“Brill goes to great lengths – in 15 chapters published one per day – to document a vast amount of the Risperdal story, so it is perplexing to try to imagine whether he might have missed those crucial pages near the beginning of the Rothman Report or whether something else happened. And if it is the latter, what could it possibly be?”
When I read the otherwise excellent* Steven Brill series “America’s Most Admired Lawbreaker,” I noticed and noted that Brill mentioned the actions associated with Diagnosisgate only very briefly and, even stranger, didn’t name the prominent individuals involved. I share Caplan’s interest in the reasons for this omission. (She notes in the comments at my first link above that she contacted Brill when his series was beginning, but didn’t even receive a reply. What’s going on here?)
* He does uncritically accept the claim that “the drug benefits many people,” presumably those alleged to be suffering from “schizophrenia,” which is unfortunate.
“[F]or the rest of us Krispy Kreme represents the siren call of diabetes, obesity, clogged hearts, and death - we can only hope a death that takes place in the Krispy Kreme Challenge Children’s Specialty Clinic, which I’m sure is a very good hospital with some now very terrible branding.”
“Repositioning American Ps[y]chiatric Association from wise sage to caring ruler, we changed everything from messaging to their logo to support the new brand persona.”
Philip Hickey has the story. (Reading his quote from Paul Summergrad’s address at the most recent APA meeting almost makes me feel sorry for them. They so desperately want to believe that discoveries validating their bogus diagnoses and magically justifying their decades of false claims and scientific fakery are right around the corner - “That we have not yet achieved interventions based on these insights or diagnostic tests is not because we will not achieve them, but because of the complexity of what we are studying.” Indeed, in his latest piece doubling down on the bizarre and patently untrue contention that psychiatry never propounded the chemical-imbalance idea, Ronald Pies actually drags out another of these perpetually “intriguing,” “promising” notions. After chemical imbalances, brain-circuit disturbances, stress hormones, telomeres,…we now have the “immune inflammatory metabolic model.” Whitaker and Cosgrove are right: their faith is too strong and too closely bound to their personal, professional, and material interests for challenges to take root within the field. Meanwhile, they cause a lot of harm.)
“[Robert] Califf’s appointment as FDA commissioner would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients.”
This report in the Guardian about the reanalysis of the infamous Study 329 links to both the reanalysis itself and an accompanying feature article by BMJ Associate Editor Peter Doshi describing the years of frustrated attempts to get the original article retracted, both of which are open access. Doshi’s piece - “No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility” – is a scathing indictment of the institutions involved, specifically the American Academy of Child and Adolescent Psychiatry (AACAP), whose journal (JAACAP) published the article by Keller et al. in 2001, and Brown University. The feature quotes several experts, including Ivan Oransky of Retraction Watch, which posted about the matter yesterday.
I’ve reproduced the press release in full. It’s quite straightforward, and potentially will mark a turning point. Please read and share widely.
16 September 2015
The BMJ
Press Release
Reanalysis of antidepressant trial finds popular drug ineffective and unsafe for adolescents
Results contradict original findings and have important implications for research and practice
The widely used antidepressant paroxetine is neither safe nor effective for adolescents with depression, concludes a reanalysis of an influential study originally published in 2001.
The new results, published by The BMJ today, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression.
It is the first trial to be reanalysed and published by The BMJ under an initiative called RIAT (Restoring Invisible and Abandoned Trials), which encourages abandoned or misreported studies to be published or formally corrected to ensure doctors and patients have complete and accurate information to make treatment decisions.
In 2001 SmithKline Beecham, now GlaxoSmithKline (GSK), funded a study (known as Study 329) to compare the effectiveness and safety of the antidepressant drugs paroxetine and imipramine with placebo for adolescents diagnosed with major depression.
It reported that paroxetine was safe and effective for adolescents and was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001.
The study was criticised by the Food and Drug Administration (FDA) in 2002. Yet, that year, over two million prescriptions were written for children and adolescents in the United States.
In 2012 GSK was fined a record $3bn in part for fraudulently promoting paroxetine.
The RIAT team, led by Professor Jon Jureidini at the University of Adelaide, identified this study as an example of a misreported trial in need of restoration.
