Cybernetic Opioid Pushers: EHR vendor Practice Fusion to Pay $145 Million to Resolve Criminal and Civil Investigations

Considering the devastating and deadly opioid problems in this country, this news release from DOJ describes particularly despicable behavior from an EHR vendor and pharmas.

These problems are likely more widespread, but this EHR company got caught.

The company admitted that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications, via "decision support" routines specifically designed by the drug company to increase drug company profits.

The DOJ reports that in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS (clinical decision support) alerts in ways aimed at increasing sales of the companies’ products.  Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself.  The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.

This story could certainly help explain why I could never get involved in EHR initiatives in pharma, despite having been at Merck in a science-support capacity, but seeking EHR involvement.  I had completed a Yale Medical Informatics postdoc and then faculty period authoring EHRs domestically and for a foreign country, and then had a period as a CMIO in Delaware. Yet, my many pharma applications over many years afterwards for EHR-related positions were mostly ignored.

The reason behind that shutout could likely be that I was known as being exceptionally honest, if only in part for my candid writing on EHR problems first on AOL 1999-2004, then at Drexel University and at this blog, at a time when the pundits and hyper-enthusiasts were pushing the technology uncritically and relentlessly.

Indeed, I would never have tolerated the types of conspiracy (DOJ's word) between EHR companies and pharma that are described in this DOJ release to help push drugs, any drugs - let alone opioids.

To make matters worse, this vendor is also described as cheating on the HHS EHR "certification" process.  The company is described as concealing from the certifying entity, known as an ONC-Authorized Certification Body (ATCB), that the EHR software did not comply with all of the applicable requirements for certification.

Apparently, no defendants were jailed.

I am posting the DOJ release in its entirety.  It is quite comprehensive, and I have nothing to add.

https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0

Department of Justice

Office of Public Affairs

---

FOR IMMEDIATE RELEASE

Monday, January 27, 2020

Electronic Health Records Vendor to Pay $145 Million to Resolve Criminal and Civil Investigations

Practice Fusion Inc. Admits to Kickback Scheme Aimed at Increasing Opioid Prescriptions

Practice Fusion Inc. (Practice Fusion), a San Francisco-based health information technology developer, will pay $145 million to resolve criminal and civil investigations relating to its electronic health records (EHR) software, the Department of Justice announced today.

As part of the criminal resolution, Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications.  Practice Fusion has executed a deferred prosecution agreement and agreed to pay over $26 million in criminal fines and forfeiture.  In separate civil settlements, Practice Fusion has agreed to pay a total of approximately $118.6 million to the federal government and states to resolve allegations that it accepted kickbacks from the opioid company and other pharmaceutical companies and also caused its users to submit false claims for federal incentive payments by misrepresenting the capabilities of its EHR software.

“Across the country, physicians rely on electronic health records software to provide vital patient data and unbiased medical information during critical encounters with patients,” said Principal Deputy Assistant Attorney General Ethan Davis of the Department of Justice’s Civil Division.  “Kickbacks from drug companies to software vendors that are designed to improperly influence the physician-patient relationship are unacceptable.  When a software vendor claims to be providing unbiased medical information – especially information relating to the prescription of opioids – we expect honesty and candor to the physicians making treatment decisions based on that information.”
The resolution announced today addresses allegations that Practice Fusion extracted unlawful kickbacks from pharmaceutical companies in exchange for implementing clinical decision support (CDS) alerts in its EHR software designed to increase prescriptions for their drug products. 

Specifically, in exchange for “sponsorship” payments from pharmaceutical companies, Practice Fusion allowed the companies to influence the development and implementation of the CDS alerts in ways aimed at increasing sales of the companies’ products.  Practice Fusion allegedly permitted pharmaceutical companies to participate in designing the CDS alert, including selecting the guidelines used to develop the alerts, setting the criteria that would determine when a healthcare provider received an alert, and in some cases, even drafting the language used in the alert itself.  The CDS alerts that Practice Fusion agreed to implement did not always reflect accepted medical standards.  In discussions with pharmaceutical companies, Practice Fusion touted the anticipated financial benefit to the pharmaceutical companies from increased sales of pharmaceutical products that would result from the CDS alerts.  Between 2014 and 2019, health care providers using Practice Fusion’s EHR software wrote numerous prescriptions after receiving CDS alerts that pharmaceutical companies participated in designing.

Practice Fusion executed a deferred prosecution agreement with the U.S. Attorney’s Office for the District of Vermont based on its solicitation and receipt of kickbacks from a major opioid company to arrange for an increase in prescriptions of extended release opioids by healthcare providers who used Practice Fusion’s EHR software.  As detailed in the criminal Information made public today, Practice Fusion solicited a payment of nearly $1 million from the opioid company to create a CDS alert that would cause doctors to prescribe more extended release opioids.  That payment was financed by the opioid company’s marketing department, and the CDS was designed with input from the marketing department.  Practice Fusion and the opioid company entered the CDS sponsorship because they believed that the CDS would influence doctors’ prescriptions of extended release opioids.  In marketing the “pain” CDS alert, Practice Fusion touted that it would result in a favorable return on investment for the opioid company based on doctors prescribing more opioids.

“Practice Fusion’s conduct is abhorrent.  During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” said Christina E. Nolan, U.S. Attorney for the District of Vermont.  “The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.  This recovery is commensurate to the nature of Practice Fusion’s misconduct, represents the largest criminal fine in the history of this District, and requires Practice Fusion to admit to its wrongs.  It is another example of pioneering healthcare fraud enforcement by the talented Assistant U.S. Attorneys and staff of this U.S. Attorney’s Office, working with their partners in law enforcement.  We cannot — and will not — tolerate technology companies influencing patient treatment merely because a pharmaceutical company provided a kickback.”

The criminal Information charges Practice Fusion with two felony counts for violating the Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b)(1), and for conspiring with its opioid company client to violate the AKS, 18 U.S.C. § 371.  This case is the first ever criminal action against an EHR vendor and the unique Deferred Prosecution Agreement imposes stringent requirements on Practice Fusion to ensure acceptance of responsibility and transparency as to its underlying conduct, and to invest heavily in compliance overhauls and an independent oversight organization.  The Deferred Prosecution Agreement requires Practice Fusion to pay a criminal fine of $25,398,300 and forfeit criminal proceeds of nearly $1 million.  In addition, the company will cooperate in any ongoing investigations of the kickback arrangement and report any evidence of kickback violations by any other EHR vendors.  To ensure transparency and public awareness of the company’s activities while the nation continues to battle an epidemic of opioid addiction, the Deferred Prosecution Agreement requires Practice Fusion to make documents relating to its unlawful conduct available to the public through a website.  Additionally, the Deferred Prosecution Agreement mandates that Practice Fusion retain an independent oversight organization that is required to review and approve any sponsored CDS before Practice Fusion may implement the CDS, and create a comprehensive compliance program designed to ensure such abuses are not repeated.

The civil settlement with the United States resolves Practice Fusion’s civil liability arising from the submission of false claims to federal healthcare programs tainted by the kickback arrangement between Practice Fusion and the opioid company.  It also resolves allegations of kickbacks relating to thirteen other CDS arrangements where Practice Fusion agreed with pharmaceutical companies to implement CDS alerts intended to increase sales of their products.  The $118.6 million settlement amount includes approximately $113.4 million to the federal government and up to $5.2 million to states that opt to participate in separate state agreements.

