Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Sunday, January 09, 2022

The New Business Coup? Increasing Evidence that Large Health Care Corporations are Funding Threats to Democracy

Introduction: Health Care Corporations' Political Contributions: From Bipartisan to Trumpian

 At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and political organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 


 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). 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 discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post, this July 7, 2021, post, and this September 7, 2021 post).

Now just after the anniversary of an insurrection that almost prevented the certification of the 2020 US presidential election results, there are new indications that leaders of big health care corporations are continuing to support Republicans in Congress who voted to overrule the results of that election.

Health Care Corporate Sponsorship of the Attempt to Overturn the 2020 Election 

Citizens for Responsibility and Ethics in Washington (CREW) has updated their report on corporate sponsorship of the politicians who wanted to overturn the election.  The January 3, 2022 version is entitled "The Corporate Insurrection: How companies have broken promises and funded seditionists." It described the "717 corporations and industry groups have donated over $18 million to 143 of the 147 members of Congress who objected to the results of the 2020 presidential election, as well as the National Republican Senatorial Committee and the National Republican Congressional Committee."  It referred to the updated data about the largest corporate funders appearing in the current version of CREW's previous report.  The health care corporations that appear in this list of 80 are:

Pfizer                                        $71,000

Merck                                      $68,000

Eli Lilly                                   $42,000

Johnson & Johnson                   $38,500

Anthem                                   $32,500

Cigna                                       $30,000

CVS Health                            $30,000 

AstraZeneca                           $26,500

Humana                                $15,000

Blue Cross & Blue Shield         $15,000 

Keep in mind that these amounts only reflect corporate donations directly to members of Congress, their own leadership PACs, and to the national Republican campaign committees, which must be disclosed by law. They do not include any amounts given by corporate executives, or amounts given to various kinds of dark money organizations, which do not have to be disclosed according to law.  Thus they may seriously undercount the financial support given by health care corporations to support those who wanted to nullify the election. But at least these figures suggest that 5 large pharmaceutical/ biotechnology companies, 4 health care insurance companies, and one diversified pharmacy company continue to be strong supporters of legislators who were willing to do so.  

Furthermore, as noted in a January 5, 2022, article in Fierce Pharma, spokespeople for some of these corporations declared they were no longer worrying about whether politicians support democracy or tried to overturn an election, but only about whether the politicians support policies that would improve their corporate bottom lines.  For example, see this from Pfizer:

Pfizer’s PAC supports policymakers who value innovation and expanded access to breakthrough medicines and vaccines that change patients’ lives,

And see this from Eli Lilly: 

[the company] supports candidates across the political spectrum who understand the value of a vibrant pharmaceutical ecosystem to address unmet patient needs.

Billionaires Who Made Their Money from Health Care Corporations Who Supported the Attempt to Overturn the Election  

A January 6, 2022 article in Forbes listed the "more than 50 billionaires [who] donated in the second half of 2021 to legislators who voted against certifying the presidential election, according to an analysis of Federal Election Commission records."  Two the billionaires made their fortunes from health care corporations.  They were: 

- Phillip Frost, worth $2,500,000,000, described as "a long-time health care investor, inventor and founder, Phillip Frost now runs diagnostics-maker Opko Health." He "joined Key Pharmaceuticals in 1972, reformulated its asthma drug and sold the company in 1986 for $836 million." Also, he "founded Ivax, a generic drugmaker, in 1987. He sold it to Teva Pharmaceuticals for $7.6 billion in 2005"  Frost supported Sen Hawley (R-MO). 

- James Leininger, worth $1,500,000,000, described as having "made his fortune founding medical devices company Kinetic Concepts (KCI), which focuses on wound care." He also runs "Medcare Investment Funds, which manages $1 billion in assets." Leininger supported Rep Cloud (R-TX). 

 Discussion

 As we said before, most health care corporations publish high-minded aspirational statements that promise pluralism, support of the community, and of our representative democratic society. Data revealed recently and discussed in our previous three posts increasingly show that some leaders of  large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would challenge election outcomes in the absence of very clear evidence of election irregularities seems to violate high-minded corporate pledges of inclusiveness.

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

Also, the quotes above support the idea that corporate leaders put their own bottom lines ahead of supporting the republican form of government that partially made their revenues possible.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top corporate managers, particular individuals can control political funds far beyond what they would  be able to control as private persons, and to do so quietly and sometimes anonymously.  Corporate leaders may thus be able to promote their own interests through their corporations' political giving.  Those interests may go beyond just personal enrichment.   Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, authoritarian, even openly fascist national political leadership.  

Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)  

There was at least one previous instance in which US business leaders tried to effect a coup to oust a President they considered too left wing.  This was sometimes called the "business coup."  According to a Washington Post article from 2021, its sponsors included "included J.P. Morgan Jr., Irénée du Pont and the CEOs of General Motors, Birds Eye and General Foods."  Their goal was to depose President Franklin D Roosevelt and 

install a dictator who was more business friendly. After all, they reasoned, that had been working well in Italy

The plot failed because the former military officer they chose to lead it informed the government.  So far, the attempt by now former President Trump and his followers to do something similar has also failed. That does not mean, however, that the next attempt will not succeed.

 


IMHO, all citizens need to wake up and  protect our republic.  Furthermore, all medical and public health professionals specifically need to take action to wake up and protect our republic specifically from self-interested health care corporate leaders.  Imagine what health care and public health might be like were they to exert near absolute control facilitated by an authoritarian they installed in office 

 

 

Wednesday, July 07, 2021

Leadership of Big Health Care Corporations Go Back to Financially Supporting the Opponents of Democratic Governance

At one time, leadership of large health corporations were circumspect in their financial support for US politicians and political causes. They provided some funds directly to politicians and poltical organizations, but often amounts given to different parties and organizations with different ideologies were balanced. Presumably, the goal was to promote access to whomever was in power at any given time. 

