Wednesday, November 11, 2020

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? 


Saturday, October 31, 2020

The President Baselessly Accuses Physicians of Inflating COVID-19 Case Rates for Financial Gain. Will Health Care Leaders Finally Challenge Him?

Introduction: the Trump Administration's Attacks on Whistleblowers

A major component of US (and global) health care dysfunction has been the anechoic effect, the ability of those in power to silence discussion of topics that might put them in a bad light.  At risk is anyone who might become a whistle-blower about poor quality care or patient safety problems; malfeasance, corruption or crime; etc.    Whistle-blowing is never easy for health care professionals.  Those who do so have been ostracized, lost jobs or been subject to lawsuits.  


 

The Trump administration has a history of intimidating health care whistle-blowers.  For example, in 2019 we noted how the administration silenced scientists in the NIMH who might disagree with a Trump tweet about mental health and violence, and a CDC official about the relationship between climate change and public health.  In February, 2020, we noted how the administration tried to intimidate a whistle-blower at the DHHS who reported deficiencies in early management of coronavirus patients. In May, 2020, we noted how Trump himself tried to verbally intimidate the President of the American Association of Nurse Practitioners when she complained in a White House meeting about the lack of personal protective equipment in facilities caring for COVID-19 patients. 

That was bad enough, but then I heard the news today, oh boy. 

Trump Claims Doctors Over-Report COVID-19 to Make More Money

In the last week, at the end of the run up to the election, President Trump doubled down.  He blamed the entire US medical profession for inflating the severity of COVID-19, which is at odds with his happy talk message that we have "turned the corner" on the virus.

On Oct 26, 2020, per Boston.com:

At a campaign rally in Waukesha, Wisconsin on Saturday, Trump told his supporters that 'doctors get more money and hospitals get more money' if they say people died from COVID-19 rather than their comorbidity — a conspiracy theory that has been debunked — as the president pressed his case that the United States is 'rounding the turn' on the pandemic, despite public health officials stressing repeatedly that the opposite is true.

On Oct 31, 2020, per CNN:

President Donald Trump on Friday baselessly claimed that doctors are inflating the coronavirus death count for monetary gain while cases, hospitalizations and deaths surge across the country.

'Our doctors get more money if someone dies from Covid. You know that, right? I mean our doctors are very smart people. So what they do is they say 'I'm sorry but everybody dies of Covid,' ' Trump said, without citing any evidence, at a rally in Waterford Township, Michigan.

In addition, per another CNN report on the same date, he also said:

'With us, when in doubt -- choose Covid,' Trump said. 'Now they'll say 'Oh that's terrible what he said,' but that's true. It's like $2,000 more, so you get more money.'

Meanwhile, we learned that this attack on physicians was part of a long-standing strategy.  Per CNN on October 28, 2020:

President Donald Trump's son-in-law and senior adviser, Jared Kushner, boasted in mid-April about how the President had cut out the doctors and scientists advising him on the unfolding coronavirus pandemic, comments that came as more than 40,000 Americans already had died from the virus, which was ravaging New York City.In a taped interview on April 18, Kushner told legendary journalist Bob Woodward that Trump was 'getting the country back from the doctors' in what he called a 'negotiated settlement.' 
So,

'Trump's now back in charge. It's not the doctors.'

The statement reflected a political strategy. Instead of following the health experts' advice, Trump and Kushner were focused on what would help the President on Election Day. By their calculations, Trump would be the 'open-up president.'

So Trump was willing to disregard the advice of public health and health care professionals, and to verbally attack and intimidate them to support the happy talk of his election strategy, even if that meant more disease, more morbidity, and more deaths.  

Finally, Influential Health Care Professionals Speak Out

Numerous individual health care professionals, particularly those on the front lines of the pandemic, have spoken out about the Trump administration's mismanagement of the crisis. They have emphasized issues such as the lack of adequate personal protective equipment in health care facilities; the need for personal action to reduce the spread of infection; and the folly of premature reopening of the economy (look here and here).  They have actively fought disinformation about the pandemic, including that disseminated by Russia and other Trump allies, and by Trump himself (look here). Yet until the last week there were only a few instances of physicians in positions of leadership and influence willing to support their colleagues on the front lines in their challenge to President Trump.

