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Thursday, November 21, 2019

Health Care Dysfunction Makes it to the Presidential Debate


In last night's debate which included leading candidates from the Democratic Party for its presidential nomination, as reported by Mother Jones, Senator Bernie Sander (D-VT) said (per Mother Jones).
the current health care system is not only cruel, it is dysfunctional

The video is here.



So the concept of health care dysfunction has officially made it to the big time.

You Heard It Here First

What took so long?

We have been talking about health care dysfunction for a very long time, starting with a publication in 2003.

To better understand health care dysfunction, I interviewed doctors and health professionals, and published the results in Poses RM.   A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14(2): 123-130. (link here).  In that article, I postulated that US physicians were demoralized because their core values were under threat, and identified five concerns:

1. domination of large organizations which do not honor these core values
2. conflicts between competing interests and demands
3.  perverse incentives
4. ill-informed, incompetent, self-interested, conflicted or even corrupt leadership
5.  attacks on the scientific basis of medicine, including manipulation and suppression of clinical research stuides

After that my colleagues and I have tried to raise awareness of these and related issues, now mainly through the Health Care Renewal blog.  We also set up FIRM - the Foundation for Integrity and Responsibility in Medicine,  a US non-profit organization, to try to provide some financial support for the blog.

Health Care Dysfunction is Multi-Dimensional

Unfortunately, one sentence in a presidential debate hardly does justice to a huge and multi-faceted set of concerns.  

Since 2003 we have broadened our thinking about what constitutes and causes US (and more global) health care dysfunction. Early on we noticed a number of factors that seemed to enable increasing dysfunction, but were not much discussed.  These factors notably distorted how medical and health care decisions were made, leading to overuse of excessively expensive tests and treatments that provided minimal or no benefits to outweigh their harms.  The more we looked, the more complex this web of bad influences seemed.  Furthermore, some aspects of it seemed to grow in scope during the Trump administration.

A brisk summary of these often complex issues follows.


 Threats to the Integrity of the Clinical Evidence Base

The clinical evidence has been increasingly affected by manipulation of research studies.  Such manipulation may benefit research sponsors, now often corporations who seek to sell products like drugs and devices and health care services.  Manipulation may be more likely when research is done by for-profit contract research organizations (CROs). When research manipulation failed to produce results to sponsors' liking, research studies could simply be suppressed or hidden.  The distorted research that was thus selectively produced was further enhanced by biased research dissemination, including ghost-written articles ghost-managed by for-profit medical education and communications companies (MECCs). Furthermore, manipulation and suppression of clinical research may be facilitated by health care professionals and academics conflicted by financial ties to research sponsors.

 Deceptive Marketing

The distorted evidence base was an ingredient that proved useful in deceptive marketing of health care products and services. Stealth marketing campaigns became ultimate examples of decpetive marketing.  Deceptive marketing was further enabled by the use of health care professionals paid as marketers by health care corporations, but disguised as unbiased key opinion leaders, another example of the perils of deliberate generation of  conflicts of interest affecting health care professionals and academics.

Distortion of Health Care Regulation and Policy Making

Similarly, promotion of health policies that allowed overheated selling of overpriced and over-hyped health care products and services included various deceptive public relations practices, including orchestrated stealth health policy advocacy campaigns.  Third party strategies used patient advocacy organizations and medical societies that had institutional conflicts of interest due to their funding from companies selling health care products and services, or to the influence of conflicted leaders and board members.  Some deceptive public relations campaigns were extreme enough to be characterized as propaganda or disinformation.

More recently,  as we noted here, we became aware of efforts by foreign powers to spread such disinformation for political, not just financial gain, e.g., in April, 2019, we discussed evidence that Russia had orchestrated a systemic disinformation campaign meant to discredit childhood vaccinations, particularly for the measles, which was likely partly responsible for the 2019 measles outbreak

Furthermore, companies selling health care products and services further enhanced their positions through regulatory capture, that is, through their excessive influence on government regulators and law enforcement.  Their efforts to skew policy were additionally enabled by the revolving door, a species of conflict of interest in which people freely transitioned between health care corporate and government leadership positions.

In the Trump era, we saw a remarkable increase in the incoming revolving door, people with significant leadership positions in health care corporations or related groups attaining leadership positions in government agencies whose regulations or policies could affect their former employers (look here).   We found multiple managers from and lobbyists for big health care corporations being put in charge of regulation of and policy affecting - wait for it - big health care corporations, a staggering intensification of the problem of the revolving door.

Bad Leadership and Governance

Health care leadership was often ill-informed.  More and more people leading non-profit, for-profit and government have had no training or experience in actually caring for patients, or in biomedical, clinical or public health research.  Lately, during the Trump administration, we began to find striking examples of top government officials expressing ill-informed, if not outright ignorant opinions about medical, health care and public health topics look here).  We had not previously expected leaders of government to be personally knowledgeable about health related topics, but traditionally they consulted with experts before making pronouncements.

Health care leaders often were unfamiliar with, unsympathetic to, or frankly hostile to their organizations' health care mission, and/or health care professionals' values. Often business trained leaders put short-term revenue ahead of patients' or the public's health.  In addition, we began to see evidence that leaders of health care corporations were using their power for partisan purposes, perhaps favoring their personal political beliefs over their stated corporate missions, patients' and the public's health, and even  corporate revenues. Then, we started seeing appointed government health care leaders who lacked medical, health care or public health background or expertise but also whose agenda also seemed to be overtly religious or ideological, without even a nod to patients' or the public' health (look here).
 
Leaders of health care organizations increasingly have conflicts of interest.   Moreover, we have found numerous examples of frank corruption of health care leadership.  Some have resulted in legal cases involving charges of bribery, kickbacks, or fraud.  Some have resulted in criminal convictions, albeit usually of corporate entities, not individuals.


