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Impunity: an Introduction

We believe that unaccountable leadership is a major cause of health care dysfunction.  Impunity is an extreme form of unaccountable leadership.

We have noted that despite numerous legal settlements made by health care organizations of alllegations like fraud, bribery, and kickbacks, almost never do top leaders who presided over these actions face any negative consequences.  Lack of deterrence caused by such impunity appears to be a major cause of  the epidemic of continuing unethical behavior, crime and corruption on the part of large health care organizations. How executives got to the point of having such impunity has never been clear.

Timidity and lenience by regulatory agencies and law enforcement seem to be factors. For example, in 2014, we noted  that Attorney  General Eric Holder had previously been reluctant to go after big organizations because of the economic consequences of their failure:

The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.
In general we have seen much tougher enforcement directed against relatively small health care players than against bigger ones.  For example, we noted in 2014 that settlements by  Merck, Eli Lilly, Takeda, and Teva, all large pharmaceutical companies, allowed the companies to pay fines to settle allegations that they pushed dangerous products, while none of the executives who authorized, enabled, or directed these actions faced negative consequences.  In contrast, at that time, the CEO of a relatively tiny Sheffield Pharmaceuticals was convicted of a felonious wastewater discharge (see this post).

However, this rationale does not address the failure to pursue enforcement actions against organizational leaders who who enabled, authorized, directed or implemented misbehavior.  It is not that there are no good legal tools available to do so.  We wrote in 2012,
As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.    Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.

Later, in 2015, under the previous administration, there was a tiny sign of progress against impunity.  Then, Attorney General Holder authorized the creation of a Corporate Strike Force to take strong actions in response to health care corporate fraud.  However, last year the Trump administration gutted even that small effort  (look here).

Why are efforts to reduce the impunity of health care corporate leaders going backward?  It may be because the very top leadership of the current administration, that is, the President himself, has long personally enjoyed his own impunity.


Examples of Donald Trump and Family's Apparent Impunity Before He Became President

As a wealthy businessman, Donald Trump and his family were often linked to apparently illegal activities, but seemed to avoid any intensive investigation, much less negative consequences.


A 2016 Politico article cataloged Trump's ties to organized crime, and found "Some of Trump’s unsavory connections have been followed by investigators and substantiated in court; some haven’t." Also,
Trump’s career has benefited from a decades-long and largely successful effort to limit and deflect law enforcement investigations into his dealings with top mobsters, organized crime associates, labor fixers, corrupt union leaders, con artists and even a one-time drug trafficker whom Trump retained as the head of his personal helicopter service.
We have found numerous examples, whic are below listed chronologically according to the time of occurrence of relevant events.

Trump Accused of Lying to Federal Investigators about his Mafia Connections in the 1980s

A WNYC piece from October, 2016, was based on an interview with a federal prosecutor who had investigated organized crime in the 1980s,

Attorney Kenneth McCallion was one of the federal prosecutors involved in that investigation. He says there appeared to be a sweetheart deal between the Teamsters Local 282 and Trump, where Trump would get a promise of cooperation from organized labor—including breaking up any strikes by minority workers—in exchange for no-show jobs, a lucrative concrete contract and a luxury apartment for the union president's girlfriend.

'After we indicted them, the Teamster leaders called a citywide strike, but there were two job sites they exempted from that. One was Trump Tower and the other was Trump Plaza,' McCallion said.

Yet despite this, Trump was never prosecuted.

'Even though Donald Trump lied to law enforcement about his relationship and lying to federal agents is a federal crime, he basically got a pass at that point,' he said.

Trump Accused in Legal Papers of Accepting Kickbacks, but the Charges were not Investigated

The 2016 Politico article also noted:

[An associate of a convicted racketeer] in court papers accused Trump of taking kickbacks from contractors, asserting this could 'be the basis of a criminal proceeding requiring an attorney general’s investigation' into Trump. Trump then quickly settled, paying the woman a half-million dollars.

No further investigation ensued.

After a Judge Found that he Conspired to Violate Fiduciary Duty and Committed Fraud, Trump was able to Settle with Details Sealed

Again in Politico,

In 1991, a federal judge, Charles E. Stewart Jr., ruled that Trump had engaged in a conspiracy to violate a fiduciary duty, or duty of loyalty, to the workers and their union and that the 'breach involved fraud and the Trump defendants knowingly participated in his breach.' The judge did not find Trump’s testimony to be sufficiently credible and set damages at $325,000. The case was later settled by negotiation, and the agreement was sealed.

It is not clear that Trump was personally responsible for paying whatever the settlement entailed.  No criminal charges apparently followed.  

Applying for a Casino License, Trump Failed to Disclose he was Under Grand Jury Investigation, but Later Kept his License

As also reported by Politico, when Trump was trying to obtain a license for a New Jersey gambling casino,

Trump was required to disclose any investigations in which he might have been involved in the past, even if they never resulted in charges. Trump didn’t disclose a federal grand jury inquiry into how he obtained an option to buy the Penn Central railroad yards on the West Side of Manhattan. The failure to disclose either that inquiry or the Cody inquiry probably should have disqualified Trump from receiving a license under the standards set by the gaming authorities.

But it didn,'t. And despite the fact that

Once Trump was licensed in 1982, critical facts that should have resulted in license denial began emerging in Trump’s own books and in reports by Barrett—an embarrassment for the licensing commission and state investigators, who were supposed to have turned these stones over. Forced after the fact to look into Trump’s connections, the two federal investigations he failed to reveal and other matters, the New Jersey Division of Gaming Enforcement investigators circled the wagons to defend their work. First they dismissed as unreliable what mobsters, corrupt union bosses and Trump’s biggest customer, among others, had said to Barrett, to me and other journalists and filmmakers about their dealings with Trump. The investigators’ reports showed that they then put Trump under oath. Trump denied any misconduct or testified that he could not remember. They took him at his word. That meant his casino license was secure even though others in the gambling industry, including low-level licensees like card dealers, had been thrown out for far less.

Trump's Casino Company Paid Multiple Fines for Violating Regulations, but Trump was not Personally Sanctioned 

An Atlantic article from January, 2017, stated,

Trump has been repeatedly fined for breaking rules related to his operation of casinos. In 1990, with Trump Taj Mahal in trouble, Trump’s father Fred strolled in and bought 700 chips worth a total of $3.5 million. The purchase helped the casino pay debt that was due, but because Fred Trump had no plans to gamble, the New Jersey gaming commission ruled that it was a loan that violated operating rules. Trump paid a $30,000 fine; in the end, the loan didn’t prevent a bankruptcy the following year. As noted above, New Jersey also fined Trump $200,000 for arranging to keep black employees away from mafioso Robert LiButti’s gambling table. In 1991, the Casino Control Commission fined Trump’s company another $450,000 for buying LiButti nine luxury cars. And in 2000, Trump was fined $250,000 for breaking New York state law in lobbying to prevent an Indian casino from opening in the Catskills, for fear it would compete against his Atlantic City casinos.

Also, while Trump was attempting a hostile take-over of a rival casino,

the Federal Trade Commission fined him $750,000 for failing to disclose his purchases of stock in the two companies, which exceeded minimum disclosure levels.

Trump and Family were Accused of Self-Dealing and Accepting Illegal Donations while Operating the Trump Foundation, but were not Individually Penalized

Also reported by the Atlantic,

The [Trump] foundation appears to have broken IRS rules on 'self-dealing” by paying to resolve the legal disputes as well as buying a portrait of Trump and a Tim Tebow helmet that went back to the Trump family. In November, in tax filings posted online, the Trump Foundation said it had violated self-dealing rules in 2015 and in previous, indeterminate, years. On the donation, Trump and Bondi both say there was no quid-pro-quo, but the donation was an illegal one for a charitable nonprofit, and the foundation had to pay a $2,500 fine. Liberal watchdog group Citizens for Responsibility and Ethics in Washington charges other laws may have been broken as well. New York Attorney General Eric Schneiderman has reportedly launched an investigation into the foundation. Schneiderman has also informed the foundation that it is in violation of rules on fundraising and ordered it to quit. Trump has announced plans to shutter his foundation, but reportedly cannot do so while it is under investigation.

Yet so far no person has been charged with any related violations. Note that it appears that Trump may have had leverage on Mr Schneiderman, who has now resigned (see below).  Although there were reports in 2017 that the Foundation was going to shut down, as of March, 2018, according to an article in The Hill, the ranking Democratic member of the House Oversight and Government Reform Committee was still trying to get records related to the self-dealing described above from the leadership of the apparently still existing foundation (look here). 

Trump's Taj Mahal Casino Was Fined for Breaking Rules about Money Laundering, but Trump Paid no Penalties

A May, 2017, CNN story stated,

The Trump Taj Mahal casino broke anti-money laundering rules 106 times in its first year and a half of operation in the early 1990s, according to the IRS in a 1998 settlement agreement.

It's a bit of forgotten history that's buried in federal records held by an investigative unit of the Treasury Department, records that congressional committees investigating Trump's ties to Russia have obtained access to, CNN has learned.

The casino repeatedly failed to properly report gamblers who cashed out $10,000 or more in a single day, the government said.

Trump's casino ended up paying the Treasury Department a $477,000 fine in 1998 without admitting any liability under the Bank Secrecy Act.

There is no record suggesting anyone looked into Trump's involvement with these violations. Note that

The 1998 settlement was publicly reported at the time, and the Associated Press noted it was the largest fine the federal government ever slapped on a casino for violating the Bank Secrecy Act.

However,

But key details of the casino's cash reporting violations are missing from the publicly released documents, including the identities of the gamblers and casino employees involved in the transactions.

Then, in 2015, FINCEN publicly announced:

The Financial Crimes Enforcement Network (FinCEN) today imposed a $10 million civil money penalty against Trump Taj Mahal Casino Resort (Trump Taj Mahal), for willful and repeated violations of the Bank Secrecy Act (BSA). In addition to the civil money penalty, the casino is required to conduct periodic external audits to examine its anti-money laundering (AML) BSA compliance program and provide those audit reports to FinCEN and the casino’s Board of Directors.

Trump Taj Mahal, a casino in Atlantic City, New Jersey, admitted to several willful BSA violations, including violations of AML program requirements, reporting obligations, and recordkeeping requirements. Trump Taj Mahal has a long history of prior, repeated BSA violations cited by examiners dating back to 2003. Additionally, in 1998, FinCEN assessed a $477,700 civil money penalty against Trump Taj Mahal for currency transaction reporting violations.

'Trump Taj Mahal received many warnings about its deficiencies,' said FinCEN Director Jennifer Shasky Calvery. 'Like all casinos in this country, Trump Taj Mahal has a duty to help protect our financial system from being exploited by criminals, terrorists, and other bad actors. Far from meeting these expectations, poor compliance practices, over many years, left the casino and our financial system unacceptably exposed.'

Trump Taj Mahal admitted that it failed to implement and maintain an effective AML program; failed to report suspicious transactions; failed to properly file required currency transaction reports; and failed to keep appropriate records as required by the BSA. Notably, Trump Taj Mahal had ample notice of these deficiencies as many of the violations from 2012 and 2010 were discovered in previous examinations.

Again, there is no record of any negative consequences for Mr Trump

Trump Made False Statements Under Oath, but was not Charged with Perjury

A Mother Jones article published February, 2016, recounted that in connection with a libel suit Mr Trump filed against journalist Timothy O'Brien alleging O'Brien under-reported Mr Trump's wealth,

In 2007—two years before a New Jersey judge tossed out the case—Trump was questioned during a deposition. Over the course of the two-day-long interrogation, Trump was forced repeatedly to acknowledge having made false statements. And at one point, a lawyer for O’Brien and his publisher asked Trump a straightforward question: Have you ever before associated with individuals you knew were associated with organized crime?'

