Update: State of Play in US Health Care Dysfunction Prior to the Coronavirus Pandemic

 Introduction: the Sorry History of US Health Care Dysfunction

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 studies

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.

It has been a slog.  For years  health care dysfunction, at least we we defined and discussed it, was practically a taboo topic.  From 2003 through 2016 we felt there were only a few incremental improvement in some aspects.  However, the advent of Donald Trump and his "base," and the first years of the Trump presidency expanded the scope and increased the intensity of health care dysfunction.  It got bad enough that the phrase "health care dysfunction" actually made it to a presidential debate, albeit a Democratic primary debate, in November, 2019.  On that occasion we summarized what we thought were the ongoing issues. 

Since then, things have only gotten worse. Then in 2020 the coronavirus pandemic spread around the globe.  That only provided more opportunities for the Trump administration to amplify dysfunction.

Now, on the occasion of the Trump administration's apparent defeat in the presidential election (setting aside for the  moment any legal or extra-legal challenges to the results), I will update what the state of play in health care dysfunction was prior the pandemic.  At a later time we will discuss how the pandemic gave Trump et al an opportunity to supercharge health care dysfunction.

The Multiple Dimensions of Health Care Dysfunction Pre-Pandemic

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.

These issues did not get much attention since November, 2019, during the Trump presidency, pushed aside by the administration's "flooding of the zone" with distractions.

 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.

These issues also did not get much attention since November, 2019.

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.

Since November, 2019, cases of US government officials traversing the revolving door continued (look here).

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). 

Since November, 2019, periodic updates about the President Trump and family's extensive conflicts of interest, and particularly how some of his conflicts appear to violate the US Constitution (eg, look  here).  Not unexpectedly, the latest version of Transparency International's Corruption Perception Index showed that the public perceived the US government under Trump has a worsening corruption problem (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 be further torn between their oaths, and the dictates of their corporate managers. 

 These issues also did not get much attention since November, 2019.

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).

These issues also did not get much attention since November, 2019.

 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 phenomenon 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.

 These issues also did not get much attention since November, 2019.

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.

These issues also did not get much attention since November, 2019.

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.

These issues also did not get much attention since November, 2019.

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).

These issues also did not get much attention since November, 2019.

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 there is the prospect of a new US administration, 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. As the coronavirus pandemic rages, the need to make our health care and public health less dysfunctional is increasingly apparent.  If not now, when? 

Adding (Corrupt Financial) Insult to (Coronavirus Pandemic) Injury

We have frequently discussed the voluminous evidence that President Trump, his family and his cronies have many more conflicts of interest, and have acted corruptly orders much more frequently than any other US administration (see this summary).  These conflicts of interest and corrupt actions likely have badly hurt the country and its people.  

Now a new story suggests that the administration's selective dissemination of information about the coronavirus pandemic may have enabled the enrichment of its supporters while simultaneously endangering public health.  This may be a new low.

Warning Donors and Supporters While Deceiving the Public

A report by the New York Times on October 15, 2020 suggested that early on top Trump administration officials warned favored donors and supporters that the coronavirus was much more dangerous than the administration had admitted publicly.  This allowed the recipients to personally profit: 

On the afternoon of Feb. 24, President Trump declared on Twitter that the coronavirus was 'very much under control' in the United States, one of numerous rosy statements that he and his advisers made at the time about the worsening epidemic. He even added an observation for investors: 'Stock market starting to look very good to me!'

But hours earlier, senior members of the president’s economic team, privately addressing board members of the conservative Hoover Institution, were less confident. Tomas J. Philipson, a senior economic adviser to the president, told the group he could not yet estimate the effects of the virus on the American economy. To some in the group, the implication was that an outbreak could prove worse than Mr. Philipson and other Trump administration advisers were signaling in public at the time.

The next day, board members — many of them Republican donors — got another taste of government uncertainty from Larry Kudlow, the director of the National Economic Council. Hours after he had boasted on CNBC that the virus was contained in the United States and 'it’s pretty close to airtight,' Mr. Kudlow delivered a more ambiguous private message. He asserted that the virus was 'contained in the U.S., to date, but now we just don’t know,' according to a document describing the sessions obtained by The New York Times.

