1 Boring Old Man

The BMJ requires data sharing on request for all trials

by Elizabeth Loder and Trish  Groves

British Medical Journal. 2015 350:h2373

Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy. The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.2 Last month, the World Health Organization [WHO] and the Nordic Trial Alliance released important declarations about clinical trial transparency.

These announcements come on the heels of the US Institute of Medicine’s [IOM] report on sharing clinical trial data, which called for a transformation of existing scientific culture to one where “data sharing is the expected norm.” The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.

WHO’s statement on public disclosure of clinical trial results and the accompanying rationale reiterate the organisation’s support for registration of clinical trials. WHO declares that the main results of clinical trials should be posted on a clinical trial registry or other acceptable website and submitted for journal publication within a year of study completion. The expectation is that results will be “made available publicly at most within 24 months of completion.” The statement does not call for mandatory sharing of primary data from trials but instead “encourages” sharing of research datasets “whenever appropriate.”

In a move that is particularly welcomed by Ben Goldacre, cofounder of the AllTrials campaign, WHO also recommends disclosure of previously conducted but unreported clinical trials in a searchable and free registry and says it is “desirable” that these trials should be published in a peer reviewed journal. Goldacre notes that this is important because “the overwhelming majority of prescriptions today are for treatments that came onto the market — and were therefore researched — over the preceding decades rather than the past five years”…

• 2001: Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial. "Paroxetine is generally well tolerated and effective for major depression in adolescents."
  by Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, and McCafferty JP
• 2002: Fluoxetine for Acute Treatment of Depression in Children and Adolescents: A Placebo-Controlled, Randomized Clinical Trial. "Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression."
  by Emslie GJ, Heiligenstein JH, Wagner KD, Hoog SL, Ernest DE, Brown E, Nilsson M, and Jacobson JG
• 2003: Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials. "…sertraline is an effective and well-tolerated short-term treatment for children and adolescents with MDD."
  by Wagner KD, Ambrosini P, Rynn M, Wohlberg C, Yang R, Greenbaum MS, Childress A, Donnelly C, Deas D; and the Sertraline Pediatric Depression Study Group
• 2004: A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. "…treatment with citalopram reduced depressive symptoms to a significantly greater extent than placebo treatment and was well tolerated."
  by Wagner KD, Robb AS, Findling RL, Jin J, Gutierrez MM, and Heydorn WE

[Paradoxically, Karen Wagner and some of her co-authors in these studies were later on the ACNP [American College of Neuropsychopharmacology] Task Force convened to report on these questions after the Black Box Warning was added by the FDA in 2004:]

• 2006: ACNP Task Force Report on SSRIs and Suicidal Behavior in Youth.
by Mann JJ, Emslie G, Baldessarini RJ, Beardslee W, Fawcett JA, Goodwin FK, Leon AC, Meltzer HY, Ryan ND, Shaffer D, and Wagner KD

Parents are key in treating child, adolescent depression

Family Practice News

By WHITNEY MCKNIGHT

February 26, 2015

Taking a thorough family history and understanding how to prescribe off-label medications can help physicians achieve more favorable outcomes when treating children and adolescents for depression, according to Dr. Karen Dineen Wagner. In addition, a willingness to prescribe newer, virtual therapies increases the chance for remission of depression in these patients, Dr. Wagner said at the annual psychopharmacology update held by the Nevada Psychiatric Association. Left untreated, the severe depression that occurs in just under 10% of U.S. teens and the more mild depression that occurs in about 12% can lead to severe impairment later in life, she said.

“If you think about it, that’s really a high prevalence in an adolescent disorder,” said Dr. Wagner, the Marie B. Gale Centennial Professor of Psychiatry and Behavioral Sciences at the University of Texas in Galveston. One out of six of these teens will go on to have depression and other psychosocial impairment in adulthood, as well as suicidal ideation [J. Am. Acad. Child Adolesc. Psychiatry 2010;49:980-989].

