Aducanumab Approval, Part 2

So how did a drug with such dubious benefit get approved? At best, another clinical trial might be warranted, but certainly not approval. It's a result

1. of a huge campaign by a company (Biogen) that would not accept the failure of its drug
and
2. of pressure from patient organizations like the Alzheimer's Association (which receives major money from pharma, including Biogen and its Japanese partner, Eisai).

The company campaign began in spring 2019, after its Phase 3 trials were stopped for futility after an interim review. A long, detailed, and excellent STATnews article published this week, drawing on insider sources, tells a fascinating but troubling story. The last-ditch effort to get approval was originally called "Operation Phoenix," but was re-titled "Operation Onyx." Biogen managed to get Billy Dunn, Director of the Office of Neuroscience at the FDA, on their side, to the point that he worked closely with them to provide a roadmap for approval, very inappropriately.

After the groundwork was laid for an approval of aducanumab despite the negative advisory committee recommendation, and prior to the announcing of a final decision, the patient organization campaign was carefully timed. In early May, the Alzheimer's Association launched a big campaign seeking to build grassroots support for drug approval. The "More TIme" campaign worked to pull at heartstrings with celebrity endorsements and poignant personal stories. Full-page ads were taken out in the Wall Street Journal and USA Today, and focused on what "more time" would mean to Alzheimer's patients and their families. There were google search ads, Facebook and Twitter and Instagram and LinkedIn posts. The campaign succeeded in getting over a million people to express support in petitions.

After the approval, the Alzheimer's Association spoke of victory:

As the first FDA-approved drug that delays decline due to Alzheimer’s disease, the approval of aducanumab (Aduhelm™) is a victory for people living with Alzheimer’s and their families.

Comments on articles including this one give the flavor of the passion with which some people want to try this unproven therapy.

Denying a medicine which might work is far more worse than approving one that might not work! Do you agree in the case of Alzheimer’s?

The negativity of these old fashion mentality is what has driven new discoveries to a halt. I don’t suffer from Alzheimer’s nor know anyone close to have been dx w it but we need to start somewhere. Prescribing the pharma will only help w research. Get in line MD.

Alzheimer’s is a horrible disease. If the medicine has a chance of success then prescribe it.

And public officials seem to be buffaloed. A Politico article said that not only are public officials mute about the approval, they are hesitant even about making a fuss about the pricing (about which more in another post):

[Politicians are] worried they’ll be seen as dashing desperate patients’ hope for an Alzheimer’s treatment — even one that may provide little or no benefit. The FDA’s controversial approval of Biogen’s drug, known as aducanumab or Aduhelm, has caught both political parties flat-footed ...Everyone is a bit terrified by Alzheimer’s, so the average person hears about the FDA approval of a treatment, and they don’t know about the controversy over whether it works or not,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management who lambasted FDA’s Aduhelm approval. “They hear there’s a new treatment and, that’s great, it’s a sign of hope. Do you want to be the politician who says, ‘I want to take that away from you?’”

Evidently, the public opinion campaign with its drumming up of support for this bogus drug has had its desired effect, creating cowardice to speak about the realities. Subsequent to the publication of the Politico article, two senators did speak out about pricing, but were careful to praise the drug:

Even as they criticize the price, however, Cassidy and Warren still stopped short of directly criticizing Biogen. They offered praise for the drug’s approval, too, calling it a “historic, watershed moment” in the history of the disease.

Public Citizen - who does not have to get elected - did not share this hesitancy. Their long public letter to HHS Secretary Xavier Becerra - which I recommend reading in full - begins as follows:

Public Citizen is writing to express its outrage over the Food and Drug Administration’s (FDA’s) indefensible decision to approve Biogen’s aducanumab (Aduhelm) for treatment of Alzheimer’s disease despite the lack of evidence that the drug provides any meaningful clinical benefit plus the fact that the drug has a well-documented risk of potentially serious brain injury. The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.

They go on to ask for resignation of key officials in approving aducanumab, including FDA acting head Janet Woodcock and Billy Dunn. They also ask that the Office of the Inspector General for HHS investigate the relationship and "close collaboration" between the FDA and Biogen prior to Aduhelm approval. In addition, they want rescission of the bogus approval:

You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn.

Those who pushed for approval seem eager to foreclose any discussions of rescission. In an interview, there was this question and answer with Acting FDA Head Janet Woodcock:

Question: "There’s been some reaction that every time this criticism comes up, the FDA just dismisses it outright and doesn’t really meaningfully engage on it —doesn’t do soul-searching. … Should the FDA do some soul searching? Should you and the FDA be trying to respond more directly to these critics?" Woodcock's reply: "I think we will have some more public soul-searching type of discussions on accelerated approval itself, but the soul-searching when a decision is made goes on before the decision, and once we’ve made the decision, we’ve made the decision."

Similarly, the head of the Alzheimer's Association wants to end discussion of the approval:

Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.”

But, if the aducanamab approval is not rescinded, what will happen and what are the consequences? More on that in another post.

Health Care Corporate Leaders Have Pledged Their Support for Racial Justice and Harmony: Will They Renounce Their Previous Support of a Very Racially Divisive Politician?

Leaders of big health care organizations frequently profess their social responsibility, and traditionally have avoided political partisanship.  However, their actions have not always been consistent with these sentiments.

Now, in response to the police killing of George Floyd and subsequent protests, many health care leaders pledged their support for racial peace and justice.  However, some of these leaders have previously supported  political leaders whose actions may have contributed to the current crisis.

Recently there were two cases showing vivid contrasts between health care leaders' pronouncements and their and their organizations' recent actions.

CEOs Condemn Racism

CVS CEO Larry Merlo

Early out of the gate was Larry Merlo, CEO of CVS, who released a statement to his employees on June 1, 2020:

The turmoil we are witnessing grows out of a long and deep history in our country, and as a nation we must focus on the injustices and discrimination that continue to divide us. I remain hopeful that we can find a way to move forward in unity to solve the nation’s most pressing issues.

In our workforce and in our communities, CVS Health’s commitment to inclusion and belonging is unwavering. It is critical to those we serve and grounded in our company values. We are a diverse community here at CVS Health – all 300,000 of us – and that diversity is one of our key strengths. It shows up in how we care for one another – walking in each other’s shoes, joining forces for the greater good and respecting one another no matter what our race or ethnicity. We will continue to uphold the commitment of mutual respect in everything we do. Discrimination and intolerance have no place in our business and will not be permitted in any form.

Johnson and Johnson CEO Alex Gorsky

On June 3, 2020, CNBC reported:

Johnson and Johnson CEO Alex Gorsky said Wednesday that white men need to 'do more listening' in the wake of George Floyd’s death at the hands of Minneapolis police.

'I realize that can be difficult,' Gorsky said during an interview with CNBC’s 'Squawk Box.' 'I think there’s no way you can just move through a checklist without I think demonstrating empathy and an understanding of some of the deep-seated nature and experiences the [black] community has had and is currently experiencing.'

Gorsky announced Tuesday that J&J is committing $10 million over the next three years 'to fighting racism and injustice in America' as people across the United States and other parts of the world protest against police killings of blacks.

'As the CEO of the world’s largest health-care company, I must state unequivocally that racism in any form is unacceptable, and that black lives matter,' he said in a LinkedIn post. 'And as a white man, I also need to acknowledge the limits of my own life experience and listen to those who have faced systemic injustice since the day they were born.'

