Friday, May 31, 2019

That Old Time Revolving Door Keeps Spinning

Traditionally, the American examples we have seen of the revolving door involved people leaving leadership positions in governmental bodies which regulate health care or make health care policy then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made, the outgoing revolving door.  These examples occurred during Democratic and Republican administrations.  However, during the Trump regime, we began to see many examples of the incoming revolving door, people coming form leadership positions in the health care industry to take government health care regulatory or policy positions that could affect their former organizations' interests (look here).

However, the old-time bipartisan outgoing revolving door keeps spinning.  Here is a collection of examples in chronologic order by the date they were made public.  Also, I found an example of the incoming revolving door at the US state level, involving Democrats, not Republicans.

From Secretary of Veterans Affairs to the Board of Armada Health

On March 12, 2019, a brief item in Modern Healthcare stated:

Former Veterans Affairs Secretary Dr. David Shulkin has joined the board of ArmadaHealth, a Maryland health data company that offers a database for patients to find physicians.

President Donald Trump fired Shulkin last year from the top post at the VA, where the former secretary also served under President Barack Obama.

I could find little further information.  Note that Dr Shulkin served in both Democratic and Republican administrations.  Note further that with the increasing push to privatize the VA, its operations may have more to do with companies like ArmadaHealth.

From US Senate to Lobbying Firm Akin Gump Strauss Hauer & Feld

On March 14, 2019, noted:

Months after advising the Democratic Party to abandon the idea of 'Medicare for All,' a former U.S. senator has been hired by a lobbying firm whose clients are leading the fight against changes to the nation’s health care system.

Akin Gump Strauss Hauer & Feld LLP, a Washington, D.C.-based law and lobbying firm, announced on Wednesday that former Sen. Joe Donnelly is joining the firm as a partner and will be counseling clients in the health care and financial industries.

In particular, the article stated that:

Akin Gump has lobbied for the Healthcare Leadership Council since 2016. The trade organization’s members include health insurance, pharmaceutical, and hospital interests -- industries whose profits could be threatened by a single-payer system. The firm has also lobbied for Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization, two powerful drug industry trade groups.

PhRMA, BIO and the Healthcare Leadership Council are members of the Partnership for America’s Healthcare Future, a coalition created last year to oppose Medicare for All, as well as any of the weaker measures offered by Democrats to provide health care coverage or insurance to more Americans.

Donnelly seemed like a pretty good candidate to lobby for thiese firms because:

He campaigned against Medicare for All, even though polling by Data for Progress and the Kaiser Family Foundation last year estimated that 55 percent of Indiana residents support a universal health insurance plan. In one Donnelly campaign ad, a narrator warned that 'socialists want to turn health care over to the government.' Donnelly replied: 'Over my dead body.'

Since his loss, Donnelly has continued to warn Democrats against pushing for a single payer health care system. 'When you talk Medicare For All … you start losing the people in my state,' he said in December. 'When we start talking about, 'Hey, we're going to work together with the insurance companies to lower premiums,' that's what connects. The talk on the coasts just doesn't get it done in the middle.'
So Donnelly's new position lobbying for industry groups that oppose single payer health insurance, which they presumably see as a threat to their revenues, could be viewed as a reward for his previous advocacy of their positions.

In that vein, the article quoted health care insurance whistleblower Wendell Potter:

a former health insurance executive who has spent a decade investigating the industry’s predatory practices, panned Donnelly’s career move.

'Sen. Donnelly kept health care reform efforts at bay his whole tenure in Congress, and on his way out he went on national news to tell Democrats that Medicare for All was dangerous,' said Potter. 'Now we see his reward: A cush lobbying gig working for the health-care industry.'

'Color me shocked,' he said.

Were Senator Donnelly to have advocated the industry position because he thought it would enhance the chances of eventually getting a lucrative industry position, that could have appeared to be an abuse of entrusted power (as a Senator, to set public policy) for private gain, that is, as corruption in the ethical, if not the legal sense.

An article in the Indianapolois Star found this response from the Republican Party:

Indiana's GOP criticized Donnelly's decision.

'While Donnelly may have moved back to Granger, he clearly can’t get enough of the swamp,' said Pete Seat, executive director of strategic communications for Indiana Republicans. 'From this day forward, consider ‘Democrat Donnelly’ retired, and ‘D.C. Lobbyist Donnelly’ deployed.'

That is a reasonable criticism, but I wonder if they would make the same criticism of similar behavior by a Republican politician?   

Meanwhile, in April, Politico briefly noted

Former Rep. Lamar Smith (R-Texas), meanwhile, who also joined Akin Gump after leaving Congress in January, reported lobbying for four clients. They include HerdX, a ranching logistics company; Otis Eastern Service, an oil-and-gas pipeline company; Pebble Limited Partnership, which is trying to develop an open-pit mine in Alaska; and Pfizer, the giant pharmaceutical company.

So this particular pathway from the Senate to this lobbying firm and then to health care industry clients is a well trodden one.

From the US  Drug Enforcement Administration to Consultant for Purdue Pharma

On March 20, 2019, NBC News reported:

A former senior U.S. Drug Enforcement Administration official who testified before Congress on the government's efforts to stop the opioid epidemic is now paid to advise one of the largest opioid manufacturers in the country, Purdue Pharma, according to people familiar with the matter.

Demetra Ashley, the former acting assistant administrator of the DEA who told a Senate committee in 2017 about the need for a 'robust regulatory program' to stop the diversion of opioids and other controlled prescription drugs, left the DEA last spring and started a consulting firm called Dashley Consulting, LLC

The arrangement inspired some critcism, for example,

'This should not be allowed,' said Dr. Andrew Kolodny, the co-director of opioid policy research at Brandeis University. 'Former DEA and FDA officials should not be allowed to take money from companies they regulated.'
The issues here seem obvious.