Even with treatment, the odds for recurrent depression later in life are 2:1 in favor of the mood disorder, according to Dr. Wagner, who cited a study showing that of 140 teens treated for depression, more than 90% experienced full remission, but more than half were depressed again an average of 6 years hence. More than three-quarters of those treated for depression went on to have nonmood disorders such as anxiety, substance abuse, and eating disorders [J. Affect. Disord. 2013;298-305]…

Repeated treatment failure, whether psychotherapeutic or pharmacogenic, therefore, might be related more to parental depression than the child’s own. “Check carefully for that. And keep in mind that the depressed parent may not be the one bringing in the child or teenager for treatment,” Dr. Wagner said [JAMA Psychiatry 2013;70:1161-1170]… 

Currently, the only approved pharmacologic options for children and teens are fluoxetine, which is indicated for use in 8- to 17-year-olds, and escitalopram, indicated for use in 12- to 17-year-olds. Dr. Wagner noted that escitalopram has only one study to back its efficacy in teens and that a second study including children as young as 6 years old was negative. Fluoxetine has three studies to back its efficacy in children and adolescents. If the age-appropriate medication elicits no response, the only pharmacologic treatments are off label. “Be sure you document that in the chart,” Dr. Wagner said.

Having surveyed available data from controlled pediatric depression trials, Dr. Wagner said the only two off-label medications she recommended physicians consider for their pediatric or adolescent patients were sertraline, which has been shown negative in individual trials but in a priori pooled analyses was found positive twice, and citalopram…

Even though some parents might worry about the demonstrated link between suicide and some antidepressants in teens, Dr. Wagner said clinicians should counsel families that the risk for suicide in untreated depression was higher at 12% [most antidepressants are around 1%] [JAMA Psychiatry 2013;70:300-310].

Making it somewhat easier to predict treatment courses is that about 60% of adolescents who respond early to antidepressant treatment will go on to remission, Dr. Wagner said. Resisting pressure from parents and patients to end the course of treatment too soon if they see early signs of recovery as synonymous with cure is important for avoiding relapse. Dr. Wagner recommended “starting the clock from the time when the child shows signs of having gotten well, and then adding 1 year.” She also said that tapering dosage over “a couple of months” was a valid approach, depending on the original dose…

Given that there is a notable placebo response rate in this population, and CBT is not thought to have harmful side effects, physicians might be tempted to start there, but Dr. Wagner said the combined effectiveness of CBT with medical management of depression was more efficacious than CBT alone. She cited a study showing that after 12 weeks, adolescents treated with fluoxetine in combination with CBT achieved a 73% response rate, whereas CBT only had a 48% rate. It wasn’t until week 36 in the study that the two methods reached parity. Fluoxetine alone in this cohort reached a 62% response rate by week 12, and an 81% response rate at week 36. “So, that’s what I say to parents, ‘Do we really have the time for psychotherapy alone to work?’ ” [Arch. Gen. Psychiatry 2007;64:1132-43]…

hat tip to 1boringyoungman… 

it is important to distinguish individual, quid-pro-quo, corruption from institutional corruption. The former is a story of “bad apples.” For instance, a politician takes a bribe in return for a political favor. That is quid-pro-quo corruption. Institutional corruption is of a different—and more societally damaging—type. Institutional corruption is a not a “bad apple” problem, but a “bad barrel” problem. The basic concept of institutional corruption is this: There are “economies of influence” that create “incentives” for behaviors by members of the institution that are antithetical to the institution’s public mission. When this happens, the “corrupt” behavior may become “normative,” and even go unrecognized as problematic by those within the institution… 

In the process of being involved in an in depth reanalysis of a Clinical Trial with full access to the raw data is that far and away, the most important deterrent to bias is strict adherence to the a priori Protocol as approved by the Institutional Review Board before commencing the study. A properly constructed Protocol covers all the bases before the batter even enters the box. It should be even possible to pre-program the analysis of the results prior to starting the study. Once you see the results, or even get a whiff of the results, Old Man Bias raises his ugly head whether you know it or not. I’m beginning to think the same thing about financial conflicts of interest. There’s a new article in the New England Journal that suggests that we’re too paranoid about industry misconduct these days, and jumping to conclusions [Reconnecting the Dots — Reinterpreting Industry–Physician Relations]. It feels like a biased report to me, designed to bring me around to a more tolerant position, but it had the opposite effect – pushing me in the direction of zero tolerance.

Efficacy and Safety of Brexpiprazole for the Treatment of Acute Schizophrenia: A 6-Week Randomized, Double-Blind, Placebo-Controlled Trial

by Correll CU, Skuban A, Ouyang J, Hobart M, Pfister S, McQuade RD, Nyilas M, Carson WH, Sanchez R, and Eriksson H.

