Showing posts with label health care ethics. Show all posts
Showing posts with label health care ethics. Show all posts

Thursday, July 02, 2020

Parlous Times—so Why Is My Dander Down?

Yes, these are parlous times, my friends, with all sorts of threat levels bouncing up and down and up again to all sorts of new heights. I've personally felt almost paralytic, in this present "Dander" series, about repeating the latest outrages from Trump-land and Corona-land.  (Lather. Rinse. Repeat.) What is there new to say? The outrages are all there, still, but with a single, over-arching theme.

To quote the great philosopher, Frankie Valli, "It's a sign!!!" The sign: a new system of governance run by a cabal of family and cronies, no inspectors-general in sight, and a whole lot of unconfirmed "acting" secretaries, under-secretaries, under-under-secretaries and under-under-under secretaries.

I've written about this syndrome in HCRenewal before, mainly in connection with the Veterans Administration. Look it up right here in HCRenewal (e.g. see here). It's a systemic neurological disorder we could call MS: Mar-a-Lago Syndrome. In this disorder the federal government is paralyzed not by the Deep State, but a pernicious Deep Nonstate of golf buddies, far-right pundits and other self-dealing defilers of democracy.

Oh, where are the mere managerialists we used to go after in HCRenewal? We do miss them so! Lather. Rinse. Repeat.

Anyway, we're in the summer of 2020 and lives have been lost. The system stays awash in waste and cronyism. But I just couldn't muster writing more about it: what was new? It's all MS and the thousand flushes of oppositional, know-nothing populist careerism that go along with it. All courtesy of a motley crew of hackers, sadly gullible flat-earthers and one particular political party busy pushing itself and the rest of us off the deep end. All exploiting the hell out of each other. Only one, the US Senate's leadership, has an internally-valid long-term goal—the judiciary—that purports to make the exercise worthwhile. Everybody else can just bump along in their miserable gerrymandered "corporations are people" lives, liking it and lumping it.

And yet: along the way, something strange seems to be happening. It's true that, yoked together and spurring on their steeds, our four horsemen of the apocalypse—America's flawed democracy, its corrupt GOP, the pandemic and its exposed systemic racism—just stay on the rampage. But look underneath all this, in health care and just maybe in the larger society, there are young hopeful shoots, sprouting somehow in the mud below. And that is something new and worth writing about.

So just now, oddly enough the dander's down. (Provisionally. Check in again in, oh, four to five months.)

Some years ago Dr. Poses, this blog's venerable editor, already pointed out how HCRenewal's message has begun to "go mainstream." Now and again, he points out further new examples.

Maybe this mainstreaming of the message—health care independence and integrity—somehow relates to a couple of major shifts in the medium, or mediums, that carry the message. The first, social networks, have worked in part to the detriment of good government. But they also enable ground-up protest in a new communications ecosystem.

Another part of this ecosystem, less evident to lay people and leaders but potentially a potent force, is the advent of a new and more independent-minded generation of science and medicine journal editors, with their accompanying editorial boards. Here we find some more of the tender young shoots, exemplifying the change that genuinely seems afoot. Let me cite three recent examples.

  • The Annals of Internal Medicine has gone from strength to strength in recent years. Under its current editor, Christine Laine, the first woman to hold that post, Annals now boasts its highest-ever impact factor [C. Laine MD, personal communication]. That's an impact in general medicine, the nation's largest specialty, boasting over a million page views per month.

    The current number of Annals, for mid-June 2020, offers an article entitled "a cautionary tale," describing last year's "orphaning" of the entire house staff of Hahnemann University Hospital. Both the content and the very fact of the publication of this article are noteworthy. The article that follows, in its title, asks "is it time to more fully address teaching religion and spirituality in medicine?" (answer: "truly caring").


    But stick for the moment with the Hahnemann debacle. The article, written by three former Drexel University College of Medicine (DUCOM) faculty members who're now spread to the four winds, probes the "diametrically opposed goals of hospital owners and educational leaders" that led to an enormously disruptive hospital closure on the verge of a pandemic, a tsunami that orphaned nearly 600 trainees and that faculty quite simply "found hard to believe."

    Those of who were around in the 1990s didn't find it so hard to believe. The authors allude to the prehistory of the Hahnemann bankruptcy in the earlier one endured by Allegheny, or "AHERF" in the late 1990s. They don't insist on the earlier one prefiguring the later one, "the largest orphaning event" in medical history, in any causal or direct fashion. But I'd argue precisely that: at the least, it made it much more likely.

    The reason, simply, a circumstance to which to their credit the authors point, was the original sin of the deal that bailed out a medical school (pre-bankruptcy MCP-Hahnemann, post-bankruptcy Drexel) and a group of hospitals (originally Tenet Healthcare). That original sin was a quarter-century earlier when the Philadelphians did a deal-that-was-never-gonna-work with Tenet Healthcare, a for-profit based west of the Mississippi. The original sin fast-fowards a quarter-century to the present authors noting that at the critical moment in 2019, "Drexel and Hahnemann released separate talking points for P[rogram] D[irector]s, but these documents contained discordant information." But the discord started in 1995 and never stopped. Graduate Medical Education run by frenemies.

    The American system of GME, like the US Constitution, contains any number of these ill fated compromises. When this happens, only a few norms serve as guardrails against disaster: in this case, the manner in which hospitals—recall that Tenet was a for profit system, and one for which both education and research are distinctively secondary—control the medical education dollars coming to them from Medicare reimbursements. "Discordant information": how can you lose?

    The departure of hundreds of residents, with all its displacement of both faculty and trainees, and with all its emotional turmoil, hardly seems like something that would cheer one up. And on its face, it's not. One can hardly overestimate the pain these authors and their colleagues went through. But what strikes me is the fact that this whole crummy system is no longer anechoic: that those within it are out there on the hustings, stating the lessons learned, trying to create the antibodies that might protect against future such occurrences. And Annals gladly published this excellent exposition-cum-cautionary tale.
  • In the same week that I received this number of Annals, I received the 25 June 2020 number of The New England Journal of Medicine. NEJM, also a super-high-impact journal, changed editorship—just a few months before the onset of the pandemic— much more recently than Annals. One waited to see whether it, too would be, shall we say, feminized. (Be clear: in this case "feminization" is for me an uncomfortable shorthand for what I dearly hope my commentators below will suggest a better word, and more or less an unmitigated good.)

