Monday, March 30, 2015

Times: American boards are exceptional--and not necessarily in a good way

The recent New York Times piece on the behavior of (mainly for-profit, but by extension...) US organizations' boards of directors, goes some way toward explaining the anechoic effect.

The redoubtable Gretchen Morgenson reports on the gulf between company directors' approach to transparency in the United States when compared, say, with a lot of boards in the UK, Holland, and the Scandinavian countries.

The novel idea of taking shareholders' views into account seems to be far more common on the other side of the pond. When it comes to for-profit entities, of course, investors' expectations come into play--you'd think this would be an easier case.

One would think that directors would take their fiduciary responsibilities seriously, and at least listen. In the US, however, there seems to be a systematic process of hiving off the directors in a sort of anechoic chamber. Two-thirds of board members in one survey didn't communicate at all with the outside world. Over half hadn't even had a discussion about their organizational communications policies!

Non-profits--and health care spans both types--don't have investors per se. But they have lots of stake-holders. Health Care Renewal's editor and lead blogger, Dr. Poses, has reported in these pages early and often about the lack of transparency on both sides of this rather artificial divide. It's a bit surprising, then, to hear that accountability is more highly valued in Europe than in these democratic United States.

My own experience with boards has been highly consonant with this insular approach. Directors seem mostly there to prop up management. Rubber stamps are the most important tools. Fat wallets also help. Circling the wagons is the most important skill set. Board members in health care organizations, including those that are not-for-profit, either don't talk about what they see lacking, or, scarier still, it's nicely hidden from them. Probably both. I've heard chairpersons publicly excoriate directors, in front of their peers, for "free-lancing" when they engaged in responsible outside communication.

These boards, and especially their chars, almost invariably defer to management. Non-profits wait until their top management do something not merely execrable but illegal and humiliating before they remove them. Is this laziness or selling-out? Unclear. Maybe both.

If this is the kind of American Exceptionalism our organizations subscribe to, they might want to try being a bit more unexceptional!
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Friday, March 27, 2015

Opinion, CIO Magazine: "The medical profession needs to get over its fear of information technology"- their complaints bogus

There comes a time when the pundits defending the status quo in the healthcare information technology sector and health IT utopianism simply need to be thoroughly and definitively refuted.

This is such a time.  CIO magazine reaches the country's information technology leadership, including those in heathcare.   Hence, canards and meritless defamation of physicians can (and in my experience does) impact the attitudes and decisions of the leaders of the very technology physicians are increasingly dependent upon to deliver safe care.

Ultimately, such misinformation can and does result in patient harm through bad health IT.

Let's start with the title and subtitle alone of an opinion piece in CIO magazine:

March 26, 2015 
Paddy Padmanabhan - Opinion
http://www.cio.com/article/2886751/healthcare/the-medical-profession-needs-to-get-over-its-fear-of-information-technology.html 

The medical profession needs to get over its fear of information technology
Continued objections to Electronic Health Records ( EHR) by sections of the physician community are bogus. They arise from past entitlements and a lack of accountability.

The term "bogus" has clear meaning:

Merriam-Webster dictionary
http://www.merriam-webster.com/dictionary/bogus
Bogus
:  not genuine :  counterfeit, sham

This is a laughable yet alarming, cavalier defamation and attempted character assassination of the medical profession.

Mr. Padmanabhan is described as a business leader & entrepreneur with over 25 years of experience in Technology and Analytics in the Healthcare sector as well as being a consultant in that domain.  I can openly aver that, with an apparent significant bias as seen below towards the medical profession, I would not want him involved in any way in my own care...

There is nothing "bogus" about, for instance,

The author risibly dismisses them all with the word "bogus."  It might be opined that he was too indolent to conduct research, but I'll just opine he doesn't know what he doesn't know and that the opinion piece was based on simple ignorant arrogance.

I am uncertain what "entitlements" he refers to, but using paper records was not a physician "entitlement" - in fact, they are still used when the lousy hospital IT decides to go on vacation as it recently did, for example, at Children's Hospital Boston ("Boston Children’s emerges from electronic records shutdown", Boston Globe, March 25, 2015,  http://www.bostonglobe.com/metro/2015/03/25/boston-children-emerges-from-day-shutdown-electronic-medical-records/Q6sE7hRM4CxFeMEDYWP8IK/story.html#). 

(Of course, patient safety was not compromised - it never is when the IT goes out - right.  See the many posts at the query link http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised.)

Further, the true "lack of accountability" lies with the healthcare IT industry itself and the hospital leadership who agree to their terms of contractual indemnification (Health care information technology vendors' "hold harmless" clause: implications for patients and clinicians. Koppel & Kreda, JAMA. 2009 Mar 25;301(12):1276-8. doi: 10.1001/jama.2009.398, http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf. 

Also see my commentary in a JAMA letter to the editor of July 2009 at http://jama.jamanetwork.com/article.aspx?articleid=184302 emphasizing how these arrangements violate Joint Commission safety standards, and my posting my health IT academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

And that was just responding to the title and subtitle.  Now to the body of the piece:

... In a recent article in a national publication, a member of our physician community raked up a debate by declaring the Electronic Health Records (EHR ) mandate to be a debacle and argued that EHR’s actually harm patients.  These are bogus objections.


Congratulations for disrespecting my mother's grave, Mr. Padmanabhan (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html)  and that of many other people harmed by Information Technology Malpractice as for example in the above links

Also see "The Malpractice Risk of Electronic Health Records", Legal Intelligencer - a Pennsylvania Legal newspaper, March 17, 2015, http://www.thelegalintelligencer.com/most-read-articles/id=1202720405290/The-Malpractice-Risk-of-Electronic-Health-Records.

Thanks for being an expert on the issues you so glibly dismiss, Mr. Padmanabhan.  I guess you forgot to check out the AHRQ hazards taxonomy (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf) and similar resources on health IT risk:




A "bogus" checklist of known EHR risks from the U.S. government.  Click to enlarge.

Back to the opinion piece:

... According to a Rand Corporation study, the three key objections against the implementation of EHR’s:

--It costs too much to implement an EHR system: Yes, it costs money to implement any new software. Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients. What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

"Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients." (?)


Really?

This is an example of a profound anti-physician bias, although one could argue that the term mentioned by Yves Smith on Naked Capitalism, "lunatic triumphalism", comes into play with that statement.

What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

And just what % of the total costs of ownership are covered, Mr. Padmanabhan?   The financial analyses I see show significant clinician unreimbursed expense for the office.

Inpatient settings - that's another matter entirely - we're talking hundreds of millions of dollars or more per organization.

Perhaps my math is wrong, but hundreds of millions of dollars hospitals dish out on corporate health IT can pay for entire new hospitals, or pay for the medical care of countless disadvantaged people.  (e.g., http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html, as well as http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html and http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html)

--It takes time away from patient care: Physicians love to talk about how much they care about being with their patients. However, they also routinely overbook their schedules with the sole intention of increasing patient visits and claiming additional reimbursement.