Using previously confidential trial documents, they reanalysed the original data and found that neither paroxetine nor high dose imipramine was more effective than placebo in the treatment of major depression in adolescents. The authors considered the increase in harms with both drugs to be clinically significant.
They conclude that “paroxetine was ineffective and unsafe in this study.”
The reanalysis of Study 329 “illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base,” say the authors.
In an accompanying article, Peter Doshi, Associate Editor for The BMJ says the new paper “has reignited calls for retraction of the original study and put additional pressure on academic and professional institutions to publicly address the many allegations of wrongdoing.”
He points out that the original manuscript was not written by any of the 22 named authors but by an outside medical writer hired by GSK. And that the paper’s lead author - Brown University’s chief of psychiatry, Martin Keller - had been the focus of a front page investigation in the Boston Globe in 1999 that documented his under-reporting of financial ties to drug companies.
Doshi also details the refusal of the American Academy of Child and Adolescent Psychiatry to intervene and retract the paper, and Brown University’s silence over its faculty’s involvement in Study 329.
“It is often said that science self corrects. But for those who have been calling for a retraction of the Keller paper for many years, the system has failed,” argues Doshi.
Dr Fiona Godlee, The BMJ Editor-in-Chief says publication of the reanalysed data from Study 329 “sets the record straight” and “shows the extent to which drug regulation is failing us.” It also shows that the public and clinicians do not have the unbiased information they need to make informed decisions.
She calls for independent clinical trials rather than trials funded and managed by industry, as well as legislation “to ensure that the results of all clinical trials are made fully available and the individual patient data are available for legitimate independent third party scrutiny.”
Liberating the data from clinical trials has the potential to benefit patients, prevent harm, and correct misleading research, writes Professor David Henry at the University of Toronto, in an accompanying editorial.
Data sharing is not without its risks, he says, but the pay-off from a systematic effort to reactivate important clinical trials will be high and will further justify the original huge investments of time and money, he concludes.
“In this murky area of standards for retraction, there are some no-brainers – fabrication of data and plagiarism as prime examples. I would propose that journals add another no-brainer. When an article is part of a conviction or settlement for a crime, it is by definition ready for immediate retraction.”
Arguably the most controversial drug study ever, Study 329, published in July 2001:
1. Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents;
2. Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine;
3. Was criticized by a few alert and concerned journalists and academics. Their voices were buried by a tsunami of positive marketing and promotion by vested interests;
4. Resulted in a successful New York state fraud lawsuit against GSK;
5. Resulted in 2012 in the biggest fine in corporate history – $3 Billion; and
6. Remains unretracted.
They referred to this proposed protocol as RIAT, and described its purpose as follows:
Unpublished and misreported studies make it difficult to determine the true value of a treatment. Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.
A team of researchers undertook to re-analyze the original data and publish a new analysis under the RIAT protocol.
In August, 2015, after a year and seven drafts, BMJ notified the team that their submission would be published in September, 2015. This will be the first ever trial with two completely different takes on the same data.
This new study, Restoring Study 329: Efficacy and harms of paroxetine and imipramine in the treatment of adolescent major depression: restoration of a randomised controlled trial, should shock all who care about integrity in drug safety. Find out the inside story when this site goes live.
How does this thing - resulting in a $3 billion fine for GSK, almost invariably referred to with adjectives like “infamous” and “notorious” - remain unretracted?
“The actual scandal of ‘The Art of the Gouge’ is that even if NYU is a particularly egregious offender of basic decency and honesty, most of the report’s indictments could apply equally to nearly any American university.”
“[N]eoliberal rationality disseminates the model of the market to all domains and activities...and configures human beings exhaustively as market actors, always, only, and everywhere as homo oeconomicus.”
“Tignous and his from now on inseparable comrades. Journalists, cartoonists, economist, psychoanalyst, proofreader, guards—they were the sentinels, the watchmen, the lookouts even, who kept watch over democracy to make sure it didn’t fall asleep. Constantly, relentlessly denouncing intolerance, discrimination, simplification. Uncompromising. Armed only with their intelligence, with their sharp eyes, with this art of making it possible to see. Armed with only their pencils. Inseparable. United in irreverence, in a gentle cruelty. They brought about the awakening of three generations. The awakening of the consciences of three generations. They taught us, sometimes without our knowing it, about the virtues of freedom of thought and speech. They nurtured our capacity for indignation. And they led us sometimes into the dizzy pleasure of forbidden laughter.