In the Trump administration, corrupt leadership extends from the corporate world to the highest levels of the US government.  We discussed the voluminous reports of conflicts of interest and corruption affecting top leaders in the executive branch, up to and including the president and his family (look here).  One cannot expect effective enforcement of ethics rules and anti-corruption laws in such an environment

Abandonment of Health Care as a Calling

A US Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members, leading to the abandonment of traditional prohibitions on the commercial practice of medicine.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition. Doctors were pushed to be businesspeople, and to give making money the same priority as upholding their oaths. Meanwhile, hospitals and other organizations that provide medical care are increasingly run as for-profit organizations. The physicians and other health care professionals they hire are thus providing care as corporate employees, resulting in the rise of the corporate physician.  These health care professionals may befurther torn between their oaths, and the dictates of their corporate managers.

Perverse Incentives Put Money Ahead of Patients, Education and Research

We have extensively discussed the perverse incentives that seem to rule the leaders of health care. Financial incentives may be large enough to make leaders of health care organizations rich.  Incentives often prioritize financial results over patient care.  Some seem to originate from the shareholder value dogma promoted in business school, which de facto translates into putting current revenue ahead of all other considerations, including patient care, education and research (look here).

 Cult of Leadership

Health care CEOs tend now to be regarded as  exalted beings, blessed with brilliance, if not true "visionaries," deserving of ever increasing pay whatever their organizations' performance.  This pheonomenon has been termed "CEO disease" (see this post).  Afflicted leaders tend to be protected from reality by their sycophantic subordinates, and thus to believe their own propaganda.

Managerialism

Leadership of health care organizations by managers with no background in actual health care, public health, or biomedical science has been promoted by the doctrine of managerialism which holds that general management training is sufficient for leaders of  all organizations, regardless of their knowledge of the organizations' fundamental mission.

Impunity Enabling Corrupt Leadership

Most cases involving corruption in large health care organizations are resolved by legal settlements.  Such settlements may include fines paid by the corporations, but not by any individuals.  Such fines are usually small compared to the revenue generated by the corrupt behavior, and may be regarded as costs of doing business.  Sometimes the organizations have to sign deferred prosecution or corporate integrity agreements.  The former were originally meant to give young, non-violent first offenders a second chance (look here).  However, in most instances in which corruption became public, are no negative consequences ensue for the leaders of the organizations on whose watch corrupt behavior occurred, or who may have enabled, authorized, or directed the behaviors.

Taboos

Some of the above topics rarely appeaedr in the media or scholarly literature, and certainly seem to appear much less frequently than their importance would warrant. We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who personally profit from the status quo in health care.  Those involved in the leadership and governance of health care organizations and their cronies, also have considerable power to damp down any public discussion that might cause them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.

However,in the Trump administration,  we began to also note examples of government officials attempting to squelch discussion of scientific topics that did not fit in with its ideology, despite constitutional guarantees of speech and press free from government control (look here).



What a witches' brew, surely leading to a cruel and dysfunctional system.

Discussion

In 2017, we said that it was time to consider some of the real causes of health care dysfunction that true health care reform needs to address, no matter how much that distresses those who currently most personally profit from the status quo.

Furthermore, in 2019 we asserted that all the trends we have seen since 2017 are towards tremendous government dysfunction, some of it overtly malignant, and much of it likely enabling even worse health care dysfunction.

Now that health care dysfunction is in the headlines, we hope health care and public health professionals, patients, and all citizens will have a much more vigorous response to it.  US health care dysfunction was always part of the broader political economy, which is now troubled in new and dangerous ways.  We do not have much time to act.

If not now, when?

If not us, who?  

Note (25 November, 2019): This post was re-posted by the Naked Capitalism blog here

Sunday, November 17, 2019

Cutting the Gordian Knot: Why a “Public Option” Won’t Work


A friend of mine is adamant in his belief that the American health care system simply cannot be fixed to operate with some semblance of humanity and rationality. Bill has become convinced that “it will never, ever work.” What does it matter if other health care systems in other countries are less crazy, cruel, convoluted, or costly? He is convinced we are FUBAR and cannot get to anything better from here.

This seems to me a nihilistic, despairing, and illogical view. Yet, Bill is right that strong, interlocking structures hold the existing order in place.

So many promising efforts in the past to reform things have been distorted, stymied, and twisted, and have not improved matters. The HMO movement comes to mind. Originally non-profit and medically-focused, it changed into something quite different, angered patients and doctors, and was a striking failure.

If the healthcare system is to be radically improved, it won’t be easy, and figuring out how to weaken structural forces that buttress the current system is a crucial part.

With this in mind, let’s consider the currently popular goal of “Medicare for All.” The most popular “compromise” path – now espoused by every candidate in the Democratic field but Sanders – involves adding a “public option” to current ACA plans alongside private insurance. Pete Buttigieg and now Elizabeth Warren have rhapsodized about how this would provide a “glide path” to real single-payer reform, because people would prefer the “public option” to private insurance plans.

But, giving people the choice between public and private health plans simply won’t work. Real single-payer eliminates an unneeded, expensive middleman – the insurance companies. A “choice” leaves the insurance companies – and the additional layer of complication and expense they add – firmly in place.  If true single-payer is implemented, administrative overhead would be reduced, because hospitals and doctors wouldn’t have to deal with dozens of differing insurance plans and their varied requirements. One set of billing procedures, forms, one drug formulary and rules, etc. would majorly lessen overhead. Adding a new “public plan” would only increase complexity, not reduce it.

A “public plan” that exists alongside private plans also will not have the leverage to reduce medical prices, including pharmaceutical prices, that the government would have in a true single-payer system. Without the cost savings from overhead reduction and better pricing, the public plan will not realize any of the potential gains that could enable substantial systemic improvement.

Crucially, if some are on private plans and some on public, adverse selection is certain to occur. Insurance companies will game the system as much as possible to retain the best risks and offload the medically needy onto the public plan. Even before such games get into play, if people who work for large employers keep their current plans, those people have a more favorable risk profile than the population at large. Warren’s means-tested initial transition plan extends coverage to those below 200 percent of the poverty level – are these going to be good risks? So, the public plan will be saddled with a population that will inevitably be costly.

