Hoffman and Podgurski: A relatively lawless industry and "meaningful use" of health IT, with safety as an afterthought

In their article "Meaningful Use and Certification of Health Information Technology: What About Safety?" (free PDF here), Sharona Hoffman (Professor of Law and Bioethics and Co‐Director of the Law‐Medicine Center, Case Western Reserve University School of Law) and Andy Podgurski (Professor of Electrical Engineering and Computer Science, Case Western Reserve) make an important case for what I've previously described as "putting the cart before the horse."

At my Oct. 1, 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC" I argued that the IOM was only called in to study HIT safety after plans for national rollout were put into law, and a "stimulus to adoption" (with penalties for refusniks) financed at the cost of tens of billions of dollars.

I found this approach to HIT and the sequencing of events - the development of "meaningful use" criteria before usability and safety criteria - quite cavalier.

Hoffman and Podgurski go a step further.

They begin:

In the summer of 2010, the Department of Health and Human Services (HHS) published three sets of regulations to implement ARRA. This article briefly describes and critiques the regulations, arguing that (1) they fail to appropriately address HIT safety and (2) further steps must be taken to protect patients and serve public health needs in the new digital era.

After a brief review of the Meaningful Use and "Certification" (a.k.a. features qualification) regulations and programs, they go on to critique those regulations and programs as a "step towards comprehensive oversight", but a very deficient step considering the ambitions and timelines of the HITECH act and the federal government.

They aptly note (along with with footnotes):

... While advocates argue that computerization will reduce errors, numerous recent reports have demonstrated that the opposite can be true. Hospitals have experienced incidents in which doctors’ orders were posted to the wrong patient charts and electronic drug orders were not delivered to nurses who needed to dispense them to patients. A published 2009 review of almost 56,000 CPOE prescriptions found that approximately 1% of them contained errors. Patients who do not receive needed medication or whose treatment is otherwise mismanaged because of software or usability problems can suffer catastrophic consequences [my own mother is sadly familiar with this latter problem - ed.]

General system safety is a property that is attainable only through rigorous processes for development and evaluation. [Evaluations of the kind the healthcare IT industry seems to have steadfastly circumvented and avoided - ed.]

However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. [In other words, they are essentially meaningless in terms of HIT safety - ed.]

Furthermore, ATCBs [ONC 'Authorized Testing and Certification Bodies'] will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions. [In other words, a preflight checklist will be conducted of aircraft that have rarely or never actually flown, to declare them flight ready for the amateur pilot - ed.]

They note the obvious:

Meticulous testing of EHR products is critical to their safety. Because of the government’s lucrative incentive payments, many new vendors may attempt to enter the market and to quickly produce EHR systems whose quality is unproven and perhaps dubious.

A key passage in this article is this:

Admittedly, clinical evaluation of new products poses challenges for vendors who would need to find facilities willing to accept the administrative burdens of assessing systems that may ultimately fail. [In other words, it will cost them to improve the safety of their products, a core competency they should have developed decades ago - ed.]

Such facilities would also experience delays in receiving incentive payments because they would use uncertified systems during the evaluation period. However, certification of HIT that has not been thoroughly evaluated is no more responsible than approval of medications or devices that have not been carefully scrutinized by the FDA

"No more responsible than approval of medications not scrutinized by FDA" is quite on target. I personally would use a stronger term than deficient responsibility, however: deliberate reckless indifference to health IT safety seems more descriptive.

The authors do note that:

The delegation of EHR approval responsibilities to ATCBs will ease HHS’s regulatory burdens and likely supply an adequate pool of experts for HIT testing. HHS is authorized to monitor ATCBs through on‐site visits, reports, and review of documentation. It remains to be seen if these measures will ensure that ATCB members are qualified, competent, and free of conflict of interest. These issues will become more critical if HHS eventually requires rigorous clinical testing of EHR systems as described above.

Considering the track record of the pharma and medical device industries as presented in many case examples at this blog, "qualified, competent, and free of conflict of interest" is a tall order indeed for the health IT industry and its "certifiers."

The authors again state the obvious (albeit an "inconvenient truth"):

... it is naive to assume that any use of HIT is better than no use of HIT. [This warning echoes the "use equals success" fallacy as described by Karsh et al. in their recent JAMIA article described here - ed.]

EHR systems constitute complex technology that can introduce errors as well as prevent them. Medical errors can occur because of computer bugs, computer shut‐downs, or user mistakes that may be attributable to a flawed user interface. Through communication tools, electronic ordering, decision support features, and data management, EHR systems will guide many aspects of patient care. Treatment success will often depend on their proper functioning.

They conclude:

HHS’ new regulations constitute positive first steps and a laudable reversal of a relatively lawless approach to EHR system design and deployment. Previously, the only certification program was offered by the Certification Commission for Health Information Technology, a private industry group that was not subject to regulation.

I used terms such as "wild west", "out of control" and "pre-Flexnerian" to describe the HIT industry. That an attorney would use the term "lawless" seems quite fitting to describe similar observations.

Finally, they state:

Still, much more work must be done to protect public health in the digital era. We urge that future meaningful use and certification criteria and the post‐2011 permanent certification program be more attentive to safety issues.

EHR system approval should be no less rigorous than the FDA’s process for drug and device approval because HIT is as safety‐critical for patients. A prime criterion for certification should be a documented history of safe operations in a number of clinical environments.

The federal government would be wise to focus less on the speed of EHR adoption and more on product quality. Only through sufficient safeguards for EHR system safety can this technology fulfill its promise to dramatically improve individual and public health outcomes.

In my opinion, the HITECH timelines are far too ambitious (I sense a similar sentiment "between the lines" in the above passage). Perhaps it's time for those timelines to be revisited.

A new Congress should take that on, or defund HITECH and rewrite it to prevent patient harm and AHLTA and UK NPfIT-like debacles, to save billions of taxpayer dollars we really don't have to spare at the moment.

-- SS

Jane Unrue - To be alive requires that we build a catalogue of like-like images and stolen words and phrases, things we can put to use

Jane Unrue, Life of a Star, Burning Deck, 2010.

“An actress of sorts, a woman recalls her childhood, longs for her absent lover, imagines traveling overseas, and wanders through gardens and galleries of art. Hers is a life meticulously lived, a carefully crafted and rehearsed engagement with a real and imagined world; a search for love and meaning that has left her, in the end, alone. Unrue’s intricate and intriguing sentences — now one word, now comprising whole paragraphs and interrupting one another — manage to fuse detachment and emotion, heartbreak and humor.”

“Artifice is at the heart of Jane Unrue's latest novella, a sequence of short, poetic reflections by an unnamed, lovelorn protagonist. This is not to say that the narrative lacks heart; if anything, this compact tour de force interrogates the truism that art can be either heartfelt or cerebral. The narrator has a passion for theatricality. Her ruminations are peppered with stage directions: " 'You’re right,’ I said (chin tuck), ‘I haven’t told you much about myself’ (syllabic lateral movement of the head on much about myself)." Her episodic memories of lost love share a similar staged quality, as much preoccupied with props as the dramatic action itself: “How I had waited for a moment when the setting and the lighting indicated we had finally found our scene, the scent of roses as if atomized through tiny tubing woven through the fence.” Behind the stagecraft, however, Unrue’s protagonist seems to search for an authenticity that she fails to find in the intimacies we take for granted. Provocatively, Unrue inverts the dichotomy of being on versus off the stage. If the narrator of Life of a Star feels like she is acting her way through life, it’s because so much of it is played out through assigned roles (child, woman, artist). By foregrounding narrative artifice, Unrue suggests new possibilities—both personal and aesthetic—such artifice obscures. The narrator’s comically surreal tryst on a cruise ship, and her memories of her actress mother, are among the most evocative sequences in a narrative that reveals emotional truths rather than evades them.” - Pedro Ponce

