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

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. 

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.  





Sunday, October 27, 2019

Circular Logic - A Revolving Door Update

We have actually managed to go for three months without posting on the revolving door.




Since then, however, we have accumulated a sufficient number of relevant cases to post another round up.


The Old School Outgoing Revolving Door

Let us begin with cases of the old fashioned outgoing revolving door, that is, of people leaving leadership positions in governmental bodies which regulate health care or make health care policy, then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made.

However, it is striking that many of the people recently reported as transiting the outgoing revolving door have also had in the past transited the incoming revolving door (see below).

Cynthia Ridgeway, From Department of Justice Prosecuting White Collar Crimes to Anthem

As reported on July 15, 2019 by Modern Healthcare:

Health insurer Anthem has hired Cynthia Ridgeway, a longtime attorney for the U.S. Justice Department, to be its corporate strategy director.

Ridgeway is first assistant U.S. attorney in the Southern District of Indiana. During her 15-year tenure at the U.S. attorney's office, she litigated high-profile white collar crimes

The brief report had no information about Ms Ridgeway's expected duties for Anthem.  It is possible, but not certain, that they could be relevant to her work in white collar crime investigations and prosecutions for the government.

Marilyn Tavenner, From Administrator of Center for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services (DHHS) to America's Health Insurance Plans (AHIP) and Now to Blue Cross Blue Shield of Arizona

As in a July 23, 2019, PR release:

Marilyn Tavenner, R.N., the former Administrator for the Centers for Medicare and Medicaid Services (CMS) and past president and CEO of America's Health Insurance Plans (AHIP), officially joined the BCBSAZ board, which provides strategic oversight to the company.

Note that Blue Cross Blue Shield of Arizona is a non-profit corporation.

Further note that Ms Tavenner had quite an interesting past history of revolving door transits.  According to her Wikipedia page, she worked for for-profit hospital system Columbia/ HCA, now HCA, from 1981 to 2005, starting as a nurse, and rising to President of the Central Atlantic Division.  While there, she worked for CEO Rick Scott, on whose watch the company made a huge settlement for Medicare fraud (look here).  Scott was not charged, left the company, and then was elected to be Governor of and the Senator for Florida as a Republican.  Ms Tavenner then went on to be Secretary of Health and Human Resources for Virginia, and then CMS administrator from 2013-15.

So Ms Tavenner moved from a for-profit hospital company to running the government agency that operates  government health insurance programs, and thus greatly influences hospital revenues.  The agency also obviously greatly influences the insurance industry, whose major trade association she then went on to lead.  Now she will be part of the governance of a large, albeit non-profit insurance company.

Erik Paulsen, From the House of Representatives to the Board of Cardiovascular Systems

As reported by the St Paul Business Journal, July 25, 2019:

Former U.S. Rep. Erik Paulsen has joined the board of directors for St. Paul medical device company Cardiovascular Systems Inc.

Cardiovascular Systems (Nasdaq: CSII) touted Paulsen’s support for the medical device industry and involvement with federal health care and economic policy in its announcement Thursday.

As a member of Congress from 2009 to 2019 representing Minnesota’s Third District, which covers suburbs of Hennepin County, Paulsen was co-chair of the bipartisan House Medical Technology Caucus. He also served on the House Ways and Means Committee, which covers taxes and policies governing health care, economics and trade.

Thus Mr Paulsen went from having a leadership role in government relationships with medical technology, and "taxes and policies governing health care," to a role in governance of a health technology company.

Dr Scott Gottlieb, From Commissioner of the Food and Drug Administration (FDA) to Venture Capital and the Pfizer Board of Directors, and now the Board of Aetion

Dr Scott Gottlieb has frequently appeard in posts on Health Care Renewal.  Our last summary of his relevant transits to the revolving door, from July, 2019 noted:

Dr Scott Gottlieb, FDA Commisioner from 2017 to May, 2019,  had been no stranger to the revolving door.  Prior to assuming leadership of the FDA, he had relationships with multiple for-profit health care corporations, which drew wide notice when he was appointed to head the FDA in 2017, as we noted at that time here.  Also, Dr Gottlieb was clearly very comfortable with the pharmaceutical and biotechnology industries.  For example, in 2007-2008, we discussed many examples of Dr Gottlieb's strident promotion of the interests of these industries (look here, here, here and here).