“Prescription decisions should be based on accurate data regarding a patient’s medical needs, untainted by corrupt schemes and illegal kickbacks,” said U. S. Attorney David L. Anderson of the Northern District of California.  “In deciding what is best for patients, electronic health records software is an important tool for care providers.  It is critically important that technology companies do not cheat when certifying that software.”

In addition to the kickback allegations, the civil settlement with the United States resolves allegations relating to two intersecting Department of Health and Human Services (HHS) programs, one at the Office of the National Coordinator for Health Information Technology (ONC) that regulates the voluntary health IT certification program, and one at the Centers for Medicare & Medicaid Services that oversees EHR incentive programs.  Specifically, the United States alleged that Practice Fusion falsely obtained ONC certification for several versions of its EHR software by concealing from its certifying entity, known as an ONC-Authorized Certification Body, that the EHR software did not comply with all of the applicable requirements for certification.  ONC’s certification criteria were designed to promote enhanced functionality, utility, and security of health information technology, and access to patient medical information across the care continuum.  HHS implemented the certification criteria for EHR software in multiple stages, known as editions.  To be certified under the 2014 Edition certification criteria, EHR software was required to allow users to electronically create a set of standardized export summaries for all patients.  When Practice Fusion sought certification of this 2014 Edition criteria, Practice Fusion falsely represented to the certifying body that its software met this data portability requirement, when several versions of its software did not.  The civil settlement resolves allegations that, at the time these versions of Practice Fusion’s software were certified, its software was unable to permit a user to create a set of standardized export summaries.  Additionally, after obtaining certification of the 2014 Edition criteria, Practice Fusion disabled access to this feature altogether.  Instead, Practice Fusion required users to contact it separately to request export of this critical patient data.

In addition to failing to satisfy the data portability requirement, Practice Fusion’s software allegedly did not incorporate standardized vocabularies as required for certification.  The United States alleged that by fraudulently obtaining certification for its products, Practice Fusion knowingly caused eligible healthcare providers who used certain versions of its 2014 Edition EHR software to falsely attest to compliance with HHS requirements necessary to receive incentive payments from Medicare during the reporting periods for 2014 through 2016 and from Medicaid during the reporting periods for 2014 through 2017.

“As new technologies continue to develop and evolve, so too do new and innovative fraud schemes,” said Shimon R. Richmond, Assistant Inspector General for Investigations of the U.S. Department of Health and Human Services. “We will continue to be vigilant in detecting and investigating these schemes in order to protect the safety of patients in federal health programs and to ensure the appropriate use of electronic health records in providing their care.”

“Today's announcement shows that Practice Fusion exploited technology to profit at the expense of a vulnerable population – patients seeking medical advice," said Timothy M. Dunham, Special Agent in Charge of the FBI's Washington Field Office, Criminal Division.  "The FBI is committed to working with our partners to bring to justice the perpetrators of healthcare fraud in all its forms, especially one that fans the flames of the already rampant opioid epidemic.”

The U.S. Attorney’s Office for the District of Vermont handled the criminal investigation and resolution.  The civil investigation was jointly handled by the Civil Division’s Commercial Litigation Branch and the U.S. Attorneys’ Offices for the District of Vermont and the Northern District of California.  The investigation was supported by the HHS Office of Inspector General and multiple HHS agencies and components.  The FBI’s field office in Washington, DC, also provided significant investigative support.

Except for the conduct admitted in connection with the criminal resolution, the civil claims resolved by the settlement are allegations only, and there has been no determination of liability as to such civil claims.

Johnson and Johnson's "Landmark" Opioid Settlement, or Just Another Chapter in the Story of Corporate Management's Impunity?

Introduction: our Chronic Narcotics Problem

Narcotic addiction has plagued human societies for hundreds of years.

[Print, 1880, opium den, London]


So as I have written before, after seeing too many dire results of narcotic addiction during my training and early career, I was dismayed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the predictable result that the US was once again engulfed in an epidemic of narcotic abuse.  In the last few years, the narcotics (now called "opioids") epidemic has frequently been in the headlines.  A few days ago, a judge decided that one large pharmaceutical/ biotechnology/ device company bears some blame for the problem

The Johnson and Johnson "Landmark" Settlement

On August 26, 2019, the New York Times reported a "landmark," per the headline, settlement:

A judge in Oklahoma on Monday ruled that Johnson & Johnson had intentionally played down the dangers and oversold the benefits of opioids, and ordered it to pay the state $572 million in the first trial of a drug manufacturer for the destruction wrought by prescription painkillers.

The judge wrote

that Johnson & Johnson had promulgated 'false, misleading, and dangerous marketing campaigns' that had 'caused exponentially increasing rates of addiction, overdose deaths' and babies born exposed to opioids.

It seems like a big story, big enough for another NYT article to fret over how the settlement might damage Johnson and Johnson's sterling reputation.  

For Johnson & Johnson, which has said it plans to appeal, the decision represents another blow to its reputation as the trusted brand of parents, doctors and nurses.

Wall Street Journal editorialists fretted even more,

the ruling could have far larger, and more dangerous, consequences by opening a vast new arena for product-liability suits.

And warned the opioid epidemic will not

be eased by bankrupting America's pharmaceutical companies

Maybe threats to this upstanding company inspired US President Trump, while running the most conflicted and corrupt administration ever (look here), to promote another fine Johnson and Johnson product.  On August 23, 2019, the Atlantic reported,

President Donald Trump said on Wednesday that the government will purchase 'a lot of the drug esketamine, a derivative of ketamine.

Though ketamine is known as a recreational hallucinogen, Trump asserted that a new nasal-spray derivative would be of great benefit to veterans with depression. As he left the White House for a veterans’ conference in Kentucky, he told reporters that he had instructed the Department of Veterans Affairs to make a large purchase—overriding a recent decision by the doctors who manage the hospitals’ formulary of which drugs are to be prescribed.

'There’s a product that’s made right now that just came out by Johnson & Johnson which has a tremendously positive—pretty short-term, but nevertheless positive—effect,' Trump said. But that statement is contrary to the evidence. A review by the Food and Drug Administration of what limited studies have been done with esketamine found mixed results, leaving many scientists unsure if the drug is indeed effective and safe. Just last week, the agency published a report that said the drug was not reliably better than placebo.

Should the Wall Street Journal (and perhaps President Trump) really be so worried? Was this settlement really so dire?

The March of Legal Settlements Continues

In fact, this particular settlement did not seem very harsh.  Per the first NYT article,

The amount fell far short of the $17 billion judgment that Oklahoma had sought to pay for addiction treatment, drug courts and other services it said it would need over the next 20 years to repair the damage done by the opioid epidemic.

The amount of the settlement would be unlikely in and of itself to give corporate leadership pause, given that the company's revenues exceeded $81 billion last year (look here).

While the judge found that Johnson and Johnson caused a "public nuisance," this seems unlikely to inspire much shame in corporate leaders, who took no overt responsibility for the narcotic epidemic:

In a statement about the Oklahoma case, Michael Ullmann, the general counsel and executive vice president of Johnson & Johnson, referring to the company’s pharmaceutical subsidiary, said that 'Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome.'