From Top White House Adviser to Adviser to Juul

On May 21, 2019, the Washington Post reported that Johnny "DeStefano, a counselor to the president who served as a bridge between the Republican Party and the administration, is leaving on Friday." As to his destination,

He is expected to advise a number of companies, including Juul, the e-cigarette company, while helping on the campaign, according to people familiar with his plans. Juul has significant business in front of the Food and Drug Administration

I could not find much more about this. However, as a top White  House adviser without a specific portfolio, DeStafano could have affected health care and specifically FDA policy.

From Venture Capital Firm New Enterprise Associates to Director of the US Food and Drug Administration (FDA) and Back to New Enterprise Associates

On May 22, 2019, Axios reported that

Scott Gottlieb, who recently stepped down as the head of the Food and Drug Administration, has rejoined venture capital firm New Enterprise Associates as a full-time investing partner, Axios has learned.

Context: Gottlieb had been a venture partner with NEA before President Trump tapped him to lead the FDA, where he became known for cracking down on e-cigarettes and working to battle the opioid epidemic.

Gottlieb previously spent a decade with NEA, but the new role is more substantive. He's expected to lead investments in life sciences startups and take board seats.

Again, there was little other information and no substantive commentary publicly available about Dr Gottlieb's return to his old firm.

We briefly noted the considerable public discussion about Dr Gottlieb's conflicts of interest at the time of his ascension to the FDA post here. He had multiple relationships with multiple for-profit health care corporations in the years leading up to his 2017 appointment.    I should note that we have discussed previous examples, in 2007 and 2008 (look here, here, here and here), of Dr Gottlieb's strident promotion of the interests of pharmaceutical and biotechnology companies.  After 2008, I  naively thought further discussion of this topic would be redundant. 

From Director of the National Institute of Mental Health (NIMH) to Google's Verily, to Mental Health App Developer Mindstrong, to California "Czar" for Mental Health

Last, but not least, also on May 22, 2019, StatNews reported:

Noted psychiatrist and former Verily leader Dr. Tom Insel is going to be the 'mental health czar' for the state of California, Democratic Gov. Gavin Newsom announced Tuesday.

Insel, the former National Institute of Mental Health director, will also continue his work with Mindstrong, a startup that is working on a mental health app, a company spokesperson confirmed. Insel joined the company in 2017 after leaving Verily, Google’s life sciences arm.

Insel’s new job will be to 'inform the state’s work as California builds the mental health system of tomorrow, serving people whether they are living in the community, on the streets or if they are in jails, schools or shelters,' according to a press release from the governor’s office.

In a press conference, Newsom said Insel was 'volunteering' his time as an adviser. 'I’m calling him the mental health czar in the state of California,' he said.

The article also noted that

Mindstrong, which is focused on using data on how people use their smartphone to detect trends in their mental health, already has a relationship with public officials in California. One of Mindstrong’s first large-scale rollouts was slated to happen in the state through county-level public mental health systems, STAT reported in October.

A spokesperson for Mindstrong said that Insel would recuse himself from conversations about the company, and noted that he will have 'no fiscal or regulatory authority and will have no oversight of current programs in this voluntary role.'

Note that even after such specific recusal, Dr Insel would be in a position to generally influence state policy in ways that could favor Mindstrong.  Futhermore, state officials working for a "mental health czar" would be aware of his commercial ties and might thus tend to try to favor Mindstrong to please him.  

Note also that in 2010 our late blogger, Dr Bernard Carroll, wrote a series of posts about conflicts of interest and other ethical questions about Dr Insel's tenure as director of the National Institute of Mental Health (NIMH) here, here, here, here, and here.  Also, in 2015 I noted that Dr Insel transited the revolving door from the NIMH to Google Life Sciences.  This is just another example of how people and organizations that get on our radar once for ethical and leadership lapses tend to appear again and again.

[photo of Dr Carroll]


We have repeatedly said,  most recently in March, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

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

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

Thursday, May 16, 2019

From "Forced Injections" to "Sorcery," - More Examples of Partisan Ideology and Religious Sectarianism Trumping Evidence in Health Policy and Public Health

Evidence-based medicine (EBM) is about medical-decision making based on critical review of the best applicable evidence from clinical research informed by knowledge og biology and medicine, of the patient's biopsychosocial circumstances, the patient's values, and of ethics and morality.  Advocating EBM, and evidence-based health care, public health, and health policy was sometimes slow going, but at least health care professionals often seemed open to these ideas.

Now we seem to be in an alternate universe.  We have discussed the rising tide of health care and public health policy unsupported by evidence, and sometimes supported only by nonsense.  This tide seems driven by ideology, partisanship, and religious sectarianism.  Furthermore, we see more and more examples of political leaders embracing such policies apparently without any input from health or public health professionals.  We discussed several relevant cases in March, and then April, and included them in an interval summary of the "new (ab)normal in health care dysfunction" in May.

Less than 10 days later, we have accumulated enough new examples to be worth summarizing, presented in alphabetical order by state.

Arizona Republican State Legislators Push Vaccine Exemptions in the Face of a Measles Outbreak, While Decrying Pornography as a Greater Public Health Hazard

In February, 2019, Arizona state legislators were pushing to further relax requirements for and even discourage vaccination.  According to CNN,

Arizona lawmakers voted last week to advance three bills that would make it easier to get exemptions from the state's vaccine requirements, and which would require doctors to provide much more information to patients and families about potential harms that vaccines pose.