That's a very serious and, to my knowledge, completely unfounded accusation.  Many physicians are burned out from being compelled to see too many patients by administrators, especially if they are employed which is becoming very common. You in my opinion need to be taught how not to hate physicians and other clinicians, Mr. Padmanabhan:

Physician Burnout: It Just Keeps Getting Worse
Medscape, Jan, 26, 2015
http://www.medscape.com/viewarticle/838437

A national survey published in the Archives of Internal Medicine in 2012 reported that US physicians suffer more burnout than other American workers.[1] This year, in the Medscape Physician Lifestyle Report, 46% of all physicians responded that they had burnout, which is a substantial increase since the Medscape 2013 Lifestyle Report, in which burnout was reported in slightly under 40% of respondents. Burnout is commonly defined as loss of enthusiasm for work, feelings of cynicism, and a low sense of personal accomplishment

Back to the opinion piece:

EHR’s can actually aid their productivity by reducing the time it takes to pull up medical history, so that they have more time to spend on actually talking to their patients.

An expert with far more experience than you, Mr. Padmanabhan, says you are flat wrong (not counting me).  His name is Dr. Clement McDonald, and he is an EHR pioneer ("The Tragedy Of Electronic Medical Records", http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html):

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

Back to the opinion of Mr P.:

--EHR systems are hard to use and are not secure: There may be some merit to this. No one is making claims that EHR systems are perfect.


"May be some merit?"

"May?"


There is perhaps merit to saying Mr. Padmanabhan is either ill-informed, or delivering deliberate misinformation  (e.g., "NIST on the EHR Mission Hostile User Experience", http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html, and multiple posts on breach issues retrievable via query link http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).

However, there are a few key aspects that these physicians prefer to not acknowledge when making these arguments:

--Shared electronic medical records can reduce expenses: Physicians routinely bill for duplicate medical expenses, such as tests, that would be avoided if the test results can simply be pulled up electronically. This should logically reduce healthcare costs at a system level.

Great in theory, but the real world is just not that simple.  Mr. Padmanabhan like many other IT hyper-enthusiasts apparently see IT as a silver bullet.  Just put it in and .... presto!  All complex multi-factorial social problems are solved, with no ill effects. Perhaps he and other hyper-enthusiastic health IT pundits need to read this article:
Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  link to pdf

And this:

"Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality", http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html

More opinion:

--Quality of treatment can improve significantly: When a complete medical record is available about a patient, including details of visits to multiple healthcare professionals, the quality of diagnosis and hence treatment decisions should improve greatly. This improves patient safety and reduces medical errors, since everyone has access to the same set of data.

 That may be the only accurate statement in the opinion piece.  Yet, even this is not proven in the real world, and with today's highly experimental health IT.

--EHR’s can enable preventive diagnosis and early intervention that reduces costs and improves patient health: Enter healthcare analytics. Having patient medical records in an electronic system enables this data to be analyzed for preventive and early action, improved disease management, and reduced hospitalizations. The whole notion of population health management rests on this premise and is hard to argue with.

It's actually easy to argue with, as are most grandiose pronouncements about computational alchemy (i.e., in the world of data, turning lead into gold).

Again in theory, yes, but Mr. Padmanabhan is seemingly unaware of issues I raised in my article "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" at http://www.jpands.org/vol14no2/silverstein.pdf.  The uncontrolled nature of aggregated EHR data, and social factors that skew and bias it, never seem to enter into the minds of the computational alchemists.

The truth is:

  • Physicians, nurses and other clinicians are rightfully afraid of having bad health IT forced upon them due to the constraints of their time, their concentration, and their obligations and legal liabilities; 
  • Physicians are rightfully unwilling to be the experimental subjects of IT hyper-enthusiasts who are so hooked on theory, they ignore the actual downsides of an immature, experimental technology in the real world, including patient injury and death; and

I note that I feel dirtied even having to write this post.

-- SS

Addendum 3/27/15:  

A colleague observed:

.. And I suppose all those current med students and residents who grew up with information technology and have known nothing but  EHR’s are “afraid” of information technology?  I’m hearing complaints from the younger generation about the problems with using them. 

-- SS
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Wednesday, March 25, 2015

Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen?

Years after his death, there is now a little more clarity about the clinical trial in which Dan Markingson was enrolled when he died.  Whether this clarity will have any impact remains to be seen.

We most recently posted about the aftermath of Mr Markingson's death here, (and see posts in 2013 here, and in 2011 here.)  Very briefly, Mr Markingson was an acutely psychotic patient enrolled in a drug trial sponsored by Astra Zeneca at the University of Minnesota.  His enrollment was said to be voluntary although at the time he enrolled he had been under a stayed order that could have involuntarily committed him to care.  Despite his mother's ongoing and vocal concerns that he was not doing well on the study drug and under the care of trial investigators, he continued in the trial until he died violently by his own hand.  After his death, his mother Mary Weiss, friend Mike Howard, and University of Minnesota bioethics professor Carl Elliott campaigned for a fair review of what actually happened.  University managers not only rebuffed their concerns, but harshly criticized Professor Elliott, and ended up reprimanding him for "unprofessional conduct."

Two New Reports

In the last few weeks, two new independent reports on the case appeared.  Both vindicated the concerns and questions raised by Mary Weiss, Mike Howard, and Prof Elliott.

Association for Accreditation of Human Research Protection

One, called for by the University of Minnesota faculty senate, was by the Association for Accreditation of Human Research Protection,  and said that the university left research subjects "susceptible to risks that otherwise would be avoidable" (see this Minneapolis Star-Tribune article.)  Furthermore, according to a post in the Science Insider blog from the American Association for the Advancement of Science, it said,

[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,

Also, it said the university has been

assuming a defensive posture. In other words, in the context of nearly continuous negative attention, the University has not persuaded its critics (from within and outside the University) that it is interested in more than protecting its reputation and that it is instead open to feedback, able to acknowledge its errors, and will take responsibility for deficiencies and their consequences.

Finally, it noted a "climate of fear" in the Department of Psychiatry.

Office of the Legislative Auditor for the State of Minnesota

The second report, available in full here,was from the Office of the Legislative Auditor for Minnesota.  If anything, it was more damning. Its summary included,

the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.

It seemed to affirm in detail nearly all of Weiss', Howard's and Elliott's concerns.  It recommended that the University should suspend new psychiatric drug trials until the problems it identified were remedied (see Star-Tribune article here.)

Vindication, but Will It Lead to Progress?  

Taken together, these reports vindicate the work of Mr Markingson's mother, friend, and academic watchdog Professor Elliott and their supporters.  As the Star-Tribune reported,

'Over the past eleven years the University of Minnesota has made us feel as if we have no voice, no rights and absolutely nothing remotely called justice,' wrote Mike Howard, a close friend to Markingson’s mother, in a letter in the audit. 'This report is the first step toward accountability.'

The Minnesota Post added the response of Professor Elliott and a colleague,

'It’s nice to have an independent confirmation of what we’ve been telling the university for five years, but which they have refused to listen to,' he told MinnPost on Thursday.

Elliott said he is not convinced, however, that Kaler and other university leaders are going to take responsibility for what happened in the Markingson case — or take the necessary steps to fix the problem going forward.

'One of the most worrying findings in the report was the widespread belief on campus that the university leadership doesn’t care about human study subjects,' he said.

Leigh Turner, another U bioethicist who has also been outspoken about the issues raised by the Markingson case, expressed similar concerns. 'Can we expect reform from the very people who have done nothing for the past several years?' he said in a phone interview.