“I wish I had a better story for you,” confides the unnamed narrator a third of the way into Jane Unrue’s new miniaturist novel, though there’s hardly cause for so modest a claim. With just over one hundred pages, some of them hosting no more than a wee phrase or the clarion burst of a sentence, and most of them giving out well shy of the bottom margins, the novel, though slender, is emotionally thorough, dense but not crammed, and unnoisily original in the bloodbeat and quiver of its prose.
Unrue writes intricate, ribbony sentences that often reel themselves into the safeholds of eccentrically stacked, unindented paragraphs as lyrically loaded as Joseph Cornell boxes. Sometimes these gracile ribbons get snipped short of tidying grammatical resolution; the narrator, we learn, is in fact something of a mean whiz with a scissors and a knife.
Nearing (or already well submerged in) the loneliness and lovelessness of early middle age, she’s the daughter of a washed-up actress, and though not officially an actress herself, she has discovered the only certain way to insert herself acutely into experience: to regard every instant as an opportunity for performance, for representing herself rather than entirely being herself (and whatever further self-discovery that might finally require). So confused is her life with theatricality that rain falls “as if it had been yanked from buckets poised on rafters up above,” and stage directions are tucked into her thoughts, slipcased between parentheses—“(Full-body modesty)”; “(Mild eyebrow tip)”; “(single-handed heart-grip).” “Since there is artificiality in mere utterance,” she’s convinced she “must live the words.”
But life, as she practices the living of it, amounts to casting herself into an ever-narrowing repertoire of melancholy enactments unfolding mostly in the galleries of a museum (through which, profusely ruffled and garbed in preposterous layerings of underskirts and other costumic outlandishments, she kills hour after hour skulking coquettishly, hoping to pry one or another man loose from an alarmed wife) and by the fountain in a public garden, where she suffers little more than half a dozen rendezvous with, one gathers, her only lover ever, a worldly man who is apparently married (it’s a furtive, futureless courtship). From these outings she returns, unconsoled, to the ticktock isolations of her rented room, where she spinsterishly busies herself with embroidering a bumblebee onto a pillowcase (her goal, fittingly enough, to arrest the buzzy wingbeats into a stitchy stillness) and broods over her rooming-house childhood, during which the arrival of an alluring slip of a girl with dollhouse manners and a goshing vocabulary left her feeling upstaged, driving her to rages of violent jealousy. Her mother admonishingly declared, of all things, “I don’t know who you think you’re fooling with these histrionics.”
But the narrator is scarcely one for foolery. Three-quarters of the way through her account, she brashly encapsulates the desperate program of her life in a dizzying, self-aggrandizing, one-sentence manifesto: “The one who stimulates attraction to herself by molding her complexities to meet a given situation and by demonstrating, at the same time, the effect her having on the situation has upon her own self, wins.” By now, though, she has been rehearsing herself further and further away from the heart-quickening enmeshments of life and deeper into claustral despair. Small wonder, then, that images of graves and buried girls figure so tormentingly in her imagination; it’s as if she wishes to be pulled alive from the burial pit of her part-playing self.
Inviting itself to be read as a phantom refinement of the celebrity-autobiography genre, Life of a Star, direly melodic and winsomely elliptical, belongs in that rich vein of contemporary fiction that forgoes narrative overrun, overmuchness of dialogue, and reportorial sprawl, and instead dispenses itself in slivery, pivotal declarations and gleaming summation. It’s a novel cored to the climactics, the crucialities—and it’s entirely a perfection.” — Gary Lutz


“In Jane Unrue’s third novella an unnamed woman visits galleries, fountains, and piers, and observes the underweight litany of her existence. This is a book to be read all at once with a long evening spreading ahead, in order to best note the slow, dexterous rising of tension, the avid portrayal, and the bare yet startling language. Unrue punctuates the unnamed woman’s thoughts (they occur while she does her needlework, visits the museum’s garden, and wanders in a city where she seemingly has no acquaintances) with muted intensity. Unrue’s sentences are as calm as they are discerning, often running against one another and interrupting in humor and emotion:
'The color of my eyes is something people might not well recall. And though petite, at times I seem
Look how her––!
wonderfully, oddly
She’s not one little bit––!'
Mine is a woman’s face, though something of the child hides back behind the surface of my veering eyes.
Prose vignettes - at times one line takes up a whole page - read like private journal entries, and reveal a woman who is either on the verge of a crisis or has barely survived one. With time we learn the woman is a kind of actress - a failed actress, a closeted actress, a successful actress are all strong possibilities. The woman bitterly recollects a carefree girl from her youth who ended up acting (“I was diminished by her”) and the memory of this girl is followed by a taunting line from an adult, which appears in quotes and occupies a page: “Child, have you ever aspired to perform upon the stage?” These and other tidbits make it clear that once upon a time the woman had wanted to be an actress, and that now she is not (or never was). In fact, the ambiguities regarding the narrator’s occupation and her general background serve to highlight the incandescent and disturbing tension Unrue has created in the narration throughout the book:
'I pick the scissors up. A sparkling vision fills my head, those long-gone Christmas Eves and other nights-before when I would feel the glittering gaze of someone peeking in to see if I was just pretending to be asleep or if I really was asleep. I clip it, thread it, knot it at the end, and tell myself I wonder if I’m acting now.'
We are in limbo, just like the narrator. We find grounding in the woman’s memories of her childhood and of the conversations she once had with her lover. The conversations appear to us snipped, but they are beguiling. The woman and her lover converse on the nature of isolation, their relationship, and sex. That was the woman’s past.
In the present, the woman stares into the eyes of the subjects of Renaissance paintings, she plays a femme-fatale role (self-cast) at a gallery in the museum, and also hires herself for a part she wrote for herself. This last role is a “straightforward though deeply layered story” about a woman who lives in a one-room flat above her mother’s defunct flower shop. The woman acts out the role in a voyage, on a boat deck. Wearing an evening gown and donning a sea-pearl evening clutch, the woman concentrates on her manner and poise. The woman plays the role, rehearsing the execution in grueling and intensive practice sessions, so that “I, please God, might not convey to those around me evidence of jealousy, resentment, malice, desperation, anything.Life of a Star reads as though Marina Abramovic or Allan Kaprow truly succeeded in erasing the lines between art and life - but the result is disturbing. Akin to the hair-rising fear we feel from looking down an abyss, we look upon the nameless woman playing her voyage role, reacting to the passangers on the boat as if her fellow actors, and we wonder how far she will be able to go without finally stepping into insanity:
'Soft blonde hair, her dress black taffeta, a beaded coral cardigan around her shoulders, she moved gracefully, so pretty, and he uttered something to her that I could not understand before I heard him tell her clearly, rather loudly, that he’d screw her (she had downward eyes) until she’s bleed (soft face; not shocked). Then suddenly she ran away.'
The mother-character in me wept for daughter’s bitter disappointment as the father in me shrank in weakness to confront that bastard piece of shit, while she, the woman that I really was
It seems I have no feelings I can call my own.'
Unrue strikes on a narrative drama that is interspersed with ordinary epiphanies, which reveal a life richly lived, but underscored by a quiet, masterful tension. The woman’s triangular connections with the world and her self (when the self she knows is slipping) are utterly intriguing. This is a portrait of a woman entering art and losing herself in it, increasingly unable to find the center of her own emotions. Life of a Star is a book for theorists, art lovers, academics, but mostly general readers who are both grateful and uneasy to find a writer who experiments with blurring the line of art and life.” - Ingrid Rojas Contreras

“Jane Unrue creates a truly riveting novel that brings new perspective on the woman’s search for love, and so much more. “Life of a Star” is a top pick for literary fiction collections.” —Midwest Book Review

