Wednesday, October 15, 2014

Are Million Dollar Plus Business Trained Managers the Right People to Lead Health Care in the Time of Ebola?

You can guess my opinion on the answer.

Introduction

News and opinions about Ebola virus are swirling around the US, fueled by a tragic epidemic in West Africa, and fears that more infections could appear here.  On October 6, 2014, I posted my concerns that despite a tremendous amount of confidence expressed by government officials and health care leaders, our dysfunctional health care system might have trouble containing Ebola virus.  Less than two weeks later, my concerns do not seem so extreme.  The first patient to be diagnosed with Ebola virus in the US has died.  Two nurses who cared for him now have the virus.

There seem to be millions of words on paper and on the internet about Ebola appearing every day.  So I certainly do not want to try to deal with the problem in all its aspects.  I do want to revisit a particular set of issues from my October 6 post: the hazards posed by generic management deluded by business school dogma running health care institutions in the time of Ebola.  In particular, my focus is the management of the US hospital at which one patient died, and two nurses were infected, based on what has come out since October 6.

The Incoherence of Hospital Leaders

On October 6, we noted that the hospital, Texas Health Presbyterian, part of the Texas Health Resources hospital system, had issued conflicting and confusing statements about why the first Ebola patient, Mr Thomas Eric Duncan, was sent home from the hospital when he first presented.  The first specific statement by hospital managers was that there had been a problem with the hospital's electronic health record (EHR), as had been suspected by my fellow Health Care Renewal blogger, InformaticsMD.  Then the hospital retracted that statement, but provided no explanation with which to replace it.

Since then, there have been more inconsistencies in statements made by hospital managers.

Fever or No Fever?

First hospital managers said Mr Duncan arrived without a fever, but then review of his medical records indicated his temperature was as high as 103 degrees F while he was in the hospital, a fever high enough that it might reasonably have prompted admission given his other symptoms, even if Ebola was not a concern.  (See this Dallas Morning News story.)

Readiness for Ebola Patients?

Hospital managers assured the public they were ready for Ebola virus patients, e.g., in the Dallas Morning News story of September 30, 2014

When Ebola arrived, they were ready.

The staff at Texas Health Presbyterian Hospital of Dallas did a run-through just last week of procedures to follow if the deadly virus landed in Dallas.

'We were prepared,' Dr. Edward Goodman, an epidemiologist at Texas Health Presbyterian, said Tuesday in a news conference. 'We have had a plan in place for some time now in the event of a patient presenting with possible Ebola. We are well-prepared to deal with this crisis.'

Presbyterian said it is following recommendations from the U.S. Centers for Disease Control and Prevention and the Texas Department of Health in responding to the patient, described as being 'critically ill' at the hospital in northeast Dallas.

All precautions are being taken to protect doctors, nurses and others in the hospital, officials said.

Sadly, this statement soon seemed, as one politician once said, inoperative. an October 14 Washington Post article described how hospital health professionals had to essentially make up their procedures as they went along.


The hospital that treated Ebola victim Thomas Eric Duncan had to learn on the fly how to control the deadly virus, adding new layers of protective gear for workers in what became a losing battle to keep the contagion from spreading, a top official with the Centers for Disease Control and Prevention said Tuesday.

'They kept adding more protective equipment as the patient [Duncan] deteriorated. They had masks first, then face shields, then the positive-pressure respirator. They added a second pair of gloves,' said Pierre Rollin, a CDC epidemiologist.

Also,

He said the hospital originally had no full-body biohazard suits equipped with respirators but now has about a dozen. Protocols evolved at the hospital while Duncan was being treated, he said: 'Collecting samples, with needles, then you have to have two people, one to watch. I think when the patient arrived they didn’t have someone to watch.'

Worse, in the last 24 hours, there have been reports by anonymous people said to be nurses at Texas Health Presbyterian that the hospital was clearly not ready, per the Los Angeles Times,

The nurses' statement alleged that when Duncan was brought to Texas Health Presbyterian by ambulance with Ebola-like symptoms, he was 'left for several hours, not in isolation, in an area' where up to seven other patients were.  'Subsequently, a nurse supervisor arrived and demanded that he be moved to an isolation unit, yet faced stiff resistance from other hospital authorities,' they alleged.

Duncan's lab samples were sent through the usual hospital tube system 'without being specifically sealed and hand-delivered. The result is that the entire tube system … was potentially contaminated,' they said.

The statement described a hospital with no clear rules on how to handle Ebola patients, despite months of alerts from the U.S. Centers for Disease Control and Prevention in Atlanta about the possibility of Ebola coming to the United States.

'There was no advanced preparedness on what to do with the patient. There was no protocol. There was no system. The nurses were asked to call the infectious disease department' if they had questions, but that department didn't have answers either, the statement said. So nurses were essentially left to figure things out on their own as they dealt with 'copious amounts' of highly contagious bodily fluids from the dying Duncan while they wore gloves with no wrist tape, flimsy gowns that did not cover their necks, and no surgical booties, the statement alleged.

'Hospital officials allowed nurses who interacted with Mr. Duncan to then continue normal patient-care duties,' potentially exposing others, it said.

In response, the official hospital statement (authored by one Wendell Watson, "a Presbyterian spokesman," according to the AP) contained vague assurances, but no specific responses to the allegations,

'Patient and employee safety is our greatest priority, and we take compliance very seriously,' the hospital said in a statement. 'We have numerous measures in place to provide a safe working environment, including mandatory annual training and a 24-7 hotline and other mechanisms that allow for anonymous reporting. Our nursing staff is committed to providing quality, compassionate care, as we have always known, and as the world has seen firsthand in recent days. We will continue to review and respond to any concerns raised by our nurses and all employees.'
So while hospital officials (and local and national politicians and government leaders) kept up reassuring statements that our sophisticated, high-technology hospitals were totally ready to deal with a disease like Ebola, the reality appeared far different. 

Other Inconsistencies

According to a USA Today story, other inconsistencies included hospital statements about the date Mr Duncan's diagnosis was confirmed, and whether or not the hospital was diverting ambulances.

Were Health Professionals Silenced?

Of course, given the suddenness of the arrival of Ebola in the US, the acuity of the first patient, and the general atmosphere of panic, initial confusion in public statements however critical the information they were meant to contain may be, is understandable.

However, there are now allegations that hospital management was not merely confused, but trying to keep critical information secret, and the allegations do not seem incredible.

In a Washington Post story on October 12, about how many US hospitals seem not well prepared for Ebola infected patients, appeared this from Bonnie Castillo, director of Registered Nurse Response Network, part of the union, National Nurses United,

Castillo said the union has been trying to contact nurses at Texas Health Presbyterian Hospital, where Thomas Eric Duncan, the Liberian man diagnosed with Ebola, died Wednesday.

'That hospital has issued a directive to all hospital staff not to speak to press,' Castillo said. 'That is a grave concern because we need to hear from those front-line workers. We need to hear what happened there. … They have them on real lockdown. There is great fear. This hospital is not represented by a union. Our sense is they are afraid to speak out.'