Very quickly after leaving the FDA in 2019, Dr Gottlieb rejoined his old venture capital firm, New Enterprise Associates, as a full-time partner investing partner specializing in life sciences companies.

Then in June, 2019, he joined the board of Pfizer.

His latest move was reported on September 17, 2019 by Fierce Healthcare:

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has added another position to his roster of board and advisory roles since leaving the agency back in March.

He'll be joining healthcare technology company Aetion’s board of directors, the company announced Tuesday. The New York-based company offers real-world evidence and analytics to drug companies, payers, life sciences companies and regulatory agencies.

The company has an interesting array of financial backers:

Sanofi, Amgen, UCB, McKesson Ventures and Horizon Healthcare Services have all backed Aetion as strategic investors, according to the company.

It appears that Gottlieb's former role as leader of the FDA is highly relevant to the business of Pfizer, Aetion, and Aetion's "strategic investors." In particular, regarding Aetion:

Gottlieb will advise the company as it expands the reach and utility of the Aetion Evidence Platform, a scientifically validated tool to assess the safety, effectiveness and value of treatments using real-world evidence, the company said in a press release.

During his tenure, Gottlieb also pushed for the FDA’s use of real-world evidence, recognizing its potential to advance medical products and their development, Aetion said.

'The widespread adoption of real-world evidence to the development and application of new treatments will improve the precision of prescribing decisions and help make drug discovery far more efficient,' Gottlieb said in a statement.'“As a member of Aetion’s Board, I’m inspired by the opportunity to join the company’s efforts to bring RWE to the forefront of drug research and development.'

'Dr. Gottlieb has played a pivotal role in advancing the use of real-world evidence for regulatory decision-making. As a real-world evidence advocate and standard-setter, he’s an ideal partner in our work to help define RWE's role in the development, delivery, and payment of treatments,' Carolyn Magill, CEO of Aetion, said in a statement.

And regarding Pfizer and other pharmaceutical companies:

Aetion works with 12 of the top 20 biopharma firms in the world, along with leading payers.

We had discussed the conflicts of interest presented by Gottlieb's Pfizer board decision, which Senator Elizabeth Warren (D-MA) asserted "smacks of corrupion," here.

Matthew Whitaker, From Acting US Attorney General to Legal Advisor to a Marijuana and CBD Company

As reported on August 28, 2019 by Forbes:

Toronto-based CBD company Alternate Health Corp has hired Matthew Whitaker, former acting U.S. Attorney General, and his law firm Graves Garrett to serve as outside counsel.

Previously, he

served as Chief of Staff to then Attorney General Sessions from September 2017 to November 2018

Why was he selected?

'The legal environment surrounding CBD is rapidly evolving and it is essential that Alternate Health stays at the forefront of new government and FDA regulations,' he said. 'We believe his experience in government and the Department of Justice is a significant asset as we move forward.'

So Mr Whitaker, after taking a leading role in US government law enforcement, including enforcement of laws related to drugs like marijuana, would not be advising a foreign company trying to get favorable legal treatment from the government.

Rebecca Wood, from Chief Counsel at FDA to Leader of Food and Drug Practice at Sidley Austin

Ms Wood had been Chief Counsel at the FDA.

Recently reported by ProPublica (in a October 15, 2019 article to be discussed further below):

Wood now leads the food and drug practice at Sidley Austin, a powerful law and lobbying firm in Washington, where her colleagues lobby the FDA for various clients.

She is an example of

former Trump administration staffers who go back to K Street but don’t register as lobbyists — the Lobbying Disclosure Act only requires those who spend 20% or more of their time lobbying to register.