Trump, who was testifying under oath, answered, 'Not that I know of.'

That was a clear and unequivocal response. But it was not true. Two years earlier, O’Brien had interviewed Trump and specifically asked him about Sullivan and Shapiro. O’Brien, now an editor and writer at Bloomberg, has provided Mother Jones with a transcript of the interview, and it conclusively shows that Trump believed that these two men were associated with organized crime....

Trump: They were tough guys. In fact, they say that Dan Sullivan was the guy that killed Jimmy Hoffa. I don’t know if you ever heard that.

O’Brien: I have heard that. And that he was, you know…

Also,

Trump: I just was able to handle them. And I, really, I was able to handle them. I found Sullivan to be the tougher of the two. I started hearing reports about Sullivan, that he killed Jimmy Hoffa….

Also,

O’Brien: What was Shapiro like?

Trump: He was like a third-rate, local, real estate mob guy. Nothing spectacular. And I, you know, I got lucky. I heard a rumor that Sullivan, because Sullivan was a great con man, I heard a rumor that Sullivan killed Jimmy Hoffa. And because I heard that rumor I kept my guard up. You know, I said, 'Hey, I don’t want to be friends with this guy.'

So here was Trump connecting Sullivan to the Hoffa murder and calling Shapiro a 'mob guy.'

The same article also asserted that Trump lied in a deposition about knowing and working with Felix Sater, who who "had once been involved in a Mafia-linked stock swindle," and who "had worked with the Trump Organization."

Ivanka Trump and Donald Trump Jr Escaped Indictment for Fraud

As reported by the New Yorker in October, 2017, despite considerable evidence that the two children of Donald Trump had misled potential buyers of Trump SoHo condominiums, Cyrus Vance, the Manhattan District Attorney overruled his staff by halting an investigation of them in 2010.  Later, the Trumps' attorney, Marc Kasowitz, made a large donation to Mr Vance's campaign.   

Trump University Settled Fraud Allegations, Trump Not Charged

As reported by the New York Times in 2017, "the final settlement of allegations that 'Trump University students had been cheated out of thousands of dollars in tuition through high-pressure sales techniques and false claims about what they would learn" was approved by a judge. Litigation about these allegations had gone on for years, but after his election in November, Mr. Trump reversed course and agreed to pay $25 million to resolve the litigation. He did not admit fault, and he maintained in posts on Twitter after the settlement announcement that he "did not have the time to go through a long but winning trial on Trump U."

The settlement resolved lawsuits brought by the Attorney General of New York, Eric Schneiderman, among others.  However, Mr Trump was never charged with a crime by Mr Schneiderman among others.  There is some reason to think Mr Trump took actions to ensure his impunity.

According to Bloomberg on May 11, 2018,
Back in 2013, Donald Trump was exploring a presidential run. His Trump University was in the crosshairs of New York’s crusading attorney general. Around the same time, Trump and his personal lawyer got an interesting piece of information: Eric Schneiderman, the AG, was accused of sexually abusing two women.

The details of the accusations were not made public at that time, but later,
Trump took aim at Schneiderman in a tweet on Sept. 11, 2013, that also referred to New York politicians who’d resigned over allegations of sexual misconduct, Anthony Weiner and Eliot Spitzer.

'Weiner is gone, Spitzer is gone -- next will be lightweight A.G. Eric Schneiderman. Is he a crook? Wait and see, worse than Spitzer or Weiner,' Trump tweeted.

Mr Schneiderman never brought criminal charges against Mr Trump.  Could it be that he was made aware that Trump had information about Schneiderman's sexual behavior that he could use against him? This month, the allegations of his sexual misconduct were finally made public and he then resigned.  The settlement, again absent any charges against Mr Trump, was approved in March, 2017.

Summary of Trump's Pre-Presidency Impunity

While Trump's firms have had to pay multiple fines for breaking rules and laws, and Trump and the immediate family members who work with him in the Trump Organization were credibly accused of multiple types of wrong-doing, including various apparent crimes, neither Trump nor his family members were ever indicted, or apparently investigated for crimes. 

President Trump's Arguments That He Has De Jure Impunity

Since he was elected, President Trump and his proxies have asserted he now has de jure impunity that seems to go well beyond the sort of de facto impunity he enjoyed as a wealthy and powerful businessman and celebrity.  Note that none of these statements attempted to deny that he had or would violate laws.  They were all assertions that President Trump is not subject to the rule of law.

Examples appear again in order of apparent occurrence.


Trump Said He is Not Subject to Laws on Conflicts of Interest.

 As reported by CNN in November, 2016:

Donald Trump said on Tuesday that he faces no legal obligation to cut ties with his businesses, even as he described how winning the presidency has made his brand 'hotter' and acknowledged advancing his business interests during a conversation with a British politician.

'The law's totally on my side, the president can't have a..
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Amidst the news deluge, a story that stood out in the last few days was that of the strange relationships between a consulting firm set up by President Donald Trump's former lawyer and Trump Organization counsel Michael Cohen, and several large corporations.  As reported on May 8, 2018 by the New York Times, the focus was on the payments made to the firm, Essential Consultants LLC, by a financial firm, Columbus Nova, associated with a Russian oligarch, Viktor Vekselberg, who has been described as "Kremlin-linked."

 Did Novartis Pay Michael Cohen's Essential Consultants LLC for Access to the White House?

However, Essential Consultants LLC also had a poorly described business relationship with Swiss-based multinational pharmaceutical manufacturer Novartis.  Per the NYT,

Among the other payments to Mr. Cohen’s company described in the financial records were four for $99,980 each between October and January by Novartis Investments S.A.R.L., a subsidiary of Novartis, the multinational pharmaceutical giant based in Switzerland. Novartis — whose chief executive was among 15 business leaders invited to dinner with Mr. Trump at the World Economic Forum in January — spent more than $10 million on lobbying in Washington last year and frequently seeks approvals from federal drug regulators.

Additional reporting on this relationship suggests that Novartis may have been trying to buy access to or influence on the Trump administration. More details on the arrangements between the firms came from Ed Silverman in Stat News ,

A Novartis unit called Novartis Investment SARL made four payments, each one totaling $99,980, to the consulting firm, according to documents released by Michael Avenatti, the lawyer for Stormy Daniels, the adult film star whose real name is Stephanie Clifford and who was paid $130,000 by Essential Consultants to keep quiet about her alleged affair with Trump.

In a statement, Novartis says it entered into a one-year agreement with Essential Consultants in February 2017, 'shortly after the election of President Trump focused on U.S. healthcare policy matters. The terms were consistent with the market. The agreement expired in February 2018.'

The first Novartis payment was purportedly made on Oct. 5, 2017, while the subsequent payments followed in successive months — Nov. 3, 2017, Dec. 1, 2017, and Jan. 5, 2018, according to the documents.

A Novartis spokesman said that 'any contracts were done prior to (chief executive officer Vasant Narasimhan) taking over' and that he 'had no involvement whatsoever with this arrangement.' He did not provide any further details concerning the payments, but indicated the agreement had expired.

Narasimhan succeeded Joe Jimenez as Novartis chief executive on Feb. 1 this year, although he attended a dinner with Trump at the World Economic Forum in Davos, Switzerland, on Jan. 25, which Avenatti noted in the documents that he released. A Novartis spokesman later added that Jimenez last met with Trump at a meeting with executives from several drug makers last spring.

Another article by Mr Silverman in Stat gave some further rationale for this agreement.

Michael Cohen, a longtime fixer for the president, reached out to Novartis’s then-chief executive officer Joe Jimenez, promising help gaining access to Trump and influential officials in the new administration, according to an employee inside Novartis familiar with the matter.

Jimenez took the call and then instructed his team to reach a deal with Cohen.

Furthermore, a Novartis empoyee said,

'With a new administration coming in, basically, all the traditional contacts disappeared and they were all new players. We were trying to find an inroad into the administration. Cohen promised access to not just Trump, but also the circle around him. It was almost as if we were hiring him as a lobbyist.'

A Huffington Post article found

an official with one of those companies [Novartis, At&T, or Korea Aerospace], who requested anonymity to speak openly, was more blunt. The official said Cohen 'was promising access to Trump and members of the administration, positioning himself as a lobbyist.'

So there seemed to be a confluence of reporting suggesting that Novartis paid Michael Cohen via the perhaps ironically named Essential Consultans LLC for access to or influence over the Trump administration, and possibly specifically President Trump himself.  Chummy relationships between large health care organizations, particularly large for-profit health care corporations, and US government agencies that regulate health care, or set health policy are old news.  We have frequently discussed the revolving door through which people travel going to and from leadership positions in health care corporations and in health related government agencies.  While we have discussed many examples of health care corporations being accused of, settling allegations of, or even pleading guilty to charges of bribery or kickbacks, I cannot recall any case of a health care corporation paying for access to and possibly raising suspicions about the bribery of the President of the US. That would be a new low in the annals of health care corruption.


Nothing New for Novartis

Thus it should be no surprise that pundits on the business of health care were back on their heels.  John LaMattina, wrote for Forbes,

The most recent revelation involving Novartis is both shocking and depressing.

Also,

One wonders what Novartis was thinking in entering such an agreement. Clearly, any sensible person would look at such an agreement cynically and come away with the view that Novartis was attempting to buy access to the President through his lawyer. Furthermore, the one year contract that Novartis had with Cohen - $100,000/month – is a lot of money for a lawyer with no background in healthcare. Didn’t anyone at Novartis think about how badly this would look if such a deal was made public?

But Mr LaMattina is a former President of Global Research and Development for Pfizer, a company with a long history of ethical misadventures (look here), so may be a bit biased about the integrity of the pharmaceutical industry.

In fact, Mr Silverman's first article suggested that Novartis is not so innocent.

Throughout much of last year, Novartis was embroiled in a bribery scandal in Greece, where the government was probing allegations that the drug maker made payments to numerous politicians to boost sales of its medicines through public agencies.

Also,

In the U.S., the drug maker is defending a long-running lawsuit that is being pressed by the federal government over allegations it provided doctors with paid speaking engagements, fancy meals, and alcohol in exchange for writing prescriptions for its drugs.

The case is being closely watched because the company has been accused of being a repeat offender. How so? In 2010, Novartis paid $422.5 million in penalties and pleaded guilty to a misdemeanor to resolve criminal allegations that it improperly promoted several medicines.

At the time, the company was already operating under a Corporate Integrity Agreement, which required establishing an internal compliance program and reporting violations, among other things. That agreement was signed in September 2010, yet the lawsuit alleged the infractions occurred afterward, suggesting Novartis might face a stiff penalty should it attempt a settlement with the government.

Moreover, those who follow Health Care Renewal would realize that Novartis' record of ethical misadventures is much more extensive than that.


In October, 2016, Novartis settled charges that from 2002-2009 it promoted use a skin cream for pediatric patients for unapproved indications and in ways that could have endangered patients (look here).  

In March, 2016, Novartis settled charges by the US Securities and Exchange Commission (SEC) under the Foreign Corrupt Practics Act (FCPA) thatfrom 2009-2013 it bribed Chinese health care professionals to increase sales (look here).  

In November, 2015 we discussed what were then the latest misadventures by Novartis and its leadership.  At that time, our post included these section headings covering 2014-15:

-  Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
- Novartis Executive Pleads Guilty to Bribing Polish Official
- Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
- Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
- Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis' previous record.   In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also,  in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here)   Other Novartis misadventures from 2010 and earlier, including the two described in the Stat News article, appear here.  So Novartis has quite an impressive, if not infamous record of ethical failures.

Note that through all these cases, Novartis leadership enjoyed impunity.  No Novartis top manager suffered any negative consequences from any of them (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers.