CEOs' Friendliness with and Support for President Donald Trump


President Trump's recent actions have fanned the flames of racial discord. Here are just a few examples of news about what is still an evolving story: He called for a tough, militarized response to peaceful protests after the killing of George Floyd.  He tweeted "when the looting starts, the shooting starts," and  called protesters "thugs" (see Washington Post, May 29, 2020.)  He told governors to "dominate" the streets (see Washington Post, June 1, 2020.)  His Attorney General arranged the clearance of peaceful protesters out of Lafayette Square near the White House using teargas and flash bang grenades so Trump could have a photo opportunity at a nearby church (see New York Times, June 3, 2020.)  He pushed to call out 10,000 active duty US troops to quell a protest in Washington DC that was largely peaceful (see Reuters, June 7, 2020).

That seems like the opposite of "focusing on injustice and discrimination," or "fighting racism."  However, in contrast with their current proclamations about racial harmony and inclusion, and against racism, these two CEOs have shown their friendliness to and support for President Donald Trump.


CVS CEO Larry Merlo

Merlo's stance on racial inclusivity and harmony, and against racism does not seem to fit with the CVS track record of quietly supporting a dark money non-profit organization whose main mission seemed to be providing political support for Trump, and was once led by people with very different views on race, as we posted in 2018.

CVS was revealed to have been contributing to a "dark money" organization called America First Policies (AFP), ostensibly a "social welfare" charity, but actually an organization devoted to promoting the Trump agenda.  While CVS said its support for AFP was related to the organization's tax reform agenda, it also promoted various policies that seemed to contradict the CVS ethics and social responsibility policies.  In addition, the relationship between CVS and AFP only came to light after some AFP leaders were found to have made racist and pro-Nazi proclamations.  When the unsavory nature of the AFP leaders' utterances came to light, a CVS spokesperson announced the company would sever ties with AFP.  However, to my knowledge, CVS never clearly explained why it was giving money to the group in the first place, and how doing so was consistent with its stated policies and goals.

CVS past support for an organization led by professed racists seems inconsistent with Mr Merlo's recent commitment to inclusion and belonging.  One wonders if he will renounce his company's previous actions.

In 2018, we also noted that CVS was making substantial contributions to the US Chamber of Commerce, which despite its bland name, some asserted had become a major source of "dark money" support for politically right-wing and pro-Trump causes.  In 2019, we noted that CEO Merlo, like many of his fellow health care corporate CEOs at the time, had become very partisan in his personal political giving.  All the money he gave around the time of the 2018 election to organizations identified with either major political party went to the Republican party.

Now that he has proclaimed his anti-racist credentials, one wonders if Mr Merlo will renounce his previous direct and indirect support of Mr Trump and his associates?

Johnson and Johnson CEO Alex Gorsky

Again, Johnson and Johnson CEO Gorsky's stance on racial inclusivity and harmony, and against racism does not seem to fit well with the company's and Gorsky's track record of coziness with Trump.

In 2017, after a rally by white nationalists in Charlotte, Virginia lead to conflicts between them and counter-protesters. Many of the latter were injured, and one was killed, Trump initially refused to take any stand against the rally, and suggested that both sides were equally responsible.  After that, some corporate leaders broke with Trump, but  at first not Gorsky.  As the outrage about Charlottesville grew, Gorsky dropped his membership in Trump's Manufacturing Council, but one year later, but then returned to Trump's in-group, as reported by CNBC:

The manufacturing council was also disbanded in August of 2017, following a wave of public resignations from its CEO members in the wake of Charlottesville.

One of these came from Alex Gorsky, who leads Johnson and Johnson. Gorsky called Trump’s response to the rally 'unacceptable,' and said in a statement that it 'has changed our decision to participate in the White House Manufacturing Advisory Council.' Nonetheless, Gorsky is on the guest list Tuesday for dinner at [Trump's] Bedminster [golf club]. A spokesman for the company did not respond to a request for comment.

In February, 2020, Vanity Fair reported that the meeting that included Trump and Gorsky at Bedminster resulted in some very suspicious activity.  Trump seemed to assume the role of salesman for a drug Johnson and Johnson just put on the market:

On March 5 [2018], Trump signed a little-noticed order to create “a national roadmap to empower 'veterans and end suicide.' That was the same day, it turned out, that the Food and Drug Administration approved the sale of Spravato, an antidepression drug manufactured by Janssen Pharmaceuticals, a J and J subsidiary.

Then,

Trump continued to be a booster of Spravato, which analysts have estimated could earn some $600 million for J and J by 2022. At a June 12 White House meeting convened to discuss the opioid crisis in America, Trump urged Robert Wilkie, who replaced Shulkin as the secretary of veterans affairs, to essentially back the truck up for Spravato at the V.A. because, Trump said, it would result in an “incredible” drop in suicide among veterans. He even offered to negotiate the price of the drug with J&J. 'I think they’ll be very generous with you,' Trump told Wilkie. 'And if you like, I’ll help you to negotiate.'

The next year,

But Trump, being Trump, was not done trumpeting the drug. In August 2019, at an AMVETS conference in Louisville, Kentucky, he repeated his view that Spravato was 'incredible' and said he’d ordered the Department of Veterans Affairs to 'get as much of it as you can from Johnson and Johnson.'

The Trump promotion of the Johnson and Johnson drug is now under investigation. 'the House Committee on Veterans’ Affairs has demanded documents and information from the V.A.

Finally, the Vanity Fair included a reminder that Trump has not only been cozy with Gorsky, but a member of the family that founded Johnson and Johnson who also may be one of the company's bigger investors:

Trump’s ambassador to the U.K., Woody Johnson, is the great-grandson of one of the founders of J and J and, reportedly, continues to own more than 1.5 million shares in the company, worth around $217 million. His net worth is said to be around $4 billion. He donated $1 million to Trump’s inaugural committee.

So it appeared that the CEO of Johnson and Johnson, and a big shareholder in the company who is descended from its founder went out of their way to cozy up to Trump, who appears to have reciprocated by doing some marketing for its drug, and possibly improperly using his executive powers to increase its use.


Furthermore, in 2018 we noted that Johnson and Johnson, like CVS, was making substantial contributions to the US Chamber of Commerce, which despite its bland name, some asserted had become a major source of "dark money" support for politically right-wing and pro-Trump causes.


Now that Gorsky is so devoted to "fighting racism and injustice," given all that Trump has done to fan the flames of racial conflict after the death of George Floyd, one wonders if Gorsky will denounce his previous coziness with Trump?


Discussion

After the killing of George Floyd, the CEOs of two large health care corporations publicly espoused  racial harmony and inclusion and condemned racism.  Both these CEOs had become very friendly with President Trump, and appeared very comfortable with his policies, despite the history of non-partisanship among leadership of the health care field.

Trump, however has sought to amplify racial conflict since protests began in response to the death of Mr Floyd.  Will these CEOs now renounce their previous coziness with and support of President Trump? 

There are bigger questions. Will there now be more attention to how health care corporations have preached social responsibility, and lately racial harmony while they were quietly pushing their own agendas, which often undermined these worthy goals?  Will health care organizations disclose their ties to political leaders, including contributions to "dark money" groups? Will there be new calls for accountability for those who lead the most powerful organizations in health care?  Will there be investigations into this or other forms of regulatory capture? Will there be penalties for resulting conflicts of interest?  Or will the leaders once again manage to make even discussions of their failings taboo?    


