Friday, August 17, 2018

#WHISTLEBLOWER tonight on CBS at 9 pm: Brendan Delaney and Electronic Medical Records

I received this today. This type of scenario is not what the pioneers intended, and is an example of how some in the healthcare information technology industry may have less of the altruism and responsibility that clinicians feel towards the medical mission. Settlement information is here: https://www.healthcareitnews.com/news/eclinicalworks-pay-155-million-settle-suit-alleging-it-faked-meaningful-use-certification --------------------------------------------------- hashtagWHISTLEBLOWER tonight on CBS at 9 pm: Brendan Delaney and Electronic Medical Records Tune in tonight to hear Brendan Delaney’s Medical Records Whistleblower story – with Stowe Vermont Gables Inn’s Randy Stern, Phillips and Cohen LLP’s Colette Matzzie, and Ass’t US Attorney, VT Owen Foster’s help telling the story. Please share widely on your social media! https://lnkd.in/deaCH2k for a clip. Thanks to all of you who have made our telling of this important story possible. And to Alex Ferrer our host and Alex, Susan Zirinsky and Ted Eccles our EP’s Ron Hill our DP! And Editors: Maria Barrow, David Spungen and Greg Kaplan. Best regards, Team Medical Records: Chiara Norbitz, Peter Bull and Marty Spanninger Martha Spanninger Producer

--------------------------------------------------- -- SS

Friday, August 10, 2018

Make Asbestos Great Again? - Trump Once Claimed "Movement Against by Asbestos was Led by the Mob," Now EPA Wants to Relax Asbestos Regulation

Introduction:  An Old Public Health Menace

This is somewhat personal.  In the early 1980s, as a general internal medicine fellow, I gave a series of talks about important medical problems that generalist physicians often missed.  One was asbestos related disease.  Although asbestos had been heavily regulated since 1973, there were stilll large numbers of people exposed to it alive in the 1980s.  One of my primitive slides, seemingly a picture of type writing, stated that around then, 2 to 4 million people who had histories of significant asbestos exposure were likely alive.  Asbestos is known to cause several cancers.  It is likely the nearly exclusive cause of mesothelioma.  It also causes lung cancer, and may act synergistically with smoking, and likely gastrointestinal and head and neck cancer.  It causes asbestosis, which can lead to respiratory failure.

In 2018, the evidence that asbestos is a major health hazard is quite clear. (See summaries by The National Cancer Institute, the Agency for Toxic Substances and Disease Registry, the Occupational Safety and Health Adminstration.)  Note that the rates of death from mesothelioma per capita are declining, but still substantial (look here).  The application of asbestos can be very hazardous, but once applied it can still endanger not only those who remove it, but firefighters, other first responders, etc.  People can be exposed indirectly, e.g., from asbestos on the clothes of people who work directly with it. 

Unlike other countries, the US never banned asbestos outright.  However, per the NCI report, 

In the late 1970s, the U.S. Consumer Product Safety Commission (CPSC) banned the use of asbestos in wallboard patching compounds and gas fireplaces because the asbestos fibers in these products could be released into the environment during use. In addition, manufacturers of electric hairdryers voluntarily stopped using asbestos in their products in 1979. In 1989, the U.S. Environmental Protection Agency (EPA) banned all new uses of asbestos; however, uses developed before 1989 are still allowed.

Trump Called the Movement Against Asbestos a Plot by Organized Crime

As we discussed in 2016, Donald Trump has pooh poohed all that.  Per Mother Jones,

In his 1997 book, The Art of the Comeback, Trump warned America not to buy the crusade against 'the greatest fire-proofing material ever used.' He claimed the movement to remove asbestos—a known carcinogen—was actually the handiwork of the mafia:

'I believe that the movement against asbestos was led by the mob, because it was often mob-related companies that would do the asbestos removal. Great pressure was put on politicians, and as usual, the politicians relented. Millions of truckloads of this incredible fire-proofing material were taken to special 'dump sites' and asbestos was replaced by materials that were supposedly safe but couldn’t hold a candle to asbestos in limiting the ravages of fire.'

Trump claimed asbestos is '100 percent safe, once applied,' and that it just 'got a bad rap.'

This year, Rolling Stone revealed,

Trump has also on multiple occasions blamed the collapse of the two World Trade Center towers on the absence of asbestos. In June, All in With Chris Hayes aired a clip of Trump defending the material before Congress in 2005. 'A lot of people say that if the World Trade Center had asbestos is wouldn’t have burned down, it’s wouldn’t have melted. OK?,' he said. 'A lot of people in my industry think asbestos is the greatest fireproofing material ever made.' Trump went on to compare asbestos to a 'heavyweight champion' compared to other building material, which he likened to a 'light-weight from high school.'

The article also stated that

As Hayes notes, Trump’s penchant for asbestos is almost certainly due to the cost of having it removed, which was undoubtedly a nuisance to a man known for stiffing contractors and cutting every regulatory corner imaginable.

Trump's beliefs, not to put too fine a point on it, to be nonsense, albeit somewhat consistent nonsense. In 2016, I wrote,

It is disturbing when one candidate for the most powerful political office in the US repeatedly disregards the best clinical and public health evidence, and offers ill considered opinions about public health that could potentially harm patients.