“A woman, alone, embroiders a bumble bee onto a pillowcase and, while doing so, she recalls the first play she ever saw, how she once terrified a young rival into leaving town, how she seduced the married man by a public fountain. Life of a Star by Jane Unrue is the story of a woman embroidering her life. The unnamed female narrator reveals to the reader that, though she was never a professional actress, acting has deeply influenced her. As a child she constantly noted the way others were perceived and, in doing so, learned how to control the ways in which she was perceived. Her remembrances are peppered with stage directions, such as in an argument with her mother: “And I hate (looked:sink) you (mirror) too! (Floor.)” Her mother was a professional actress, but the narrator uses the craft of acting as a lifestyle choice rather than a profession. Instead of making money off her acting skills, she makes relationships.
The most emotional recollections are those surrounding an unnamed ex-lover, a married man. These moments, as all moments in the book, are recalled out-of-order, but the encounters with the lover are differentiated in that they are numbered in chronological order: “Encounter number four. ‘You’re right,’ I said, (chin tuck), ‘I haven’t told you much about myself’ (syllabic lateral movement of the head on much about myself).” The narrator uses the same self-employed stage directions with the man she loves and she did with her mother, constantly manipulating the distance between herself and the other through this carefully constructed artifice.
The novel unfolds as a series of disjointed thoughts, images, scenes, and memories. The book is 112 pages long, but may be read in a single sitting. No scene lasts for more than a page and a half, and an entire page may contain only a single sentence:
“It seems I have no feelings I can call my own.”
“New needle. (Bigger eye.)”
“Black satin thread emerges through a tiny hole: beginnings of a body.”
When multiple sentences do appear on the same page the language goes to the opposite extreme, becoming complex and lyrical: “Retracing all your steps along the corridor of trees, to search for an escape look up and see if you can find a dirty-looking star above this dead-eyes image of a garden conjured as if just to keep you from returning to the woman underneath you in your bed and telling her that it was only sadness for the many losses in your life, the many tragedies you’ve see, that caused your gaze to wander toward the wall.” It becomes difficult to get your bearings in a sentence such as that, especially in the middle of a story that is being told unchronologically by an unreliable narrator. It becomes essential, then, to approach the novel as you would a poem, to untether yourself from the presumptions of narrative and allow the sentences to grab you and pull you along like a riptide.
When the narrator decides she wants to close her self-created dramatic distance she finds herself unable to do so, commenting “it’s always stumped me why so many of my very most tender and authentic memories are tangled up with over-practiced words and stiff, exaggerated moves.” Having practiced fake emotion so well for so long, she has robbed herself of the ability to show genuine emotion in a genuine moment. This touches on an even greater question: is it possible to react genuinely once you’ve peered behind the curtain and seen the power of staged drama?
Ultimately, the narrator discovers through her musing both that she desires emotional intimacy and that she absolutely cannot have it. And even as she recalls her life to the faceless reader, she ponders the question, “I wonder if I’m acting now.”” – Dana Norris

“Anxiety suffuses much of Life of a Star, Jane Unrue’s lapidary bloodletting, and much of it is borne from the narrator’s bemoaning of language’s limitations, memory’s imprecision, romance’s sudden changes, and the seeming impossibility of love. The novella, composed of luminous, evocative fragments, is much like a mosaic wall, albeit a ruined one, missing patches of tiles, where the viewer must fill in the necessary blanks. Incredibly perceptive and imaginative, the unnamed narrator elliptically relays her brief moment in the limelight, her strained “encounters” with a lover, her attempted suicide, and her difficulties with finding a language to seam the mangled threads of her life together into some kind of whole:
'No matter how I try to focus motivation, limiting associations, drilling each part of a sentence individually, not too emphatically, it’s always stumped me why so many of my very most tender and authentic memories are tangled up with over-practiced words and stiff, exaggerated moves. For instance, any recollection of a figure standing next to me is so unbearably entwined within the lifting of my hands as if to block the morning light out, that I’m left to pick through words and objects, moments of remembrance, for the slightest hint of anything that I can even begin to recognize as someone close enough to reach.'
It’s a despair familiar to any writer who, continually exploring the vast resources of language, still finds him- or herself incapable of generating the proper vocabulary, syntax, and narratological framework to encompass the baffling complexity of psychological and emotional experience, of pain in all its forms. Emotionally off-kilter, the narrator isn’t satisfied with what she sees, feels, and thinks unless her experiences are given some kind of form or contained in a concrete way. She’s utterly self-conscious and spilling over with doubt: “It seems I have no feelings I can call my own.” Finding “artificiality in mere words,” she feels she must “live words.” Wandering naked in an idyllic scene, she distances herself from her surroundings by wondering how to contain it, capture it, control it: “It was the kind of scene to paint on onion skin, and then to wrap around a lantern, turn it slowly, see the bridge slide into view and out, and my naked body coming, going too.” Oscillating in time, the narrative also sometimes shatters into incomplete sentences, mirroring the narrator’s own fractured perception of both her past and present. And many of these fragments are intruded upon by other voices:
'The color of my eyes is something people might not well recall. And though petite, at times
I seem
Look how her—!
Wonderfully, oddly
She’s not even one little bit—!'
Unrue’s performance is quite arresting, here. Her poetic renderings of consciousness are expertly handled: she carefully maps her narrator’s vacillations and her confused outlook on life; and she harnesses the flotsam and jetsam of external things: the observations and judgments from other people she’s collected over the course of her troubled life. The narrator, embroidering, sewing, and stitching in the midst of her reveries is, at times, overwhelmed by her fanciful surroundings and the gravity of her personal history. Her own expressive inventorying serves as a way of bringing sense to the senselessness in her life: “To be alive requires that we build a catalogue of like-like images and stolen words and phrases, things we can put to use.”
Immersed in these wrenching scenes, where Unrue’s melancholic lyricism overflows, it’s easy to feel like her narrator who, after reminiscing about kissing her lover says, “This was a moment when the image and the words collide, the kind of moment people live for.” At one point, the narrator, embroidering, compiles a wish list of all the things she needs for her craft. This list could also serve as the best summation of how this novella was put together for it, too, is a “catalogue of patterns, stitches, backgrounds, combinations and suggestions, useful bits and pieces, images.” Unrue’s imaginative precision gives way to indeterminacy, clarity to tentativeness, cohesion to dislocation. The events and images in this world are delivered in a sensuous prose that harkens back to Carole Maso, another accomplished master whose prose belies great intelligence, insight, and a willingness to submit to the seductive power of the sentence. Think of Life of a Star, then, as an illuminated viewfinder, one where parallax, ambiguity, blur, and discontinuity may impede immediate recognition, but one which still impresses through the sheer power of its startling imagery and commanding poetics, its accretion of clues and repetitions. In the end, all of the fragmentary, floating images in Life of a Star finally cohere into an enigmatic portrait of a burned out visionary, an object lesson on the fleetingness of desire, of the perpetuity of pain, on the doubtful, but nevertheless worthwhile, possibility that language may bring meaning to life, or, at the very least, help one to endure its vicissitudes.” - John Madera

“arrived the other day courtesy of Waldrop generosity.
I started it tonight and read to page 62, just over half the little novel.
It's quite good.
I was already a fan of Jane Unrue.
Googling her just now, she seems to be a well-kept secret.
For now.
But that situation cannot last when one writes as well as she does.
Jane Unrue reminds me in an odd way of Jane Mendelsohn (I Was Amelia Earhart).
They both write subtle novels composed of almost ectoplasmic prose.
In a weird way, it's like an inheritance of the Jamesian thing (the supernatural James anyway).
But they conveniently clean up his ridiculously Byzantine grammar and tool sentences and paragraphs of much more palatable length.
They keep that Jamesian mystery inherent in grammar itself, but they get rid of the Jamesian sprawl.
I suppose Mendelsohn's vampire novel is a bit slight, but I liked it. She was sort of the literary belwether on that, as vampire erotic lit broke shortly after her first novel along those lines.
But the Amelia Earhart novel was wonderful.
I listed Unrue's book House on my shortlist of "The Ten (or was it Twelve?) Books by Burning Deck Press You Should Own."
This one is about strange-fitting clothes of the erotic.
Also, it is about the torturously well-fitting clothes of jealousy.
Jealousy's ridiculous sartorial splendor.
And the wreckage that follows.
As usual, Unrue shows us that a straight line or direct stare is always the longest distance between two points we are trying to use to reperer in any real investigation of the world.
(Sorry, Kaplan's novel uses the French verb on every other page and now it's stuck in my head!)
Unrue's prose is deliciously Lobachevskian like that.
The irreal is found, as ever, to be more convincing. At least when it comes to that strange creature we call narrative.
She writes very well.
I see I have missed a novel, Atlassed, which came out in 2005, which I will need to hunt down.
And I see she published a novella in the swan song of 3rd Bed, Vincent Standley's wonderful magazine (of which I was happy to be a part on more than one occasion).
I probably actually have that somewhere in this house or the old one.
I'll try to review this when I finish it.
I can already recommend it.
Stylistically, it's that delightful mix of novelistic innovation and unapologetic anachronism--that thing so many contemporary French novelists (yes, P.O.L!) do so well.
P.S. Love Keith Waldrop's cover art for this!” - Willliam Keckler