With the rise of Donald Trump, things changed. Many leaders apparently went all in for Trump and his Republican supporters.  In June, 2018  we discussed how CVS channeled money to a "dark money group," that promoted Trump administration policies, including repeal of the Affordable Care Act (ACA). 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 discussed how in the 21st century, health care corporate CEOs' personal political contributions were increasingly partisan, that is individual CEOs gave predominantly or exclusively to one party, and for the vast majority, to the Republican party. 


 

Some corporations paused some of their political giving after a mob whipped up by Trump at a January 6, 2021, rally violently stormed the US Capitol to try to prevent the certification of the 2020 election. However, within two months they started giving again in support of Republicans in Congress who voted not to certify the election (see this April, 2021, post).

Now two new reports show continuing support by large health care corporations for Republican legislators who also supported the nullification of the election, and legislation that might decrease voting by citizens who oppose Trump

Health Care Corporate Sponsorship of Voter Suppression

In April, 2021, Public Citizen published "The Corporate Sponsorship of Voter Suppression." It detailed support from direct corporate contributions and corporate political action committees (PACs) from 2015 through March, 2021, to state legislators who authored, sponsored or voted for 245 bills that could have made it more difficult for citizens to vote in elections. 

The 25 companies contributing the largest amounts of money to these legislators included UnitedHealth Group ($411,200 total); Pfizer ($308,085); and Centene Corp ($205,200).  Companies that gave somewhat less included Merck ($180,000),  CVS ($174,000), Anthem ($138,150) Eli Lilly ($124,000) and Cigna ($109,225).

Two health care related trade groups also gave significant funds to these legislators: the Virginia Dental Association ($223,000) and the  Pharmaceutical Research and Manufacturers Association of America/PhRMA ($200,000).   

Note that the data did not include personal contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators.

Health Care Corporate Sponsorship of the Attempt to Overturn the 2020 Election

In June, 2021, Citizens for Responsibility and Ethics in Washington (CREW) published "This Sedition is Brought to You By..." It detailed contributions from corporate PACS and trade groups to those in the US Congress who voted against certifying the results of the 2020 election and the two main party organizations that supported them, the National Republican Senatorial Committee (NRSC) and National Republican Congressional Committee (NRCC) since the vote not to certify.  

The largest contributions from health care corporate PACs included those tied to Fresenius Medical Care Holdings ($76,000); CVS ($45,000); Cigna ($42,500); Johnson & Johnson ($30,000); Pfizer ($20,000); and Humana ($15,000).

Note that the data also did not include contributions from corporate leaders, and could not include corporate money directed to dark money organizations that ended up supporting these legislators. 

Discussion

Most health care corporations profess to missions that are pluralistic and support the community and society as a whole.  For example, Pfizer's mission statement includes:

We partner with governments, non-profits, and other organizations to ensure that more people around the world have access to the medicine and resources they require.

UnitedHealthCare's mission statement includes:

UnitedHealthcare is dedicated to helping people live healthier lives and making the health system work better for everyone

Merck's mission statement includes:

We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships

However, leaders of some large health care corporations saw fit to direct contributions to politicians who promoted anti-democratic policies. Funding political leaders who would restrict voting rights in ways likely to impact already disadvantaged groups, and challenge election outcomes without strong evidence of irregularities would seem to violate high-minded corporate pledges of inclusiveness like those above.    

Is it that health care corporate leadership just are more interested in making money than in bettering society, despite their aspirational mission statements? As we previously discussed, that is a plausible formulation.  For example, per the Washington Post in January, 2021,

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee.

However, there are problems with this formulation.  As we wrote before,  it is obvious why a pharmaceutical company might want to defeat legislation that would lower its prices or raise its taxes.  It is not obvious why it would want to consistently support actions by one party, or by people at one end of the political spectrum, even if some such people seem generally "pro-business."  After all, for years big corporations and their executives openly gave money to both US parties and their candidates, apparently in the belief that this would at least allow more visibility for the corporations' priorities no matter who was in power.

Maybe it is not just about money.  Again, as we said before, by virtue of being top management of a corporation, particular individuals can control political funds far beyond what they may be able to control as private persons, and to do so anonymously.  It may be that top corporate leaders are not just interested in making more money.  Some may also be interested in personal political power, or have other ways they might benefit from anti-democratic, if not openly fascist national political leadership.  Big industrialists have backed authoritarian and openly fascist regimes in other countries before, some to make more money, but in retrospect, some for darker reasons. (See, for example, this article on how German industrialists financially bailed out the Nazi party in 1932.)

At least health care professionals, policy makers, patients and the public at large deserve to know how health care corporate leadership is directing money to political causes, and how they benefit from doing so. 

 

    

Sunday, April 04, 2021

A Few Leaders of Big Health Care Corporations Hesitate in Their Support of Extreme Politics and Insurrection, But Will Anything Really Change?

 Some recent but not well publicized articles suggests how big health care corporations are still enabling some of the worst aspects of health care and larger political economic dysfunction.

Introduction - Health Care Corporate Political Donations Become More Partisan and Ideological

A long time ago in a galaxy far, far away big health care corporations in the US had an apparently straightforward philosophy of political giving.  They gave contributions more or less equally to both major political parties.  Apparently the theory was that the corporate giving would be remembered favorably by whoever won elections and got governmental power.  Corporate contributions raised major concerns about their ability to purchase access and influence policy far beyond those of less wealthy groups and the public at large.  At least, however, it was overtly non-partisan, and ostensibly not ideological.