The bills cleared the House's Health and Human Services Committee on a 5-4 GOP-led, party-line vote, and head to the Rules Committee on their way to the floor.

HB 2470 adds a religious exemption to the existing law requiring vaccinations, and carries an amendment that would eliminate the requirement for parents to fill out an exemption form that informed them of potential consequences of not vaccinating their children. Those consequences can include requirements to keep children who haven't received vaccinations out of school during disease outbreaks.

HB 2471 requires medical providers to give detailed information about vaccines, including the prescription's package insert, to parents.

It was not clear that any of the legislators pushing these measures based their arguments on evidence about vaccines, the diseases they may prevent, or public health in general. Instead, for example:

the bills' sponsor, Rep. Nancy Barto ... told Capitol Media Services: 'These are not, in my view, anti-vaccine bills. They are discussions about fundamental individual rights.'

In this case, was she expousing a fundamental right of a parent to increase the likelihood that the parent's child would get an unpleasant, and dangerous disease, and to transmit such a disease to others?  Soon after, in March Arizona recorded its first case of the measles, affecting an 11 month old child.

Meanwhile, Arizona state legislators decided to worry about the public health hazards, not of the measles outbreak, but of ... pornography.  We had noted also  in March that Republican legislators were pushing the notion, unsupported by evidence, that pornography is a public health crisis.  In May, CBS reported,

A Republican-backed measure in the Arizona State Senate to formally denounce pornography as a public health crisis has passed. The resolution, which does not require the governor's signature for approval, will now go to the secretary of state to be certified. According to text of the bill, the legislation claims that pornography 'perpetuates a sexually toxic environment that damages all areas of our society.'

It goes on to claim, without any medical citation, that pornography is 'potentially biologically addictive and requires increasingly shocking material for the addiction to be satisfied' leading to 'extreme degradation.'

Again, the resolution seemed to have only Republican support. It was "Introduced by Republican Rep. Michele Udall and backed by six other Republican co-sponsors...."

While there is very good evidence that measles vaccination prevents the disease, that the disease can have serious, sometimes fatal consequences, and that measles is easily transmitted to others; and there is no good evidence that pornography is harmful, the legislators treated the latter is a more serious threat.  I saw nothing to suggest they had any personal experience in medicine, health care, or public health, or that they consulted anyone with any expertise in their areas.  Although they cited "individual rights" to support vaccine exemption, they were silent about rights to free expression that might have been affected by their crusade against pornography.  Finally, all the legislators prominently involved in these moves were from one party.  

Oregon Republican Party Derides Vaccinations as "Forced Injections"

This story comes via Vice News on May 8. In response to a bill sponsored by Oregon Democrats that would remove the "moral exemption" for vaccination,

Oregon’s Republican Party isn’t on board with this whole 'forced injections' thing — otherwise known as mandating kids get their shots against life-threatening illnesses like measles, mumps and rubella.

'Oregon Democrats were just joking about 'my body, my choice' while rammimg (sic) forced injections down every Oregon parent's throat,' the state’s official GOP account tweeted Monday night, apparently referencing the Democrats’ argument that Republicans shouldn’t interfere with a woman’s ability to access abortion.

Note that parents are making decisions about measles vaccinations, which are injections, for their children, not themselves in this context.  Although Oregon apparently has not had its own measles outbreak, there is one in neighboring Washington state.  According to Vice News, the vaccination rate in some parts of Oregon may be as low as 80%, reducing herd immunity and making the risk of an outbreak high.  Again, I could find nothing to suggest whoever in the state Republican party coined the perjorative "forced injections" had any understanding of the data about vaccine effectiveness versus adverse effects, or the severe consequences and transmissability of measles.  Finally, again this seems to be making a discussion of public health partisan.

Texas Republican State Legislators Also Advocate More Vaccine Exemptions, While One Accuses Public Health Authority of "Sorcery"

In April, the Corpus Christi, Texas, Caller-Times reported that four Texas state legislators were introducing bills to make it easier to avoid vaccination,

H.B. 3857: by Rep. Tony Tinderholt, R-Arlington, would prohibit doctors from refusing to see unvaccinated patients. Pediatricians tend not to want unvaccinated children in their waiting rooms, exposing other children and their parents to preventable deadly diseases like measles. Pediatricians are kind of funny that way. So are parents who believe in vaccination.

H.B. 1490: by Rep. Matt Krause, R-Fort Worth, would make it easier for parents to opt out of vaccinations. But perhaps of bigger concern is that it would prevent the Texas Department of State Health Services from tracking non-medical exemptions. This would make it harder to respond to outbreaks and certainly harder to predict them by identifying potential hotspots.

H.B. 4274: the 'informed consent' bill by Rep. Bill Zedler, R-Arlington, would require doctors to explain the benefits and risks in detail, including ingredients in the vaccines. That may sound like a good thing on face value. But this is technical information that is more likely to cause confusion and fear than understanding and appreciation. It's like telling someone what's in menudo first, then trying to get them to eat it.

H.B. 4418: by Rep. Jonathan Stickland, R-Bedford, would let nurses rather than only doctors sign off on vaccination exemptions.

The reporters tried to understand the rationale for these bills.  The best they could do was to write

that it appears to be a mix of political opportunism and ignorance. Suspicion of vaccinations is suspicion, period, and suspicion helps drive votes. The ignorance part is best summed by Zedler, who told the Texas Observer that concerns about measles are overblown because it's beatable 'with antibiotics and that kind of stuff.' The punchline is that antibiotics don't kill viruses and measles is a virus.