“Reading Jane Unrue’s novel Life of a Star is similar to the experience of entering a quiet room and seeing the broken shards of a glass figurine lying on the floor and though when seeing the wreckage one is not familiar with what the shards once composed while intact, the essence has not changed—the figurine exists broken, it’s brokenness animated to high art.
The novel is made up of brief sections no more than two pages long. The unnamed female narrator at the center shifts back and forth between childhood and adulthood, between angst and agony, between galleries of art, the sewing of a bumble-bee pillowcase, lovelorn encounters and an early envy for a little girl “…far more likely to dazzle than” she could ever be. She hasn’t always been alone, but she is now.
What does this narrator want? Certainly the title is a wry play on words. The narrator is in an incredible amount of pain. She is a star only in her own multitudinous mind that announces stage directions for her to enact like “(Full body modesty.)” “(Eyes wide.)” “(Repeat for other side; wrist up.)” Her best performances, solo of course, are not attended:
That night, all husbands, wives, long gone, the water was so quiet underneath the little bridge, dark foliage all around, a moon up high, and I was wearing nothing on my body or my head. It was the kind of scene to paint on onion skin, and then to wrap around a lantern, turn it slowly, see the bridge slide into view and out, my naked body coming, going too. p. 94
The “naked body coming, going too” might be the sine qua non of this entire endeavor. The narrator and her stories can’t keep still. She searches, spins and hams her way into a container impervious to other people. Escape, even from such agonies as lovers sleeping with others can never be commensurate with the self-flagellation in its wake:
…I lay there on my bed and wished I had not tried to lift you off my floor and bring you back into the bed…” Don’t tell me that you love me,” you said. He’s already gone, I thought, my gaze up at the ceiling flooded as if by a bucket full of liquid silver pouring down into my eyes and in my mouth. p.71
The last sentence is a Lynchian dissolve, a rainbow shimmer and ungluing of sense that stomps any snaky sentimentality and keeps loss lyrically stifling.
One may wonder what sense this journey into dark sludge has—where is the uplift, where lies redemption? but Unrue has gone into the well many scribblers have spelunked. As in Rilke’s novel The Notebooks of Malte Laurids Brigge, there are mystical childhood encounters, the changing galleries and gardens the narrator wanders through, the bumblebee pillowcase (reminiscent of the mother’s lace), and the concern with how to make prose sing (to be seen shortly). Each also concerns singular narrators who want to be more than they’ve become, but first they must struggle to see the world. Unrue (like Rilke’s directive from the Sonnets to Orpheus) “dances the orange” through a fine needlework of phraseology that takes what is melodrama and heightens it, producing not so much the life of a star, but the scrawl of a poet planting and detonating verbs, adverbs and nouns into sinuous strobes of sound:
No matter how I try to focus motivation, limiting associations, drilling each part of a sentence individually, not too emphatically, it’s always stumped me why so many of my very most tender and authentic memories are tangled up with over-practiced words and stiff, exaggerated moves. For instance, any recollection of a figure standing next to me is so unbearably entwined within the lifting of my hands as if to block the morning light out, that I’m left to pick through words and objects, moments of remembrance, for the slightest hint of anything that I can even begin to recognize as someone close enough to reach. P.104
Her text is the toil that separates her. The narrator is conscious of other ways to communicate but the struggle carries both the singe of the past and the problem of the future. Is there understanding? Is there a way to see truth and breathe into the pain? Unrue’s narrator does plenteous breathwork and the result is a tidy but by no means lean novel wherein the cries to stay private get choked by a willowy wordsmith, a shooting star—shot and fallen.” – Greg Gerke
Jane Unrue, Atlassed, Triple Press, 2005.

“Where does one go after Joyce? This fiction shows the possibility of a way beyond his shadow. Or the possibility of the nutrition that can grow from it. A collection of fictions in Unrue's precise, evocative style with section such as:"Looking Sideways" and "Hands Emerging Out of a Black Background." Perfectbound, with an elegant cover designed by Deron Bauman.”

“Somewhat on the Joyelle McSweeney page maybe, Unrue creates these worlds that exist nowhere but in her books, like little mirrored halls that go on forever, and new new new language mashes, I loved this, 'The Snarl is on the Mask' is one of my new favorite stories.” – Blake Butler

“Jane Unrue's Atlassed has many of the characteristics of a short story sequence, but its carefully composed language recalls the prose poetry of Fred Wah or perhaps Lyn Hejinian. In a sense, Unrue reproduces the peripatetic urban roaming of Paterson or Leaves of Grass—except that the stomping grounds of her metropolitan flaneur is not the city, but the human body itself. The book is composed of a series of prose vignettes, some that are more or less narrative, and others that are more like stylistic improvisations, or prose poems that read like grab-bags of linguistic synergy. The result is both a mapping and an erotics of the body, as indicated by the evocative chapter headings (eg. "Brow and Chin Variations," or "Topmost Portion of the Forehead, a Common Omission"). These headings supply in large part the "unity" of this book, which attempts to nominally fasten these evocative if not necessarily transparent prose pieces to a conceptual map of the body which though present, hovers just beyond our comprehension.
At first, the separate chapters seem thrown together, ill-fitting lyric improvisations, voiced by different speakers on different topics. By the end of the book, what unites these pieces becomes much clearer—a kind of aesthetics of dissection, a discomposition of the elements of the body and a re-rendering of the human form as mosaic. This is elegantly expressed in a phrase that I read as a sort of mission statement for the book, from a section titled "A Neatly Folded Pile of Clothes" (a title at once evocative and ironic):
That same day I'd seen a temporary residence designed by different architects to occupy a plot of land devoted to the exhibition of new works of art. Each architect had been assigned a portion of the residence; they brought their portions in by truck, then everything got put together. That the pieces did not fit and that the residence looked unappealing was, I guessed, supposed to be the beauty of it. (134, emphasis added)
Perhaps this in part explains the continual linkage between love and violence in Atlassed, since one of the questions this book repeatedly asks is whether there is "any sort of line dividing deep-felt pleasure from the icy horror of a white-hot violent encounter?" (110). And this is in a sense, the exact experience of reading Atlassed; it is full of sequences that are at once erotic and horrifying, others that are evocative and enigmatic. Moreover, Atlassed always creates the sense that a greater conceptual unity exists, and that we are doomed to desire it forever. In "Table, Heart, Breasts, Kidneys," Unrue suggests that even a family on a road trip may feel an unrequited desire for a map, to render the events of their life, their stubborn anomie in the face of absolutism, easier to comprehend:
A sense of loss like nothing ever known is passed from family member on to family member in the car, each person holding fast to something: steering wheel, a seatbelt buckle, handle on a door. A slippery drop of rain has hit the windshield, and the father conjures up an image of two massive feet of stone adhered for centuries to the ground. (119)
The family knows that "mapping" is an impossibility, and that any attempt at its broad, totalizing vision will result in an image that is incomplete, disorienting. Unrue goes on to say that
This miracle, this nightmare, this at once so terrifying and enchanting scenic drive—it winds from left to right across the outer portion of the mighty granite wall, diminishing the sense of trust felt by the mother and the children toward the car, the tires, and the ability of the man behind the wheel to keep the car from swerving suddenly and plowing through the railings in the road. (119)
In the end, the book is a sort of revelation in reverse—Unrue brings the veil of language between the reader and the illusion of realism, suggesting dark and frightening possibilities beyond our ken that are at the same time exhilarating. Like the "leafy vines" in "Passion (Asleep)," Atlassed "rocks you in the manner of the darkest pleasures you have yet encountered" (155). Reading Atlassed is at times mystifying; but in the end, its alchemic blend of imminent horror with immanent revelation and its apocalyptic mixture of mystery and desire, create a dark and evocative beauty that is both enigmatic and enlightening.” - Gunnar Benediktsson
Jane Unrue, The House, Burning Deck, 2000.

“A woman wanders from room to room, or ventures outside, and throughout the ensuring procession of locations, ruminations, or dreams, is transported into the past, or to a love affair, or a marriage, or into the future, or to an ending, perhaps her own."

“Jane Unrue's extraordinary prose unfolds within the confines of a mythological house: I used to walk when the moonlight was just enough to make the metallic structural elements (the rest of the house as if missing) appear to be coming at me from all sides. 'I know those door frames and window frames are not really coming at me,' I remember saying, 'but it sure does look as if they are.' In restless, suspended sentences that seem to push closure beyond the horizon, a woman wanders from room to room or ventures outside.”

"Quietly plumbing the intimacies of architecture, landscape, and domesticity, Jane Unrue's debut, The House, develops a muted intensity through serial blocks of meditative prose... Displaying the influence of writers as diverse as Wittgenstein, Bachelard, Charles Olson and Mei-mei Berssenbrugge, Unrue successfully forges an evocative approach that could be seen as metacubist in its dizzying, varied takes of the familiar world." - Publishers Weekly

GlaxoSmithKline Subsidiary Pleads Guilty to Manufacturing Adulterated Drugs: Three Strikes and ...?