American Journal of Psychiatry. 2015 Apr 16 [Epub ahead of print]

[NCT01396421]

A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.

by Kane JM, Skuban, Ouyang, Hobart, Pfister, McQuade, Nyilas, Carson, Sanchez, and Eriksson.

Schizophrenia Research. 2015 Feb 12. [Epub ahead of print]

[NCT01393613]

• Funding:
  These were both industry funded and industry managed studies [Otsuka and Lundbeck].
• Trial:
  I look for who is in charge, an academic or company PI/Coordinator. These were both coordinated by the same industry employee. I also look at how many sites? US vs non US? academic vs CRC? These studies used 117 site! All over the place. And I look to see if the results have been posted – in this case neither had them…
• Authors:
  Academic versus industry? In both articles, there was only one academic author for each, both from the same department of psychiatry, both with extensive industry affiliations. Everybody else was a company employee.
• Acknowledgements:
  I look for "editorial support" AKA ghost-writers. Each of these had an individual ghost-writer but both from the same company.
• Chemistry:
  In this case, Otsuka now has the number one selling drug, now going off-patent [Abilify®] so I looked to see if it is a knock-off of Abilify® [which it is]:
  

So what’s my point? I think a better question is what’s their point? Of what use is an industry-funded, industry-orchestrated, industry-analyzed, ghost-written, blockbuster clone article ticketed into a scientific journal by professional KOL physicians who had little if anything to do with it? Maybe the drug is okay, and maybe not. For sure, it’s presented in its Sunday best in these papers. Is it any better than Abilify®? as good? worse? We’re unlikely to know from this made for television production. It just all seems like such a silly game being played – and played in the American Journal of Psychiatry and Schizophrenia Research at that.

There’s something kind of unique about the last paradigm shift in American Psychiatry [see roots… and agendae…]. It didn’t happen just because of changes in the ways people thought or some scientific advances. It was orchestrated by the American Psychiatric Association and effected by a change in the Diagnostic System [which nail?…, a card laid…]. The changes were dramatic, and instituted by the professional organization itself instead of being put together after the fact. The 1980 DSM-III was a cause rather than a result.  I don’t think it was imposed, because it caught on so quickly. But it wasn’t a grass roots change for sure. What it meant was that there was a concentration of power in the APA. The organization was put in charge in a different way. That’s a speculation on my part, but I think it’s pretty close. Since then, American psychiatrists have looked to the APA for direction. One could also say that in 1980, American psychiatry became homogenized. The internal discord that came before essentially faded away. Instead of being a forum where dissidents shook fists at each other, dissidents just faded away. Again, that’s my speculation based on my own observations – evidence-based but with a very small sample. In that sense, Levine and Whitaker are using the word «psychiatry» correctly to describe the homogeneous APA membership [in a guilded cage…].

The DSM-III was a raging success. Psychologists and Social workers gained more access to third party medical reimbursement by agreeing to accept the carriers’ terms. The insurance companies paid psychiatrists well for Med Checks. The analysts finally got around to settling for a role as psychotherapists and began training psychologists and social workers after losing a suit. PHARMA was generous to the academics with grants, and the drugs flowed out of the pipeline at a steady rate. Over the ensuing years, psychiatrists became medicators, the role Managed Care assigned to them. Tom Insel talked on about Clinical Neuroscience.

And then the Primary Care Physicians began to prescribe psychiatric medications, and a subset of the new academic psychiatrists got exposed as crooked; many of the industry-funded RCTs were questioned; the pipeline ran dry; the wondrous brain discoveries didn’t materialize; the medications didn’t turn out as planned; the cost-cutting kept happening; and the DSM-5 bombed; the anti-psychiatry forces were on the ascendancy… well, you know the rest. And I expect psychiatrists are looking to the APA for guidance. After all, that was now the seat of power, the self proclaimed compass for the medical specialty of psychiatry.

1. Population Studies suggest that the incidence of untreated mental illness is high.
2. Most psychiatric medication is prescribed by primary care physicians.
3. Mentally ill people are high service users of medical facilities costing billions.

Although we have effective pharmacological and psychosocial treatments for most common mental disorders, they are not widely accessible, and only a minority of patients receive them. Many patients are not on medications at therapeutic doses or for long enough to see positive effects, while others continue to use medications even if they are not effective. As few as 20 percent of patients started on antidepressant medications in primary care show substantial clinical improvements. The situation is not much better for those referred for psychotherapy. Many who are referred don’t go. Others may receive an insufficient number of visits or ineffective forms of therapy, leaving big opportunities to close the gaps between what we know and what we do.