…And at the end of these horrible crimes, we can see that something was in the process of going lax in us. And this alarm reminds of our ambitions—which have been too long silent, too easily abandoned—for social justice, equality, education, and attention to others. We must find again that humanity and that uncompromising outlook that characterized Tignous.”
I’ve been asked to clarify my argument with regard to Charlie Hebdo and the various claims that have been made about the magazine since many of its staff were murdered by an Islamist death squad in January. I have never claimed, as this comment insinuates, that my views about various individual cartoons, whatever they may be, are the only decent ones. My argument all along has concerned the ethics of learning and speaking about the magazine.
What I’ve consistently found indecent is the approach so many have taken, one in which they were immediately prepared to believe the worst claims about Charlie Hebdo and to coldly repeat them. One in which people who knew nothing or virtually nothing (or less than nothing, having seen altered images and read false reports) about the publication set themselves up as implacable judges. One in which upon learning that the claims of intentional racism were false, people immediately shifted to accusations of negligent, callous, or irresponsible racism, propped up by clichés about intent not being magic, punching down, and splash damage.
I expected better. I expected that people would show a modicum of intellectual humility and responsibility, especially when they began to see indications that their early suspicions didn’t hold up on further inspection. First, because our community is supposed to be about humility, questioning, curiosity, evidence, and care in our claims-making. Second, because having been murdered the people they were discussing were no longer here to defend themselves. Third, because tossing out irresponsible claims about the willful or negligent racism of people who were just massacred for drawing cartoons and whose families and colleagues are grieving is disrespectful and cruel - not to mention hypocritical - and so the only decent way to proceed is to take great care in our public statements so as not to perpetuate falsehoods. (I think this is what we’d want for ourselves in similar circumstances.) Fourth, because isolating the victims and targets of Islamist hit men on the basis of an ignorantly-applied purity test endangers us all.
Certainly, the fact that Charlie Hebdo is and is well known in France to be a leftwing, anti-racist publication whose primary target is the racist, xenophobic Right, was information easily available to anyone who cared to look, and is relevant not only to understanding their intent but to understanding the likely reception of the images in context. If nothing else, I would have expected that fact to give people pause before they continued to comment on the subject. No one was being compelled to declare themselves Charlie. It makes sense for people who don’t feel they have enough information to step back before taking a position. But in that case the decent approach is to remain silent while you seek out more information, including the statements of the survivors and of the victims before their deaths, and listen to those who perhaps know more. It’s also to conscientiously retract previous public statements or insinuations that have turned out to be unsupported.
I think we can all agree that her understanding of the image, its intent, context, and effects is probably greater than ours. But many of Charlie’s critics were either ignorant of or unconcerned with her views. Those who thought the publication of the images of Mohammed was racist or purely provocative in intent or consequence didn’t care to hear from those of us who knewbetter. Those who had claimed the magazine targeted Muslims weren’t generally provoked to correct themselves when this appeared. In fact, in general the self-appointed prosecutors went silent – not, as I’d hoped, in order to learn more so as to correct misconceptions, but evidently more for a lack of continuing interest.
We’ve reached an incredibly high level of stupidity and intellectual dishonesty.
This must stop. Charlie Hebdo is the greatest antiracist weekly magazine in this country. Every week in Charlie Hebdo, every week, half [of the magazine’s articles] is against racism, against antisemitism, against hatred towards Muslims… I mean, [some people didn’t like a caricature and said “Well, okay but…”] There is no “but”. Charlie Hebdo fought against all kinds of racisms. Cabu drew cartoons for us, he even made a book for us. Charb drew cartoons for us, they [the cartoonists] gave us drawings on a regular basis, every time we asked; we used those drawings as we wished. Wolinski did the same. [Take a look at the past and ask] every antiracist organisation, they’ll tell you [that] they [Charlie Hebdo] really were antiracist and obviously everyone knows it. And so, people who argue that “Ah, Charlie Hebdo, so full of hate…” Did you know that Charlie Hebdo petitioned to ask for Claude Guéant [then minister of the Interior] to resign right after his anti-Muslim words? For an islamophobic weekly magazine, honestly, that’s quite unusual. So actually, this must stop, okay? And these people who try to make you believe that Charlie Hebdo was a racist magazine, honestly, this is scandalous, they insult the memories and the fights of the ones we lost, most of whom we knew on a personal level, needless to say, and you have to stop insulting the living and the dead. Because when you insult, and when you spread an ideology full of hate, when you lash out at journalists like a pack, this is what happens. So this must stop, everyone is called to its personal responsibility.