Paxil

First there was Paxil (Seroxat in the UK, or paroxetine), the anti-depressant whose marketing lead GlaxoSmithKline (GSK) to settle allegations of fraud brought by then New York Attorney General Elliott Spitzer in 2004.  That case included allegations of suppression and manipulation of clinical research, and was discussed in great detail in the book Side Effects by Alison Bass.  We posted about various aspects of this case, e.g., more recently here, here, and here

Avandia

Then there was Avandia (rosiglitazone), the anti-diabetic drug whose use was just restricted by the US Food and Drug Administration.  This GlaxoSmithKline product inspired a "spin cycle" which provided us with endless grist for the Health Care Renewal mill.  A good summary of the case appeared in September in the British Medical Journal (Cohen D. Rosiglitazone: what went wrong: Brit Med J 2010; 341: 530-534.  Link here)  Once again, it appears that research was suppressed and manipulated (e.g., see here), Avandia critics were attacked by "experts" whose financial relationships with GSK were not always obvious (e.g., see here), and there were allegations that GSK executives tried to intimidate those who disagreed with them (e.g., see here and here). 

Adulterated Drugs

And now it is adulterated drugs.  Here is the version from Bloomberg:
GlaxoSmithKline Plc, the U.K.’s largest drugmaker, will pay $750 million to settle a U.S. whistleblower lawsuit over the sale of defective drugs.

Glaxo and the U.S. Justice Department announced the agreement yesterday, resolving a false-claims lawsuit first filed in 2004 by Cheryl D. Eckard, a former global quality assurance manager for the London-based company.

'This is not something I wanted to do, but because of patient safety it was necessary,' Eckard, 51, told reporters following a Justice Department press conference in Boston. As a whistleblower, she will receive $96 million from the settlement money.

Glaxo was accused in court papers of selling tainted drugs under false pretenses. The medicines, made at a Glaxo plant in Cidra, Puerto Rico, were misidentified as a result of product mix-ups, according to papers filed in federal court in Boston. The affected drugs included the antidepressant Paxil CR and the diabetes treatment Avandamet. [Note that this is a combination drug that includes Avandia - ed]

The settlement includes a criminal fine and forfeiture totaling $150 million and a $600 million civil settlement under the False Claims Act and related state claims, the Justice Department said in a statement.

'We will not tolerate corporate attempts to profit at the expense of the ill and needy in our society -- or those who cut corners that result in potentially dangerous consequences to consumers,' Carmen M. Ortiz, the U.S. Attorney in Boston, said at yesterday’s news conference.

SB Pharmco Puerto Rico Inc., a Glaxo unit, agreed to plead guilty to charges relating to the manufacture and distribution of adulterated drugs made at the now-shuttered plant, the Justice Department said. Glaxo said in July it had agreed in principle with the U.S. to pay 500 million pounds ($791 million) to resolve the investigation.

'We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice requirements and with GSK’s commitment to manufacturing quality,' PD Villarreal, a Glaxo senior vice president, said in an e-mailed statement.

Eckard’s take is the largest ever for a single whistleblower, said Patrick Burns, spokesman for Taxpayers Against Fraud, a nonprofit Washington group that publicizes the use of legal means to combat fraud against the U.S. The federal government will receive $436.4 million from the settlement and participating states will split as much as $163.6 million, the Justice Department said.

Other drugs made at the plant include Kytril, an anti- nausea medication, and Bactroban, an ointment used to treat skin infections, the Justice Department said.

'The false claims arose out of chronic, serious deficiencies in the quality assurance function at the Cidra plant and the defendants’ ongoing serious violations of the laws and regulations designed to ensure the fitness of drug products for use,' the government said in court papers.

The U.S. Food and Drug Administration in 2005 seized some Paxil CR lots after it was discovered that the pills sometimes split inappropriately, according to court papers. Some of the pills lacked an active ingredient.
It seems that not only questions about GSK sponsored clinical research about and GSK marketing of Paxil and Avandia, but the company has problems even supplying tablets that contain the pure drugs at the right dose.
Summary and Discussion

First, this is another dreary marcher in the parade of legal settlements that we have now been chronicling for years. This case has some particular features. It included a guilty plea to a crime. Although the allegations included fraud, the fundamental problem seemed to be the selling of adulterated, impure drugs.

So my first comment is that this is the latest instance of a major pharmaceutical company not being able to fulfill its most basic responsibility and reason for being, the manufacture of pure, unadulterated drugs. We previously discussed problems with adulterated drugs made by Baxter International and Johnson and Johnson. We have discussed, seemingly endlessly, how big health care corporations, including but certainly not limited to pharmaceutical companies, have engaged in various sophisticated deceptions involving marketing and clinical research to sell more products at higher prices. Now it seems that while these companies have put so much of their resources into marketing and public relations, not necessarily in honest ways, they have neglected to put the necessary expertise and resources into their most basic manufacturing functions.

So while drug industry sycophants prattle on endless about life-saving innovations, not only have industry marketing and research become less trustworthy, but now we cannot even trust the companies to supply the drug that is on the label in a pure form at the labelled dose.

My next comment is that this is the third big case involving GlaxoSmithKline reported in the last few years. (Although, like the previous cases, the events that lead to recent relevations actually occurred over the last 10+ years.) This would suggest that there is a serious problem with the culture, leadership, and governance at this corporation.

Maybe one reason such problems are allowed to fester is that in the current case, like the last two involving GSK, and as is typical for the legal settlements and crimes we have discussed before, no individuals who authorized, directed, or implemented the problematic behavior seem to have suffered any negative consequences or paid any penalty. In fact, the Guardian just pointed out:
Five of the six senior GlaxoSmithKline executives cited by a whistleblower as part of a cover-up of contamination problems at the group's Puerto Rico factory are understood to still be employed by the pharmaceuticals company.

Cheryl Eckard, who was sacked by the company as a quality control manager in 2003 after repeatedly raising her concerns with a series of GSK executives, received a $96m (£61m) reward this week as part of a $750m criminal and civil settlement between US regulators and the company.

Her evidence stated that she believed company executives refused to acknowledge the gravity of the production violations – which included the wrong strength of pills being shipped – because it would delay the approval of two new drugs by the US Food and Drug Administration.

The court documents allege that Eckard, who had recommended the factory be shut until the issues were resolved, communicated the quality violations at the plant in Cidra to David Pulman, president of global manufacturing and supply; Janice Whitaker, senior vice president of global quality; Peter Savin, vice president of global quality assurance; Diane Sevigny, director of global quality assurance, risk management and compliance; and Jonathan Box, vice president of manufacturing and supply for North America.

All five executives are believed to be still working for the London-listed company, while Pulman is also a member of the company's 18-strong corporate executive team, which includes chief executive Andrew Witty.

As we have said endlessly, penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue. 

When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.  Further, expect organizations that did not uphold high standards in one instance to fail to uphold them in other instances.

See also comments on the Postscript blog.

Adam Levin reminds us that discovering you might be the messiah would be both a holy and hilarious thing: 'War and Peace' in middle school

Adam Levin, The Instructions, McSweeney's, 2010.

"Beginning with a chance encounter with the beautiful Eliza June Watermark and ending four days later with the Events of November 17, this is the story of Gurion Maccabee, age ten: a lover, a fighter, a scholar, and a truly spectacular talker. Ejected from three Jewish day schools for acts of violence and messianic tendencies, Gurion ends up in the Cage, a special lockdown program for the most hopeless cases of Aptakisic Junior High. Separated from his scholarly followers, Gurion becomes a leader of a very different sort, with righteous aims building to a revolution of troubling intensity. The Instructions is an absolutely singular work of fiction by an important new talent. Combining the crackling voice of Philip Roth with the encyclopedic mind of David Foster Wallace, Adam Levin has shaped a world driven equally by moral fervor and slapstick comedy—a novel that is muscular and rollicking, troubling and empathetic, monumental, breakneck, romantic, and unforgettable."