    I grew up in a tradition of ritualistic CPCs—clinicopathologic conferences—in my own medical school and in key journals such as NEJM. A case would be presented of a patient who had to die. They had to die because the autopsy findings would be tortuously predicted by the academic physician as the solution to a diagnostic dilemma. This would be followed by a learned exposition of the histology and gross pathology of the disease that furnished the answer to the puzzle. Sometimes the clinician even got it wrong. The pathologist of course was always right, He—it was virtually always a he—always got the last word.

    But what the CPC model did was to reify the classic post-Laennec medical model of equating medical decision making to its laboratory-based problem-solving narrative. This began to change a bit beginning in the Journal's post-Ingelfinger and post-Relman eras, where editors began to stress correlations of clinical findings with those of the new molecular biology and immunochemistry. Now the patient didn't even have to always die! But the classic medical model, even then, was preserved. Riddle me a riddle: bench science, properly coupled with bedside wisdom, will provide the answer.

    Imagine my surprise then to find the CPC of a few weeks ago, entitled "a girl with severe psychological distress after family separation," focused on "trauma-informed care" in which the clinical outcome was not "a post-mortem examination was performed" or "a diagnostic procedure and laboratory study were performed." Here "a diagnosis and management decisions were made" and both clinical and patholgocial diagnoses were "post-traumatic stress disorder."

    The graphic is that of a cartoon pediatrician with an immigrant child, blowing bubbles together.

    Make no mistake: this is both a scientific and literary breakthrough, and a political statement. It is enormously heartening to view such a sea change in one of our most august journals. It tell us that a new, younger leadership in academic medicine is stepping up to address the socioeconomic problems that are now—far more than whether or not SARS-CoV-2 does or does not interact with ACE inhibitor agents—threatening health care in the more dire existential fashion.

    Can we extrapolate from these straws-in-the-wind? Is medicine becoming less anechoic and able to counter the threats against it? I know of no other recent precedent, but there's one from classical antiquity: the very bedrock of our medicine today, the Hippocratic tradition. In his magisterial 1995 work Hippocrates in an Age of Pagans and Christians, Owsei Temkin of Johns Hopkins showed how the classical traditions of independent medicine were able to persevere even in a later era in which they were threatened by religious authority. It was a close call then and it's a close call now: viz., the decision by a mere five to four, just a few days ago, preserving the physician's right without hindrance to provide services to a pregnant woman.

    Sometimes it comes down to one vote. And, granted, it ain't over until it's over: in November, voters in the United States will, in momentous fashion, decide the future direction not just of their own people but of the healthcare they're going to get going forward.
  • What's going on here? In truly extraordinary circumstances, leaders in medicine seem to be not abandoning the scientific model, but expanding it to incorporate insights and perspectives drawn from ethics and the social sciences, including economics. (The Allegheny-Hahnemann case is a classic example of business-economics-gone-wrong through failures of basic socioeconomic analysis.) Even in the non-clinical literature, if you take even a cursory look, you can find these tender young sprouts of freedom.

    The journal Cell, in a number published last month, began with an editorial entitled "Science has a racism problem," stating that "We are the editors of a science journal, committed to publishing and disseminating exciting work across the biological sciences. We are 13 scientists. Not one of us is Black." Cell also boats an editor of recent vintage (2018).

    But what followed was even more astounding. Amidst articles discussing matters such as how "Epitope pools detect CD4+ and CD8+ T cells," in the very next number of the journal, Duke neuroscientist and MD-PhD Kafui Dzirasa provides his account of how "[f]or Black scientists, the sorrow is also personal." This article has been widely reprinted and sent out to many thousands of physicians who practice in domains as far away from cell biology as orthopedics. It is worth quoting in extenso, and speaks for itself.

I am a medical doctor and a scientist; the first African American awarded a PhD in neuroscience at Duke University. I have led a National Institutes of Health-funded research lab for almost a decade, and I was awarded the Society for Neuroscience Young Investigator Prize in 2019. I am an American Association for the Advancement of Science Alan I. Leshner Public Engagement Fellow, and I have hosted TEDMED three times. I am a scholar, teacher, mentor, speaker, and mental health advocate. I have served on national commissions, I have advanced federal policy, and I have even held court with a president of the United States. I have published in Cell scientific journals, and as a peer reviewer, I have worked to advance the scientific rigor of my colleagues. Yet, most days, I am unseen and unknown. As I watched a knee slowly, mercilessly, and inhumanly extinguish yet another black life, I was overwhelmed by anger and sorrow, and at this very moment, I am terrified to run on the trail near my home. I am a black academic in America.

That these three examples of medical communication all point to inherent problems in American medicine, no doubt in world medicine as well, is daunting in one sense. But in another it is undaunting. It shows us how far we have left to go. By looking in the mirror and recognizing that they share the challenges of the larger society, medicine and science have at least a fighting chance of transcending them—and in doing so, regain their independence. The manner in which these authors have taken the knee, and in doing so stood very, very tall, shows us a path of speaking truth to power. In doing so, and in our anticipation of their being heard, they give us hope.

Wednesday, December 14, 2016

Despite Long Record of Misadventures, Johnson and Johnson to Receive Award for "Ethical Leadership?!"

What does it take for a big pharmaceutical/ device/ biotechnology company to get an ethics award?

Reported by Sheila Kaplan at Stat (but for subscribers only), and first noticed by Carl Elliott and just discussed on his Fear and Loathing in Bioethics blog, it appears that the giant Johnson and Johnson pharma/ device/ biotech company will get an award in "ethical leadership" from and "organization called Fellowships at Auschwitz for the Study of Professional Ethics, or FASPE."

The Stat report, quoted by Dr Elliott, stated:

FASPE Chairman David Goldman, an attorney in New York, said he was aware of the pharma giant’s various ethical tangles, but believes the company has moved beyond them. 'We do think they’ve acknowledged their failures and taken the apropriate steps to resolve them,' he said. 'They know what they’ve done; we talked to them about it and they’ve taken the right action.'