The Los Angeles Times story included,

The Dallas nurses asked the union to read their statement so they could air complaints anonymously and without fear of losing their jobs, National Nurses United Executive Director RoseAnn DeMoro said from Oakland.

The October 14 Washington Post story noted

the labor organization National Nurses United read a statement that it said came from nurses at the hospital who 'strongly feel unsupported, unprepared, lied to and deserted to handle their own situation.'

The AP story of October 15 stated,

The Presbyterian nurses are not represented by Nurses United or any other union. DeMoro and Burger said the nurses claimed they had been warned by the hospital not to speak to reporters or they would be fired.

The AP has attempted since last week to contact dozens of individuals involved in Duncan's care. Those who responded to reporters' inquiries have so far been unwilling to speak.
 Covering up information vitally needed by health care professionals, other institutions, the government, etc to better manage a potentially fatal disease that is already epidemic in other countries appears completely unethical.  Doing so to preserve the reputation of managers seems reprehensible.  But the implication of the recent stories is that is what happened. 

Why Hospital Managers May Not Deserve Our Trust

The US has had no recent experience with any disease like Ebola.  So that mistakes, sometimes very serious ones, were made in the management of the first Ebola patients is not a big surprise.
 
What may be a big surprise to many Americans is how untrustworthy health care leaders, and in particular the managers of Health Texas Presbyterian hospital and its parent system, Health Texas Resources now appear.  After all, USA Today published on October 14, "Texas Health Presbyterian was a respected, renowned hospital."  While even people at respected, renowned institutions make mistakes when confronted with sudden, unfamiliar problems, should not the institution's leaders at least be trusted to in their public pronouncements?

Instead, it appears that the leaders appeared tremendously overconfident, and worse, may have silenced employees from raising concerns that could have reflected badly on leadership.  This occurred in a context in which transparency was imperative so that other people who might have to deal with Ebola patients might be better prepared.


On the other hand, based on what we have been posting on Health Care Renewal for nearly 10 years, the conduct of the Texas Health Resources leaders should have come as no surprise.  On Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty. 

We have seen many examples of hospital executives who seemed vastly impressed by their own brilliance, egged on by board members who were themselves executives of other organizations, and by marketing and public relations functionaries dependent on these executives for their own career advancement.  In particular, we have posted examples of hospital CEOs and other top executives making millions of dollars a year based on their supposed "brilliance," or "visionary" capacity, at least according to the board members who supposed to be exercising stewardship over their institutions, and the public relations people they hired.  Such brilliance has often been asserted, but rarely been explained or justified  (The latest example was here, and much more discussion is here.)

Most such ostensibly "brilliant" hospital executives had no direct experience in clinical care, public health, or biomedical science.

Making hospital leaders feel entitled to make more and more money regardless of their or their institutions' performance seems to be a recipe for "CEO Disease," leading to disconnected, unaccountable, self-interested leaders.  Hospital leaders suffering from the CEO disease may be particularly willing to countenance suppression of any facts or ideas that might raise doubts about their brilliance.  

So the leadership of Texas Health Resources may in fact be very typical of that of large non-profit hospital systems.  THR is such a system.  A Dallas Morning News article about Mr Doug Hawthorne, the Texas Health Resources CEO who just retired in September, 2014, stated


In 1997, Doug Hawthorne helped reshape the health care industry in North Texas by leading the creation of Texas Health Resources, an alliance of Presbyterian Healthcare Resources, Harris Methodist Health System and Arlington Memorial Hospital.

By 2014,

 With more than 22,000 employees in fully owned and joint venture operations, Texas Health is one of the largest care providers in North Texas. For its 2012 fiscal year, it had $3.7 billion in total operating revenue and $5.3 billion in total assets.
For leading this system, Mr Hawthorne made a lot of money, although apparently no recent data is available on his compensation,

He was among the most highly compensated not-for-profit CEOs in the region. For 2012, the most recent information available, his base salary was about $1 million and his bonus was about $1.1 million.

It should be no surprise that to justify this compensation, Mr Hawthorne was proclaimed a visionary.  According to the Dallas/ Fort Worth Healthcare Daily, Mr Hawthorne was inducted in 2014 into the Texas Business Hall of Fame.  At that time, 

'A healthcare visionary, Mr. Hawthorne is at the helm of one of the largest faith-based, nonprofit health care delivery systems in the United States, Texas Health Resources,' the Hall said in a release announcing the induction.

Yet Mr Hawthorne had no direct patient care experience, public health experience, or biomedical or clinical science experience.  Mr Hawthorne is on the board of directors of the LHP Hospital Group Inc, a for-profit that provides capital and services to non-profit hospitals.  The official bio, posted by LHP stated his educational background only included

B.S. and M.S. degrees in healthcare administration from Trinity University in San Antonio.

Furthermore, as we mentioned earlier, the current CEO of Texas Health Resources, Mr Barclay E Berden, who has only been on the job since September 1, 2014, also was hailed by system board of trustees for his "unique leadership strengths."  His current compensation is unknown, but I would guess is likely over $1 million/year.  He highest degree is a MBA, and like his predecessor, had much experience in hospital management, but apparently none in clinical care, public health, or biomedical science. 

Summary

Texas Health Resources' recent CEOs have been paid millions, and hailed for their brilliance, despite a lack of any direct experience in health care, public health, or biomedical science.  Leaders convinced of their own brilliance may live in bubbles that prevent penetration of any ideas or facts that may challenge that brilliance, making them thus susceptible to hubris.

So should we have been surprised that the leadership of the first US hospital system to directly confront Ebola de novo seemed more concerned with polishing their supposed brilliance than with transparently providing the information that other people who have to confront Ebola in the future so greatly need?

No, but one tiny silver lining to the time of Ebola is that it may make it glaringly obvious that we need true health care reform that focuses on reforming the leadership of big health care organizations. In particular, we need leadership that is well-informed about health care and public health; that upholds the values of health care professionals, specifically by putting patients' and the public's health ahead of their own remuneration; is willing to be held accountable; and is honest and unconflicted.

Allowing the current dysfunction to continue, while it will be very profitable to the insiders who run the system, will continue to enable tragic outcomes for patients and the public.  

If we had a widespread outbreak of virulent, drug-resistant Bubonic Plague in another country, would we ban travel from that country to ours?

Bubonic plague is known to have killed massive numbers of people in the 6th century and after (http://en.wikipedia.org/wiki/Bubonic_plague).

... The first recorded epidemic ravaged the Byzantine Empire during the sixth century, and was named the Plague of Justinian after emperor Justinian I, who was infected but survived through extensive treatment. The epidemic is estimated to have killed approximately 50 million people in the Roman Empire alone.




Of course, epidemiology was not understood then - or even the nature of infectious disease. 

... Bubonic plague is an infection of the lymphatic system, usually resulting from the bite of an infected flea, Xenopsylla cheopis (the rat flea). In very rare circumstances, as in the septicemic plague, the disease can be transmitted by direct contact with infected tissue or exposure to the cough of another human.

We supposedly understand infectious disease better now.  We supposedly understand how to limit epidemics through quarantine of those affected, and via keeping those affected away from those who are not - via, for example, travel restrictions regarding entry into an unaffected country.