However, things changed, and health care (and larger corporate) political giving became more partisan, and and more ideological. As we discussed here

- In June, 2018, we first noted how the huge pharmacy chain CVS, had been secretly making contributions to America First Policies, an ostensibly non-profit organization.  CVS claimed that it helped fund AFP because it supported tax reform.  Actually, AFP acted to promote Trump administration policies. AFP encouraged repeal of the Affordable Care Act (ACA), and building a wall on the US southern border.  These seemed at odds with CVS claims about its social responsibility.  


- 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 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. 

- In October, 2020, we discussed the apparent relationship between the support to Trump provided by large pharmaceutical corporations and his inclination to outsource his coronavirus pandemic management to them. 

Corporate leadership's enthusiasm for Trump, his policies, and his associates seemed to arise from  economic interests of the corporations and the self-interest of their top management, but without consideration of how Trump and associates' actions may have harmed larger corporate, social, or national interests.  As discussed in a Washington Post article on January 8, 2021:

Business groups big and small largely stuck by Trump as he broke one norm after another over the past four years, including insulting immigrants, appearing to empathize with white supremacists in Charlottesville and clearing a Black Lives Matter protest in Washington for a photo op. They stuck by him still after he pressured the Ukrainian president in a bid to help his own election chances, after his impeachment, after he intentionally downplayed the effects of the novel coronavirus and last week after he was recorded pressuring the Georgia secretary of state to overturn the election results.

Even Trump supporters admitted the corporate leaders' extreme compartmentalization:

'It isn’t going to affect tax rates. How about monetary policy? Allow me to stay pure to my turf,' Art Laffer, a supply side economist who is close with White House economic officials and speaks to the president, said in a brief interview.

One observer described their thinking thus:

'Their attitude was: ‘Let’s take the big tax cuts and hold our noses for the obvious xenophobia and authoritarianism.’ It was a classic Faustian bargain,' said Rep. Brendan Boyle (D-Pa.), a member of the House Ways & Means Committee. 'They should have known from the beginning.'

However, the Trump administration's actions and policies often seemed to directly contradict the stated values, visions and missions of health care corporations.  For example, Pfizer declares its values to be:

customer focus, leadership, quality innovation, collaboration, respect for people, integrity, and performance

How would the value "respect for people" align with Trump's hostility toward immigrants, or sympathy for white supremacists?  How would the value "integrity" align with Trump's pressure on the Ukraine to influence his election, or his pressure on officials in the state of Georgia to alter the election results in his favor?  

Nonetheless, until very recently, hardly anyone seemed to notice that large health care corporations had changed their political giving so as to make its effects antithetical to the corporations' declared principles and values.  

Trump's Attempt to Overturn the 2020 Election Inspire A Few in Corporate Leadership to Rethink Its Political Support for Him and His Associates

Yet things apparently changed after Trump's attempts to overturn the election, including claims that he actually won despite obvious evidence to the contrary, baseless legal challenges to the election results that were almost all dismissed by the courts, and an attempt by Trump supporters in Congress to challenge and possibly override the election results in congressional proceeding.  That crossed a line.

Within days, corporate leaders who had generally been quiet about Trump administration's actions and policies that ran counter to their organizations' stated goals and mission began to speak up.  Several hundred signed a statement:  

Congress should certify the electoral vote on Wednesday, January 6. Attempts to thwart or delay this process run counter to the essential tenets of our democracy.

Most of those who signed lead financial firms, but the list did include Albert Bourla, CEO of Pfizer, a firm that had been one of Trump's favorites (see above).

Then, Trump's exhortation to his supporters at a rally to march on the Capitol while congress was debating Trump's supporters' challenge to the election results, which led to an insurrection and armed occupation of the Capitol building,  which was eventually beaten back by law enforcement with significant casualties led some corporate leaders to rethink their positions. 

The next day, per the Washington Post:

The mob scenes at the Capitol attracted harsh and unusual criticism from business groups, including the chief executive of one of the nation’s largest banks saying he is 'disgusted' and a manufacturing trade group calling it 'sedition' and suggesting that President Trump must be removed from office immediately.

It was a stunning series of rebukes for a president who had received widespread support from corporate America for most of his turbulent term, especially for his efforts to cut government regulations and reduce corporate tax rates.

But what occurred Wednesday seemed finally to be too much. Trump staged a rally in Washington a short walk from where Congress was counting the electoral college votes, with Trump whipping up his followers with fabrications about election results and urging them to march to the Capitol to protest. Later, Trump appeared to sympathize with the mob and support the violent actions.

 The National Association of Manufacturers soon after released an extraordinary statement from its president, Jay Timmons, saying Vice President Pence 'should seriously consider working with the Cabinet to invoke the 25th amendment to preserve democracy.'

At that time, one more CEO of a pharmaceutical company that had been one of Trump's favorites spoke up:

Alex Gorsky, the chief executive of Johnson & Johnson, said in a statement that he is 'devastated by this assault on what our country has stood for since its founding: free, fair and peaceful elections.' He said it is time to stand for unity, 'not face-to-face in conflict — and to chart our path to a better and healthier future.'

Furthermore, some large corporations, including health care corporations, announced a review or freeze on political donations through their corporate political action committees (PACs). Per the New York Times, January 11, 2021:

A flurry of companies have since reviewed political giving via their corporate political action committees.... Blue Cross Blue Shield, Boston Scientific... are taking a similar, targeted approach to donation freezes.