'I hope there’s some change,' he added. 'But the fact that [Markingson died in 2004] and it’s now 2015, I think hope has to be tempered with a dose of realism. There are some very powerful forces interested in minimizing the findings and suggesting that there are only minor things that need to be done.'

It appears there a several major remaining questions.

What Were the Underlying Causes?

Although both reports went into some detail about what happened to Mr Markingson, they seemed not to dwell on why it happened.  They did not seem to address relevant contextual factors, policies, and decisions.  For example, the report by the Office of the Legislative Auditor included,

We understand that the University of Minnesota has been and should continue to be an institution that delivers not only high quality medical care but also engages in cutting edge medical research— research that does pose risks to human subjects. In addition, we do not question the appropriateness of the University obtaining money from pharmaceutical and other medical companies to support that research. However, in every medical research study—whether supported with public or private money—the University must always make the protection of human subjects its paramount responsibility.

However, as we and many others more erudite have discussed frequently, clinical research that evaluates products or services made by the commercial sponsors of the research has proven to be highly susceptible to manipulation by these sponsors to increase the likelihood that the results will serve marketing purposes, and suppression if the manipulation fails to produce the wanted results.  Commercial sponsors often strongly influence the design, implementation, analysis and dissemination of clinical research.  Often their influence is mediated by financial relationships with individual researchers and with academic institutions who seem more and more beholden to outside sponsors, that is, by conflicts of interest.  The report by the Auditor noted pressures, including financial pressures on the physician who ran the study in which Mr Markingson was a subject to enroll more patients and keep them enrolled.  To protect patients better in the future, in my humble opinion the relationships among commercial sponsors, academic medical institutions, and individual researchers need further consideration.  Is the easy money supporting research coming from commercial firms with vested interests in the outcome of that research really worth the risks of biased results, hidden results, and to research subjects?   

Will Anything Change and Will Anyone be Held Accountable?

Once these two reports were delivered, it now seems to be up to university managers to make needed changes.  In general, these are the same managers who are described above as so "defensive," who not only ignored complaints, but appeared to try to silence those who complained.  If they are left in charge, why should we expect them to make any meaningful changes?  Instead, should they  not be held accountable for their actions?  

Will the University Cease Hostilities Against Dr Elliott?

Again, as noted above, university managers did not merely disagree with Professor Elliott.  They disparaged him, appeared to try to intimidate him, and reprimanded him.  It seems at the very least he is owed an apology.  So far, nothing in the news coverage suggests he has or will receive one.

Will Anyone Notice? 

So far, this case has gotten good coverage in Minnesota media.  However, it has largely been ignored in the national media.  Beyond Minnesota, I could only find mention in some blogs, e.g., in PharmaLot by Ed Silverman, and in Forbes by Judy Stone.  I have seen nothing in any US medical or health care journal, although the British Medical Journal did cover it in a news feature.  This case clearly has global implications, and ought to be considered one of the most important cases illustrating the perils of commercially sponsored human research, but it remains proportionately anechoic.

Summary

The latest reports seem only to confirm that clinical research at major academic institutions has gone way off track.  It now seems that in their haste to bring in external funding, university administrators and the academic researchers who are beholden to them have sadly neglected the protection of their own patients.  As we have said ad infinitum, true health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (25 March, 2015) - See also numerous posts by Professor Elliott on the Fear and Loathing in Bioethics blog,  by Bill Gleason in the Periodic Table blog,  and by Mickey Nardo on the 1BoringOldMan blog. 

ADDENDUM (30 March, 2015) - Note that after receiving offline comments, I changed the first paragraph to emphasize the clarity is about the trial, rather than the patient's death, and second paragraph to clarify that the order to commit was stayed.
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Friday, March 20, 2015

A $6.6 Million CEO Dreams of a "Doctor-Less" Future

The CEO of giant hospital system UPMC, Mr Jeffrey Romoff, has been one of the best compensated CEOs of ostensibly non-profit hospital systems.  As we noted here, his 2013-14 compensation was $6.6 million.  UPMC has become so big and its top managers so rich that a former Mayor of the city of Pittsburgh sued the organization claiming it was not really not-for-profit (look here and here).  The leadership of UPMC has previously supplied us with some interesting examples of conflicts of interest (look here and here). 

The announcement of a new alliance of Pittsburgh organizations provided an interesting insight into the thinking for which such a CEO is paid the big bucks.  Leaders of three big organizations, UPMC, the University of Pittsburgh (with which UPMC is affiliated), and Carnegie-Mellon University announced an alliance to use "big data" in health care (see this article in the Pittsburgh Post-Gazette).


UPMC, the University of Pittsburgh and Carnegie Mellon University on Monday announced the formation of the Pittsburgh Health Data Alliance to 'revolutionize health care and wellness' by using data to detect potential outbreaks as well as create health care innovations that will spawn spinoff companies.

The clinical goal, the leaders of the three institutions said, is to remake health care so that it is at once more computerized, yet more personalized, using millions of gigabytes of accumulated health records to predict and treat patients’ health issues in a manner far more specific than is possible today.


Big data now seems to be the latest rage in business schools and among the high-tech crowd, never mind the failures of fancy statistical modeling based on big data that helped lead to the global financial collapse of 2008.  Similarly, despite at least 30 years of research, multivariate prediction and diagnostic modeling in medicine has never lived up to its expectations.  Few models have been demonstrated to be better than mediocre predictors when tested in real-life clinical settings.  Finally, there are numerous concerns about privacy and data security when patients' data is being avidly traded back and forth.

The most striking talk in this meeting, however, was by UPMC CEO Jeffrey Romoff.  The Pittsburgh Post-Gazette noted,

Mr. Romoff said he envisioned 'doctor-less health care,' which is not to say there will be no doctors in the future, but they will be greatly aided by computerized diagnoses, by biometric data gathered on smartphones and transmitted in real time, and by a patient’s own genome. It could result in a new form of  'artificial intelligence,' he said.

The reporter, however, seemed to have edited Mr Romoff to take the edge off what he said.  A video of that part of the conference can be found, for the moment, here.  I transcribed, I believe accurately, Mr Romoff's three most relevant sentences.

The majority of healthcare that everybody receives will be accessible on their handheld device.

We will be thinking about 'doctor-less' healthcare.

We will in fact create an artificial intelligence better than the superb level of intelligence we now have among our physicians and our healthcare professionals.

So, in my humble opinion, it did not sound like Mr Romoff was just envisioning that physicians someday may actually have access to diagnostic or predictive models that are highly accurate for real patients.  He was envisioning replacing physicians with machines, with artificial intelligence. 

Again, never mind that despite years of work and billions of dollars, artificial intelligence so far has proved remarkably dumb.

So furthermore, in my humble opinion, this provided a glimpse into how health care managers now think.  Mr Romoff appears to be a generic manager.  He is not a health care professional, and has no apparent experience taking care of patients (see his official bio, listing his most advanced degree as a Masters in Philosophy).  Generic managers now often seem to think of themselves as some sort of new aristocracy, far removed from the peasants who work for them.  Would not it be easier for such aristocracy to avoid working with such peasants at all?  Machines would be so much neater and cleaner, would not ask for raises or think of unionizing or rebelling (at least outside of the world of Terminator movies).