Note that we had discussed Rep Zedler's remarkably wrong headed statement that measles can be treated with antibiotics here.

The Caller also noted that

not one of these bill sponsors is a medical professional or scientist. Nor are they acting on the advice of medical professionals or scientists. If they had listened to and heeded medical advice, they would not have filed these bills.

In May, a follow to this story was a bit wilder.  The Washington Post reported on the latest antics of Rep Strickland, who introduced the fourth bill in the list above,

 A Texas state legislator unleashed a vilifying attack on a leading vaccine scientist Tuesday, accusing the doctor of 'sorcery.'

It started with a report published Monday by the Texas Department of State Health Services that noted the state recorded a 14 percent rise in parents opting out of their children’s vaccinations. It was a new statistic that alarmed Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor College of Medicine.

'We have more than 64,000 kids not getting vaccinated in the state of Texas, and that doesn’t account for the over 300,000 home-schooled kids,' Hotez said during an interview with The Washington Post.

Hotez took his concerns about the report to Twitter. And then he received an unexpected, seething personal attack from the Republican state legislator, Rep. Jonathan Stickland.

New school #vaccine exemption numbers reported yesterday by @TexasDSHS. Now >64,000 kids not vaccinated, with #Austin schools, which can no longer be considered safe for kids. All to benefit outside #antivax groups from CA NY DC monetizing the internet. Where is our leadership? — Prof Peter Hotez MD PhD (@PeterHotez) May 7, 2019

'You are bought and paid for by the biggest special interest in politics,' Stickland wrote. 'Do our state a favor and mind your own business. Parental rights mean more to us than your self enriching ‘science.’'

In a tweeted response, Hotez, a pediatrician and vaccine scientist, noted to Stickland that he does not receive money from the vaccine industry; instead, his work focuses on 'neglected disease vaccines for the world’s poorest people.'

Stickland, who told The Post he is 'not anti-vaccination,' tweeted his response to Hotez.

'Make the case for your sorcery to consumers on your own dime,' the Republican, who represents an area of suburban Fort Worth, snapped back Tuesday. 'Quit using the heavy hand of government to make your business profitable through mandates and immunity.'

(Hotez is not part of a for-profit business, either as a dean at the Baylor College of Medicine or as an endowed chair at the nonprofit Texas Children’s Hospital.)

What was the rationale for Strickland's position?

'It comes down to whether the government should be mandating what’s right for us,' Strickland said. 'I side with the individual.'

So note that Rep Strickland not only apparently falsely accused Dr Hotez, a recognized public health expert, of a conflict of interest, but of "sorcery," that is, witchcraft  The latter was apparently not clearly satirical, or metaphoric.  This suggests that underlying the ideology may be some very extreme religious sectarianism.  It looks like the idea of a witch hunt is not dead.


As we noted above, here are three more cases in which politicians in three states, all Republican, none of whom had any obvious background or expertise, in medicine, health care, or public health, pushed public health policies that were unsupported by evidence and poentially harmful.

Their rationale seemed at best ideological, based on "individual rights."  Yet while focusing on the rights of parents to not vaccinate the children, they ignored how these rights could adversely affect the children, and anyone who might be exposed to disease the children might acquire.  In the case of Arizona, they also simultaneously ignored rights of free expression while they denounced pornography.

Since all the polticial leaders involved were Republicans, and in some cases their advocacy was in the context of deriding their Democratic political opposition, it seemed that their public policy stances were also partisan.  Such ideologically based and partisan arguments should alarm health care professionals who are sworn to put the patients' and the public's health ahead of other concerns, including political ideology.

Finally, the last case, which included a state legislator accusing a physician and public health expert not only of having a conflict of interest (which he apparently did not have), but of "sorcery," their public health stances also seemed to come from religious sectarianism, at its most extreme. Such  arguments are also concerning because they seem to be an attempt to use the govenrment to promote a particular set of religious beliefs ahead of patients' and the public's health, and to impose these beliefs on people of other faiths.  This apparently contradicts the US constitutional prohibition against governmental establishment of religion.

True health care reform would require government officials to use evidence, rather than personal ideology and particularly rather than their own religious beliefs when making health care and public health policy. 


Monday, May 06, 2019

The New (Ab)normal in Health Care Dysfunction

Introduction: The Issues Ignored by Discusisons of Health Care Reform

After the failed attempt to "repeal and replace" the Affordable Care Act (ACA, Obamacare) in 2017, we summarized what we thought were the main issues that traditional discussions of health care reform in the US (and sometimes in other countries) did not address.Despite some protestations to the contrary (e.g., here), the US health care system has been plagued by dysfunction.  According to a recent Commonwealth Fund study, the US was ranked 11 out of 11 in health care quality, but 1 out of 11 in costs.  Traditionally, health care reform has targeted ongoing problems in the cost, accessibility and quality of health care.  The ACA notably seems to have improved access, but hardly addressed cost or quality.

Now, in 2019, these issues also seem to only be getting more so.  So a little more than two years into the Trump regime, I thought we should assess the new (ab)normal in health care dysfunction, trying as best as possible to use the framework from our 2017 summary, with examples from our blog posts.

Distortion of Health Care Regulation and Policy Making: the Rise of the Incoming Revolving Door

We had previously noted that companies selling health care products and services further enhanced their positions through regulatory capture, that is, through their excessive influence on government regulators and law enforcement.  Their efforts to skew policy were additionally enabled by the revolving door, a species of conflict of interest in which people freely transitioned between health care corporate and government leadership positions.  Up to the Trump era, nearly all those cases involved people who left government who were offered corporate positions in firms that might have been affected by regulations or policies influenced by the government agencies for which they formally worked, the outgoing revolving door.