The document, written by a hedge fund consultant who attended the three-day gathering of Hoover’s board, was stark. 'What struck me,' the consultant wrote, was that nearly every official he heard from raised the virus 'as a point of concern, totally unprovoked.'

The consultant’s assessment quickly spread through parts of the investment world. U.S. stocks were already spiraling because of a warning from a federal public health official that the virus was likely to spread, but traders spotted the immediate significance: The president’s aides appeared to be giving wealthy party donors an early warning of a potentially impactful contagion at a time when Mr. Trump was publicly insisting that the threat was nonexistent.

Those Who Got the Information Were Trump Cronies and Supporters

 Note that those most likely to hear about the more realistic and dire, but non-public predictions of Trump insiders were people who were supporters of and donors to Trump et al at the Hoover Institute, whose board

includes the media mogul Rupert Murdoch and the venture capitalist Mary Meeker, neither of whom attended the meetings in February

Also,

The Hoover Institution has close relations with the Trump administration, and the White House has pulled from its ranks to fill top positions. Joshua D. Rauh, one of the White House economists addressing the Hoover crowd on Feb. 24, has returned to the institution, where he worked previously. Kevin Hassett, who moderated the panel and has served as the chairman of the White House Council of Economic Advisers, is now a Hoover Institution fellow.

Receiving Information Enabled Personal Profit

Those who heard about the Trump administration insider's non-public concerns soon acted on them, thus profiting from their enhanced knowledge of the pandemic to come:

'Short everything,' was the reaction of the investor, using the Wall Street term for betting on the idea that the stock prices of companies would soon fall.

That investor, and a second who was briefed on the Hoover meetings, said that aspects of the readout from Washington informed their trading that week, in one case adding to existing short positions in a way that amplified his profits. 

 

Corruption that Endangered Public Health

 Note that the Times article stated

it is not apparent that any of the communications about the Hoover briefings violated securities laws. The Justice Department and the Securities and Exchange Commission would have several hurdles to clear before establishing that Appaloosa or other funds that received insights from Mr. Callanan, either directly or through intermediaries, acted improperly.

However, consider this: The Trump administration had a duty to manage the growing coronavirus pandemic so as to protect the lives and health of the American people.  The administration had access to considerable information about the pandemic which was not widely available.  We know from reporting by Bob Woodward that President Trump knew how serious the pandemic was likely to be, but concealed that information to prevent "panic." In particular, per Reuters, September 9, 2020:

'I wanted to always play it down,' Trump told author Bob Woodward on March 19, days after he declared a national emergency. 'I still like playing it down, because I don’t want to create a panic.'

Yet, the Trump administration did not act on the information it had.  Many public health experts believe its inaction resulted in the loss of thousands of lives, and resulted in many more cases of COVID-19, some quite morbid that might have been prevented by more forceful action.  Trump avoided effective action while constantly reassuring the public. Meanwhile, his appointees were giving Trump supporters and donors cause to think that the pandemic would actually be quite serious.  Some of them took advantage of that information to make financial transactions, like selling stocks short, enabling them to personally profit.

Transparency International defines corruption as

Abuse of entrusted power for private gain

Whether or not they were legal, the actions above by Trump and his political appointees appeared to have abuse their entrusted for the private gain of their supporters and donors.

We have frequently discussed, most recently here, the many conflicts of interest affecting and corrupt action by Trump, his family, and his cronies.  This case above adds to that list.  

We know of one way that the conflicts of interest generated by Trump's continued ownership of the Trump Organization may have enabled his mismanagement of the coronavirus pandemic. We discussed here and here how concerns about financial losses incurred by the Trump Organization due to lockdowns and other restrictions by state and local public health authorities to manage the pandemic may have influenced Mr Trump to urge premature reopening of the economy.  Thus he may have prioritized his personal finances over public health.

However, the danger of the apparent corruption revealed by the newest case seems more direct. Trump and cronies' restricted dissemination of information about the pandemic allowed enrichment of their supporters while endangering the population at large. In any case, once again, private profit trumped public health.