The morning of the awards gala in New York there was a panel discussion on “Charlie Hebdo and Challenges to Free Expression.” I went, reported back, and posted the video of the event.* I was hoping that at least one or two of the more than 200 writers who had sanctimoniously denounced the magazine would accept the invitation to come and discuss the matter with Charlie Hebdo’s editor and film critic. But none did. Not a single one. I don’t think anything could have been a bigger insult to the dead and to the survivors at CH than this refusal even to talk with them. That was indecent.
I think that for us tonight, in honoring Charlie Hebdo, we honor the magazine, we honor the talent and the courage of the people who work for it, and above all we honor their antiracist commitment which has been consistent throughout their existence. Charlie Hebdo in France is something that has stood for the antiracist voice in many kinds of combat, whether it be combat due to religious dogma, a rising up against anti-Semitism, against violence, against Jews, against the Roma people, against Arabs. Charlie Hebdo is always in the forefront of all of these battles. I speak both on behalf of my own organization, SOS Racisme, but also for all of the other organizations—we know this.
There are new booksbyCarolineFourest, Charb (posthumously), and Luz. I’ve yet to read these last two, although I’ve read excerpts from Charb’s, but I have read Fourest’s, which was published earlier this week. It gives a good deal of background which would be useful to those trying to sort out their understanding of Charlie Hebdo. But again, I haven’t seen people who were so keen to interrogate CH going out of their way to engage with them.
And guess what? Both Fourest and Charb, as well as others I agree with in general, say several things with which I disagree. There are probably also many individual CH cartoons I’d find cringeworthy or offensive or “problematic” (not the ones I’ve seen shared around, but surely some). And I’ve never seen any representative of CH dismiss that reaction or treat it as invalid. In fact, even in the face of the most vicious attacks and unfair criticisms, they’ve been entirely decent.
As I said at the beginning of this post, my concern here isn’t about any specific content. My idea of what’s decent, as I’ve said all along, doesn’t necessarily concern any particular opinion, but the way in which opinions are reached, expressed, and revised. I think it’s decent, when people have just been massacred, to avoid rushing to judgment about them. To appreciate the limits of our knowledge, recognizing when we might not have the requisite information or skills to form a proper opinion. To hold off on making public suggestions about their motives, actions, or impact until we’ve learned more. To treat the question holistically instead of plucking a handful of superficially questionable images out of context. To approach the matter, not with a prosecutorial zeal, but with a high level of care that we not erroneously smear people (we could still in the end conclude that they’re intentional or negligent racists, but this is different from beginning with this presumption and then expecting to have to be convinced out of it).
To correct previous statements if they prove to have been exaggerated or mistaken, and to correct other people when they make those errors. To apologize if we’ve said something ignorant and potentially damaging. To seek out more information, especially from the people about whom we’re forming our views, and to take that information fully into account. To appreciate that our intentions are (ha – not magic!) irrelevant, no matter how good or well-meaning, if their application is based on misinformation and stubborn ignorance. To recognize that it doesn’t show a weaker commitment to social justice or give comfort to racists to admit that our initial judgments were mistaken in any particular instance.
To proceed otherwise is, yes, offensive and indecent.
* Incidentally, Voltaire’s play Fanaticism was mentioned there. I’ve now read it and have been writing about it: part 1, part 2.
[I know this is a second one: I haven’t posted in a few days and have a bit of a backlog.]
“The more fundamental question is what it means for society, for politics or for personal life stories, to operate according to certain forms of psychological and neurological explanation. A troubling possibility is that it is precisely the behaviourist and medical view of the mind – as some sort of internal bodily organ or instrument which suffers silently – that locks us into the forms of passivity associated with depression and anxiety in the first place.