Yet we have this:

http://www.nytimes.com/2014/10/16/us/ebola-infected-dallas-health-worker-was-on-flight.html

Ebola-Infected Health Worker Took Flight From Cleveland to Dallas

By TIMOTHY WILLIAMS
OCT. 15, 2014

The second health care worker who tested positive for the Ebola virus [after caring for the late Thomas Duncan] took an airline flight from Cleveland to the Dallas/Fort Worth International Airport the day before she reported symptoms of the disease, federal health officials said Wednesday.


Why was this person on a commercial flight while supposedly being "monitored" for the disease?  How did the worker get from Dallas to Cleveland in the first place?  (Another flight, most likely.)

The federal Centers for Disease Control and Prevention said in a statement that “because of the proximity in time between the evening flight and first report of illness the following morning,” it was reaching out to passengers.

Frontier Airlines said Flight 1143 landed in Dallas-Fort Worth at 8:16 p.m. Monday and remained at the airport over night.

When, exactly, is the disease transmissible and when is it not?  Before symptoms, "in proximity" to symptoms, after symptoms?  The calls for "reaching out" suggests nobody is quite confident of the exact time of infectivity of an affected person.

The hospital worker, who has not been identified, was part of the medical team that cared for the Thomas Eric Duncan, the Ebola patient who was admitted to a hospital in Dallas on Sept. 28 and put in isolation. The worker reported a fever on Tuesday and was immediately isolated at Presbyterian hospital.

Crew members said the woman had shown no signs of illness while on the flight, according to a statement from the airline and the disease centers.

I don't think the crew members were either qualified or equipped to render a definite diagnosis.

The agency asked that all 132 passengers who took the Cleveland flight to contact the federal health authorities (1-800-232-4636). “Individuals who are determined to be at any potential risk will be actively monitored,” it said in a statement.

Why are all flight passengers being asked to contact the authorities, one wonders?  Just who is "at potential risk?" What about people the worker may have contacted in the airport, in the waiting lines, in the restaurants, in the bathrooms?
 
Frontier said in a statement that the aircraft “received a thorough cleaning per our normal procedures,” at Dallas-Fort Worth and that it was then cleaned last night in Cleveland.

Is this some type of guarantee of non-spread of Ebola?  I seem to recall the apartment of the first healthcare worker to contract the disease was fumigated.

It seems clear the mode of spread of this disease is not truly understood to a great degree of confidence by our officials or governmental leaders.

What Ebola does apparently have, however, is up to a 70% mortality rate, and that rate is likely higher in children and the aged.

Our politicians, however, seem to have no problem with using the public as laboratory specimens to figure out how the virus spreads, rather than taking immediate action to, as in any epidemic, quarantine the sources.

Has quarantine all of a sudden been determined to have no role in limiting the spread of infectious diseases for which there is no treatment, and which have an exceptionally high mortality rate? 

Is political correctness more important than our lives?  What kind of idiots do we have as our leaders?

Why the hell was this healthcare worker - or any other worker potentially exposed to the virus - permitted to fly before the transmission of the virus is truly understood?

Is not extreme caution with a disease of this nature, and scientific study in confined laboratory environments a wise path, rather than hope, wishful thinking, and putting the public health at risk? 


Quarantine by travel restrictions is overdue, and it is unclear how many people will pay the price for that fundamental (and seemingly deliberate) scientific faux pas.

Welcome to the public's new role as laboratory rats.  I, for one, did not sign up.

-- SS

Thursday, October 09, 2014

The Mystery of the Discharged Ebola Patient - Where is Sherlock Holmes When We Need Him?

As discussion, if not outright panic, about Ebola infections increases in the US, it is still hard to figure out what heath care professionals and the health care system need to do to protect patients and the public in a very changed world.

One pressing question is how to identify people at risk of having the infection so as to best care for them, and to protect the public from further spread of the infection, without swamping the health care system, needlessly reducing civil liberties, or spreading further panic.

To better answer question, better understanding why the first patient who was diagnosed with and then died from Ebola in the US was initially not diagnosed might help.  However, at this time, the whole thing seems mysterious. As a column published on October 7, 2014 in the Dallas Observer was entitled,


"Why Don't We Know Yet Exactly What Happened When Our Ebola Patient Zero Appeared?"
 

On this blog, InformaticsMD was the first to speculate that problems with the design and implementation of an electronic health record (EHR) might have enabled the discharge of this patient, after he presented to the emergency department with non-specific symptoms soon after returning from Liberia.  The next day, an official statement from Texas Health Resources seemed to confirm that a "flaw" in the hospital's EHR prevented adequate communication of the patient's travel history between  a nurse and a physician.  However, one day later, as InformaticsMD discussed here, the hospital reversed itself, releasing another statement that there was no "flaw" in the EHR.  That statement, however, did not explain either why the first statement came out, or anything more about the diagnostic failure.

So, as the Dallas Observer column stated,

The question of why Duncan was sent home initially instead of isolated is still the most stubborn mystery in the saga of 'Ebola Comes to Dallas.'

As columnist Jim Schultze explained, this question has implications for health care professionals and health care organizations who need to figure out how to best deal with the next patient who shows up who might or might not have Ebola.

If Duncan's dismissal from the emergency room on his first visit was a bungle, then it's reasonable to assume that everybody knows about the bungle by now and a similar goof is unlikely to happen again at any decent hospital in America. But if the handling of Duncan grew out of something more systemic, especially a business or management style or policy, then it may be less reasonable to assume the next hospital will be immune from the same issue.


In other words,

if the Eric Duncan mistake flowed from something more systemic, then we absolutely need to know what it was and how it happened so that we can look for the same problems everywhere else. If it was a non-medical problem, I can almost guarantee you it will turn out to be an issue not be unique to this hospital.

Mr Schultze is not the only one to point out the critical need to solve this mystery.  He quoted

former Boston hospital CEO, Paul Levy, called on Texas Health to open up: 'A failure by a hospital to be open about what went wrong in a major medical case such as this," Levy said, "does a major disservice to everyone else in the health care industry.'

Similarly, the editor of FierceEMR wrote,

The Texas Health situation may be setting a dangerous precedent. This is a major world health crisis for which providers worldwide are trying to prepare. If truly the mistake Texas Health made in releasing Duncan was its mistake alone, so be it.

But if there really was a design flaw, then every provider--and every vendor--needs to know about it, evaluate whether it has the same problem, and correct it.

The patients deserve no less.

So far, to date, we have heard nothing more from the managers of Texas Health Presbyterian or its parent non-profit corporation, Texas Health Resources.  It appears we need a reincarnation of Sherlock Holmes to solve this one.



Sifting a Few Clues

I am not he.  But I do believe there are some clues, however, weak, that suggest system flaws.  They can be found in an interview of the new Texas Health Resources chief operating officer (COO), Dr Jeffrey Canose, published in Healthcare Informatics a few weeks before Mr Duncan presented first to the Texas Health Presbyterian emergency department.

One of his points was that the hospital system is changing its emphasis from acute care to population health (however that may be defined),

we made the decision to become more of an integrated health system, and started to build the infrastructure for population health

Then,

The biggest challenge is to continue on our journey to increase our capabilities as a fully integrated health system; to develop the competency to be a high-performing system in the realm of population health management; to shift our focus from sick care to actually managing well-being....