For all these reasons, after implementation, the public plan won’t be in a good position to present a favorable profile compared to the cream-skimming private plans, which will offer sets of benefits designed to attract younger and healthier people. This will raise the cost of the public option and together with the lack of administrative savings, will be a financial disaster.

The government will pick up more of the tab for the sick; people will NOT prefer the “public option” to private insurance; and the leaders of the insurance companies, pharmaceutical companies, and hospitals will continue making our healthcare "system" complicated, expensive, and corrupt. The suffering it imposes will continue. And my friend Bill will be confirmed – again - in his belief that American healthcare will “never, ever work.”

The truth, of course, is that American healthcare does work, superbly, for its overarching purpose – to make money for capitalists. At that, it is indeed the very best in the world. But if we want it to work for other purposes, we have to cut the Gordian knot, rather than try to untie it gradually. The rapid, drastic, and successful implementation of the National Health Service in Britain after World War II affords an example.

A tweet from @SableViews makes the point in a different way that incrementalism can be a horrible strategy:
You can't leap a chasm in two bounds. So what does [Warren] suggest? Break the leap into two bounds so that M4A falls down the damn chasm never to make it to the other side.
"Getting to the other side" is possible – but it can’t be done in the way proposed.

Friday, November 15, 2019

In addition to it being time for patients to refuse use of EHR's in their care, is it time for clinicians to refuse forced use of same? - "Association Between Perceived Electronic Health Record Usability and Professional Burnout Among US Physicians"

At my Nov. 12, 2019 post "Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans - Time to Refuse Use Of EMR's In Your Healthcare?" (https://hcrenewal.blogspot.com/2019/11/googles-project-nightingale-secretly.html) on a massive clinical data project by Google and Ascension Health, I wrote:

... I believe invasive healthcare data trafficking projects like this, with potential for massive abuses, provide reasonable justification for patients to REFUSE the use of EHR's in their care.  Paper works just fine.  In fact, when the IT goes down, it's what hospitals and doctors go right back to, and the PR always claims that "patient care was not compromised."

Yale's Dr. Edward Melnick, assistant professor of emergency medicine and director of the Clinical Informatics Fellowship at Yale (I am Yale FW '94 after completing my postdoctoral fellowship in Yale's Center for Medical Informatics 1992-1994) authored an article further supporting the contention I've been expressing for many years, as have many others.  My belief is that commercial EMR's have become so complex and overwhelming that they actually impair the well-being of clinicians, and thus the very practice of medicine:

The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among US Physicians
Mayo Clinic Proceedings
Edward R. Melnick, MD, et al.

https://www.mayoclinicproceedings.org/article/S0025-6196(19)30836-5/fulltext

Abstract

Objective
To describe and benchmark physician-perceived electronic health record (EHR) usability as defined by a standardized metric of technology usability and evaluate the association with professional burnout among physicians.

Participants and Methods
This cross-sectional survey of US physicians from all specialty disciplines was conducted between October 12, 2017, and March 15, 2018, using the American Medical Association Physician Masterfile. Among the 30,456 invited physicians, 5197 (17.1%) completed surveys. A random 25% (n=1250) of respondents in the primary survey received a subsurvey evaluating EHR usability, and 870 (69.6%) completed it. EHR usability was assessed using the System Usability Scale (SUS; range 0-100). SUS scores were normalized to percentile rankings across more than 1300 previous studies from other industries. Burnout was measured using the Maslach Burnout Inventory.

Results
Mean ± SD SUS score was 45.9±21.9. A score of 45.9 is in the bottom 9% of scores across previous studies and categorized in the “not acceptable” range or with a grade of F. On multivariate analysis adjusting for age, sex, medical specialty, practice setting, hours worked, and number of nights on call weekly, physician-rated EHR usability was independently associated with the odds of burnout with each 1 point more favorable SUS score associated with a 3% lower odds of burnout (odds ratio, 0.97; 95% CI, 0.97-0.98; P<.001).

Conclusion
The usability of current EHR systems received a grade of F by physician users when evaluated using a standardized metric of technology usability. A strong dose-response relationship between EHR usability and the odds of burnout was observed.

I have two observations:

1.  My January 31, 2018 Healthcare Renewal blog post "The inevitable downgrading of burdensome, destructive EHRs back to paper & document imaging" at http://hcrenewal.blogspot.com/2018/01/the-inevitable-downgrading-of.html, in which I opined that the downgrading of the clinician-facing components of EHRs was essential and inevitable, is increasingly supported by empirical research. 

Research such as this further invalidates marketing-driven  industry narratives about the benefits of today's commercial health IT, which is often bad health IT:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy, lacks evidentiary soundness, or otherwise demonstrates suboptimal design and/or implementation. (S. Silverstein/J. Patrick, 2012, http://cci.drexel.edu/faculty/ssilverstein/cases/)

and

2.  In addition to patients having increasingly good reasons to refuse the use of EHRs in their care, clinicians have increasingly good reasons to boycott the forced use of these systems as well. 

In that statement I am not even accounting for EHR malfunctions that lead to patient harm and clinician liability.

-- SS

Tuesday, November 12, 2019

Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans - Time to Refuse Use Of EMR's In Your Healthcare?

I have long written that leadership of EMR technology by the wrong people will create exceptionally adverse outcomes, clinically speaking. 

The same appears true socially.  In fact, adverse social outcomes (especially with regard to societal power structures) is one of the pillars of the domain of Social Informatics, the field that studies social impacts of new information & communication technologies (ICTs), about which I've taught and written.  (See http://www.dlib.org/dlib/january99/kling/01kling.html)

Now there's this stunning new story regarding clinical data trafficking. 