'We recognize the opioid crisis is a tremendously complex public health issue,' he said, 'and we have deep sympathy for everyone affected.'

And like many other legal settlements which we have discussed in the past, this one caused no one at Johnson and Johnson who approved, directed, or implemented the deceptive marketing and other bad behavior to suffer any negative consequences. 

Ignoring Another Corporation's Dismal Record

Furthermore, the settlement, like most others we have discussed, ignored Johnson and Johnson's extensive track record of misbehavior.

The second NYT article did allow that the company has withstood

a series of damaging setbacks to its brand, including a spate of lawsuits over whether its talcum powder led to ovarian cancer, and high-profile cases over other potentially flawed products, like pelvic mesh and the anti-stroke drug Xarelto, which has caused excessive bleeding.

'Johnson & Johnson is a corporation under duress on a number of fronts,' said Stephen Hahn-Griffiths, an executive at Reputation Institute, which tracks public perception of companies through regular surveys.

However, that barely scratched the surface of Johnson and Johnson's record.  In a 2018 post we discussed accusations that Johnson and Johnson tried to cover up the adverse effects of its baby powder.  However, we also discussed a settlement the company made of allegations it gave kickbacks to patients to facilitate its over-pricing of Tracleer, a drug for pulmonary artery hyptertension.  These were just the latest in a long string of misadventures by the company, as we have been documenting over years.  (Our collected posts on Johnson & Johnson are here.  An updated version of their legal record from 2010 to 2016 is at the end of this post.)

Perusing the list suggests that this giant company is a poster child for bad behavior by health care organizations.  It has faced a multitude of allegations leading to settlements, and sometimes findings of guilt.  The charges included many instances of deceptive and unethical marketing, some that promoted drugs or devices for use in situations in which they may have had harms outweighing their benefit, some that involved concealing knowledge of their risks, and some of selling adulterated drugs or defective products. 


What is striking is that the company and its management have not faced more consequences for this sorry track record.

Although the company has paid multiple fines and made numerous monetary settlements over the years, none have been big enough to affect its immense revenues.  Furthermore, ultimately the monies used to pay them came from all Johnson & Johnson employees in the form of smaller paychecks; customers, patients and the public at large in the form of higher prices; and only to some extent by investors in the form of slightly lower profits.  Meanwhile, it appears that the company's top managers made an immense amount of money, possibly in part as rewards for the revenues produced by the misadeventures.

Former Johnson & Johnson CEO William Weldon, upon his retirement in 2014, was to receive a retirement package estimated to be worth from $143 to $197 million (look here).  In 2010, his total compensation was $29 million (look here).   According to the 2012 Johnson and Johnson proxy statement, his 2011 total compensation was greater than $26 million. As far as I can tell, Mr Weldon never suffered any negative consequences for his company's sorry record, and retired a very rich man. (look here).

Current CEO Alex Gorsky received  $25 million total compensation in 2014 (look here).  More recently, the New York Times reported his 2017 total pay was $22.8 million, making him the seventh highest paid health care executive that year. 

While management made so much money, very rarely has anyone who was involved in authorizing, directing, or implementing bad behavior had to suffer any negative consequences, therefore appearing to enjoy impunity.

So what was to deter management from embarking on further misadventures, as long as the results might be enlarging their personal wealth? 

And why should we expect that this settlement will lead to any meaningful solution to the ongoing narcotics (opioid) epidemic?

Summary: Meaningless Settlements and the Impunity of Top Management

Nothing changes.  We have seen many legal settlements by health care organizations of charges of  fraud, bribery, and kickbacks.  Often such behaviors appeared to risk patient harms.  However, the companies involved usually paid tiny fines that relative to their revenues.  Rarely did they have to admit responsibility, and almost never did a settlement cause company managers and leaders to  suffer any negative consequences for enabling, authorizing, directing or implementing the bad behavior.

Thus it seems that US health care is rigged to benefit top insiders and their cronies, and is part of a larger rigged system.  We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, concentrating corporate power while top managers got rich. Other employees, patients, customers, vendors and suppliers, and the public at large lost out.   In health care, these changes led to an increasingly costly system which produced increasingly bad results. 

We have called for true health care reform to derig the system. Unfortunately, despite our hopes, perceptions of a rigged system may not always inspire honest reform. Instead, they can facilitate the rise of demagogues and would be dictators.  Donald Trump cried out that only he could fix our problems and drain our swamps, but the waters are now rising (look here) while he has enjoyed his own impunity (look here).  

The "landmark" settlement by Johnson and Johnson should remind us of the reforms we have not achieved.  However, to have a chance of truly reforming health care, we need to accomplish wholesale government reform. We need to excise the deception, crime and corruption at the heart of our government and restore government by the people, of the people, and for the people. 

Appendix - A Look at Some of Johnson and Johnson's Legal Record 2010-2016

Derived from our previous blog posts - 

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

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

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

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

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

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

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

More Than Just Dander

First, a sort of meta-comment in the form of a shout-out to HCRenewal's intrepid editor, Dr. Roy Poses, for his just-published analysis of what we might call "blogging: rise and fall." He sees decline reflected in publications long  devoted to health and health policy, yet now flaking off.

Methinks, however, despite the usefulness of his overview of recent decades, Dr. P need not fret excessively. Water spilling out of the barrel's lip will slow down once folks come along and punch a whole bunch of little mid-section tweet-holes in it. Information still flows. (Sort of.)  In any case, surely there's overlap between blogs' and tweets' readerships. Surely well-researched and -reasoned long form still has its place. Unfortunately, hard to know for sure: it's hard to measure. Nobody's polling these folks and to my knowledge information scientists haven't published much--a quick search inside Google Scholar bears this out--that's of a quantitative nature.

So we're left with admittedly rather unsatisfactory anecdotal reports on people who need blogs like ours and find their way to it. Congressional staffers you know who you are. Rightly or wrongly, I'm hopeful. Maybe we shade this a little by the suspicion that many younger social media users share with me a short attention span. Hence they come to rely more and more on quick hits. In any case, let's hope this is evolution and diversification, not just entropy and a race to the bottom.

Now to my theme of the day. Yet again the dander hath risen for I've lost count how many times around what ails our health delivery systems. And so is my lunch: the gorge, too, hath risen. The miscreants' very relentlessness is nauseating. More, then, on two of them that keep cropping up here like those small burrowing insectivores in this tedious yet oddly riveting game of Whack-A-Mole.

A. Chicanery at the VA: looking back and looking forward.

On balance, and despite its many flaws, VA health's operation in all its enormity is not itself a miscreant. Different story for those folks trying to destroy it from within, on the dubious premise that lest we privatize it it's irredeemable. Search this blog on "VA Cetona" for detail on such matters.

Why does this even happen? We've described the VA's Shadow Rulers (search here on that as well) in these pages. The SR's fall in the 0.1%. Why do they need or want the headache of trying, in what's fated to be a futile effort, to upend and hollow out the health lifeline extended for nearly a century to patriots returning from the military?

When the left gets power it tries to expand and improve government. (Of course the efforts can unfortunately go awry, viz. Hillarycare in the 1990s, and cast shade on future attempts.) When the right gets power, at least in the two generations since an actor became president in 1980, government is seen as "not the solution but the problem." The response may be to try to rejigger and downsize. "Drown the baby in the bath." Or, perhaps far more likely, something else now happening in the VA and throughout the Trump kakistocracy.