Now Trump is President, and in a position to act on nonsense.

Trump's EPA Appears Ready to Relax Asbestos Regulation

This week, the distinguished occupational health journal Rolling Stone reported,

On June 1st, the EPA enacted the Significant New Use Rule, which allows the government to evaluate asbestos use on a case-by-case basis. Around the same time, the EPA released a new framework for how it evaluates chemical risk. Not included in the evaluation process are the potential effects of exposure to chemicals in the air, ground or water. It’s as absurd as it sounds. It is ridiculous,' Wendy Cleland-Hamnett, who recently retired after four decades at the EPA, told the New York Times. 'You can’t determine if there is an unreasonable risk without doing a comprehensive risk evaluation.'

The new evaluation framework is a nifty way for the EPA to circumvent an Obama-era law requiring the EPA to evaluate hundreds of potentially dangerous chemicals. Asbestos is among the first batch of 10 chemicals the EPA will examine, and also one of the most blatantly dangerous to public health.

Quartz explained further,

On July 1, the US Environmental Protection Agency issued a 'significant new use rule,' which invites manufacturers to petition the EPA to seek approval of any new asbestos product on a case-by-case basis.

The rule says that the EPA will evaluate new asbestos products as 'new use' if they’ve determined they aren’t currently being manufactured. The categories the EPA says it will consider as new uses include 'adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; extruded sealant tape and other tape; filler for acetylene cylinders; high-grade electrical paper; millboard; missile liner; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; and any other building material (other than cement).'
Today, the New York Times reported that the EPA's new approach was launched by Trump political appointees over the objections of career, professional staff.

Top officials at the Environmental Protection Agency pushed through a measure to review applications for using asbestos in consumer products, and did so over the objections of E.P.A.’s in-house scientists and attorneys, internal agency emails show.
So it looks like these top officials are trying to operationalize Trump's enthusiasm for asbestos despite the absence of any new evidence that asbestos is less dangerous than previously thought, and despite the suggestion that Trump's enthusiasm may be self-interested.

On No, Russians Too

Two years ago, it seemed that one could attribute all of Trump's bias against asbestos regulation had to do with his real estate development background.  However, Rolling Stone found another possible influence on him.

As with many of his more insidious actions as president, there’s a Russia connection. As the Washington Post points out, until recently, 95 percent of asbestos used in the United States came from Brazil, while the rest came from Russia. But the South American nation recently banned the mining and sale of the toxic substance, opening the door for Russia to fill the gap, which will be even larger if the U.S. resumes using the carcinogen in building materials. Russian asbestos manufacturers are thrilled. In July, the Russian company Uralasbest posted an image of its asbestos packaging, which features a smirking President Trump.

The NY Times verified that 

the Russian firm Uralasbest posted on Facebook an image of its asbestos packaging that featured President Donald J. Trump’s face along with the words: 'Approved by Donald Trump, 45th president of the United States.' 

So it appears that the push by EPA political appointees to make asbestos regulation lax again would benefit Russia, a country for which Trump seems to feel great affection. 

Summary

Donald Trump long has had strong opinions on all sorts of topics.  His opinions about the public health hazards of asbestos seemed more informed by his self-interest as a real estate developer than anything resembling clinical or epidemiological evidence.  When he was just a rich real estate developer these seemingly misinformed opinions were of little consequence.

Now he is US President and his misinformed decisions could have major consequences, including eventually lethal ones.  Unfortunately, he seems to make such decisions so rapidly that no one can keep up.  And few of the people he has appointed to top leadership positions, particularly in health care and public health, seem inclined to stand up for more logical, evidence-based, and unconflicted and uncorrupted decision making. 

Obscure parts of asbestos regulation may not get a lot of attention, and may not be as dangerous as decisions about, say, nuclear weapons, but they still could be quite dangerous.  I hope those who care about medicine, health care, and public health will speak out against any new laxity in asbestos regulation.  In 2016 we had an opportunity to prevent a regime of the conflicted and uninformed.  Now we must challenge its bad decisions more directly. 

Musical Interlude

The immortal Warren Zevon, Lawyers Guns and Money: "how was I to know she was with the Russians too?" - Live Version







Sunday, August 05, 2018

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.   

Friday, July 27, 2018

Spin it Again - Four More Go Through the Revolving Door From the World of Corporate Health Care to Top US Government Leadership Positions


While we were distracted by the daily onslaught of news, it appears that the revolving door continues to spin.



This month there has been a flurry of transitions from big health care and health care related corporations to the federal government.  So it appeared to be time for another revolving door update.


We start with a transition from a few months ago that we had not previously discussed, and then list in chronologic order those occurring this month.

Dr Kurt Rasmussen from Senior Research Advisor, Eli Lilly & Co to Director of the Division of Therapuetics and Medical Consequences, National Institute for Drug Abuse (NIDA)

This was noted in Stat News Plus, behind a pay wall, and in an official announcement from NIDA on April 30, 2018,

The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, welcomed Dr. Kurt Rasmussen today as the Director of the Division of Therapeutics and Medical Consequences (DTMC). Dr. Rasmussen’s career spans more than 30 years of research and leadership experiences in pharmacology and neuroscience therapeutics.