On January 12, 2021, StatNews summarized responses by health care corporations:

 The list, so far, is short: the Blue Cross BlueShield Association, an insurer federation, said this week it would pause contributions specifically to candidates who effectively voted to overturn the results of the U.S. presidential election.  Drug manufactures Gilead Scientific and Amgen, as well as BIO, the biotech lobbying group, said they would pause contributions to all candidates regardless of how they voted on election certification, according to spokespeople.  UnitedHealth Group and Boston Scientific, the medical device giant, said the same.

Others, like CVS Health and the insurance lobby group America's Health Insurance Plans, were more cautious, saying they would review their future giving.

However,

Many other health care corporations and lobby groups... have not responded publicly.

The article also noted:

Many of the GOP lawmakers who voted against certifying the Electoral College results are those whom the drug industry and other health care sectors have long viewed as allied.  

The list included Republicans in Congress whom may be regarded as extreme supporters of Trump, eg Rep Devin Nunes (R-CA), and Rep Andy Harris (R-MD).

I found one other report of a big health care corporation which changed its political donation policy in response to the attempt to overturn the election.  Per the Kansas City Star, January 13, 2021:

Cerner Corp. will suspend political donations to Sen. Josh Hawley and other politicians who it determines helped to incite the violent mob that attacked the U.S. Capitol building last week.

The North Kansas City-based healthcare IT firm is the latest to seek distance from Hawley, a Missouri Republican, and others who have supported baseless allegations of voter fraud in the November presidential election. 

A company spokesperson said:

'Effective immediately, Cerner PAC will suspend contributions to any candidate or official who took part in or incited violence last week in Washington, D.C.,' the statement said. 'Focusing on the health and well-being of the American people transcends partisan politics, and we will continue working with all elected leaders to advance policies that put the patient at the center of their care.'

I found another report of a big industry group which planned a "review" of its giving.  The American Hospital Association announced on January 14, 2021:

The tragic events last week at the U.S. Capitol were an assault on our democracy. This prompted the AHA to begin an immediate review of our political giving practices to ensure they are guided by our Association’s vision and mission, as well as the democratic values we share as a nation.

But that was it, a total of six large health care corporations and three industry groups announced a pause or review of political contributions (apparently limited to those from corporate PACs) to some of the politicians who voted to challenge the election results.  The Potter Report, authored by health care insurance whistle blower Wendell Potter, noted

There’s been a lot of talk this week about big corporations such as Amazon, Verizon and Comcast deciding to stop giving money to House and Senate Republicans who voted to overturn last year’s election. 

Guess which giants aren’t on that list? America’s big for-profit health insurers

Over the past two election cycles, Big Insurance has donated to just about all the 147 House and Senate Republicans who voted against certifying the election. That includes Cigna and Humana, where I once worked, and Centene and CVS/Aetna. Plus, the industry’s lobbying group, the American Health Insurance Plans (AHIP).

 The Blue Cross Blue Shield Association, which represents a lot of nonprofit insurers and for-profit Anthem, says it’s suspending donations to those Republicans. And UnitedHealth says it will 'pause' its political donations. But let’s see how long these 'pauses' actually last. 

So far, we haven’t heard a peep from AHIP or the other big for-profits, all of which have made huge profits during the pandemic, thanks largely to having lawmakers on both sides of the political aisle in their pockets. 

Big Insurance donated more than $9 million to House and Senate candidates during the 2020 cycle. Among their favorites? Ted Cruz and Josh Hawley, who led the effort to overturn the election. All the big for-profits donated to Cruz, and all but CVS/Aetna donated to Hawley. 

Note that no health care corporation announced changes in the donations by its top management.  Certainly none even mentioned political contributions through dark money groups (like those that CVS had been revealed to be making, see above).  So the attempt at overturning the election to keep Trump in office, first by quasi-legal maneuvering, then by an armed insurrection, had little effect on continuing underwriting by big health care corporations of the politicians who acquiesced to or actively supported this assault on the fundamentals of our representative democracy 

Two Months Later, Health Care Corporations "Back to Bankrollling Insurrectionists"

Within months, some of the few health care corporations who paused donations again seemed ready to cozy up to anti-democratic politicians.  As reported by the Daily Beast, March 24, 2021:

After the Jan. 6 insurrection, more than 120 corporations swiftly vowed to suspend campaign donations to Republicans who objected to certifying the 2020 election....

But it took less than two months for Pfizer to break that pledge. Their PAC gave $15,000 to the National Republican Senatorial Committee, led by one of eight GOP Senators who voted to decertify election results—Rick Scott of Florida—on Feb. 23.

In total, The Daily Beast identified four companies that appear to have gone back on their suspension of donations to GOP election objectors: AT&T, Cigna Health, Ford Motors, and Pfizer.

[Note that I had not earlier found notice that Cigna Health, a for-profit insurance company, had suspended donations.]

Summary

So as far as I can tell, while Trump is out of office, the big health care corporations that provided plentiful financial support for his initial election and attempts at remaining in office, through electoral and anti-democratic means, are back to supporting the political party that has become his personal sandbox.

 It is increasingly evident that big health care corporations, despite their protestations of social responsibility and non-partisanship, now are actively supporting one wing, an extreme one, of the political spectrum.  This raises big questions: cui bono? Who benefits?

It is obvious why a pharmaceutical company, for example, might want to defeat legislation that would lower its prices or raise its taxes.