However, in the Trump era, we saw a remarkable increase in the incoming revolving door, people with significant leadership positions in health care corporations or related groups attaining leadership positions in government agencies whose regulations or policies could affect their former employers.

- We noted a stealth marketer for health care corporations becoming a key Trump economic adviser (look here)

- We found numerous more examples in October, 2017, including two people from the same lobbying firm, Greenberg Traurig Alston & Bird, which that year had  "earned more than $4.4 million lobbying so far this year for health care companies and trade groups including Novartis AG, Verax Biomedical, the American Hospital Association, St. Jude Children’s Research Hospital, and Aetna....," given top Department of Health and Human Services (DHHS) positions.

- A little later that month, we noted that one of those two former lobbyists, Mr Eric D Hargan, had become acting Secretary of DHHS (look here).

- Slightly later that month, there was an even more striking example, the new (permanent) Secretary of DHHS, Mr Alex Azar, who replaced Mr Hargan, was a former top executive of pharmaceutical company Eli Lilly.

- In November, 2017, an advocate for the discredited former CEO of UnitedHealth become an Assistant Secretary of DHHS. 

-  Later in November, we found two more examples of the incoming revolving door, including a lobbyist for pharma/ biotech company Gilear becoming director of health programs for the Office of Management and the Budget (OMB) here.

- In March, 2018, we posted a long list of industry figures, including a slew of lobbyists appointed to DHHS leadership positions.

- in April, 2018, we posted the next list, of top industry executives going to major executive branch positions.  The most striking example was a vice president at CVS, formerly at Pfizer, becoming a senior advisor to the Secretary of DHHS (who is a former Eli Lilly executive) for drug price reform. Pfizer and Eli Lilly alumni in charge of drug price reform, what could possibly go wrong?

- In July, 2018, the next list included a senior advisor at again Eli Lilly appointed to head an FDA division.

- In February, 2019, the list included a person with multiple leadership positions in for-profit health insurance companies, including WellPoint, and most recently a Medicaid managed care insurance provider, appointed to lead "health care reform" for DHHS.  Again, from the insurance industry to lead health care reform, what could possibly go wrong.

- In March, 2019, we noted that the newly appointed acting director of the FDA had founded and/ or was on boards of directors of multiple biotech companies.

This was a staggering record of managers from and lobbyists for big health care corporations being put in charge of regulation of and policy affecting - wait for it - big health care corporations, a staggering intensification of the problem of the revolving door, which some have already asserted should be regarded as not merely severe conflicts of interest, but of corruption.  

Distortion of Health Care Regulation and Policy Making: Stealth Policy and Advocacy Morphing into Propaganda and Disinformation, Now may be Orchestrated by a Hostile Foreign Power

We had previously noted that promotion of health policies that allowed overheated selling of overpriced and over-hyped health care products and services included various deceptive public relations practices, including orchestrated stealth health policy advocacy campaigns.  Third party strategies used patient advocacy organizations and medical societies that had institutional conflicts of interest due to their funding from companies selling health care products and services, or to the influence of conflicted leaders and board members.  Some deceptive public relations campaigns were extreme enough to be characterized as propaganda or disinformation.  Now this information may be connected to, or even organized by a hostile foreign power  

In March, 2018, based on revelations of what appeared to be an organized disinformation effort engineered by Cambridge Analytica and associates, using large amounts of personal data liberated from Facebook, to promote the Trump campaign, we started to ask how we could address deceptive public relations, propaganda, and disinformation in health care under a regime that had so benefited from foreign based disinformation efforts?

In April, 2019, we discussed evidence that Russia had orchestrated a systemic disinformation campaign meant to discredit childhood vaccinations, particularly for the measles, which was likely partly responsible for the 2019 measles outbreak, and possibly for some of the unsupported assertions made about measles and measles vaccinationa by government leaders (see below).  The Soviet Union, which of course then included Russia, had orchestrated a disinformation campaign about HIV in the 1980s.  Erroneous beliefs generated by this campaign persist to this day.  The USSR had a principle role in the development of disinformation and other active measures meant to destablize western democracies.

 As recently documented in the redacted version of the Mueller report, Russia launched a disinformation campaign to swing the election to its preferred candidate, Donald Trump.  The role of a hostile foreign power which had used active measures during the election also using active measures to spread disinformation about medicine and public health should not be dismissed. 

Bad Leadership and Governance: Ill-Informed Leadership Now Approaching Flagrant Ignorance While Eschewing Expertise

We have long decried leaders of big health care organizations who seemed to have little background in or knowledge of biology, medicine, health care, or public health.  Typically, these were leaders of big health care corporations, such as pharma/device/ biotech companies, health insurance companies, hospitals and hospital systems, etc who were trained in management, and thus could be called managerialists.  

However, during the Trump regime we began to find striking examples of top government officials expressing ill-informed, if not outright ignorant opinions about medical, health care and public health topics.  We had not previously expected leaders of government to be personally knoweldgeable about health related topics, but traditionally they consulted with experts before making pronouncements.

Since the Trump regime began, perhaps inspired by examples from Trump himself, various political/ government leaders began to publicly say ignorant or downright stupid things about such topics.

-  For example, in September, 2017, we noted a series of examples showing some basic ignorance of health policy, including fundamental confusion about the nature of health insurance.