Dr. Rasmussen comes to NIDA from Eli Lilly & Co., where he served as a senior research advisor, leading drug discovery research programs.

At least he is an actual biomedical researcher.

I could not find any information on whether he has ongoing financial ties to Eli Lilly, e.g., stock holdings.

Dr Richard Stone from Vice President, Booz Allen Hamilton, [a Management Consultancy] to Temporary Executive in Charge of the Veterans Health Administration

Per the Wall Street Journal, July 17, 2018,

The Department of Veterans Affairs will replace the acting head of its health care system with a temporary appointee on Wednesday, the VA’s acting secretary said Tuesday, though the department still hasn’t settled on a permanent replacement to lead the sprawling division.

Dr. Richard Stone will take over the Veterans Health Administration, the VA’s acting secretary, Peter O’Rourke, told reporters. The health administration is one of the three main branches of the VA and comprises more than 1,500 health-care facilities, thousands of physicians and nurses and a budget of about $70 billion to treat some nine million veterans.

Also

Dr. Stone, a retired Army doctor, previously served at the VA as deputy undersecretary for health before becoming a vice president at Booz Allen Hamilton focused on military health.

Booz Allen Hamilton is a management consulting firm.  The Booz Allen Hamilton press release of January 29, 2016, issued when Dr Stone joined the firm, described his responsibilities 

General Stone will serve as medical advisor for Booz Allen’s healthcare clients who are transforming healthcare delivery in the defense, civil, and commercial markets. He will assume a leadership role in the firm’s work for the Military Health System (MHS) across the Services and ultimately across the new Defense Health Agency (DHA) and Enhanced Multi-Service Markets (eMSMs).

Booz Allen Hamilton apparently does not widely advertise the identities of its clients, but on the Markets section of its website, claims

We serve commercial clients across all industries, including some of the largest organizations in critical infrastructure sectors like financial services, energy, healthcare, and manufacturing, and we have a thriving cadre of international clients in the Middle East and Southeast Asia.

So presumably Dr Stone had responsibilities helping big commercial health care firms improve their bottom lines. In his new position, Dr Stone may be in a position to influence how some such big firms interact with the VA in an administration that is increasingly advocating privatization of many VA functions.

Paul Mango from Director, McKinsey & Company, [a Management Consultancy] to Chief of Staff and Principal Deputy Administrator, Center for Medicaid and Medicare Services (CMS), Department of Health and Human Services (DHHS)

Per the Philadelphis Inquirer on July 24, 2018,

Paul Mango, a former health-care consultant who lost a bid this year to be the Republican nominee for governor of Pennsylvania, is joining the Trump administration.

The Center for Medicare and Medicaid Services, which is housed in the Department of Health and Human Services, on Tuesday named Mango chief of staff and chief principal deputy administrator.
In addition,

Mango, who lives outside Pittsburgh, was a longtime executive at the consulting firm McKinsey & Co.

It appeared he needed something new to do.  He had left his very long-term position with McKinsey & Company to run for Governor of Pennsylvania in 2017, per Politics PA,

PoliticsPA has learned that Gubernatorial Candidate Paul Mango of Allegheny County is no longer with McKinsey & Company. This move could signal he is closer to an official announcement of a run for Governor.

Mango left the firm earlier this year. He joined McKinsey in 1988,

But then, per the Inquirer,

He finished second in a three-candidate primary in May for the GOP gubernatorial nomination, losing to former State Sen. Scott Wagner.
leaving Mr Mango temporarily unemployed.  His new employment apparently was not due to any actual background or expertise in medicine, health care, or public health,
An Army veteran, Mango graduated from the U.S. Military Academy and Harvard Business School.

The Inquirer article suggests Mr Tango was attractive to the Trump regime more for his political views than any expertise or lack thereof in health care,

Mango ran as a social conservative who attacked Wagner for supporting anti-discrimination legislation that would protect LGBT individuals. He said during the campaign that he supported work requirements for able-bodied adults on Medicaid. The Trump administration has adopted that approach.

Mr Mango does claim expertise as a business manager in the health care sphere.  He has an affiliation with the University of Pennsylvania's  Center for Health Incentives and Behavioral Economics in the Leonard Davis Institute.  His profile there explains his former work at McKinsey thus,

Mr. Paul Mango is a Director for McKinsey & Company and leads the North American Payor/Provider practice. Mr. Mango has been addressing new approaches to medical management, development of distinctive service strategies, physician channel management effectiveness, and applying lean manufacturing principles to patient care delivery processes. He has led health care engagements spanning a broad spectrum of strategy, operations and organization topics related to these new approaches. Paul works extensively with some of the country’s largest payers and providers....

McKinsey & Company does not advertise its clients, but it is likely that the Payor/ Provider group worked with major, non-profit and for-profit hospital systems and health insurers.  Its website discusses its "payor strategy" thus,

The challenges facing the leaders of payor organizations—improving financial performance, increasing cost effectiveness, improving population health status, and boosting quality of care—are not new. What is different today is the increasing need to address them all.