So is it at all surprising that the previous Novartis CEO did not see a big problem paying Donald Trump's lawyer and former corporate counsel to a little access to The Donald?

Discussion

Most corrupt actions require two parties.  While it is understandable that there has been tremendous recent interest in evidence that the Trump regime is corrupt (look here), any such corruption had to have been enabled by unethical actions on the parts of others.  Those others likely included large numbers of leaders of large corporations, including health care corporations.  We have shown repeatedly that top leaders of US health care organizations have enjoyed impunity that has allowed them to foster a host of unethical actions, including crimes such as bribery, fraud, and kickbacks, and true health care corruption.

Our societal tolerance of health care (and other forms of) corruption probably enabled the currently breathtaking scope of executive branch corruption.  For a long time we have argued that health care corruption is a major cause of health care dysfunction.  As we wrote in August, 2017, 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 somewhere else, 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, 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.


The continuing festering of widespeard amorality and corruption at the top of US business has fostered a situation in which now corruption appears to have spread to the top of the US government.
 The only way we can now address health care corruption is to excise the corruption at the heart of our government.
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Let me second the emotion now recently and repeatedly voiced by Dr. Poses in these pages. It's getting real hard to separate the health policy and malfeasance fecaliths from the general Washington Scheißsturm raining down on us. We all feel pretty much buffeted non-stop, like (whomp!) badminton shuttlecocks in the corruption game the prevaricator-in-chief seems happily destined to carry on forever. Or at least until some better angels out there in America rise up to put an end to it. Because it's pretty obvious the party hacks clearly aren't going to. They're way too busy (padre you're fired! padre you're unfired!) doing other important stuff. And avoiding the wrath (why invite trouble?) of the prevaricator-in-chief.

Maybe tweets are effective covering fire. Maybe it's not a kakistocracy we live in so much as a tweetocracy.

In fact it's also getting pretty easy to find the links between the micro- and the macro-misdeeds in today's kakistocracy. I want to talk about two of those today. Both stem from recent months' events in the game of musical chairs at two of the most cost- and problem-ridden departments overseen by our executive branch. Of course, as the reader likely already surmised, these are health and human services and veterans' affairs. Dr. Poses has in fact just posted on the latter, given the zany events in the previously barely-known White House Medical Unit.

(In fact, in discussing what happens with the current administration Dr. P has hit upon an essential mechanism liking the macro and the micro: "inbound revolving door" plants from the White House directed to administrations such as HHS and VA. Where a guy with some expertise in any given position may show questionable judgment in comporting himself--yes we're always talking about men these days--all too soon he's offed by the political hacks appointed to "help" him. This makes for great press but poor government. But since when is anything like good government even the point? Hacks make hay while the sun shines. They're out to satisfy their rich donors like the Kochs and Mercers. Some hacks get to stay in place if they're somnolent enough. I mean you, Carson. Others, including folks who're not hacks like David Shulkin at the VA, are out on their tushies before press or good-government critics get to prove much of anything.)

Let's take these two agencies in turn.

The VA. First there was David Shulkin. I've written about him before (e.g. here and here), as has Dr. Poses. Not much more to say here about the guy who came in with good intentions, inaugurated some important positive changes in information technology and elsewhere in a badly-battered organization, then made what might at worst be characterized as some slightly sloppy mistakes in his record-keeping and travel-planning while on official business.

Then the jackals swooped. Out he went. Next up: Ronny Jackson, ER doctor, erstwhile head of the White House Medical Unit and Navy frat-boy par excellence. Ronny was to be Shulkin's replacement, until his boss rewarded his sucking up with a now-standard distancing maneuver. Which might be described as "stir up a fuss, you go under the bus." Jackson, AKA "Dr. Feelgood" (ibid. and here), will never be VA Secretary now, or get his second admiral's star. (Or whatever it is that admirals get.) His unit's curiously isolated place in the hierarchy allowed him allegedly to abuse his reports, but at the same time seemingly left him, his boss, and anyone who's supposed to vet cabinet-level appointees, blind-sided about what it takes to run a large health care organization. Oh, wait, they actually started with someone who had what it takes. But none of this is any longer about good government or effectiveness or expertise. It's about ideology, or ideology as refracted through donors' eyes.

And Jackson's boss, as his latest hapless subaltern edges closer to the undercarriage of the bus, says "[t]hey’re trying to destroy a man," Ronny's such a good guy--just look what he said about my health, my hands are clean, it's all fake fake fake. Fake news. Actually, classic gaslighting. Now the boss is going after Ronny's tormentor, Montana Sen. Tester. But my friends in Montana tell me Tester's got not so much to worry about. Montanans are a cussedly independent lot. They don't take too kindly to these bad-mouthing bad boys from out of the swamp over there in Dee-Cee.

So who's next in the cavalcade of stars for the truly humongous VA bureaucracy and its leadership?

One name being bruited about is that of Jeff Miller, a lobbyist who once as a congressman chaired the House Committee on Veterans' Affairs. But according to Newsweek, Miller's real claim to fame is his work lobbying for insider trading hedge funder and Very Happy Guy Steven A. Cohen. Turns out Cohen is a major funder for the privatized health care that Shulkin quite rightly opposed. (See ibid. in Newsweek, and here.) Super-tight in with this crowd are also the Koch Brothers, the Daddies Warbuck for Concerned Veterans for America. CVA is a remarkable organization. It's lofty aims "to preserve the freedom & prosperity we & our families fought & sacrificed to defend" (where'd they find this copywriter?) include notable projects such as "VA Fail."  "VA Fail" is a "tracker" to which you can actually subscribe in order to follow each and every one of this department's "missteps, mismanagement and misguidance." A set-up to do away with an essential and in many ways still-vital branch of government. One that really needs help to change some dysfunctional internal systems, but still really helps people at reasonable cost compared to the fragmented private systems.

Right now I'm a long, long way from Washington. I'm in a place where government is equally corrupt and dufus-like. But at least the people are nice to each other and hip to their government's misdeeds. Still, it seems these democracies are having a really hard time right about now. Many citizens of the First World have lost faith in their voters' ability to impact the bizarre bull-in-china-shop behaviors of their leaders. Truth is, veterans want an effective and separate VA health system. I know, I worked there for a lot of years. The K-Stone Cops want to give them anything but.

Profit motive über alles. An awful lot of  members of "the Base" are veterans. Will they notice this scam?

Health and Human Services. First there was Tom Price, who was soon out of that job because a minor corruption scandal far eclipsed by his own entirely legal but misguided antics. Antics that while perfectly legal were perfectly dangerous, attempts to make good on campaign promises to sunder HHS and the Affordable Care Act. While Secretary, Georgia orthopedist and anti-Medicare activist Price approached the ACA the way he had most issues once arrived in Congress: undermine, undermine, undermine.

Look at him now. While Secretary, the Post tells us, he was all
"The individual mandate is one of those things that is actually driving up the cost for the American people in terms of coverage” ... on ABC’s “This Week” last summer. So, what we’re trying to do is make it so that Obamacare is no longer harming the patients of this land — no longer driving up costs, no longer making it so that they’ve got coverage but no care.”

But in a preternatural paroxysm of honesty just a week ago, on May Day, Price goes and tells a health conference just the opposite. It was the Congress that knew that the lack of the mandate would drive up the cost of insurance. But ideology and the donors said do it, so with his help they did it anyway. Along with any number of other measures to try and deep-six Obamacare. Of course they failed in spite of themselves--Obamacare is hanging in there. But it's no thanks to the guy whose job it was to make it work. He did everything he could to make it not work. (After his talk, of course, Price tried to walk back some of these views.)

Following Price, we now have a drug company executive, Alex Azar. He's actually done a few good things in his short time over at HHS. I've known a lot of drug company executives, as well as a lot of right wing doctors. The former are often a lot less ideological and a lot more practical than the latter. In conversation with one of the most successful members of the latter group--a widely recognizable pair of names, corporation and leader alike--I find that when it comes to steps that the political left questions, such as lobbying, the responses are remarkably forthright and lacking in hysterical right wing cant. "We need to sell our product" is the main message, on which more in a minute.

Right wing doctors who go into politics have all sorts of extra axes to grind. So Azar sort of had a head start on Price.

Thus the focus now shifts at least for the moment from insurance to drug prices, one of the bugabears both of Azar and his boss Donald Trump. At this year's World Health Congress, Azar teed up the trial balloon that floated around the campaign and still bears watching. Azar stated that "President Trump wants to go 'much further' to attack high drug prices," according to many sources including CNBC's Angelica LaVito. But what does this mean? Drug companies have recently upped their spending on both lobbying and campaign giving. This has caused heavy breathing in health policy circles--see here for example--but in my opinion it's mostly chump change. A doubling from spending in the low six figures to the mid six figures for activities that impact government drug-price awareness is, to me, just budget dust for drug companies, and not the driver of change so much as keeping up with the Joneses.

The Big Nut is Medicare and active direct bargaining to get prices down. Will Azar be able to do the in-sell that gets his boss to come out swinging with the biggest weapon he has? The drug companies, when they spend the big bucks, are really playing a different game. There are so many players in the pharmaceutical sales-and-distribution space, most notably the separately powerful PBM (pharmacy benefits management) companies, that everyone's pushing on a wet noodle. The one really reliable weapon Azar and company have, if they're willing to use it, is Medicare spending. This one will be truly fascinating to watch. It will say a lot about whether the President wants truly to drain the swamp and hence really please those in his Base who need affordable meds. Or just refill that swamp in order to please the hacks with whom he's now surrounded himself.
TO PRESERVE THE FREEDOM &
PROSPERITY WE & OUR FAMILIES FOUGHT & SACRIFICED TO DEFEND.TO PRESERVE THE FREEDOM &
PROSPERITY WE & OUR FAMILIES FOUGHT & SACRIFICED TO DEFEND.TO PRESERVE THE FREEDOM &
PROSPERITY WE & OUR FAMILIES FOUGHT & SACRIFICED TO DEFEND
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Introduction: Pressures on Health Care Professionals to Violate Core Values and Ethical Standards

Our first discussions with health professionals about the causes of health care dysfunction(1) quickly revealed concerns about influences that push professionals towards unethical actions.  We first heard about cases in which physicians were influenced to suppress clinical research whose results threatened vested interests, and punished when they did not cooperate.  These included the cases of Dr David Kern in the US, Dr Nancy Olivieri in Canada, (look here for summary) and Dr Aubrey Blumsohn in the UK (look here).  We also heard about numerous cases of whistleblowers who also were punished after revealing research misconduct, quality problems, mismanagement, financial malfeasance, etc, etc, etc.

We found evidence that many young medical faculty members felt pressured by leaders who put money ahead of professional core values.  Pololi and colleagues' qualitative interviews of young medical faculty included anecdotes of angst due to academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain.(2)   (Also, see our comments on this paper)(3)  Pololi and colleagues' large survey of US medical faculty showed that over half were being pressured to put revenue generation for the organization ahead of all else, including their professional values.(4)

Many attempts to influence health care professionals used financial incentives that generated conflicts of interests.  Some rose to the level of kickbacks or bribery.  On the other hand, some used threats, including intimidation and extortion.  In nearly all the cases the physicians were pushed towards behavior that would help out large organizations and those who lead them, including hospitals and hospital systems, insurance companies, and drug, device and biotechnology companies.

However this week we heard two instances involving attempts to influence one physician that seemed to come from an alternate universe.

Donald Trump Dictated the Content of a Letter His Physician Signed, Describing Trump's Health in Glowing Terms

First on May 1, 2018, NBC reported, and then CNN reported on May 2, 2018 that a well publicized letter Donald Trump's former private physician,  Dr Harold Bornstein, signed in 2015 about Trump's health was in fact written by Mr Trump.  To quote CNN,

When Dr. Harold Bornstein described in hyperbolic prose then-candidate Donald Trump's health in 2015, the language he used was eerily similar to the style preferred by his patient.