This still generates important conflicts of interest.

Wood said she 'advises clients on FDA-related issues and, in doing so, complies with all applicable ethics requirements.'

There is nothing illegal about returning to an old employer or being hired by a new one. Nor is there anything wrong with having colleagues who lobby the federal government. But the revolving door does present the possibility of conflicts of interests.

'The most important commodity in D.C. is information,' Hauser said. 'Former insiders have rare access to strategic intelligence, which is of significant value to corporate entities, and they can do so without registering as a lobbyist.'

Dr Karen DeSalvo, from Assistant Secretary of Health, DHHS and Office of the National Coordinator, to the University of Texas, now to Google as Chief Health Officer

As reported by Health Care Dive on October 18, 2019

Google has hired ex-Obama administration official Karen DeSalvo as its first chief health officer, further solidifying its investment in the $3.5 trillion industry by rounding out its healthcare team.

DeSalvo, a well-respected healthcare executive and public health expert, was the acting Assistant Secretary for Health at HHS and ran the Office of the National Coordinator, which manages the nation's health IT, under President Barack Obama. She has spent the past two years teaching at the University of Texas at Austin's Dell Medical School.

Note that there was a two year delay after Dr DeSalvo left the government until her hiring by Google.  This does apparently lessen the conflicts of interest generated.  However, many think 

The Au Courant Incoming Revolving Door

In the Trump era, many people have come through the incoming revolving door, that is, people with significant leadership positions in health care corporations or related groups have attained leadership positions in government agencies whose regulations or policies could affect their former employers.

On October 15, 2019, ProPublica published a striking article on people transiting the incoming revolving door from lobbying positions to leadership positions at government agencies whose regulations or policies could affect their lobbying clients.

Two of the people recently added to the ProPublica data base got major government health care leadership positions after working as lobbyists, and then returned to lobbying after ending their government "service."

By way of background:

At the halfway mark of President Donald Trump’s first term, his administration has hired a lobbyist for every 14 political appointments made, welcoming a total of 281 lobbyists on board, a ProPublica and Columbia Journalism Investigations analysis shows.

With a combination of weakened rules and loose enforcement easing the transition to government and back to K Street, Trump’s swamp is anything but drained. The number of lobbyists who have served in government jobs is four times more than the Obama administration had six years into office. And former lobbyists serving Trump are often involved in regulating the industries they worked for.

Even government watchdogs who’ve long monitored the revolving door say that its current scale is a major shift from previous administrations. It’s a 'staggering figure,' according to Virginia Canter, ethics chief counsel for the D.C.-based legal nonprofit Citizens for Responsibility and Ethics in Washington. 'It suggests that lobbyists see themselves as more effective in furthering their clients’ special interests from inside the government rather than from outside.'

Colin Roskey,  from Health Care Lobbying for Lincoln Policy Group to Deputy Secretary, DHHS, then back to Lobbying for Lincoln Policy Group

Per ProPublica:

Consider Colin Roskey. Days after leaving a two-decade career as what one former employer called the 'smartest' health care lobbyist, he joined the Department of Health and Human Services in January. As deputy secretary for legislation for mandatory health, he headed the portfolio that he tried to influence for most of his career.

HHS declined to reveal any recusals he signed while appointed. A spokesman said that “all employees are expected to abide by the ethics rules.”

Just days before joining HHS, Roskey listed among his clients major dialysis providers that receive federal payments through Medicare, including Fresenius Medical Care — an industry juggernaut, with more than 330,000 patients in thousands of dialysis clinics in the U.S. A third of the company’s billion-dollar revenue comes from Medicare. A recent revamp in the dialysis industry ordered by Trump, expected to shift millions of dollars from dialysis centers to cheaper home-based options, put Roskey’s office at the heart of regulating how much profit or loss some of his former clients will see in coming years. Roskey said in an interview that he recused himself from this matter.