Our strategy work focuses on driving value. The starting point varies depending on the clients and geography, but whether we are supporting a public payor, a private payor, or a mix, we have a deep understanding of the complexities our clients face and can draw upon our international experience for best practices and key insights.


Its website also discusses "provider performance" thus,

We help hospitals implement strategies, operating models, and organizational enhancements that sustain improvements in quality of care and boost cost effectiveness.

So presumably Mr Tango's responsibilities including the cost effectiveness of commercial health insurance firms and quite possibly for-profit hospital systems.  In his new position with CMS, Mr Mango may be in able to influence how big payors and providers interact with the Medicare and Medicaid systems, potentially to their benefit.


Chris Traylor from the [Health Care Consultancy] Advanced Perspectives Group to Deputy Administrator for Strategic Iniatives for the Center for Medicare and Medicaid Services (CMS) of DHHS

On July 24, 2018, an announcement from CMS noted that Chris Taylor was joining the organization along with Mr Mango,

Chris Traylor joins the Office of the Administrator as the Deputy Administrator for Strategic Initiatives. Chris comes to CMS with over 26 years of public sector service in the area of healthcare and social services. His lengthy public service career in Texas concluded in 2016 when he retired as the Executive Commissioner of the Texas Health and Human Services Commission (HHSC) after previously serving as the commission’s Chief Deputy Executive Commissioner.

So it appears Mr Taylor has a long experience in health care management within state government.  I could find nothing to indicate he has any direct experience or expertise in medicine, the actual provision of health care, or public health.  But also,

Since 2016, Chris has been leading a healthcare consulting firm serving clients in hospital operations and finance, long term services and supports, dental and oral health services, managed care and bio-health.

It appeared that since 2016, he worked for the Advanced Perspectives Group, which is, per its web-site,

a newly formed consortium of uniquely qualified consultants who have worked extensively in the health and human services arena both at the state and federal levels. Collectively, we have over 200 years of experience working in a variety of leadership positions in state and federal government. This experience brings our clients an important resource and an unparalleled understanding of agency operations and policy formulation-which enables us to help our clients create solutions that fit within the framework of Texas Health and Human agencies, their federal partners, and the policies that fall within those jurisdictions.

Advanced Perspectives Group, like other commercial health care consultancies, does not advertise its clients, but the biographies of individual principals suggest that clients include for-profit health care corporations.  Again, in his new position Mr Traylor may be able to influence how such corporations interact with Medicare and Medicaid. 

Discussion

So this round of revolving door transitions featured a top pharmaceutical company researcher going to a leadership position at the NIH, which was considered long ago as a producer or unbiased science; and one physician-manager and two pure managers going from big management consultancies to DHHS.  All these consultancies seem to have thriving businesses working with big commercial health care firms. So the Trump regime continues to stock top health care leadership positions with people from the commercial health care world.  These leadership positions will allow them to to control contracting with, policies that affect, and regulation of big health care corporations, including those they worked with or for, and their competitors, for that matter.

So, as I have said before, e.g., three and four months 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 regime once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

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

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

Friday, July 20, 2018

Chipping Away at the Anechoic Effect: Now the New York Times Protests the Demise of the AHRQ National Guidelines Clearinghouse

Background: the Quiet Announcement of the Death of the Clearinghouse

On June 1, 2018, we wrote:

Apparently as of late April, a terse announcement appeared on the website of the US AHRQ National Guideline Clearinghouse:


The AHRQ National Guideline Clearinghouse (NGC, guideline.gov) Web site will not be available after July 16, 2018 because federal funding through AHRQ will no longer be available to support the NGC as of that date. AHRQ is receiving expressions of interest from stakeholders interested in carrying on NGC's work. It is not clear at this time, however, when or if NGC (or something like NGC) will be online again. In addition, AHRQ has not yet determined whether, or to what extent, the Agency would have an ongoing role if a stakeholder were to continue to operate the NGC. We will continue to post summaries of new and updated evidence-based clinical practice guidelines until July 2, 2018. For any questions, please contact Mary.Nix@ahrq.hhs.gov.

There was no further explanation.

This announcement has been largely anechoic, noted only by a few blogs and websites, e.g. the American Bar Association.

We went on to summarize the importance of this clearinghouse as a reasonably comprehensive source of material about the myriad clinical practice guidelines that have been promulgated ostensibly to improve medical care.  Its importance was recently enhanced by the addition of ratings of the trustworthiness of particular guidelines derived from standards developed by the US Institute of Medicine (look here).  In turn, these standards were necessary because many published guidelines were afflicted with methodologic problems.  Some amounted to little more than informal recommendations of experts.  Many guidelines were suspected of being influenced by commercial sponsors or by the financial relationships of the people involved in developing them.  Pharmaceutical, biotechnology, device and other firms that market health care goods and services have long been interested in meddling in guideline development to assure that guidelines put their products and services in a favorable light.

We concluded

Now we will lose an important resource for teaching, research, and evidence-based practice, whose loss will make it easier to hucksters to promote drugs, devices, and programs that are not as efficacious or safe as advertised.  But the good times will continue to roll.

We could call for the reinstatement of the AHRQ National Guideline Clearinghouse.  Ah, but we may as well try and catch the wind.