One way to help close these gaps is for psychiatrists to work more closely with our colleagues in primary care using a collaborative care approach. Originally developed and tested by Dr. Wayne Katon and colleagues at the University of Washington in the early 1990s, collaborative care has been examined in the treatment of depression and anxiety disorders in more than 80 randomized, controlled trials and has consistently been found to be more effective than care as usual. In such programs, psychiatrists work closely with primary care physicians and mental health care managers [usually a licensed clinical social worker, nurse, psychologist, or therapist]. Each team has a designated psychiatric consultant who provides systematic treatment recommendations on patients who are not improving as expected…

Here are some of blogs about it from people I respect:
• on Psycritic: On Integrated Mental Health Care, Assimilation vs. Independence
• on Mad in America: The End of Psychiatry
• on PsychPractice: APA-thetic
• on Real Psychiatry: The Model of Psychiatric Care for the Future, Collaborative Care Model – Even Worse Than I Imagined
Here are a few of my takes on it from last year:
• tested soon…
• the Age of Meta…
• two versions…
• my say…
• not directly seeing the patients…

… So I don’t believe it will be possible for psychiatry to change unless it identifies a new function that would be marketable, so to speak. Psychiatry needs to identify a change that would be consistent with its interests as a guild. The one faint possibility I see – and this may seem counterintuitive – is for psychiatry to become the profession that provides a critical view of psychiatric drugs. Family doctors do most of the prescribing of psychiatric drugs today, without any real sense of their risks and benefits, and so psychiatrists could stake out a role as being the experts who know how to use the drugs in a very selective, cautious manner, and the experts who know how to incorporate such drug treatment into a holistic, integrated form of care. If the public sees the drugs as quite problematic, as medications that can serve a purpose – but only if prescribed in a very nuanced way – then it will want to turn to physicians who understand well the problems with the drugs and their limitations. That is what I think must happen for psychiatry to change. Psychiatry must see a financial benefit from a proposed change, one consistent with guild interests.

But with the ACA, the ability of psychiatry to survive independently is quickly fading. Mickey has addressed this in some of his posts about the move to integrated care. And speaking as a psychiatrist who has spent her career in public sector work – where some of the most impaired and disenfranchised seek care [and have no other option] – we do not have the option to ignore the economic issues. This is one reason why I believe that for change to occur, many of the current functions of psychiatry need to be taken away from psychiatry and medicine. I think it is legitimate and important for there to be branch of medicine whose practitioners truly understand the judicious use of psychoactive drugs. They are complicated substances. I just do not think that function needs to be at the core of what we offer to people who experience the vast array of emotional/cognitive problems that currently fall under the umbrella of psychiatric attention [and to re-state, this is not intended to criticize the work of those who found their ways into doing psychotherapy as physicians. This was a viable career path for many at the time].

I’m going to have to reread this stuff and let it settle…

Update: Sandra Steingard just wrote and clarified her comment above [which I really appreciate]:

I would like to elaborate a bit on what I have in mind because it seems I have not been as clear as I would like. My concept has nothing to do with collaborative models where a physician opines about a person he has never met. It also has nothing to do with assessment scales. It also is in no way tied to the widespread use of psychoactive substances for a myriad of quasi disorders for which drug efficacy is marginally if at all established. I continue to believe that the problems we are trying to address are complex and it often take time to establish a relationship and hear the full story. I see no way around that. And while I think there are ways to use the drugs to help people, I think there is still much we do not understand and this leads me to have a therapeutic conservatism in how the drugs are used. But the drugs are going to be used and some specialty in medicine would do well to make it their business to understand them, to be sophisticated about the inevitable polypharmacy, and to to delve into the consequences of long term use and withdrawal effects.

Psychiatry Now Admits It’s Been Wrong in Big Ways – But Can It Change?

Truthout

by Bruce Levine

March 5, 2014

Bruce Levine’s Question: Is it really possible for psychiatry to reform in any meaningful way given their complete embrace of the "medical model of mental illness," their idea that emotional and behavioral problems are caused by a bio-chemical defect of some type? Can they really reform when their profession as a financial enterprise rests on drug prescribing, electroshock and other bio-chemical-electrical treatments? Can psychiatry do anything but pay lip service to a more holistic/integrative view that includes psychological, spiritual, social, cultural and political realities?