Original article is at the WSJ by Gerald F. Seib here: https://www.wsj.com/articles/google-s-secret-project-nightingale-gathers-personal-health-data-on-millions-of-americans-11573496790, but it's behind a paywall:

Google’s ‘Project Nightingale’ Secretly Gathers Personal Health Data on Millions of Americans

November 12, 2019

https://www.theepochtimes.com/googles-project-nightingale-secretly-gathers-personal-health-data-on-millions-of-americans_3143843.html

Google has been working with one of the largest healthcare systems in the U.S. to collect and analyze the personal health information of millions of citizens across 21 states, The Wall Street Journal reports.  The Tech giant reportedly teamed up with St. Louis-based Ascension, the largest non-profit health system in the country, last year, and the data sharing has accelerated since summer.

Code-named Nightingale, the project saw both companies collect personal data from patients, which included lab results, doctor diagnoses, and hospitalization records, as well as patient names and dates of birth.
Google said it plans to use the data to create new software that will improve patient care and suggest changes to their care.

First and foremost, the focus of this "project" is the hackneyed cybernetic miracle we've been promised for decades, the "Artificial Intelligence" that will "revolutionize" medicine. 

I view this concept as massively over-hyped and likely fraudulent, an effort to salvage the very same promises made of the entire EMR project on which has been spent hundreds of billions of dollars (more likely beyond the trillion range by now), while waiting for Godot. 

Those monies could have been better used to provide world-class healthcare for an entire population, especially considering the lack of evidence of the miracles promised.


   
CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.

... Patients and doctors were not notified that their data is being shared, and did not give their consent, according to the report.

One individual who was familiar with the project told the Journal that at least 150 Google employees already have access to much of the data on tens of millions of patients.
I have already written that the entire national EMR project is a mass human-subjects experiment without informed consent that can maim or kill patients in many different ways, including clinician distraction and IT error, among others.  I also note that as I've been involved in litigation support over the past decade, I've been exposed to what really happens without the filter of the press and the IT industry.  (The verdict in the last case in which I testified about Bad Health IT, for example, went to the deceased plaintiff's heirs - amounting to more than $16 million; others were in a lower but still multi-million dollar range.  Yet, you likely will never read about these in the HIT literature)

I believe this new account of clinical data trafficking is, more likely than not, true. It is a development I've fully been expecting for at least a decade now. (See my February 26, 2012 post "Proposed new Consumer Privacy Bill of Rights: Is It Too Late For Healthcare?" at https://hcrenewal.blogspot.com/2012/02/proposed-new-consumer-privacy-bill-of.html and my Oct. 7. 2009 post "Health IT Vendors Trafficking in Patient Data?" at https://hcrenewal.blogspot.com/2009/10/health-it-vendors-trafficking-in.html).

This new development would represent an invitation to massive deliberate or inadvertent abuse, and is likely a massive violation of the HIPAA Privacy Act, despite claims to the contrary.

Just hours after the secret project was revealed, the two companies announced the collaboration in a press release, in which they said the joint project would see Ascension’s data moved onto Google’s Cloud platform.
The statement said the joint project aims to “optimize the health and wellness of individuals and communities and deliver a comprehensive portfolio of digital capabilities that enhance the experience of Ascension consumers, patients, and clinical providers across the continuum of care.”

More cybernetic miracles promised for the true believers, expressed in the typical IT-magic phraseology.  Plenty of profits, too.

Eduardo Conrado, Executive Vice President of Strategy and Innovations at Ascension, said: “As the healthcare environment continues to rapidly evolve, we must transform to better meet the needs and expectations of those we serve as well as our own caregivers and healthcare providers.

The "transformations" needed are to scale back the IT and the bureaucracy that burdens good clinicians and consumes massive amounts of $, and the reduction of waste on worse-than-useless Bad Health IT (http://cci.drexel.edu/faculty/ssilverstein/cases/):

Bad Health IT is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy, lacks evidentiary soundness or otherwise demonstrates suboptimal design and/or implementation. 

More corporate mumbo-jumbo:

“Doing that will require the programmatic integration of new care models delivered through the digital platforms, applications, and services that are part of the everyday experience of those we serve.”
The partnership will also explore artificial intelligence and machine learning applications to help improve clinical quality, and effectiveness, patient safety and increase consumer and provider satisfaction, according to the statement.

The data collected by today's EMRs is subject to inaccuracy for multiple reasons mentioned at this blog, including perverse incentives, clinician harassment and cognitive overload, time limitations, forced entry of some data to move further on in the record, and others.  Further,  the Bad Health IT systems used to collect and display it exposes patients to risk and injury.  "AI" will not solve these "issues."

Tariq Shaukat, President of Google Cloud, added: “Ascension is a leader at increasing patient access to care across all regions and backgrounds, particularly those in disadvantaged communities. We’re proud to partner with them on their digital transformation.

"Digital transformation" is, quite frankly, the same BS as "IT revolutionizing healthcare" that I'd heard since at least the mid-1990s (see my post "Bill, Have You Lost Your Mind?" at https://hcrenewal.blogspot.com/2006/07/bill-have-you-lost-your-mind.html where I reposted my earlier memorialization of such baldly overwrought and preposterous claims.)
 
“By working in partnership with leading healthcare systems like Ascension, we hope to transform the delivery of healthcare through the power of the cloud, data analytics, machine learning, and modern productivity tools—ultimately improving outcomes, reducing costs, and saving lives.”

More billions of dollars are to be transferred from patient care to the IT industry. 

These $ could be far better spent, IMHO, on care delivery, including to the disadvantaged and minorities, and in rethinking the current health IT morass.  (See my Jan,. 2018 post "The inevitable downgrading of burdensome, destructive EHRs back to paper & document imaging" at http://hcrenewal.blogspot.com/2018/01/the-inevitable-downgrading-of.html).

I have passed the newly-released articles on this matter to attorneys with access to the national trial lawyers' listservs, where the merits of "Project Nightingale" can be considered from the perspective of non-toothless patient's rights advocates.

FINALLY:

I believe invasive healthcare data trafficking projects like this, with potential for massive abuses, provide reasonable justification for patients to REFUSE the use of EHR's in their care.  Paper works just fine.  In fact, when the IT goes down, it's what hospitals and doctors go right back to, and the PR always claims that "patient care was not compromised."