In September, after the Trump administration's total mismanagement of the coronavirus pandemic had become manifest, and in response to its efforts to turn the CDC, the lead US public health agency, into a propaganda outlet, we complained that no health care leaders, "no chairpersons, deans, chancellors, vice-presidents for health affairs, university presidents; or journal editors, hospital executives, leaders of professional societies, executives of health care corporations, etc, etc were willing to publicly challenge Trump and his top collaborators.  Such leaders so far have also been unwilling to challenge Trump's efforts to spread disinformation."

Since then, editors of two major British medical journals have condemned the actions of the Trump administration.  Lancet Oncology and the prestigious British Medical Journal have published editorials calling out Trump.  

Yet the first instance of a real challenge to Trump from the leaders of US health care did not come until October, 2020.  At least it was from the editor and editorial board of perhaps the best-known American medical journal, the New England Journal of Medicine. They called for Trump to be voted out of office for "dangerous incompetence."

Now that Trump has tried to intimidate physicians in general, days before the election, there is the beginning of pushback from a few leaders of medical societies and academic institutions.  Per Boston.com:

The American College of Emergency Physicians issued a statement rebutting Trump’s  claim, calling it 'reckless and false' that doctors are over-counting deaths related to COVID-19.

'To imply that emergency physicians would inflate the number of deaths from this pandemic to gain financially is offensive, especially as many are actually under unprecedented financial strain as they continue to bear the brunt of COVID-19,' the group wrote. 'These baseless claims not only do a disservice to our health care heroes but promulgate the dangerous wave of misinformation which continues to hinder our nation’s efforts to get the pandemic under control and allow our nation to return to normalcy.'

 Also,

 Ashish Jha, dean of the Brown University School of Public Health, didn’t mince words. 

'This is crap,' he wrote of the conspiracy theory pushed by the president. 'Everyone knows it.'

In a thread on Twitter, he laid out in detail the debunking of the theory, blasting Trump for continuing to peddle it. 

'While doctors and nurses are dying on the front lines, our leaders aren’t working to get them protective equipment,' Jha wrote. 'Instead, they are falsely accusing our front line providers of fraud. It’s reprehensible.'

Per Forbes on Oct 31, 2020:

The president of the American College of Physicians characterized Trump's comments as 'a reprehensible attack on physicians' ethics and professionalism.'

Per CNN:

Susan Bailey, the president of the American Medical Association, said in a statement that the claim that doctors are overcounting Covid-19 patients or 'lying to line their pockets is a malicious, outrageous, and completely misguided charge.' 

Conclusion

Better late than never. Kudos to the ACEP, ACP, AMA, and the Dean of the Brown School of Public Health. (Full disclosure: I am a voluntary faculty member at the Alpert Medical School at Brown University.)  

But where are all the leaders of the other medical societies, and all the other US academic medical institutions, not to mention the leaders of US hospitals and other health care organizations? The pandemic is getting worse and the election in three days.

We said in May:  

So health care professionals trying just to uphold their mission to put patients' and the public's health first have stumbled into a conflict far beyond anything we have seen in our lifetimes.  Upholding the mission will be difficult, unpleasant, quite likely dangerous.  The danger is not just from the virus, but from our fellow humans.  That does not make the mission any less important.  Innocent lives are still hanging in the balance.

We could retreat in fear from the powerful opposition we have stirred up.  That would allow complete politicization of the management of the coronavirus pandemic, doubtless leading to increased disease and death (and ironically, even worse economic disruption).  Retreating would betray our patients and make a mockery of our mission.  Or we could persist.  What will it be? 'And if not now, when?'

It is Halloween, October 31, 2020.  Again, "if not now, when?"

 

 

Thursday, October 15, 2020

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?

 

 

 


Sunday, October 04, 2020

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.