It is not obvious why it would want to consistently support actions by one party, or by people at one end of the political spectrum, even if some such people seem generally "pro-business."  After all, for years big corporations and their executives openly gave money to both US parties and their candidates, apparently in the belief that this would at least allow more visibility for the corporations' priorities no matter who was in power.

Now, the most obvious theory is that the new practice of secret donations only in right-wing, Republican, pro-Trump, and/or anti-democratic directions, which must be orchestrated by top corporate management, and which are not disclosed to employees or smaller corporate shareholders, are likely made to support the top managers' self interest more than the broad priorities of the corporations and their various constituencies. By virtue of being top management of a corporation, particular individuals can control political funds far beyond what they may be able to control as private persons, and to do so anonymously.  This could present many temptations, but the rationales for particular managers directing their corporations' fund to particular politicians or organizations remain unknown.  

Thus not only is more investigation needed, at the very least, "public" corporations ought to fully disclose all donations made to outside groups with political agendas.  This should be demanded by at least the corporations' employees and shareholders, but also by patients, health care professionals, and the public at large. Furthermore, it is not unreasonable to ask that all organizations disclose all political funding which allows their leaders and managers to leverage their own political intentions.

Meanwhile we are left with the suspicion that top health care corporate management is increasingly merging with the Trumpist movement in one giant corporatist entity which is not in the interests of health care, much less government by the people, of the people, and for the people.

 

ead more here: https://www.kansascity.com/news/politics-government/article248457745.html#storylink=cpy

 


Read more here: https://www.kansascity.com/news/politics-government/article248457745.html#storylink=cpy

 


 

Sunday, October 04, 2020

For Coronavirus Pandemic Management, In Johnson and Johnson and Pfizer Trump Trusts: Public Health at Risk ... Due to Corruption?

In 2003 we found that health care professionals felt one reason for US health care dysfunction was that it was increasingly "dominated by large, bureaucratic organizations which do not honor ... [its] core values"(1)  These organizations included big health care corporations like pharmaceutical, biotechnology and device companies, and large non-profits like hospital systems.  Since then, the power of the largest health care organizations has only increased.  Now we learn how President Trump seems to have ceded control of the management of the coronavirus pandemic to a few big pharmaceutical companies.

In "Massive Companies" Like Johnson and Johnson and Pfizer, Not the FDA, We Trust?

The first US presidential debate included a performance by the president which was likened to something out of professional wrestling. In addition, as reported by StatNews on September 29, 2020:

Throughout a turbulent, disorganized, and hostile debate, Trump highlighted his government’s efforts on vaccine development, pledging, dubiously, that the country is 'weeks away from a vaccine' and contradicting high-level officials within his own government who have suggested it will be months, at least, before a vaccine is available.

And

Trump viewed vaccines and his government’s vaccine moonshot, known as Operation Warp Speed, as the centerpiece of a pandemic response and his campaign rhetoric.

Yet Trump continued to undercut two officials central to that effort: Moncef Slaoui, Warp Speed’s director, and Robert Redfield, the director of the Centers for Disease Control and Prevention. They are 'both wrong' for standing by published timelines for vaccine distribution, Trump said, which show vaccines will be widely available to the U.S. public by mid-2021.

 So

At one point, Trump even appealed to drug companies’ trustworthiness on vaccine safety, asking Biden at one point: 'You don’t trust Johnson & Johnson, Pfizer?'

This mirrored what he had said a few days before.  Per the New York Times on September 23, 2020, in the context of threatening to counter efforts by the FDA to impose strict efficacy and safety standards on coronavirus vaccines, apparently so he could speed them to market and then claim a major victory against the pandemic, Trump said

he had 'tremendous trust in these massive companies' that are testing the vaccines, adding, 'I don’t know that a government as big as' the federal government could do as well.

In "massive companies," like Johnson and Johnson and Pfizer we trust? 

Trump Has Benefited from the Actions of Leaders of Massive Corporations, Including Johnson and Johnson and Pfizer

Making pandemic management policy under the motto of  "in massive companies we trust" fits with Trump's coziness with big corporate leadership, particularly that of  Johnson and Johnson and Pfizer. 

Health Care Corporations, Their Executives and Board Members Supported Trump's Political Causes

Trump's campaign has benefited from massive support from big corporations, including pharmaceutical companies, specifically Johnson and Johnson and Pfizer


Large health care corporations have funded dark money organizations that  strongly supported Trump and his agenda.  For example,Johnson and Johnson made large donations to the US Chamber of Commerce, which at that time "mostly endorses Republican candidates" and had contributed to a campaign to support Trump's appointment of US Supreme Court Justice Kavanaugh (look here).  

Johnson and Johnson and Pfizer are members of pharmaceutical trade organization PhRMA, which also acts as a political funding organization.  According to Sludge on April 6, 2020:

[The] Job Creators Network has been funded by Pharmaceutical Research and Manufacturers of America (PhRMA)

And,

The Job Creators Network was founded in 2011 by billionaire Home Depot co-founder Bernard Marcus, a major GOP donor who spent more than $7 million through outside groups to help elect Trump in 2016. Marcus has said that he plans to spend part of his fortune to help re-elect Trump in 2020.

We have noted that prior to the 2018 election, health care corporate CEOs often gave large political donations heavily biased in favor of Republicans.  For example, the CEO of Pfizer, Ian Read, gave $145K to Republicans, but only $26K to Democrats (look here).