Namely, don't seize power to return it to the people. Seize it in order to use it in a third-dimensional play to drain resources. As for the first two dimensions, don't even try to improve--David Shulkin's mistake (see below)--or eliminate (despite Mick Mulvaney's baby drowning proclivities, hugely unpopular) care provided by the VA. Not when there's a third way: divert those resources. In fact, from the earliest instances of frontier exploitation to the newest frontier we have--our heretofore private personal information--despoliation has been the watchword, the core motive, the secret sauce: don't ameliorate. Don't eliminate. (Honestly: viz., Shrub's expansion of guvmint.) Despoliate.

It is, as Shrub used to say (maybe), one of our country's most basic pieces of strategery.

Such a strategy was discussed (and surely it's as old as the hills) by Times tech reporter Steve Lohr in a recent piece on, of all things, artificial intelligence. ("Elixir of prosperity [or] job killer"?) Lohr makes clear that what's old is new again, linking the asset of private data to all the other assets that've been strip-mined. "In the American model," notes Lohr, "coming from Silicon Valley in California, a handful of Internet companies become big winners and society is treated as a data-generating resource to be strip mined."

As Buffy the Vampire Slayer once said, "can you spell 'duh'?"

Strip mining started with the earliest settlers, and now ... data, the final frontier. Same deal, though. The American model, and economic maldistribution, and so much of our plight is bound up with this baked-in trait, which seems to've seeped into society's DNA. Or else originated there. Find a mine. Strip it. Let others pick up the pieces.

But let's go back to that last credible VA Secretary. How do we know that Shulkin pissed off the strip-miners? Why, just read what he himself wrote in a scholarly publication just a few months ago in the prestigious New England Journal. In a piece entitled "why the VA needs more competition," he and closely-associated Michigan colleague Kyle Sheetz first declared, unequivocally and repetitiously, competition: good!!! Emphasis in the original through repetition. Clever. After reassuring their audience how much they liked competition they let the cat out of the bag in the final paragraph of a long-ish article: "Privatizing the VA by offering unregulated access to private-sector providers is probably not feasible, necessary, or the best way to care for veterans."

That's exactly what the quietly-undermining, unelected Trumpsters pushing for strip-mining veterans' health care didn't want to hear. We know (see below) how that came out.

Similar in emphasis is a piece just out (January 2019) in the equally prestigious Annals of Internal Medicine, by (no pun intended) veteran federal health official Carolyn Clancy and her own VA/AHRQ colleagues. I'm perplexed at the way Clancy herself has hung in there (and yet she persisted) at the federal agencies to which she's contributed greatly over recent decades. I'm perplexed about how, within these agencies,she's been bounced around, most recently landing as the VA's "Deputy Under Secretary for Discovery, Education and Affiliate Networks." (That top's spinning so fast what I just wrote may already be superannuated news.)

In any case Clancy et al. put their shoulders to Shulkin's wheel extolling the May 2018 federal MISSION legislation streamlining VA and non-VA care, and the ostensible role their new Center for Innovation might play in such an effort. They pointed out all the right innovation-cum-research caveats about the need for adequate data: "paying for value could backfire without accurate measurement of costs and outcomes." In this case they were certainly correct: privatizers in this particular world aren't interested in evidence-based anything. They're profiteers. (See: "Department of Education." See: "Department of the Interior." See: Environmental Protection Agency.)

Shulkin's words saw the light of day about a month after the MISSION legislation, in the final days of June, 2018. But here's why I put Shulkin having "liked competition" in the past tense. By the time his NEJM piece appeared Shulkin, also accused of what I still deem to've been truly flimsy ethics violations, was already gone from his organization. By the end of March the Orange Man had already fired him. As a personal fiasco this was unseemly, since the VA secretary was a rare bird who both consented to be a hold-over from early administrations, yet managed early on to be a current POTUS favorite. Surprising? In this White House?

In none of these events was there ever put forward any really compelling justification either for privatizing VA care or for starting with the assumptions that outside "leaders" and outside doctors could do a better job than--what with all their flaws--VA medical staff. Suzanne Gordon, a distinguished journalist and author, admittedly parti pris as a fellow of the Oakland-based 501(c)3 Veterans Healthcare Policy Institute, has just published an American Prospect piece on "Trump’s under-the-radar push to dismantle veterans' health care." Her central thesis is worth quoting in extenso.

[The Republican] strategy will not only erase what has been the most successful American experiment in government-delivered health care, but will also send veterans out into a private system that is more expensive, less accountable, and unable to meet their particular needs. The key notion underpinning the Mission Act, that the private sector can offer comparable care to the VHA, is deeply flawed. Study after study (after study) has found that the VHA generally outperforms the private sector on key quality metrics, and that private providers are woefully unprepared to treat the often unique and difficult veteran patient population. The most recent evidence came in a Dartmouth College study published in December, which compared performance between VHA and private hospitals in 121 regions across the country. The results: In 14 out of 15 measures, government care fared “significantly better” than private hospitals.

Gordon also has a new book out on this subject, as most supporters of the traditional VA system already know. Worth a look. Meanwhile the Senate and White House and those advising them clearly never really cared about quaint ideas such as "studies," "evidence," or "data." They cherry-pick a few quotes about the brusqueness of some VA care, which often is admittedly more bureaucratic than today's "consumer-facing" and endlessly-polling private-care organizations. You can find those quotes as well as I can--any search engine known to man will do the trick.

Recent events on the larger political canvas make it abundantly clear, in the meantime. It's not about quality. It never was. It's about callously starting with a dismissive attitude toward government workers, then back-solving from there. Having worked for years at the VA, I can vouch for its quality as well as its struggle to assist the really needy patients who depend upon it. In fact, this new study shows quite rigorously that the VA was already dramatically reducing wait-times within multiple VA installations, right down to private-sector levels. So this branch of government has listened and successfully striven to achieve a performance level that's not just high-science but also high-touch, as medicine's "customers" (yechhh) have come to expect.

The present furlough of federal employees proves the point. If you can dismiss someone as human collateral-damage, you don't start first by examining the good things they've done for you. You're an elephant poacher. Take the spoils and leave the carcass to rot.


B. More on the Opiate Eaters Who Eat Very Well.

Speaking of despoliators, Dr. Poses and I both wrote here recently on how, in the world of dangerous narcotics, this single family of mostly physicians, the Sacklers, garnered a much more grand market share than they like to let on. Time to add to that and earlier reporting with a few updates.

When, in a different venue than the VA I was providing front line medical care to privately-insured patients, I noticed an arresting change. I saw more and more folks arrive in my office in shop-till-you-drop mode seeing opiate renewals. Always OxyContin, Percocet or Vicodin. If I didn't provide the "fill" they'd go next door. The demand built and built. The drug makers kept assuring they were safe and effective. At free dinners they paid an army of fellow physicians to regale us with the same message.

Then those patients started to die on me. OD courtesy of "safe" Purdue (and others') product.