Sunday, September 20, 2020

Attempts to Transform the CDC into a Propaganda Outlet and the Silence of the Health Care Leaders

First they came for the CDC staffers, but I was not a CDC staffer so I did nothing...

Then they came for me. And there was no one left to speak for me.

- with apologies to Martin Niemoller (look here


The US is continuing to suffer during the coronavirus pandemic.  Meanwhile, the lead US government public health agency, the Centers for Disease Control and Prevention (CDC) has suffered two attempts by the Trump administration to transform it into a propaganda outlet.

Mysterious Revisions of Pandemic Management Guidelines to Hinder Testing of Exposed Persons

This story broke in late August, 2020.  As reported by the New York Times on August 25, 2020:

The Centers for Disease Control and Prevention quietly modified its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus.

The new guidelines went against public health practice for managing epidemics.  People who have been exposed are at increased risk of infection.  Infected people may not have symptoms but may still transmit the virus to others.  Identifying infected people allows them to be quarantined, and any further contacts to be traced.  In particular, as the NYT article pointed out:

Although researchers remain unsure how often asymptomatic people unwittingly transmit the coronavirus, studies have shown that the silently infected can carry the virus in high amounts. The evidence is more clear-cut for pre-symptomatic people, in whom virus levels tend to peak just before illness sets in — a period when these individuals might be mingling with their peers, seeding superspreader events. Notably, experts can’t distinguish asymptomatic people from those who are pre-symptomatic until symptoms do or don’t appear.

No Obvious Justification and No One Accountable for the Change

The CDC did not initially provide a clear justification of the change:

The reasons behind the surprise shift in testing recommendations are unclear. In response to an inquiry from The New York Times, a representative for the C.D.C. directed the questions to the U.S. Department of Health and Human Services. 

A report from ABC News on August 26 quoted Admiral Brett Giroir of the White House coronavirus task force:

This is evidence-based decisions that are driven by the scientists and physicians, both within the CDC, within my office in the lab task force, and certainly amongst the task force members

However, he did not provide any of the evidence on which it was supposedly based, or any logic underlying the change based on this evidence.  Nor did he make clear who was accountable for the change

 I worked on them. Dr. Fauci worked on them. Dr. Birx worked on them. Dr. Hahn worked on them. Dr. Atlas provided input. So, it's kind of hard to know how much was written by one person at this time

On the other hand, a CNN report from the next day suggested that the change came due to political pressure:

A sudden change in federal guidelines on coronavirus testing came this week as a result of pressure from the upper ranks of the Trump administration, a federal health official close to the process tells CNN, and a key White House coronavirus task force member was not part of the meeting when the new guidelines were discussed.

'It's coming from the top down,' the official said of the new directive from the Centers for Disease Control and Prevention.
 
An AP article from August 26 included speculation about the real reasons for the change:
 
Dr. Carlos del Rio, an infectious diseases specialist at Emory University, suggested in a tweet that there are two possible explanations.

One is that it may be driven by testing supply issues that in many parts of the country have caused widely reported delays in results of a week or more, he suggested.

 Admitting problems providing testing might be a reason to consciously temporarily limit testing, of course, but not to pretend the testing would not be useful.  Then

Another possible explanation for the change is that President Donald Trump simply wants to see case counts drop, and discouraging more people from getting tested is one way to do it, del Rio said in his tweet.

A Washington Post article on August 27, 2020 explained this further:

The revised guidelines come as President Trump has feuded with the CDC and the Food and Drug Administration, both parts of the Department of Health and Human Services, and marginalized officials who would ordinarily play leading roles in a pandemic response. He has repeatedly said that he did not like that more testing had revealed more cases.

'I said to my people, ‘Slow the testing down, please!’ ' Trump said at a rally two months ago. Aides said he had been speaking tongue-in-cheek. But asked later whether he had been kidding, Trump replied, 'I don’t kid.'