Leaving aside such fantasies for the moment, the most concerning problem with Mr Romoff's dream of robotic doctors is that anyone who has ever had any direct involvement in health care knows that doctors need to do much more than crunch data and make predictions and diagnoses.  Doctors and other health care professionals have sworn to put patients' interests first.  That implies that doctors must talk to, endeavor to understand, and be empathetic towards their patients.  Many times we doctors may not do this anywhere near perfectly.  But we are human, so can at least try.  Artificial intelligence may be getting closer to making better health care predictions and diagnoses, but does anyone seriously think we are close to making an understanding, empathetic machine?

I believe that Mr Romoff has unwittingly made another argument why he and his fellow generic managers should not be leading health care.  Health care should be lead by people who understand the actual care of patients, uphold health care professionals' values, and are willing to be accountable for putting patients' and the public's health first. 

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Wednesday, March 18, 2015

Same Old, Same Old - Johnson and Johnson Settles Charges it Concealed Adverse Effects of Risperdal, Vaginal Mesh Device, Pleads Guilty to Selling Adulterated Tylenol, Announces CEO Got 48% Raise to $25 Million

We have devoted a lot of bytes over the years to the stream of allegations and ethical questions about Johnson and Johnson, the giant pharmaceutical/ biotechnology/ device company, and resulting legal actions.  Meanwhile, the company has bestowed a gushing stream of money on its top executives.  Its almost spring, 2015, and it seems nothing has changed.

Johnson and Johnson's Latest Legal Misadventures

Jury Verdict that Company Concealed Harms of Risperdal

Let us start with the latest legal news about J&J.  In late February, 2015, as reported on the PharmaLot blog by Ed Silverman,

In a setback to Johnson & Johnson , a Philadelphia jury decided the health care giant must pay $2.5 million in damages for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.

The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.

Moreover, former FDA commissioner David Kessler served as a paid expert witness for the family and testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, had violated the law.

Note that the central allegation in this case was not simply that the drug had adverse effects, but that the company knew about these effects, and hid them.  In my humble opinion, since we entrust pharmaceutical companies to provide safe and effective products, withholding information about adverse effects is a fundamental violation of this trust. 

As noted above, this follows on another case with a much bigger financial settlement about questionable marketing of Risperdal. In addition, as the PharmaLot post noted, there are many more individual cases like this one waiting in the wings, "J&J says there are about 1,200 such lawsuits filed in courts around the country,..."

Jury Verdict that Company Concealed Harms of  Vaginal Mesh Device

Similarly, as reported by Reuters in early March, 2015,

A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to 'malice,' her lawyer said.

Again, note that this lawsuit was not merely about the adverse effects of, in this case, a device, but about allegations that the company knew about these effects, but hid them.  My comments about violation of a fundamental trust above apply. 

Again, this is but one of the earlier cases of a cohort that may number 36,000.

Company Pleads Guilty to Selling Adulterated Tylenol

Finally, as reported in mid-March, 2015, by Reuters,

A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.

The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.

In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.

It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children's Tylenol off pharmacy shelves and seriously tarnished J&J's once-sterling reputation.

In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems.

Furthermore, as emphasized in a report in the Philadelphia Business Journal, this case also involved allegations that the company seemed to conceal the problem.

McNeil, after receiving the consumer complaint, did not initiate or complete a 'corrective action preventive action' plan as required by the federal government.

The federal government also alleged other instances in which McNeil found metal particles in bottles of infants' Tylenol at its Fort Washington facility, but failed to initiate or complete a corrective action plan.

Note that in this case, the company pleaded guilty and so could not claim it was merely settling to put the case behind it.  Furthermore, note that this was not the first case arising from charges that the company sold adulterated products made in the Pennsylvania and other factories (for example, see this post.)   We posted frequently about a long string of recalls of presumed defective or adulterated Johnson and Johnson products (here, here, here and here).  Again, in my humble opinion, we we trust drug companies to sell pure, unadulterated products.  Selling adulterated products again fundamentally violates this trust.

Unfortunately, these three cases, like many of the legal settlements we discuss, involved relatively small penalties that only accrued to the company as a whole.  The monetary penalties, while they may seem large to regular citizens, could appear as relatively trivial costs of doing business to company management.  Furthermore, no individual who authorized, directed, or implemented the behavior identified in these cases suffered any kind of penalty.  So these cases added to the many examples of the impunity of managers of large corporations who almost never seem to bear any legal responsibility for their actions.  In the case of Johnson and Johnson managers, this is all the more striking, since the current cases are just the latest in a very long string.  (See Appendix below for a list of Johnson and Johnson legal misadventures we have discussed since 2010.)


Johnson and Johnson CEO's Latest Raise


Finally, a day later, the Wall Street Journal reported on the continuing good fortune of the Johnson and Johnson CEO, to be contrasted with the company's poor fortunes in the courts of law.

Johnson & Johnson said Chairman and Chief Executive Alex Gorsky’s total compensation jumped 48% to $25 million last year, lifted by an increase in stock and option awards. Mr. Gorsky’s stock and option awards rose to a total value of $13.6 million from $8.7 million a year earlier. The board also raised Mr. Gorsky’s base salary to $1.5 million from $1.45 million in 2013, and the CEO also benefited from a jump in pension value.

In a filing Wednesday, the pharmaceutical giant said Mr. Gorsky’s compensation increase was based on the board’s conclusion that J&J successfully executed near-term priorities, exceeded financial goals and built on momentum in its pharmaceutical business.

As a result, J&J awarded Mr. Gorsky an annual performance bonus of 135% of target and long-term incentives at 130% of target. Awards at J&J are capped at 200% of target.

The article noted that at least one other top Johnson and Johnson manager also was raking it in.

Paulus Stoffels, world-wide chairman of Pharmaceuticals, made $18.3 million last year, more than double his 2013 total compensation, boosted by a stock award of $10.7 million.
Funny, the board's rosy view of Mr Gorsky's performance seemed totally uninformed by the company's latest legal misadventures.

(By the way, to anyone who would argue that many of these misadventures were the results of behavior that occurred before Mr Gorsky became CEO, note that his official company biography stated that he joined the company's Executive Committee in 2009, implying some shared responsibility for overall company management since then.)

Same Old, Same Old

A few weeks back, one of our commentators complained that our posts have a certain sameness.  Unfortunately, we agree.  We keep seeing variants of the same sorts of outrageous stories in the news media that we began to post about in 2004.   The problems are not getting better.  Perhaps they are getting worse.

In particular, we have previously contrasted this particular company's recurrent legal and ethical problems with its top managers' accumulating wealth.  In 2011 we posted about the contrast between previous Johnson and Johnson CEO William Weldon's enlarging fortune and political influence with some of the earlier legal cases that raised questions about the trustworthiness of the company.

But the point of this blog is not to come up with titillating stories to make people chuckle.  The point is to challenge the continuing, severe problems afflicting the leadership and governance of health care, the resulting incompetent, unethical, and sometimes criminal behavior, and the downstream effects on patients' and the public's health.  Do not blame the messenger for the sameness of the problem.  Blame those who are getting wealthy and powerful from the ongoing decline in health care. 

If we truly want to see more accessible, more effective, less costly health care in our life times, we need to first call out the bad leadership that has kept such aspirations at bay for so long, and second start to hold current leadership accountable for the mess they have made.