Then in the past very few years, and I honestly should've seen it coming but didn't, the crisis spilled over from doctors' exam rooms into the political arena. It's actually something, unlike the VA, that's garnering a certain timid degree of nonpartisan interest in finding practical solutions, call it consensus even, starting with decriminalizing measures. But I find it gorge-raising to see the usual suspects continuously fighting the notion that as a society, we blew it with opiates. We blew it. With their help.

I've spent a fair amount of time looking at similar medico-legal crises, including the far-reaching tobacco and environmental lead poisoning matters, as well as narrower ones such as evolving surgical and pharmacological approaches to certain diseases. In every case our tort system, combined with the deep pockets of those who are (allegedly) truly guilty, conspire to perpetuate Bleak House-style court battles over culpability. Strip miners seem to believe--or want us to swallow whole the absurdist notion--that they leave the world a better place. In the case of Purdue, this false consciousness is undoubtedly propped up by the Sacklers' prowess as culturati: one can hardly turn around, as I recently did at the Met in New York, without finding their name plastered on this gallery or that institution of higher learning. But the motive, be it within the strip miners' organization or that of a cultural organization, comes down to the same thing: "we need the money." Allegedly.

Recent disclosures from "sources," including internal Purdue emails, clarify all this. Fortunately for us it turns out the founder's (Raymond's) son Richard was an early adopter--relatively so--of email. Both were physicians, but Richard was of the first generation to be granted an American MD. Email was barely used at all in 1995 when Microsoft first added a TCP/IP stack to its operating system, with the introduction of Windows 95. Then email really took off, by 2001 having a fair amount of penetration in the business world. So maybe we shouldn't be so surprised that Purdue Pharma was squirreling away some of Richard's pronouncements in an archival time capsule for our delectation nearly a generation later.

According to a new court filing recently revealed in the NY Times, Richard Sackler said some, um, fairly incriminating things to say in these internal emails. Still earning his spurs as head of daddy's (and Uncle Mortimer's) company after a couple of years or so in the saddle, and undoubtedly aware of the dramatic uptick in addiction issues that I saw in my own clinic in those turn-of-the-century years, he allegedly blasted everyone else in sight--except, of course, his own ever-so-cultured family.

"[T]he launch of OxyContin tablets will be followed by a blizzard of prescriptions that will bury the competition. The prescription blizzard will be so deep, dense, and white...." said Sackler fils. Based on no evidence reps were told to claim a “less than one percent" risk of addiction. As for that small subset of patients who did find themselves hopelessly addicted, the claim was to be made that “We have to hammer on abusers in every way possible.... They are the culprits and the problem. They are reckless criminals.”

Now, hot off the press in 2019, the Guardian reports how this overall attitude has been replicated within the lobbyist-influenced government of Messrs. Trump and Azar. Since 2015 (pre-Trump! pre-Azar!) chair of the FDA's own Anesthetic and Analgesic Drug Products Advisory Committee, Kentucky anesthesiology professor Raeford Brown has bravely characterized the rift that now mires down the FDA in tackling this crisis seriously. Admittedly with cover from many in Congress, Brown said this to interviewers.

I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.

Scott Gottlieb, who's tying your hands? Is it this guy? The FDA seems to be replete with such interlocking-directorate staff, all trying to assure  the "level playing field." And what is that playing field? Who are the players? We can answer this. Talk to the drug reps (I have). Except of course those who wake up and see what they're really doing, burn out and bail out. Talk to the lobbyists and the investors (I have). The watchword is not "safe and effective." It's blame-the-victim and lucrative. Let's get our motives straight here. You can do that just fine without listening to us at Health Care Renewal. Just listen to Richard Sackler in a time capsule from 2001.

Ever wonder why the strip-miners need so much of our patients' loot? Well, take a little trip to Davos, Switzerland, where the rich and rich go to rub shoulders and tell each other how smart they are: YouTube offers a hint here.

B'bye--too much dander, got to go take a bath.

The Mysteries Surrounding Rhodes Pharmaceuticals, the Sackler Family's Second Opioid Company

 Mysteries still abound in the not so wonderful world of health care dysfunction, so, quick, the game's afoot...

Today's mysteries involve beneficial ownership.  Beneficial ownership questions are important to anti-corruption campaigners.  Beneficial ownership simply refers to "anyone who enjoys the benefits of ownership of a security or property, without being on the record as being the owner." (per Wikipedia). Concealing who really owns a company enables concealing sources of funds (as in money laundering), market power (when the owner also owns competitors), and sources of political influence, and enables those benefiting from the actions of the company to escape responsibility for their consequences.

A few months ago, a big question about the beneficial ownership of a local (to me) company suggested important local and national health care implications, and yet the case has remained anechoic.  The case has some mysterious aspects.

The  Mystery of the Ownership of Rhodes Technologies and Hence Rhodes Pharmaceuticals Solved

In September, the UK based Financial Times reported,

The billionaire Sackler family, which has been blamed for fuelling the US opioid addiction epidemic, owns a second drugmaker that churns out millions of addictive painkiller pills every year, the Financial Times can reveal.

The Sacklers are best known as the owners of Purdue Pharma, the privately held drugmaker that makes the now infamous opioid painkiller OxyContin, which has been described as 'heroin in a pill'.

However, an FT analysis of company registration documents has established that the family also owns Rhodes Pharma, a little-known Rhode Island-based drugmaker that is among the largest producers of off-patent generic opioids in the US.

Furthermore,

Rhodes Pharmaceuticals was set up in 2007, four months after Purdue pleaded guilty to federal criminal charges that it had mis-marketed OxyContin over the previous decade.

The little-known company now makes several opioid-based products containing highly-addictive drugs such as oxycodone, morphine and hydrocodone, according to a US Food and Drug Administration database. Many of its drugs are made in factories owned by Purdue.

The Mystery of the Mysteriousness of the Rhodes Companies and Facility

The FT report was noted by our local on-line news site, GoLocalProv, which tried to find out more about the company. It reported,

And tucked away in Coventry, Rhode Island, along a country road, is Rhodes Technology — surrounded by massive security. The company’s website has been under -reconstruction for the past few years -- all an effort to keep a low profile.

A 2005 version of the Rhodes Technologies’ website GoLocal uncovered said, 'We have very broad capabilities in developing sophisticated chemicals and offer confidential production of high purity APIs and finished dosage forms of innovative pharmaceuticals, as well as marketing and sales services. A multi-million dollar investment in a new cGMP facility completed in 2002 added controlled substances to our manufacturing capabilities. Rhodes is a diversified, dependable firm well positioned for partnerships.'

The marketing arm of the Rhodes Technologies is Rhodes Pharmaceuticals and it self-describes itself as 'a privately held company headquartered in picturesque Rhode Island....developing and distributing quality pharmaceutical products since 2008.'

Emails and requests for an interview were not responded to by Rhodes Pharmaceuticals.

GoLocalProv article included a blurry picture of a large factory building apparently copied from an old website.  I could find no pictures or descriptions of the Rhodes facility on the web other than the picture below from Google Satellite:

The satellite picture does suggest that the Rhodes facility is apparently massive.  However, I could find nothing, at least via web searching, to otherwise describe it.  Despite its size, I could find no coverage of the company, the facility, the buidling of the facility (which likely was quite a project), or anything else relevant in local media, or on the web.