Reducing testing, of course, would reduce the number of apparent, not real cases, allowing Trump to exaggerate his ability to manage the pandemic

On September 17, 2020, the source of the controversial change in the CDC guideline was somewhat clarified again according to the New York Times:

A heavily criticized recommendation from the Centers for Disease Control and Prevention last month about who should be tested for the coronavirus was not written by C.D.C. scientists and was posted to the agency’s website despite their serious objections

The source of the change was 

the Department of Health and Human Services [which] did the rewriting and then 'dropped' it into the C.D.C.’s public website, flouting the agency’s strict scientific review process.

'That was a doc that came from the top down, from the H.H.S. and the task force,' said a federal official with knowledge of the matter, referring to the White House task force on the coronavirus.

Yet neither that nor earlier reports explained who at "the top" directed the change.

And soon the change it self disappeared as mysteriously as it appeared.  On September 18, 2020 per the AP:

U.S. health officials on Friday dropped a controversial piece of coronavirus guidance and said anyone who has been in close contact with an infected person should get tested.The Centers for Disease Control and Prevention essentially returned to its previous testing guidance

Criticism of the Change

 Public health and health care professionals criticized the changes, e.g.,  per the AP article of August 26, 2020:

Dr. Tom Frieden, who was head of the CDC during the Obama administration, said the move follows another recent change: to no longer recommend quarantine for travelers coming from areas where infections are more common.

'Both changes are highly problematic' and need to be better explained, said Frieden, who now is president of Resolve to Save Lives, a nonprofit program that works to prevent epidemics.

Also, Dr Leana Wen wrote an op-ed for the Washington Post on August 26, 2020:

you don’t have to be a public health expert to know the CDC’s guidance is nonsensical.  

In MedPage Today of August 28, 2020:

pulmonologist William Janssen, MD, section head of Critical Care Medicine at National Jewish Health, said the new guidance recommending testing for fewer people 'flies in the face of everything we have been told and understand about this disease.'

Also,

Another pulmonologist at National Jewish Health, Kenneth Lyn-Kew, MD, called the CDC move 'a step backwards.'

'The CDC was flat out wrong and the epidemiologists there know this,' he said, adding that testing and tracing are cornerstones of epidemiology.

Major health care organizations also criticized the change. The AMA issued a statement:

Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus. When the Centers for Disease Control and Prevention (CDC) updates a guidance the agency should provide a rationale for the change. We urge CDC and the Department of Health and Human Services to release the scientific justification for this change in testing guidelines

The American Association of Medical Colleges asserted:

These CDC guidelines go against the best interests of the American people and are a step backward in fighting the pandemic. The AAMC urges the CDC to return to its earlier testing recommendations

The Chair of the Board of Regents of the American College of Physicians wrote that the organization:

supports the use of science, based on the best available evidence, in the fight against COVID-19. Public health agencies should not be subjected to pressure or be influenced to issue policies that are not based on evidence and expert recommendations of their own scientists.

 Also

The recent revision of the CDC’s COVID-19 testing guidelines of asymptomatic individuals lacks transparency and clarity, sending a confusing message to both physicians and the public on appropriate and necessary testing that will ultimately help to mitigate the spread of COVID-19.

Summary

So far we only know that someone at "the top" of the government directed the change in the CDC guidelines.  No person or group has stepped forward as accountable. No one at any US government agency has explained the rationale for the change, much less provided clear evidence and logical reasoning underlying it.  The best explanation for the change seems to be that it fit President Trump's message. It would have made his administration's problems organizing adequate testing for coronavirus less apparent.  By reducing testing, it would make the rate of the spread of disease temporarily appear lower, allowing Trump to exaggerate his ability to manage the pandemic.

Yet I could find no health care or public health professional, or any leader of a health care organization willing to criticize "the top" of the US government for directing the change, to criticize the opaque, apparently evidence-free process that produced the change, or to question whether the change was meant to fit with Trump's propaganda, that is, his claims of brilliant management of the pandemic. 