However,

Others disagree, noting that in 2013, J&J and its subsidiaries agreed to pay $2.2 billion to resolve criminal and civil allegations of improperly promoting several prescription drugs, including paying kickbacks to physicians. That was one of the largest health care fraud settlements in US history. The company has also lost recent product liability cases involving allegations of its talcum powder causing ovarian cancer.

If only it were just that.

In fact, we have been writing about the ethical misadventures of Johnson and Johnson for a long time.  Our collected posts are here.  An updated version of their legal record since 2010 is at the end of this post. Their misadventures go well beyond those listed in the Stat article, and new cases of them have been appearing regularly, most recently this year.

Perusing the list suggests that this giant company (with about $70 billion in yearly revenue) is a poster child for bad behavior by health care organizations.  Despite the multitude of allegations leading to settlements, and sometimes findings of guilt, the company has never faced a penalty of significant size, given its revenue.  Furthermore, almost no company leaders who enabled, authorized, directed or implemented the various misadventures have suffered any negative consequences, therefore appearing to enjoy impunity

There are many more examples on this blog of legal settlements, and even episodes involving bribery, fraud, kickbacks, and other crimes that demonstrate the continuing impunity of leaders of large health care organizations.  It is likely that such impunity has led to the general concerns that the system is "rigged" in favor of the wealthy, the well-connected, and the insiders. 

(And now we have a president-elect who has promised to act against the "rigged system," but seems to be bent on appointing wealthy, well-connected people to run his executive branch, but in any case, as we have said before...)

We once again see the perverse incentives at work that drive bad behavior by health care oragnizational leaders.  One can obviously become very rich by directing this bad behavior.  Up to now, the likelihood that one would eventually pay any penalty for doing so was tiny.  Now it is slightly higher.  Whether those up the ladder, who might have authorized the behavior, turned a blind eye to it, or avoided enquiring about anything that could be bad behavior, as long as the money came in, will suffer any negative consequences from these actions or inactions in the future is still unclear.

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it.  True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why.  But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position.  It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public. 


 Appendix - Johnson and Johnson Legal Record since 2010
 2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
2012 
  - Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post).
2015
-  Johnson & Johnson found by jury to have concealed harms of Risperdal.
-  Johnson & Johnson Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
-  Johnson & Johnson McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)
2016
- Johnson & Johnson subsidiary Aclarent settled allegations that it sold its Stratus device for unapproved uses.  Two former executives of that subsidiary also were found guilty of distributing misbranded and adulterated devices (see this post

Wednesday, May 06, 2015

MBA-holding Informatics Fellow's Portfolio: Revolutionizing Healthcare Through Plagiarism

I highlighted the MBA culture at least once before on this site, on April 16, 2010 at "Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'", http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html.

In that post, I noted MBA candidates/Cerner employees happily conspiring in a paper at Duke's Fuqua School of Business towards combination in restraint of trade through "recommending that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. "

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

The paper was highlighted at  professor David Ridley's page "Duke University Fuqua School of Business: Past Papers" - that is, until a few days after my blog post went up and he was informed of it.   You can see cached copies of the paper and page at the post at link above.

Today, I've had another experience with an MBA holder who has decided to enter the field of Medical Informatics.

I received an unsolicited Cc: of an email, sent by a professional in my field I do not know at a university in Australia.  The email was directed at a postdoctoral fellow at a U.S. medical informatics program in the Midwest, advising the fellow that his 'Portfolio' brag page page was plagiarized directly almost verbatim from a personal essay I'd written ca. 1999 and now archived at my current Drexel site at http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm, and that plagiarism was bad for informatics careers:

Date: Tue, May 5, 2015 10:28 pm
To: [Name of recipient MBA-holding informatics fellow redacted - ed.]

I was disappointed to find the following three paragraphs on the homepage of your site ([URL redacted] - ed.)

"It became apparent to me and many informatics professionals that significant confusion and misconceptions exist in hospitals, industry, and the world at large about what medical informatics is, and what experts in medical informatics do (and are able to do if given the opportunity). Also, there is confusion as to what medical informatics is not.

"The available quantity of information in most subject areas ("domains") has grown rapidly in recent decades. Issues about information and its use have become quite complex, and the issues themselves have undergone scientific study. Informatics is information science. In other words, informatics is a scientific discipline that studies information and its use.

"Both theoretical and practical issues are studied. Examples of theoretical issues include terminology, semantics (term meaning), term relationships, and information mapping (translation). Practical issues include information capture, indexing, retrieval, interpretation, and dissemination. Medical informatics, an informatics subspecialty, is the scholarly study of these information issues in the domain of biomedicine."

This text is an almost perfect copy of the introduction to Scott Silverstein’s page (http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm).

Plagiarism has no place in Medical Informatics, and could harm your career. I would appreciate it if you could rewrite or remove this content on your site

Best Regards 

[Professor name redacted - ed.]

There was other copied material after these paragraphs as well; almost the entire page was my words and ideas.  The page shamelessly concluded with this:

Shamelessly copied from http://cci.drexel.edu/faculty/ssilverstein/informaticsmd/infordef1.htm#importance

I do not know how the Australian professor detected the plagiarism, if he had involvement with the fellow, or the context of the interaction.

This fellow had an MBA and the title of his "portfolio" page was about his passion for 'revolutionizing healthcare.'

It's clear he thought his stealing my words and ideas would never be noticed. In other words, exploiting my creativity for his own gain and image-enhancement was fine.

Obviously in our connected world, plagiarism is not a good idea. Perhaps not so obvious are the predatory values of the MBA degree and the damaging effects on all our healthcare when such individuals 'revolutionize' it.

I sent a demand for the material's immediate removal along with a polite suggestion of unpleasantness if he does not comply.

I am not naming the postdoc due to having bigger fish to fry.

-- SS

Update 5/6/2015: 

The fellow has removed about 3/4 of my material from the webpage in question, but a passage remains verbatim.

I've sent another request backed by a screenshot and link to my material, and a rather more direct consequence of failure of complete removal.

Between the IT invasion of health IT and the MBA invasion, perhaps patients need to hire fulltime medical advocates for everything more serious then getting a boil lanced.