Also, he referred to participation in the Pioneer ACO program as

one of our first significant efforts in shifting our focus from being acute-care-centric to being more focused on the full continuum of care

Recall Mr Schulze's point that the failure to diagnose Mr Duncan could have been due to a business management style or policy.  So maybe we have a clue that the hospital's policy to reduce emphasis on acute care, including the emergency department, might have had to do with problems in the ED leading to a diagnostic misadventure.

 In addition, Dr Canose noted,

 the electronic health record is a huge enabler to all this; the next challenge will be to enable things further, including through data mining, working with big data, and clinical and operational support

So,

around collaboration at the sharp point of redesigning patient care—... people in IT are mission-critical partners in hearing what kinds of problems we’re trying to solve, and in helping us to figure out how to drive clinical transformation and care design, and how to drive efficiency.

So maybe we have a clue that the management was very heavily intellectually invested in their health care information technology infrastructure, and perhaps thus less willing to think about how health care IT could be the cause, rather than solution of problems, such as diagnostic problems in the ED.

Finally, this may be just a hint, but Dr Canose spoke

We have a clear focus on continuing to elaborate the infrastructure we need in order to do population health management, and we’re continuing to build those capabilities over time, and explore ways we can deploy through our employed physician groups,...

This implies that many physicians who practice at Texas Health Resources hospitals are in fact its employees.  We have at times written about the perils being a corporate physician.  One is loss of autonomy, as physician employees become beholden to organizational managers.  So maybe we have a clue that physicians' loss of autonomy, perhaps the autonomy to put patients ahead of corporate policies and managerial edicts, such as those deemphasizing emergency care, could have enabled the failure to diagnose the Ebola "patient zero?"

Summary

We wrote earlier that the rise of generic managers as leaders of health care organizations degrade the US' ability to deal with Ebola.  In the mystery of the discharged Ebola patient, we seem to see the sort of managerial obfuscation that seems characteristic of many generic managers.  More transparency from the management of Texas Health Resources would surely help the US deal better with the ongoing challenge of Ebola.  In the long run, Ebola may teach us a hard lesson about the need to put health care leadership in the hands of people who understand health care, and subscribe to its mission to put patients and the public health first.   

ADDENDUM (10 October, 20140 - This post was re-posted on the Naked Capitalism blog.

Tuesday, October 07, 2014

Speculation about EHR role in Texas Ebola debacle vs. real evidence - will it take a lawsuit to know what's real? Probably.

In the past several days the media has been abuzz with stories about the admission, then the following retraction, by a Texas hospital that and EMR "flaw" had caused a man who had been in West Africa and was infected with the Ebola virus to be sent home, instead of admitted and put into isolation.

I wrote about these matters at my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) and the followup October 4, 2014 post
"Dallas Hospital reverses EHR-related explanation for fumbling Ebola case" (http://hcrenewal.blogspot.com/2014/10/dallas-hospital-reverses-ehr-relarted.htm).

A spectrum of the healthcare IT ecosystem seems represented (see http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=ecosystem).  The technology enthusiasts and hyper-enthusiasts seem to believe the computer could have done no wrong (and usually lack medical and Medical Informatics expertise).

Some people such as myself with specific Medical Informatics experience and who know the failure modes via AHRQ, FDA, ECRI Institute etc. believe the EHR was quite likely contributory or causative of the mistake (see my April 9, 2014 post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html).

The reason I have written little after my initial two posts is that the only was to resolve the controversy is to actually examine the EHR screens, screen navigation and behavior of the EHR, if possible both before and after the hospital's stated "fix" of the problem, the EHR audit trails (automatically generated EHR accounting logs of user accesses, action taken, time, location etc.) and to examine the EHR in actual operation to evaluate it in context with the clinical setting in which it was installed.

Barring that, everything else is speculation usually biased either by the speculator's own beliefs about either the beneficence or fallibility of information technology in healthcare, and perhaps IT generally, and/or conflicts of interest.

Unfortunately, considering the health IT industry and environment, the only way I believe such an examination of the EHR can come about is via litigation.  I doubt it will come from the traditional regulators of medical devices and healthcare safety.

I do note the following of interest at Politico:

... While all EHRs difficult to use, some are set up better than others.

At Mount Sinai Hospital in New York City, information that a patient was feverish and recently flew in from Liberia would have set off an alarm, with the nurse’s screen flashing yellow and giving instructions to immediately isolate the patient, said Jason Shapiro, an emergency room physician and informatics expert at the hospital.

The nurse entering “fever” into the record would “get a hard stop. They immediately have to enter a response to a travel history question. And if there’s fever and the right kind of travel history, the whole isolation mechanism is supposed to swing into play,” Shapiro said.

... Both Mount Sinai and Texas Health Presbyterian have health records systems they purchased for hundreds of millions of dollars from Epic.


At least some users of EPIC seem to have a system configured to catch such a problem.  In my mind, this speaks the need to industry regulation, to ensure all EHRs meet basic standards of safety and reliability and are not haphazardly designed or implemented from one hospital to the next.

-- SS

10/9/14 Addendum:  

Prof. Jon Patrick of Australia, cited numerous times on this blog, relates this:

"I always talk about data capture and data reuse and the reuse is defined by the data flows required in the design of the system. EPIC might well have allowed for the the data capture but failed to deal with the data flow to properly effect the required reuse."

As may the implementers at the hospital in question also have failed at the flows supporting appropriate and fail-safe reuse in a hectic ED environment.

He adds, for further clarification:

A footnote to this point. We separate data flow from work flow. Data flow is the movement of data from context to reuse in another context, or you collect data on this screen(first context) and then you see it later on another screen (=another context).

Workflow is the route staff team members take in moving from one context to another, that is the movement from using one screen to another screen. Most often triggered by clicking a button that moves you to the chosen screen(next context).

The two are very different things and require close thinking in both cases to not trip up with unhelpful and frustrating system solutions.

Historically, Information Systems development has dealt with these issues both poorly and without adequate separate planning. In the past the focus has been on the data capture and storage, because the notion of reuse and context shifting has been left behind. This has been OK for many business systems where contexts have only small variations and workflow are simple or unimportant.

In medicine that just isn’t the case.

-- SS

Monday, October 06, 2014

Can Our Dysfunctional Health Care System Contain Ebola?

Not to bury the lede, I think it can, but it will be a lot harder than the talking heads on television predict.

I have been writing about health care dysfunction since 2003.  Lots of US politicians would have us believe we have the best health care system in the world (e.g., House of Representatives Speaker John Boehner (R-Ohio), here),   Much of the commentary on Ebola also seems based on this "best health care system in the world" notion.  For example, in an interview today (5 October, 2014) on Meet the Press, Dan Pfieffer, "senior White House adviser," said

There is no country in the world better prepared than the United States to deal with this.  We have the best public health infrastructure and the best doctors in the world.

However, at least the statistics say compared to other developed countries, US processes and outcomes are at best mediocre using the best of some admittedly flawed metrics (look here), yet our costs are much higher than those of comparable countries.  Furthermore, on Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty.