Trump Political Appointees Attempt to Intimidate CDC Staff to Manipulate Publications in the Morbidity and Mortality Weekly

White House Installed Pro-Trump Propagandist with No Health Care or Public Health Background as Head of Public Relations for DHHS

 The second case began in April, 2020.  Then Politico reported:

 The White House is installing Trump campaign veteran Michael Caputo in the health department’s top communications position

Caputo was given the title of Assistant Secretary for Public Affairs. He has an unlikely background to have been named head of public relations for the Department of Health and Human Services (DHHS). He has no apparent background in health care or public health. Also, Politico noted:

Caputo is an intense Trump loyalist whose recent book 'The Ukraine Hoax,' alleged a conspiracy behind Trump’s impeachment.

Furthermore

 Caputo is a longtime friend of Trump ally Roger Stone and former Trump campaign chairman Paul Manafort, both of whom were convicted of crimes in the last two years. 

Then CNN reported:

The new spokesman for the Department of Health and Human Services in a series of now-deleted tweets made racist and derogatory comments about Chinese people, said Democrats wanted the coronavirus to kill millions of people and accused the media of intentionally creating panic around the pandemic to hurt President Donald Trump.

In particular,

In a series of tweets on March 12, Caputo responded to a baseless conspiracy theory that the United States brought the coronavirus to Wuhan, China, by tweeting that 'millions of Chinese suck the blood out of rabid bats as an appetizer and eat the ass out of anteaters.'

 
CNN had many more graphic examples.  
 
Also, Mother Jones reported more about Caputo's involvement in Russia and Ukraine:
 
A longtime Republican operative who was ousted from a job on Trump’s 2016 campaign, Caputo recently worked to boost discredited claims alleging that Ukraine, not Russia, meddled in the 2016 election.
 
In particular, Caputo was alleged to have been involved in political dirty tricks on behalf of Trump in 2016:
 
In June 2018, the Washington Post reported that ... [Caputo] and Stone had met in 2016 with Henry Oknyansky, a Russian expat living in Florida, who wanted to sell damaging information about Hillary Clinton. Caputo, in text messages with Stone the Post obtained, referred to Oknyansky as 'the Russian.' Though no deal was reached, news of the meeting seemed to contradict claims both Stone and Caputo had made in testimony to the House Intelligence Committee. Both men denied any contact with Russians during the 2016 campaign.
 
Also, Caputo was alleged to have been involved in creating propaganda or disinformation about Ukraine's supposed intervention in the 2016 campaign, and Hunter Biden's actions there:
 
Last year, Caputo, along with other figures in Trump’s orbit, turned his focus to Ukraine. He says he travelled there last August to try to bolster the theory that Ukrainians interfered in 2016 election to help Clinton. He subsequently wrote a book, titled The Ukraine Hoax: How Decades of Corruption in the Former Soviet Republic Led to Trump’s Phony Impeachment, which pushes discredited allegations, including claims that former Vice President Joe Biden intervened in Ukrainian affairs to help his son, Hunter. Caputo produced a documentary offering similar allegations that aired in January on the rabidly pro-Trump One America News. Giuliani starred in a separate OAN series which pushed similar claims based his own trip to Ukraine.

 
Yet  despite Caputo's record as an unscrupulous political operator, and allegations that he was involved in peddling propaganda and disinformation, his appointment drew no outcry.

Assistant Secretary for Public Relations of DHHS Orchestrated Intimidation to Distort the Morbidity and Mortality Weekly Report

Somehow Caputo and the associates he brought to the DHHS managed to avoid much public notoriety for a few months.  Then on September 11, 2020 Politico reported that Caputo and his associates had been quietly busy.  Their apparent mission was to turn the respected CDC public health publication, the Morbidity and Mortality Weekly Report, into a vehicle for pro-Trump propaganda.  Politico noted that:

The CDC's Morbidity and Mortality Weekly Reports are authored by career scientists and serve as the main vehicle for the agency to inform doctors, researchers and the general public about how Covid-19 is spreading and who is at risk. Such reports have historically been published with little fanfare and no political interference, said several longtime health department officials, and have been viewed as a cornerstone of the nation's public health work for decades.

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department's new spokesperson, there have been substantial efforts to align the reports with Trump's statements, including the president's claims that fears about the outbreak are overstated, or stop the reports altogether.