Yet up to now, protests of his conflicts of interest and corruption have been feeble, while the country has been distracted by each new surprise from a presidency run like a reality television show.  How much longer can the country survive our lack of focus on how we are threatened?

 

 

 

For Coronavirus Pandemic Management, In Johnson and Johnson and Pfizer Trump Trusts: Public Health at Risk ... Due to Corruption?

In 2003 we found that health care professionals felt one reason for US health care dysfunction was that it was increasingly "dominated by large, bureaucratic organizations which do not honor ... [its] core values"(1)  These organizations included big health care corporations like pharmaceutical, biotechnology and device companies, and large non-profits like hospital systems.  Since then, the power of the largest health care organizations has only increased.  Now we learn how President Trump seems to have ceded control of the management of the coronavirus pandemic to a few big pharmaceutical companies.

In "Massive Companies" Like Johnson and Johnson and Pfizer, Not the FDA, We Trust?

The first US presidential debate included a performance by the president which was likened to something out of professional wrestling. In addition, as reported by StatNews on September 29, 2020:

Throughout a turbulent, disorganized, and hostile debate, Trump highlighted his government’s efforts on vaccine development, pledging, dubiously, that the country is 'weeks away from a vaccine' and contradicting high-level officials within his own government who have suggested it will be months, at least, before a vaccine is available.

And

Trump viewed vaccines and his government’s vaccine moonshot, known as Operation Warp Speed, as the centerpiece of a pandemic response and his campaign rhetoric.

Yet Trump continued to undercut two officials central to that effort: Moncef Slaoui, Warp Speed’s director, and Robert Redfield, the director of the Centers for Disease Control and Prevention. They are 'both wrong' for standing by published timelines for vaccine distribution, Trump said, which show vaccines will be widely available to the U.S. public by mid-2021.

 So

At one point, Trump even appealed to drug companies’ trustworthiness on vaccine safety, asking Biden at one point: 'You don’t trust Johnson & Johnson, Pfizer?'

This mirrored what he had said a few days before.  Per the New York Times on September 23, 2020, in the context of threatening to counter efforts by the FDA to impose strict efficacy and safety standards on coronavirus vaccines, apparently so he could speed them to market and then claim a major victory against the pandemic, Trump said

he had 'tremendous trust in these massive companies' that are testing the vaccines, adding, 'I don’t know that a government as big as' the federal government could do as well.

In "massive companies," like Johnson and Johnson and Pfizer we trust? 

Trump Has Benefited from the Actions of Leaders of Massive Corporations, Including Johnson and Johnson and Pfizer

Making pandemic management policy under the motto of  "in massive companies we trust" fits with Trump's coziness with big corporate leadership, particularly that of  Johnson and Johnson and Pfizer. 

Health Care Corporations, Their Executives and Board Members Supported Trump's Political Causes

Trump's campaign has benefited from massive support from big corporations, including pharmaceutical companies, specifically Johnson and Johnson and Pfizer

Large health care corporations have funded dark money organizations that  strongly supported Trump and his agenda.  For example,Johnson and Johnson made large donations to the US Chamber of Commerce, which at that time "mostly endorses Republican candidates" and had contributed to a campaign to support Trump's appointment of US Supreme Court Justice Kavanaugh (look here).  

Johnson and Johnson and Pfizer are members of pharmaceutical trade organization PhRMA, which also acts as a political funding organization.  According to Sludge on April 6, 2020:

[The] Job Creators Network has been funded by Pharmaceutical Research and Manufacturers of America (PhRMA)

And,

The Job Creators Network was founded in 2011 by billionaire Home Depot co-founder Bernard Marcus, a major GOP donor who spent more than $7 million through outside groups to help elect Trump in 2016. Marcus has said that he plans to spend part of his fortune to help re-elect Trump in 2020.

We have noted that prior to the 2018 election, health care corporate CEOs often gave large political donations heavily biased in favor of Republicans.  For example, the CEO of Pfizer, Ian Read, gave $145K to Republicans, but only $26K to Democrats (look here).