Thus there is reason to worry that it will be harder than many expect for the US to deal with Ebola.  There is already some evidence that some of the sorts of problems we have been discussing for years made it harder for the US to cope with even the so far limited incursion of Ebola.

Financialization of Pharmaceutical and Biotechnology Companies

George W Merck famously said,
 
We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

In the pharmaceutical industry, the era of George W Merck is over.  The failure to have access to an effective Ebola virus vaccine exemplifies how things have changed.

If we were to have an effective Ebola virus vaccine, we could have likely used it to vaccinate health care workers and contacts of infected patients and likely thus halt the epidemic early.


A story in Modern Healthcare suggested that now many of the big experts on Ebola and public health are concluding having a vaccine available would be very helpful,

 As West Africa's Ebola outbreak continues to rage, some experts are coming to the conclusion that it may take large amounts of vaccines and maybe even drugs — all still experimental and in short supply — to bring the outbreak under control.

Specifically,

'It is conceivable that this epidemic will not turn around even if we pour resources into it. It may just keep going and going and it might require a vaccine,' Dr. Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases, told The Canadian Press in an interview.

The main reason we do not yet have such a vaccine does not appear to be scientific, but economic.

Here we posted discussion of arguments that pharmaceutical and biotechnology companies up to now have been uninterested in developing Ebola vaccines because they did not anticipate that such vaccines would produce a lot of revenue.  About one month ago, the Independent ran yet another story about an Ebola expert who believed this was the main reason for the lack of effective vaccine development up to now.

The scientist leading Britain's response to the Ebola pandemic has launched a devastating attack on 'Big Pharma', accusing drugs giants including GlaxoSmithKline (GSK), Sanofi, Merck and Pfizer of failing to manufacture a vaccine, not because it was impossible, but because there was 'no business case'.

West Africa's Ebola outbreak, which has now claimed well over 2,000 lives, could have been 'nipped in the bud', if a vaccine had been developed and stockpiled sooner – a feat that would likely have been 'do-able', said Professor Adrian Hill of Oxford University.


The US health care system is now heavily commercialized.  Health care corporations, including pharmaceutical and biotechnology companies, are often lead by generic managers who subscribe to the business school dogma of the "shareholder value theory," which seems to translate into putting short-term revenues ahead of all other goals.  Thus they have been "financialized."  At least in the pharmaceutical and biotechnology sector, such financialization appears to now be global. 

It may now be too late to contain this particular Ebola virus epidemic using a vaccine.  But unless we change how decisions are made about vaccine development, and end the dominance of financialization over drug and vaccine development, we may not be able to control the next deadly epidemic using vaccines either.

Generic Management Deluded by Business School Dogma

On 2 October, 2014, InformaticsMD posted on Health Care Renewal his speculation that the Ebola patient now hospitalized in Dallas was not identified on his first emergency department visit to Texas Health Presbyterian hospital even though a nurse apparently found out he had recently traveled from Liberia because of problems with how the hospital's electronic health record (EHR) transmitted or displayed this information.  This supposition was later apparently confirmed, but then the hospital system CEO retracted this explanation, leaving the reason he was sent home from the ED, thus risking infection of more contacts, unclear (see this post).

I now speculate that the larger reason for the problems the hospital had and is having both handling this patient, and explaining how it handled the patient is hospital leadership by generic managers who do not really understand the relevant health care issues.


Mr Barclay E Berden, the CEO of Texas Health Resources, has had a long career in hospital management.  However, his most advanced degree was "a master's degree in business administration with a specialization in hospital administration from the University of Chicago Graduate School of Business."   His official biography suggests that he has no direct experience or training in medicine, health care, or biological sciences.  Nonetheless, when he became CEO this year, according to Modern HealthCare, the chairperson of the hospital system board thought he was fully qualified,

'He brings a well-rounded perspective and unique leadership strengths to the CEO position,' board Chair Anne Bass said in a news release. 'At the same time, he represents stability and continuity that will be critical to advancing our strategy as we confront the challenges of a rapidly changing healthcare environment.'

Nonetheless, the hospital systems seems to have had trouble confronting the challenges of the change in environment due to Ebola.  Also, according to a very recent story in the Dallas Morning News, there have been performance issues at Texas Health Resource hospitals, and specifically at Texas Health Presbyterian,

Texas Health Presbyterian Hospital — under fire for releasing a Liberian man who later turned out to have the Ebola virus — has lagged behind its peers on emergency room care and lost some federal funds the past three years because it had high discharge rates of patients who later had to return for treatment.

The hospital scored significantly worse than the state and national averages in five of six emergency care indicators, with emergency room wait times twice as long as the averages, according to data from the U.S. Centers for Medicare & Medicaid Services.

The hospital also was the most penalized in Dallas under a three-year program designed to reduce the number of patients readmitted for care, according to the data.

The delays in patient treatment in the emergency room, in particular, raise important questions about Presbyterian’s emergency care, said Dr. Ashish Jha, a professor at Harvard University’s School of Public Health and a practicing general internist.

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician. 

We have frequently discussed how generic managers in charge of health care organizations may follow business-school dogma at the expense of patients' and the public's health.  In particular, they may also prioritize short-term revenue ahead of all other concerns, and hence may favor high-technology and procedural care, often performed electively, ahead of the the less glamorous and remunerative parts of health care, e.g., ED care of poor, uninsured, febrile patients.

Unfortunately, much of the country's efforts to ward off Ebola are likely to be lead by generic managers who may have little understanding of epidemiology, public health or virology, and little understanding of the state of health care at the sharp end.  So unfortunately I expect continuing "glitches," or worse.  Hopefully, the country, although not every single one of its inhabitants, will survive them.  Then we need to seriously reflect on the wisdom of handing control of health care over to generic managers, rather than health care professionals. 


Commercialization of Health Care Leading to Neglect of Routine Acute Care and Public Health 

Just as national politicians and government leaders have repeated the meme of the US health care system being "the best in the world," now that Ebola has come to Texas, state leaders have sung the same song.  For example, an editorial in the Baltimore Sun quoted the state health commissioner,

'This is not West Africa,' Texas health commissioner Dr. David Lakey said Wednesday at a news conference designed to dispel Texans' (and Americans') fear of an Ebola outbreak after a man there was diagnosed with the disease. 'This is a very sophisticated city, a very sophisticated hospital.'

The Texas Tribune ran a story produced in cooperation with Kaiser Health saying,

At a Wednesday press conference to discuss the Ebola case, Gov. Rick Perry said he was confident in the state’s preparedness. 'There are few places in the world better equipped to meet the challenge that is posed in this case,' he said. 'We have the health care professionals and the institutions that are second to none.'

However, another Dallas Morning News story recounted various problems in the public health response to the Dallas Ebola patient, including,

Delay in blood testing
After Duncan was admitted to the hospital, health officials waited nearly two days to test his blood for the Ebola virus. This may have delayed containment of people who had contact with him.
Slow containment and cleanup
Health officials left some of Duncan’s close contacts in the apartment where soiled linens and towels that he had used remained.
Failure to avoid contact with emergency workers
Ambulance workers and sheriff’s deputies are among those being monitored.