…
The question of how we explain and respond to human unhappiness is ultimately an ethical and political one, of where we choose to focus our critique and, to be blunt about it, where we intend to level the blame.
…
Treating the mind (or brain) as some form of decontextualized, independent entity that breaks down of its own accord, requiring monitoring and fixing by experts, is a symptom of the very culture that produces a great deal of unhappiness today. Disempowerment is an integral part of how depression, stress, and anxiety arise. And despite the best efforts of positive psychologists, disempowerment occurs as an effect of social, political and economic institutions and strategies, not of neural or behavioral errors.”
(I was expecting something different from this book, and was, in general, pleasantly surprised. I do have some problems with some of Davies’ arguments, particularly as they’re distorted by speciesism. He notes, for example, that Jeremy Bentham, with his emphasis on pleasure and suffering, found sympathies with other animals – who also experience pleasure and suffering – and included them within the sphere of ethics, which Davies seems to regard as (vaguely) positive. But then he goes on to assume that an ethics and public policy that encompasses both humans and other animals necessarily has to be based on a simplified and attenuated vision of humans. Psychological traditions that reduce human experience and needs to pleasure seeking and pain avoidance, to simple calculations of utility, to a one-dimensional material idea of “happiness” are guilty, he argues, of treating humans like animals; a valid psychology would appreciate what’s distinctively human about us – in other words, how we differ fundamentally from all other animal species, including the white rats, dogs, and monkeys on whom psychologists in these traditions have so often experimented.
But this argument has it backwards. Rightly rejecting a ridiculously attenuated view of human psychological experience, it leaves unquestioned a ridiculously attenuated view of the psychological experience of other animal species. A valid psychological-ethical-political approach, in fact, would remain inclusive of other animals. Rather than understanding humans in terms of a degraded view of other animals as mere responders to stimuli, though, it would understand that other animals have emotions, desires, needs, social relationships, and so on. This isn’t a radical view: it was recognized by Darwin and has been extensively documented over the past decades. There’s simply no way human psychology and politics can be approached validly without appreciating it.)
“As a writer whose work is largely predicated on diligent and careful research, I am reluctant to admit that in this case, I didn’t do enough of it before sending my name out into the Cloud. Unfortunately, though, that is the conclusion to which I’ve been forced to come, and I thought it best to acknowledge it publically and head-on rather than disingenuously pretending otherwise.”
I read Epstein’s letter at Ophelia’s blog moments after beginning Caroline Fourest’s new book on blasphemy (released today!). The beginning is about her experience of going to the Charlie Hebdo office in the immediate wake of the attack and learning of her murdered colleagues, and then finding hope in the solidarity of so many in France and elsewhere in the days that followed. Reading that section reignited my anger toward the PEN protesters, but Epstein’s letter has been a salve.
“[I]t was our government that made this very bad arrangement, so the way to fix it is not to ask the CDC to ‘pretty please be more ethical, and avoid conflicts of interest’; rather, as a society, we have to get the government to reject this devil’s bargain, by changing the rules so this can no longer happen.”
“If you want to see just how long an academic institution can tolerate a string of slow, festering research scandals, let me invite you to the University of Minnesota, where I teach medical ethics….”
Robert Whitaker writes about how John Nash’s story has been dishonestly and disrespectfully hijacked in “Reflections on a Beautiful Mind”:
…[A]s our country mourns Nash’s death, I think the story of the movie serves as a reminder of how our societal thinking about psychiatric drugs arises from a narrative that is regularly filled with distortions and misinformation. Think of “drugs that fix chemical imbalances like insulin for diabetes,” and of studies that appeared in the scientific literature during the 1990s that told of how the atypicals were so much better than the first generation of psychiatric drugs, and of Russell Crowe in the movie A Beautiful Mind, and you can see a script that tells of a medical breakthrough and, if truth be told, it is that script that has governed our society’s “treatment” of those diagnosed with schizophrenia for the past 20 years.
“Again and again, proponents of free trade agreements claim that this time, a new trade agreement has strong and meaningful protections; again and again, those protections prove unable to stop the worst abuses. Lack of enforcement by both Democratic and Republican presidents and other flaws with the treaties have allowed countries with weaker laws and standards and widespread labor and environment abuses to undermine treaty provisions, leaving U.S. workers and other interested parties with no recourse.”
