questions," he means the explorative kind.

    I won’t go on and on here. I expect I’ve really already said what I wanted to say in another IRT prequel…. I think the reason this doesn’t feel like something new is that it’s about training the patients, yet it’s not informed by the patients themselves or what we know about them. What would be new would be to organize this around learning together rather than how to train them. I agree with Dr. Steingard that these clinicians need something to go on, but I think we’d be much more effective if we tried to train the clinicians in the ways of these specific patients. The manual may offer a road-map to some of the areas in need of exploration [and some of the examples are useful]. But if the point is to teach the clinicians to do their jobs ["many well meaning and caring people will use the manual but end up not following it to the T"] and the hope is that "some of them are bound to look up and see the human being sitting in the room," why not start there in the first place?

    This RAISE program is a good idea. It gives these patients some time to work with clinicians who can get to know them. The clinicians aren’t "dumb" either. We need to support them not as trainers with a training manual, but as people who have been given the tools [and the opportunity] to engage their patients, and learn with them what might move things along a helpful path…
As I gave this manual a second chance and read it again, it became clearer to me what bothers me about it. It’s strategic. People with paranoid trends [these patents] see through strategies and are suspicious of their indirectness independent of the content. If implemented as it is, they will feel "talked at" rather than helped. So I hope Dr. Steingard is right, "many well meaning and caring people will use the manual but end up not following it to the T." The principles in the Vermont Study and the Drugs and "Moral Treatment" article would be a useful guide to its rewriting…

An Aside: Discussions of this topic this often deteriorate into Either/Or ["Moral Treatment" vs Drugs] and tend to become contentious. The "Moral Treatment" advocates are characterized as trying to love people into health and in turn become self-righteous accusers. Those advocating Drug treatment are seen as controlling and ignoring the patient’s humanity while seeing their opponents as naive. I tend to see window-shades coming down when such arguments get going and become uncontrollably sleepy. I think that’s a developed somnabulism after twenty-five or thirty years of hearing those arguments go nowhere. I’m a Both person. Without the neuroleptics, we had huge "snake pits." Without "Moral Treatment," we had a different kind of chronic problem with mental patients living under bridges and in prisons. So I’m a careful-and-wary-use-of-existing-medications person and also a moral-treatment-is-the-way-to-go person who is in that dualistic position for life and will likely ignore invitations to change my mind. And while the below [from Drugs and "Moral Treatment"] was written in 1963 about a previous era, it could’ve equally been written in the present about the contemporary past:
    Moral Treatment in Decline: The Rise of Custodialism

    Many authors have discussed the slow attrition of "moral treatment", attributing its decline to such general factors as increasing urbanization, mass immigration, increase in the size of mental hospitals and, in psychiatry itself, to a mechanistic approach patterned on the discoveries in cellular pathology made by Virchow and Van Gicson. In addition, towards the end of the nineteenth century, the development of Kraepelin’s comprehensive nosological system led to a preoccupation with patterns of disease or constellations of pathological entities while mental hospital inmates were regarded as of little interest and of only minor importance as individuals. Whatever the reason, the mentally ill were regarded as suffering from incurable degenerative diseases and were locked away in huge human warehouses which, of necessity, began to be organized on custodial lines. Conditions worsened towards the end of the nineteenth century, and as late as Meyer’s early days at Kankakee, a vigorous search for specific causative agents or noxae, adequate to account for the various manifestations of mental illness, was stall in progress. In the general climate of enthusiasm which surrounded this quest for specific etiological factors the lessons of the past were forgotten or ignored, and only painfully and slowly did academic psychiatry, through Bleuler, Freud and Meyer, return to consider the claims of individual patients.
Mickey @ 8:00 AM
Filed under: politics
a long hot summer…

Posted on Wednesday 9 July 2014

Further discussion required on wording and practical arrangements
European Medicines Agency
Press Release
09/07/2014

The Management Board of the European Medicines Agency [EMA] has postponed formal adoption of the policy on publication of clinical trial data to its 2 October 2014 meeting. Further clarifications on wording and practical arrangements will be discussed by Board members, who have confirmed their general support to the overall aims and objectives of the policy, including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

Further to the agreement reached with the European Commission in accordance with Article 80 of Regulation [EC] No 726/2004, the Board was not able to conclude on the final wording of the policy through a written procedure. Members of the Board have offered additional valuable contributions which will now be considered and addressed in the next few weeks, with a view to reaching final agreement at the next Management Board meeting in October.