"This novel is beautiful and warm-hearted, yet at the same time terrifying and may betray you as you turn any page. Here is a book that will haunt your thoughts long after you've closed its covers and will have you longing to discuss just exactly what happened. Adam Levin will be compared to literary wunderkinds of days gone by, but do not be fooled: he is a standalone original, and the bona fide next big thing." — Jamil Zaidi

"The Instructions is brilliant. A virtuoso literary performance that is wildly entertaining from beginning to end (page 1 to page 1024). It is ambitious, provocative, touching, hilarious and sad. The experience of reading this novel is exhilarating and extremely powerful." —Ed Conklin

"The Instructions is a sizzling fire-cracker of a book. Readers beware: you will not be able to put this book down, you will not be able to get ten-year old Gurion Maccabee's fevered voice out of your head, and you will not be able to read anything else for like six months without thinking back to this book. The Instructions is a thrilling hurricane of an epic—1,000 pages that takes places over a mere four days—and it will chew you up and spit you out and you will be better for it." — Rachel Meier

"The Instructions inverts the world; the deeply human concerns—love, war, religion, power, morality—are recast in a junior high setting. But these issues are by no means lessened in Levin's novel—on the contrary, the reader becomes more acutely aware, perhaps even less jaded, by the weird juxtaposition. Gurion ben-Judah Maccabee (budding Hebrew messiah and revolutionary) is devastatingly romantic, wise, innocent, conniving, pugilistic, and intensely funny. His family, friends and enemies, and teachers (who are sometimes a bit of both) are all fully realized. Stories run like filigree through The Instructions, adding to the Epicness, but Levin always brings us back to Gurion and his conflicts and machinations... Yes, The Instructions is a Big Fat Book, the kind you kill vicious marsupials with, prop a door, or block a bullet; it can intimidate, and perhaps cause a wrist injury, but as may not be the case with other BFBs, this sprawling novel is a delightful reward; diving into it feels like an indulgence, and the inappropriate-laughter-on-public-transit moments feel like revenge upon a bland, workaday world. I love books like this: just the right amount of clever & inventiveness; compelling narratives; a questing and questioning nature; how it expands the emotional range with which one interacts with literature. There's so much to say about The Instructions, and it's hard to know where to stop. I could be succinct and say, 'This is War and Peace in middle school, filtered through Roth, Bellow, and Scheherazade', but I think I just threw up in my mouth a little." — Vlad Verano

"The Instructions is brilliant: genuinely funny, genuinely compelling. It's unique and intriguing. I find myself wanting to tell people about it every day. I haven't loved a book this much since I discovered Gary Shteyngart, lo those many years ago." — Catherine Weller

"I know what it’s like to believe a thing that lots of people think is crazy to believe. In my case, it is that there is a God, that that God has a Son, and that that Son died and then, three days later, wasn’t dead anymore. It is the craziest thing that I believe wholeheartedly.
I mention this, because it shapes how I come at a book like Adam Levin’s The Instructions. That isn’t to say that you have to be religious or even to believe in God to enjoy it. You don’t. But it made me empathize with Gurion Macabee (a boy who may or may not be the messiah) all the more. This is the story of a boy who struggles to know what it is he’s meant to do and who it is he’s meant to be. A boy who feels a high degree of confidence that he is the messiah, but a willingness to admit that he can’t really know until he knows. You know?
It’s that kind of struggle, a knowing unknowing, that make faith the exciting adventure that it is. I’m pretty sure I’m right… but what if I’m wrong? I have to live into the truth of what I believe in order to discover whether it is true, but what if I give my whole life to that truth only to discover it’s a lie? This is the risk of faith. To watch that risk play out in the life and mind of a twelve-year-old boy is a marvelous and sometimes frightening thing.
And kudos go to Adam Levin for delving so deftly into the heart and mind of a twelve-year-old boy. Levin captures the thoughts patterns, the voice patterns, the confidences and lack of confidence. Twelve is an age that is wrought with insecurities and yet an age when our sense of what is right and true can be unshakable. An age when we’re never more sure of our own righteousness, even if we aren’t always sure that we’re right. This is what Gurion wrestles with and we wrestle along with him.
The Instructions is brilliant for a lot of reasons; the main one being that Levin leaves room for us to draw our own conclusions. No two readers will feel exactly the same way about this story and its protagonist. Some won’t agree at all. Some will dismiss Macabee as misguided, others will find that more difficult to do. Some will simply call him “crazy.” others will be reminded of the “crazy” things they themselves believe. Hopefully, all will be challenged to think and to feel and to wonder.
And, if this sounds like a story so epic as to be daunting (the 1000+ pages may feel daunting as well), it is also worth mentioning that The Instructions is funny. Sometimes it’s wry and sometimes ridiculous. Sometimes the chuckle comes with an ache and sometimes a guffaw bursts through.
This, again, is why The Instructions is brilliant. Levin reminds us that discovering you might be the messiah would be both a holy and hilarious thing. By doing so, even his moments of irreverence are imbued with a kind of reverence. It makes for a powerful story, one I am confident that you will enjoy." - Kester Smith

"If The Anarchist's Cookbook provided recipes for potent literature, Adam Levin's The Instructions would be in there, a feast for the Che Guevara shirt–wearing, pissy, lovestruck kid in all of us. Yet Levin's massive novel—his first, on which he spent around a decade working—is assembled with stock-shelf ingredients.
Among them: the rebellion parable of Animal Farm, with after-school detention monitors replacing Orwell's dictatorial barnyard traif. Fistfuls of Robert Cormier's bittersweet Chocolate War dystopia and the poetic pidgin of S.E. Hinton's The Outsiders. Dashes of Philip Roth and pinches of Vonnegut, both of whose works are directly referenced. The entire thing is finished with a glaze of Joseph Campbell and served by Dave Eggers (published by McSweeney's, it basically is). Essential to The Instructions' success is the careful moderation Levin took with his influences. They're not distracting.
The novel is a "scripture" written by the Judaism-obsessed, prodigal, possibly messianic 10-year-old Gurion Maccabee, who has skipped almost as many grades as the schools he's been kicked out of for fighting. Gurion, waiting to see his principal after yet another fight, meets and falls in love with a pretty classmate. It's the first step of a hysterical, heartfelt journey of self-discovery, perpetually foreshadowed by an inevitable climax: the adolescent-lead revolution against the Powers That Be (mainly, the public school system). Each half of The Instructions is devoted to two different days, with the occasional flashback or historical aside, the writing catching the way kids slowly watch the world tick forward. Yet the thousand-page youth-in-revolt epic flies by.
The result? A book that moves beyond completely transparent influences to reach its own distinct, new, great height. Finding out whether or not Gurion is the messiah pales to watching Levin earn him his rightful place alongside Holden Caulfield, Harry Potter, Pony Boy, and every other classically young, angry character who's fought to change his or her world, whether or not they succeeded." - Kamer Foster

THAT'S EDUCATION!

THAT’S EDUCATION!

You can’t make this stuff up.

This week I received a cheerful E-mail from a well known academic key opinion leader or KOL. Only the E-mail didn’t really come from Dr. Ian Cook at UCLA. It really came from a company called PeerView Institute for Medical Education. The E-mail offered on-line CME content with the topic Essential Aspects to Building a Therapeutic Alliance Between Patients and Practitioners for the Treatment of Mood Disorders. Whenever I see an anodyne title like that I know there’s trouble ahead.

The content came in the form of a dialogue between Dr. Cook and another well known academic KOL, Dr. Michael Thase from Penn. Beneath two prominent corporate logos, a disclosure stated This activity is supported by educational grants from AstraZeneca LP and Lilly USA, LLC. Another disclosure stated This CME/CNE/CPE activity is jointly sponsored by Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. The program also states This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Purdue University College of Pharmacy and PVI, PeerView Institute for Medical Education. Purdue University College of Pharmacy, an equal access/equal opportunity institution, is accredited by the ACCME to provide continuing medical education for physicians.

I happen to know Dr. Cook and Dr. Thase, so already I am thinking why are these productive academic researchers from first tier universities doing a yawner CME gig like this? Then I get it. Most academic physicians have been told by now that they may no longer speak for hire at dinners and events sponsored by Pharma. You know, the sort of thing that Charles Nemeroff tried to pass off as CME-like, only Senator Grassley wasn’t buying it. So now the action has moved to commercial CME activities that carry the imprimatur of ACCME, thus confirming the principle that the flow of marketing money must find an outlet.

My jaundiced view of ACCME’s performance and credibility is a matter of record. For that matter, I am on record with a jaundiced view of the entire CME business. Here is what I said back in 2008.