Again, note that as of June 1, 2018, nothing about the shutdown of the clearinghouse had appeared in the media, or in medical or health care scholarly journals.  We hoped maybe the post in our humble blog would start some discussion.

Further Media Coverage

At the time, despite our hopes, experience suggested nothing much would happen.  This time, however, we were wrong.

Stat News

The topic was picked up on June 13, 2018 by Stat News.  Ivan Oransky and Adam Marcus opened with:

Diagnostic and treatment guidelines aren’t sexy, but they play a vital role in the practice of medicine.

Oransky and Marcus found that the NGC was actually fairly heavily used, drawing 200,000 visitors a month.  After further summarizing the issue, they noted the ambiguous official justification for the closure of the clearinghouse.

'The decision to end support for the NGC was an Agency decision based on assessing how best to use our current resources, including both appropriated dollars and dollars from the Patient-Centered Outcomes Research Trust Fund,' the AHRQ spokesperson told STAT. The AHRQ budget for the 2019 fiscal year, as proposed by the Trump administration, 'will re-focus support to only the highest priority research programs.'

They also excerpted our conclusions above, and lamented,

With the date of death for the NGG barely a month away, America’s doctors — and their patients — may, to paraphrase another clearinghouse, already be losers.

Daily Beast

One month later (July 12, 2018) the Daily Beast published a longer account of the then impending shut down of the clearinghouse, written by Jon Campbell, an investigator for the Sunlight Foundation.  Campbell noted how

medical research like that maintained by the NGC can be politicized, [so] AHRQ drew the ire of then-congressmember Tom Price in 2016 when it published a study critical of a drug manufactured by one of his campaign donors. According to ProPublica, one of Price’s aides emailed 'at least half a dozen times' asking the agency to pull the critical research down. Price was the first director of HHS, AHRQ’s parent agency, under the Trump Administration, before resigning under pressure last year over his spending on chartered flights.

Note that we had discussed then Representative Price's intervention here.

Campbell interviewed several people, including your humble scribe, about the meaning of the AHRQ's actions, and concluded with

'Losing [the NGC] is really losing a valuable resource,' said Ana Maria Lopez, President of the American College of Physicians. She said the NGC is a primary source for her organization’s research, and noted that digital repositories like the NGC are only more critical today.

Other Coverage

Since then, Vox and CNN have covered the issue on July 16, the day of the planned shutdown. The surge of concern about the topic did not apparently prevent it from happening, however.

The New York Times Weighs In

Today, however I was surprised by the lead editorial in the New York Times today about the demise of the NGC, entitled "Want Reliable Medical Information? The Trump Administration Doesn’t." It included this pithy comparison:

The official explanation is maddening enough: a budget shortfall that roughly equals the amount Tom Price spent on travel during his brief tenure as department secretary. The site costs just $1.2 million a year to operate, and is maintained by an agency with a budget of more than $300 million.

It concluded hopefully with:

A better solution would almost certainly be for Congress to appropriate the money needed to keep the database up and running. It could do that simply by renewing the Affordable Care Act fund that was covering the database’s operating costs, and that is scheduled to expire in 2019.

Of course, Congress will take that action only if constituents demand it. But in a country that has voted representatives in and out of office based on their health care policies, and that prides itself on drawing attention to intractable diseases (we dump ice buckets on our heads to raise funds to fight A.L.S., and walk countless miles for breast cancer), evidence-based medicine should be an easy sell. 

I am not holding my breath.  However, I never thought this issue, perhaps a small on given the huge political dysfunction that grips the country, would make it much farther than my blog post of June 1.  So we can hope. 

Furthermore, there has been movement towards preserving some of the clearinghouse's functions.  As discussed in Modern Healthcare on July 17, 2018, the ECRI Instsitute plans to resurrect the site.  It would no longer be free, but will be based on a subscription model which ECRI hopes will keep the costs reasonable.  So at least that is real progress since June 1.  

Discussion

Many people bemoan the current political situation, but some feel there is nothing they could possibly do the improve things.  We have been publishing this blog since 2004 with the hopes that chipping away at the anechoic effect which has hid the severity and nature of health care dysfunction might actually help to improve things.  However, at times we wondered if we were having any effect.  What good are individual actions like blog posts? 

It seems that most of us have little individual power.    Collectively, though we may have more than we realize.  Small individual actions can add up. I hope the at least partial resurrection of the National Clinical Guidelines Clearinghouse will provide an example that will inspire further individual actions to address health care dysfunction, and the much larger political and economic dysfunction that generate it, and that now threatens us all.  

Sunday, July 15, 2018

A Physician Who Had Run Clinics Which Proselytized Patients is Now a Government Health Care Leader Positioned to Enforce Her Religious Beliefs on Patients and Citizens Who Do Not Hold Such Beliefs

Introduction: Physicians' Values and Organizational Missions

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

VIII. 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 finances 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 hospitals and health systems, insurance companies, and pharmaceutical, biotechnology and device companies.


That was then.  This is now.