It turns out the patient himself wrote it, according to Bornstein.

'He dictated that whole letter. I didn't write that letter,' Bornstein told CNN on Tuesday. 'I just made it up as I went along.'

Bornstein's signature on a letter whose content was largely dictated by Trump was obviously  deceptive and unethical, and possibly illegal.  A brief article in RawStory quoted President Obama's former physician.

CNN anchor Erin Burnett asked. 'And is there any issue you have ethically with this, that Trump dictated it and the doctor would sign it?'

'Yeah, if the doctor signed it and it’s not his medical report, it’s fraudulent,' Dr. [David] Scheiner explained.

An article in Fortune quoted a physician who believes Dr Bornstein's actions were medical misconduct.

Dr. Anirban Maitra, an oncologist at the MD Anderson Cancer Center in Houston, pointed out on Twitter that Bornstein’s admission about the dictated doctor note could amount to misconduct under New York law. 'Permitting, aiding, or abetting an unlicensed person to perform activities requiring a license' is indeed listed under the state’s Office of the Professions definitions of professional misconduct by doctors.

This raises a big question.  Why did Dr Bornstein do something so patently dishonest?  Nothing published so far establishes an answer.  IMHO, it does not seem unreasonable to suppose that he was intimidated by Mr Trump, a billionaire known to use aggressive and well-funded legal tactics against anyone who opposed him.  The second part of Dr Bornstein's story corroborates the intimidation scenario.

Trump Organization Functionaries Confiscated All Copies of President Trump's Medical Records

NBC also reported on May 1, 2018, that President Trump sent minions, including two lawyers from the Trump Organization, and his former personal bodyguard, to Dr Bornstein's office to confiscate all the records Dr Bornstein had for Trump

In February 2017, a top White House aide who was Trump's longtime personal bodyguard, along with the top lawyer at the Trump Organization and a third man, showed up at the office of Trump's New York doctor without notice and took all the president's medical records.

The incident, which Dr. Harold Bornstein described as a 'raid,' took place two days after Bornstein told a newspaper that he had prescribed a hair growth medicine for the president for years.

In an exclusive interview in his Park Avenue office, Bornstein told NBC News that he felt 'raped, frightened and sad' when Keith Schiller and another 'large man' came to his office to collect the president's records on the morning of Feb. 3, 2017. At the time, Schiller, who had long worked as Trump's bodyguard, was serving as director of Oval Office operations at the White House.

Yet,

Bornstein said he was not given a form authorizing the release of the records and signed by the president known as a HIPAA release — which is a violation of patient privacy law.

Also,

Bornstein said the original and only copy of Trump's charts, including lab reports under Trump's name as well as under the pseudonyms his office used for Trump, were taken.

Another man, Trump Organization chief legal officer Alan Garten, joined Schiller's team at Bornstein's office....

An AP story explained why it may have been unethical, or illegal, for Dr Bornstein to hand over the records in these circumstances.

Patients have a right to a copy of their medical records but the original physical record belongs to the doctor, said Dr. Matthew Wynia, director of the Center for Bioethics and Humanities at the University of Colorado.

'If a patient wants a copy, they can have a copy, but they don't get the original. Patients can also ask for their records to be transferred to a new doctor, but that also involves making copies (i.e., transferring the information), not literally packaging up the originals and sending them off,' Wynia said in an email.

Most states require doctors to keep and maintain records, Wynia said. Federal patient privacy law bars doctors from relinquishing records without a signed release from the patient or an authorized representative.

Nonetheless, per NBC

White House Press Secretary Sarah Huckabee Sanders said that taking possession of medical records was 'standard operating procedure for a new president' and that it was not accurate to characterize what happened as a "raid."

'Those records were being transferred over to the White House Medical Unit, as requested,' said Sanders.

In my humble opinion, third parties confiscating all copies of a patient's records from a physician's office, whether or not at the behest of the patient, is the opposite of standard operating procedure.

Again, in this case, Dr Bornstein appears to have violated HIPAA regulations, and probably New York State law on the integrity of medical records.  However, it also appears that he did so under duress from three men, two of which he described as "large," presumably meaning physically intimidating, and two of which were top lawyers for the Trump Organization.   

Why Mr then President Trump was so intent on covering up his medical records is yet another queston about which speculation seems fruitless at this point.

Discussion

As noted above, we have seen many cases in which health care professionals were pressured to violate their core values and ethical norms by outside parties, most often large health care organizations seeking financial gain.

Now, in this new case, we see a single health care professional twice pressured to violate core values and ethical norms by a patient, a wealthy billionaire corporate CEO who became President of the United States.  Thus we are now in a situation in which the President of the US, to whom all federal health care regulatory and law enforcement agencies at least nominally report, has shown contempt for the core values and ethical standards of the medical profession.

This lowers whatever minimal expectations we might have had that the US government might help health care professionals defend their values and ethics.  However vulnerable health care professionals used to feel to outside pressure from large private organizations, they now must feel much more vulnerable.

We used to rant that health care professionals' values and ethics needed better defense, and that the government should be urged to take a greater role in providing it.  Now the government under Trump seems to be raising the threat level to health care professionals.  True health care reform now seems to require not just changes in government processes and attitudes, but a new person to sit at the head of government.


References

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

2.Pololi L, Kern DE, Carr P, et al. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link here.
3.  Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link .
4. Pololi L, Ash A, Krupat E. Faculty values in the culture of academic medicine: findings of a national faculty survey. Link here
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Here we go again.  As we  We have frequently discussed how health care leadership is often ill-informed ( look here).  More and more people leading non-profit, for-profit and government health care organizations have had no training or experience in actually caring for patients, or in biomedical, clinical or public health research.  Obviously health care and health policy decisions made by ill-informed people could have detrimental effects on patients' and the public's health.

Through 2016, our examples of ill-informed leadership in health care tended to be executives of hospital systems (e..g.,in 2014, here, on the mishandling of a patient with Ebola in a hospital system led by generic managers; and in 2013, here, on a luxurious hospital led by a former hotel executive).  Others were top executives of pharmaceutical corporations (e.g., in 2011, here, on previous Pfizer CEOs).

Now, however, the most ill-informed people in health care leadership seem to be running US government health related agencies.  Worse, the latest examples we have found also appear to be mission-hostile leaders.

Ximena Barreto, Deputy Director Of Communications, Office Of The Assistant Secretary For Public Affairs,, Department of Health and Human Services (DHHS)

Ms Barreto's new position was first discussed in an article in Media Matters on April 9, 2018.  The article described her background:

Barreto (who also goes by the surname Barreto-Rice) was a right-wing pundit who used the screen name 'RepublicanChick' on her personal website and social media. She regularly posted commentary on Periscope and briefly co-hosted a YouTube show called The Right View by Deplorable Latinas. She also said she helped Trump’s California efforts during the 2016 election.

I can find nothing to indicate she has any background or expertise in biomedical science, health care, or public health.

Note that the mission of DHHS currently is:

to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

Yet according to Media Matters, Ms Barreto did not appear to be committed to the health and well-being of all Americans.

As a fringe right-wing political commentator, Ximena Barreto claimed that 'African-Americans are way more racist than white people,' labeled Islam 'a f*** cult' that has 'no place' in the United States,... and attacked the 'retarded' 2017 Women’s March.

In particular,

In her November 30, 2016, Periscope video (starts roughly 8:00 into the video), during a discussion about 'f*** reverse racism,' Barreto said: 'African-Americans are way more racist than white people.'

She continued shortly after: 'I’ve been attacked by more African-Americans on Twitter than white people, in all honesty. … They’re the most racist people I ever met.' She then said that she’s been insulted and called slurs by African-Americans.

Also,

During her November 30, 2016, Periscope, Barreto said (starts roughly 7:26 into the video) that Islam advocates for 'killing other people and abusing women; that’s not a religion, that’s a f*** cult. Like, I’m serious. Like, that’s not religion.' She also said during a June 12 video that Islam is 'just a cult. All the practices are cult-like, all that they do.'

In a May 25 post on the now-defunct website Borderland Alternative Media, she suggested that practicing Islam should not be allowed in the United States.

She also expressed sentiments that suggested she was not comfortable with the reality-based approach of the "sciences underlying medicine, public health, and social services."

Barreto has repeatedly pushed the false Pizzagate conspiracy theory that claimed prominent political figures were trafficking children through a Washington, D.C., pizza restaurant. She tweeted in November 2016 that efforts by supporters of former Democratic presidential candidate Hillary Clinton to trigger a recount were 'a hoax so we get distracted from #PizzaGate.'

She appeared in a November 30, 2016, Periscope video in which she also said (starts roughly 1:45 into the video) the presidential recount effort is an attempt to distract people 'from Pizzagate.' She later claimed that former Republican presidential candidate Mitt Romney is also tied to Pizzagate. 'A lot of people are connected to it,' she remarked.

Near the end of the video, Barreto told viewers: 'Don’t listen to the recount and relax. We’ve got to use all of our efforts into Pizzagate and not let that one die because that’s what the mainstream media is trying to get distracted from. So check all the Pizzagate stuff.'

Furthermore, additional investigations by CNN revealed

In May of 2017, Barreto retweeted an image saying the 'our forefathers would have hung' Clinton and Obama for treason. In August of 2017 Barreto retweeted an image of a statue of Obama labeling him 'a Muslim terrorist.' In January of 2017, Barreto wrote in a tweet that Obama was a 'pansy and a traitor.'

The Hill reported on  April 9, 2018, that Ms Barreto was placed on leave.  Her online comments have apparently been erased.


So while Ms Barreto was hired in a top communications role for DHHS, which is supposed to improve the health of all Americans, she previously displayed virulent prejudice against African-Americans and Muslims.  Also, DHHS is supposed to uphold evidence- and science-based health care, public health and social services, but Ms Barreto has promoted grossly false conspiracy theories.

She seems to be uniquely unqualified for her leadership position in DHHS.  In fact, she seems like one of the last people one should consider for such a position.  Worse, since she also appears to have no background or experience in communications, public relations, or journalism, it appears that there was no obvious reason to hire her other than her reputation for taking extreme positions on social media. 

Roger Severino, Director, Office for Civil Rights (OCR), DHHS

Shannon Royce,  Director of the Center for Faith-based and Neighborhood Partnerships at the U.S. Department of Health and Human Services

Mr Severino and Ms Royce work together (see below) and so will be discussed together

According to his official DHHS biography,

Mr. Severino served as Director of the DeVos Center for Religion and Civil Society in the Institute for Family, Community, and Opportunity at The Heritage Foundation.

Before joining Heritage in 2015, Mr. Severino was a trial attorney for seven years in the Department of Justice’s Civil Rights Division....

Mr. Severino was previously chief operations officer and legal counsel for the Becket Fund for Religious Liberty.

Mr. Severino holds a J.D. from Harvard Law School, received a master’s degree in public policy, with highest distinction, from Carnegie Mellon University, and has a bachelor’s degree in business from the University of Southern California.

According to her official biography, Ms Royce

worked for over seven years on Capitol Hill, including serving as Counsel to Senator Chuck Grassley (now Chairman of Senate Judiciary Committee).

In the private sector, Shannon worked in several faith-based non-profits. Early on, she led the D.C. office of the Ethics & Religious Liberty Commission (ERLC), a group focused on issues such as sex trafficking, global hunger, and protecting religious liberty. Most recently, Shannon served as Chief of Staff and C.O.O. at the Family Research Council (FRC)....

Again, neither Mr Severino or Ms Royce have any background or expertise in biomedical science, health care, or public health.