Public records show that Roskey lobbied for at least 27 clients between January 2017 and December 2018 on an array of issues other than dialysis involving public health care programs, from prescription drugs to palliative care.

In early October, Roskey stepped out of government and went straight back to work for his old lobbying firm, Lincoln Policy Group, which specializes in health care policy. “Spending time at HHS will make [Roskey] even more valuable to our team — and we are so excited to have him back,” the lobbying firm announced in a statement.

Roskey said he had no knowledge of how the new kidney care regulations will be implemented.

After his monthslong stint with the Health Department, Roskey said he plans to lobby the legislative branch, which is not prohibited by the current ethics rules. 'While working with the government I gained knowledge and background, intellectually and professionally, and I intend to unapologetically utilize those skills for my employer and clients,' he said.

The conflicts of interest generated by the moves from and to the lobbying firm are are obviously significant.

Laura Kemper from Health Care Lobbyist to Deputy Assistant Secretary of DHHS, then to Lobbying as Vice-President for Governmental Affairs for Fresenius

We had previously discussed Ms Kemper's transit from lobbyist to government health care leader here.   From the ProPublica article,

Laura Kemper, [is] a former HHS senior official who, within days of leaving her post in March, was hired by Fresenius. Now vice president for government affairs, Kemper heads the company’s policy group.

According to lobbying records, she is listed among the in-house lobbyists who have visited Congress, the White House and HHS since March, pushing everything from reimbursement for dialysis services to home dialysis. The records show Fresenius shelled out more than $2.2 million for lobbying activities during the first half of the year.

Furthermore, ProPublica noted:

Her pass through the revolving door tests the boundaries of ethics rules. Indeed, Trump’s pledge prohibits staffers-turned-registered lobbyists from advocating for the special interests of their corporate bosses before the agencies where they used to work for at least five years. It also restricts former employees from behind-the-scenes lobbying with any senior federal official for the remainder of Trump’s presidency. Kemper signed that pledge.

Kemper declined to comment. In a statement, Fresenius said Kemper “has strictly followed her legal and ethical obligations and has not been involved in lobbying the administration or anything related to the Executive Order.” Disclosure forms filed by Fresenius “cite the general activity of a team and do not ascribe any particular lobbying activity,” according to its statement.

Recently, during an earnings call to investors, Fresenius CEO Rice Powell said that the company has talked to the 'appropriate people in Washington,' without naming any particular Fresenius or government staffer. “We are in the midst of commenting and asking questions” with HHS officials, he added.

As ProPublica has reported, political appointees who return to lobbying have found ways to tiptoe around ethics rules. Some register as lobbyists but limit their interactions to Congress, leaving colleagues to lobby the executive branch. Ethics restrictions don’t apply to congressional lobbying.

Summary

We have repeatedly said,  most recently in March, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big health care corporations increasingly control the governmental regulatory and policy apparatus.  This will doubtless first benefit the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people, due to detriment of patients' and the public's health, the pocketbooks of tax-payers, and the values and ideals of health care professionals.  

 The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

Saturday, October 19, 2019

Government Increasingly Promoting Sectarianism-Based Health Policy

Traditionally, physicians and other health care professionals are taught to put the care of the individual patient first.  Patients deserve care according to their own values as best they can be realized.  Physicians whenever possible should avoid substituting their own values for those of the patient.  In particular, they should avoid imposing their own religious beliefs on those of patients.

In the US, we live under a Constitution whose First Amendment states "Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof."

Thus it is concerning that under the Trump administration we have seen efforts apparently meant to orient government agencies involved with health care and public health to a particular set of religious beliefs.  We summarized here instances in which appointments to government agencies seemed to be based on appointees' religious view, and/or in which appointees seemed to be promoting health policies based on their personal religious beliefs.  These included instances of appointees arguing against the adoption of children, and making assertions that "intersex patients do not exist, that contraception causes cancer and violent death, that pornography is a major public health hazard."

This year, we have seen more evidence that the administration has been appointing people to health care or public health related leadership positions based on their religious views, and promoting sectarianism-based health care and public health.