The reasons to keep the ownership of this company mysterious are not hard to fathom.  But the reasons for the company itself to maintain such a "low profile," and for its facilities to be so well hidden, and to have such "massive security" (not otherwise described by GoLocalProv), are ongoing mysteries.

The Mystery of the Sackler Family's Opioid Market Power Partly Solved


It appears that the Sackler's previously secret ownership of Rhodes enabled them to conceal their market power. Per the FT,

Purdue Pharma has always insisted that its drug OxyContin cannot be considered a prime culprit in the crisis because it accounts for only 1.7 per cent of overall opioid prescriptions in the US.

However, Rhodes and Purdue combined accounted for 14.4m opioid prescriptions in 2016, according to figures seen by the FT, giving them a total share of 6 per cent of the US opioid market.

That puts the combined Rhodes-Purdue in seventh place among opioid makers by market share, behind Teva, the generic drugmaking giant, and well ahead of other pharma groups that have been named in lawsuits, such as Johnson & Johnson and Endo.

'This further debunks the Sackler family’s whole claim that they are not responsible for the crisis,' said Andrew Kolodny, a professor at Brandeis University who is one of the foremost experts on the US addiction epidemic.

He added: 'They have always said, ‘Why is everyone picking on us, we’re only 2 per cent of prescriptions?' A spokesperson for the family declined to comment.

A second GoLocalProv article also revealed that

The billionaire family whose company is being sued by states and cities across the country for their role in creating the opioid crisis is now launching a new recently patented antidote for the drug known as ‘heroine in a pill.’

Both oxycodone and the new drug will be produced side-by-side at the Rhodes Technologies plant -- an affiliate company of Purdue Pharma -- in Coventry, Rhode Island.

To corroborate that,

The U.S. Patent and Trademakr [sic] Office information shows the Rhodes Technologies’ plant in Coventry, RI is assigned the patent for the new drug. Rhodes Technologies is the subsidiary of Purdue Pharma owned by the Sackler family.

Calls and emails to Rhodes Technologies and its affiliated marketing company Rhodes Pharma have not been responded to.

Note that the "new drug" that is considered an "antidote" to oxycodone is simply a minor modification of an old drug, buprenorphine, already used to treat opioid addiction.  Per Stat News,

The patent concerns a new formulation of buprenorphine, one of the medications shown to help people with opioid addiction. It is already approved by the Food and Drug Administration in tablet and film form, but the patent describes a wafer that could dissolve even faster than existing forms when put under the tongue.

The patent says that the faster the treatment dissolves, the less risk there is for diversion.

So now we know more about the power of the Sackler family in the opioid market.

The Mystery of Accountability for Deceptive Marketing of Opioids Partly Solved

Purdue Pharma has a long and sorry history of deceptive marketing of its narcotics, and has been accused of being a major driver of the ongoing opioid (narcotic) epidemic.  The case has recently been very well covered in the media.  (Our latest discussion is here, our discussion of Purdue Pharma's first legal troubles, which were fairly anechoic at the time, is here, and all our Purdue Pharma related posts are here.)

It appears that the Sackler's concealed ownership of Rhodes Technologies/ Pharma also put them in a position to generate more financial conflicts of interest among physicians which could be used to enable more deceptive marketing.  A search of the ProPublica "Dollars for Docs" data base revealed that Rhodes paid $1.43M to physicians from August, 2013, to December, 2016.  They paid the most, $121K, to a single physician in Saint Charles, MO.

Admittedly, their contribution to physicians' conflicts of interest was modest compared to that of the Sackler's better known Purdue Pharma, $27.9M over the same time period, but it should not be overlooked.

So we now know a bit more about the extent Sackler family owned opioid manufacturers enlisted physicians to market their products, at times deceptively. 

The Mystery of the Sackler Family's Political Influence

This is admittedly speculation, but it is possible that Rhodes Technologies/ Pharma was also used as a vehicle for political influence to affect policy making relevant to the Sackler's interests.  Purdue Pharma certainly has a track record of such influence.

For example, we noted here that Purdue Pharma donated money to the Washington Legal Foundation in support of its efforts to weaken enforcement of laws that could have penalized the company's misbehavior.   In particular, the Washington Legal Foundation challenged the responsible corporate officer doctrine that allowed legal action against corporate executives for company wrong-doing that occurred on their watches.  Perhaps corporate leaders were worried that its executives could again face penalties, given the Purdue Pharma executives had previously pled guilty to misbranding Oxycontin (look here).  Purdue Pharma had also worked with the Washington Legal Foundation to push against guidelines from the Centers for Disease Control that would have potentially reduced opioid prescribing.

Furthermore, we noted here that Rudolf Giuliani, now President Donald Trump's lawyer, and previously and probably currently highly influential in the Trump regime, formerly represented Purdue Pharma and had helped mitigate the company's punishment for past mischief, an interesting example of the revolving door from the pharmaceutical industry to government.

So I think it is reasonable to say that whether Sackler-owned Rhodes Technologies/ Pharma was also used as a tool to conceal political influence remains a mystery.

Summary

So we now know that the Sackler Family, owner of Purdue Pharma, also owns a generic pharmaceutical company that manufacturers an important portion of the narcotics sold in the US.  Thus the share of the opioid market held by the Sackler family is likely four times larger than was previously apparent .  The Sackler's generic drug company is now known to have paid physicians a small but important amount to assist in its marketing of opioids.  It is also possible that the generic company also has been used to increase the family's influence over politics and policy that increased opioid sales and hence its responsibility for the opioid epidemic.  Thus, it is likely that the Sackler family's responsibility for the ongoing opioid epidemic is larger than was previously appreciated.

Why the Sackler's may have concealed their ownership of the company seems obvious.  Why the company and its physical plant were so secretive is not so clear.  

It is unknown whether the family owns similar companies that have not been discovered.  It is unknown whether big pharmaceutical and other big health care corporations similarly have concealed beneficial ownership of other companies that could be used to conceal all manners of mischief.

Anti-corruption campaigner have pushed to reveal the beneficial ownership of all corporate entities.  (Look here for the relevant report from Transparency International.) They have made little headway, so far.  The case of the mysteries surrounding Rhodes Technologies/ Pharma should be another impetus to support this campaign. 

True health care reform requires all sorts of transparency, now particularly including transparency about corporate beneficial ownership.  

Ill-informed, Mission-Hostile Health Care Leadership... in the White House and the US Department of Health and Human Services

Introduction - What Has Gone Wrong with the Leadership of Health Care Organizations

A major focus of Health Care Renewal has been problems in leadership and governance of health care organizations, which we believe became major causes of health care dysfunction.  For example, 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 as professional managers largely supplanted health care professionals as leaders of health care organizations.  This is part of a societal wave of "managerialism."  Most organizations are now run by such generic managers, rather than people familiar with the particulars of the organizations' work.  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.

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).

We have also discussed mission-hostile management, which in many cases has been demonstrated by ill-informed leadership.

Physicians professional values require them to put the interests of their individual patients ahead of all else, including the physicians' self interest.  The AMA Principles of Medical Ethics, for example, includes

A physician shall, while caring for a patient, regard responsibility to the patient as paramount.

Similarly, in health policy and public health, the goal ought to be putting the health of patients as a group, and the public at large, ahead of other considerations.