- In August, 2018, we noted that Trump had long been an apologist for asbestos, which is known to cause asbestosis, lung cancer, and mesothelioma, claiming that those opposing use of asbestos were associated with organized crime, while more recently Trump's EPA seemed willing to relax regulation of asbestos, at a time when Russia seemed ready to become the major US supplier of it.

Bad Leadership and Governance: From Incompetence (in the Colloquial Sense) to Cognitively Impaired or Demented Leadership

Again, previously we had discussed  ill-informed and incompetent leadership in terms of leaders who had no training or experience in actually caring for patients, or in biomedical, clinical or public health research.

However, we began to note concerning examples suggesting that the top leader of the US executive branch, President Trump himself, could be cognitively impaired perhaps from a dementing, neurological or psychiatric disorder.

- In October, 2017, we first started cataloging pronouncements by President Trump on health care and related topics that started with a grossly cavlier attitude toward health policy (e.g., it is only about fixing somebody's back or their knee or something," and ended with word salad:

Well, I’ve — I have looked at it very, very strongly. And pretty much, we can do almost what they’re getting. I — I think he is a tremendous person. I don’t know Sen. Murray. I hear very, very good things.

I know that Lamar Alexander’s a fine man, and he is really in there to do good for the people. We can do pretty much what we have to do without, you know, the secretary has tremendous leeway in the — under the Obama plans. One of the things that they did, because they were so messed up, they had no choice but to give the secretary leeway because they knew he’d have to be — he or she would have to be changing all the time.

And we can pretty much do whatever we have to do just the way it is. So this was going to be temporary, prior to repeal and replace. We’re going to repeal and replace Obamacare.

As we were taught in medical school, word salads may be produced by patients with severe neurological or psychiatric disorders.

- In January, 2018, we discussed more examples of Trump's confused, incoherent comments on health care.

- In May, 2018, we noted attempts by Trump Organization functionaries to intimidate Trump's former personal physician, presumably to prevent him from revealing details of the president's medical history.

- In December, 2018, we cataloged Trump's counter-factual, and often severely incoherent pronouncements - basically more examples of word salad - about public health, health care and other topics, at times interspersed with claims of his high intelligence.

Health care led by people with business or legal training who are willing to get advice from health care, public health and medical specialists may be as good as it gets.  Health care led by such people who do not consult experts if worrying.  Health care led by people who report to a cognitively impaired, demented or psychotic leader is extremely worrying (as is government with such leadership.)

Bad Leadership and Governance: Mission-Hostile Management Now Driven Less by Pecuniary Considerations, More by Ideology, Partisanship, and Religious Sectarianism

We had previously noted that health care leaders often were unfamiliar with, unsympathetic to, or frankly hostile to their organizations' health care mission, and/or health care professionals' values.  The example we cited then was a hospital CEO who allegedly over-ruled medical leadership to hire a surgeon despite reports that his patients died more frequently than expected, gamed reports of clinic utilization, and associated with organized crime (look here).  Most such examples seemed to be generated by leaders who put their organization's revenue, often in parallel with their own compensation ahead of patients' and the public's health.

We also began seeing examples of how politically appointed officials of health related government agencies who had no experience or expertise in health care or related fields began to assert control over health care professionals in the agencies to facilitate the Trump regime's political agenda apparently regardless of the effects on health. Sometimes the problem seemed to carry over from the leaders' previous management, rather than medical, health care or public health experience.  For example, in February, 2018, we noted that the physician who was Secretary of the Veterans Administration was challenged by a political a political appointee who used to run a brewery.

However, we then began noting leaders who also lacked medical, health care or public health background or expertise whose agenda seemed to be overtly religious or ideological, without even a nod to patients' or the public' health.

- In April, 2018, we noted a host of appointments of people who flagrantly lacked any health care or public health related experience or expertise to leadership positions in government agencies whose agenda seemed to be overtly religious or ideological, without even a nod to patients' or the public' health. For example, a 23-year old whose only experience after college was in Trump's campaign was given a significant position in the Office of National Drug Control.

- In April, 2018, we posted another such list, including a blogger who promoted racism and conspiracy theories given the Deputy Directorship of Communications for DHHS.

- In July, 2018, we noted the appointment of a physician to a leadership position in family planning within the DHHS who cited "facts" completely unsupported by evidence to justify religiously based health care policies, e.g., using her argument that adopting a child is like a "second death" to argue that mothers should not give their children up for adoption.

- In August, 2018, we discussed  three political appointees to DHHS, none of whom had any health care or public health related experience or expertise, all of whom made pointedly political public comments after their appointments, from deriding their political opponents as "clueless" and "crazy"to alleging Hillary Clinton arranged a murder.

 - In November, 2018, we noted pronouncements about health care or public health by federal agencies under the Trump regime, right-wing politicias who back Trump, and propagandists who back Trump which were unsupported by evidence, but seemed designed to support right-wing ideology or sectarian religious belief.  These included assertions that immigrants and asylums seekers carried infectious disease, that intersex patients do not exist, that contraception causes cancer and violent death, that pornography is a major public health hazard, etc.

- In March, 2019, our list included examples of multiple leaders at the state level, all Republicans, including the Kentucky Governor asserting that zombie television shows cause mass shootings, but exposure to extreme cold does not harm schoolchildren; and numerous unsupported pronouncements by state legislators about measles, including the Texas state representative who stated antibiotics can treat measles.

- In April, 2019, we discussed another batch of bizarre statements about the measles and vaccination policy made by President Trump, again the Republican Governor of Kentucky, and various Republican state legislators.  