 

Transparency International's Corruption Perceptions Index 2019: Political Corruption in the US Worsens, and Results are Largely Anechoic

Transparency International has just released its 2019 version of the Corruption Perceptions Index.  This version emphasized public sector corruption.  Once again, it appears the US has a worsening corruption problem.  Once again, the results are largely anechoic.

Summary of the 2019 CPI

Methods

Per the TI summary

The CPI scores 180 countries and territories by their perceived levels of public sector corruption, according to experts and business people.

The CPI uses a scale from 0 to 100.  100 is very clear and 0 is highly corrupt.

Results

TI provides CPI results for 180 countries.

The US had a score of 69, tied with France for 23rd best.  The score has declined since 2015 (when it was 76).

TI designated the US as a country to watch, with the following explanation:

With a score of 69, the United States drops two points since last year to earn its lowest score on the CPI in eight years. This comes at a time when Americans’ trust in government is at an historic low of 17 per cent, according to the Pew Research Center.

The US faces a wide range of challenges, from threats to its system of checks and balances, and the ever-increasing influence of special interests in government, to the use of anonymous shell companies by criminals, corrupt individuals and even terrorists, to hide illicit activities.

While President Trump campaigned on a promise of 'draining the swamp' and making government work for more than just Washington insiders and political elites, a series of scandals, resignations and allegations of unethical behaviour suggest that the 'pay-to-play' culture has only become more entrenched. In December 2019, the US House of Representatives formally impeached President Trump for abuse of power and obstruction of Congress.

The report emphasized that many countries, including the US, had increasing problems with political integrity:

This year, our research highlights the relationship between politics, money and corruption. Unregulated flows of big money in politics also make public policy vulnerable to undue influence.

Countries with stronger enforcement of campaign finance regulations have lower levels of corruption, as measured by the CPI. Countries where campaign finance regulations are comprehensive and systematically enforced have an average score of 70 on the CPI, whereas countries where such regulations either don’t exist or are poorly enforced score an average of just 34 and 35 respectively.

Sixty per cent of countries that significantly improved their CPI scores since 2012 also strengthened their enforcement of campaign finance regulations.

In addition, when policy-makers listen only to wealthy or politically connected individuals and groups, they often do so at the expense of the citizens they serve.

Countries with broader and more open consultation processes score an average of 61 on the CPI. By contrast, where there is little to no consultation, the average score is just 32.

A vast majority of countries that significantly declined their CPI scores since 2012 do not engage the most relevant political, social and business actors in political decision-making.

Countries with lower CPI scores also have a higher concentration of political power among wealthy citizens. Across the board, there is a concerning popular perception that rich people buy elections, both among some of the lowest-scoring countries on the CPI, as well as among certain higher-scoring countries, such as the United States.

The Anechoic Effect Lives

At least the 2019 CPI got some attention in 2020, as did the 2017 version (look here).  I found articles briefly summarizing the US results in a few US media outlets: Bloomberg (behind a paywall), the Associated Press (here, via the New York Times), and Forbes. There was also one op-ed, again in the WaPo.

This was some improvement from how previous relevant results from TI research were covered earlier.   There was virtually  no coverage of a 2013 survey that showed 43% of US respondents believed that US health care was corrupt.

One could argue even so that the current coverage of the 2019 report was inadequate given the importance of the topic and the apparent worsening of the US corruption problem.  This lack of coverage inspired me to write this post, in the hopes of making the issue just a little less anechoic

Discussion

We have argued again and again that health care corruption is an important reason for US (and global) health care dysfunction.  As we wrote in 2019,  Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, historically the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.  Now the problem appears to be getting worse in the US.  We have argued that a major reason is the miasma of corruption now surrounding the top of the US government, specifically the Trump administration (see again this 2019 post).

Now the TI discussion of its 2019 Corruption Perceptions Index points to increasing problems of public sector corruption in the US. Many of the issues it cites have been discussed on Health Care Renewal, including: problems in "campaign finance regulation" and "perception that rich people buy elections" (see our discussion of dark money); and "policy-makers [who] listen only to wealthy or politically connected individuals and groups" (see our discussion of the revolving door and regulatory capture).

The op-ed by Hough in the Washington Post included this parallel discussion:

First, successful anti-corruption policy centers on transparency and accountability. Reports such as this one by the UNDP make a strong case that clear lines of accountability improve the quality of governance, and sharpen attempts to fight corruption. Openness and transparency also need to be default settings. These are both areas where the U.S. could improve. The tone set by Donald Trump, whether by refusing to publish his tax returns or personally profiting from his position as president is indicative of a much broader problem. Neither transparency nor accountability are ever absolute, but analysts find plenty of scope for the U.S. to improve.

Second, the more opaque and complex the relationship between money and power, the more difficult it is to pinpoint and counteract corrupt relationships. Again, getting this right is not an exact science — and there’s no perfect system for funding political activity. But campaign finance, along with lobbying, are what corruption scholar Michael Johnston calls influence markets — areas where the wealthy can trade money for influence on policy outcomes. In other words, the rules and regulations let rich benefactors buy themselves a hearing. Yes, there are countries in worse positions, but that doesn’t hide the fact that the U.S. is also far from a model pupil.

And third, fewer Americans now trust either the politicians that rule them or indeed the institutions that help shape public life. Successful anti-corruption is built around integrity management, which requires public servants to act in appropriate ways — but also be seen acting in such ways. The highest ethical and moral standards — and transparency about potential conflicts of interest and recognizing when personal and public interests clash — would let U.S. citizens begin to believe that a cleanup of American government was underway.

In summary, there is growing evidence of a worsening corruption problem in the US.  As of today, responses to it have been ineffective.  Political corruption, especially at the top of the US government, makes addressing health care corruption increasingly difficult.

So we welcome any additional attention to health care corruption, or the larger corruption within the US government that is making health care corruption even harder to address.

But even if we can take that step, when the fish is rotting from the head, it makes little sense to try to clean up minor problems halfway towards the tail. Why would a corrupt regime led by a president who is actively benefiting from corruption act to reduce corruption? The only way we can now address health care corruption is to excise the corruption at the heart of our government.

It is now over three years since Trump was inaugurated, and there has been no real progress.  The fish is still rotting, and so is health care.  What will it take to make something happen?

Circular Logic - A Revolving Door Update

We have actually managed to go for three months without posting on the revolving door.

Since then, however, we have accumulated a sufficient number of relevant cases to post another round up.


The Old School Outgoing Revolving Door

Let us begin with cases of the old fashioned outgoing revolving door, that is, of 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.

However, it is striking that many of the people recently reported as transiting the outgoing revolving door have also had in the past transited the incoming revolving door (see below).

Cynthia Ridgeway, From Department of Justice Prosecuting White Collar Crimes to Anthem

As reported on July 15, 2019 by Modern Healthcare:

Health insurer Anthem has hired Cynthia Ridgeway, a longtime attorney for the U.S. Justice Department, to be its corporate strategy director.

Ridgeway is first assistant U.S. attorney in the Southern District of Indiana. During her 15-year tenure at the U.S. attorney's office, she litigated high-profile white collar crimes

The brief report had no information about Ms Ridgeway's expected duties for Anthem.  It is possible, but not certain, that they could be relevant to her work in white collar crime investigations and prosecutions for the government.

Marilyn Tavenner, From Administrator of Center for Medicare and Medicaid Services (CMS) of the Department of Health and Human Services (DHHS) to America's Health Insurance Plans (AHIP) and Now to Blue Cross Blue Shield of Arizona

As in a July 23, 2019, PR release:

Marilyn Tavenner, R.N., the former Administrator for the Centers for Medicare and Medicaid Services (CMS) and past president and CEO of America's Health Insurance Plans (AHIP), officially joined the BCBSAZ board, which provides strategic oversight to the company.