Also, Trump appointed Robert (Woody) Wood Johnson IV, heir of the family which founded Johnson and Johnson, and major Johnson and Johnson shareholder, as ambassador to the UK.   The New York Times reported in July, 2020, that Johnson's support of Trump included using his official position to tout Trump's golf resort in Scotland as a site for the British Open. Johnson's monetary support for Trump's causes included

$1.2 million to the Republican National Committee and the Trump Victory fund, as well as another $1 million to America First Action, a super PAC supporting Mr. Trump’s re-election.

Health Care Corporations, Their Executives and Board Members Patronized Trump's Properties to His Personal Benefit

The biggest owner of the Trump Organization is President Trump, so he personally profits from revenue to it. Health care corporate managers and owners, including those of Johnson and Johnson and Pfizer, and health care corporate lobbyists, including one who worked for Pfizer, patronized Trump Organization properties directly or indirectly.  For example, according to the Observer in 2013,

Johnson & Johnson heiress Libet Johnson loved the Trump International Hotel and Tower [in New York]—so much so that it’s nearly impossible to keep track of [all the condominiums she owned in it]. So difficult, in fact, that we lost count.

 

Lobby, Trump International Hotel, Washington, DC

Big corporate donors, including Pfizer, supported the Trump Inauguration Committee, which then spent considerable sums at the Trump International Hotel in Washington DC, to Trump's personal benefit (see Newsweek, January, 2019).  Prominent Pfizer lobbyist Kenneth M. Duberstein is a long-time member of Trump's Mar A Lago resort in Florida (New York Times, 2017).

Trump's Coziness with Managers and Owners of Massive Corporations, Including Johnson and Johnson and Pfizer

Health Care Corporate Executives Got Access to Trump

Trump has spent a lot of time meeting with top executives and owners of big corporations, including health care corporations. For example, as reported by Becker's Hospital Review in April, 2020, 27 health care executives were appointed to Trump's economic revival task force (during and after the pandemic), including Albert Bourla, the CEO of Pfizer, and Alex Gorsky, the CEO of Johnson and Johnson.

Back in 2017, Johnson and Johnson CEO Gorsky was appointed to Trump's Manufacturing Council.  He temporarily left that position after Trump refused to disavow the right-wing extremists who marched in Charlottesville, but then was put "on the guest list Tuesday for dinner at [Trump's] Bedminster [golf club]."  After that, Trump seemed to be promoting Johnson and Johnson products, particularly Spravato touted as a treatment for opioid dependence (look here).

Health Care Corporate Executives and Lobbyists Appointed to Government Leadership Positions Affecting Health Care

We have noted that many of Trump's political appointments to leadership positions in government that affect health care came through the revolving door from health care corporations and lobbying firms that worked for them.  For example, the current Secretary of the Department of Health and Human Services (DHHS) is a former top Eli Lilly executive.

 


Several top positions as DHHS were filled by former lobbyists for big pharma and other health care corporations (look here). Particularly, Daniel Best went from Pfizer to DVS and then to DHHS as a Senior Advisor (look here.)

Also, Dr Scott Gottlieb, a former commissioner of the US Food and Drug Administation (FDA) under Trump soon became of member of Pfizer's board of directors (look here).

Should Trump Trust Johnson and Johnson and Pfizer?

Trump's affinity for Johnson and Johnson and Pfizer may be based on personal relationships and perceived political common interests, as well as on how he has politically and personally benefited from the actions of their leaders and owners. That affinity should not be sufficient for him to trust them to run a coronavirus pandemic response.  Arguing against placing so much trust in them are their corporate track records of misbehavior.  

On Health Care Renewal, we have been tracking ethical misadventures by big health care organizations for a long time.  The records of Johnson and Johnson and Pfizer stand out, but not in a good way.  To summarize what we have discussed about each...

Johnson and Johnson

Derived from our previous blog posts - 

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

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

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

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

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

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

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

2018
- settled allegations that subsidiary Actelion used illegal kickbacks to market Tracleer for an inflated price (see this post)

2019
- found by Oklahoma judge to have launched a deceptive marketing campaign for opioids (see this post)

And we recently learned that Johnson and Johnson settled allegations of deceptive marketing of surgical mesh in lawsuits in multiple states (per the AP, May 202, here)

Pfizer

 From this post:

The company's track record from 2000 to 2017 is staggering.

Since 2000, Pfizer's troubles started, according to the Philadelphia Inquirer, with the following...

- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,

- In 2009, Pfizer paid a $2.3 billion settlement of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  In that year the company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- In early 2011, Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York (see post here).
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).
- In October, 2015, a  UK judge found that the company had threatened health care professionals for using a generic competitor (see this post).
- In February, 2016, Pfizer settled a lawsuit for $785 million for overcharging the US government for Protonix (look here).
- In August, 2016, Pfizer made a $486 million settlement of allegations it bilked shareholders by concealing research showing the harms of Celebrex (look here for this and next two items)
- In December, 2016, Pfizer fined $106M in UK for using monopoly on production of generic phenytoin to overcharge National Health Service
- In November, 2017, Pfizer made $94 million settlement of allegations of fraud to delay generic competition

Note that other companies involved in Trump's crash project to develop a coronavirus vaccine, preferably in time to influence the 2020 election, Astra Zeneca and Merck, also have questionable track records. 

Summary

Health care is increasingly dominated by large organizations who may threaten the values of health care professionals.  Now in a pandemic the US President seems determined to trust in a few large pharmaceutical corporations rather than public health experts and health care professionals.  His trust may be based on his personal affinity for the leadership of such corporations, and the cozy relationships they have cultivated with him. Worse, it may be based on how he has politically benefited and personally profited from their actions.  To the extent that Trump has ceded control of the pandemic to large corporations because he has politically benefited and personally profited from them, his actions appear to fit the ethical definition of corruption, as defined by Transparency International:

the abuse of entrusted power for private gain

Meanwhile, the pandemic has been steadily worsening, and as of this week, the president himself, along with key political allies have been infected. 