-- SS

11/15/2019 Addendum:

There is a whistleblower (https://www.theguardian.com/commentisfree/2019/nov/14/im-the-google-whistleblower-the-medical-data-of-millions-of-americans-is-at-risk):

I didn’t decide to blow the whistle on Google’s deal, known internally as the Nightingale Project, glibly. The decision came to me slowly, creeping on me through my day-to-day work as one of about 250 people in Google and Ascension working on the project.

When I first joined Nightingale I was excited to be at the forefront of medical innovation. Google has staked its claim to be a major player in the healthcare sector, using its phenomenal artificial intelligence (AI) and machine learning tools to predict patterns of illness in ways that might some day lead to new treatments and, who knows, even cures.

Here I was working with senior management teams on both sides, Google and Ascension, creating the future. That chimed with my overall conviction that technology really does have the potential to change healthcare for the better.

But over time I grew increasingly concerned about the security and privacy aspects of the deal. It became obvious that many around me in the Nightingale team also shared those anxieties.

After a while I reached a point that I suspect is familiar to most whistleblowers, where what I was witnessing was too important for me to remain silent. Two simple questions kept hounding me: did patients know about the transfer of their data to the tech giant? Should they be informed and given a chance to opt in or out?

The answer to the first question quickly became apparent: no. The answer to the second I became increasingly convinced about: yes. Put the two together, and how could I say nothing?
-- SS

Friday, November 08, 2019

The Managers' Coup d'Etat in Health Care Appears Complete - a Study of Top Health Care "Influencers"

Introduction: the Managers' Coup d'Etat

As we wrote in 2006... in 1988, Alain Enthoven, an original member and driving force of the Jackson Hole group, published a short manifesto about "managed competition." (Entoven AC. Theory and Practice of Managed Competition in Health Care Finance. Amsterdam: North Holland, 1988.) This is now not easy to find (but see Amazon here).

In this volume, Enthoven expounded on his scheme to wrest power over health care from physicians and give it to managers and bureaucrats. Enthoven thought of physicians as part of a tightly organized "guild," that is, an economic alliance. His model for this was a pre-World War II document from a French medical society. Basically, he thought such guilds, which he believed to be in place in all Western democracies except in the UK and Scandinavia, were based on principles that were "not the natural expression of a free market in health care," (p.33) and furthermore, that the guild model associated with health insurance "makes it very difficult for government or private payors to control cost growth," (p.41) while they paradoxically "can also produce poor service (p. 42). To combat physicians' overwhelming economic power, Enthoven called for managers to use "tools they have found to counteract market failure." (p. 98) Finally, he suggested using a coordinated strategy to "break up the guild," noting that "overcoming the guild has not been easy in the United States.... However, the guild has broken down." (P. 122)

How much the guild has broken down, leaving health care leadership in the hands of managers, was illustrated by a recent research letter in the Mayo Clinic Proceedings (Logeman AL et al. Who Influences Health Care in the United States? A Study of Trends From 2002 to 2018. Mayo Clin Proc 2019; 94: 2360-1. Link here.)

Managers are Now the Most Influential People in Health Care

The authors studied the list of the 100 Most Influential People in Healthcare published by Modern Healthcare yearly since 2003. (The 2018 version is here.)   They stated that:

Because it receives wide reporting and limited critique, this list stands as a useful longitudinal account of who others perceive to be in a position to influence health care.

Then,

Using the published yearly list and the reported characteristics of the persons listed, we sought to determine the relative ranking over time, covering the period 2002 to 2018, of executives and administrators, academics and frontline advocates, and government officials. To achieve this, we determined the influencer’s sex and role (executive, member, independent, or other) as well as the sector from which each individual exerted their influence grouped into industry (nonprofit, for profit, payers, products, and providers), academia/advocacy, and government.

The results showed a striking trend over time.

There were 1700 persons named from 2002 to 2018, a minority of them women (range over the period, 17% to 28%). Most influencers are top executives from nonprofit health care provider organizations; their proportion has increased from 23% in 2002 to 72% in 2018, with an apparent substantial upward inflection in this trend since 2009 (Figure). This predominance appears to be at the expense of academics, advocates, and government officials.


A news article that featured an interview with Dr Victor Montori, the senior author of the article, noted in fact that the most recent (2018) list included quite a few CEOs of large for-profit health care corporations.

Among those topping the latest installment of the influential Modern Healthcare power index are the corporate heads of Amazon, Apple, Aetna, Humana, CVS and Minnetonka, Minn.-based United Health/Optum.

The authors concluded that

perceived influence over US health care of chief executives of health systems is increasing. To the extent that the ranking validly reflects influence, the sharp rise in the influence of chief executive officers at the expense of representatives of patients or health professionals may underscore the increasing industrialization of health care. It is not possible to find patients, patient advocates, clinicians, or clinician advocates at the top of this list. This trend placing health care influencers within C-suites, accountable to boards mostly comprising other corporate leaders, may explain the rise of business language and thinking

They suggested that it is possible that there is a

causal association between the concentration of executive influence and problems of patient care derived from efforts to optimize operational efficiency and financial performance, for example, clinician burnout, the heavy burden of treatment afflicting patients with chronic conditions, and the erection of barriers to care to optimize 'payer mix.'

Dr Montori also said in the interview

Americans increasingly find themselves in a corporate-centric healthcare echo-chamber, one in which the public will increasingly approach tough policy decisions having heard only the viewpoint from the top.

'The primary goals of CEOs are to advance the mission of their organization,' Montori says. 'If all that influences healthcare are the ideas of people who advocate for the success of their organizations, people who are not served by them will not have their voices heard.'

Furthermore, he suggested that the public may be befuddled by the current health policy debates, including those about universal health care and the possibility of reducing the power of commercial health insurance companies because

in the rest of the narrative all that they hear is about are the successes of biotech, the successes of tech companies, and the successes of healthcare corporations who achieve high levels of innovation thanks to the bold leadership of their executives. It's why we have been calling for greater awareness of the industrialization of healthcare for some time now

Summary

The new study by Longman, Ponce, Alvarez-Villalobos and Montori adds to the evidence that health care has been taken over by business-trained managers, and in the US, especially by large commercial health care organizations run by such managers.