…Continuing Medical Education (CME) is a second front in the campaign to expand (drug markets). The standard formula calls for corporate sponsorship channeled through an “unrestricted educational grant” to a medical education communications company (MECC). The MECC employs writers to prepare the “educational content,” and academic KOLs are recruited to deliver this content. The KOLs are chosen for their willingness to be “on message” for the corporate sponsor. If they go “off message” they know they will not be invited back. The talk of “unrestricted grants” is window dressing. The MECC also secures the imprimatur of a nationally accredited CME sponsor, typically an academic institution. The sponsor is paid to certify that the CME program meets the standards of the Accreditation Council on Continuing Medical Education (ACCME). Everybody turns a buck: the MECC and its staff are handsomely paid (CME is now a multi-billion dollar business); the KOLs are generously rewarded with honoraria and perquisites; the academic sponsor is well paid by the MECC; the ACCME receives dues from the academic sponsor; the audience obtains free CME credits rather than having to pay for these required educational experiences; and the corporate sponsor gets what it considers value for its marketing dollar.

So, I approached this free on-line CME offering with a good deal of skepticism. Most of the content was pedestrian and scripted – not because these KOLs couldn’t have done better but because someone at the MECC scripted it for them. Someone at the MECC also put the slides together, about which more in a moment. The material was formulaic, a succession of clinical banalities accompanied by Power Point slides that said everything and nothing. I cannot imagine that a physician would learn anything substantive from these educational tropes.

The impresarios at PeerView Institute for Medical Education, funded by Lilly and AstraZeneca, came through with the desired spin. The corporate sponsors obtained the soft messaging they wanted. Their products olanzapine and quetiapine were not promoted overtly, but it was surely gratifying that the content emphasized the accepted place of such second generation antipsychotic drugs as a class in mood stabilization for bipolar disorder and in augmentation for nonresponsive major depression. This soft messaging was delivered with the appearance of authority, within a package of algorithms, strategies, Venn diagrams, and measurement tools that featured potential upsides but gave hardly a nod to the worrisome side effects of such drugs, especially in depressed patients . And it surely was no accident that the sponsors’ drugs appeared as exemplars in slides and in the follow-up questions – another form of soft messaging.


Finally, I came upon incontrovertible evidence that these KOLs did not prepare the educational content of the program. A slide that discussed antidepressant drug options contained a panel dealing with the MAO Inhibitors (MAOIs). This class of antidepressant drug appeared in the 1950s, and MAOIs still have a limited place in clinical practice. The information given about the MAOI drugs in the enduring material (slide) of this program, however, is dated, inaccurate, and dangerous. Here is the relevant section of the slide.

CLASS
MAOIs (eg, benmoxin, hydralazine phenelzine, pheniprazine)

EFFICACY
↓ efficacy compared to TCAs 4

COMMON SIDE EFFECTS
• Drowsiness, dizziness, loss of visual acuity, GI side effects, insomnia, irritability 4

What’s wrong with this? Plenty. Benmoxin has never been marketed in the US and was discontinued in Europe many years ago. Hydralazine is not an MAOI but an antihypertensive agent. Pheniprazine was discontinued many years ago due to marked toxicity. Meanwhile there is no mention of tranylcypromine or selegiline or moclobemide, which are in current use. The listing of hydralazine, which has no antidepressant activity, is especially dangerous. Likewise, the laundry list of side effects manages to omit the single most important problem with the MAOI class – potentially lethal dietary and drug interactions.

There is only one way to say it – this educational content is incompetent, reckless, and dangerous. I know both the KOLs well enough to be certain they would never develop such educational content themselves. So, who did develop it? Some functionary at PeerView Institute for Medical Education, who had no clue what s/he was doing. Compounding the problem, the Purdue University College of Pharmacy waved through this incompetent material for CME credit. If the Purdue University College of Pharmacy wants to provide continuing education for pharmacists, fine. But I draw the line at allowing an institution that does not train physicians to provide continuing education for physicians. I do not understand why this is permitted by ACCME. On the evidence of this program, the Purdue University College of Pharmacy lacks the expertise to provide continuing education for physicians.

The standard is simple. The standard is not ‘we try to ensure accuracy’… the standard is we get it right – that’s what our role models teach us in medical school and residency training. These KOLs are accountable for the reckless errors in this content because they allowed their names to be featured as the authorities. Plainly, they did not develop the educational content and they did not take the time to review the enduring materials as their accountability required.

Why have the deans of US medical schools not banned academic physicians from participating in such commercial CME gigs? It is no secret how phony these events are. Why not help these busy academic clinical scientists to maintain their focus by limiting them to educational programs at academic medical centers and at meetings and functions genuinely sponsored by professional medical societies? As the present example shows, anything else is business as usual under cover of a fig leaf.

I want to be clear that I have enjoyed friendly relationships with Ian Cook and Michael Thase for a long time. It’s not personal, it’s about standards and it’s about tradecraft. If academic KOLs are too busy to maintain standards and tradecraft then they should pass up these educational charades. For shame, guys.

Bernard Carroll

RUC It Up - How the US Government Fixes Physicians' Payments Becomes Less Anechoic

We have frequently posted, first here in 2007, and most recently here and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC. 

Since 1991, Medicare as set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort the expend, and the resources they consume on particular patient care activities.  Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care, vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1)  A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, understanding patients' values and preferences, when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients. 

As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.


To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership as at best relatively opaque.

To expand on the ultimate point, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."

The fog surrounding the operations of the RUC seems to have affected many who write about. We have posted (here, herehere, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until now in 2010, after the US recent attempt at health care reform, the RUC seems to remain the great unmentionable. Even the leading US medical journal seems reluctant to even print its name.

That has just changed.  A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser yielded two major articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted by Kaiser Health News.)  The articles cover the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc.

So the RUC has suddenly become less anechoic.

However, despite the best efforts of some very good investigative reporters, there still are important unanswered questions, questions we have raised before:
  • How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
  • Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
  • How did the RUC become de facto in charge of this process?
  • Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
  • Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
  • Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?
Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them?  If we do not fix them, do we really think we can "bend the cost curve?"  If we do not control our costs, do we really think that we will be able to make good health care accessible for all?  At least now I can say that the issue may really be in play for health care professionals, health care policy experts, and the public at large.
See also comments on other blogs: DBs Medical Rants, GoozNews, and Managed Care Matters.

ADDENDUM - Additionally, see comments on the Retired Doc's Thoughts blog, and the Running a Hospital blog.

References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)

2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)

Not "the Best and the Brightest" - Drug Marketers and the Creation of "Thought Leaders"

A combined investigative reporting effort by Pro Publica, partnering with the Boston Globe, Consumers Reports, the Chicago Tribune, National Public Radio, the Public Broadcasting System on seven major pharmaceutical companies' payments to doctors who make speeches on the companies' behalf has gotten a lot of press.  It inspired several separate reviews by news organizations in ColoradoIllinoisMinnesota, Ohio,Washington, etc on local doctors who were paid to talk.  Many of my fellow health care skeptic bloggers, including the Carlat Psychiatry Blog, Hooked: Ethics,Medicine and Pharma blogthe Health Beat blog, have been all over this story.

Yet I think it is reasonable to underline three important points.

Not the Brightest

Pharmaceutical and other health care corporations are fond of saying that the doctors they hire to give talks are the "best and the brightest," thought leaders respected by other physicians.  In fact, the lead article by Pro Publica suggested that some of these supposed "best and the brightest" have dubious credentials, indeed.

Some were not board-certified, and lacked credentials suggesting great expertise:
Among the top-paid speakers, some had impressive resumes, clearly demonstrating their expertise as researchers or specialists. But others did not –contrary to the standards the companies say they follow.

Forty five who earned in excess of $100,000 did not have board certification in any specialty, suggesting they had not completed advanced training and passed a comprehensive exam. Some of those doctors and others also lacked published research, academic appointments or leadership roles in professional societies.

In summary,
Pharma companies often say their physician salesmen are chosen for their expertise. Glaxo, for example, said it selects 'highly qualified experts in their field, well-respected by their peers and, in the case of speakers, good presenters.'

ProPublica found that some top speakers are experts mainly because the companies have deemed them such. Several acknowledge that they are regularly called upon because they are willing to speak when, where and how the companies need them to.

Not the Best

Worse, some of the pharmaceutical paid speakers had records of ethical problems.
A review of physician licensing records in the 15 most-populous states and three others found sanctions against more than 250 speakers, including some of the highest paid. Their misconduct included inappropriately prescribing drugs, providing poor care or having sex with patients. Some of the doctors had even lost their licenses.