However, we have often discussed how leaders of large health organizations seemed to put other considerations ahead of individual patients', patients' collectively, or the public's health.  Most of those examples of mission-hostile management involved putting organizational finances, or the leaders' own self-interest ahead of patients' and the public's health.  For example, in 2017 we discussed a New York hospital CEO who seemed to put revenue generation in support of his own very generous paycheck ahead of quality of care and patient safety (look here).  Also, the revered Mayo Clinic seemed to let patients with more remunerative commercial insurance coverage get attention before poor patients who have only government insurance, despite its stated mission "providing the best care to every patient" (look here).  Before November, 2016, our examples of mission-hostile management were mainly from hospitals and health systems, insurance companies, and pharmaceutical, biotechnology and device companies.

But since November, 2016, the most vivid cases we have found of ill-informed and/or mission-hostile management have come from the US federal government, run by the Trump regime. Note that Mr Trump himself has a bachelors degree in business administration, but no experience as a government leader prior to his election.

New cases continue to arise, while old cases continue to fester. In chronological order based on date of reporting,...

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

We first discussed the hapless Mr Weyeneth in April, 2018.  At the time he was appointed to a position in the White House Office of National Drug Control Policy (ONDCP), Mr Weyeneth was 23, had recently finished his bachelor's degree, and had previously worked as a legal assistant.  He rose to be Deputy Chief of Staff, before he was moved to another job.

In June, 2018, the Washington Post published a long article on Mr Weyeneth's brief government career.  It noted how rapidly at first he rose through the ranks:

Weyeneth received six promotions in the campaign and administration. They culminated with his appointment as deputy chief of staff at the Office of National Drug Control Policy, where he oversaw veteran employees and helped steer an operation that was supposed to lead the fight against the opioid epidemic.

The main reason for his rise seemed to be politics, not any particular qualifications. The White House office of personnel:

wanted someone loyal to Trump and his policies in a position of authority, at a time when the office had lost most of its political appointees and had no leader, Weyeneth said.

Weyeneth had worked on the Trump campaign, starting as an intern, rapidly rising to coordinator of interns, then coordinator for national voter services.  He joined the Trump transition team in an administrative role which included '"helping staff with travel arrangements."  In these roles, he was tasked with determining political loyalty.  For the campaign he created "a list of Republican lawmakers and political figures who openly supported Trump."  For the transition team, he "helped compile a list of trusted politicians who could serve on the 'beachhead teams' that would flood federal agencies in the days and weeks after Trump's inaguration."  We had noted  here various ill-informed, and/or conflicted appointments to the beachhead teams that operated in the health care sphere.  Mr Weyeneth subsequently joined the beachhead team for the Treasury Department.  From there he jumed to the Office of National Drug Control Policy.  Then he became Deputy Chief of Staff, third in command of that agency.

There is nothing in his background to suggest he had any knowledge of medicine, health care, biomedical science, public health, or biomedical science, related or not to drug use.  He did seem to realize how unqualified he was for this job:

'This is more than I ever dreamed of,' Weyeneth recalled thinking, even as he worried about a possible backlash over his lack of qualifications: 'Have I reached too far? Is public opinion going to take over? Is this going to become an article?'

Thus he seemed to realize that he was a profoundly ill-informed leader.


Meanwhile, though, he seemed to have a role in spying on, and ensuring the political loyalty, if not the competence of Office of National Drug Control Policy career staff

The White House tasked him with reporting back on the ­ONDCP operations and the activities of its acting director, a career bureaucrat, Weyeneth said.

That would seem to be an example of mission-hostile management, since government employees are supposed to uphold the US Constitution and work for all the people, and those in health care have an obligation to put patients' and the public's health first.

 In any case, after the media discovered his lack of qualifications, he soon was gone.

Today, Weyeneth is doing temp work, including outdoor labor for a contractor at an intelligence agency.

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

We first discussed Ms Barreto in late April, 2018, here.  She was appointed to a responsible position of leadership in communications for DHHS.  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.

Nonetheless, her previous experience was as an extreme right-wing political commentator who regularly impugned African-Americans and Muslims.  She had talked about hanging former Presidents Clinton and Obama, and accused the latter of being a "Muslim terrorist."

Thus she seemed likely to be a remarkably mission-hostile leader.  Furthermore, there is no evidence she had any background or experience in medicine, health care, biomedical science, public health, or health policy.  Instead, it appears that she was appointed for no reason other than her extreme political beliefs.

In fact, a CNN article from June 22 indicated that Ms Barreto listed her previous on-line career, which would have included some of the postings listed above, on her resume, and hence posited them as qualifications for her leadership position at DHHS.

A copy of Barreto's resume, obtained by CNN on Thursday through a Freedom of Information Act request, shows she listed her previous conspiratorial work on her resume as a qualification for the communication position.

The resume noted her work from June 2017 through the present on 'The Right View' and on the Halsey News Network -- YouTube shows she co-hosted where she said Islam was 'a cult and said the Republican Party shouldn't allow a Muslim to run for Congress.

Another portion of her resume noted her work as a writer for the conspiracy-driven website 'Borderland Alternative Media' from April 2017 to the present. Barreto notes in description the website was funded by 'Joe Biggs, ex-InfoWars journalist' who himself repeatedly pushed the false Pizzagate conspiracy.

So she too was a profoundly ill-informed leader.

By June, she had been suspended, and then demoted, but still seemingly held a responsible position at DHHS.  After her extreme reviews became public, on June 21, 2018, the Mediate website reported 

Health and Human Services official Ximena Barreto publicly apologized recently for her 'heated and hyper-passionate' tweets on race and far-right conspiracies, after they were reported on by CNN.

And,

After her apology, Barreto, who worked as a far-right media personality before joining HHS in December 2017, was allowed to keep her Trump administration job — albeit, with a demotion from her old deputy director of communications post.

In that capacity

She made her Twitter account private ..... But on that now-private account, she’s been unapologetic — recently calling the reports exposing her fringe views a 'smear campaign.'

Mediaite conducted an extensive review of her social media posts and found that the HHS appointee pushed the baseless Pizzagate conspiracy theory even more than previously reported. Her tweets include smearing former Clinton campaign chairman John Podesta as 'a pedophile,' accusing Democrats of hosting 'Pedophile dinners,' and claiming liberals abuse children during satanic rituals.

Remember, this is the former Deputy Director of Communications for DHHS who was still in a leadership position, albeit one whose nature was unclear.

The Department of Health and Human Services and Barreto were contacted repeatedly via email and phone for comment, but did not respond. After this reporter asked for comment, Barreto shut down her private Twitter account and deleted her tweet calling the CNN articles on her views a 'smear campaign.'

Further gory details of her previous online posting are describe in the Mediate article.

Despite all this, Ms Barreto hung onto her DHHS position for more than a month. On July 27, 2018, Politco finally reported:

Ximena Barreto — a Donald Trump political appointee who used social media to spread conspiracy theories about a supposed pizza shop sex ring and made other inflammatory remarks — was escorted from Health and Human Services Department headquarters Friday, according to an individual with knowledge of the situation.

Barreto resigned, the individual said. HHS did not immediately respond to a request for comment.