More Appointments Apparently Based on Religious Views Rather than Health Care or Public Health Expertise

In May, Reuters published an article entitled "the foot soldiers in the Trump-Pence religious health movement."  Its introduction stated

With Donald Trump’s election in 2016, Vice President Mike Pence emerged as a force in reshaping American health policy. Aligning the policy with Pence’s evangelical Christian principles, the administration stocked the Department of Health and Human Services and other federal agencies with a cadre of pro-life staff members.

The implication is that the appointments were made according to the appointees' religious beliefs, rather than their knowledge of or experience in relevant health care or public health spheres.

It included capsule biographies of several people heretofore unknown to me.

ANDREW BREMBERG

Position: Former head of Domestic Policy Council; now nominated as ambassador to the United Nations mission in Geneva.

Background: Bremberg, a health policy expert, served as co-chair of the HHS transition team that stocked the agency with religious conservatives before serving as chief of the White House policy operation. He drafted the expanded Mexico City policy that imposes anti-abortion rules on billions in U.S. health aid.

MAGGIE WYNNE

Position: HHS, Counselor for Human Services Policy

Background: A former HHS official under the Obama administration and director of the U.S. House Pro-Life Caucus, Wynne worked for the Knights of Columbus, a Catholic service organization, before rejoining HHS. She served on the transition team, helped bring in other anti-abortion activists and participated in attempts to prevent pregnant immigrant girls from obtaining abortions.

STEVEN VALENTINE

Position: Chief of Staff, Office of the Assistant Secretary for Health

Background: A former interim legislative director at Susan B. Anthony List, an anti-abortion group, Valentine helps supervise the Title X grant program. With other anti-abortion advocates in the office, he tried to end the Teen Pregnancy Prevention Program, [more about contraception than abortion] a move blocked by the courts.

VALERIE HUBER

Position: Senior policy advisor, HHS Office of Global Affairs

Background: The former president of a Washington group that championed 'sexual risk avoidance,' or abstinence as an alternative for birth control, Huber wrote a paper that said Christians should promote 'God’s sexual guidelines to life' in sex education and public health policy. Huber worked on the attempt to kill the Teen Pregnancy Program, and now works on international health policy.

MARCH BELL

Position: Chief of Staff, Office for Civil Rights

Background: An abortion opponent and former Justice Department attorney, Bell was staff director for a House panel that investigated Planned Parenthood [which provides contraception services, cancer screening, and other health services in addition to providing abortions] for selling baby parts, an inquiry that grew out of a controversial video sting operation.

MATTHEW BOWMAN

Position: Deputy general counsel, HHS

Background: As senior counsel at the Alliance Defending Freedom, an organization that defends religious conservatives, Bowman was part of a 'life litigation project,' working on cases against the contraception mandate in Obamacare. He himself has been arrested for demonstrating outside abortion clinics.

Note that these appointees advocacy of religious beliefs about health care were not limited to their views on the highly controversial topic of abortion, but also were directed against, for example, provision of contraception and other family planning services.

SCOTT LLOYD

Position: Former head of the Office of Refugee Resettlement, now senior advisor at the Center of Faith and Opportunity Initiatives

Background: When Lloyd ran the office responsible for caring for young migrants, he tried to block some of the underage women from having abortions, sparking court battles. A lawyer, Lloyd helped found a firm that worked on cases based on Catholic doctrine on birth control and abortion. 'The law is pagan territory,' he has written. 'Look no further than no fault divorce, legalized abortion on demand, and gay marriage as confirmation.'

I can find no information suggesting that any of the people above has direct experience or training in biomedical science, medicine, other health professions, or public health.  Note that in previous posts we had mentioned several of the people appearing in this article: Katy Taalento, Diane Foley, and Roger Severino. Others we had noted as apparently unqualified members of the Trump "beach head teams," but without knowledge of their sectarian focus.