-- SS

Additional thought 5/7/2015:

I should add the misleading credentials exaggeration of minimal exposure to informatics (a seminar or AMIA short course at best) leading to a claim of a non-existent "American Medical Informatics Certification for Health Information Technology" by an erstwhile NextGen VP who also apparently holds a MBA with a concentration in Health Administration, see http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html.

Wednesday, June 26, 2013

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to take care of patients as corporate employees give up their professionalism.

Shut Up...

In April, 2013, Medscape published an article whose striking title was "Can You Speak Out Without Getting Fired or Being Labeled a Troublemaker?"  The answer was basically "no."

Physicians often see problems at their workplaces relating to patient quality of care, financial practices, mistreatment of staff, and other issues. But as more doctors take jobs as employees of hospitals, medical groups, and other large organizations, they increasingly face the same dilemmas as millions of other working stiffs. When they come across actions or policies that they don't think are right, they have to decide whether it's worth it to speak out and get labeled as a troublemaker -- or perhaps even get fired.

 Across the country, a growing number of physicians are indeed losing their jobs -- and often their hospital staff privileges -- after protesting employment conditions. Such complaints may involve patient quality-of-care problems, short staffing, misallocation of funds, improper financial incentives, fraud and abuse, discrimination, overuse or withholding of medical services, or other misconduct, say organized medical groups, employment attorneys, and physician recruiters.

Of course, physicians swear oaths to put the needs of their individual patients first, and doing so within a large organization might well involve protesting conditions and practices that may affect the quality of care or even endanger patients.  But woe unto physicians who try to fulfill their professional responsibility when doing so goes up against the top executives to whom the physicians must now report.

'We were naive when we went into this,' says Maria Rivero, MD, who with her professional colleague and significant other Derek Kerr, MD, filed administrative complaints against their long-time hospital employer in 2010. 'We thought if we just brought it to people's attention, they would fix the problem and leave us alone. But if you blow the whistle on high-level executives, you need to prepare to be harassed and lose your job.'

Even working within the system to fix problems can lead to big trouble,


Still, the formal professional approach doesn't always work either. Cloyd Gatrell, MD, an emergency physician who was employed by EmCare, says that he and his wife Kathryn, a nurse, voiced concerns and presented data to executives at Carlisle Regional Medical Center in Pennsylvania in 2008 and 2009 on what they saw as inadequate nurse staffing levels that endangered patients.

After getting no results, Dr. Gatrell contacted the state health department, prompting a state inspection that found insufficient staffing. In 2010, he was fired by EmCare at the request of the hospital, according to his 2011 lawsuit against the hospital and EmCare claiming violation of whistleblower protection laws. His wife was fired earlier, and she sued separately. The hospital issued a statement declining comment on the litigation.

'We're supposed to be advocates for patients, but being employed puts us in a precarious position in taking a position on patient interests that's against what the hospital administration favors,' says Dr. Gatrell, whose suit is in the discovery stage. 'I think a physician still has that responsibility.'

Physicians who sign contracts with corporate employers, perhaps thinking that they will have less bureaucracy with which to contend and a more certain salary than they did in private practice, seem blissfully, or willfully unaware that those contracts may take away their ability to control their practices and stand up for their patients.


Still, federal and state whistleblower laws only provide protection from retaliation for physicians in certain situations, such as those employed by public entities or those who complain about civil rights violations or Medicare and Medicaid fraud and abuse. Otherwise doctors may have to rely on contract provisions or on state employment law, which may not offer much protection.

[An anesthesiologist on the AMA Board of Trustees and his hospital system's board,] Dr. Annis says that the AMA's new statement of principles for physician employment -- which asserts that physicians should not be retaliated against by their employers for speaking out on patient care issues -- provides support for doctors when they raise legitimate professional concerns with their employers. He says it's best for physicians to work through their medical staff organization.

But Dr. Gatrell points out that the AMA statement explicitly accepts that physician employment contracts may allow hospitals to strip doctors of their medical staff membership and clinical privileges at the same time they are terminated, known as a 'clean sweep' clause. 'If that's accepted by the AMA, the rest of the principles protecting physicians are meaningless," he argues. "If physicians can be fired without cause and then automatically lose their medical staff membership and its due process protection, how many will dare be a patient advocate?'

Some experts advise physicians not to sign employment agreements with such onerous provisions. But others say that physicians often have little leverage to remove them. 'It's not an equal negotiating table,' says Dr. Gatrell, who's now working for a small urgent care practice.

A May, 2013 article again in Medscape about the "4 Top Complaints of Employed Doctors," explained why physicians often see a lot they could or should protest to assure the quality of their patients' care,

 Some doctors report that hospital administrators treat them with a lack of respect. One female doctor said, also on condition of anonymity, that her biggest challenge on her job was 'how to handle nonphysician high school grads bossing you around when they function as your 'superiors' in your employer's organization. They manage their insecurities by bullying physicians and through passive aggressiveness, but always seem to gain the upper hand with those at the top.'

These are the sorts of brilliant administrators often hired by brilliant top executives, maybe at a cheap price to keep the bottom line and executive compensation healthy..  Furthermore, given that as we have discussed, "financialization" of hospital management often puts a bigger priority on short-term revenue than on quality care, as per one senior physician,


 'physicians are being increasingly targeted when they get in the way' of hospitals' agendas

To make more money faster, many hospital systems now seem to want physicians to only make referrals for lucrative tests and treatments within the system, even if some patients might be better served elsewhere,


The AMA recently issued guidelines for physician employment stating that 'a physician's paramount responsibility is to his or her patients.' Employers should not retaliate against physicians for asserting their patients' interests, according to these guidelines. 'In any situation where the economic or other interests of the employer are in conflict with patient welfare, patient welfare must take priority,' the AMA says.

The guidelines also call for employers and employed physicians to disclose to patients any agreements or understandings they have that restrict, discourage, or encourage particular treatment or referral options.

Nevertheless, employed physicians are often expected to refer patients within their own groups and send tests to a hospital laboratory or imaging center. Hospitals may tell employed surgeons which kinds of joint implants to use, and according to a New York Times article even whether to implant defibrillators in Medicaid patients. It's unclear how often any of this is disclosed to patients.