Also, Trump appointed Robert (Woody) Wood Johnson IV, heir of the family which founded Johnson and Johnson, and major Johnson and Johnson shareholder, as ambassador to the UK.   The New York Times reported in July, 2020, that Johnson's support of Trump included using his official position to tout Trump's golf resort in Scotland as a site for the British Open. Johnson's monetary support for Trump's causes included

$1.2 million to the Republican National Committee and the Trump Victory fund, as well as another $1 million to America First Action, a super PAC supporting Mr. Trump’s re-election.

Health Care Corporations, Their Executives and Board Members Patronized Trump's Properties to His Personal Benefit

The biggest owner of the Trump Organization is President Trump, so he personally profits from revenue to it. Health care corporate managers and owners, including those of Johnson and Johnson and Pfizer, and health care corporate lobbyists, including one who worked for Pfizer, patronized Trump Organization properties directly or indirectly.  For example, according to the Observer in 2013,

Johnson & Johnson heiress Libet Johnson loved the Trump International Hotel and Tower [in New York]—so much so that it’s nearly impossible to keep track of [all the condominiums she owned in it]. So difficult, in fact, that we lost count.

 

Lobby, Trump International Hotel, Washington, DC

Big corporate donors, including Pfizer, supported the Trump Inauguration Committee, which then spent considerable sums at the Trump International Hotel in Washington DC, to Trump's personal benefit (see Newsweek, January, 2019).  Prominent Pfizer lobbyist Kenneth M. Duberstein is a long-time member of Trump's Mar A Lago resort in Florida (New York Times, 2017).

Trump's Coziness with Managers and Owners of Massive Corporations, Including Johnson and Johnson and Pfizer

Health Care Corporate Executives Got Access to Trump

Trump has spent a lot of time meeting with top executives and owners of big corporations, including health care corporations. For example, as reported by Becker's Hospital Review in April, 2020, 27 health care executives were appointed to Trump's economic revival task force (during and after the pandemic), including Albert Bourla, the CEO of Pfizer, and Alex Gorsky, the CEO of Johnson and Johnson.

Back in 2017, Johnson and Johnson CEO Gorsky was appointed to Trump's Manufacturing Council.  He temporarily left that position after Trump refused to disavow the right-wing extremists who marched in Charlottesville, but then was put "on the guest list Tuesday for dinner at [Trump's] Bedminster [golf club]."  After that, Trump seemed to be promoting Johnson and Johnson products, particularly Spravato touted as a treatment for opioid dependence (look here).

Health Care Corporate Executives and Lobbyists Appointed to Government Leadership Positions Affecting Health Care

We have noted that many of Trump's political appointments to leadership positions in government that affect health care came through the revolving door from health care corporations and lobbying firms that worked for them.  For example, the current Secretary of the Department of Health and Human Services (DHHS) is a former top Eli Lilly executive.

 

Several top positions as DHHS were filled by former lobbyists for big pharma and other health care corporations (look here). Particularly, Daniel Best went from Pfizer to DVS and then to DHHS as a Senior Advisor (look here.)

Also, Dr Scott Gottlieb, a former commissioner of the US Food and Drug Administation (FDA) under Trump soon became of member of Pfizer's board of directors (look here).

Should Trump Trust Johnson and Johnson and Pfizer?

Trump's affinity for Johnson and Johnson and Pfizer may be based on personal relationships and perceived political common interests, as well as on how he has politically and personally benefited from the actions of their leaders and owners. That affinity should not be sufficient for him to trust them to run a coronavirus pandemic response.  Arguing against placing so much trust in them are their corporate track records of misbehavior.  

On Health Care Renewal, we have been tracking ethical misadventures by big health care organizations for a long time.  The records of Johnson and Johnson and Pfizer stand out, but not in a good way.  To summarize what we have discussed about each...

Johnson and Johnson

Derived from our previous blog posts - 

 2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax

2011
- Guilty pleas to bribery in Europe by DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by subsidiary Scios (see post here)

2012 
  - Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).