More Administration Action Promoting Sectarianism-Based Health Policies

Several relevant articles have appeared this year.  In March, the Washington Post reported on efforts to promote policies oriented specifically to evangelical Christian and Catholic beliefs.   In summary,

In the first year of the Trump administration, Christian social conservatives placed in high-level jobs — [Valerie] Huber [see above] among them — focused mostly on U.S. policy. They were highly successful, pushing through a religious exemption to the Affordable Care Act’s birth-control mandate, prioritizing abstinence-only sex education and imposing what critics call 'gag rules' on family planning groups receiving $286 million in the United States and up to $7.4 billion around the world that prohibit them from referring for abortions.

Now, they are seeking to spread those views to the rest of the world by building a coalition of nations that would wield clout beyond the Trump administration.

In May, another Reuters article noted

the quiet, behind-the-scenes influence of Vice President Mike Pence, who has been driven throughout his political career by his evangelical Christian beliefs to restrict abortion and prioritize the rights of religious conservatives.

So,

Under the direction of two secretaries recommended by Pence, the Department of Health and Human Services has moved to slash funds from teen pregnancy-prevention programs, curb abortion both in the United States and abroad and strip civil protections for transgender patients.

The administration has emphasized abstinence programs, led by appointees who believe contraception harms women, and pushed to cut government funds for Planned Parenthood – a longtime cause for Pence while he was in Congress. Planned Parenthood, a national network of healthcare providers, offers infertility services, contraception and abortions.

Again, the focus goes way beyond the controversial abortion issue:

In Kenya, services are already being reduced, said Jedidah Maina, director of the Trust for Indigenous Culture and Health, which offers programs on sexual and reproductive health and operates a health services hotline. One partner organization no longer provides free healthcare for the impoverished, and another was forced to reduce HIV services, she said.

In Peru, the reproductive-rights advocacy group PromSex said it was unable to apply for a grant to combat human trafficking from the U.S. Agency for International Development because it fights for access to abortion. In a November 2017 email obtained by Reuters, a USAID contracting officer said if the group 'were carrying out activities or planning to carry out any activity related to family planning methods, it could not commit itself with the Government of the United States.'

Also,

Christine Dehlendorf, director of the Person-Centered Reproductive Health Program at the University of California, San Francisco, said HHS cancelled two grants for ongoing research into contraception. One was restored through litigation.

Dehlendorf said she lost about $800,000 in funding for a study of how well medical providers meet women’s contraception preferences, which included natural family planning methods favored by some conservatives. There was 'no reason to eliminate it other than a lack of a general desire to meet women’s reproductive health needs,' Dehlendorf said.

Top Administration Leaders Advocating Government Establishment of Religion

Recently, two top Cabinet Secretaries gave speeches in their official capacities advocating government oriented to particular religious beliefs, conservative Christian principles.  One was Attorney General William Barr, as reported by Mother Jones on October 12, 2019, decried the influence of people who do not believe in organized religion

'This is not decay,' Barr said. 'This is organized destruction. Secularists and their allies have marshaled all the forces of mass communication, popular culture, the entertainment industry, and academia in an unremitting assault on religion & traditional values.'

Then,

In his address Friday, Barr thundered against what he described as a 'moral upheaval.' 'Virtually every measure of social pathology continues to gain ground,' he said. 'Along with the wreckage of the family we are seeing record levels of depression and mental illness, dispirited young people, soaring suicide rates, increasing numbers of alienated young males, an increase in senseless violence and the deadly drug epidemic.'

So he seemed to imply that the cure for depression, mental illness, and drug abuse is ... conservative Christian religion.  Again, here is sectarianism-, not evidence-based health policy.  Note that the article also stated,

Barr’s depiction of a war between the non-religious and people of faith shocked legal experts, who saw Barr’s defense of religious freedom as an assault on the First Amendment’s protection against the government’s establishment of any religion.