Gavin Smith, Former Deputy Director of Communications, DHHS; David Pasch, Digital Director, DHHS; Tim Clark, Former White House Liaison and Interim Director of  Communications, DHHS


The issue with Ximena Barreto was her activities prior to taking a leadership position at DHHS.  However, on June 29, 2018, Politico reported on several DHHS officials who had been publishing pointed political opinions on the internet while in office.  It opened with

One staffer publicly mocked senators who criticized Donald Trump as 'clueless' and 'crazy.' Another accused Hillary Clinton of having a campaign aide killed and employing pedophiles. A third wrote the 'shameful' press was trying to deny Trump his victories.

These are not faceless trolls but midlevel political appointees at the Health and Human Services Department who have helped shape the agency’s communications strategy — even while taking a page out of President Donald Trump’s playbook.

Politico summarized how this might be mission-hostile management.

The behavior evokes Trump’s taunts and gibes, suggesting that some officials feel empowered to mimic the president even while representing the government to millions of taxpayers and working alongside career federal employees.

Again, as noted above, DHHS is supposed to work for all the people, not just the political allies of the current administration.  Furthermore, because these activities were by people within the government, there was an immediate legal question.

It also raises questions about whether any officials are violating the Hatch Act, which is intended to ban most federal personnel from bringing politics into the workplace.

Further details about each individual case follow.

Gavin Smith

One official involved was "Gavin Smith, an HHS staffer who identifies himself as deputy communications director."  His interests focused on pursuing Republicans who had opposed Trump in some sense.  His offerings on Twitter included the following directed to Republican Senator Bob Corker, who has frequently disagreed with Trump:

Just saw where Crazy @BobCorker called the #TrumpTrain a 'cult! Let's be clear sir, we're not a cult — we're a movement that defeated Crooked @HillaryClinton and that's committed to ridding Washington of politicians like you. Good riddance — DC will be better off with you!

Other Tweets included:

'Well, we've always known he's clueless,' Smith said, retweeting a quote about Sen. Lindsey Graham, and in another tweet telling the Republican senator to 'delete your account.' Other Smith tweets mocked Mitt Romney as a “clown” and encouraged all living ex-presidents 'to finally pipe down and get on board with the will of the #American people to #MAGA!

'Getting your ass kicked once just wasn't enough for you, was it @JohnKasich? Lookin' forward to Round Two! #MAGA' Smith tweeted in response to reports that the Ohio governor was considering a 2020 presidential bid. Meanwhile, Smith has waded into politics in his home state of South Carolina, including sharing an article about him possibly challenging a sitting House representative and repeatedly weighing in on local issues.

'Perhaps the South Carolina legislature will finally listen to @TreasurerLoftis — or will they make yet another bad deal on behalf of the #SC taxpayers?' Smith wrote in December, referencing a failed energy project. 'Make no mistake legislators, we are watching you. Each and every one of you.'

Smith's pinned tweet, posted last Saturday and retweeted hundreds of times, features a photo of Smith behind a Trump-emblazoned podium and endorses South Carolina Gov. Henry McMaster for reelection.

Note that #MAGA stands for Trump's campaign slogan, not an official US government policy.

So Smith was again acting like his job was to promote Trump's politics, not patients' and the public's health.  So he was at least a mission-indifferent leader.

Smith's LinkedIn profile claimed he, unlike Ms Barreto, actually had a background in communications/ public relations.  His other positions ranged from managing in a real estate firm and a deli, and various political jobs.  A managerialist might have deemed him qualified.  However, he provides no evidence of any background or experience in medicine, health care, biomedical science, public health or health policy. Thus he was another ill-informed leader.

The Politico article quoted one expert who suggested that Smith's Tweets might have been illegal

Government transparency experts said that some of Smith’s tweets could violate the Hatch Act’s prohibitions on executive branch employees engaging in partisan messages, pointing to February 2018 guidance released by the Office of Special Counsel.

'The Hatch Act prohibits federal employees from engaging in political activity, including posting on Twitter or Facebook, while on duty or in the federal workplace,' said Daniel Stevens of the Center for Accountability. 'If James posted comments regarding McMaster while in a federal building or during his work hours, he likely violated the Hatch Act.'

David Pasch

The article included a picture to illustrate how

David Pasch, who ran HHS’ digital communications until this month, regularly parked his car — with 'FAKENWS' vanity license plates — outside of agency headquarters.

Pasch also had a

Facebook profile photo also touts an image of him with the message 'fake news.'

Pasch's LinkedIn profile only included political jobs.  One was with an organization called  Generation Opporunity. A 2015 Politico article stated

Generation Opportunity, a libertarian-leaning group with ties to the Koch brothers, released a series of ads featuring 'Creepy Uncle Sam' to discourage young people from enrolling. But this season, the group is putting its energy into other issues like higher education and unemployment, said communications director David Pasch.

We had posted about the Creepy Uncle Sam ads as examples of stealth health care policy advocacy that encouraged bad decision making.  So Mr Pasch seemed to be a classically ill-informed leader, whose previous work on "Creepy Uncle Sam" suggests he was mission hostile as well.
 
And just to gild the lilly, while Pasch's disclosures of possible financial conflicts of interest per ProPublica are not too striking, an easy Google search revealed one possibly significant conflict of interest that he did not reveal, albeit on involving his spouse.  Per their marriage announcement in the New York Times from 2017,

The bride’s father is the chairman, president and chief executive of Sanderling Healthcare in Nashville. He was also the founder of REN Corporation-USA, a provider of dialysis services.

Tim Clark

The Politico article stated

Tim Clark, the agency's White House liaison who also served as HHS' interim communications chief this year, in 2016 sent tweets sharing allegations that Hillary Clinton's campaign paid people to incite violence at Trump's rallies, based on a hidden-camera video produced by Project Veritas' James O'Keefe. Democrats disputed the charge and distanced themselves from the individuals in the edited video.

'Wikileaks & O'Keefe video shows Hillary blatantly disregards election laws,' Clark tweeted in October 2016, while he was California director for the Trump campaign.'"Election must be free & fair.'

Clark also repeatedly used a #SpiritCooking hashtag to promote his pro-Trump tweets, referencing allegations about Clinton campaign chief John Podesta engaging in Satanic practices, based on an email forwarded to Podesta's brother Tony and obtained by WikiLeaks. The term 'spirit cooking' was used by artist Marina Abramović, who was hosting a dinner and invited the Podestas, and in November 2016 said the term was "taken completely out of my context ... it was just a normal dinner."

Clark's Twitter account is now private.

Clark seems likely to have been mission-hostile because of his apparent hostility to various groups within the US population whom he was obligated to serve while at DHHS.

Because he has a very common name, searching did not reveal much specific information about Clark's background, but a subsequent article on July 13, in Politico that noted his and Smith's departure, stated, 

Clark was the California chairman of Trump's campaign and became the health department's chief liaison with the White House, a crucial gatekeeper for the agency's policies and staffing. Clark worked to hire and protect a number of Trump campaign veterans who were allowed to remain on the job after their social media posts became public, according to multiple sources inside the agency.

These included Ms Barreto. I found nothing to suggest Mr Clark had any experience or expertise in medicine, health care, biomedical science, public health, or health policy.  So he was an ill-informed leader as well

Again, per the July 13 article, Clark and Smith have left DHHS.

Summary

So our knowledge of cases of ill-informed and mission-hostile leadership of health care agencies within the US government increases.  As we stated in April,

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.