'What we doctors say is that we're ethically bound to our patients because we took an oath, and that's what our license is based on,' says Linda Brodsky. 'But many hospitals say, 'No, you're employed here, and what we say goes.'

Note that so far there seems to be little evidence that the AMA guidelines about physician employment are being honored other than in the breach.  It is also disappointing that the leadership of the medical society that represents internists seems so unworried,

 David L. Bronson, MD, President of the American College of Physicians, disputes Brodsky's assertion that hospitals tend to squelch doctors who criticize leadership for policies that they believe harm patient care. In fact, he says, healthcare organizations may identify outspoken physicians as potential leaders, 'as long as they're collaborative and trying to solve problems, and not just be a thorn in the side of everyone they know. Organizations are looking for physician leaders, and physicians who can collaborate and not just be adversarial can go far inside organizations.'

I would guess, having seen so many examples of generic management, mission-hostile management, management that seems more focused on the money than patient care, and management that seems to be able to make itself rich without evidence that it has done anything noteworthy to uphold hospitals' clinical missions, that hospital systems that promote physicians who are willing to speak out against hired executives are vanishingly rare.

And Sell

In June, 2013, Beckers Hospital Review published an article suggesting that now hospitals are going beyond just pressuring employed physicians to refer potentially profitable patients within the system, and now are pressuring physicians to act as salespeople to their colleagues,

 A few hospitals are beginning to train their employed physicians to "sell" the hospital, which involves asking referring doctors in the community to send patients their way....  the pressure to bring doctors into sales is mounting.

The author, the former publisher of Modern Healthcare, made a remarkable argument based on a definition that seems wildly optimistic,

 Customer service lies at the core of salesmanship. The Business Dictionary defines salesmanship as satisfying customer needs through a sincere and mutually beneficial process aimed at a long-term relationship.

Of course, skeptical physicians used to exposure to the sales tactics pharmaceutical and device companies use (look here, here, and here,  for example) might wonder why the author did not discuss such marketing tactics as the employment of half-truths and biased information, and the use of emotional appeals to trump reason and logic.

That the author was serious was shown by his list of seven pointers for hospitals seeking to transform its employed physicians into marketers.

Of course, physicians who are already "key opinion leaders" employed by drug and device companies, whose marketing executives may think. that "key opinion leaders were sales people for us," (see this post), might not be fazed by now being asked to market their own hospital.  Never mind about Principle II of the AMA Code of Ethics

II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.


The Moral of the Story

We have previously discussed various aspects of the travails of the brave new world of the corporate physician.  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation.  Physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.

It is disappointing that even medical societies that ostensibly support physicians' professional values have been afraid to warn against such employment, or do much to help physicians trapped within it.

Physicians who go to work for big corporations have to realize that they may be forced to put corporate executives' vested interests ahead of their patients.  Patients whose physicians work for big corporations must realize that their health care will now be corporate, with all that entails.

  As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.


Wednesday, October 03, 2012

Health Care Academics' Unrest and Bad Health Care Leadership?

Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypothesized,  based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on Health Care Renewal.

After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more.  [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]

Study Design

This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country.  At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.

The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine.  Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree.  The items on the survey were combined into various scales.  A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal.  These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress.  The survey items are listed below, grouped by issue, with the scales into which they were combined noted.

Issue: Mission-Hostile Leadership

Administration only interested in me for revenue   (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)

Issue: Deceptive, Unethical Leadership

Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)

Issue: Generation of the Anechoic Effect by  Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,

Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)

So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.

Results

The response rate was 52% (N=2381.)

Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores.  The values for the scales of most interest were:
Relatedness/Inclusion  3.56 SE= 0.022
Values Alignment  3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022

Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.


A small majority of faculty indicated their intentions to stay at their institutions (57%).  Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction.  The remainder were considering leaving due to personal/ family reasons or to retire.

The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave.  Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress.  Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave.  The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools. 

Summary and Comments

This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress.  Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.

These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal.  Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis.  Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here). 

One part of the author's discussion of their findings was particularly relevant:


Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.

 The scale of ethical/moral distress (see Table 1) reflects reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions
of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.
I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics.  This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations.  As we said before, if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing  cushy compensation to their executives, first.  

Wednesday, August 22, 2012

BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and as a guest blogger on KevinMd.  The post was about other physicians can become big-time KOLs by using social media, and refers to another post which indicates that pharmaceutical companies look for physicians who are big prescribers of their products and have a lot of influence to, guess what, help market their products.  Although the blogger refers to ethics more than once, how it is ethical to trade on the trust physicians get for their professional vows to put patients first to market products (that may not always be good for patients) remains beyond me.

ADDENDUM (27 August, 2012) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.  

Tuesday, June 05, 2012

Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

(Addendum: the AHRQ hazards manager taxonomy report can see seen at http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf.)

In a July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and an Oct . 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?" I wrote about the postmodern "ready, fire, aim" approach to health IT:

In the first post, I wrote:

... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.
For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

However, this situation is anything but humorous.

How more "cart before the horse" can government get?

In the second post, I wrote:

... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?

Here we go yet again.

The problem with the AHRQ (Agency for Healthcare Research and Quality, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind.

If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., Health IT and Patient Safety: Building Safer Systems for Better Care, pg. S-2), then health IT is, it follows, an experimental technology.

If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar:

Sent: Tuesday, June 05, 2012 12:23 PM
To: OHITQUSERS@LIST.NIH.GOV
Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET

Agency for Healthcare Research and Quality

Purpose and Demonstration of the Health IT Hazard Manager and Next Steps

June 11, 2012 — 2:30-4 p.m., EST

The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards.

The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers.

... Webinar learning objectives include:

1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing.
2. Explain the process for identifying and categorizing health IT-related hazards.
3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors.
4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities).

In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence.

Have we thrown out all we know about medical research and human subjects protections in face of the magical powers and profits of computers in medicine?

-- SS

Tuesday, March 06, 2012

Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon.

Short Course: Why Do Physicians Not Make Rational, Evidence Based Decisions?


A full-day course at the 14th Biennial European Meeting of the Society for Medical Decision Making on Sunday, 10 June, 2012 in Oslo, Norway. Taught by bloggers Dr Roy Poses and Dr Wally Smith, the course will address both the effects of cognitive psychological limitations and of external influences by vested interests leading to less than optimal decisions.