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). 
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Monday, March 16, 2015

Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

Here are three candid, quite revealing articles about the distaste for today's health IT that appeared recently.  I will address each,

The first seems like pure deja vu (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html):

1.  Forbes:  Pentagon's $11 Billion Healthcare Record System Will Be Obsolete Before It's Even Built -  March 3, 2015
http://www.forbes.com/sites/lorenthompson/2015/03/03/military-healthcare-11-billion-record-system-will-be-obsolete-before-its-even-built/

... No doubt about it, the project managers understand how to speak the language of acquisition reform.  However, a close look at what their site proposes to do for the 9.6 million active-duty warfighters and dependents in the military healthcare system reveals that this effort is going to fail.  It will probably be better than what it replaces, but it will lag far, far behind the kind of performance that users of internet-based technologies have come to expect.  So soldiers and sailors and airmen and marines — and their dependents — aren’t going to get the quality of care they deserve, and some will suffer mightily as a result.

In order to understand why the modernization initiative is doomed to failure, you need only grasp the significance of two key phrases the program office uses in its approach to industry for proposals.  First, it says it is seeking a “state-of-the-market” electronic health record system.  Second, it says whatever it selects will be an “off-the-shelf” product.  In other words, it is seeking to acquire an electronic health record system that already exists in an industry noted for its antiquated approach to the movement of information.  Furthermore, despite the program office’s insistence that it will avoid getting locked into reliance on a single monopolistic vendor, the project manager told Politico he envisions the contract as “an extensive prenup and no divorce.”

In other words, what I have described for years as a "business computing" oriented approach to clinical computing - an approach as guaranteed to fail as confusing psychiatry with neurosurgery because they both treat brain disorders, and trying to treat a brain tumor with psychotherapy or a personality disorder with a scalpel.  Specifics matter.

Sounds like vendor lock to me.  The business model the program is pursuing resembles a proprietary enterprise software system of the sort that many major hospitals have installed.

If you don’t know what an enterprise software system is, the first sentence in Wikipedia’s entry on the subject gets to the point: “Enterprise software…is purpose-designed computer software used to satisfy the needs of an organization rather than individual users.”  Got that — rather than individual users?  This approach to information system design is a throwback to the pre-internet days of mainframe computers.  In fact, the dominant version currently in use by private healthcare providers relies on upgrades to software developed nearly half a century ago at the Massachusetts General Hospital.

It's not a throwback to the mainframe era.  It represents the now-obsolete but still dominant, defective control-mentality acculturation and over-empowerment of information technologists (e.g., http://dl.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM).  This acculturation is a remnant not of mainframe days but of the card tabulator data processing era (http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html).


2.  Health Affairs:  Where Is HITECH’s $35 Billion Dollar Investment Going? - March 4, 2015
http://m.healthaffairs.org/blog/2015/03/04/where-is-hitechs-35-billion-dollar-investment-going/

by Sen. John Thune, Sen. Lamar Alexander, Sen. Pat Roberts, Sen. Richard Burr, and Sen. Mike Enzi
 
On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

I note that the statement "there is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care" is a euphemistic way of saying "there is conclusive evidence that the program has not achieved its goals of increasing efficiency, reducing costs, and improving the quality of car."

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

Instead, according to physician surveys, electronic health records (EHRs) are a leading cause of anxiety for physicians across the country. The EHR products are not meaningful to physicians, which is clear when you consider that half of all physicians will have their Medicare payments cut in 2015 for not adopting government benchmarks for EHRs. ... After spending $28 billion so far of the $35 billion total taxpayer investment, significant progress toward interoperability has been elusive.

Sadly, our elected officials still don't quite understand that the largest drawback to today's health IT is not lack of interoperability, but lack of basic operability (usability). 

However, $7 billion of the HITECH $35 billion is still available to waste in order to learn that lesson.


... In listening to the concerns from EHR vendors and EHR users from across the care continuum, ONC has taken an important turn under the leadership of Dr. Karen DeSalvo. The previous ONC leadership did not understand the difficulty and enormity of creating government-approved products in a market that struggled to exist before government incentives arrived.

As a result, our nation’s health care providers are stuck with the huge cost of unwieldy systems trying to conform to government mandates. They are stuck adopting EHR systems which don’t fit into their established workflows. And if they actually want to share their patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the exam room looking at her physician use a computer instead of directly talking with her, who likely has seen no better access to her own data, and who is struggling to understand why her doctor has such a difficult time getting her lab results.

This is not exactly an endorsement of ONC's prior leaders.  Perhaps the aforementioned "previous ONC leadership" should have read this blog more carefully.  Or the Wall Street Joutnal where I spelled these outcomes out in 2009.  Emphases mine:

http://www.wsj.com/articles/SB123492035330205101

Feb. 18, 2009

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

These were easy predictions to make based on experience and papers such as this.

Finally:

3.  HealthcareDive.com, Has the AMA lost its mojo?  - March 9. 2015
http://www.healthcaredive.com/news/has-the-ama-lost-its-mojo/372532/

As the mainstream media has begun to realize that organized physicians groups are doing all they can to resist adopting EHRs, the coverage of the dispute has revealed just how little impact their efforts—​led by the AMA—​are achieving in accomplishing their goals.

The AMA has come out vehemently against the Meaningful Use program and the high velocity with which the HHS and Congress want doctors to adopt EHRs, and they have written countless letters, position papers and blueprints for reform to announce their displeasure. Moreover, more than 30 other physicians groups have signed on to their copious letters. A recent USA Today piece quoted the incoming chief of the AMA about EHRs.

"Physicians passionately despise their electronic health records," says Lexington, KY, emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

A 2013 AMA/RAND study revealed that EHRs are at the root of the modern doctor’s dissatisfaction with his job.

I note that up until relatively recently, the AMA was largely a defender of today's EHR technology.  They certainly got what they wished for...

"Physicians believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a natural scientist at RAND, a nonprofit research organization. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients."

In fact, I believe this oft-made statement about "most do not want to go back to paper charts" is incomplete and misleading.  In terms of retrieving data such as labs and images, most probably would not want to go back to paper.  On the other hand, most probably would like to be able to document and enter orders on paper and have clerical personnel transcribe that information into computers - instead of the physicians being the clerical persons themselves, and gratis.


... According to a piece on Wall Street Cheat Sheet, there could be a couple of reasons why the AMA seems to keep getting shut out—​namely the AHA and the Blues.

While the AMA had $19 million to lobby Congress, the American Hospital Association—​which represents providers who took a financial hit after the last ICD-10 adoption delay—​spent $20.75 million last year to lobby lawmakers. Big insurer Blue Cross and Blue Shield, which would also benefit from wide adoption of EHRs and ICD-10, spent $21.3 million in 2014. That's a combined $42 million, more than double the AMA's effort.

Now, factor into that the extreme amount of influence wielded by the tech sector—​Google alone spent $17.5 million in lobbying Congress in 2014—​and the scent in the wind becomes easy to identify. The tech sector stands to make billions from EHR creation and management. Insurers need ICD-10 and EHRs to bring better cost management into their industry, enabling them to spend less as they pay for more care for more patients. Finally, hospitals need the tech because the ACA is bringing millions of new patients into their doors, and the old pegboard and paper systems that doctors are trying to cling to just won't work for hospitals that see tens of thousands of patients each month.

The AMA has set up a showdown on ICD-10 and EHRs that it will lose, and lose big, because it just plain does not carry the muscle it used to.