Note that Blue Cross Blue Shield of Arizona is a non-profit corporation.

Further note that Ms Tavenner had quite an interesting past history of revolving door transits.  According to her Wikipedia page, she worked for for-profit hospital system Columbia/ HCA, now HCA, from 1981 to 2005, starting as a nurse, and rising to President of the Central Atlantic Division.  While there, she worked for CEO Rick Scott, on whose watch the company made a huge settlement for Medicare fraud (look here).  Scott was not charged, left the company, and then was elected to be Governor of and the Senator for Florida as a Republican.  Ms Tavenner then went on to be Secretary of Health and Human Resources for Virginia, and then CMS administrator from 2013-15.

So Ms Tavenner moved from a for-profit hospital company to running the government agency that operates  government health insurance programs, and thus greatly influences hospital revenues.  The agency also obviously greatly influences the insurance industry, whose major trade association she then went on to lead.  Now she will be part of the governance of a large, albeit non-profit insurance company.

Erik Paulsen, From the House of Representatives to the Board of Cardiovascular Systems

As reported by the St Paul Business Journal, July 25, 2019:

Former U.S. Rep. Erik Paulsen has joined the board of directors for St. Paul medical device company Cardiovascular Systems Inc.

Cardiovascular Systems (Nasdaq: CSII) touted Paulsen’s support for the medical device industry and involvement with federal health care and economic policy in its announcement Thursday.

As a member of Congress from 2009 to 2019 representing Minnesota’s Third District, which covers suburbs of Hennepin County, Paulsen was co-chair of the bipartisan House Medical Technology Caucus. He also served on the House Ways and Means Committee, which covers taxes and policies governing health care, economics and trade.

Thus Mr Paulsen went from having a leadership role in government relationships with medical technology, and "taxes and policies governing health care," to a role in governance of a health technology company.

Dr Scott Gottlieb, From Commissioner of the Food and Drug Administration (FDA) to Venture Capital and the Pfizer Board of Directors, and now the Board of Aetion

Dr Scott Gottlieb has frequently appeard in posts on Health Care Renewal.  Our last summary of his relevant transits to the revolving door, from July, 2019 noted:

Dr Scott Gottlieb, FDA Commisioner from 2017 to May, 2019,  had been no stranger to the revolving door.  Prior to assuming leadership of the FDA, he had relationships with multiple for-profit health care corporations, which drew wide notice when he was appointed to head the FDA in 2017, as we noted at that time here.  Also, Dr Gottlieb was clearly very comfortable with the pharmaceutical and biotechnology industries.  For example, in 2007-2008, we discussed many examples of Dr Gottlieb's strident promotion of the interests of these industries (look here, here, here and here).

Very quickly after leaving the FDA in 2019, Dr Gottlieb rejoined his old venture capital firm, New Enterprise Associates, as a full-time partner investing partner specializing in life sciences companies.

Then in June, 2019, he joined the board of Pfizer.

His latest move was reported on September 17, 2019 by Fierce Healthcare:

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., has added another position to his roster of board and advisory roles since leaving the agency back in March.

He'll be joining healthcare technology company Aetion’s board of directors, the company announced Tuesday. The New York-based company offers real-world evidence and analytics to drug companies, payers, life sciences companies and regulatory agencies.

The company has an interesting array of financial backers:

Sanofi, Amgen, UCB, McKesson Ventures and Horizon Healthcare Services have all backed Aetion as strategic investors, according to the company.

It appears that Gottlieb's former role as leader of the FDA is highly relevant to the business of Pfizer, Aetion, and Aetion's "strategic investors." In particular, regarding Aetion:

Gottlieb will advise the company as it expands the reach and utility of the Aetion Evidence Platform, a scientifically validated tool to assess the safety, effectiveness and value of treatments using real-world evidence, the company said in a press release.

During his tenure, Gottlieb also pushed for the FDA’s use of real-world evidence, recognizing its potential to advance medical products and their development, Aetion said.

'The widespread adoption of real-world evidence to the development and application of new treatments will improve the precision of prescribing decisions and help make drug discovery far more efficient,' Gottlieb said in a statement.'“As a member of Aetion’s Board, I’m inspired by the opportunity to join the company’s efforts to bring RWE to the forefront of drug research and development.'

'Dr. Gottlieb has played a pivotal role in advancing the use of real-world evidence for regulatory decision-making. As a real-world evidence advocate and standard-setter, he’s an ideal partner in our work to help define RWE's role in the development, delivery, and payment of treatments,' Carolyn Magill, CEO of Aetion, said in a statement.

And regarding Pfizer and other pharmaceutical companies:

Aetion works with 12 of the top 20 biopharma firms in the world, along with leading payers.

We had discussed the conflicts of interest presented by Gottlieb's Pfizer board decision, which Senator Elizabeth Warren (D-MA) asserted "smacks of corrupion," here.

Matthew Whitaker, From Acting US Attorney General to Legal Advisor to a Marijuana and CBD Company

As reported on August 28, 2019 by Forbes:

Toronto-based CBD company Alternate Health Corp has hired Matthew Whitaker, former acting U.S. Attorney General, and his law firm Graves Garrett to serve as outside counsel.

Previously, he

served as Chief of Staff to then Attorney General Sessions from September 2017 to November 2018

Why was he selected?

'The legal environment surrounding CBD is rapidly evolving and it is essential that Alternate Health stays at the forefront of new government and FDA regulations,' he said. 'We believe his experience in government and the Department of Justice is a significant asset as we move forward.'

So Mr Whitaker, after taking a leading role in US government law enforcement, including enforcement of laws related to drugs like marijuana, would not be advising a foreign company trying to get favorable legal treatment from the government.

Rebecca Wood, from Chief Counsel at FDA to Leader of Food and Drug Practice at Sidley Austin

Ms Wood had been Chief Counsel at the FDA.

Recently reported by ProPublica (in a October 15, 2019 article to be discussed further below):

Wood now leads the food and drug practice at Sidley Austin, a powerful law and lobbying firm in Washington, where her colleagues lobby the FDA for various clients.

She is an example of

former Trump administration staffers who go back to K Street but don’t register as lobbyists — the Lobbying Disclosure Act only requires those who spend 20% or more of their time lobbying to register.

This still generates important conflicts of interest.

Wood said she 'advises clients on FDA-related issues and, in doing so, complies with all applicable ethics requirements.'

There is nothing illegal about returning to an old employer or being hired by a new one. Nor is there anything wrong with having colleagues who lobby the federal government. But the revolving door does present the possibility of conflicts of interests.

'The most important commodity in D.C. is information,' Hauser said. 'Former insiders have rare access to strategic intelligence, which is of significant value to corporate entities, and they can do so without registering as a lobbyist.'

Dr Karen DeSalvo, from Assistant Secretary of Health, DHHS and Office of the National Coordinator, to the University of Texas, now to Google as Chief Health Officer

As reported by Health Care Dive on October 18, 2019

Google has hired ex-Obama administration official Karen DeSalvo as its first chief health officer, further solidifying its investment in the $3.5 trillion industry by rounding out its healthcare team.

DeSalvo, a well-respected healthcare executive and public health expert, was the acting Assistant Secretary for Health at HHS and ran the Office of the National Coordinator, which manages the nation's health IT, under President Barack Obama. She has spent the past two years teaching at the University of Texas at Austin's Dell Medical School.