The Agency welcomes this additional round of joint reflections and respects all opinions, as well as the views expressed by several Member States, which largely reproduce the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases. In the last 12 months the Agency has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.

The Agency management remains committed to introducing this additional measure towards transparency as soon as possible, so as to enhance citizens’ awareness and confidence in the EU authorisation system for medicinal products. The Agency has also underlined several times that the new policy, if approved, will be without prejudice to the provisions of Regulation [EC] No 1049/2001 on access to documents and the new clinical trial Regulation [EC] No 536/2014, which will become applicable in 2016 at the earliest and, as also noted during the debate, will apply to clinical trials conducted in the European Union.

The Agency management is conscious that any delay prevents citizens, and in particular academics and non-commercial researchers, from enjoying the benefits of proactive publication of clinical trial data for a further period. The Agency will continue to work with the Management Board and the European Commission ahead of the 2 October meeting to ensure that members receive the clarifications requested and to facilitate the adoption of the policy.
Pharmalot
By Ed Silverman
July 9. 2014

Drug makers and academic researchers will have to wait a little longer for the new policy on disclosing clinical trial data from the European Medicines Agency. The regulator has postponed formal adoption of the policy until its next board meeting on October 2, according to a statement issued today. Why? The EMA did not offer many specifics, other than to say its board was unable to reach agreement on final wording, although board members have “confirmed their general support to the overall aims and objectives of the policy.”

This is the second time that approval has been delayed in two months and one source indicated there may be disagreement among member states. The continual delays come amid controversy over the direction the EMA has taken in finalizing its stance toward the disclosure of clinical trial data, a hot-button issue for the pharmaceutical industry. Disclosure has been a contentious topic following scandals over safety or effectiveness data that was not publicly shared. The EMA had publicly committed itself to ensuring trial data is accessible and easily analyzed. And its public statements suggested the pharmaceutical industry would be required to release significant amounts of data, including clinical study reports, which collect and summarize trial data.

For their part, however, drug makers maintained that the EMA sought to go too far in releasing data that could contain trade secrets or compromise patient privacy. In fact, two drug makers – AbbVie and InterMune – went to court in hopes of preventing the agency from releasing data about some of their drugs. Those cases were recently settled. Last month, though, the EMA began circulating its draft policy and was accused by some academics and policy makers of doing an about face in the wake of the settlements. European Ombudsman Emily O’Reilly claimed the agency revised its policy to adhere to the “wishes” of the pharmaceutical industry and she is now reviewing redacted records from those court cases for clues to the EMA change in policy. Despite such impressions, the EMA attempted yesterday to reassure its critics that the policy will lead to greater transparency and, in particular, noted that access to documents will be permitted under freedom of information requests in keeping with European Commission regulations. The EMA also reiterated its willingness to allow data to be downloaded, saved or printed, a restriction that was unexpectedly included in the draft policy, but removed last month amid the burst of criticism.
I’m actually neither surprised nor disheartened. Literally Billions of Dollars, Pounds, and Euros are riding on this decision, and we would be naive indeed to think that this could happen without a fight. Had there been true data transparency, the last twenty-five years might have been very different, particularly in psychiatry. The Clinical Trials of the SSRIs and Atypical Antipsychotics might have looked very different if we had the opportunity to thoroughly evaluate them. And that’s also true of many of the general medicine "blockbusters" [> $1B/year]. So I wouldn’t be terribly surprised if another suit popped up along the way. And I wonder how solid that 2 October deadline will turn out to be. We can almost be guaranteed that some PhRMA/EFPIA workgroup is very busy at work even as I write this, jockeying for position. Remember this [a closing argument…]. A long hot summer up ahead…
Mickey @ 5:27 PM
Filed under: politics