So, there is reason to suspect that the public health system in Texas may not exactly be the best in the world.  In fact, there seem to be systemic problems with public health in Texas that the Ebola scare is bringing to increased public notice.  The Texas Tribune/ Kaiser story went on to explain that in Texas, a state in which distrust of central government is great, and confidence in the private sector is high, public health is both decentralized and often poorly funded,

'We don’t really have a unifying construct for public health in Texas that’s comprehensive,' said Dr. Eduardo Sanchez, the former commissioner of the Texas Department of State Health Services (DSHS) and current chairman of the Texas Public Health Coalition. 'The system is not as connected as it could be.'

Furthermore,

But public health experts argue that the state’s response system is 'fragmented' and vulnerable to local budget cuts, which they say could hamper crisis-response efforts in the case of diseases that are more easily transmitted.

Texas’ local health departments, which provide services like immunizations and disaster response planning, operate autonomously and are funded primarily by local taxes but may be supplemented by state and federal grants. Because local health departments are not held to a single standard, their services and budgets vary tremendously around the state.

A report critical of the state’s public health system, prepared by the Sunset Advisory Commission, found that 'the roles and responsibilities of DSHS and local health departments remain undefined.' The Sunset Commission is tasked with highlighting inefficiencies at state agencies and recommending legislative action.

'A ‘local health department’ can be a few staff conducting restaurant inspections and animal control duties, or a large agency directing sophisticated disease surveillance, operating a public health laboratory and providing direct services to citizens,' according to the report.>

Some public health officials have criticized the state’s model as disjointed. Many local health departments operate independently; however, if local budget cuts to a public health department force it to discontinue a health service, DSHS is often required to step in and take responsibility for that service. The state is then left to foot the bill.

'In the event of a public health emergency ... the resources necessary to adequately respond to that are not all in the control of the health department,' Sanchez said. 'You have to have the money and the authority — whether it’s informal or formal — to actually lead a response and take care of business.'

Local entities have slashed funding for health departments in recent years, said Catherine Troisi, an epidemiologist at the University of Texas School of Public Health in Houston. Thirty-six percent of local health departments in Texas laid off staff as a result of budget cuts between 2008 and 2013, according to the National Association of County and City Health Officials.

'Public health is politics,' Troisi said.

In the US, we have pushed commercialization of health, health care and public health.  Much of our health insurance is provided by for-profit corporations.  Some of our hospitals and other organizations that provide direct patient care are for-profit.  As we noted above, most of our health care organizations are now run in a "business-like" manner by managers trained in business, but not necessarily in health care or biological science.  The thus revenue-focused health care system has emphasized procedures and high-technology, often at the expense of the basics.  So it should not be s surprise that Reuters just reported,

 Nurses, the frontline care providers in U.S. hospitals, say they are untrained and unprepared to handle patients arriving in their hospital emergency departments infected with Ebola.

Many say they have gone to hospital managers, seeking training on how to best care for patients and protect themselves and their families from contracting the deadly disease, which has so far killed at least 3,338 people in the deadliest outbreak on record.


Furthermore, using as an example Medstar Washington Hospital Center, the largest hospital in Washington, DC,

Nurses argue that inadequate preparation could increase the chances of spreading Ebola if hospital staff fail to recognize a patient coming through their doors, or if personnel are not informed about how to properly protect themselves.

At Medstar, the issue of Ebola training came up at the bargaining table during contract negotiations.

'A lot of staff feel they aren't adequately trained,' said [Emergency Department nurse Micker] Samios, whose job is to greet patients in the emergency department and do an initial assessment of their condition.

So Young Pak, a spokeswoman for the hospital, said it has been rolling out training since July 'in the Emergency Department and elsewhere, and communicating regularly with physicians, nurses and others throughout the hospital.'

Samios said she and other members of the emergency department staff were trained just last week on procedures to care for and recognize an Ebola patient, but not everyone was present for the training, and none of the other nursing or support staff were trained.

'When an Ebola patient is admitted or goes to the intensive care unit, those nurses, those tech service associates are not trained,' she said. 'The X-ray tech who comes into the room to do the portable chest X-ray is not trained. The transporter who pushes the stretcher is not trained.'

If an Ebola patient becomes sick while being transported, 'How do you clean the elevator?'

Nurses at hospitals across the country are asking similar questions.

A survey by National Nurses United of some 400 nurses in more than 200 hospitals in 25 states found that more than half (60 percent) said their hospital is not prepared to handle patients with Ebola, and more than 80 percent said their hospital has not communicated to them any policy regarding potential admission of patients infected by Ebola.

Another 30 percent said their hospital has insufficient supplies of eye protection and fluid-resistant gowns.

So up to now, it appears that in the state of Texas, and across the country, the preparedness of public health systems and of front-line hospitals to deal with Ebola is unclear.  This may be due to political cuts in funding of public agencies, a payment system that favors procedures and high-technology over basic care, and leadership by generic managers who prioritize making money short-term over less financially advantageous priorities like preparedness for epidemics.  

Summary
Thus again there is reason to fear that our commercialized health care system run by generic managers, and our neglected public health system scorned because it is not "business-like" may not be fully up to the task of containing Ebola.  Again, hopefully this too will pass, without too many casualties.  However, one, maybe the only silver lining in the dark clouds of the Ebola crisis seem to be its capacity to challenge the pompous certainty by those invested in the status quo that we have the best health care system in the world.

The Ebola crisis should, again, lead to serious reflection on true health care reform, reform that would address concentration and abuse of power, reform that would enable leadership of health care by  well-informed people who are devoted to patients' and the public's health, who are honest and ethical, who are willing to be held accountable, and would shrink the size and power of individual health care organizations to make them truly responsive to patients' health care needs and the public's health needs. 

ADDENDUM (10 October, 2014) - This post was re-posted on the Naked Capitalism blog, and on OpEdNews.com

Saturday, October 04, 2014

Dallas Hospital reverses EHR-related explanation for fumbling Ebola case

At my Oct. 2, 2014 post "Did Electronic Medical Record-mediated problems contribute to or cause the current Dallas Ebola scare?" (http://hcrenewal.blogspot.com/2014/10/did-electronic-medical-record-mediated.html) I questioned a possible role for an EMR-related mishap, including known disruptions of teamwork and suboptimal presentation of information, to have contributed to or led to the release of a man carrying the Ebola virus from a Dallas Hospital.

I then related how the press reported, the very next day, that this was indeed the case.

Now...gee whiz...the hospital changes its tune. "No, it wasn't the EMR after all!" 

See "Hospital reverses explanation for fumbling Ebola case" at http://www.dallasnews.com/news/metro/20141003-hospital-reverses-explanation-for-fumbling-ebola-case.ece. The reversal strains credibility and sounds like redirection, to my ear possibly due to inside attorney and/or EMR company attorney pressure. 