In other words, medicine has been invaded by the Information Technology industry and the profiteers who stand to benefit from that technology, with the bulk of the work being performed by clinicians, for free and to patient detriment.

This seems a clear formula for clinicians to simply refuse to use health IT altogether for data entry and demand a return to paper data recording with clerical transcription, but alas, it's likely too late for a revolt like that.

As health IT continues to get well-deserved and long-overdue bad press like this, one wonders if our culture will start to recover from the state of health IT delirium it is in.

I am in doubt.

(See my Jan. 20, 2011 post "Healthcare IT delirium" at http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html for more on that issue).

-- SS

3/16/15 Addendum:

A physician actually proposes physicians be paid for clerical work:

Pay doctors and nurses for the time they spend charting
http://www.kevinmd.com/blog/2015/03/pay-doctors-nurses-time-spend-charting.html

-- SS

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An ironically titled session by ECRI Institute: "Would You Bet Your Mother's Life on the Safety of Your EHR?"

An ironically titled session by ECRI Institute "Would You Bet Your Mother's Life on the Safety of Your EHR?" is being held at the annual Health Information Management Systems Society (HIMSS) meeting by Ronni Solomon, JD and William Marella, MBA of the ECRI Institute on April 13, 2015 (http://www.himssconference.org/event.aspx?ItemNumber=36765).

It is announced in the HIMSS press release below in Healthcare IT News.

I should probably be the keynote speaker to that session, as I am suitably qualified to speak of that exact issue.  My mother and I lost such a "bet" (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html).

It's about time these topics were surfaced, but I still feel there is far too little public awareness of the risks of bad health IT.

http://www.healthcareitnews.com/news/ridding-ehrs-dangerous-often-undetectable-bad-data 
Ridding EHRs of dangerous, often undetectable, bad data
March 13, 2015
As the healthcare industry continues toward its goal of making all patient health records electronically accessible, a health system’s safety increasingly is determined by the quality of its EHR implementation.


Last November ECRI Institute, a non-profit organization that uses scientific methods to test medical products, rated “incorrect or missing data in electronic health records and other health IT systems” as the No. 2 hazard that will put patients at risk in 2015.

“Once inaccurate data gets into the electronic health record, it’s hard to get it out,” said Ronni Solomon, executive vice president and general counsel for ECRI Institute. “That’s a challenge, and the less detectable it is, the higher the risk. You don’t know it’s in there.”

Such incorrect information probably has far more impact than it did on paper, I believe; computer output is often uncritically taken as gospel, and is often cut-and-pasted to newer records without patient interaction, thus propagating an error of omission, commission or data loss or corruption (due to malfunction).

The negative impact of bad data in electronic health records is both immediate and long-lasting. “In the short-run, bad data in the system limits the effectiveness of clinical communications and the effectiveness of decision support,” added William Marella, ECRI’s executive director, PSO operations and analytics. “And basically it undermines people’s confidence in the system.”

Especially the clinicians' confidence, which is already low (e.g., see my Jan. 28, 2015 post "Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html).

Solomon and Marella will conduct an educational session at HIMSS15 in April on how healthcare organizations can apply safety science to IT and informatics to improve patient safety.

The first step they can take is to strip control of critical health IT decisions from the business-IT personnel and put heath IT under the aegis of medical leadership, especially medical leadership that contains formally-educated Medical Informatics and related professionals.  (This admittedly and unfortunately has a very low chance of happening due to hospital politics and power structures.)

“Would You Bet Your Mother's Life on the Safety of Your EHR?” is designed to help attendees create a framework for planning and implementing IT strategies, processes and tools to increase the safety of healthcare patients.

Both Ms. Solomon and Mr. Marella are aware of what happened to my mother.  I wonder out loud if the title is based on, at least in part, that incident.

... “The promise of these systems is that they’re going to make the health care system more efficient and ultimately more safe,” Marella said. “Now the administrators in hospitals and health systems that have financed these systems want a return on their investment.”


Perhaps the administrators should have done due diligence on the realities of this technology before investing the money.

The session will cover how organizations can: establish an infrastructure for identifying and responding to patient safety problems; assess safety challenges facing health IT users and implementers; identify partnerships that can accelerate safety improvements; and analyze opportunities to use informatics to prevent adverse events.


“What we’re trying to do in this talk is get in front of the IT leaders of these institutions and help them understand where patient safety people are coming from and how we can bridge these two silos within the health system, because they will both be more effective working together,” Marella said.

I add that all of these goals should have been met prior to a national rollout and, at each organization, prior to subjecting patients to these technologies, but I speak common sense, which in medicine is no longer common.  Thus, sessions like this one in 2015.



Perhaps this could be the theme poster for the session.


-- SS
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Monday, March 09, 2015

Health Care Run by Those "Who See the Practice of Medicine as a Set of Economic Transactions," or as a "Moral Endeavor?"

Calls are getting louder for restoring medicine and health care as a calling that puts patients first, versus a business that puts money first.  For example, in the conclusion of her opening talk for the 2015 Lown Institute Annual Conference: the Road to RightCare, Shannon Brownlee said, [with italics added for emphasis]

So today I stand before you not as a writer turned health policy expert turned health care activist, though I’m still all of those things. I stand before you as a mother, a wife, a daughter . . . and a citizen. I stand before you filled on the one hand, with dismay . . . and on the other hand with a full measure of hope. I stand here to welcome you to the work we are all doing to transform healthcare.

And our first step is to name our task. It is not just stamping out overuse, though we must do that. It is not just ensuring that patients get the care they need. Though that is unfinished business.

Getting to the right care also requires that we recognize the historic choice we face between opposing world views. On one side are those who see the practice of medicine as a set of economic transactions, and healthcare as just another business. This side thinks the market solves all ills. This side sees the health professions as the labor needed to run a highly profitable industry. You are the 'providers' of services -- the help. Patients are revenue. Excuse me, 'consumers.'

On the other side of this divide are those who see healthcare as a moral endeavor. This side seeks to serve both patients and the common social good. This side knows that ignoring the patient as vulnerable human being is the quintessential failure of our system. This side acknowledges our need for hospitals, and for companies to manufacture drugs, and devices, and scalpels and surgical gloves. But the delivery of healthcare should not be designed for their benefit.

If we want to get to the right care, we must begin to envision a vastly different system. A just system. A system whose purpose is to serve patients and communities. A system that is not just reformed, but radically transformed.

The purpose of this conference, the reason we are all here today, is to find our way towards that transformation.
[The above was reprinted with Ms Brownlee's permission.]

On Health Care Renewal, we have long been showing the consequences of health care run by generic managers who believe the business school dogma of promoting "shareholder" value, even when their organization has no shareholders, by putting short term revenue ahead of all else.  They are backed by market fundamentalists who believe all of human life can be reduced to business transactions.  The results have been very profitable to some, particularly to the very same generic managers, in terms of every rising executive compensation untethered to any clear evidence for these managers' achievements, beyond making money.  I have suggested that this has become a major cause of health care dysfunction, of ever rising costs, shrinking access, and threatened quality.  True health reform, or transformation, to use Ms Brownlee's term, would restore the priority of patients' and the public's health, and return health care to those who see it as a calling, not just a way to get rich. 
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Thursday, March 05, 2015

A "PR Pawn" Confounds the Public Relations Burnishing of Texas Health Resources and its CEO

The Ebola virus epidemic in Africa is hopefully winding down.  The uproar, if not panic, over Ebola virus in the US has been eclipsed by the latest  internet craze.  However, we are still learning from the echoes of the brief, and thankfully very localized US experience with Ebola.