In particular, Caputo et al tried to

retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior

and

halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence

To underscore that the effort was to promote Trump's political self-interest

an aide to Caputo berated CDC scientists for attempting to use the reports to 'hurt the President' in an Aug. 8 email sent to CDC Director Robert Redfield and other officials that was widely circulated inside the department and obtained by POLITICO. 'CDC to me appears to be writing hit pieces on the administration,' appointee Paul Alexander wrote, calling on Redfield to modify two already published reports

Alexander tried to gain control of the contents of the MMWR, calling

 on Redfield to halt all future MMWR reports until the agency modified its years-old publication process so he could personally review the entire report prior to publication, rather than a brief synopsis. Alexander, an assistant professor of health research at McMaster University near Toronto whom Caputo recruited this spring to be his scientific adviser, added that CDC needed to allow him to make line edits — and demanded an 'immediate stop' to the reports in the meantime.

Apparently CDC staffers resisted Caputo, Alexander et al, so that eventually contents untouched by their manipulations did become public.

One day after the Politico article, the New York Times  confirmed its essential findings

Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies said on Saturday that meddling from Washington was turning widely followed and otherwise apolitical guidance on infectious disease, the Morbidity and Mortality Weekly Reports, into a political loyalty test, with career scientists framed as adversaries of the administration.

The Times called Caputo's work a "bullying operation."  

The Washington Post also confirmed the Politico report after gaining access to emails sent by Alexander.

The Assistant Secretary's Actions Became Bizarre, and He Resigns Citing Mental Health Issues

As soon as the story of his attempts to "bully" the MMWR became public, Caputo's actions became more bizarre.  On September 14, 2020, the New York Times reported:

The top communications official at the powerful cabinet department in charge of combating the coronavirus made outlandish and false accusations on Sunday that career government scientists were engaging in 'sedition' in their handling of the pandemic and that left-wing hit squads were preparing for armed insurrection after the election.

Michael R. Caputo, the assistant secretary of public affairs at the Department of Health and Human Services, accused the Centers for Disease Control and Prevention of harboring a 'resistance unit' determined to undermine President Trump, even if that opposition bolsters the Covid-19 death toll.

Then he announced:

he personally could be in danger from opponents of the administration. 'If you carry guns, buy ammunition, ladies and gentlemen, because it’s going to be hard to get,' he urged his followers.

He went further, saying his physical health was in question, and his 'mental health has definitely failed.'

'I don’t like being alone in Washington,' Mr. Caputo said, describing 'shadows on the ceiling in my apartment, there alone, shadows are so long.'

 One day later Politico reported an announcement:

Today, the Department of Health and Human Services is announcing that HHS Assistant Secretary for Public Affairs Michael Caputo has decided to take a leave of absence to focus on his health and the well-being of his family

Alexander also left the agency 

Since Caputo's departure, Politico published an article detailing how he placed "his own loyalists and Trump veterans" into public relations positions at the DHHS. 

Also, the New York Times published an article detailing some of his efforts to bully CDC staff,

Mr. Caputo moved to punish the C.D.C.’s communications team for granting interviews to NPR and trying to help a CNN reporter reach him about a public relations campaign. Current and former C.D.C. officials called it a five-month campaign of bullying and intimidation.

For instance, after Mr. Caputo forwarded the critique of Dr. Schuchat to Dr. Redfield, C.D.C. officials became concerned when a member of the health department’s White House liaison office — Catherine Granito — called the agency to ask questions about Dr. Schuchat’s biography, leaving the impression that some in Washington could have been searching for ways to fire her.

In another instance, Mr. Caputo wrote to C.D.C. communications officials on July 15 to demand they turn over the name of the press officer who approved a series of interviews between NPR and a longtime C.D.C. epidemiologist, after the department in Washington had moved to take ownership of the agency’s pandemic data collection.

'I need to know who did it,' Mr. Caputo wrote. A day later, still without a reply, Mr. Caputo wrote back. 'I have not received a response to my email for 20 hours. This is unacceptable,' he said.