The "new explanation" itself per the new article is that:

... A written statement Thursday said hospital officials identified and corrected “a flaw in the way the physician and nursing portions of our electronic health records (EHR) interacted in this specific case.” That statement implied, without directly saying it, that the flaw left the doctor uninformed about Duncan’s travel history. In Friday’s statement, though, the hospital said, “The patient’s travel history was documented and available to the full care team in the electronic health record.” “There was no flaw in the EHR in the way the physician and nursing portions interacted related to this event,” the statement said.

Again, sounds like redirection and making the doctor (and perhaps the ED doctor's group, if they were contractors) the sole scapegoat.  


"Available to the full care team?"  "Available" in a complex computer system with myriad screens is a very relative term.  The issue seems not "how the physician and nursing portion interacted", it is "how the physician portion made the information readily apparent to the physicians and other team members, or not."
 

The problem here, I believe, still likely amounts to "information hard to find" and "suboptimal support of teamwork (situational awareness)", among others, per the AHRQ hazards taxonomy. 

See, for instance, this.  Either it is true, or not, regarding the travel history:


 (click to enlarge)

I think an impartial investigation is needed to get to the truth.  

What we have now is likely healthcare defense attorney and/or risk management "fog", a phenomenon I have both professional and (sadly) personal experience with.

One also wonders if the EHR vendor had a contractual defects non-disclosure ("gag") clause with the organization, and is now threatening suit, leading to the retraction.  (See http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda for more on that issue, and of corporate "hold harmless" clauses).

Unfortunately, a comprehensive investigation would be likely to only occur in a courtroom via Discovery if others become infected.

If any reader has knowledge of details, my email address is scotsilv AT aol DOT com.

-- SS

Addendum: A medical informatics colleague, Dr. William Goossen of the Netherlands, sent me a reminder about this article on the de-professionalizing aspect of health IT:

Harris BL. Becoming de-professionalized: One aspect of the staff nurse’s perspective on computer-mediated nursing care plans. Advances in nursing science. 1990: 13, 2,  3-74.

Some content of this study - Nurses who participated in this study felt to some degree:
  • De-professionalized: being controlled by the computer, not formally planning individualized care, losing skills to develop NCP's (Nursing Care Plans).
  • De-autonomizing: - control by supervisors - linear operations of the computer and nurses felt to think like that - the system doesn't allow  free texting, - nurses must follow the rules of the computer.
  • De-individualizing: - 'one-size-fits-all' - routinized care - eliminating creativity.
  • De-expertizing: - mindlessness and losing the skills learned in school, the computer does the work.

There is a human aspect to computerization in medicine that is often overlooked, especially by the health IT hyper-enthusiasts (see http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html). 

Perhaps the ED staff at the Dallas hospital needs to be surveyed on these issues.

-- SS

Friday, October 03, 2014

A Little Sunshine Peeking Through the Clouds? - the Sunshine Act is Finally Implemented, Sort of

"Conflicts of interest" is probably the most frequently used Health Care Renewal tag.  We believe conflicts of interest are a major causes of health care dysfunction.  Therefore, I felt that one of the truly reformative aspects of the US Accountable Care Act (ACA, "Obamacare") could be the "Sunshine Act," a provision championed by Iowa Senator Grassley (R) and his staff investigator, Paul Thacker, that would require public reporting of most financial interactions among health care corporations and health care professionals and hospitals.

The roll-out of Sunshine Act implementation occurred this week, and not unexpectedly, was very rocky.   As reported by the Wall Street Journal,

it hasn't been a smooth process. First, CMS delayed the public reporting of the data by a year to give companies more time to prepare. The Open Payments online system has experienced technical problems, including a data mix-up that resulted in some doctors being linked to payment records for other doctors with the same surname. The preview function for doctors had a cumbersome registration process, some doctors said, and was taken offline at times in recent weeks.

The first batch of data is incomplete. CMS in August said it removed about one-third of the payment records from the physician-preview database because it said some of the state medical-license numbers that companies reported for doctors didn't match a database that the agency was using for verification, among other problems. CMS now is releasing those records but without identifying the physicians tied to them. It will update the database to include the physicians' names for those records next year. Also, CMS isn't immediately releasing payments related to proprietary research-and-development; those will be reported at a later date.

 But why should we have expected anything else, given the parties involved?

Drug, Device and Biotechnology Companies

As reported by the NY Times,

all manufacturers of drugs, medical devices and medical supplies that have at least one product covered by Medicare or Medicaid must report payments or gifts they make to doctors and teaching hospitals. This can be as seemingly trivial as a bag of bagels — all payments above $10 are included — or as lofty as a research grant. It also includes meals, travel expenses and speakers’ fees. Group-purchasing organizations, which serve as middlemen between health care providers and manufacturers, also must disclose doctors’ ownership and investment interests in their companies.

Presumably such reporting actually was quite burdensome to the companies.

Furthermore,company executives might not be exactly thrilled about putting all this information out there.  As we have frequently discussed, to serve their own interests, such companies make all sorts of payments to physicians, other health care professional, and hospitals and other non-profit health care organizations.  In particular, payments to health care professionals may foster companies' marketing and public relations goals.

While some payments are made for technical and clinical consulting, many are to support "education" that may serve marketing or public relations.  In particular, many payments are for "drug talks," that is, talks sponsored by the drug companies, usually through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education.  Since the publication of "Dr Drug Rep" in the New York Times in 2007, it became evident that such talks emphasize content provided by the pharmaceutical companies, and are intended to be corporate marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.)

In addition, pharmaceutical companies often pay physicians deemed to be "key opinion leaders," whose opinions are promoted supposedly for their brilliance and erudition.  However, as noted here and here, the companies buying their services think of KOLs as sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how corporate managers view key opinion leaders as marketers.

Pharmaceutical, biotechnology, and device companies protest that much of the money they pay goes to support research.  But the clinical research they sponsor has been shown to be frequently subject to manipulation designed to increase the likelihood of results favorable to these companies' products.  When manipulation fails to provide sufficiently favorable results, corporations may simply  suppress it.  Academic institutions desperate for more external funding, and physicians whose continued gainful employment at such institutions requires external funding may not be too quick to protest manipulation and suppression by those paying the bills.

Vox just summarized some of the relevant evidence:

Research for decades has shown that relations with industry — from industry-sponsored education to encounters with pharmaceutical-company sales representatives, and even drug samples provided by those companies — can bias a doctor's judgment in all sorts of ways. It can color the medical education they give to future doctors, cause them to inappropriately prescribe drugs, to push for the FDA approval of medicine, or for drugs to be included on their hospital formularies. Industry-funded studies are also four times more likely to lead to favorable and positive results than independent research.

The side-effects of this 'Bad Pharma' behavior range from waste in the health system, to mistreatment of patients, and even avoidable patient death.

So is it any surprise that industry may not have been enthused or comfortable about complying with the Sunshine Act?  Instead of admitting that, of course, they have complained, as reported by the NY Times,

the website is being questioned by the industry, which says that technical problems and data inaccuracies limit its value.

But it seems that industry may have created the sorts of data problems about which they now complain.  Note that when ProPublica made this first assessment of the database,

Many drug and device companies attributed payments to multiple subsidiaries, rather than reporting them under the name of a single parent company. Johnson & Johnson, for instance, submitted payments under at least 15 subsidiaries. The device maker Medtronic reported payments by at least six subsidiaries. So did the drug maker Novartis. On first blush, that makes it tough to calculate how much each company spent overall.