Robert Whitaker’s Answer: I think we have to appreciate this fact: any medical specialty has guild interests, meaning that it needs to protect the market value of its treatments. If it is going to abandon one form of treatment, it needs to be able to replace it with another. It can’t change if there is no replacement in the offing. 

When the APA published DSM-III, it basically ceded talk therapy to psychologists, counselors, social workers and so forth.

Psychiatry’s three domains, in the marketplace, were diagnostics, research, and the prescribing of drugs. Now, 34 years later, we see that its diagnostics are being dismissed as invalid; its research has failed to identify the biology of mental disorders; to validate its diagnostics; and its drug treatments are increasingly being seen as not very effective or even harmful. That is the story of a profession that has reason to feel insecure about its place in the marketplace.

Yet, as you suggest, this is why it is going to be so hard for psychiatry to reform. Diagnosis and the prescribing of drugs constitute the main function of psychiatrists today in our society. From a guild perspective, the profession needs to maintain the public’s belief in the value of that function. So I don’t believe it will be possible for psychiatry to change unless it identifies a new function that would be marketable, so to speak. Psychiatry needs to identify a change that would be consistent with its interests as a guild…

Is it really possible for psychiatry to reform in any meaningful way given their complete embrace of the "medical model of mental illness," their idea that emotional and behavioral problems are caused by a bio-chemical defect of some type? Can they really reform when their profession as a financial enterprise rests on drug prescribing, electroshock and other bio-chemical-electrical treatments? Can psychiatry do anything but pay lip service to a more holistic/integrative view that includes psychological, spiritual, social, cultural and political realities?

Dr. Levine’s comment which contains a definition of psychiatry that I was talking about when I said "My own complaint about Whitaker and his followers is that they use the word «psychiatry» as if it represents a personified unitary entity, but I’ll clarify that point later" in my last post [in a guilded cage…]. In 1980, I was a trained psychiatrist running a psychiatry training program and was in training as a psychoanalyst. But what I really was was an Internist who had become fascinated with the psychology of my medical patients and decided that’s what I wanted to treat. I was doing psychiatry for obvious reasons, and psychoanalysis because those were the guys who I thought knew how and where to listen. It wasn’t the theories that mattered to me, it was listening to the background and I was well pleased with the training I was getting. And then the world went kind of crazy, and all that business in Dr. Levine’s definition came up. It’s not that I was opposed to biology. I had come from a background steeped in that. But, as they say, "Been there, Done that, Got my tee shirt."

I’m not giving my history as a template for others. It was my road, not a highway system. But I fled from the direction mainstream psychiatry was taking  because I didn’t want to go in that direction [and because I thought it was a bad idea]. I was absolutely fine with the ambiguity of psychology, philosophy, biology, and socio-something I had found. In the years that followed, "my kind of" psychiatry was vilified and I became pretty isolated. But I was plenty busy and found my work satisfying and effective enough for my patients. But here’s my only real point. I am and was a psychiatrist that whole time. Psychiatrists are physicians who specialize in the treatment of mental illnesses. The revolution of 1980 was because people thought that psychoanalysis had too much influence on psychiatry. They were right. I sort of knew that at the time, and I know it even more now. But changing over to a system where another dead european guy, Emil Kraepelin, got to have too much influence wasn’t okay with me either [all ears…, an open question…].

• Psychiatry Now Admits It’s Been Wrong in Big Ways – But Can It Change?
  Truthout; by Bruce Levine; March 5, 2014.
Bruce Levine’s Question: In Anatomy of an Epidemic, you also discussed the pseudoscience behind the "chemical imbalance" theories of mental illness – theories that made it easy to sell psychiatric drugs. In the last few years, I’ve noticed establishment psychiatry figures doing some major backpedaling on these chemical imbalance theories. For example, Ronald Pies, editor-in-chief emeritus of the Psychiatric Times stated in 2011, "In truth, the ‘chemical imbalance’ notion was always a kind of urban legend – never a theory seriously propounded by well-informed psychiatrists." What’s your take on this?