More than 40 have received FDA warnings for research misconduct, lost hospital privileges or been convicted of crimes. And at least 20 more have had two or more malpractice judgments or settlements. This accounting is by no means complete; many state regulators don’t post these actions on their web sites.

The Pro Publica story lead with three disturbing anecdotes:
The Ohio medical board concluded [1] that pain physician William D. Leak had performed 'unnecessary' nerve tests on 20 patients and subjected some to 'an excessive number of invasive procedures,' including injections of agents that destroy nerve tissue.

Yet the finding, posted on the board’s public website, didn’t prevent Eli Lilly and Co. from using him as a promotional speaker and adviser. The company has paid him $85,450 since 2009.

In 2001, the U.S. Food and Drug Administration ordered [2] Pennsylvania doctor James I. McMillen to stop 'false or misleading' promotions of the painkiller Celebrex, saying he minimized risks and touted it for unapproved uses.

Still, three other leading drug makers paid the rheumatologist $224,163 over 18 months to deliver talks to other physicians about their drugs.

And in Georgia, a state appeals court in 2004 upheld [3] a hospital’s decision to kick Dr. Donald Ray Taylor off its staff. The anesthesiologist had admitted giving young female patients rectal and vaginal exams without documenting why. He’d also been accused of exposing women’s breasts during medical procedures. When confronted by a hospital official, Taylor said, 'Maybe I am a pervert, I honestly don’t know,' according to the appellate court ruling.

Last year, Taylor was Cephalon's third-highest-paid speaker out of more than 900. He received $142,050 in 2009 and another $52,400 through June.

It also included:
The Medical Board of California filed a public accusation against psychiatrist Karin Hastik in 2008 and placed her [8] on five years’ probation in May for gross negligence in her care of a patient. A monitor must observe her practice.

Kentucky’s medical board placed Dr. Van Breeding on probation [9] from 2005 to 2008. In a stipulation filed with the board, Breeding admits unethical and unprofessional conduct. Reviewing 23 patient records, a consultant found Breeding often that gave addictive pain killers without clear justification. He also voluntarily relinquished his Florida license.

New York’s medical board put Dr. Tulio Ortega on two years’ probation [10] in 2008 after he pleaded no contest to falsifying records to show he had treated four patients when he had not. Louisiana’s medical board, acting on the New York discipline, also put him on probation [11] this year.

Yet during 2009 and 2010, Hastik made $168,658 from Lilly, Glaxo and AstraZeneca. Ortega was paid $110,928 from Lilly and AstraZeneca. Breeding took in $37,497 from four of the firms.

The Biggest Prescribers = "Thought Leaders"

An accompanying NPR story suggested that most physicians are recruited as speakers because they are big prescribers of the drugs the companies want to market, with the expectation that they will be even bigger prescribers once they start giving paid talks. Furthermore, the companies' representatives use a carefully programmed psychological strategy to allow the physicians they recruit to think they are being paid as "thought leaders" to give educational talks.
Drug companies train representatives to approach a narrow set of doctors in a very specific way, using language that deliberately fosters this idea that the doctors who speak are educators, and not just educators, but the smartest of the smart.

For example, every drug representative interviewed for this story used the exact same phrase when approaching a doctor with a pitch to become a speaker: Each doctor approached to speak was told that he was being recruited to serve as a "thought leader."

This phrase, Webb says, seems to have incredible psychological power.

'When you do say 'thought leader' I think it's a huge ego boost for the physicians,' Webb says. 'It's like a feather in their cap. They get a lot from it.'

This is because most doctors have a very specific idea in mind when you ask them what constitutes a thought leader. Most doctors, including Clawson, cite two important qualifications. 'First, the other doctors in the community respect that person's opinion,' Clawson says. 'And the other way to become a 'thought leader' is to become an academic researcher and try to push the bounds of science further, and then by definition you're a thought leader.'

But some drug representatives, like Maher, have a more cynical view of why drug companies choose the doctors they choose. It's not about how well respected the doctor is, according to Maher; it's about how many prescriptions he writes.

'I think nowadays a thought leader is defined as a physician with a large patient population who can write a lot of pharmaceutical drugs. Period,' she says.

These "thought leaders" may find it comfortable to think that they are paid as experts to give educational talks, but really, they are paid to persuade themselves to prescribe more. If audiences prescribe more, it's just a bonus.
This doesn't mean that every doctor recruited is not a high-quality doctor. Many are. But every representative NPR spoke to had a stable of stories about profoundly unimpressive doctors that they'd recruited as thought leaders essentially for the same reason that a robber robs a bank: because that's where the money is.

The fact is that the top 20 doctors in a representative's territory prescribe the vast majority of the medication. According to Webb, the top 20 percent prescribe as much as the lower 80.

So if you want to sell more of your product, and every representative is required to sell more, those are the physicians to target.

Which brings us to the hard reality about doctor speaking: Although doctors believe that they are recruited to speak in order to persuade a room of their peers to consider a drug, one of the primary targets of speaking, if not the primary target, is the speaker himself.

That's where reps look for a real increase in prescriptions — after a speech.

Here's how the money works out, at least for Webb. It's hard to know whether he's typical because there haven't been any published studies of this subject. But according to Webb, he would give a high-prescribing doctor about $1,500 to speak. And following that speech, Webb would see the speaking doctor write an additional $100,000 to $200,000 in prescriptions of his company's drug.

Webb points out that the people recruited to speak are almost always high prescribers with incredibly high patient populations. 'That much money, easily,' he says. 'So yeah, it was a good return on investment.'

The article also suggested that most of the paid "thought leaders" do not realize on a conscious level how they have been bought.
Dr. James Dickie, an endocrinologist in Westminster, Md., was very clear that his prescription-writing was unaffected by speaking. 'Absolutely not. The physicians who are in the audience may notice it if they have been educated to that drug and the benefits of that drug — they may see an increase in writing. But specifically in my own? I don't believe so.'

When NPR told Dickie about the findings learned from drug reps like Maher and Webb, he seemed genuinely surprised and disturbed and began to wonder out loud if he was, in fact, affected.

'It would really bother me,' Dickie says. 'Because I perceive myself as always prescribing in the best interest of my patient, and even unconsciously if I was unduly influenced, that would really bother me. I usually pride myself on keeping up my guard to prevent undue influence.'

But Maher says it's almost impossible for a doctor to keep up his guard. She points out that before doctors speak to their peers about a drug, they review slides provided by the company and talk to the company medical officers. And this process, she says, focuses the doctor on the most positive aspects of a drug.

'What is happening is that you are being manipulated to talk about the drug out loud,' Maher says. 'Kind of like talking themselves into knowing that what they were saying, were actually believing. And if they believed what they were saying, then they would write more drug.'
Summary

Marketers, especially but not only pharmaceutical marketers, have become very adept at using psychology to manipulate their targets, so that marketing campaigns have begun to resemble disinformation campaigns.  Pharmaceutical marketers in particular have used their ability to convince physicians that they are "thought leaders," (or "key opinion leaders") to get physicians who are already favorably inclined toward their products to prescribe even more.  It is a bonus for the companies if these physicians can also persuade other physicians to prescribe more.  The fact that these supposed "thought leaders" have become real leaders of medicine, to a great extent on the basis of marketers' decisions (also abetted in the academic setting by medical schools' and academic medical centers' love of "external funding," including the sort supplied by marketers to "thought leaders", see this post) is the perhaps unintended but unhappy consequence.  Thus the leaders of medicine and health care are more and more those doctors who are most compliant with and least questioning of pharmaceutical (and other health care) companies' marketing. 

No wonder the leadership of medicine has been so passive as health care has become more dysfunctional.

What is to be done?

-  Physicians and others who are paid to give talks by commercial firms must read the series of articles noted above. 
-  We need to be very skeptical of all "thought leaders" and "key opinion leaders," especially if it is not clear whether they were first dubbed as such by marketers rather than by their own achievements.
-  We need as rapidly as possible to mandate full disclosure of all payments by health care corporations others with vested interests in promoting products or services to physicians, academics, and others with decision making ability or influence in medicine and health care.
-  Hopefully full disclosure of the scope of the thus revealed conflicts of interest will persuade health care professionals and society that we need to eliminate such conflicts, allowing professionals to eventually return to their once respected status as those pledged to put their patients' (rather than their financial backers') interests first. 

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