In an editorial in the NY Times, Paul Krugman wrote in reference to Barr's speech

how inappropriate it is for Barr, of all people, to have given such a speech. The Constitution guarantees freedom of religion; the nation’s chief law enforcement officer has no business denouncing those who exercise that freedom by choosing not to endorse any religion.

Furthermore,

And he didn’t just declare that secularism is bad; he declared that the damage it does is intentional: 'This is not decay. It is organized destruction.' If that kind of talk doesn’t scare you, it should; it’s the language of witch hunts and pogroms.

Meanwhile, Secretary of State Mike Pompeo was even more explicit about how he deliberately establishes his religion in his government work, as reported by the Times of Israel also on October 12,

In his official capacity as America’s top diplomat, US Secretary of State Mike Pompeo delivered a speech on Friday on 'what it means to be a Christian leader' during a State Department event, prompting criticism that he crossed the line denoting the separation of church and state.

Addressing the American Association of Christian Counselors in Nashville, Tennessee, Pompeo emphasized what he deemed the main components of Christian leadership.

'I want to use my time today to think about what it means to be a Christian leader, a Christian leader in three areas,' he said. 'First is disposition. How is it that one carries oneself in the world? The second is dialogue, talking. How is it that we engage with others around the world? And third is decisions, decisions that we make.'

By the way, just to underline that this was an official speech, not just Pompeo speaking personally about his religious beliefs, the transcript of the speech is now on the official US State Department website here.

The Times of Israel quoted

Aaron Keyak, the former head of the National Jewish Democratic Council, [who] questioned the propriety of Pompeo’s using his platform to promote a particular religion.

'There’s obviously no issue with the secretary of state being a leader, nor his being a proud Christian,' Keyak told The Times of Israel. 'But it’s a problem that Secretary Pompeo thinks it’s appropriate to put those two words together and hold an official State Department event on being a Christian leader.'

'He’s an American leader, who is also a practicing Christian,' Keyak went on. 'Him talking as a Christian leader and billing it as such is an affront to our separation of church and state.'

Summary

As we said before, basing health care and public health decisions on political ideology or religious belief seems worse than just basing them on money, which had become prevalent in the dysfunctional US health care system. In some cases, the resulting mission-hostility seems to translate into violations of the US constitution.  For example, making health care decisions based on a particular religion's beliefs could be harmful for patients or citizens who do not share these beliefs, plus violate the Constitution's guarantee of freedom of a government establishment of religion.

For years, I thought that health care dysfunction was primarily about individuals and private organizations, including but not limited to pharmaceutical, biotechnology and device companies; hospitals and hospital systems; insurance companies, academic medical institutions; physicians and their practices; etc, etc, etc.  Consequently, I thought these individuals and organizations needed better awareness of health care dysfunction to provoke them to improve matters.  I thought of the government as being involved, but mainly because of well-intentioned, sometimes bumbling government actions and policies that often had unintended effects, and sometimes excess coziness with the health care industry.  While I knew that the government was subject to regulatory capture and various leadership problems, its role in health care dysfunction, at least in the US, seemed almost secondary.

But in the Trump era, there is a new (ab)normal.  All the trends we have seen since our last discussion of health care reform are towards tremendous government dysfunction, some of it overtly malignant, especially in terms of corruption of government leadership of unprecedented scope and at the highest levels, and overt influence of government-favored political ideology and religious beliefs on health care policy and other policies and actions.

I hope that our update above will add to the urgency pointing health care and public health professionals, patients, and all citizens towards a much more vigorous response.  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? 

Friday, October 11, 2019

The Rise of the Suits - First Hints of Managerialism in Health Care

Tom Mueller just published a monumental work on whistleblowing, Crisis of Conscience - Whistleblowing the an Age of Fraud



The introductory chapter starts with the TMAP/ Risperdal/ Johnson and Johnson case.  We first posted on this case in 2006 here.  Briefly, as revealed by whistleblower Allen Jones, Johnson and Johnson subsidiary Janssen was accused of conducting a campaign of deception, which we labeled a systematic stealth marketing campaign, to push use of the  anti-psychotic drug Risperdal (risperidone).