2013
-  settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
-  Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
-  Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).

2014 
- DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post).

2015
-  found by jury to have concealed harms of Risperdal.
-  Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
-  McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)

2016
- subsidiary Aclarent settled allegations that it sold its Stratus device for unapproved uses.  Two former executives of that subsidiary also were found guilty of distributing misbranded and adulterated devices (see this post)  

2018
- settled allegations that subsidiary Actelion used illegal kickbacks to market Tracleer for an inflated price (see this post)

2019
- found by Oklahoma judge to have launched a deceptive marketing campaign for opioids (see this post)

And we recently learned that Johnson and Johnson settled allegations of deceptive marketing of surgical mesh in lawsuits in multiple states (per the AP, May 202, here)

Pfizer

 From this post:

The company's track record from 2000 to 2017 is staggering.

Since 2000, Pfizer's troubles started, according to the Philadelphia Inquirer, with the following...

- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,

- In 2009, Pfizer paid a $2.3 billion settlement of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  In that year the company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- In early 2011, Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York (see post here).
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).
- In October, 2015, a  UK judge found that the company had threatened health care professionals for using a generic competitor (see this post).
- In February, 2016, Pfizer settled a lawsuit for $785 million for overcharging the US government for Protonix (look here).
- In August, 2016, Pfizer made a $486 million settlement of allegations it bilked shareholders by concealing research showing the harms of Celebrex (look here for this and next two items)
- In December, 2016, Pfizer fined $106M in UK for using monopoly on production of generic phenytoin to overcharge National Health Service
- In November, 2017, Pfizer made $94 million settlement of allegations of fraud to delay generic competition

Note that other companies involved in Trump's crash project to develop a coronavirus vaccine, preferably in time to influence the 2020 election, Astra Zeneca and Merck, also have questionable track records. 

Summary

Health care is increasingly dominated by large organizations who may threaten the values of health care professionals.  Now in a pandemic the US President seems determined to trust in a few large pharmaceutical corporations rather than public health experts and health care professionals.  His trust may be based on his personal affinity for the leadership of such corporations, and the cozy relationships they have cultivated with him. Worse, it may be based on how he has politically benefited and personally profited from their actions.  To the extent that Trump has ceded control of the pandemic to large corporations because he has politically benefited and personally profited from them, his actions appear to fit the ethical definition of corruption, as defined by Transparency International:

the abuse of entrusted power for private gain

Meanwhile, the pandemic has been steadily worsening, and as of this week, the president himself, along with key political allies have been infected. 

Thus, at a crucial time, the country is increasingly being run by a cozy group of insiders with ties to both government and industry.  Top health care (and other) corporate management is increasingly merging with the current administration in one giant corporatist entity. This merger is not in the interests of peoples' or the public's health, especially in a time of pandemic.  Instead, benefits will go to the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people.  At times the actions of the current administration, and in particular, its maximum leader, may be abuse of power for private gain, apparently corruption, and in this instance, health care corruption.  This fits a pattern of wholesale corruption and conflicts of interest at the top of the administration that we have often decried, most recently here.

To unrig the system, we need wholesale, real health care reform that would make health care leaders accountable for what their organizations do, and 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.

However, before thinking about true health care reform, we need top accomplish wholesale government reform. We need to excise the deception, crime and corruption at the heart of our government and restore government by the people, of the people, and for the people. 

Reference

1.  Poses RM. A cautionary tale: the dysfunction of American health care.  Eur J Inte Med 2003; 14: 123-130.  Link here.

The Big Spin Out: 2020 Revolving Door Update

In  2020, cases of the revolving door accumulated quickly. 

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.

Dr Vindell Washington from National Coordinator for Health Care Information Technology to Alphabet

Per FierceHealthCare, January 7, 2020:

Alphabet, the parent company of Google and Verily Life Sciences, continues to bolster its ranks of healthcare experts with the latest hiring of Vindell Washington, M.D.

Verily Life Sciences hired Washington as its new chief clinical officer as part of its health platforms team, Verily Life Sciences representative Kathleen Parkes confirmed to FierceHealthcare Tuesday.