Robert Whitaker’s Answer: This is quite interesting and revealing, I would say. In a sense, Ronald Pies is right. Those psychiatrists who were "well informed" about investigations into the chemical imbalance theory of mental disorders knew it hadn’t really panned out, with such findings dating back to the late 1970s and early 1980s. But why, then, did we as a society come to believe that mental disorders were due to chemical imbalances, which were then fixed by the drugs?

Dr. Pies puts the blame on the drug companies. But if you track the rise of this belief, it is easy to see that the American Psychiatric Association promoted it in some of their promotional materials to the public and that "well informed" psychiatrists often spoke of this metaphor in their interviews with the media. So what you find in this statement by Dr. Pies is a remarkable confession: Psychiatry, all along, knew that the evidence wasn’t really there to support the chemical imbalance notion, that it was a hypothesis that hadn’t panned out, and yet psychiatry failed to inform the public of that crucial fact…

• Nuances, Narratives, and the ‘Chemical Imbalance’ Debate in Psychiatry
  ^{Medscape; by Ronald Pies; April 15, 2014.}
• Chemical Imbalance
  ^{Slate Star Codex; by Scott Alexander; April 5, 2015.}

• Psychiatry DID Promote the Chemical Imbalance Theory
  ^{Mad in America; by Philip Hickey; June 6, 2014.}
• The Spurious Chemical Imbalance Theory is Still Alive and Well
  ^{Mad in America; by Philip Hickey; April 27, 2015.}

As for my new book, co-written with Lisa Cosgrove, Psychiatry Under the Influence, this came out of a fellowship I had at Harvard University, in a lab devoted to studying institutional corruption. And while we do write about pharmaceutical influence on psychiatry, the real focus of the book is how the APA and academic psychiatry—the institution of psychiatry we were asked to study — were corrupted by psychiatry’s own guild interests since the publication of DSM-III. The pharmaceutical influence is a distraction from this internal problem within the profession, and I have to say, we believe that the “institution of psychiatry” remains quite oblivious to how this guild influence has corrupted its behavior, in terms of fulfilling its ethical duties to serve the public, over the past 35 years.

Innovations form the Safra Center Ending iCorruption Conference

It is really too bad the project on institutional corruption was only meant to last five years.  It was the only game in town, and one of the few concerted academic initiatives to address systemic corruption, specifically including health care corruption, of which I know.  The project produced some innovations – a word that has become overused business-speak, but is appropriate in this case – to improve disclosure and even somewhat discourage conflicts of interest, and some good ideas – that are unfortunately unlikely to gain any traction – to reduce corruption.  If only this torch will be picked up now that the project is over.  And if only there could be other projects like this in the US and around the world.  But corruption produces a lot of money with which to sustain itself, and the honest are increasingly poor these days.

Although the title of his new book [Psychiatry Under the Influence] suggests some outside force; he says, "the real focus of the book is how the APA and academic psychiatry — the institution of psychiatry we were asked to study — were corrupted by psychiatry’s own guild interests since the publication of DSM-III." And he sees attempts to move the blame for the Chemical Imbalance meme to PHARMA as an attempt at weaseling out of responsibility. Some of Whitaker’s critics propose that his criticism is motivated by his own alliance with other guilds or movements [like in the old Spy vs Spy cartoons in MAD]. Guild vs Guild. I tend to agree with both perspectives.

“Is [Whitaker] wrong? What he says is preposterous. He’s a menace to society because he’s basically fomenting misinformation and misunderstanding about mental illness and the nature of treatment. What he just said in that clip you ran about, if you’re taking an antidepressant and you go off it and you get sick again… the same thing could be said about insulin for diabetes and asthma medication… Whitaker, he ostensibly considers himself to have been a journalist, God help the publication that employed him, but he has an ideological grudge against psychiatry for whatever reason and there’s no, what he calls research is simply his opinion and his construction of information"…

… Whitaker’s sincerity about seeking better treatment options, his command of the facts and his lack of anti-drug dogma compelled all but the most dogmatic psychiatrists to take him seriously. In the past four years, the psychiatry establishment has pivoted from first ignoring Whitaker to then debating him and attempting to discredit him to currently agreeing with many of his conclusions. But will Whitaker’s success in changing minds result in a change for the better in treatment practices? I was curious about Whitaker’s take on the recent U-turns by major figures in the psychiatry establishment with respect to antipsychotic drug treatment, the validity of the "chemical imbalance" theory of mental illness and the validity of the DSM, psychiatry’s diagnostic bible. And I was curious about Whitaker’s sense of psychiatry’s future direction.