Since we started Health Care Renewal, we have frequently discussed the rise of generic managers, which later we realized has been called managerialism.  Managerialism is the belief that trained managers are better leaders of health care, and every other sort of organization, than are than people familiar with the particulars of the organizations' work.  Managerialism has become an ascendant value in health care over the last 30 years.  The majority of hospital CEOs are now management trained, but lacking in experience and training in medicine, direct health care, biomedical science, or public health.  And managerialism is now ascendant in the US government.  Our president, and many of his top-level appointees, are former business managers without political experience or government experience.

We noted an important article in the June, 2015 issue of the Medical Journal of Australia(1) that made these points:
- businesses of all types are now largely run by generic managers, trained in management but not necessarily knowledgeable about the details of the particular firm's business
- this change was motivated by neoliberalism (also known as economism or market fundamentalism)
- managerialism now affects all kinds of organizations, including health care, educational and scientific organizations
- managerialism makes short-term revenue the first priority of all organizations
- managerialism undermines the health care mission and the values of health care professionals

Generic or managerialist managers by definition do not know much about health care, or about biomedical science, medicine, or public health.  They are prototypical ill-informed leadership, and hence may blunder into actual incompetence.  They are trained that they have a right to lead any sort of organization, which breeds arrogance.  These managers are not taught about the values of health care professionals.  Worse, they are taught in their business style training about the shareholder value dogma, which states that the main objective of any organization is to increase revenue.  Thus, they often end up hostile to the fundamental mission of health care, to put care of the patient and the health of the population ahead of all other concerns, which we have called mission-hostile management.  (Furthermore, it appears that the shareholder value dogma is just smokescreen to cover the real goal of managers, increasing their own wealth, e.g., look here.)  Finally, arrogance and worship of revenue allows self-interested and conflicted, and even sometimes corrupt leadership. 

Managerialists may be convinced that they are working for the greater good.  However, I am convinced that our health care system would be a lot less dysfunctional if it were led by people who actually know something about biomedical science, health care, and public health, and who understand and uphold the values of health care and public health professionals - even if that would cost a lot of very well paid managerialists their jobs.

Maybe someday the top "influencers" in health care will actually be people who know something about health care and actually care about patients' and the public's health. 

Note (25 November, 2019): this post was re-posted by the Naked Capitalism blog here

Sunday, November 03, 2019

How Can We Promote Evidence-Based Medicine Under a Regime that Insists on Its Power to Say "2+2=5"?

Introduction: Evidence-Based Medicine

We have consistently advocated for Evidence-Based Medicine (EBM), which is about medical-decision making based on critical review of the best applicable evidence from clinical research informed by knowledge of biology and medicine, of the patient's biopsychosocial circumstances, the patient's values, and of ethics and morality. Since EBM depends on the availability of evidence from the best clinical research, we have advocated for the integrity of clinical research, and decried  manipulation of clinical research done to increase the likelihood that its results would please vested interests, and suppression of research whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results.

Addressing such threats to the evidence-based required challenging the role of large for-profit corporations, principally pharmaceutical, biotechnology, and device companies, in clinical research.  In doing so, we depended on support from other concerned health care professionals and scientists.  Sometimes, when manipulation and suppression crossed over the line to become fraud and deceptive marketing, government regulators and lawyers stepped in.  We have discussed numerous legal settlements involving penalties - admittedly, often less severe than we would have preferred  - on particular corporations.

So we have counted on governments having a shared interest in promoting the integrity of clinical research, and more broadly of clinical and public health science, and when necessary, acting to enforce such integrity.  

However, we have increasing reason to doubt these shared interests under the current US regime.



Administration Comfort with Suppression of Speech about Research

Consider episodes in which political appointees of the Trump regime seemed comfortable with the suppression of speech about medical, health care and public health research.

In 2016, we discussed several cases in which officials at the Department of Health and Human Services stifled responses to journalists about scientific issues.  In particular, employees of the Center for Disease Control (CDC) were told not to respond to any journalists' requests for information, even "simple data-related questions," in lieu of responses from agency public relations personnel.

In 2017, we discussed how President Trump's first Secretary of Health and Human Services, Dr Tom Price, had been involved in attempted suppression of the results of research about the drug Bildil at the behest of a previous campaign donor.

In addition, three recent episodes, one from August, 2019,  two more in late October, suggest that under Trump, open discussion of the science pertaining to health care and public health, and the pursuit of scientific truth in these areas have been increasingly subordinated to politics, and particularly to supporting the notion that the President is sole keeper of all truth. 

Silencing National Intstitute of Mental Health (NIMH) Scientists about the Relationship of Mental Health to Violence to Avoid Contradiction of a Trump Tweet


Per a Washington Post article from August 20, 2019, after mass shootings in El Paso, TX and Dayton, OH,

'Mental illness and hatred pull the trigger. Not the gun,' Trump said immediately after the shootings. In the following days, he reiterated that statement, arguing that the United States should reopen mental institutions shuttered decades ago as a way to address mass shootings.

But then,

federal health officials made sure no government experts might contradict him.

A Health and Human Services directive on Aug. 5 warned communication staffers not to post anything on social media related to mental health, violence and mass shootings without prior approval.

The particulars were as follows:

On Aug. 5, Trump was scheduled to speak following the weekend shootings. That morning, some HHS employees, including those at the National Institutes of Health, received an email asking those who contribute to official social media accounts to hold off on posts until 'we get the green light from HHS,'

Then,


some employees received another email from Renate Myles, an NIH spokeswoman. Social media posts could resume, the note said, butemployees were asked to 'please send any [social media] posts related to mental health, violence or other topics associated with mass shootings for review before posting.'