Note that there was a two year delay after Dr DeSalvo left the government until her hiring by Google.  This does apparently lessen the conflicts of interest generated.  However, many think 

The Au Courant Incoming Revolving Door

In the Trump era, many people have come through the incoming revolving door, that is, people with significant leadership positions in health care corporations or related groups have attained leadership positions in government agencies whose regulations or policies could affect their former employers.

On October 15, 2019, ProPublica published a striking article on people transiting the incoming revolving door from lobbying positions to leadership positions at government agencies whose regulations or policies could affect their lobbying clients.

Two of the people recently added to the ProPublica data base got major government health care leadership positions after working as lobbyists, and then returned to lobbying after ending their government "service."

By way of background:

At the halfway mark of President Donald Trump’s first term, his administration has hired a lobbyist for every 14 political appointments made, welcoming a total of 281 lobbyists on board, a ProPublica and Columbia Journalism Investigations analysis shows.

With a combination of weakened rules and loose enforcement easing the transition to government and back to K Street, Trump’s swamp is anything but drained. The number of lobbyists who have served in government jobs is four times more than the Obama administration had six years into office. And former lobbyists serving Trump are often involved in regulating the industries they worked for.

Even government watchdogs who’ve long monitored the revolving door say that its current scale is a major shift from previous administrations. It’s a 'staggering figure,' according to Virginia Canter, ethics chief counsel for the D.C.-based legal nonprofit Citizens for Responsibility and Ethics in Washington. 'It suggests that lobbyists see themselves as more effective in furthering their clients’ special interests from inside the government rather than from outside.'

Colin Roskey,  from Health Care Lobbying for Lincoln Policy Group to Deputy Secretary, DHHS, then back to Lobbying for Lincoln Policy Group

Per ProPublica:

Consider Colin Roskey. Days after leaving a two-decade career as what one former employer called the 'smartest' health care lobbyist, he joined the Department of Health and Human Services in January. As deputy secretary for legislation for mandatory health, he headed the portfolio that he tried to influence for most of his career.

HHS declined to reveal any recusals he signed while appointed. A spokesman said that “all employees are expected to abide by the ethics rules.”

Just days before joining HHS, Roskey listed among his clients major dialysis providers that receive federal payments through Medicare, including Fresenius Medical Care — an industry juggernaut, with more than 330,000 patients in thousands of dialysis clinics in the U.S. A third of the company’s billion-dollar revenue comes from Medicare. A recent revamp in the dialysis industry ordered by Trump, expected to shift millions of dollars from dialysis centers to cheaper home-based options, put Roskey’s office at the heart of regulating how much profit or loss some of his former clients will see in coming years. Roskey said in an interview that he recused himself from this matter.

Public records show that Roskey lobbied for at least 27 clients between January 2017 and December 2018 on an array of issues other than dialysis involving public health care programs, from prescription drugs to palliative care.

In early October, Roskey stepped out of government and went straight back to work for his old lobbying firm, Lincoln Policy Group, which specializes in health care policy. “Spending time at HHS will make [Roskey] even more valuable to our team — and we are so excited to have him back,” the lobbying firm announced in a statement.

Roskey said he had no knowledge of how the new kidney care regulations will be implemented.

After his monthslong stint with the Health Department, Roskey said he plans to lobby the legislative branch, which is not prohibited by the current ethics rules. 'While working with the government I gained knowledge and background, intellectually and professionally, and I intend to unapologetically utilize those skills for my employer and clients,' he said.

The conflicts of interest generated by the moves from and to the lobbying firm are are obviously significant.

Laura Kemper from Health Care Lobbyist to Deputy Assistant Secretary of DHHS, then to Lobbying as Vice-President for Governmental Affairs for Fresenius

We had previously discussed Ms Kemper's transit from lobbyist to government health care leader here.   From the ProPublica article,

Laura Kemper, [is] a former HHS senior official who, within days of leaving her post in March, was hired by Fresenius. Now vice president for government affairs, Kemper heads the company’s policy group.

According to lobbying records, she is listed among the in-house lobbyists who have visited Congress, the White House and HHS since March, pushing everything from reimbursement for dialysis services to home dialysis. The records show Fresenius shelled out more than $2.2 million for lobbying activities during the first half of the year.

Furthermore, ProPublica noted:

Her pass through the revolving door tests the boundaries of ethics rules. Indeed, Trump’s pledge prohibits staffers-turned-registered lobbyists from advocating for the special interests of their corporate bosses before the agencies where they used to work for at least five years. It also restricts former employees from behind-the-scenes lobbying with any senior federal official for the remainder of Trump’s presidency. Kemper signed that pledge.

Kemper declined to comment. In a statement, Fresenius said Kemper “has strictly followed her legal and ethical obligations and has not been involved in lobbying the administration or anything related to the Executive Order.” Disclosure forms filed by Fresenius “cite the general activity of a team and do not ascribe any particular lobbying activity,” according to its statement.

Recently, during an earnings call to investors, Fresenius CEO Rice Powell said that the company has talked to the 'appropriate people in Washington,' without naming any particular Fresenius or government staffer. “We are in the midst of commenting and asking questions” with HHS officials, he added.

As ProPublica has reported, political appointees who return to lobbying have found ways to tiptoe around ethics rules. Some register as lobbyists but limit their interactions to Congress, leaving colleagues to lobby the executive branch. Ethics restrictions don’t apply to congressional lobbying.

Summary

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.

April, 2019, Update: How to Challenge Health Care Corruption Under a Corrupt Regime?

In these last few weeks, the US news has been dominated by the release of a redacted verion of the Mueller report which included extensive evidence of questionable behavior by President Trump, his campaign, and various Trump associates.  This week, an editorial in Mother Jones suggested:

The Russia scandal was never, in the main, about whether the president would be prosecuted for a crime. It was, and is, about a bigger issue: A wealthy politician who hoped to profit from pandering to a foreign autocrat put his own financial interests above those of his country, who abetted a foreign attack, and who lied about it to those he swore to serve.

There is a word for this, but it’s not collusion. It’s corruption.

The editorial suggested that journalists have not done an adequate job pursuing the underlying "rot" in the US government and the Trump administration:

And rather than laying off investigating it, as too many are suggesting now, journalism needs to back up and look at the whole thing.

It seems to be a great idea, but in fact, some journalists, scholars, bloggers, etc have been looking at corruption for a long time, including health care corruption, and corruption in the US government.  The problem, however, is that much of the discussion of corruption has been anechoic.

Background: Health Care Corruption

As we wrote in August, 2017, Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.

Health Care Corruption in the Context of a Corrupt Government

Instead, things now only seem to be getting worse, given the increasing evidence that the Trump administration is corrupt at the highest levels.   In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.