Again, basing health care and public health decisions primarily on money seems likely to be bad for patients' and the public's health, but basing them purely on political ideology or religious belief seems worse. In some cases, the resulting mission-hostility seems to translate into violations of the US constitution.  For example, making health care decisions based on a particular religion's beliefs could be harmful for patients or citizens who do not share these beliefs, plus violate the Constitution's guarantee of freedom of a government establishment of religion.

Bad Leadership and Governance: Mission-Hostile Management by Now Partisan Corporate Leadership  

Again, previously the mission-hostile management we noted at the corporate level seemed mainly driven by pecuniary concerns, putting corporate revenues and resulting management compensation ahead of patients' and the public's health.  However,we began to see evidence that leaders of health care corporations were using their power for partisan purposes, perhaps favoring their personal political beliefs over their stated corporate missions, patients' and the public's health, and even  corporate revenues.

- In June, 2018, we first noted how a large health care corporation, the huge pharmacy chain CVS, had been secretly making contributions to an ostensibly non-profit organization which actually served solely to promote Trump regime policies, including some that seemed to subvert claims the corporation had made about social responsibilty.  The contributions themselves seemed to conflict with the corporation's charitable giving policies.

- In September, 2018, we noted that big health care corporations often make high-minded public pledges about supporting patients' and the public's health, and sometimes social responsibility, but have been found to be covertly supporting policy initiatives that seemed to subvert these goals, using "dark money."  The dark money groups they used to channel this money often had explicitly partisan leadership and direction, usually right-wing and Republican.

 - In October, 2018, we discussed important but incomplete revelations about corporate contributions to such dark money groups that mainly favored again right-wing ideology, the Republican party, and Trump and associates.

- In November, 2018, we noted that health care corporations funneled funds through dark money organizations to specifically attack designated left-wing, Democratic politicians.

- In March, 2019, we noted a Transparency International study of policies on political engagement of multinational pharmaceutical companies, all of which operate in the US.  Only one disavowed the revolving door, and only two eschewed direct corporate political contributions.

- Also, in March, 2019, we discussed a study of the personal political contributions of CEOs of large corporations.  In the 21st century, the CEOs' contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party.

This suggests yet another route towards government putting ideology and partisanship ahead of patients' and the public's health.

Bad Leadership and Governance: Conflicted, Corrupt Corporate Leaders Now in the Context of Flagrant Conflicts of Interest and Corruption at the Highest Levels of the US Government

We had previously discussed numerous examples of frank corruption of health care leadership.  Some have resulted in legal cases involving charges of bribery, kickbacks, or fraud.  Some have resulted in criminal convictions, albeit usually of corporate entities, not individuals.  One would hardly expect corrupt leadership to put patients' and the public's health ahead of the leaders' ongoing enrichment.

Prior to July, 2017, we had discussed some particular cases in which Donald Trump and his family had been involved in ethically questionable activities prior to his becoming president.  However, by  August, 2017, we started to discuss the corruption at the top of the regime. 

- In January, 2018, we first discussed the accumulating evidence of pervasive corruption at the top of the US executive branch, based on articles in the media, and the launch of a website devoted to tracking such corruption.

- In July, 2018, we summarized new sources of evidence about top level government corruption.

- In October, 2018, we posted yet another update, including summarizing a new and very lengthy report about the scope of Trump and associates' conflicts of interest and corruption, which at the time required 26 pages to print. It documented multiple ongoing instances of the Trump Organization, whose biggest owner is Trump, receiving large ongoing payments from foreign governments, the US government, and state governments.  The former payments seemed to explicitly violate the "foreign emoluments clause" of the US  Constitution, which bans presidential conflicts of interst involving foreign governments, and the "domestic emoluments clause," which bans those involving the federal and state governments.

- In October, 2018, we discussed the latest advances in understanding of global corruption, via Tranparency International's global meeting, which included description of trans-national kleptocratic networks, which now seems to describe Trump and the Trump Organization.

- In April, 2019, we posted our latest discussion of pervasive high-level corruption, which referenced updates from sources mentioned earlier, plus three new sources.

Prior to the Trump regime we had criticized law enforcement for a lack of interest in vigorously prosecuting health care corruption.  We documented numerous examples of the impunity of top health care corporate executives who almost always escaped any negative personal consequences even when their organizations paid large fines for bribery, kickbacks, fraud and the like.  We often attributed this laxity to excessive sensitivity respect of the value of these corporations and their products.  However, the potential for encouraging health care (and other kinds of) corruption under a regime that is itself frankly corrupt is mind boggling.

[picture of Trump International Hotel in Washington, which is frequently patronized by foreign government officials, whose payments to Trump via the Trump Organization appear to amount to the "foreign emoluments" prohibited by the US Constitution.]

Overarching Issue: Taboos Previously Enabled by Private Organizational Behavior, Now by Government Agencies and Officials, Despite the First Amendment

When we started Health Care Renewal, such issues as suppression and manipulation of research, and health care professionals' conflicts of interests rarely appeared in the media or in medical and health care scholarly literature.  While these issues are now more often publicly discussed, most of the other topics listed above still rarely appear in the media or scholarly literature, and certainly seem to appear much less frequently than their importance would warrant.  For example, a survey by Transparency International showed that 43% of US resondents thought that American health care is corrupt.  It was covered by this blog, but not by any major US media outlet or medical or health care journal.  We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who personally profit from the status quo in health care.  As we noted above, the people who profit the most, those involved in the leadership and governance of health care organizations and their cronies, also have considerable power to damp down any public discussion that might cause them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.  But, if we cannot even discuss what is really wrong with health care, how are we going to fix it?