A full description of the course is here.
 
Online Course: Corruption in the Health Sector

A 30 hour online course given by the U4 Anti-Corruption Resource Center, offered in collaboration with the Boston University School of Public Health.  The course is "on causes and consequences of corruption in the health sector; vulnerabilities in drug supply systems, informal payments, and strategies to minimise the problems." 

A full description is here

Conference: Deception, Incentives and Behavior

A two-day conference given by the Rady School of Management, University of California - San Diego, on 20-21 April, 2012 in San Diego, California, USA.  This will be a multidisciplinary meeting to facilitate "research of deception and related unethical behavior in the fields of economics and psychology/judgment and decision making (JDM)."

The conference web-site is here

Conference: Third Annual PharmedOut Conference on How Patient Harms May Result from Industry Promotion

A two-day conference given by PharmedOut at Georgetown University in Washington, DC on
14-15 June, 2012.  The conference will focus on the how industry promotion may lead to under-use, over-use, or mis-use of drugs and devices.

The conference web-site is here.

Monday, February 20, 2012

The First State's Deadest (Deadliest?) Duck - Is This ED EHR Harming or Killing Anyone in NSW?

Nobody seems to be asking this simple question:

Is This ED EHR harming or killing anyone in NSW?

It cannot be "not compromising patient care" on first principles.

This type of practical and ethical question seems to never get asked, while what appears to be a tit-for-tat political kerfuffle goes on.

This is due in part to the baffling special accommodations afforded worldwide towards an extremely profitable but potentially extremely dangerous medical device, as well as due to the issues I described in my post about reckless technophilia and the accompanying disregard for rights of others here.

The Register

NSW government accused of dodgy software cover-up

FirstNet: the First State's deadest duck [or "deadliest duck?" - ed.]

The buggy FirstNet emergency department software has become the subject of a political argument in NSW. [What about a clinical and ethical argument? - ed.]

In one of those paradoxes of democracy, an opposition which, in government, was responsible for a now-despised implementation is now using the IT project as a stick to beat a government which was in opposition when the system was chosen.

Last week, the Sydney Morning Herald obtained a report into the system by Deloitte, under a freedom of information request. It says [1] the Deloitte report criticises FirstNet because it is:

- Is chronically under-funded;

- Produces inadequate records;

- Was unreliable in delivering messages, and did not provide alerts when messages failed to reach their destination; and

- Demanded excessive amounts of screen time from clinicians.

[But is it harming or killing anyone? Are those statistics being collected robustly and scientifically, or are self-serving statements by hospital executives that "care was never compromised, and nobody was injured" simply being taken at face value?

Further, the obvious increased risk of harm due to deficient IT currently in operation is being cavalierly ignored. This is alien to medicine, and could cause career termination or land people in jail in fields such as aviation if planes with known potentially-dangerous avionics software or other defects are kept flying - ed.]

In spite of its inadequacies, the Deloitte report seen by the SMH said the $AU100-plus million Cerner FirstNet system is too entrenched to abandon.

[I'm quite sure dead or injured patents would not appreciate that explanation - ed.]

Over the weekend, opposition health spokesperson Dr Andrew McDonald issued a statement accusing NSW health minister Jillian Skinner of covering up the report since August 2011.

However, other published studies into FirstNet, such as a detailed investigation by Sydney University e-health expert Professor Jon Patrick here [2], identify problems similar to those apparently cited by Deloitte. This study was undertaken to investigate issues with FirstNet outlined in November 2008 in a special commission of review, conducted by Peter Garling,

While noting that FirstNet represented an improvement on some aspects of its predecessor, Garling said the system attracted complaints that it was unfriendly to users, that the vendor and Health Department did not respond to complaints about the software, and that emergency department patients were being held in triage for excessive times, while clinical staff fought with the software.

[What sane patient would want such a system used in their care? - ed.]

Deloitte, on the other hand, was far less critical of FirstNet in 2008, when in a review [3] of triage benchmarks it managed to turn up a downtime issue, difficulty in uploading triage data to the Health Department, and the identification of the wrong doctor or nurse with a patient’s records.


Stunning.

On the argument that "the older system was worse", or the corollary argument that "paper harms and kills too", I suggest anyone who proffers that argument should realize VIOXX (refoxicib) helped far more people than it harmed in reducing pain while sparing them from GI side effects compared to "older" drugs.

Over 84 million people were prescribed rofecoxib at some time and only mere thousands, or tens of thousands, are presumed to have been injured or died.

Therefore, following their own illogic and ethical (dis)orientation, they should put all their family members on the drug - especially the elderly with cardiovascular disease - to benefit from pain relief and VIOXX's other miraculous effect, suppression of colonic polyps.

Surely those benefits outweigh the risks, and therefore it is ethical to do so, no?

Of course not.

Health IT, as I've written in many posts on this blog, has a magnitude of harms that is admittedly unknown. Health IT needs significant further study and improvement, certainly before national rollouts, and before decisions are made that particular systems are "too entrenched to abandon."

-- SS

Thursday, February 09, 2012

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:

Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164


The section I find most interesting is this:

We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) at two Australian teaching hospitals. In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and we compared before and after error rates. Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors (where system functionality or design contributed to the error) were calculated.

Here is my major issue:

Unless I am misreading, this research took place in hospitals (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) discharge prescriptions.

I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at discharge, or in outpatient clinic/offices to communicate with a pharmacy selling commercially and not involved in inpatient care.

From the U.S. Centers for Medicare and Medicaid Services (CMS), for example:

E-Prescribing - a prescriber's ability to electronically send an accurate, error-free and understandable prescription [theoretically, that is - ed.] directly to a pharmacy from the point-of-care

I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT.

This study appears to be of an inpatient Computerized Practitioner Order Entry (CPOE) system, not e-Prescribing.

Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via ONC-Authorized Testing and Certification Bodies) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you.

(This is not to mention the irony that one major aspect of Medical Informatics research is to remove ambiguity from medical terminology, e.g., via the decades-old Unified Medical Language System project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.)

I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE.

That said, looking at the nature of this study:

The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data:

Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards.

Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.

I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words, these were unintended adverse events as a result of the technology itself.