Thus, at a crucial time, the country is increasingly being run by a cozy group of insiders with ties to both government and industry.  Top health care (and other) corporate management is increasingly merging with the current administration in one giant corporatist entity. This merger is not in the interests of peoples' or the public's health, especially in a time of pandemic.  Instead, benefits will go to the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people.  At times the actions of the current administration, and in particular, its maximum leader, may be abuse of power for private gain, apparently corruption, and in this instance, health care corruption.  This fits a pattern of wholesale corruption and conflicts of interest at the top of the administration that we have often decried, most recently here.

To unrig the system, we need wholesale, real health care reform that would make health care leaders accountable for what their organizations do, and 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.

However, before thinking about true health care reform, we need top accomplish wholesale government reform. We need to excise the deception, crime and corruption at the heart of our government and restore government by the people, of the people, and for the people. 

Reference

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

Sunday, July 07, 2019

Making the Revolving Door Great Again: Recent FDA Commissioner Dr Scott Gottlieb Joins the Pfizer Board of Directors

It has been less than six weeks since our last post on the revolving door. 



That post emphasized cases of the 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, the outgoing revolving door. Now we have another big case.

Former US Food and Drug Agency (FDA) Commissioner to Join Pfizer Board


As we discussed in May, 2019, here, 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, as reported by CNBC on June 27, 2019,

Scott Gottlieb, who stepped down as Food and Drug Administration Commissioner in April, will join Pfizer’s board of directors, the company announced Thursday.

Gottlieb resigned from the FDA this spring after nearly two years at the helm.

This seemed like an even more consequential case of the outgoing revolving door, obviously, because Dr Gottlieb held an extremely important position of responsibility in health care regulation, and because he quickly moved on to hold an important position of governance in one of the world's largest pharmaceutical/ biotechnology companies.  It also occurs as the next big thing after an unrelenting stream of revolving door issues affecting health care policy and regulation in the Trump regime (look here)

An Immediate Protest by Senator Elizabeth Warren


So this time, not only did dissidents like your obedient servant mutter online, but a US Senator authored a swift rebuke.  As reported by Sheila Kaplan in the New York Times,

Senator Elizabeth Warren on Tuesday called on Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, to resign from the board of Pfizer, saying his decision to join one of the country’s leading pharmaceutical companies 'smacks of corruption.'

Ms. Warren, who is seeking the Democratic presidential nomination, said in a public letter to Dr. Gottlieb that the revolving door between government and industry 'makes the American people rightly cynical and distrustful about whether high-level Trump administration officials are working for them, or for their future corporate employers.'

The explicit reference to "corruption" is notable.  Most people would think of cases of the outgoing revolving door as conflicts of interest.  The concern is that people in government regulatory or policy positions might bias their decision making, possibly unconsciously, to increase the likelihood of lucrative employment after the end of their government service.  Transparency International's definition of corruption is abuse of entrusted power for private gain.  The outgoing revolving door seems to make such abuse more likely, but does not mandate it.

However, as we noted here, some, including experts from the distinguished European anti-corruption group U4, think the revolving door is corruption

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.
Senator Warren now seems to agree, at least in the case of Dr Gottlieb's move to the Pfizer board.

Did Dr Gottlieb's FDA Favor Pfizer?

In fact, within days, two reports surfaced that suggested possible reasons to think that Dr Gottlieb's FDA had taken actions that would have benefited Pfizer, and hence that his appointment to its board might be corrupt.

Drop in FDA Enforcement Activities During Gottlieb's Tenure

First, Science Magazine noted considerable evidence that the FDA during the Trump and Gottlieb era had notably deregulated the pharmaceutical industry.

By several measures ... FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office, Science has found.

In particular,

The agency’s 'warning letters'—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1033 warning letters, compared with 1532 for the most recent equivalent period under former President Barack Obama.

Also,

Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years.

And,

Several other FDA actions under Trump show similar declines when measured against the end of the Obama administration. FDA inspection reports labeled 'official action indicated'—typically a trigger for warning letters or similar actions—have fallen by about half under Trump and are continuing to trend downward. Even FDA’s rare injunctions, a more forceful step than warnings to prevent sales or distribution of unsafe or otherwise illegal products, fell from 35 in the last part of the Obama administration to 26 under Trump. (During a comparable period at the start of the Obama years, FDA issued 51 injunctions.) The agency’s 'untitled letters'—for concerns that fall short of thresholds for formal warnings—also have dropped sharply under Trump.

Several experts interviewed by Science emphasized the importance of these findings.

'FDA’s power to enforce its requirements is an important part of how it achieves its public health mission,' says Patricia Zettler, a law professor at Ohio State University in Columbus and former FDA attorney. 'If FDA is not using that power, it sends a signal that violations will be tolerated.'

Dr Gottlieb defended his former agency's regulatory role, and implied, of course, that any criticisms were political:

Scott Gottlieb, Trump’s first FDA commissioner, defended his record after reviewing a summary of Science’s data. 'We were pretty aggressive,' he wrote in an email. 'I don’t think you can paint us with a political narrative—that just because we were a Republican administration, somehow we must have ratcheted down enforcement activity. We didn’t.'

However, given the magnitude of the changes found, it is reasonable to wonder if Pfizer executives noted, and approved.

Lax Regulation of a Pfizer Drug (Xeljanz)

The next day, an article in the Milwaukee Journal Sentinel by John Fauber noted what appeared to be lax enforcement specifically involving a Pfizer product.