Since the beginning of the Trump administration,  we began to note more examples of government officials under Trump attempting to squelch discussion of scientific topics that did not fit in with its ideology, despite constitutional guarantees of speech and press free from government control.

- In September, 2017, we noted an attempt for Trump political appointees to blockade information released from the Department of Health and Human Services (DHHS) that the regime found offensive.

- In February, 2018, we noted attempts by a consultant for the Center for Medicare and Medicaid Services (CMS), a major component of DHHS, to intimidate a health care journalist.

- In April, 2018, it became apparent that the head of CMS has directed millions in contracts to a Republican public relations firm, partly to burnish her image, and that firm had hired the consultant noted above.

- We also found attempts to squelch attempts by current or former government workers to criticize Trump and his policies.  In August, 2018, we noted Trump had White House staffers sign non-disclosure agreements, which seems to expressly violate first amendment protections of free speech and federal law.

Given how hard it was to reverse the anechoic effect in the past, how much harder will it be to open discussion of what is really wrong with health care when the power of the US government is used to censor ideas which the regime dislikes?


For years, I thought that health care dysfunction was primarily about individuals and private organizations, including but not limited to pharmaceutical, biotechnology and device companies; hospitals and hospital systems; insurance companies, academic medical institutions; physicians and their practices; etc, etc, etc.  Consequently, I thought these individuals and organizations needed better awareness of health care dysfunction to provoke them to improve matters.  I thought of the government as being involved, but mainly because of well-intentioned, sometimes bumbling government actions and policies that often had unintended effects, and sometimes excess coziness with the health care industry.  While I knew that the government was subject to regulatory capture and various leadership problems, its role, at least in the US, seemed almost secondary.

But in the Trump era, there is a new (ab)normal.  All the trends we have seen since our last discussion of health care reform are towards tremendous government dysfunction, some of it overtly malignant, especially in terms of corruption of government leadership of unprecedented scope and at the highest levels, and overt influence of government-favored political ideology and religious beliefs on health care policy and other policies and actions.

I hope that the above attempt to summarize these new trends will urgently point health care and public health professionals, patients, and all citizens towards a much more vigorous response.  US health care dysfunction was always part of the broader political economy, which is now troubled in new and dangerous ways.  We do not have much time to act.

If not now, when?

If not us, who? 


Wednesday, May 01, 2019

Why Are We Complicit? A Narrative for Our Era

Why are seemingly good people complicit with bad things?  In health care, we have seen seemingly good health care professionals and academics silent in the face of manipulation and suppression of clinical research; deception, attacks on free speech and the press, silencing of whistleblowersconflicts of interest; ill-informed, incompetent, self-interested leadership; and outright corruption and crime, including fraud, bribery, and extortion.

We have seen the anechoic effect, that cases of such behavior are not the subject of polite discussion.  When I saw a whistleblower being threatened (he ultimately lost his job), one colleague said I should ignore it, and keep my nose "to the grindstone."

Why?  One explanation is that ordinary people are afraid to challenge behaviors that help the rich and powerful, fear losing their jobs, fear angering others.  It seems hard to comprehend the mindset of those who are complict.

Niemoller wrote

First they came for the socialists, and I did not speak out—because I was not a socialist.

The poem ended

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

Today we have a new narrative about how people are sucked into complicity, in an op-ed in the New York Times by James Comey,

Amoral leaders have a way of revealing the character of those around them. Sometimes what they reveal is inspiring.

Then again,

But more often, proximity to an amoral leader reveals something depressing. I think that’s at least part of what we’ve seen with Bill Barr and Rod Rosenstein. Accomplished people lacking inner strength can’t resist the compromises necessary to survive Mr. Trump and that adds up to something they will never recover from.

It starts with your sitting silent while he lies, both in public and private, making you complicit by your silence. In meetings with him, his assertions about what 'everyone thinks' and what is 'obviously true' wash over you, unchallenged, as they did at our private dinner on Jan. 27, 2017, because he’s the president and he rarely stops talking. As a result, Mr. Trump pulls all of those present into a silent circle of assent.

Speaking rapid-fire with no spot for others to jump into the conversation, Mr. Trump makes everyone a co-conspirator to his preferred set of facts, or delusions. I have felt it — this president building with his words a web of alternative reality and busily wrapping it around all of us in the room.

I must have agreed that he had the largest inauguration crowd in history because I didn’t challenge that. Everyone must agree that he has been treated very unfairly. The web building never stops.

From the private circle of assent, it moves to public displays of personal fealty at places like cabinet meetings. While the entire world is watching, you do what everyone else around the table does — you talk about how amazing the leader is and what an honor it is to be associated with him

Next comes Mr. Trump attacking institutions and values you hold dear — things you have always said must be protected and which you criticized past leaders for not supporting strongly enough. Yet you are silent. Because, after all, what are you supposed to say? He’s the president of the United States.

You feel this happening. It bothers you, at least to some extent. But his outrageous conduct convinces you that you simply must stay, to preserve and protect the people and institutions and values you hold dear. Along with Republican members of Congress, you tell yourself you are too important for this nation to lose, especially now.

You can’t say this out loud — maybe not even to your family — but in a time of emergency, with the nation led by a deeply unethical person, this will be your contribution, your personal sacrifice for America. You are smarter than Donald Trump, and you are playing a long game for your country, so you can pull it off where lesser leaders have failed and gotten fired by tweet.

Of course, to stay, you must be seen as on his team, so you make further compromises. You use his language, praise his leadership, tout his commitment to values.

And then you are lost. He has eaten your soul. 

 Preserve your souls before it is too late.

[photo of Nuremberg trial]