According to a Politico article from January, 2018, they are

politically prominent religious activists inside the Department of Health and Human Services have spent months quietly planning how to weaken federal protections for abortion and transgender care....

Mr Severino in his capacity with the OCR

laid out new protections allowing health care workers with religious or moral objections to abortion and other procedures to opt out. Shannon Royce, the agency's key liaison with religious and grass-roots organizations, has also emerged as a pivotal player.

As we discussed in January, 2018, the OCR is part of an effort officially aimed at protecting doctors, nurses and other health-care workers who decline to participate in care that goes against their moral or religious convictions.  At that time we raised the probably naive hope that this would particularly help health professionals who felt pushed to participate in unethical and illegal activities like conflicts of interest, outright crime, such as fraud, bribery or kickbacks, or other criminal or corrupt practices to which they had moral objections.  That was not to be.

Instead, as Politico suggested in January, the aim was to support people who believe abortion, favorable treatment of LGBT people, even contraception are morally wrong.  In particular, Mr Severino and Ms Royce have
- "selectively post[ed] public comments that were overwhelmingly anti-abortion"
- started a "vast outreach to religious groups," apparently limited to those who agree with the moral positions above
- kept secret "decisions about controversial issues like abortion, contraception and transgender care"

At one point, speaking to a sympathetic religious audience, Ms Royce acknowledged the purpose of their actions,

Royce said last Thursday, appearing at the anti-abortion conference. 'We have such an amazing team at HHS that is absolutely a pro-life team across the spectrum.'

And,

'You will see exciting things in the coming days, and that's all I can say right now. But good stuff is coming,' Royce promised attendees at last Thursday's anti-abortion conference.

Politico noted that people and groups who have religous beliefs compatible with those of Severino and Royce voiced their approval of these policies.

'To have leaders like Roger, like Shannon, it’s so important," said Deanna Wallace of Americans United for Life, an anti-abortion group that was frequently at odds with the Obama administration. 'It’s extremely encouraging to have HHS on our side this time.'

Also,

'You're over at HHS, a true bright spot in this administration when it comes to protection of life and protection of conscience,' a moderator at the Evangelicals for Life conference said when introducing Royce last Thursday. 'It's no exaggeration to say that you guys have just had a monster year over at HHS.'

Again, note that the purpose of the OCR on paper was to allow health care professionals to avoid being forced to take actions which they found morally objectionable for whatever reasons, not just to cater to people who are against abortion for religious reasons. 

However, Politico quoted a variety of experts who underlined that the work by Severino and Royce amounted to favoring particular religious beliefs and the people who hold them.

'It’s supposed to be the faith-based partnership center, not the Christian-based partnership center,' said a longtime HHS staffer, referencing the HHS Center for Faith-Based and Neighborhood Partnerships led by Royce.

Also,

'This administration is focused on recognizing one set of religious beliefs,' said Gretchen Borchelt of the National Women’s Law Center. 'It’s going to do whatever it can to reshape or violate the law to do that.'

A follow-up article by Kaiser Health News in March emphasized how fundamentally hostile the activities of Severino and Royce are to the DHHS mission, quoting

Mary Alice Carter, executive director of a new watchdog group called Equity Forward. 'But the core issue here is we have individuals coming in who fundamentally don’t believe in the very mission they’re serving.'

'They are coming in with the agenda of burning it down,' she said.

Nonetheless, these efforts are gathering momentum and spreading throughout the Trump regime.  An article in Buzzfeed on April 17, reported that an the annual UN Commission on the Status of Women meeting,

Bethany Kozma — a senior adviser for gender equality and women’s empowerment at the US Agency for International Development (USAID) and anti-transgender activist — emphasized that the US was a 'pro-life nation,'

Summary

We have noted, most recently here, how the current Trump administration has been appointing many people without any qualifications in biomedical science, health care, or public health to leadership positions in health and public health agencies.  Obviously health care and health policy decisions made by ill-informed people coule have detrimental effects on patients' and the public's health.

Worse, it now seems that some ill-informed appointments have more nefarious purposes, including the subversion of the mission of these health related agencies.  The group of leaders discussed above seem to be hostile to the notion that health care and public health should serve all people, regardless of their religious beliefs, race, ethnicity, or sex.

Furthermore, they seem to be undermining fundamental principles of US government enshrined in the Constitution, including prohibiting the government from establishing a religion or preventing the free expression of any religion, and equal application of the laws and provision of due process to all people, again regardless of their religious beliefs, race, ethnicity or sex.

We have been writing about health care dysfunction since 2003, and publishing this blog since 2004.  A major concern all along has been how threats to health care professionals' core values generate  health care dysfunction.  Up through 2016, these threats came principally from large private health care organizations.  While the US government was not always as good at defending these values as it could have been, at least it rarely presented its own set of active threats.  Under Trump, that situation has been changing for the worse.  This is obviously hugely dangerous, (and made more so by the regime's threats to other core values of US society, to US law, and the US Constitution.)

To prevent the decline and fall of US health care, and maybe the entire US experiment in representative democracy, health care professionals, academics, patients and citizens concerned about health care will have to join up with the larger populace to defend our core values while they still have any force.   
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We continue to see a remarkable stream of people transiting the revolving door from high-level positions in health care corporations to high-level positions in health care policy or regulation for the Trump administration.  Lately, though, these transitions have not been without missteps. 



The most recent cases we have found, in the order of their public appearance, appear below.


John Bardis, Who Went from MedAssets to Assistant Secretary of Health and Human Services for Administration, Resigned Under Fire

We first discussed the appointment of Mr Bardis in May, 2017, here.  We noted then that most recently Mr Bardis was the CEO of a health care financial firm and thus was responsible for that company's financial fortunes.  While he has previous experience running other health care related companies, he seemed to have no direct experience in health care or public health, per his official biography.

On March 22, 2018, Politico reported

John Bardis, a top HHS official who signed off on ex-Secretary Tom Price's charter jet flights, is resigning effective April 6, the agency confirmed Thursday.

The health care entrepreneur and longtime friend of Price's from Georgia served as HHS assistant secretary of administration since March 2017 and was responsible for departmental operations. He also helped oversee the ReImagine HHS project, an initiative to overhaul the agency and cut costs.

Bardis' office has been the focus of a probe about whether Price's use of charter-jet flights for routine domestic travel — which cost more than $400,000 — complied with federal regulations. The HHS inspector general's office, which is conducting the probe, told POLITICO that the final report is expected later this spring.

Note that the resignation under fire of  Dr Tom Price, Trump's first Secretary of the Department of Health and Human Services (DHHS) after accusations of conflicts of interest and abuse of his office was a signal example of major issues affecting the leadership of health care and public health agencies in the Trump administration. We had written about some of Dr Price's less well publicized conflicts of interests and questionable conduct before we was appointed Secretary of DHHS, here, and here.

Now a good buddy of Price's, who also had a severe conflict of interest, has come a cropper.


Daniel Best from Corporate Vice President of Industry Relations at CVS Health, and from Pfizer Before Then, to Senior Adviser to the Secretary of DHHS for Drug Pricing Reform

This transition was described in some detail in FierceHealthCare on March 29, 2018:

Daniel M. Best, the former corporate vice president of industry relations for CVS Health’s Medicare Part D business, will serve as senior adviser to the secretary for drug pricing reform.

Given,

The Trump administration has outlined a number of policy changes it believes can drive down drug prices, and the president predicted during his State of the Union address that drug costs 'will come down substantially.' But skeptics argue that some of those changes—like making generic drugs free for Medicare patients, or moving expensive drug coverage out of Part D plans—would merely shift the cost and raise premiums.

Best, who will help oversee some of those efforts, worked at Pfizer for 12 years prior to his time at CVS. HHS highlighted his expertise in the pharmaceutical industry generally, and his familiarity with Medicare Part D specifically, as critical to the task of trying to reduce prescription drug costs.

However, this appointment rapidly generated some public political push-back because of its revolving door nature.  As reported by Vox on April 9, 2018,

Rep. Keith Ellison (D-MN), one of the top progressives in the House and deputy chair of the Democratic National Committee, sent a letter Monday to HHS Secretary Alex Azar inquiring about the appointment of Daniel Best to oversee drug pricing reform. Best most recently worked at CVS CareMark before starting at HHS last week. He also worked at Pfizer for four years in the early 2000s.

'Given Mr. Best’s career working for the pharmaceutical and pharmacy industry, the decision to hire him poses significant potential for conflicts of interest, placing him in a position to make decisions that may pit the income of his former employers against the interests of patients in reducing prescription drug prices,' Ellison said in the letter, shared exclusively with Vox.

Ellison flagged past drug price hikes at Pfizer and a lawsuit filed against CVS CareMark by HIV patients over access to drugs. In general, pharmacy benefits managers are under the microscope of both parties these days for their role as mysterious administrators with great power over drug transactions.

The Congress member includes a string of questions about who was involved in hiring Best, whether outside groups (particularly pharmaceutical lobbying groups) were consulted, and how Best will prevent any potential conflicts of interest from getting in the way of his job description.
So this case of the revolving door has not gone without (negative) notice, although whether that will be sufficient to change anything remains to be seen.

Note that public biographical information on Mr Best seems to be scanty, but there is nothing to indicate that he has  training, experience, or expertise in biomedical science, health care, or public health.


Adam Boehler from CEO of Landmark Health, Previously Founder of Avalon Healthcare Solutions and Trellis Rx, and Operating Partner of Private Equity Company Francisco Partners, to Director of Center for Medicare and Medicaid Services (CMS) Innovation Center (CMMI)

As reported, again by FierceHealthCare, this time on April 6, 2018,

Health and Human Services Secretary Alex Azar has named a successful healthcare entrepreneur to lead the Centers for Medicare & Medicaid Services Innovation Center.

Adam Boehler, the founder and former CEO of Landmark Health, will join the department next week as the deputy administrator and director of the center. Landmark is a medical group that uses a technology platform to deliver medical services to complex and chronically ill patients at home.

The article also documented that:

He is also the founder of Avalon Healthcare Solutions, a company which provides lab benefit management services, and Trellis Rx, a company that partners with health systems to fund, build and operate specialty pharmacies. Boehler was formerly an operating partner at Francisco Partners, a global private equity firm focused on healthcare technology and services investing.

According to Bloomberg, Mr Boehler has extensive background in the financial sector:

Mr. Adam Boehler serves as Executive Chairman at Avalon Health Management LLC and Avalon Health Services, LLC. Mr. Boehler served as Principal at Accretive, LLC. He served as Vice President of Business Development at MedeAnalytics, Inc. since July 2005. Mr. Boehler joined MedeAnalytics, Inc. in February 2005 and was responsible for all hospital sales, product marketing, and business development. He also drove several major product solutions from concept to customer sale and established MedeFinance’s international business in London. Prior to joining MedeAnalytics, Inc. (formerly MedeFinance), Mr. Boehler was an Associate at Battery Ventures. While at Battery, he focused on investments in software and emerging technologies. Previously, Mr. Boehler was an investment banker at Wasserstein Perella in their media, telecommunications, and technology group, where he worked on merger and acquisition transactions with leading companies such as News Corp., Imax, and SpectraSite Holdings. In addition, he spent time as a public finance consultant for the Financial and Fiscal Commission in South Africa, where Mr. Boehler focused on provincial revenue issues

His educational background was:

Mr. Boehler graduated magna cum laude from the Wharton School at the University of Pennsylvania.

So he also seems to have no training, experience, or expertise in biomedical science, health care, or public health.