A Physician Who Seemed to Put Her Religious Beliefs Ahead of Patients' Interests

Late this spring, we noticed the appointment of a US government health care leader which raised concerns about mission hostile management, but in a new dimension. The appointment was summarized by Rewire on May 30, 2018,

Diane Foley, who ran a Christian organization operating two Colorado anti-choice 'crisis pregnancy centers,' or fake clinics, was quietly installed on Tuesday as deputy assistant secretary for population affairs, where she will lead the office responsible for the Title X federal family planning program.

The U.S. Department of Health & Human Services (HHS) said little about Foley in its announcement of her appointment to the Office of the Assistant Secretary for Health, saying she 'has a long and distinguished career working in the healthcare and the public health arenas.'

Foley will oversee the Office of Population Affairs (OPA), which administers Title X, a program providing family planning and related services to more than 4 million primarily low-income people in the United States, many of whom face systemic barriers to health care.

While Dr Foley's purview would be providing family planning services, she seems to opposed to the provision of most conventional family planning services,not only abortion, which is admittedly controversial, but also including contraception, and adoption.  For example, as reported by Tonic (a part of Vice News) on June 5, 2018, she said in a speech on 2016 that a pregnant woman has three choices

parent the child, give it up for adoption, or have an abortion .... She said that having the baby is thought of as 'death to [the parents] and the life they thought they were going to have,' adding, 'The next choice is, let’s do an adoption plan. Well, that’s a double death, because not only does it interrupt [the parents] plans for the next several months, right? But then their child is going to be adopted, and they’re going to grow up thinking they’ve been abandoned by their parents. So they’re going to have all kinds of issues with their life. So that’s a double death. That’s worse.'

Given her opposition to adoption, it is not much of a surprise that she seems opposed to even talking about the simplest forms of contraception. The Rewire article stated,

Foley suggested that it may be considered 'sexually harassing' to demonstrate in a classroom how to use a condom on a banana, the Colorado Springs Independent reported in 2010.
Foley is a physician.  Another Tonic (from Vice) article on June 5, 2018, noted that an official DHHS statement about Dr Foley's hiring stressed,

that Foley is a board-certified pediatrician with 30 years of experience, most recently in private practice in Colorado.
 
The DHHS official leadership bio for Dr Foley went into more detail,

Dr. Foley is a graduate of Marion College (now Indiana Wesleyan University) and of Indiana University School of Medicine. She is a Diplomat of the American Board of Pediatrics, a member of the Society of Adolescent Health, and served on numerous other national boards and committees.

Also,

Dr. Foley has spent her professional career in the clinical practice of pediatrics with a focus on adolescent health. Originally from Indiana, Dr. Foley founded and served as medical director of Northpoint Pediatrics shortly after completing a residency in pediatrics. She spent the next seventeen years establishing what is still one of the largest pediatric practices in central Indiana. During this same period, she also served as a pediatric clinical instructor for pediatric and family practice residency programs at the Indiana University School of Medicine. Dr. Foley’s areas of special interest are adolescent gynecology, prevention and treatment of sexually transmitted diseases, healthy family formation, and global health, all of which she continued to focus on after her move to Colorado in 2004.

Most recently, she was in part-time clinical practice at a certified Centers for Medicare & Medicaid Services Critical Access Hospital in Lamar, Colorado.
As a physician, Dr Foley's prime directive was to put the interests of individual patients ahead of her self-interest.  If Dr Foley had religious convictions that would not allow her offering women patients mainstream management approaches to family planning, for example, adoption or contraception planning, Dr Foley could have chosen to practice in a setting where she need not have ever offered those options, for an example relevant to pediatrics, neonatology.  However, it seemed that Dr Foley chose to explicitly put herself in situations where she could combine proselytizing with practice.  As described in a Slate article of June 1, 2018, stated,

Until last year, she was the president and CEO of the Life Network, an organization that operates two anti-abortion crisis pregnancy centers in Colorado Springs that run abstinence-only education programs for teens. The purpose of crisis pregnancy centers is to convince women not to have abortions, sometimes after luring them in with deceptive advertising that makes them seem like abortion clinics or general health facilities. 'Through our pregnancy centers we have the opportunity to see God use the miracle of ultrasound to change and save lives,' Life Network’s website says. The first element of its mission is 'presenting the gospel of Jesus Christ.'
The fundamentally deceptive nature of these clinics seem to suggest that Dr Foley violated another provision of the AMA Principles of Medical Ethics

II. A physician shall uphold the standards of professionalism, be honest in all professional interactions,...

Thus, rather than avoid clinical situations in which abortion would be considered to be a management option, she chose to work in such settings in order to try to prevent patients from having abortions, based on religious grounds.  She worked in what looked like clinics, but which were dedicated to preaching the gospel.

Furthermore, the organization Dr Foley ran also specifically sought to deter young women from using conventional contraception. Tonic (part of Vice News) reported that the organization Dr Foley led

Life Network, the organization that Foley led until 2017, offers 'sexual risk avoidance programming,' aka abstinence-only sex ed, for middle and high school students, under the moniker Education for a Lifetime. As part of her work with that program, Foley told a reporter in 2010 that it’s too difficult to teach teenagers how to use condoms and that demonstrating how to use a condom on a banana could be considered 'sexually harassing.'