The second directive applied most directly to the National Institutes of Mental Health, where nearly all of the agency’s social media activities relate to mental health. It remains unclear how many people received that instruction, which was lifted by week’s end.

The administration's explanation was:

'It’s the department’s long-standing practice to not get ahead of the president’s remarks,' HHS spokeswoman Caitlin Oakley said. 'This allows the president to share his message first with the nation. Any suggestions that this was a formal policy put in place related to social media, or meant to stymie work on this issue, are factually inaccurate. These were staff-level discussions seeking to be sensitive and respectful to the victims and their families affected by tragedies of that weekend.'

However,

By contrast, two former senior health officials in the Obama administration said they did not recall ever receiving such a directive after a mass shooting.

Also,

In the days and months following the mass shooting at Sandy Hook Elementary School in Newtown, Conn., which killed 20 first-graders and six staff members, the National Institutes of Mental Health spoke extensively about mental illness and violence. 'The conversation has evolved, recognizing that violence most often associated with mental illness is suicide, and that most violence is unrelated to mental illness,' the NIMH director said at a meeting three months later. NIMH also hosted a special panel discussion, How Sandy Hook is Changing the Conversation,' during which mental health experts worked to dispel stereotypes that link mental illness to violence.

After this month’s shootings, however, NIMH and its director were largely silent on the shooting. The only mention on the official NIMH Twitter account was a retweet of the NIH account, directing those struggling with grief and emotional distress to the Substance Abuse and Mental Health Services Administration for counseling and support.

Furthermore,

An HHS employee who spoke on the condition of anonymity to describe internal discussions said he had 'no doubt this was meant to prevent anybody from making any statements that might contradict the president.'

The Post consulted one ethics expert:

'To say that scientists and experts who know the data and facts best are not allowed to speak — that’s very concerning,' said Dominic Sisti, a University of Pennsylvania professor who studies ethics in mental health and psychiatry.

Silencing the Director of the National Institute of Environmental Health Sciences (NIEHS)  and National Toxicology Program to Support Industries Favored by the Administration

The case had to do with the health risks posed by PFAS, industrial chemicals found in the environment.

Per an October 24, 2019 article in The Intercept, the background is:

the company that first developed both PFOA and PFOS and sold PFOA to DuPont for many years, still argues that the compounds do not cause health problems. In her testimony before the House Committee on Oversight and Reform in September, Denise Rutherford, 3M’s senior vice president of corporate affairs, said that 'the weight of scientific evidence has not established that PFOS, PFOA, or other PFAS cause adverse human health effects.' The company also requested that The Intercept remove the word “cause” in a recent article about PFAS. That request was denied.

However, Linda Birnbaum, recently retired director of the National Institute of Environmental Health Sciences and the National Toxicology Program, thought

'In my mind, PFAS cause health effects because you have the same kind of effects reported in multiple studies in multiple populations,' she said in a phone interview. Birnbaum pointed in particular to longitudinal studies, which follow populations’ exposures and health over time. 'You have longitudinal studies showing the same effects in multiple populations done by multiple investigators and you have animal models showing the same impact,' said Birnbaum. In addition, she pointed to studies that show the mechanism through which PFAS chemicals cause harm in people.

'That is pretty good evidence that PFAS or certain PFAS can cause health effects in people. It is not as strong for every effect, but there are quite a number of effects where they’re strong enough to say ‘caused,’' Birnbaum said. She pointed in particular to the relationship between the chemicals and immune response, kidney cancer, and cholesterol in humans, saying, 'That data is very clear.'

Dr Birnbaum had upset industry in the past, but in particular,

Her run-in with Republicans on the House Science Committee last year may have had the most severe consequences. Reps. Andy Biggs and Lamar Smith accused Birnbaum of lobbying based on an editorial in the journal PLOS Biology. In it, Birnbaum wrote that 'U.S. policy has not accounted for evidence that chemicals in widespread use can cause cancer and other chronic diseases, damage reproductive systems, and harm developing brains at low levels of exposure once believed to be harmless.' She called for more research on the risks posed by chemicals and noted that 'closing the gap between evidence and policy will require that engaged citizens — both scientists and non-scientists — work to ensure that our government officials pass health-protective policies based on the best available scientific evidence.'

Under the Trump administration, there were consequences:

'everything was scrutinized that I did. Everything I did required clearance. Even in my lab,' said Birnbaum. 'All of a sudden, everything had to go up at least to building 1,' she said, referring to the Bethesda building that serves as the administrative center for the National Institutes of Health. Birnbaum was also denied a salary increase after the incident and became aware that her job was at stake. 'I was told that they were trying to fire to me.'

Also,

Birnbaum was not allowed to use the word 'cause' when referring to the health effects from PFAS or other chemicals.

'I was banned from doing it'” said Birnbaum. 'I had to use ‘association’ all the time. If I was talking about human data or impacts on people, I had to always say there was an association with a laundry list of effects.' Birnbaum said this restriction 'was coming from the office of the deputy director. His job hinged on controlling me.'

Again, while there is room for debate about whether PFAS causes the problems, or are simply associated with the problems.  However, the accusation is not that there was debate within the government, but that Dr Birnbaum's government supervisor silenced her opinions about causation, whaterver the evidence on which she based them.

Silencing the Director of the Centers for Disease Control and Prevention (CDC) Climate and Health Program About "Climate Change"

On October 29, 2019, CBS News reported that Dr George Luber, Director of the CDC Climate and Health Program, had to stop talking about "climate change," particularly its health consequences,

In late 2016 Luber was organizing a climate change conference. Al Gore was to be the keynote speaker. But right after Donald Trump was elected president, Luber's boss called him in.

Luber recalled, 'I was told the optics are not good and that I needed to cancel it.'

Correspondent Mark Strassmann asked, 'Did he explain what the optics issue was?'

"That the meeting was happening three weeks after the inauguration."

'And that the White House would be unhappy?'

'Yeah,' Dr. Luber said.

America's new president had a dim view of Luber's science, referring to climate change as a hoax, 'created by and for the Chinese.'