Efforts to Turn the MMWR Into Propaganda Criticized byAcademics in Public Health and Health Care, and the CEO of the Robert Wood Johnson Foundation

Per the Politico article above, Jennifer Kates, leader of the Kaiser Family Foundation's global health work

defended the CDC's process as rigorous and said that there was no reason for politically appointed officials to review the work of scientists.

Per the New York Times article above, Dr. William Schaffner, an infectious disease specialist at Vanderbilt University who sits on the external editorial board of the Morbidity and Mortality Weekly Report, said Caputo's operation 

undermines the credibility of not only the M.M.W.R. but of the C.D.C. And the C.D.C.’s credibility has been tarnished throughout Covid already

Per USA Today on September 13, 2020:

The interference is not just anti-science but disinformation intended to deceive the American public, said Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.

'This is outright egregious. It’s despicable,' Topol said, accusing Redfield and other leaders of allowing the agency to be hijacked by politics.

Also,

 On Twitter, Dr. Sherri Bucher, a global health researcher, wrote, 'There are no words to articulate how horrific this is. Trust & credibility, shattered, overnight. MMWR has been, for a long time, one of the most reliable, steadfast, scientific resources; unquestioned veracity, impeccable reputation for quality of data/analysis. No longer.

The Washington Post published an op-ed by Dr Erin Marcus, a professor of clinical medicine at the University of Miami Miller Medical School:

Caputo’s manipulation is appalling. If left unchecked, it could have disastrous consequences for the reputation and reliability of the CDC, which has already been battered by the U.S. response to covid-19. It could also prove devastating for medical practice in the United States more broadly.

In Scientific American, Dr Richard Besser, the CEO of the Robert Wood Johnson Foundation, wrote an op-ed entitled "We can't allow the CDC to be tainted by politics," noting:

 To meddle with, delay or politicize these [MMWR] reports would be a form of scientific blasphemy as well as a breach of public trust that could undermine the nation’s efforts to fight the coronavirus.

Summary

So to summarize, the White House put a pro-Trump political operative who had allegedly been involved in producing propaganda and disinformation in support of Trump to oversee all Department of Health and Human Services communications.  He and his hired cronies tried to bully and intimidate DHHS, particularly CDC staff, and to distort the contents of the renowned MMWR to support the Trump message.  Had these efforts succeeded they would have seriously impeded efforts to control the coronavirus pandemic by undermining the dissemination of scientific evidence needed for pandemic management and clinical care for affected patients.  

I found several academic public health and health care professionals willing to criticize Caputo and cronies' actions.  I found one leader of a prominent health care foundation willing to at least implicitly criticize them.  I found no one willing to hold accountable anyone at the "top" of the government who hired Caputo or encouraged his actions.  On this case, I could find no leader of a health care organization other than Dr Besser willing to say anything at all.   

Conclusions

Last month, we noted how disinformation about the coronavirus pandemic is being disseminated by the US president. 

Since then, two major efforts to use the CDC, the lead US public health organization, to support President Trump's political messaging, in effect, to function as a political propaganda outlet.  Individual US academic and practicing public health and health care professionals have been willing to decry these efforts, though not to directly hold Trump and his top lieutenants in the executive branch accountable.  In some cases, leaders of major medical organizations have been willing to state the principles that should have been upheld within the government.  

However, no chairpersons, deans, chancellors, vice-presidents for health affairs, university presidents; or journal editors, hospital executives, leaders of professional societies, executives of health care corporations, etc, etc were willing to publicly challenge Trump and his top collaborators.  Such leaders so far have also been unwilling to challenge Trump's efforts to spread disinformation.

To be charitable, such leaders may be to used to a kinder, gentler era to be able to fully comprehend that parts of the US government meant to be apolitical advocates for public welfare, such as the CDC, are being pushed to become part of an incipient Ministry of Propaganda.  



Fighting a deadly pandemic is hard enough.  It is gut wrenching that the fight is being subverted by political leaders spreading propaganda and disinformation.  It is sad that front line public health and health care professionals are hardly supported in their work by those who claim to lead them.  Where is the courage?  Where is the outrage?

"If not now, when?"