As an aside, in an interview reported by Tonic, Dr Foley seemed to espouse views on adverse effects of abortion that are unsupported by clinical research evidence,

'The way abortions are done, there is not enough supervision or regulation for them and it puts women at risk. There are not the same standards as other surgical centers, there are not the same requirements in terms of having the same hospital privileges in case something goes wrong,' she said. 'What I'm concerned about is that there is a sense that it's healthcare for women and there are a lot of things about it that are not good healthcare," Foley added. Abortion care has significantly lower complication rates than other common procedures (like wisdom tooth extraction and tonsillectomy), and patient satisfaction rates are much higher than they are for general medical care.

Another falsehood Foley has repeated, and that her former company Life Network also claims is true, is that abortion causes lasting mental-health problems. In a September 2016 presentation for Charis Bible College where Foley was introduced as the president of Life Network, she claims ... that this is a condition with an accepted diagnosis:

'There is actually a true, emotional diagnosis that is now starting to be recognized—even though if you look at national media and secular media, they still try to ignore the fact—but there is actually a diagnosis called post-abortion stress and also post-abortion traumatic syndrome, that is a result directly of someone having an abortion or being involved with an abortion that happens,' she said. 'Here is the thing that is incredible to me. I am a trained physician, went through training, got not one single lecture throughout the course of my training about this situation.'

The American Psychiatric Association does not recognize post-abortion syndrome or any related category as an identifiable mental health condition in the DSM-V , a manual that defines and classifies mental disorders.

 So Dr Foley seemed to have engineered an ostensibly clinical career that put her in a position to proselytize patients in the guise of medical practice, not only about abortion, but about contraception.  It is not at all obvious that Dr Foley limited her anti-abortion, anti-contraception, and presumably even anti-adoption preaching to women who agreed with her religious views and who had no interest in any of these options.

Discussion

Dr Foley is certainly entitled to her religious views.  She is also entitled as a physician to avoid situations in which normal standards of care would push her to provide services to patients that conflict with her religious conviction.  But she is not entitled as a physician to proselytize in the guise of medical practice.

Furthermore, as a leader in a government health agency, she is not entitled to use that agency's power to enforce her personal religious beliefs on patients who do not hold such beliefs.  Given her career, though, there is every reason to worry that she will do so.  Furthermore, it was not clear why she was selected for this powerful government leadership position other than to allow her to proselytize.

We recently discussed other examples of people appointed to top positions in the US Department of Health and Human Services who seemed very hostile to the organization's mission.  Again, it seemed unlikely that these people were appointed for any reason other than to attack the mission.

Furthermore, like Dr Foley, they seemed to have been appointed to impose their personal religious views on the American population.  As we stated then, they all seem to be in a postion to undermine 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.    



Sunday, July 08, 2018

"Hope in a Bottle" - Components of Purdue Pharma Stealth Marketing Campaign for Oxycontin Revealed by Legal Documents from Tennessee

Introduction: Disinformation and Stealth Marketing Campaigns

Back in the distant past the US government made some attempt to hold big health care corporations to account for misleading marketing practices.  We learned a lot about these practices from documents revealed in the resulting litigation, and in particular, about stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies.  For example, in 2012 we found out about the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This 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 Risperdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).  We also found that stealth marketing seemed to be partially responsible 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).

Nowadays, the current Trump administration does not seem interested in pursuing unethical or corrupt practices by big health care corporations.  A health care corporate fraud strike force was downsized by the Trump administration as we noted in July, 2017.  By May, 2018, legal actions by the US government against apparently corrupt acts by large US health care organizations seemed to be falling off.  Only one significant settlement had made that year.  Bloomberg published a report with the headline, "White-Collar Prosecutions Fall to 20-Year Low Under Trump," on May 25, 2018.  Meanwhile, the administration pulled one former stealth marketer through the revolving door to serve in the White House (look here), and has been  pushing its own disinformation campaigns (look here).
 
However, some state attorneys general and local prosecutors have picked up the baton.  In particular, as the opioid epidemic continues, they have filed many lawsuits against corporations that profited from narcotics sales.

Sleazy Marketing Tactics Used to Sell Oxycontin

And glory be, one such lawsuit has led to the disclosure of the shady marketing tactics used by the now notorious Purdue Pharma to sell Oxycontin.  Several news reports summarized the lawsuit filed by the Tennessee Attorney General against that company.  As described by the Knoxville News Sentinel,

The lawsuit, filed by Tennessee Attorney General Herbert H. Slatery III, uses Purdue’s own company records and its staffers’ own words to show the firm’s founders and executives pushed medical providers to prescribe increasingly high doses of OxyContin for longer periods — even after Purdue promised the state it would stop.

It lays bare a marketing campaign that was highly regimented and highly profitable, built upon a foundation of lies and trickery, and specifically targeted Tennessee’s most vulnerable medical providers and patients, including the elderly and veterans.

'Purdue summarized the marketing for its opioid products with the tagline, ‘We sell hope in a bottle’ in one of the company’s hiring guides for incoming marketing employees,' the lawsuit revealed.