1. Psychiatry Now Admits It’s Been Wrong in Big Ways – But Can It Change?
   ^{Truthout; by Bruce Levine; March 5, 2014.}
2. Nuances, Narratives, and the ‘Chemical Imbalance’ Debate in Psychiatry
   ^{Medscape; by Ronald Pies; April 15, 2014.}
3. Psychiatry DID Promote the Chemical Imbalance Theory
   ^{Mad in America; by Philip Hickey; June 6, 2014.}
4. The Most Popular Antidepressants Are Based On An Outdated Theory
   ^{io9; by Levi Gadye; April 1, 2015.}
5. Chemical Imbalance
   ^{Slate Star Codex; by Scott Alexander; April 5, 2015.}
6. Psychiatrists Still Promoting Low-Serotonin Theory of Depression
   ^{Mad in America; by Rob Wipond; April 15, 2015.}
7. The Spurious Chemical Imbalance Theory is Still Alive and Well
   ^{Mad in America; by Philip Hickey; April 27, 2015.}

• Serotonin and depression: The marketing of a myth
  ^{British Medical Journal; by David Healy; April 21, 2015.}

As for my new book, co-written with Lisa Cosgrove, Psychiatry Under the Influence, this came out of a fellowship I had at Harvard University, in a lab devoted to studying institutional corruption. And while we do write about pharmaceutical influence on psychiatry, the real focus of the book is how the APA and academic psychiatry—the institution of psychiatry we were asked to study—were corrupted by psychiatry’s own guild interests since the publication of DSM-III. The pharmaceutical influence is a distraction from this internal problem within the profession, and I have to say, we believe that the “institution of psychiatry” remains quite oblivious to how this guild influence has corrupted its behavior, in terms of fulfilling its ethical duties to serve the public, over the past 35 years. Anyway, that is what is “new” about this book: It really focuses on the guild interests of psychiatry, once it promoted its biological model, and how guild influence has led the institution astray. It is also meant to be a “case study” of institutional corruption, as opposed to a story only about psychiatry.

AllTrials campaign raises the game on clinical-trial transparency

PharmaTimes

by Peter Mansell

January 10, 2013

The push from the UK for wholesale transparency of clinical-trial data has taken on a new dimension with the launch of the AllTrials public campaign. An accompanying petition – already close to 3,000 over 7,000 signatures at the time of writing – calls on governments, regulators and research bodies to put in place measures ensuring that “all trials past and present” are registered and “the full methods and the results” reported. The initiative follows last month’s call by the UK House of Commons Science and Technology Committee for submissions on transparency and the disclosure of study data as part of a broader inquiry into clinical trials.

Among the campaign backers are some familiar names in the recent drive for clinical-data transparency: Bad Science – i.e., epidemiologist and Bad Pharma author Dr. Ben Goldacre; the BMJ; the James Lind Initiative; and the Centre for Evidence-Based Medicine. Joining them in the campaign is Sense About Science, a UK-based charitable trust that works in partnership with scientific bodies, research publishers, policymakers, the public and the media to change public discussions about science and evidence.

Sense About Science director Tracey Brown commented: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements.” Government and regulators “must listen to what the public thinks about this”, Brown insisted. “It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future”…

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^{Who is James Lind? He’s the 18th centery British Naval Surgeon who did the first real controlled clinical trial – citrus fruits for Scurvy [he published his data and did a literature review]…}

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So I thought I’d go back to the Proprietary Data Act and see why they were given that right in the first place. Only I couldn’t find the Proprietary Data Act anywhere no matter what I put in Google®. That happens, so I wrote everyone I knew asking for leads. They kindly agreed to help, but they couldn’t quite recall – Was it Congress back in 1962? Just not sure. So they looked and couldn’t come up with anything either. So how am I going to mount a campaign to Repeal the Proprietary Data Act if I can’t even find it?

I finally heard from some people-in-the-know who had obviously gone on the same Hegira and found nothing either. It just happened apparently. The pharmaceutical companies had the data from the CROs they hired, and they kept it to themselves. There is no Proprietary Data Act. Never was. I guess it’s something like staking a claim in the Klondike during the gold rush or squatter’s rights. So much for my Repeal the Proprietary Data Act Movement..