Washington served as the national coordinator for health IT from August 2016 to January 2017.

As one of the highest health IT policy leaders, Washington brings to Verily a deep understanding of the industry. He is an emergency medicine physician by training.

So he moved from a position with significant influence over government health IT policy to a big IT company involved in health care.  Admittedly though, this moves comes three years after he left the ONC.

Dr Kate Goodrich from Chief Medical Officer of the Center for Medicare and Medicaid Services (CMS) to Humana Inc

Per Louisville Business First, January 17, 2020:

Humana Inc. has hired away a key regulatory insider from the federal government.

Dr. Kate Goodrich will leave the chief medical officer role at Centers for Medicare & Medicaid Services in February. Politico reported Thursday Goodrich will become a senior vice president for the company.

CMS is the agency that oversees both Medicare and Medicaid, the government-backed health plans. Goodrich was also director of the Center for Clinical Standards and Quality, the CMS website states.

Note that Humana's business is heavily influenced by the actions of CMS.

Humana's core business is providing Medicare Advantage plans, a private version of the federal health plan for seniors. It has about 4.1 million members in Medicare Advantage plans, according to its latest financial disclosure.

The Medicare Advantage segment brought in about $37.1 billion of revenue in the nine months ended Sept. 30, 2019.

Mary Sumpter Lapinski from Government Affairs at Bristol-Myers-Squibb to Counselor to the Secretary of the Department of Health and Human Services (DHHS) for Public Health and Science, then to Vice President of Global Governance Affairs for Greenwich Biosciences


Note that in this case, someone recently reported as transiting the outgoing revolving door has also had in the past transited the incoming revolving door.

Per a Buzzfeed News article, January 24, 2020 (which also discussed the larger revolving door problems involving the pharmaceutical industry and the Trump administration):

Mary-Sumpter Lapinski, who worked in government affairs for Bristol-Myers Squibb from 2002–2007, served as a counselor to the health and human services secretary for public health and science. As of April 2019, Lapinski is the vice president of global government affairs for biopharmaceutical company Greenwich Biosciences.

Again, most recently she moved from a senior position in DHHS affecting public health and science to a biotech company.

Roxana Weil, Lead Toxicologist from the Center for Tobacco Products at the Food and Drug Administration (FDA) and Gabriel Muniz who inspected tobacco manufacturers for the FDA to Juul Labs Inc

Per Bloomberg (via the Detroit News, February 5, 2020):

Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top U.S. e-cigarette maker.

So

Roxana Weil, formerly a lead toxicologist at the agency’s Center for Tobacco Products, joined Juul as principal scientific adviser in September. Gabriel Muniz, who worked in an FDA division that inspects tobacco manufacturers, joined Juul last month as a director of regulatory compliance.

Note that

The company and its peers must submit applications to the FDA by May 12 in order to continue selling their products. The deadline is a defining moment for the e-cigarette industry, which has been under fire following a surge in teen vaping and a lung-injury outbreak that sickened thousands and was later tied to THC.

For Juul, securing a swift clearance is critical. The company has seen its once-rich valuation drop since the broader vaping backlash began. Failing to win the FDA’s blessing could shut it out of a market it has dominated.

So they moved from regulating tobacco to a company essentially involved in selling tobacco analogues.  Note that the tobacco company Altria made a major investment in Juul (look here.)

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.

There are two recent examples

Brad Smith, Chief Operating Officer of Anthem's Diversified Business Group to be Director, Center for Medicare and Medicaid Innovation (CMMI) at the DHHS

Per FierceHealthcare, January 6, 2020:

The Trump administration has selected Brad Smith to serve as the director of the Center for Medicare and Medicaid Innovation (CMMI), where he will oversee the creation and stewardship of value-based payment models.

Smith most recently was the chief operating officer of Anthem’s Diversified Business Group, a division of the insurance giant that includes provider services. He was also the co-founder and CEO of palliative care services company Aspire Health.

Anthem is a health insurer which provides Medicare supplements and Medicare Advantage programs, so its business is greatly affected by any changes in how Medicare or Medicaid makes payments.