Dr Kenneth William Staley from Consultant for McKinsey to Coordinator of US Government Activities to Combat Malaria

The information made public about this appointment was extremely sparse, e.g., see this brief item from the Kaiser Family Foundation on April 10, 2018, in its entirety:

President Donald J. Trump Announces Intent to Appoint Personnel to Key Administration Posts On Monday, President Trump announced his intent to appoint several individuals to key positions in the administration, including Kenneth William Staley, a consultant at McKinsey, to the position of Coordinator of U.S. Government Activities to Combat Malaria Globally (4/9).

At least he actually is Dr Staley, according to the US Department of State website.  

Acting Deputy Assistant Secretary for Counterproliferation in the Department of State’s Bureau of International Security and Nonproliferation. His portfolio includes preventing the smuggling of weapons of mass destruction (WMD), international threat reduction, nuclear nonproliferation policies, tracking, controlling, and securing dangerous chemical and biological material, multilateral arms control, nonproliferation, WMD terrorism, disarmament issues, and responsible use of chemical and biological sciences.

Previously, Dr. Staley served as Director for Biodefense Policy at the White House Homeland Security Council, where he coordinated implementation of the National Strategy for Pandemic Influenza and the development of policies related to biodefense and the medical consequences of weapons of mass destruction.

So he does have a substantial clinical and public health background relevant to his appointment.

Summary

We have long chronicled cases in which people leave government leadership positions having to do with medical science, health, health care and public health and soon wind up working for corporations regulated or affected by the policies of these government agencies.  These were examples of the outgoing revolving door.  Such transitions raise worries that people in government might behave in ways that increase their attractiveness for such jobs when they leave.

However, in the Trump regime, we have seen a new a even more pernicious species of the revolving door, transitions from leadership positions in or lobbying/ advocacy positions for health care corporations directly into positions in government agencies that regulate or whose policies influence those selfsame corporations.

So, as I have said before, e.g., one month ago,

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 from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still 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.
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We have often cited bad leadership and governance of health care organizations as a major causes of health care dysfunction.  In particular, we have discussed how leadership is often ill-informed.  More and more people leading non-profit, for-profit and government health care organizations have had no training or experience in actually caring for patients, or in biomedical, clinical or public health research.  Obviously health care and health policy decisions made by ill-informed people are likely to have detrimental effects on patients' and the public's health.

One reason for ill-informed leadership is the doctrine of managerialism promoted in business schools.  This proclaims that people trained in business management should lead every type of human organization and endeavor.  According to this doctrine, there is no need for leadership by people from the disciplines most relevant to the mission and nature of particular organizations.  So, for example, generic business managers, not doctors, nurses or other health professionals should lead hospitals. Likewise, business managers should make health policy, rather than health care professionals, public health, or health policy experts.

Through 2016, our examples of ill-informed leadership in health care tended to be executives of hospital systems (e..g.,in 2014, here, on the mishandling of a patient with Ebola in a hospital system led by generic managers; and in 2013, here, on a luxurious hospital led by a former hotel executive).  Others were top executives of pharmaceutical corporations (e.g., in 2011, here, on previous Pfizer CEOs).

Now, however, the most ill-informed people in health care leadership seem to be running US government health related agencies.  Here are our latest examples, presented in order of initial reports found in the news media...

Charmaine Yoest, Assistant Secretary of Public Affairs, Department of Health and Human Services

Per NBC News, April 29, 2017

The White House says President Donald Trump is appointing the former president of a leading anti-abortion organization to a senior position at the Department of Health and Human Services.

Charmaine Yoest, who actively supported Trump in his campaign, will serve as assistant secretary of public affairs at HHS. From 2008 until February 2016, she was president of Americans United for Life, which campaigned at the federal and state level for tough restrictions on abortion.

Formerly,

Yoest began her career serving under Ronald Reagan in the Office of Presidential Personnel and was an adviser to former Arkansas Gov. Mike Huckabee's 2008 presidential campaign. Most recently she has served as a senior fellow at American Values, a conservative group in Washington.

I can find nothing to indicate she has any background or expertise in biomedical science, health care, or public health.

Note that according to StatNews, in February, 2018 she left her DHHS position, but only to go onto another health related position, at the Office of National Drug Control Policy.

Kellyanne Conway, White House Opioids "Czar"

As first reported by Newsweek, November 29, 2017,

White House counselor Kellyanne Conway will be the point person for the Trump administration's opioid crisis efforts, U.S. Attorney Jeff Sessions announced Wednesday.

President Donald Trump tapped Conway to help 'change the perception' about opioids and reduce addictions and deaths, Sessions said at a press briefing about the Justice Department’s efforts to combat the crisis. Sessions said Trump had made the epidemic 'a top priority for his administration, including every senior official and Cabinet member.'

Conway worked as a pollster before becoming Trump's campaign manager, and she now serves as a White House spokeswoman and Trump surrogate.

Also,

She has no formal experience in drug policy or law enforcement. Conway has a law degree and started her own polling company, The Polling Company, in 1995, often consulting on consumer trends. She worked as an adviser for several Republicans, including Mike Pence and Newt Gingrich.


An article in the Atlantic noted,

In the past, these czars have been selected for one of two principal reasons: outstanding knowledge of the underlying policy issues or shrewd understanding of the bureaucratic processes of government.

However,

Kellyanne Conway is neither of those things, obviously enough. A pollster before she joined the Trump campaign, she has emerged there as its most brazen and shameless cable-TV talker.

In addition, the Newsweek article stated,

She has become notorious for defending some of Trump's most blatant mistruths, and she pioneered the term 'alternative facts' to excuse the president's troubles with the truth.

One might hope that someone involved in policy regarding drug abuse would have at least some understanding of evidence-based health policy assessment.  However, Ms Conway's promotion of "alternative facts" suggest outright hostility to the such assessment, and even to the idea of the existence of an objective reality, at least to the extent such a rejection serves political purposes.

In addition, a Politico article from February, 2018, suggested that in her capacity as opioids "czar," Ms Conway has operationalized her hostility to facts and logic in policy making in favor of political advantage and ideology,

White House counselor Kellyanne Conway has taken control of the opioids agenda, quietly freezing out drug policy professionals and relying instead on political staff to address a lethal crisis claiming about 175 lives a day.

By the way, while opioids "czar," Ms Conway has combined her hostility to evidence-based policy-making with contempt for ethical standards.  As reported by US News and World Report in March, 2018,

The U.S. Office of Special Counsel (not to be confused with the office of Special Counsel Robert Mueller) issued a report Tuesday calling for 'disciplinary action' against Conway for 'impermissibly mix[ing] official government business with political views about candidates in the Alabama special [Senate] election' which took place in December. Under the Hatch Act, federal employees are prohibited from engaging in political activities from their official positions, but Conway did just that, according to Special Counsel Henry Kerner, going out of her way to attack Democratic senatorial candidate (and ultimate victor) Doug Jones twice in television interviews in the run-up to the election.

Robert Weaver, Nominated to Direct the Indian Health Service

Mr Weaver's background and qualifications actually is in considerable doubt.  As reported first by CNBC on January 5, 2018,

President Donald Trump's pick to head the nation's Indian Health Service was hit by a bombshell report Friday that suggested he misrepresented his prior work experience to a Senate committee.

And a senator on that committee said later Friday that the story about Trump nominee Robert Weaver has raised 'very serious concerns' that he now wants answers to.

The Wall Street Journal quoted multiple former workers at what was once known as St. John's Regional Medical Center in Joplin, Missouri, who called into question Weaver's claims to the Senate Indian Affairs Committee that he had worked in supervisory and management positions at that hospital.

Weaver, 39, worked at St. John's from 1997 to 2006, according to his resume. His nomination to run the federal agency that provides health services to American Indians and Alaska Natives is pending before the Senate.

'I don't recall that name whatsoever,' Augusto Noronha, the hospital's chief financial officer from 1999 through 2005, told the Journal when asked about Weaver.

A former controller of the hospital told the newspaper, 'I've never heard that name before.'
Another executive said he remembered 'a subordinate named Rob Weaver who registered E.R. patients, gathered insurance information and collected copays, and who eventually supervised a few other patient-registration workers,' according to the Journal.

Weaver eventually declined the nomination, and then wrote a defense of his record in the Washington Examiner in March, 2018. There he stated,

I’ve spent the last decade of my life starting and operating successful businesses and creating jobs in Indian country that improve native peoples’ access to healthcare.

He acknowledged that he never completed college, and described his hospital work experience as purely administrative,

as an entry-level weekend admissions clerk. I then became patient access coordinator in 1999.

Thus he also had no training or experience in actually caring for patients, or in biomedical, clinical or public health research.

Teresa Manning, Deputy Assistant Secretary for Population Affairs, DHHS

I first learned about Ms Manning on the occasion of her resignation, as reported by the Washington Post on January 13, 2018, she

spent much of her career fighting abortion and has publicly questioned the efficacy of several popular contraception methods.

She

formerly lobbied for the National Right to Life Committee and worked as a legislative analyst for the Family Research Council.

She was notable for her skepticism that contraception even works,

she also has expressed deep skepticism of birth control overall, suggesting in a 2003 interview with NPR that 'contraception doesn’t work.'

I also can find no evidence that he has training or experience in actually caring for patients, or in biomedical, clinical or public health research.

Taylor Weyeneth, Deputy Chief of Staff, Office of National Drug Control Policy

as reported on January 14, 2018 by the Washington Post,

In May 2016, Taylor Weyeneth was an undergraduate at St. John’s University in New York, a legal studies student and fraternity member who organized a golf tournament and other events to raise money for veterans and their families.

Less than a year later, at 23, Weyeneth, was a political appointee and rising star at the Office of National Drug Control Policy, the White House office responsible for coordinating the federal government’s multibillion dollar anti-drug initiatives and supporting President Trump’s efforts to curb the opioid epidemic. Weyeneth would soon become deputy chief of staff.

Also,

Weyeneth’s only professional experience after college and before becoming an appointee was working on Trump’s presidential campaign.

He did have some sketchy job experience while he was in ... high school

Weyeneth was 'Director of Production' for Nature’s Chemistry, a family firm in Skaneateles, N.Y., that specialized in processing chia seeds and other health products. One résumé said he served in that job from 2008 to 2013, and two others indicate he stopped working there in September 2011.

In the summer and fall of 2011, the firm was secretly processing illegal steroids from China as part of a conspiracy involving people from Virginia, California and elsewhere in the United States and one person in China, federal court records show. Weyeneth’s stepfather, Matthew Greacen, pleaded guilty to a felony conspiracy charge last year and received two years probation and a fine.

Weyeneth was not charged in the investigation, known as Operation Grasshopper.

Then a subsequent Washington Post story raised further questions about his rudimentary employment history,

A former Trump campaign worker appointed at age 23 to a top position in the White House’s drug policy office had been let go from a job at a law firm because he repeatedly missed work, a partner at the firm said.

While in college, late in 2014 or early in 2015, Taylor Weyeneth began working as a legal assistant at the New York firm O’Dwyer & Bernstien. He was 'discharged' in August 2015, partner Brian O’Dwyer said in an interview.

'We were very disappointed in what happened,' O’Dwyer said. He said that he hired Weyeneth in part because both men were involved in the same fraternity, and that the firm invested time training him for what was expected to be a longer relationship. Instead, he said, Weyeneth 'just didn’t show.'

By then he had the distinction of being called "an emblem of the White House's recklessness,"  in an op-ed by Kathleen Parker.  He was gone from this job in a few days, only to end up as "a mid-level official in the Office of Community Planning and Development in the Department of Housing and Urban Development (see Politico), but at least will seemingly have nothing to do with health care or public health.   

Jim Carroll, Deputy Chief of Staff, Office of National Drug Control Policy

After the resignation of Mr Weyeneth, the administration came up with a nominee to run the Office of National Drug Control Policy, a position that was vacant while Mr Weyeneth was there, as reported by the Associated Press on February 9, 2018,

President Donald Trump has tapped deputy White House chief of staff Jim Carroll to serve as the administration's next drug czar.