Unlike European drug regulators, the U.S. Food and Drug Administration under Scott Gottlieb did not say doctors should stop prescribing a potentially dangerous dose of a drug made by Pfizer — a company whose board Gottlieb soon joined.

In February, when Gottlieb still was head of the FDA, a Pfizer safety trial showed that rheumatoid arthritis patients who got a higher dose of the drug Xeljanz had a 'statistically and clinically important difference' of blood clots in the lungs and deaths.

The safety trial, which was required by the FDA, did not focus on the other two conditions for which the drug is approved — ulcerative colitis and psoriatic arthritis. The trial involved patients 50 or older with at least one risk factor for cardiovascular disease.

After safety concerns were found, Pfizer immediately stopped giving the higher dose to those in the trial.

Regulators in Europe went further.

The European Medicines Agency said in May doctors must stop giving the high dose to all patients who were at higher risk for blood clots, including those with ulcerative colitis for whom the higher dose was already recommended.

The FDA did not take that action, though it warned doctors about the safety findings that were discovered in the trial.

One ethics expert interviewed by Mr Fauber raised clear concerns about corruption.

'It sounds like a reward for a job well done,' said Carl Elliot, a physician and professor of bioethics at the University of Minnesota, when told by the Milwaukee Journal Sentinel about the FDA's failure to halt prescribing of the potentially dangerous high dose of the drug.

'It sure does look suspicious.'

Dr Gottlieb, not unexpectedly, denied direct involvement in the decision.

Decisions regarding Xeljanz were made by the agency’s career professional staff without my involvement. I did not participate in any matters involving this drug while I was at FDA

However, Senator Warren's concerns about corruption were heightened:

'Unfortunately, Scott Gottlieb joining the board of Pfizer will raise these kinds of questions about FDA decisions concerning Pfizer, whether it’s this or others,' Warren said in a statement to the Journal Sentinel. 'He shouldn’t have joined Pfizer’s board.'
IMHO, concerns that under the Dr Gottlieb the FDA could have taken a lax approach to drug industry regulation, particularly in the case of Pfizer's Xeljanz, ought to be enough to launch an investigation into whether his appointment to the Pfizer board was corrupt.

Dr Gottlieb Will Now Engage in Governance of a Company with an Already Spotty Ethical Record

Dr Gottlieb's appointment to the Pfizer board shuld raise major ethical questions.

Another set of questions he ought to contemplate is how he will deal with his new responsibility for Pfizer's conduct given the company's chequered ethical record.

We have long been posting about an amazing series of ethical missteps by Pfizer leadership, evidenced by various legal settlements, regulatory sanctions, and occasional guilty pleas.    Our most recent post on the subject, in 2018, noted how Pfizer settled charges of giving kickbacks to patients through disease advocacy organization to mask the prices of its drugs.  Our over 100 posts on Pfizer can be found here.

The company's track record from 2000 to 2017 is staggering.

Since 2000, Pfizer's troubles started, according to the Philadelphia Inquirer, with the following...

- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,

- In 2009, Pfizer paid a $2.3 billion settlement of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  In that year the company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- In early 2011, Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York (see post here).
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).
- In October, 2015, a  UK judge found that the company had threatened health care professionals for using a generic competitor (see this post).
- In February, 2016, Pfizer settled a lawsuit for $785 million for overcharging the US government for Protonix (look here).
- In August, 2016, Pfizer made a $486 million settlement of allegations it bilked shareholders by concealing research showing the harms of Celebrex (look here for this and next two items)
- In December, 2016, Pfizer fined $106M in UK for using monopoly on production of generic phenytoin to overcharge National Health Service
- In November, 2017, Pfizer made $94 million settlement of allegations of fraud to delay generic competition

That Dr Gottlieb waltzed through the revolving door to a major role in the governance of Prizer does not give me great confidence that he will be part of the solution to the company's ongoing ethics problems.

Discussion: the Swamp Gets Swampier

 President Trump came to office promising to drain the swamp.



[An alligator in the Everglades, 1963]

At least in terms of health care, Dr Gottlieb's transit through the revolving door is just the latest example of how the swamp waters are rising.  So, as we have said again and again...

Our health care system appears to be rigged to favor of leadership and management of large companies, as opposed to health professionals, and particularly as opposed to patients.  For years now we have discussed stories which include allegations of severe misbehavior by large health care companies affirmed by legal settlements, but which only involve paltry financial penalties to the companies, and almost never any negative consequences to any humans, demonstrating the impunity of health care managers and executives. Furthermore, these stories are often relatively anechoic, noted often only briefly in the media, and have inspired no real action by the US government. We have previously discussed how market fundamentalism (or neoliberalism) led to deregulation, which enabled deception, fraud, bribery, and intimidation to become standard business practices, and allowed increasing concentration of power by large corporations. Managerialism allowed the top leaders of these corporations and their insider cronies to amass increasing power and money. Everyone else, other employees, stockholders of public corporations, customers, vendors and suppliers, and the public at large lost out.   These changes led to an increasingly costly system which produced increasingly bad results for patients and the public.

We have called for years for what we sometimes term "true health care reform" to derig the system. Unfortunately, despite our hopes, perceptions of a rigged system may not always inspire honest reform. Instead, they can enable the rise of demagogues and would be dictators who promise only they can solve the problem.  Donald Trump cried out that only he could fix our problems and drain our swamps.  However, at least in terms of policing white-collar crime, particularly in health care, he seems to be letting the swamp waters rise.

Nonetheless, let us remember the need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, and 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.