In particular, the country's response to the virus should continue to inspire unease about how our supposedly market based, managerially focused health care non-system can handle real public health threats.

Background - Ebola at Texas Health Presbyterian

Starting on October 2, 2015, we discussed numerous concerns about whether problems with leadership or management at Texas Health Presbyterian hospital, part of the Texas Health Resources system, contributed to the poor outcomes of its Ebola patients.  First, InformaticsMD raised questions about whether a badly designed or implemented electronic health record at the hospital enabled the initial misdiagnosis of Eric Duncan, the first patient to present with the Ebola virus on US soil.  These questions were reinforced when hospital managers gave conflicting responses on this issue.  He expanded on these questions here.

A week later, I wrote about the "mystery of the discharged Ebola patient," asking:  why don't we know yet exactly what happened when our Ebola patient zero first appeared?  I wondered then whether a decision by management to shift the health system's emphasis from acute care to "population health management," whatever that is, might have lead to problems addressing what was a severe, acute medical problem (albeit with public health implications.)    About a week later, I wrote about the questions raised by inconsistencies in hospital managers' statements, about Mr Duncan's clinical status and the failure to initially accurately diagnose his infection, about the hospital's readiness to handle Ebola patients, and about whether hospital professional staff may have been silenced by administrators, and if so, why?


By late November, 2014, a Texas Health Presbyterian nurse had gone public with accusations that the initial care of Mr Duncan had been chaotic; Mr Duncan had died; and two nurses who cared for him after he was admitted after his second emergency visit to Texas Health Presbyterian had contracted Ebola infections; but no new Ebola cases had been diagnosed in the US, and Ebola was starting to fade from the media.   At that time, I wrote that the three questions above remained unanswered.  However, Texas Health Resources, the parent system for Texas Health Presbyterian, had hired Burton-Marsteller, a big public relations firm, and  managers of both companies generated considerable verbiage, but no specific answers and no real enlightenment.  Hospital managers had already pointed their fingers elsewhere, at the US Centers for Disease Control and Prevention (CDC) for inadequate guidelines, unnamed third parties for exploiting the crisis, and the media for sensationalizing it. Hospital managers had sponsored a pep rally, but the health professionals who appeared there either seemed to stick to talking points, or remained "tight lipped."   The hospital settled a lawsuit filed by Mr Duncan's relatives, and Micahel Barden, the THR president, submitted to an interview in which he boasted of a "high level of communication" and asserted the system had "maintained the trust level," but did not supply any specifics.

Since November, 2014, no further specifics have appeared about what happened at Texas Health Presbyterian.

The Public Relations Burnishing of Texas Health Resource Management

Instead, since October, 2014, a series of events and media reports seemed more about burnishing the management of Texas Health Resources, and particularly its CEO, Barclay Berdan, than about learning from the problems that occurred when the US first encountered the Ebola virus.

On November 29, 2014, Modern Healthcare published an interview with Mr Berdan including leading questions like:

Has this Ebola crisis caused you to take a broader look at hospital-acquired infections?

How were you able to maintain high staff morale throughout this crisis?

The answer to that last question was particularly upbeat:

It was really important to make sure that we had a high level of communication and that we maintained trust inside the organization while we were in many cases being attacked from the outside, as the world moved from science to political science to social science to superstition and fear. That helped us keep the morale of the organization up and to keep people focused on the fact that we had a lot of patients to take care of.

Even though our patient census dropped by 20%, we told everybody we weren't going to reduce staffing. We were going to keep people working at their regular rates and times. We kept everybody really focused on this challenge, that we had to stay strong and get through this period of time.

Note that this implied communications had always been good, trust had always been maintained, and morale had never declined. There were no followup questions, particularly whether staff morale could have seemed good because dissent had been silenced? 

On December 5, 2014, the D Healthcare Daily reported on an event in which Mr Berdan participated, and treated him as an honored expert.  Berdan was quoted, for example,

The best thing you can do—if you’re a local hospital, if you’re a rural hospital or an urban hospital—is to try and figure out how to manage the safety of your employees, the safety of your institution, the safety of patients who may present with, in this case, a disease that already causes people great fear.

The article trumpeted how selflessly Berdan has led THR to teach other hospitals about Ebola, with the underlying assumption that it had valuable lessons to teach:
 
THR has shared what it’s learned with other hospitals, both in North Texas and across the country. It held a webinar with 1,200 medical professionals to share what it learned and changed....

On December 5, 2014, D Healthcare Daily also noted that at the event, an award was given to caregivers who dealt with ebola at Texas Health Presbyterian, but who accepted the award on their behalf? 

Barclay Berdan, CEO of Texas Health Resources, was center-stage on Tuesday at the Sheraton downtown, flanked by more than a dozen staffers representing the 100-plus caregivers who helped treat the three Ebola patients in October.

The Dallas Regional Chamber presented the caregivers of Texas Health Presbyterian Dallas with the Courage of Public Service Award, an annual recognition that honors groups or officials who 'demonstrated significant leadership on important issues.'

After Berdan gave his little speech, next up on stage were:

Texas Health Resources Board Chair Anne Bass and Presbyterian Hospital Board Chair Stan Rabin walked up first,... 

Although the actual caregivers were supposedly being honored, airtime and coverage went to board chairs.

Then last month (February, 2015), it began again. Another interview with Mr Berdan appeared in D Healthcare Daily. It allowed Mr Berdan to pontificate on issues like the hospital system's growth plans, and to go back to the idea of population health as more important than acute care,

I think we’re looking always to find good opportunities to improve the health of the people in the communities we serve, and that’s our mission. In fact, we have really changed the scope and direction of our organization over the last four or five years from being a great acute care hospital company—you referenced all of our hospital properties in North Texas—to really being a health company.

Ebola, and the questions I raised above, were not featured. 

Finally, in the March issue (available in late February, 2015), D Magazine published, "How Texas Health Managed its Ebola Crisis," focused, of course, on CEO Barcaly Berdan. It featured a large color photograph of Mr Berdan.  It seemed to suggest that the most important issue was maintaining the reputation of the hospital system, rather than for example, being transparent about and learning from mistakes. It featured a big informal portrait of Mr Berdan, and started with how Mr Berdan managed the first news conference about Ebola, rather than, for example, the details of Mr Duncan's encounters with THR.

To Berdan, it was important to show that Presby—one of Dallas County’s largest and busiest hospitals—was safe and open for business.

The article described Berdan as an "unassuming man who speaks with confidence and fatherly authority," an "able communicator," a man whose "word is his bond," and eventually, "a battle tested CEO." It stated that "the treatment of Duncan - and the safety of the men and women who volunteered to care for him - rested squarely on his shoulders." Yet, of course, Mr Berdan's highest degree was an MBA, from University of Chicago, no less. He may have had a public relations battle, but he did not have to walk into a room containing a highly infectious Ebola patient. He actually should not have had any authority over the actual treatment of Mr Duncan. That should have been in the hands of the patient's doctors and nurses.