Carroll's position as head of the Office of National Drug Control Policy will make him the most public face of the administration's efforts to fight the opioid epidemic — an effort critics say hasn't gone nearly far enough.

But,

Carroll does not appear to have any public health experience. He worked for the Ford Motor Company before joining the administration and also worked for the Justice and Treasury departments.

But the White House said that after law school, Carroll spent five years as the assistant commonwealth attorney for Fairfax, Virginia, where the majority of the cases were drug-related and he worked directly with those affected by drug abuse.

He also worked with attorneys facing substance abuse issues at the Virginia State Bar.

He may have worked with substance abuse issues from a legal standpoint, as a lawyer, but again he has no  training or experience in actually caring for patients, or in biomedical, clinical or public health research.

Discussion

 Again, it stands to reason that people entrusted with running US government health care, public health and health policy should have some level of knowledge of biomedical science, health care, public health and/or health policy.  I dimly remember that before the Trump administration, many such leaders did have such background.  Not any more.

This is only the latest examples of amazingly ill-informed people taking important responsibilities in government agencies having to do with health care, public health, and/or health policy.  Remember the brew-master with power over major policies in the Veterans Administration having to do with the huge VA health system (look here); or the White House economic adviser who did not seem to understand what health insurance does (look here); the Director of the Office of Management and the Budget who said people who make bad dietary choices do not deserve health insurance (look here)? and then there were all the appointments to health care related leadership positions of people whose main qualification seemed to be they would come through the revolving door after being lobbyists for health care corporations, e.g., look here

How are we to survive these times?  We need health policy leadership that is well-informed, understands the health care mission, avoids self-interest and conflicts of interest, and is accountable, ethical and honest.   (Of course, we have often said we need leadership of health care organizations with these characteristics.)  Right now, we are not coming close.  Preventing even worse health care dysfunction would seem to require wholesale replacement of the current US executive branch leadership that has influence on health care.
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What follows is numero sesto if memory serves in a series of what gets one's dander up in this era of dysfunctional health care. Of course it seems these days our news in Health Care Renewal is so often all about focal dysfunction mirroring much broader problems governmental and societal dysfunction. It's in this context that I learned just now of the current VA Secretary's ouster while overseas in a country that does things in many ways much more effectively.

Today we blog about this one issue only. It seems to perfectly encapsulate the Reality Show-cum-wrestling match that our Republican leadership has morphed into. Oh, wait, maybe it didn't morph. It was always that way, perhaps, and people are just now twigging to that fact.

David Shulkin, the Emblematic Case. In this series I've written before about how Shulkin was undermined by his own communications people once those political-appointee ideologues smelled blood in the water over his perceived transgression--like many others'--in accepting gifts and padding overseas travel.

But how did those guys win? Shulkin resisted their efforts but ultimately they got to their boss, Donald Trump, anyway. After trying to out-wait Shulkin in hopes he'd not have to utter those infamous words "you're fired" to someone for whom he'd promised never to do that, Trump dropped the axe.

But to what end? Is our president so enamored of privatizing an improving VA health system that he'd go back on his word and risk the ire of so many vets? Make no mistake, a very large percentage of vets love their VA medical care. I worked in it myself, back in the day, and am acutely aware of its problems past present and future. But Shulkin was not only making it better, he was handing the president a lot of his most conspicuously successful legislative victories.

Nope, none of this explains it. There's only one thing that can. The burger-meister himself is rudderless. And his increasingly whacked-out toadies, the ones who know how to survive the snake-pit and play him, are successful at turning the boss against reasonable conservatives like Shulkin. What's so scary is that it's whimsical. Are we going to create a whole new gi-normous cadre of vets from World War III, this time not only with amputations but also radiation poisoning?

Oh, and one more thing. These political hacks now clearly believe every voter will, in perpetuity, continue implacably to believe in Ronald Reagan's dictum that government in never the solution, but always the problem. Hence, effectiveness in delivering health care on Shulkin's part is something that to them is at best a cognitive inconvenience, at best a full-on tautology: "good government health care" as oxymoron. Ultimately this flaw in reasoning and resulting inhumanity can only be solved at the ballot box. Are there enough vets out there whose dander is as far up as mine?

Addendum. Dr. Shulkin has gone public in an elegant op-ed pieces in his former boss's favorite newspaper, the New York Times. Most definitely worth a read.
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"Don't worry, things could be worse.  And sure enough, things got worse."

Disinformation in Medicine and Health Care

Stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies, have long been a subject of Health Care Renewal.  A relatively recently revealed example was the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This campaign included manipulating and suppressing clinical research, bribing physicians to prescribe the drug, use of key opinion leaders as disguised marketers, and manipulation of continuing medical education.  Other notable examples included Johnson and Johnson's campaign to sell Respirdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).   Notably, stealth marketing seemed to be one reason for the growing popularity of narcotics (opioids) starting in the 1990s (look here).

The organization and complexity of stealth marketing, lobbying and policy advocacy campaigns have often been sufficient to characterize them as disinformation.  For example, we characterized the campaign by commercial health insurance companies to derail the Clinton administration's attempt at health reform in the 1990s, as described by Wendell Potter in his book, Deadly Spin, as just that (look here).  The tactics employed in that campaign included: use of front groups and third parties (useful idiots?); use of spies; distractions to make important issues anechoic; message discipline; and entrapment (double-think).

Many of the stealth marketing campaigns we discussed came to light through regulatory and law enforcement action.  For example, the public was made aware of the GSK stealth marketing of Paxil due to Eliot Spitzer's prosecution in 2004 (documented in Side Effects by Alison Bass).  Ultimately, that campaign resulted in a settlement including a multi-billion dollar fine in 2012 (look here).

So we have long advocated better awareness of these insidious disinformation campaigns, and more vigorous regulatory and law-enforcement action against them.   Thus we were aghast in 2017 when a accomplished stealth  health care marketer transited the revolving door to wind up in a top federal position, on the President's Council of Economic Advisors (look here).

That was bad.  Worse, now it appears that the disinformers are in charge of all regulation and law-enforcement.

Disinformation at the Heart of the Current President's Election Campaign

Cambridge Analytica's Appropriated Facebook Data

Less than 10 days ago, the New York Times broke a complex story about the disinformation campaign at the heart of the Trump presidential campaign in 2016.  The campaign used

private information from the Facebook profiles of more than 50 million users without their permission, according to former Cambridge employees, associates and documents, making it one of the largest data leaks in the social network’s history. The breach allowed the company to exploit the private social media activity of a huge swath of the American electorate, developing techniques that underpinned its work on President Trump’s campaign in 2016.

Note that

The data Cambridge collected from profiles, a portion of which was viewed by The Times, included details on users’ identities, friend networks and 'likes.' Only a tiny fraction of the users had agreed to release their information to a third party.

Thus the campaign was based on inappropriately and unethically accessed, that is, hacked data from millions of people.  Such data hacking may prove to be illegal (see below). 

PsyOps

According to a companion article in the Guardian, Cambridge Analytica was linked to and its work based on that of a company called SCL Group,

one of whose subsidiaries, SCL Elections, would go on to create Cambridge Analytica (an incorporated venture between SCL Elections and Robert Mercer, funded by the latter). For all intents and purposes, SCL/Cambridge Analytica are one and the same.

Notably, SCL Group's

expertise was in 'psychological operations' – or psyops – changing people’s minds not through persuasion but through 'informational dominance', a set of techniques that includes rumour, disinformation and fake news.

Per the NY Times, Christopher Wylie, who blew the whistle on Cambridge Analytica et al,

said of its leaders: 'Rules don’t matter for them. For them, this is a war, and it’s all fair.'

'They want to fight a culture war in America,' he added. 'Cambridge Analytica was supposed to be the arsenal of weapons to fight that culture war.'
Per NPR, Wylie later told a UK parliamentary committee

Donald Trump makes it click in your head that this has a much wider impact. I don't think that military-style information operations is conducive for any democratic process.

Furthermore,

They don't care whether or not what they do is legal as long as it gets the job done
Thus it seems pretty clear that Cambridge Analytica/ SCL were in the disinformation business, and were happy to use various tactics, probably unethical and some likely illegal, to accomplish psychological operations to manipulate their subjects.

Overlaps with Trump Campaign

The company leveraged the unauthorized Facebook data:

Under the guidance of Brad Parscale, Mr. Trump’s digital director in 2016 and now the campaign manager for his 2020 re-election effort, Cambridge performed a variety of services, former campaign officials said. That included designing target audiences for digital ads and fund-raising appeals, modeling voter turnout, buying $5 million in television ads and determining where Mr. Trump should travel to best drum up support.

Note that Cambridge Analytica was run by some of Mr Trump's closest associates, including Steve Bannon, a Cambridge Analytica board member, who became Trump's third campaign director, and then a top White House strategic advisor, and Robert Mercer and his daughter Rebekah, investors and board members, who were notable Trump donors and gurus of related political causes. Although the firm first attached itself to the campaign of Ted Cruz, after that lost steam,  according to a Washington Post article

the Mercers switched their allegiance to Trump and pitched their services to Trump’s digital director, Brad Parscale. The company’s hiring was approved by Trump’s son-in-law, Jared Kushner, who was informally helping to manage the campaign with a focus on digital strategy.

Kushner said in an interview with Forbes magazine that the campaign 'found that Facebook and digital targeting were the most effective ways to reach the audiences. . . .We brought in Cambridge Analytica.' Kushner said he 'built;' a data hub for the campaign 'which nobody knew about, until towards the end.'
 Thus the Cambridge Analytica/ SCL disinformation campaign, built on hacked data, was done in the service of the Trump campaign, and with apparent full knowledge, acquiesecence, and sometimes active cooperation of top campaign leaders.  Mr Trump, of course, was ultimately responsible for the actions of his campaign, although none of the reporting so far speaks to his day-to-day participation in the Cambridge Analytica/ SCL disinformation campaign.


A Platform Built on Manipulated Emotion

It appears that the campaign used a variety of disinformation techniques.  It is striking that these techniques were ultimately used to push themes and policies that Cambridge Analytica/ SCL had developed prior to their involvement with Trump, not merely the themes and policies that Trump and his advisers had devised.  Furthermore, these  themes and policy positions later used by the Trump campaign were based not on ideology or policy research, but on the hidden fears and resentments of people assessed by Cambridge Analytica in its "psychographic" analysis campaign. Again, according to the Washington Post article,

The data and analyses that Cambridge Analytica generated in this time provided discoveries that would later form the emotionally charged core of Trump’s presidential platform, said Wylie, whose disclosures in news reports over the past several days have rocked both his onetime employer and Facebook.

'Trump wasn’t in our consciousness at that moment; this was well before he became a thing,' Wylie said. 'He wasn’t a client or anything.'

The year before Trump announced his presidential bid, the data firm already had found a high level of alienation among young, white Americans with a conservative bent.

Furthermore, a later Washington Post article stated,

Cambridge Analytica used that information, together with insights gained from focus groups with angry Americans, to identify issues and target voters. Bannon supplied the ideological focus of wanting to remake America and billionaire Robert Mercer provided the money. Neither Bannon nor Mercer has publicly commented since the allegations emerged.


Then,

'One of the things that started to emerge was that we literally heard these sort of narratives about Washington as something that was, like, gross and disgusting, that was dirty,' Wylie said.

So his team tested the phrase 'drain that swamp' to see if people would respond to it on social media. After all, they had access to the data of millions of Facebook users without their knowledge.

And people responded. Through the internet and Trump’s speeches, the slogan became one of the campaign’s most identifiable soundbites.