In October, 2018, we summarized the content of the voluminous Tracking Corruption and Conflicts of Interest in the Trump Administration summary appearing in the Global Anti-Corruption Blog. The blog organized corrupt activities within the Trump administration into the following categories:

1. U.S. Government Payments to the Trump Organization

2. Use of the Power of the Presidency to Promote Trump Brands

3. U.S. Government Regulatory and Policy Decisions that Benefit Business Interests of the Trump Family and Senior Advisors

4. Private and Foreign Interests Seeking to Influence the Trump Administration Through Dealings with Trump Businesses

Not only was the report voluminous, the October version of the report requiring 26 pages to print, it suggested that many examples of corruption by Trump et al were not one-offs, but were long-term activities.  For example, every time President Trump travels to on of the properties he owns through the Trump Organization, for example, has Mar-a-Lago resort in Florida, the US government is obligated to pay Trump himself through that organization for various expenses, e.g., the Secret Service renting golf carts at Mar-a-Lago.  Each time that happens it seems to violate the "domestic emolument clause" of the US Constitution, which prohibits state or US government payments to a President for anything other than his salary.  Also, foreign governments and corporations seeking to promote specific government policies in their self-interest, similarly seeking favorable regulations, or other seeking to influence government actions in their favor are making periodic payments to the Trump Organization, such as buying accomodations or paying for events at Trump properties.  When foreign governments do so, that appears to violate the "foreign emoluments clause" of  the US Constitution, which prohibits payments by a foreign government to the US President.

Updates on the Corruption of the US Government


New Source: Bloomberg's "Tracking the Trump Team's Conflicts and Scandals"

Bloomberg produced an interactive guide, most recently updated in March, 2019, and divided into sections on individual members of the team, including Trump and his family, Trump appointees, and associates and outside advisers.

New Source: the Citizens for Responsible Ethics in Washington's Blog

CREW is a non-profit organization whose goal is "to reduce the influence of money in politics and help foster a government that is ethical and accountable."It produces a blog with very frequent posts that center on conflicts of interest and corruption affecting Trump and associates.  For example, recent posts included: "IRS Commissioner Charged with Releasing Trump Tax Returns Profits from Trump-Branded Property" and "Turkish Interest Group Event Kicks Off at Trump Hotel, with Government Sponsors."

New Source: Zach Everson's 1100 Pennsylvania Avenue

Threre are so many instances of violations of the foreign and domestic emoluments clause occurring just at the Trump Organization hotel in Washington, DC that there is now a blog and newsletter dedicated to essentially daily reporting about them.

Updates of the Global AntiCorruption Blog's "Tracking Corruption and Conflicts of Interest in the Trump Administration"

Since October, the report has been updated nearly monthly .  These updates suggest new variations on these corrupt themes, for example: November, 2018, Interior Secretary Ryan Zinke's "shady property development deal;"January, 2019, questions of illegal actions by Trump's inaugural committee;
March, 2019, possible special treatment by the Government Services Administration of the Trump Organization's flagship Trump International Hotel in Washington, DC; and April, 2019, how Trump-connected lobbyists are directing clients to book rooms at that hotel.


Updates of the Sunlight Foundation's "Tracking Trump's Conflicts of Interest"

At the same time, the Sunlight Foundation's "Tracking Trump's Conflicts of Interest" project is also frequently updated.  Note that its main webpage includes links to weekly reports about relevant issues.  For example, the most recent is " This Week in Conflicts: Redacted Mueller Report Released, Undisclosed Cash Flow from Inaugural Ball and Mueller Explains Why His Family Left Trump’s Golf Club"


Discussion

Since October, the evidence of pervasive conflicts of interest and outright corruption affecting President Trump, his family, the Trump Organization, and his administration continues to mount.  The totality of the array of unethical and probably illegal activities has become mind numbing.  To underscore what we wrote in October

So the driver of US health care corruption may now be the executive branch of government and its relationship with the Trump family and cronies, trumping even the influence of health care corporate corruption.

That corruption appears to be ongoing, getting worse not better, and is not receiving adequate notice.

In November, 2017, we noted that another report by Transparency International that showed that in an international survey of corruption perceptions, substantial minorities of US respondents thought that US corruption was increasing, and was a particular affliction of the executive and legislative branches of the national government, other government officials, and top business executives.  There was virtually no coverage of these results in the US media, just as there was virtually no coverage of a 2013 survey that showed 43% of US respondents believed that US health care was corrupt.

Similarly, despite, or perhaps because of their tremendous scale, the reports about Trump related corruption listed above have generated little discussion.  Despite the extensive and ever-increasing list of apparently corrupt acts by the Trump and cronies, grand corruption at the top of US government, with its potential to corrupt not just health care, but the entire country and society, still seems like a taboo topic.  The US news media continues to tip-toe around the topic of corruption, in health care, of top health care leaders, and in government, including the top of the US executive branch.  As long as such discussion seems taboo, how can we ever address, much less reduce the scourge of corruption?  The first step against health care corruption is to be able to say or write the words, health care corruption.

So we welcome any additional attention to health care corruption, or the larger corruption within the US government that is making health care corruption even harder to address. We thus specifically welcome Mother Jones' added emphasis on this topic.


But even if we can take that step, when the fish is rotting from the head, it makes little sense to try to clean up minor problems halfway towards the tail. Why would a corrupt regime led by a president who is actively benefiting from corruption act to reduce corruption? The only way we can now address health care corruption is to excise the corruption at the heart of our government.

For Whom the Door Revolves: Founder and Director of Multiple Biotechnology Companies Became Director of the NCI and Now Nominated to be Acting Commissioner of the FDA

Dr Scott Gottlieb, the first commissioner of the US Food and Drug Administration (FDA) appointed by President Trump, has announced his plans to depart.  At the time of his nomination, Dr Gottlieb's many conflicts of interest were well known (see this NY Times article, for example), as were his exceedingly friendly views of the pharmaceutical/ biotechnology industry (see this long ago post, for example).


President Trump's regime just announced a new acting commissioner, Dr Norman ("Ned") E Sharpless, another industry fan.


Founder and Director of Several Biotechnology Companies

G1 Therapeutics

As StatNews just reported, Sharpless "founded two biotech companies."  His fans cited as proof of the "breadth of his experience,"

the $105 million that G1 Therapeutics, a company Sharpless co-founded, raised in 2017 while developing the lung and breast cancer drug trilaciclib.

Apparently, his work in industry has made Dr Sharpless rich

According to public records, founding these companies may have paid off.  Sharpless reported selling more than 400,000 shares of G1 Therapeutics in October 2017 - which, at the time, were worth more than $9 million.

So far, I have seen no other recent reporting that goes into any detail about Dr Sharpless' connections to the pharmaceutical and biotechnology industry.  Nor did I see much reporting about these relationships from the time Dr Sharpless was appointed to head the National Cancer Institute in October, 2017, again by the Trump regime.

A little digging provided a bit more detail about his relationship to G1 Therapeutics.Crunchbase revealed that Dr Sharpless was a Co-Founder of G1 Therapeutics, a member of its Scientific Advisory Board, and a member of its board of directors.  A  press release from the UNC Lineberger Comprehensive Cancer Center did gush a bit about his ability to raise capital for G1 Therapeutics in May, 2017, a few months before he was appointed to head the NCI.

G1 Therapeutics, Inc., a clinical-stage oncology company in Research Triangle Park with ties to the University of North Carolina Lineberger Comprehensive Cancer Center, has raised approximately $108.6 million in an initial public offering of its stock. The company began trading on the NASDAQ Global Market under the ticker symbol 'GTHX' on May 17.

Furthermore,

Founded in 2008 with support from KickStart Venture Services, a UNC-Chapel Hill program that works to turn University research into new companies, G1 is developing novel therapeutics based on discoveries made by UNC Lineberger Director Norman E. Sharpless, MD, and Kwok-Kin Wong, MD, PhD, then at Dana-Farber Cancer Institute and now at the Perlmutter Cancer Center, NYU Langone Medical Center. The early research that led to the formation of G1 was supported by the University Cancer Research Fund.