Targeting the Beleaguered

Hope could best be sold through the prescriptions of the most beleaguered prescribers:

Purdue told its sales staffers to target medical providers who were overworked, serving poor communities in Tennessee and had less training, calling them 'high value prescribers' who could be easily persuaded to increase prescriptions and dosages of OxyContin.
To do this, most likely the pharma representatives used psychological manipulation, such as assuring the practitioners that the representatives were their true friends in a hostile health care environment.  Such tactics were well-documented in articles by Ahari and Fugh-Berman, e.g., look here and here

Perverse Incentives for Sales Reps

The company provided perverse incentives to its pharmaceutical representatives (perverse, at least, from the standpoint of the patients' welfare and health professionals' values):

Sales staffers’ bonuses were tied to how well they pushed 'super core' providers — the Tennessee prescribers handing out OxyContin prescriptions at a rate guaranteed to cause fatal overdoses — to keep pushing the drug on their patients.

The firm even had a 'toppers club' for sales staffers who pushed the most OxyContin, awarding them trips and cash, the lawsuit stated.

Deceptions and Third-Party Strategies

Although none of the Tennessee pharma reps were "medical professionals," they

were trained to position themselves as medical experts and then supply providers with carefully scripted lies about the addictive and deadly properties of OxyContin, the internal records show.

'Do (providers) believe (in) me on info?' one sales staffer wrote. 'Buy-in … (Provider) buys me first.'
Again, to do this they likely traded on the misguided trust of the physicians generated by the representatives' psychological manipulations.

Practitioners were supplied with biased, and in today's argot, fake literature to give to the physicians,

literature from fake advocacy groups touting the safety of opioids and labeling the growing opioid epidemic as 'pseudoaddiction' that would level off if providers simply prescribed more OxyContin.

Sales staffers were trained to teach providers that the best way to keep patients from addiction was 'to actually prescribe more and higher doses' until the 'symptoms' of addiction went away, the lawsuit stated.

The suit claimed that Purdue set up a "third party strategy," using "astroturf" organizations to pretend that influential health care professionals and sincere patient advocates supported ever increasing narcotics use:

The firm funded the creation of advocacy groups with names such as the American Pain Society and American Pain Foundation, and pamphlets, videos and social media campaigns to convince Tennesseans that OxyContin was a wonder drug — even as the number of fatal overdoses tied to it began to skyrocket.

The firm specifically targeted veterans with a web campaign titled 'Exit Wounds,' and called OxyContin the 'gold standard' for pain treatment.

'Long experience with opioids shows that people who are not predisposed to addiction are unlikely to become addicted to opioid medications,' veterans were told. 'When used correctly, opioid pain medications increase a person’s level of functioning.'
Third party strategies have been widely used in public relations/ propaganda/ disinformation campaigns. 

Profits Before Patients, and the Law

Purdue Pharma reps were instructed to keep pushing narcotic prescribing by physicians who were in danger of being sanctioned.

The lawsuit reveals Purdue’s sales staffers were instructed to ignore police warnings, indictments and overdose deaths involving Tennessee medical providers and to continue to call on them to hand out high-dose OxyContin — the firm’s most profitable brand — so long as they still had prescription pads.

The lawsuit and Purdue’s internal records link the firm’s sales staffers to some of Tennessee’s most notorious pill mill doctors, including one of the largest such operations in East Tennessee.

Purdue staffers called one medical provider, who is not identified in the lawsuit, 48 times — after law enforcement told the firm the provider had prescribed fatal doses of OxyContin and was running a cash-for-pills clinic.

A Nashville Public Radio report additionally noted that

According to the lawsuit, Purdue reps also continued to call on doctors after:

Law enforcement identified two particular doctors responsible for significant diversion
Credible reports of patient overdoses
A provider admitting to heroin addiction
Muggings over controlled substances outside a pharmacy linked to a provider
Admission by a provider he was running a pill mill
Observing a patient being coached in a waiting room
Choreographed pill counts and urine screenings
Standing-room-only waiting rooms
Clearly, generating more revenue by selling more drugs trumped respect for ethics or the law. 

Summary

Thus, Purdue Pharma appeared to use the same sort of multi-pronged deceptive marketing approach to ramp up prescriptions of its potent narcotics, even as more and more people became addicted.

While we have been (probably appropriately) distracted by larger scandals, managers of big health care corporations have continued their cynical tactics that put profits ahead of patients, and ahead of professional values. It is likely that deceptive marketing, and full blown stealth marketing is flourishing even more in the shadows created by a government that seems to put the profits of President and family's company ahead of taking "care that the laws be faithfully executed."

At least to some degree state law enforcement is beginning to step into the breach.  As a Tenessee attorney who is also involved in lawsuits against Purdue said (per NPR)  "I think it helps all of us engaged in this fight to better understand what has happened and ultimately to get more quickly and more efficiently to a resolution,..."

So to conclude,

 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 under a regime that was perfectly happy to use disinformation to secure its election?

It apparently makes no more sense than advocating for better federal law enforcement measures to reduce conflicts of interest and corruption in health care under an extraordinarily conflicted and corrupt regime (look here.)

The fish is rotting from the head. 

So in parallel with what we said then, the only way we can now address health care deception, crime, and corruption is to excise the deception, crime and corruption at the heart of our government.