The authors conclude:

Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed.

The authors do acknowledge some limitations of their (CPOE) study:

Limitations included a lack of control wards at Hospital B and an inability to randomize wards to the intervention.

Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial.

Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in this comment thread).

In that thread I wrote to a commenter [a heckler, actually, apparently an employee of HIT company Meditech] with a stated absolute faith in pre-post studies that:

... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc.

There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here.

The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong.

Stated simply, in pre-post trials the results may be affected by changes that occur other than the intervention. HIT implementation does not involve just putting computers on desks, as I point out above.

In other words, the study was essentially anecdotal.

The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course.

Next, on ethics:

CPOE has already been demonstrated in situ to create all sorts of new potential complications, such in at Koppel et al.'s "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors", JAMA. 2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded:

In this study, we found that a leading CPOE system often facilitated medication error risks, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent.

CPOE technology, at best, should be considered experimental in 2012.

In regards to e-Prescribing proper, there's this: Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten and this: Upgrading e-prescribing system can bump up error risk to consider; in other words, the literature is conflicting, confirming the technology remains experimental.

This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards."

In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid.

Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones did not provide informed consent to the experimentation with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. This phenomenon represents a pervasive, continual world-wide oversight with regard to clinical IT.

Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful.

What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this:

The impact of possible non-cybernetic interventions (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions."

Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like this affecting an entire country.

There is something very wrong with this, both scientifically and ethically.

-- SS

Note:

[1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment


Addendum Feb. 10, 2012:

An anonymous commenter points out an interesting issue. They wrote:

The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices.

Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.

I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant.

I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky.

Addendum Feb. 12, 2012:

A key issue in technology evaluation studies is to separate the effects of the technology intervention from other, potentially confounding variables which always exist in a complex sociotechnical system, especially in a domain such as medicine. This seems uncommonly done in HIT evaluation studies. Not doing so will likely inflate the apparent contribution of the technology.

A "control ward" where the same education and training, process re-engineering, procedural improvements, etc. were performed as compared to the "intervention ward" (but without actual IT use) would probably be better suited to pre-post studies such as this.

A "comparison ward" where human interventions were implemented, as opposed to cybernetic, would be a mechanism to determine how efficacious and cost-effective the IT was compared to less expensive non-cybernetic alternatives.

-- SS

Friday, October 28, 2011

Cybernetik Über Alles: Computers Have More Rights Than Patients?

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]

What medical devices are shielded from liability?

Are there other examples of legislation seeking legal protections for wide-scale use of medical devices that even the device's trade group leadership admits are not ready, and are experimental?

Here we have a proposal from a member of the U.S. Congress to shield health IT software, a medical device (per FDA's Director of CDRH - the Center for Device and Radiological Health and others), and its users from liability through an apparently unique special accommodation.

This from iHealthBeat.org:
Thursday, October 27, 2011
On Wednesday, Rep. Tom Marino (R-Penn.) introduced legislation (HR 3239) that would create certain legal protections for Medicare and Medicaid providers who have implemented electronic health record systems, the Wilkes-Barre Times Leader reports.
The bill -- called the Safeguarding Access for Every Medicare Patient Act -- would create a system for reporting potential medical errors that occur when using EHRs, but it would not allow such information to be used as legal admission of wrongdoing.
The bill would cover certain physicians and hospitals that serve Medicare and Medicaid beneficiaries. It also would cover participants and users of health information exchanges.
Marino, who is a member of the House Judiciary Committee, said that offering the new legal protections to health care providers would promote greater use of EHRs and encourage Medicare and Medicaid providers to continue serving beneficiaries. [As if they could not do so without EHR's? - ed.]
He said, "Many providers are reluctant to use [EHRs] because they believe the practice will make them more vulnerable to unnecessary legal action," [unnecessary? How about real and necessary, as per the White Paper Do EHR's Increase Liability? - ed] adding, "This [bill] protects access for seniors in the Medicare and Medicaid programs" (Riskind, Wilkes-Barre Times Leader, 10/27).

From Rep. Marino's website (my comments are in [bracketed red italics]):


Marino Introduces Safeguarding Access For Every Medicare Patient Act
FOR IMMEDIATE RELEASE
Oct. 26, 2011
WASHINGTON -- U.S. Rep. Tom Marino, PA-10, has introduced legislation that offers limited legal protection to Medicare and Medicaid providers who use electronic records. [Which, I fear, could effectively act as, or mutate into, absolute protection in the environs of the legal system - ed.]
HR3239, the Safeguarding Access For Every Medicare Patient Act, would ensure patient access to Medicare and Medicaid providers; reduce health care costs [really? That's not what Wharton and others write - ed.]; guarantee incentives to providers to remain in the Medicare and Medicaid programs; and promote participation in health information technology.
Providers will eventually be required to participate in electronic recordkeeping or face a reduction in payments.
Marino said the bill offers incentive in the form of legal protection to providers who may be reluctant to remain in the Medicare and Medicaid programs due to low reimbursement rates which are constantly being targeted for further reductions.
[I imagine the known risks of health IT such as these at "MAUDE and HIT Risks: What in God's Name is Going on Here?" are a minor consideration if you receive legal immunity - ed.]
HR3239 would create a system for reporting potential errors that occur when using electronic records without the threat of that information being used as an admission of guilt. [Even if the physician or nurse is guilty of EHR-caused or aggravated, i.e., "use error" per NIST, malpractice - ed.]
It also prevents electronic records from being used as an easy source for “fishing expeditions,’’ [like this case, this case, this case and this case where patients died? - ed.] while making sure that parties responsible for errors are held accountable [how? -ed].
The proposal allows for providers who use electronic records to take remedial measures without having those actions be used to establish guilt [even though remediation may be very relevant to malpractice, patient injury and death prior to the remediation, and the remediation is informed by the error - ed.]; places time limits on the filing of lawsuits; and offers protection against libel and slander lawsuits.
[If this provision were to allow clinicians to speak publicly about HIT flaws without legal retaliation or sham peer review, I'd be all for it - ed.]
“Many providers are reluctant to use electronic records because they believe the practice will make them more vulnerable to unnecessary legal action,” Marino said. [I think it's much more likely they are reluctant to use them due to the aforementioned hair-raising MAUDE reports and literature such as here, here and here - ed.] and “Every time a doctor or hospital chooses not to participate because of these fears, our seniors lose another provider. This protects access for seniors in the Medicare and Medicaid programs.”
Marino said HR3239 is a two-pronged attack against rising health care costs: It provides legal protection to providers while encouraging the use of health information technology which has been shown to reduce costs. [See above links on that issue - ed.]
“Best of all, passage of this bill would require no new spending,” Marino said. [Besides the hundreds of billions to be spent on the IT itself - ed.]