Dr. Luber said his boss wanted something else: 'Just don't say 'climate change.' Can you call it 'extreme weather?' Can you call it something else?'

Strassmann said, 'You're saying that the Centers for Disease Control was suddenly afraid to use the term 'climate change'?'

'Yeah. Absolutely. I was told to use a different term,' he said.

CBS confronted Dr Patrick Breyesse, Dr Luber's manager, who essentially gave a non-denial denial:

He's the senior manager who Dr. Luber said ordered him to scuttle the science conference.

'It wasn't cancelled; we postponed it,' Dr. Breysse said.

'You didn't feel any pressure at all?' Strassmann asked.

'No.'

'Politically?'

"No."

That conference happened, but without CDC sponsorship.

Strassmann asked, 'Were any CDC employees ever told, 'Stop using the phrase 'climate change'?'

'Not to my knowledge,' Dr. Breysse replied, 'but we did discuss it.'

'That you change from 'climate change' to 'extreme weather,' because 'climate change' was more radioactive?'

'We talked about making the change, but we never made the change.'

Meanwhile, it appears that CDC leadership retaliated against Dr Luber,

In March 2018 the CDC revoked Dr. Luber's badge, phone and credentials. He was escorted off the property. The CDC moved to fire him. He faced more than 30 'troubling allegations,' from falsifying timecards to seeming hung over. Dr. Luber refuted all but one charge, and was allowed to stay.

However,

Dr. Luber still works at the CDC, but potentially faces up to a four-month suspension. He has to work from home, where he reviews scientific papers unrelated to climate change.

When asked about that, Dr Breyesse responded

'I can't talk about personnel matters, I'm sorry, Mark,' he responded.

'Has he been banned from the campus?'

'So, that's a personnel matter that I can't discuss.'

'Is the CDC retaliating against him?'

'I'm just not going to comment on that,' he said.

A Larger Pattern

To summarize, in the second half of 2019, we have seen three episodes of scientists/ health care professionals at the premier US government health and public health agencies silenced about relevant issues to apparently avoid contradicting Trump administration political goals and/or the pronouncements of the President himself.  There is reason to suspect that agency leaders punished or retaliated against the scientists and health professionals for speaking out.

These appear to be part of a larger pattern.  There have been a lot of similar episodes involving other kinds of science.  For example, there was the infamous case of government climate scientists attacked after they contradicted a Trump tweeted his erroneous take on the course of Hurricane Dorian.  As the New York Times reported on September 8, 2019:  

The Secretary of Commerce threatened to fire top employees at the federal scientific agency responsible for weather forecasts last Friday after the agency’s Birmingham office contradicted President Trump’s claim that Hurricane Dorian might hit Alabama, according to three people familiar with the discussion.

That threat led to an unusual, unsigned statement later that Friday by the agency, the National Oceanic and Atmospheric Administration, disavowing the National Weather Service’s position that Alabama was not at risk. The reversal caused widespread anger within the agency and drew accusations from the scientific community that the National Weather Service, which is part of NOAA, had been bent to political purposes.

After that episode, the National Task Force on Rule of Law and Democracy developed a report on government attaacks on the integrity and rigor of government research, as summarized in an op-ed in the Washington Post on October 3, 2019, entitled "Under Trump, the integrity of government research is in shambles." The authors wrote,

This isn’t the first time this administration has retaliated against scientists for doing their jobs. The Agriculture Department recently decided to relocate an entire staff of career economists from Washington to the Kansas City area after they published reports on the financial harms of Trump’s trade policies. The Interior Department moved a climate scientist to an accounting role after he stressed the dangers of climate change to Alaska’s Native communities. A recent tally by the Union of Concerned Scientists listed more than 120 attacks on science by the Trump administration.

The report called for a variety of legislative solutions, but these may be insufficient.

The pattern may be even larger.  In the Atlantic, Quinta Jurecic, the managing editor of Lawfare, wrote on September 11, 2019,

The saga of Dorian is a snapshot of Trump’s refusal to accept the reality of a world that looks any different from what he wants to be true, and a demonstration of how such an instinct in a leader is incompatible with the requirements of democracy.

Furthermore,

Trump’s behavior regarding Dorian is yet another example of his strained relationship with the truth, something that is at this point so routine as to be barely worth commenting on. In the language of the philosopher Harry Frankfurt, he is a 'bullshitter'—someone who does not so much lie in order to consciously obscure the truth as make statements without any thought or care to what the truth might be. Bullshit, Frankfurt argues, is careless, in that it requires no commitment to a stable universe of facts. And Trump’s falsehoods are careless insofar as he makes them without any regard for consistency or internal logic, but there is also a stubbornness to them. His bullshit is a way of insisting that the world take the shape he wants it to have, regardless of the facts on the ground.

Government by BS is not just a threat to science and scientific discussion.

Democracy, as Arendt writes, depends on the existence of a shared universe of mutually agreed-upon facts—like whether or not it is raining in Alabama. It also depends on the willingness of leaders to acknowledge that some things, including the weather, are beyond their control. That is not Donald Trump’s way. He is the strong man standing alone at the front of the crowd, who is strong only when there is no one there to tell him differently.

Trump seems to want to be like the Inner Party in Orwell's 1984. In Part III, Chapter 2, when Inner Party member O'Brien interrogates and tortures Winston Smith, he says:

reality is not external.  Reality exists in the human mind, and nowhere else.  Not in the individual mind, which can make mistakes, and in any case soon perishes: only in the mind of the Party, which is collective and immortal.  Whatever the Party holds to be truth, is truth.  It is impossible to see reality except by looking through the eyes of Party.  

So when O'Brien holds up his hand with four fingers extended, and Smith says he sees four fingers,

And if the Party says that it is not four but five - then how many?

The Party says the answer must be "five"

So the answer to the question posed by the title of this post is "we can't"

As long as we are led by a President who believes he has the power to make 2 + 2 equal "5," we will be unable to meaningfully promote clinical research integrity, much less evidence-based medicine.  Any progress will only come with a new President.