'Congratulations to Dr. Sharpless and the entire G1 Therapeutics team for achieving this major milestone, making an impressive market debut and accelerating important advances in cancer therapies,' said Judith Cone, Vice Chancellor for Innovation, Entrepreneurship and Economic Development at UNC-Chapel Hill.

It was an advance in raising capital, although the eventual clinical value of the venture may not yet be clear.  Trilaciclib is apparently still under development and has not been yet subject to big randomized clinical trials.

Sapere Bio


StatNews also reported,

The second company that Sharpless-directed science helped spawn is Sapere Bio, also based in North Carolina

which is

developing a diagnostic text to measure a patient's 'molecular age.'

whatever that may be, and whatever use it may turn out to have, or not.


There is not much more information about Dr Sharpless' relationship with Sapere Bio.  In February, 2019, the WRAL Tech Wire stated,

Physician Norman 'Ned' Sharpless and Natalia Mitin, Ph.D., founded Sapere Bio in 2013. It was originally called HealthSpan Diagnostics, a reference to the period in your life when you’re healthy. The company grew out of the research of Sharpless, who at the time was director of the Lineberger Cancer Center at the University of North Carolina at Chapel Hill.

Apparently, by the time this article was written, he was "no longer involved" with the company.


Consulting and Other Financial Relationships

Further web searching revealed that Dr Sharpless had to disclose other financial relationships with health care corporations in the past.  In 2017, he was one of multiple authors on a paper in The Oncologist (Patel NM et al. Enhancing next-generation sequencing-guided cancer care through cognitive computing. Oncologist 2017; 22: 1-7.)

Norman E. Sharpless: G1 Therapeutics, Unity Biotechnology, HealthSpan Diagnostics (C/A, IP,SAB, OI), Pfizer (H)

Where

(C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (ET) Expert testimony; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/ inventor/patent holder; (SAB) Scientific advisory board

The ProPublica Trump Town database also stated that Dr Sharpless was a former consultant to Unity Biotechnology and that

Compensation to be an advisor to Unity is solely through an option to purchase up to 50,000 shares of their stock. Roughly half of these options are unvested.

I cannot find anything more about Dr Sharpless' relationship to Unity Biotechnology, which is apparently yet another start-up biotechnology corporation with drugs in the development pipeline.
 
Again, it appears that Dr Sharpless may have ended these relationships when he became NCI director.  A disclosure in December, 2018, for a talk he gave at the American Society of Hematology included

Sharpless: Pfizer(relationship ended): Honoraria; G1 Therapeutics (relationship ended): Membership on an entity's Board of Directors or advisory committees; G1 Therapeutics (divested): Equity Ownership; Healthspan Diagnostics (relationship ended): Membership on an entity's Board of Directors or advisory committees; Healthspan Diagnostics (divested): Equity Ownership; Unity Biotechnology (divested): Equity Ownership; Unity Biotechnology (relationship ended): Membership on an entity's Board of Directors or advisory committees; Unity Biotechnology (relinquished)

Summary

Dr Norman "Ned" E Sharpless is clearly an experienced academic physician, and hence is a welcome contrast with the many ill-informed ideologues lacking any experience or expertise in biomedical research, medicine, health care or public health recently appointed to important US government health care related positions (for the most recent example, look here).

However, while he held a major academic leadership position, Dr Sharpless had multiple important conflicts of interest, including founding and serving on the boards of directors of several for-profit biotechnology companies, as well as having other financial relationships with health care corporations.  He apparently had already become rich via these relationships before he became director of the US National Cancer Institute (NCI), although he apparently ended the relationships when he assumed the directorship.  As the head of the NCI, he was in a position to have some influence over US health care research policy affecting the pharmaceutical and biotechnology industry.  Hence his appointment to that position was an example of the revolving door.

Now about one and one-half year later, his position as acting commissioner of the FDA will give him much more influence over pharma and biotech.  This appointment is an even more strking example of the revolving door.

Both examples seem to have so far gotten lost in the continuing chaos generated by the Trump regime.

Yet, as we have said until blue in the face, and most recently less than a month ago...

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

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door from industry to the Trump 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.

Update: How to Challenge Health Care Corruption Under a Corrupt Regime

Summary: the Corruption of Health Care Leadership as a Major Cause of Health Care Dysfunction

As we wrote in August, 2017, Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.

the scale of corruption is vast in both rich and poor countries.

Also,

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.  For example, we had long complained that US law enforcement had not been devoting enough effort going after the corruption of the leadership of large health care organizations, thus effectively allowing these leaders' impunity. However, in the later years of the Obama administration the US Department of Justice during the Obama administration made some modest attempts to decrease such impunity, including the formation of a Health Care Corporate Strike Force.

As reported by Law.com,

the strike force was created in the fall of 2015, with five dedicated lawyers working on about a dozen of the most complex corporate fraud cases in the health care space.

Andrew Weissmann, the then-chief of the DOJ’s fraud section, told a health care conference in April 2016 that the section was placing 'a heightened emphasis' on corporate health care fraud investigations. He pointed to the recently established Corporate Fraud Strike Force that he said would focus resources in investigation and prosecution of larger corporate health care law violations, as opposed to smaller groups or individuals.

This little bit of progress was not to last.  Unfortunately, that strike force was downsized by the Trump administration as we noted in July, 2017.  Then as we noted in May, 2018, even the previously modest efforts by the US government to challenge corrupt acts by large US health care organizations were decreasing.  By that date, we found only one significant settlement made during the year.  That month, a report by Bloomberg, appeared with the headline, "White-Collar Prosecutions Fall to 20-Year Low Under Trump," on May 25, 2018.

Increasing Evidence of Corruption in the Trump Administration

Meanwhile, the Trump administration itself increasingly appeared corrupt.  In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.


The Global Anti Corruption Blog Update

This month, the Tracking Corruption and Conflicts of Interest in the Trump Administration–October 2018 UpDate appeared in the Global Anti-Corruption Blog.  It is voluminous, requiring about 26 single-spaced pages to print, with numerous references.  But then again...

 Poster displayed in front of Trump International Chicago Hotel, displaying the slogan: "Subtlety is not our strength.  Indulgence is."

So let me try to summarize the main points of Trump's indulgence, keyed to the four sections of the report.


1. U.S. Government Payments to the Trump Organization

One of the most direct ways that President Trump can profit from the presidency is by making decisions that effectively require U.S. government agencies to purchase goods or services from the Trump Organization. Though unseemly and costly to taxpayers, this is one of the less destructive forms of potential profiteering by President Trump, since it does not significantly distort U.S. policy.

Examples included the Secret Service and Department of Defense renting expensive space in Trump Tower in New York;  the Secret Service paying the Trump Organization in order to protect President Trump during the many occaisions (208 days at that point) he has spent at Trump Organization luxury properties; payments to the Trump Organization for Secret Service and other government staff presence at overseas Trump properties when visited by the President on ostensibly government business; and payments to the Trump Organization when Trump and his family fly on his private planes for non-government business.

Note that these payments seem in gross violation of Article II, section 1 of the US Constitution, which states:

The President shall, at stated Times, receive for his Services, a Compensation, which shall neither be encreased nor diminished during the Period for which he shall have been elected, and he shall not receive within that Period any other Emolument from the United States, or any of them.

This has been called the "domestic emoluments clause," and is supposed to prohibit a kind of conflict of interest, that is, a President getting paid by some part of the US government, or by state governments separate from his regular salary and benefits.  Nonetheless, Trump has been effectively paid, again and again, through the Trump Organization by the US government.