Amanda Adkins, Executive for Cerner Corp, Now Running for the House of Representatives as a Republican

This could be called a running start that will likely lead through the incoming revolving door.

Per the  Kansas City Star, January 23, 2020:

Cerner executive Amanda Adkins has taken a leave of absence from the company to focus on her campaign to unseat Democratic Rep. Sharice Davids.

Adkins, a former Kansas Republican chair, launched her bid for Kansas’ 3rd congressional district in September, but initially planned to remain as Cerner’s vice president of strategic growth through the campaign.

But as of last week, according to a company spokeswoman, Adkins went on unpaid leave after from her role after 15 years with the health care IT giant.

Note that the Star article, unlike the others quoted above, provided at least a slightly detailed discussion of why this (potential) move poses a conflict of interest:

The Kansas City-based company is a major federal contractor with a $10 billion contract to design a new health care records system for the U.S. Department of Veterans Affairs. The new system is expected launch later this year.

Federal election rules prohibit federal contractors from giving directly to federal candidates. Craig Holman, a lobbyist for Public Citizen, a national group which advocates for tougher ethics standards, said Adkins’ unpaid leave protects Cerner from violating this rule.

But Holman said the fact that she can return from leave after the election still raises questions about a conflict of interest since she could end up on committees with oversight of the company’s contracts if elected to Congress.

'The conflict still persists,' Holman said in a phone call. 'The fact that she has not resigned and remains an employee of Cerner means that conflict of interest remains front and center.'

Summary

Sigh.  So while there is much discussion of corruption in high places, and its potential link to high crimes and misdemeanors, the revolving door quietly spins on well-oiled hinges, as it has for years, including many years before the current administration.  

So as we have repeatedly said,  most recently in October, 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.

Transparency International's Corruption Perceptions Index 2019: Political Corruption in the US Worsens, and Results are Largely Anechoic

Transparency International has just released its 2019 version of the Corruption Perceptions Index.  This version emphasized public sector corruption.  Once again, it appears the US has a worsening corruption problem.  Once again, the results are largely anechoic.

Summary of the 2019 CPI

Methods

Per the TI summary

The CPI scores 180 countries and territories by their perceived levels of public sector corruption, according to experts and business people.

The CPI uses a scale from 0 to 100.  100 is very clear and 0 is highly corrupt.

Results

TI provides CPI results for 180 countries.

The US had a score of 69, tied with France for 23rd best.  The score has declined since 2015 (when it was 76).

TI designated the US as a country to watch, with the following explanation:

With a score of 69, the United States drops two points since last year to earn its lowest score on the CPI in eight years. This comes at a time when Americans’ trust in government is at an historic low of 17 per cent, according to the Pew Research Center.

The US faces a wide range of challenges, from threats to its system of checks and balances, and the ever-increasing influence of special interests in government, to the use of anonymous shell companies by criminals, corrupt individuals and even terrorists, to hide illicit activities.

While President Trump campaigned on a promise of 'draining the swamp' and making government work for more than just Washington insiders and political elites, a series of scandals, resignations and allegations of unethical behaviour suggest that the 'pay-to-play' culture has only become more entrenched. In December 2019, the US House of Representatives formally impeached President Trump for abuse of power and obstruction of Congress.

The report emphasized that many countries, including the US, had increasing problems with political integrity:

This year, our research highlights the relationship between politics, money and corruption. Unregulated flows of big money in politics also make public policy vulnerable to undue influence.

Countries with stronger enforcement of campaign finance regulations have lower levels of corruption, as measured by the CPI. Countries where campaign finance regulations are comprehensive and systematically enforced have an average score of 70 on the CPI, whereas countries where such regulations either don’t exist or are poorly enforced score an average of just 34 and 35 respectively.

Sixty per cent of countries that significantly improved their CPI scores since 2012 also strengthened their enforcement of campaign finance regulations.

In addition, when policy-makers listen only to wealthy or politically connected individuals and groups, they often do so at the expense of the citizens they serve.