Crisis of Conscience includes a substantial amount of material on whistleblowing in health care, drawn from interview with many in the field, including Steven Aftergood, Elliot Aronson, Elin Baklid-Kunz, Alison Bass, Max Bazerman, Sara Miron Bloom, Donna Boehm, Lori Brown, Diane Burton, Richard Condit, Daniel Fessler, Skip Freedman, Adrian Furnham, Susan Gouinlock, Mark Greenberg, Eric Havian, Jim Helmer, Marianne Jennings, Erika Kelton, Don Kettl, Brian Knutson, Steve Kohn, Sheldon Krimsky, Jeanne Lenzer, Harry Lewis, Harry Litman, Iain McGilchrist, Cheryl Eckard Mead, Tom Melsheimer, Russell Mokhiber, Mickey Nardo, Cliff Palefsky, Robert Prentice, Jim Ratley, Lesley Ann Skillen, Lynn Stout, Skyler Swisher, Paul Thacker, Janine Wedel, Marlan Wilbanks, Scott Withrow and Lin Wood.  It also includes material supplied by yours truly.

I am taking this opportunity to provide brief excerpts showing the very earliest beginning of my realizations that health care professionals were losing control of medicine, and health care.

The Early Days of Managerialism

1978, during my internship, from the haze of sleep deprivation, remembered with emotion

In October 1978, Dr. Roy Poses, an intern at the University Hospital in Boston’s South End, the teaching hospital of Boston University, had just completed the first twenty-five hours of another brutal, sleepless shift. 'People were horrendously overworked,' Poses remembers. 'You walked in at seven a.m. and worked to seven p.m. the next day, with about two hours of sleep— no night floats, no day floats, no hours restrictions.' Waiting for an elevator, eyes glazed and head bowed with fatigue, he wondered how he’d get through the day. When the elevator finally arrived, he stepped on, and found himself surrounded by men and women whose perfumes and colognes contrasted with the alcohol and disinfectant of the ward he’d just left, much as their tailored business suits contrasted with his body fluid–flecked, sweat-soaked scrubs. Conversation ceased. The well-groomed visitors were all watching him.

'It took me a while to figure out who they were,' Poses remembers. 'They certainly weren’t doctors or patients. They were too well-dressed to be vendors. I thought they might be bankers.' Eventually he understood: these were the hospital’s financial executives, just arriving for their day’s work in the management suite on the top floor. 'I felt like rubbing up against them and saying, ‘Go ahead, folks, take a whiff! I’m the guy you’re paying minimum wage to keep this f***in’ place running.’ 

Sorry, but to this day, it inspires anger.  As Mueller later noted

This was Poses’s first encounter with managerialism, which has seen financial managers take control of major hospital chains and other healthcare providers. He initially believed that the problem was limited to Boston University. 'I just assumed that the chief of medicine and the chief of surgery ran most hospitals, and that the business people worked for them, to keep the finances straight.' In fact, at that point CEOs, CFOs and COOs were a rarity at hospitals. 'There might have been an ‘executive director’ or a ‘hospital superintendent,’'  Poses remembers, 'but he was a retired doctor, and his office wasn’t too grand. There were ‘hospital administrators,’ but you’d only contact them if the lights went out or there were no linens on the beds.' However, as he moved to other posts at university medical centers in Pennsylvania, New Jersey and Virginia, before ending up at Brown University medical school in 1994, he found the same widening gulf between the values of medicine and the methods of hospital leaders, most of whom were skilled in capital rather than health.


Recap: Managerialism

Since we started Health Care Renewal, we have discussed the rise of generic managers, which later we realized has been called managerialism, quite a bit. 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 inmedicine, 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.  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.

 Reference

1.  Komesaroff PA, Kerridge IH, Isaacs D, Brooks PM.  The scourge of managerialism and the Royal Australasian College of Physicians.  Med J Aust 2015; 202: 519- 521.  Link here.