Similarly, companies reported payments associated with particular drugs in different ways. The expensive drug Acthar, which is marketed for a variety of different conditions, is listed under at least eight different name variations. The diabetes drug Januvia is reported as both 'Januvia' and 'Januvia Diabetes.' There is one drug simply listed as 'KNEES' and another as 'Foot and Ankle.'


So it appears that the companies reported data in a confusing, perhaps deliberately confusing manner, obfuscating the relationships between companies and subsidiaries, and between essentially similar drugs with different names.  It is hard to believe that all, or even most of these problems were due to mishandling by the government.  So it is a little hard to take the companies' criticisms of the quality of the data seriously.

Physicians and Organized Medicine

"We have met the enemy and he is us." - Pogo

On the other hand, news articles suggested some physicians were also unhappy with the data release.  For example, per the WSJ article,

Some doctors disputed details of the payment data. The database shows John LeDonne, a surgeon from Baltimore, as having received about $78,200 in payments for food and beverage for the five-month period from medical-device maker Dr. LeDonne acknowledged he performs paid consulting work for health-care companies including Teleflex, but that he rarely received free meals. He said the total payment amount was in the right 'ballpark,' but should not have been classified in the food-and-beverage category. 

That seems to be a bit of quibble.  The amount he received, and its source, seem more important than whether it was labelled "consulting," or "food and beverage" payments.

More importantly, a few doctors were worried, as reported by the Minneapolis Star-Tribune, that the information may reflect negatively on them,
 'Overwhelmingly, the interaction between industry and physicians is positive,' said Dr. Robert Harbaugh, chairman of neurosurgery at Penn State and president of the American Association of Neurological Surgeons.

Maybe Dr Harbaugh should realize that there already are a lot of reasons to think about the negative aspects of physician - industry paid interactions, as summarized above. And Vox reported,
 Dr. Thomas Stossel, known as Harvard's 'pro-industry professor,' says 'doctors' work with industry is necessary and beneficial.' He worries that the Sunshine Act could make it embarrassing and difficult for doctors to do work like developing medical devices or designing clinical trials, and that industry may start avoiding working with American doctors because of the time and investment disclosure will require.  

Dr Stossel did not provide evidence to explain the necessity or benefits of the work for industry, nor why doctors could not design clinical trials outside of industry relationships. 
Doctors also complained about data quality, but I am not aware that the medical profession rushed to help with improving the data for the Sunshine Act.  Obviously, there are some physicians who have personally profited quite a lot from their relationships with drug, device, and biotechnology companies but who may not be comfortable having the figures booted around in public, e.g., per the WSJ,
Among individual physicians, Stephen Burkhart was one of the top recipients of non-research payments from industry. The San Antonio orthopedic surgeon received $7.4 million in non-research payments or transfers of value for the five-month period, mostly from device manufacturer Arthrex Inc. for payments identified as 'royalty or license.'

Dr. Burkhart couldn't be reached for comment. Arthrex said in a statement that it has 'financial relationships with a number of orthopedic surgeons and teaching hospitals,' like many manufacturers, for their advice and expertise.

Chitranjan Ranawat,a New York orthopedic surgeon, received about $4 million in nonresearch payments or transfers of value, mostly from DePuy Synthes unit for 'royalty or license,' according to the database. 

 Dr. Ranawat couldn't be reached for comment.

And those were payments made in a five month period.  Maybe the doctors have a reason to be uncomfortable.

Furthermore, ProPublica reported that 21% of the $3.5 billion in payments, approximately $735 million, reported by the system were for "promotional talks," a la "drug talks" as noted above.  Since "Dr Drug Rep," such talks have gotten something of a bad reputation, but are obviously lucrative, so those who got paid to give them may not be happy with their detailed disclosure.

The US Department of Health and Human Services

The Sunshine Act was but a small part of the huge ACA, most of which the US DHHS, and particularly the Center for Medicare and Medicaid Services (CMS) was charged with implementing, but probably with proportionately insufficient funding and time.  So no wonder that the Sunshine Act never seemed to find a vocal champion within DHHS.

Most likely money concerns, and the constant din of outside criticism of "government bureaucrats" by those demanding more "business-like" government lead CMS to outsource the work on the Sunshine Act database, as described by another ProPublica article,
While the payments database is a far cry from Healthcare.gov — and less complex – it's reasonable to expect some glitches. CGI Federal, the company that led what turned out to be the botched launch of Healthcare.gov, is also responsible for the release of the payment data.

Massachusetts also outsourced operation of its Health Connector to CGI Federal, with equally bad results.  The state had to terminate the contract (look here.)

So if lackadaisical bureaucrats outsourced the Sunshine Act to contractors of questionable competence, what result should have been expected?

Why the present administration, and the bureaucrats it supposedly commands, seemed so uninterested in this particular aspect of the ACA is not clear, but perhaps we should peer around some revolving doors for the answer.  (For example,  John Podesta, a current White House adviser, worked for non-profits funded by drug company Eli Lilly and device company Synthes [look here]; and Nancy-Ann DeParle, former White House "health czar," had previously served on the boards of of Boston Scientific, Cerner and Medco [look here], and now is involved in health care investments made by private equity, and is on the board of CVS [look here]).

Of course, the sort of conflicts of interest that were supposed to be revealed by the Sunshine Act are highly beneficial to the parties directly involved, whatever embarrassment they may cause.  Given the power of those parties, plus the lukewarm, outsourced effort by government perhaps influenced by government officials with their own "revolving door" conflicts of interest, is it any wonder that the Sunshine Act implementation was "rocky?"

Summary

Nonetheless, because of the Sunshine Act, we do now know a bit more about conflicts of interest involving drug, device, biotechnology and related companies on one hand, and physicians, other health care professionals and hospitals on the other.

Maybe throwing even veiled sunshine on some of these relationships will inspire some people to rethink whether they want to continue them.  There are other reasons they should do so.

We have called endlessly for full, detailed disclosures of all conflicts of interest, for honesty's sake if for no other reason.  We have also called for severe curtailment of all conflicts affecting clinical decision making, health care education, clinical and health care research, and health policy making.  But Health Care Renewal can easily be dismissed as a voice crying out in the wilderness.  However, we are really not alone.

The 2009 Institute of Medicine report set relatively tough standards for managing conflicts of interest affecting clinical research and teaching, which unfortunately since have largely been ignored.  It did call for senior institutional officials to disclose their conflicts of interest, and for institutional boards of trustees to form conflicts of interest committees that would exclude conflicted individuals, but otherwise did not address conflicts of interest affecting academic leaders or institutional trustees.  The 2013 Pew Charitable Trusts Conflicts-of-Interest Policies for Academic Medical Centers suggested restrictions on conflicts affecting faculty, trainees, and students, but again did not mention senior institutional leaders or boards of trustees.  Implementing even some of these recommendations would be true health care reform.

Maybe more publicity about the web of conflicts of interest that drapes of over health care will lead to some further steps in the needed direction.