The article obliquely addressed the unanswered questions, but did provide substantive answers. Why was Mr Duncan not diagnosed accurately?

Privacy laws prevented the hospital from discussing the care provided Duncan until he permitted them to....

Was the hospital prepared to take care of Ebola patients?

We were moving in parallel with the CDC's ongoing recommendations....

Were health professionals silenced? The hospital paraded four nurses in front of 60 Minutes' cameras:

On the evening of Oct. 26, wearing blue scrubs and seated in front of a jet-black background, nurses Sidia Rose, John Mulligan, Richard Townsend, and Krista Schaefer offered a poignant and moving narrative of Duncan’s treatment. It was the most substantive account offered to that point.

The final section of the article was entitled, "On the Mend." Again, the emphasis was on PR.

THR had positive momentum. Once a pin-cushion, its public reputation was improving.

The hospital settled a lawsuit with Mr Duncan's relatives for an undisclosed sum. After the settlement was announced, Mr Duncan's nephew proclaimed:

This facility is an outstanding facility, and we as humans are not perfect.

Maybe getting a big sum of money can make one more philosophical about human imperfections.

The article ended up describing how

North Texas seems to have appreciated the efforts of THR under Berdan....

It all sounded so rosy, at least for a few days.

A "PR Pawn" Strikes Back, or, Nina Pham Administers a Corrective

Only a few days after the D Magazine piece appeared, the Dallas Morning News published an article about Nina Pham, the first THR nurse to have been infected with Ebola virus after caring for Mr Duncan.  Pham had never previously been portrayed as a dissident, and had been seen in the media as a young professional gamely facing down the virus and supporting her fellow nurses.  Now, however, rather than participating further in the feel good celebration of THR and Mr Berdan, Ms Pham announced she would be suing the hospital and THR.


She says the hospital and its parent company, Texas Health Resources, failed her and her colleagues who cared for Thomas Eric Duncan, the first person in the United States diagnosed with Ebola.

'I wanted to believe that they would have my back and take care of me, but they just haven’t risen to the occasion,' Pham told The Dallas Morning News

Pham reaffirmed the contention that Texas Health Presbyterian was not prepared to care for Ebola patients.

In her 90-minute interview, Pham described working in chaotic surroundings at the hospital with ill-prepared nurses who received little guidance on how to treat Ebola and protect themselves.

In particular,

She said the extent of her Ebola training was a printout of guidelines that her supervisor found on the Web.

And


The day Duncan moved to ICU, Pham said, she and the charge nurse went in with double gloves taped to double gowns and wore double booties and a face shield. The hospital did not have hazmat-type suits, and Pham said her neck was always exposed.

'We’ve had nurses that I’ve worked with that worked in other states, and they worked in hazmat suits for flu and H1N1,' Pham said. 'Why aren’t we wearing hazmat suits for Ebola?'

After days of asking, Pham said, the nurses were given hazmat suits. She said all the decisions to upgrade the protective gear and precautions were made by the nurses 'on the fly.'

 Meanwhile, the nurses devised their own hazardous waste area. In a room adjacent to Duncan’s, the nurses set up a place to take off their protective gear and shower after caring for him. In another nearby room, they placed bags of dirty linens, towels and other soiled items.

Finally,

while she became the American face of the fight against the disease, the hospital’s lack of training and proper equipment and violations of her privacy made her 'a symbol of corporate neglect — a casualty of a hospital system’s failure to prepare for a known and impending medical crisis.'

She also contradicted much of the feel good public relations speak found in the articles above.  The D Magazine article had referred to Pham and the other nurses who care for Mr Duncan as "the men and women who volunteered to care for him."  In contrast, the Dallas Morning News article said "she did not volunteer to care for Duncan, but felt she couldn't say no."

During the crisis, Pham was seen in a video where she appeared gamely optimistic.  However,

She says that Texas Health Resources violated her privacy while she was a patient at Presbyterian by ignoring her request that 'no information' be released about her. She said a doctor recorded her on video in her hospital room and released it to the public without her permission.

While the hospital argued that Pham gave permission to make the video,


The day Pham was transferred to NIH, a notation was made in her medical file that 'she does not have the mental capability to make end-of-life decisions,' [Pham's attorney Charla] Aldous said. But PR people from Texas Health were trying to talk to her for a media release 'about how much she loves Presbyterian,' Aldous said.

Texas Health, with a PR firm’s help, developed a slogan — 'Presby Proud' — aimed at restoring the community’s faith in the beleaguered hospital.

Before Pham’s flight to Maryland on Oct. 16, she said, a doctor wearing a video camera under his protective hood came into her room and said he was filming her for educational purposes. Pham said she did not give permission for the video, which was released to the media.

'Thanks for getting well. Thanks for being part of the volunteer team to take care of our first patient,' a man’s voice said in the video. 'It means a lot. This has been a huge effort by all of you guys.'

'I could tell they wanted me to stay just because they kind of knew, they could see I was getting better. They wanted that ‘yes we cured her’ kind of attitude. They wanted a win, especially after a loss.' - Nina Pham


Charla Aldous, Pham’s attorney, put it all more simply:

Texas Health Resources 'used Nina as a PR pawn.'

Summary

So it looks like back to the drawing board for the public relations flacks who have been defending the "reputation" of Texas Health Resources, and, in my humble opinion, mainly the reputation of its CEO, Barclay Berdan.  After questions about its preparedness for and the care of Ebola patients, and about whether managers overrode and silenced health care professionals, the hospital system had put on a big public relations campaign, in concert with a big outside PR firm.  Yet all the questions have now resurfaced as one of the hospital nurses put before the public as brave yet ever loyal to "Presby" now says she was turned into a "PR pawn." 

Of course, the immediate response by the hospital and the CEO were to trot out the old talking points.  In the Dallas Morning News article, spokesman Wendell Watson said,

Nina Pham bravely served Texas Health Dallas during a most difficult time.  We continue to support and wish the best for her, and we remain positive that constructive dialogue can resolve this matter.

Later, as again reported by the Dallas Morning News, CEO Barclay Berdan tried to refute Ms Pham's contention that her privacy was violated by saying:

We adhered to HIPAA rules in determining what information to share publicly.  

But HIPAA rules are notoriously hard to interpret and implement.

Also,

We had Nina's consent to share the information about her that was released.

But she had contended she was too ill, and confused on pain relief medicines to give informed consent, and aspects of her record apparently corroborate that. 

So the questions about what was going on at THR persist.  The latest twist in the story does emphasize how important public relations has become to contemporary hospital managers.  One cannot avoid the notion that most of what went on in the C-suites of Texas Health Presbyterian and Texas Health Resources in response to the presence of three Ebola patients was about public relations, protecting the reputation of the hospital, and particularly celebrating its very well paid MBA CEO.  Of course if leaders focus on public relations, maybe they will not do such a good job supporting the health care professionals who actually care for patients, and ultimately supporting the patients' and the public's health.

So as I said a while ago about this case, the rise of generic managers who value, among other things, favorable public relations perhaps to the detriment of patient care, threatens the US' ability to care for acutely ill patients, especially in the context of new or epidemic diseases.  True health care reform would restore leadership by people who understand the health care context, uphold health professionals' values, are willing to be held accountable, and put patients' and the public's health ahead of self-interest.

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