2. Use of the Power of the Presidency To Promote Trump Brands

Donald Trump and his family can also enrich themselves by taking advantage of the unique status and exposure of the President of the United States to promote Trump family brands.

Albeit,

While distasteful, this brand-promotion activity is also one of the less harmful ways in which the Trump Administration may seek to profit from the Presidency, as it does not involve significant distortions of U.S. policy. Nonetheless, the overt attempts to use the presidency as a marketing opportunity indicate a troubling underlying attitude.

Examples included the White House website promoting Melania Trump's jewelry line; WH senior advisor KellyAnne Conway, speaking in the Briefing Room, endorsing Ivanka Trump's fashion line; various activities that served to promote Trump Organization luxury properties, particularly Mar-a-Lago and Bedminster; promotion of Ivanka Trump's fashion line via her official participation in a World Bank Women Entrepreneurs Finance Initiative; the Voice of America and State Department promoting Ivanka Trump's book; the Trump Organization's apparently illegal use of the Presidential Seal to promote golf products; Trump Organization's discount promotion of golf merchandise to WH staff; and Trump Campaign and Republican National Committee events at Trump properties.

3. U.S. Government Regulatory and Policy Decisions that Benefit the Business Interests of the Trump Family and Senior Advisors

Federal government decisions—on regulation, law, enforcement, and discretionary spending—may be influenced or manipulated in ways that benefit the private commercial interests of the Trump Organization or other businesses closely tied to President Trump, his family, or his senior advisors. This is a much more serious problem, as it involves not only enrichment of the Trump family and associates at taxpayer expense, but also potential distortions of U.S. policy.

This has occurred on such a massive scale that

The extent of the Trump Organization’s business interests makes it impossible to summarize all of the potential conflicts of interest that might arise. For example, the Trump Organization has been involved in labor disputes; Trump businesses regularly apply for visas for foreign workers (see here, here, and here); and Trump businesses are subject to countless federal safety and environmental regulations. (See here for an in-depth analysis of many of these potential conflicts.) As head of the executive branch, President Trump might have influence over numerous decisions that affect the Trump Organization’s business interests. 

Some of the examples provided were government actions that affected the Housing and Urban Development (HUD) subsidies being received by Trump Organization properties; the Dakota Access Pipeline, which was being built by a company in which Trump owned stock; the Clean Water Act, whose rollback would benefit Trump Organization golf courses; the General Services Administration lease held by the Trump Organization to operate the Trump International Hotel in Washington, DC; the decision to demolish the current FBI headquarters, possibly allowing a competitor to the Trump International Hotel in Washington to be built across the street; various business interests of Ivanka Trump and her husband; the proposed infrastructure project which could variously affect the Trump Organization; the Justice Department investigation of Deutsche Bank, a large source of loans to Trump and his family; offshore oil drilling which could affect the attractiveness of Trump properties like Mar-a-Lago; Fannie Mae and Freddie Mac, controlled by the government, but whose investors include a large hedge fund in which Trump has a stake;  the travel ban so as not to affect countries in which the Trump Organization has operations; H2B visa applications which supply workers to Trump properties; the tax reform plan which greatly affected Trump's taxes; and the choice of US Attorneys in jurisdictions in which the Trump Organization operates and whose offices may be in a position to investigate Trump, the Trump Organization, and Trump associates.

Furthermore, government decisions may have affected the financial fortunes of Trump associates such as Commerce Secretary Wilbur Ross, special advisor Carl Icahn, confidant Rupert Murdoch, Tennessee Valley Authority nominee Kenneth Allen, Department of Homeland Security Secretary  Kirstjen Nielsen, Interior Secretary Ryan Zinke, former director of the Centers for Disease Control Brenda Fitzgerald, Housing and Urban Development Secretary Ben Carson, etc, etc, etc

4. Private and Foreign Interests Seeking To Influence the Trump Administration Through Dealings with Trump Businesses

Another significant concern is that individuals, private firms, and foreign governments may believe—rightly or wrongly—that they can curry favor with the Administration and increase their odds of favorable policy decisions by engaging in private business transactions with companies owned by or connected to President Trump—or, in the case of foreign governments, granting favorable regulatory treatment to Trump business operations in their countries. This is one of the most serious concerns related to the Trump family’s interest in profiting from the presidency, as it gives rise both to the appearance of corruption and the risk of actual corruption.

While again the scope of  this problem was again "too broad to summarize," let me give some examples:

- Bookings made at the Trump International Hotel in Washington DC by foreign governments including Bahrain, Saudi Arabia, Kuwait, Turkey, Malaysia, the Phillipines, and Afghanistan.

- Events at other Trump properties, the renting and purchasing of Trump properties, Trump Organization developments in countries including Indonesia, India, Panama, Turkey, United Arab Emirates, Scotland, Dominican Republic, and Taiwan.

- Trump Organization seeking trademarks in China.

- Membership in Trump golf courses

-  Trump real estate transactions with secretive buyers

- A large number of business dealings by Jared Kushner, Trump's son-in-law involving China, Qatar, Russia, Israel, and Japan

- former Trump lawyer and "fixer" Michael Cohen's consulting company's dealings with Russia, and allegedly creating a "slush fund" to be used by Trump

Note that any of the payments made to Trump via the Trump Organization by foreign govenments could  violate the "foreign emoluments clause" of the US Constitution, that is, Article I, Section 9

No Title of Nobility shall be granted by the United States: And no Person holding any Office of Profit or Trust under them, shall, without the Consent of the Congress, accept of any present, Emolument, Office, or Title, of any kind whatever, from any King, Prince, or foreign State.

This again is supposed to prohibit a species of conflict of interest, any payment to a US government official, including the President, by a foreign government, without the express consent of the US Congress. 

There are several lawsuits in progress on this matter, but no action has been taken by the Trump regime, or its supporters in Congress, to curtail these foreign emoluments.  

In addition, the Trump Organization has had dealings with US state governments that may violate the domestic emoluments clause of the US constitution.  These included tax breaks recently given to new Trump hospitality properties by the state of Mississippi.

Meanwhile Corruption, Even of a President, Remains a Virtually Taboo Topic

The scope of conflicts of interest and corruption affecting US President Donald Trump, his vast business empire, his family and associates seems incomprehensively big.

And still, corruption remains a nearly taboo topic. 

In November, 2017, we noted that once again, a report by Transparency International that showed that in an international survey of corruption perceptions, substantial minorities of US respondents thought that US corruption was increasing, and was a particular affliction of the executive and legislative branches of the national government, other government officials, and top business executives.  There was virtually no coverage of these results in the US media, just as there was virtually no coverage of a 2013 survey that showed 43% of US respondents believed that US health care was corrupt.

Similarly, the reports about Trump related corruption listed above have generated little discussion.  Despite the extensive and ever-increasing list of apparently corrupt acts by the Trump and cronies, grand corruption at the top of US government, with its potential to corrupt not just health care, but the entire country and society, still seems like a taboo topic.  The US news media continues to tip-toe around the topic of corruption, in health care, of top health care leaders, and in government, including the top of the US executive branch.  As long as such discussion seems taboo, how can we ever address, much less reduce the scourge of corruption?  The first step against health care corruption is to be able to say or write the words, health care corruption.

But even if we can take that step, when the fish is rotting from the head, it makes little sense to try to clean up minor problems halfway towards the tail. Why would a corrupt regime led by a president who is actively benefiting from corruption act to reduce corruption? The only way we can now address health care corruption is to excise the corruption at the heart of our government.