Perhaps it is the idea of building a wall along the Mexican border that best illustrates Wylie’s work for Cambridge Analytica.

Bannon, Wylie said, was obsessed with the idea of separating the U.S. from the rest of the world so the country can rediscover itself. Trump’s campaign for a wall along the Mexican border is not really about stopping immigrants, Wylie said.

'It’s to embody separation,' he said. 'If you can embody that separation and you can further distance in the minds of Americans us here in America and them elsewhere, even if it is just across a river, or just across a desert, then you have won that culture war.'
So "drain the swamp" was not a catch phrase for fighting corruption, but a hook to deep-seated fears of contamination, and "build the wall" was not a policy position to literally build a physical wall, but a hook to deep-seated fears of otherness.  Yet in office Mr Trump has continued to use these slogans as if they were policy positions, and has remained fixated on building a physical wall.  As we discussed here, there is plenty of evidence that he has fostered, not fought corruption. 


Use of "Proxy Organizations"

Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients. As reported by the Guardian,

Turnbull said the company sometimes used 'proxy organisations', including charities and activist groups, to help disseminate the messages – and keep the company’s involvement in the background.

Use of proxies and third parties are commonly used disinformation tactics.



Questions of Illegality

Claims of Impunity

During the Channel 4 undercover interview, Mr Nix claimed impunity,

When the undercover reporter expressed worries that American authorities might seize on details of a dirty campaign, Nix said the US had no jurisdiction over Cambridge Analytica, even though the company is American and is registered in Delaware.

'I’m absolutely convinced that they have no jurisdiction,' he told the purported client. 'So if US authorities came asking for information, they would simply refuse to collaborate. 'We’ll say: none of your business.''

Maybe his beliefs in impunity facilitated his comfort with the use of some apparently illegal tactics.

Violation of UK Data Privacy Laws


The UK has stringent laws on data privacy.  Its Information Commissioner's Office is apparently actively investigating whether Cambridge Analytica/ SCL violated them.  Late last week, the Guardian reported  

Investigators from Britain’s data watchdog have spent nearly seven hours searching the London offices of Cambridge Analytica.

Eighteen enforcement officers entered the Cambridge Analytica headquarters in London’s West End on Friday night to search the premises after the Information Commissioner’s Office (ICO) was granted a warrant to examine its records.

The officials concluded the search at about 3am on Saturday.
According to CBS News, at least three US states are now investigating whether the company broke US laws by accessing the Facebook data.

Work on a US Campaign by Foreign Nationals

As implied above, Cambridge Analytica and SCL were basically UK operations.  A Guardian article noted the apparent illegality of involvement in US political campaigns by foreign nationals.  The organization's own lawyers warned its leaders that

'Any decision maker must be a US citizen or green card holder,' the memo, seen by the Observer, warned. It also provided a brief legal history of cases involving foreign involvement in election campaigns, drawn up by a lawyer at the firm founded by former New York mayor Rudy Giuliani.

So,

It was clear that as a company largely run and staffed by Britons and Canadians, apart from Bannon and Mercer at the top, Cambridge Analytica – which was to go on to work on Donald’s Trump presidential election campaign – had a looming problem.

The management's response appeared to be subterfuge.

Two employees confirmed that they were still answering ultimately to Nix throughout the mid-term election campaigns that ended in November 2014. In total, more than a dozen foreigners, including Britons and Canadians, filled strategic roles in campaigns across the US.

'We were really speaking directly to the voters in a number of states,' said one former employee, who served on a team with several people who were not US citizens or green card holders.

It is understood that some were working on tourist visas. Another ex-employee claimed that they had been provided with letters to give to US border control officials where needed, stating that they would not be working there.

It seems likely that the Cambridge Analytica/ SCL work for the Trump campaign was mainly accomplished by citizens of countries other than the US.

Coordination with PACs

 Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients. As reported by the Guardian, not only did he boast of his influence in the Trump campaign,

Senior managers then appeared to suggest that in their work for US clients, there was planned division of work between official campaigns and unaffiliated 'political action groups'.

That could be considered coordination – which is not allowed under US election law. The firm has denied any wrongdoing. Also,

In another exchange, Tayler describes an apparently planned division of spending on the campaign trail, with the candidate organising positive' messages, with negative attack ads left to the super Pacs, which may engage in unlimited political spending independently of the campaigns.

'As part of it, sometimes you have to separate it from the political campaign itself ... campaigns are normally subject to limits about how much money they can raise. Whereas outside groups can raise an unlimited amount.'

'So the campaign will use their finite resources for things like persuasion and mobilisation and then they leave the ‘air war’ they call it, like the negative attack ads to other affiliated groups.'

Note that,

The Campaign Legal Center has accused Cambridge Analytica over allegations of illegal coordination of this nature.

It has filed evidence with the FEC alleging that the super Pac Make America Number 1 made illegal contributions to Trump’s campaign, 'engaging in unlawful coordinated spending by using the common vendor Cambridge Analytica'.

Boasts of Greater Nefariousness

Great Britain's Channel 4 interviewed Mr Nix, the CEO of Cambridge Analytica, posing as potential clients.  As reported by the NY Times, he boasted that the organization had capabilities more nefarious than those above:

We can set up fake IDs and websites, we can be students doing research projects attached to a university, we can be tourists. There’s so many options we can look at.

He also mentioned apparent extortion:

But you know equally effective can be just to go and speak to the incumbents and to offer them a deal that’s too good to be true, and make sure that that’s video-recorded, you know. These sorts of tactics are very effective, instantly having video evidence of corruption, putting it on the internet, these sorts of things.

Finally, he discussed apparent extortion in the form of classic KGB style honey-traps.

Or, Mr. Nix said, they could 'send some girls around to the candidate’s house — we have lots of history of things'

The reporter asked what kind of girls, and Mr. Nix said they could find some Ukrainian women. 'I’m just saying, we could bring some Ukrainians in on holiday with us you know,” Mr. Nix replied. “You know what I’m saying.'

'They are very beautiful,' he said. 'I find that works very well.'

Whether Cambridge Analytica/ SCL actually undertook such activities, particularly on behalf of the Trump campaign, is unknown.  However, their leadership clearly had no qualms about considering them to be options.


Discussion

An international organization, Cambridge Analytica/ SCL based in the UK, led by Trump confidantes including his last campaign leader and former White House strategic adviser Steve Bannon, and major Republican donors and hedge fund magnates Robert and Rebekah Mercer, worked with the Trump 2016 campaign, particularly coordinating with digital coordinator Brad Parscale.  Cambridge Analytica/ SCL leveraged Facebook private data on millions of people, obtained from most without their specific permission, to create a "psyops" political disinformation campaign featuring emotional appeals to voters' internal psychology, coupled with a variety of other tactics.  The campaign used foreign workers within the US, and apparently coordinated with political action committees, possibly violating US law.  The appropriation of private Facebook data possibly violated UK law.  The Cambridge Analytica/ SCL CEO also boasted that the organization was capable of various dirty tricks, including several species of extortion.

It is unclear to what extent, if any, this disinformation campaign helped Mr Trump to win the presidency.  But clearly we now have a president whose campaign was apparently happy to employ disinformation on a grand scale, likely violating US and UK laws in the process, to win election.

We have long advocated better awareness of insidious disinformation campaigns in health care, which we previously separated into stealth systematic marketing, lobbying, and policy advocacy campaigns.  Furthermore, we have long advocated more vigorous regulatory and law-enforcement action against them.  Remember that many of the stealth marketing campaigns we discussed came to light through regulatory and law enforcement action.

Yet what sense does that make when the federal regulators and law enforcers operate..
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This is número cinco in our series of attempts to shed some of this dander. But it keeps on rising. Here are two recent reports both relating to the life-on-the-ground of North American rank and file physicians, especially as that life increasingly revolves around data entry and digital madness over and above everything else.

Are physicians suffering from acute, maybe by now chronic, PTSD? In the 20 March 2018 number of the important Boston Globe-affiliated newsfeed STAT, Elizabeth Métraux, a prolific staffer and author at the eminent organization Primary Care Progress, gives us another quite useful take on physician burnout. An Iraq War veteran herself, the author gives us a provocative title that
pretty much says it all: "I experienced trauma working in Iraq. I see it now among America’s doctors." Her diagnosis is stark.
[A]s a health care advocate who has struggled with PTSD, it’s clear to me that many of our country’s health care providers are struggling with trauma, as well. And we’re doing little to support them.
Here's another snippet of conversation she recently had with a phyhsician colleague who'd also served in Iraq.
You know, I’d go back to the field any day. Beats practicing in my clinic. ... I didn’t become a doc to put up with billing codes and power struggles. I thought that PTSD would hit when I came home from Fallujah. It’s so much worse when I come home from the office. Truth is, I’ve lost my sense of purpose.
In what she terms "tiny betrayals of purpose," the death of 1000 tiny cuts, she outlines the extent to which the endless obsession by bosses with data entry and charge capture, the eight-minute patient encounter, the constant deflection of attention away from the patient all the while marketing and admin people are trumpeting "patient-centered everything" to their "customers," all of these have taken their toll.

Unfortunately, the usual caveat applies: making the diagnosis is a lot more straightforward than establishing the right therapy for the PTSD viewed by every student who rotates through a preceptor's community office: rapidly driving the best and brightest young physicians away from primary care. The author suggests the patient turn around and ask the physician how she is doing. But much more structural reform will be needed to curb these excesses and reverse these trends. Higher pay would be a fabulous start, not to mention forgiveness of medical school loans.

Less empathic but no less important: revenge of the EHR--more paper records than ever, revealing private information. A fascinating research letter published the same day in JAMA (behind paywall), out of several hospitals in Toronto, Ontario, reveals still more new--but actually, hardly new at all--issues raised by perverse effects of Electronic Health Records. More, not less, paper documents are being discarded because of the EHR. The investigators spent about half a year auditing all the recycling-bound paper from five hospitals. The results are arresting. Here are the key take-aways. Bear in mind the context: these institutions had Protected (Personal) Health Information (PHI) policies; they also had recycling bins and shredders where they needed to be.

  • Nearly a ton of paper was examined including nearly 3000 discrete documents.
  • The study was multi-institutional.
  • Every hospital contained examples--lots of examples--of PHI discarded in both in- and out-patient settings.
  • Over 2500 documents containing PHI were found, including over 1000 with highly sensitivbe information (defined as including both diagnoses and descriptions of patients' conditions).
  • The vast majority of these documents were found in out-patient settings.
  • The highest proportion of PHI-containing documents was found in physicina offices--not hospitals or institution-bound clinics.
  • Paper records were impossible--in distinction to electronic privacy breathes--to trace with respect to identifying responsible individuals.
  • The authors reported no actual harms accruing to the documents' discovery.
The biggest drawback of this study was its focus on recycling materials, as opposed to other random discards. But recycling does not means properly-disposed-of, so the data are important. Most important is the Revenge Effect, to quote from Edward Tenner's important analysis of technology's impact, of the EHR.

To any of those of us who've lived this scenario, it all sounds drearily familiar. EHR allows managerialism to run rampant in terms of up-coding and adherent to more often than not perverse incentives around Meaningful Use of EHRs. Not to mention outright abuse. But it actually produces all sorts of other perverse effects. One near and dear to our hearts is the "credit" for printed "Clinical Summaries cited as "performed" in EHR databases, but actually abandoned on printers. And, when retried, lacking any information on the clinical plan--essentially only listing medication lists that are often dangerously erroneous.

Now, from Toronto, but we already knew this, we're reminded that EHR didn't do away with paper. Because so much paper comes in and gets scanned to EHR, it is rather more pervasive--but now discarded in the wrong palce--than ever.
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