Countries with broader and more open consultation processes score an average of 61 on the CPI. By contrast, where there is little to no consultation, the average score is just 32.

A vast majority of countries that significantly declined their CPI scores since 2012 do not engage the most relevant political, social and business actors in political decision-making.

Countries with lower CPI scores also have a higher concentration of political power among wealthy citizens. Across the board, there is a concerning popular perception that rich people buy elections, both among some of the lowest-scoring countries on the CPI, as well as among certain higher-scoring countries, such as the United States.

The Anechoic Effect Lives

At least the 2019 CPI got some attention in 2020, as did the 2017 version (look here).  I found articles briefly summarizing the US results in a few US media outlets: Bloomberg (behind a paywall), the Associated Press (here, via the New York Times), and Forbes. There was also one op-ed, again in the WaPo.

This was some improvement from how previous relevant results from TI research were covered earlier.   There was virtually  no coverage of a 2013 survey that showed 43% of US respondents believed that US health care was corrupt.

One could argue even so that the current coverage of the 2019 report was inadequate given the importance of the topic and the apparent worsening of the US corruption problem.  This lack of coverage inspired me to write this post, in the hopes of making the issue just a little less anechoic

Discussion

We have argued again and again that health care corruption is an important reason for US (and global) health care dysfunction.  As we wrote in 2019,  Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, historically the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.  Now the problem appears to be getting worse in the US.  We have argued that a major reason is the miasma of corruption now surrounding the top of the US government, specifically the Trump administration (see again this 2019 post).

Now the TI discussion of its 2019 Corruption Perceptions Index points to increasing problems of public sector corruption in the US. Many of the issues it cites have been discussed on Health Care Renewal, including: problems in "campaign finance regulation" and "perception that rich people buy elections" (see our discussion of dark money); and "policy-makers [who] listen only to wealthy or politically connected individuals and groups" (see our discussion of the revolving door and regulatory capture).

The op-ed by Hough in the Washington Post included this parallel discussion:

First, successful anti-corruption policy centers on transparency and accountability. Reports such as this one by the UNDP make a strong case that clear lines of accountability improve the quality of governance, and sharpen attempts to fight corruption. Openness and transparency also need to be default settings. These are both areas where the U.S. could improve. The tone set by Donald Trump, whether by refusing to publish his tax returns or personally profiting from his position as president is indicative of a much broader problem. Neither transparency nor accountability are ever absolute, but analysts find plenty of scope for the U.S. to improve.

Second, the more opaque and complex the relationship between money and power, the more difficult it is to pinpoint and counteract corrupt relationships. Again, getting this right is not an exact science — and there’s no perfect system for funding political activity. But campaign finance, along with lobbying, are what corruption scholar Michael Johnston calls influence markets — areas where the wealthy can trade money for influence on policy outcomes. In other words, the rules and regulations let rich benefactors buy themselves a hearing. Yes, there are countries in worse positions, but that doesn’t hide the fact that the U.S. is also far from a model pupil.

And third, fewer Americans now trust either the politicians that rule them or indeed the institutions that help shape public life. Successful anti-corruption is built around integrity management, which requires public servants to act in appropriate ways — but also be seen acting in such ways. The highest ethical and moral standards — and transparency about potential conflicts of interest and recognizing when personal and public interests clash — would let U.S. citizens begin to believe that a cleanup of American government was underway.

In summary, there is growing evidence of a worsening corruption problem in the US.  As of today, responses to it have been ineffective.  Political corruption, especially at the top of the US government, makes addressing health care corruption increasingly difficult.

So we welcome any additional attention to health care corruption, or the larger corruption within the US government that is making health care corruption even harder to address.

But even if we can take that step, when the fish is rotting from the head, it makes little sense to try to clean up minor problems halfway towards the tail. Why would a corrupt regime led by a president who is actively benefiting from corruption act to reduce corruption? The only way we can now address health care corruption is to excise the corruption at the heart of our government.

It is now over three years since Trump was inaugurated, and there has been no real progress.  The fish is still rotting, and so is health care.  What will it take to make something happen?

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.