This sounds like a healthcare IT vendor marketing piece, with claims refuted repeatedly here at HC Renewal, usually via the biomedical literature. It's slick, purporting to "protect Medicare access" while actually promoting health IT sales.

Did Rep. Marino get snowed by the health IT lobby? (See "The Machinery Behind Healthcare Reform" in the Washington Post.)

A major question is:

What are the patients and their rights to redress for injuries that occur due to EHR's? Chopped liver?

Isn't this bill really saying that patients are experimental subjects with limited rights? In other words, that improving EHR's should be at the expense of the unfortunate patients treated under its auspices? That the computers have more rights than the patients?

That line of thinking about what in reality is unconsented medical experimentation (i.e., "First, let's experiment" as opposed to "First, do no harm") has led to some very dark places in medicine, and not just in ancient history (e.g., see "Bioethics panel blasts late U. Pittsburgh professor").

See this reading list for more on these issues. Also see the many other posts on this blog about health IT quality, usability, efficacy, risk (and that the levels of that risk are admittedly unknown), lack of informed consent, and other issues via query links such as here, here, here and here - and the hyperlinks within those lists of posts - to more fully understand this perspective.

The text of the proposed legislation is here. While not all bad, it raises a number of concerns.

Excerpts are as follows:

H. R. 3239

To provide certain legal safe harbors to Medicare and Medicaid providers who participate in the EHR meaningful use program or otherwise demonstrate use of certified health information technology.

... SEC. 4. RULES RELATING TO E-DISCOVERY.

    In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--

      [I'm not sure what "certification" has to do with litigation, since "certification" of health IT has nothing to do with safety or usability; see note below - ed.]

      (1) information that is related to [what does that mean? - ed.] such EHR-related adverse event; and
      (2) information from the period in which such EHR-related adverse event occurred.

      [eDiscovery related to EHR-related adverse events is already difficult, e.g., obtaining complete metadata. What these provisions would do is likely to increase the complications through legal maneuvers on terms such as"related to", "period" etc. - ed.]

SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.

    (a) General- For a covered entity described in section 2, the following protections apply:
      (1) ENCOURAGING SPEEDY RESOLUTION OF CLAIMS-
        (A) GENERAL- A claimant may not commence a health care lawsuit against a covered entity on any date that is 3 years after the date of manifestation of injury or 1 year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. This limitation shall be tolled to the extent that the claimant is able to prove--
          (i) fraud;
          (ii) intentional concealment; or
          (iii) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.
      ... (2) EQUITABLE ASSIGNMENT OF RESPONSIBILITY- In any health care lawsuit against a covered entity--
        (A) each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury, as determined under clause (iii);
        (B) whenever a judgment of liability is rendered as to any such party, a separate judgment shall be rendered against each such party for the amount allocated to such party [does that include the IT vendor? - ed.] ; and
        (C) for purposes of this paragraph, the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm.
      (3) SUBSEQUENT REMEDIAL MEASURES- Evidence of subsequent remedial measures to an EHR-related adverse event with respect to certified EHR technology used or provided by the covered entity (including changes to the certified EHR system, additional training requirements, or changes to standard operating procedures) by a covered entity shall not be admissible in health care lawsuits.

      [This in and of itself seems to give special accommodation to health IT, since remediation helps make the case for the presence of problems to begin with - ed.]
      (4) INCREASED BURDEN OF PROOF PROTECTION FOR COVERED ENTITIES- Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any covered entity in a health care lawsuit only if it is proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant. In any such health care lawsuit where no judgment for compensatory damages is rendered against such entity, no punitive damages may be awarded with respect to the claim in such lawsuit.

      [Would that apply to a case such as this? Does it apply to the health IT vendors and their often cavalier software development and quality practices
      , if patients become injured, such as here, "A Study of an Enterprise Health Information System?" How about to this case, "A Lawsuit Over Healthcare IT Whistleblowing?" - ed.]

      (5) PROTECTION FROM LIBEL OR SLANDER- Covered entities and employees, agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified EHR technology and for the transfer of such information to another eligible provider, hospital or health information exchange, if the information, transfer of information, or entries were made in good faith and without malice.

      [Does that include defects reports? - ed.]


    From an ethical perspective, when you know a technology can be unsafe, but you don't know the levels of risk it creates, and the literature is conflicting on the benefits (prima facie evidence the technology is still experimental), you do not promote its wide-scale use in medicine and offer special accommodations to the technology's producers and users. Period. This is especially true without explicit patient informed consent and opportunity for opt-out. To promote such technology is not ethical.

    Note: I believe the misunderstanding of "certification" of health IT contributes to the problems with such proposals. "Certification" of HIT has little if anything to do with safety, reliability, usability, etc. (e.g,, see http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html).

    "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.")

    Health IT "certification" is not like Underwriters Laboratories (UL) certification of appliances. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.")

    -- SS

    10/28/11 Addendum:

    This Representative seems to represent districts in Pennsylvania served by the Geisinger healthcare system, including Danville, PA where their main campus is located. His legislative assistant on healthcare represented Geisinger to me in a conversation today in glowing terms. However, I suggest that Geisinger does not have a perfect track record, e.g., see the post "A 'safe' technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation" and its reader comments and links.

    10/30/11 Addendum:

    It occurred to me that in the post "Is Healthcare IT a Solution to the Wrong Problem?" referencing a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "Temporal Trends in Rates of Patient Harm Resulting from Medical Care" [Landrigan N Engl J Med 363;22] I pointed out that the abilities of health IT to "reduce medical error" may be significantly less than imagined.

    This is because most medical errors have little to do with record keeping, but instead with human factors. See the post at http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html.
    -- SS