More Large Health Care Corporations Are Again Funding Politicians Who Threatened Representative Democratic Governance

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, and this July 7, 2021, post).

Now yet another report shows continuing support by large health care corporations for Republican legislators who supported the nullification of the election.

 Health Care Corporate Funding of Politicians Who Would Overturn an Election

On August 17, 2021, Popular Information published The January 6 Corporate Accountability Index.  It promised to be results of a comprehensive monitoring efforts of corporate pledges to make changes in their political giving to the "147 Republicans who voted to overturn the election, setting the stage for the riot." It included several categories of pledge violations.  Its results included some of the companies who went back on their pledges as described in our April and July posts.  It also included many more companies that did not make it to previous reports.  The relevant results by category were as follows

Corporations that pledged to suspend donations to the 147 Republican objectors but directly donated to those Republicans

Not included in previous reports: none

Included in previous reports: Cigna, Eli Lilly

Corporations that pledged to suspend donations to all 147 Republican objectors but violated the spirit of the pledge

Not included in previous reports: 

"After January 6, Genentech [part of the "Roche group'] said it would suspend contributions to Republican objectors. Genentech donated $15,000 to the NRCC and $15,000 to the NRSC on June 30."

"After January 6, Sanofi said it would suspend contributions to Republican objectors. Sanofi donated $15,000 to the NRSC on 3/17."

Corporations that pledged to suspend all PAC donations and then directly donates to the 147 Republican objectors

Not included in previous reports:

DaVita 

Included in previous reports: Abbott Laboratories, Gilead, Novo Nordisk

Corporations that pledged to suspend all PAC donations and then indirectly donated to the 147 Republican objectors

Not included in previous reports:

Baxter International

Included in previous reports: United Healthcare

Corporations that pledged to reevaluate their donation criteria after January 6 and directly donated to GOP objectors

Not included in previous reports:

Amgen, Laboratory Company of America

Corporations that pledged to reevaluate their donation criteria after January 6 and then indirectly donated to the 147 Republican objectors

Not included in previous reports: none

Included in previous reports: CVS

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.  For example, Sanofi Pasteur claims:

Sanofi’s social impact strategy aims to build a healthier, more resilient world by ensuring access to healthcare for the world’s poorest people

However, the new data revealed above, and data discussed in our two previous posts showed that leaders of  more and more 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 seem s 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.

On the other hand, maybe it is not just about money.  Again, as we said before, by virtue of being top managers corporations, 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.)

Leaders of large corporations now appear willing to wield large amounts of political power leveraged by the organizations they control.  Yet until recently they may have been able to do so without disclosure to society at large.  That society may be greatly affected by this power, but when it can be wielded quietly, have had little say in who has it and its uses.  

We as health care professionals, policy makers, patients and members of 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. If they are not doing this in our interests, our we need to make sure things change.

A Stealth Health Policy Advocate Goes Through the Revolving Door ... Now to Chair the White House Council of Economic Advisers

In 2017, we noted that President Trump had appointed a member of his Council of Economic Advisers who previously was a master corporate stealth health policy advocate.  Now he is getting a promotion.

Prof Tomas Philipson to be Named to Chair of the President's Council of Economic Advisers

On June 29, the Washington Post reported,

President Trump plans to name economist Tomas Philipson as the next head of the White House Council of Economic Advisers, according to senior administration officials.

Philipson has worked at the White House for nearly two years as a senior economist after serving briefly on the transition team. Best known for his research on health care, Philipson has been a key player in the Trump administration’s efforts to lower drug prices and push back against Democrats’ proposals for a Medicare-for-all system.

The Post noted that during his tenure on the Council it released a report warning of the financial dangers of proposals for a national single payer health insurance system ("Medicare for all"), which is labelled "socialism."

Also, it quoted him as saying

Deregulation is the cornerstone of the president’s pro-growth economic policies that has been implemented since he took office,

The article also briefly described his "long career and academia and public service."

An article on the NPR site included this testimonial:

'Tom is a very fresh thinker,' said Mark McClellan, a veteran of the George W. Bush administration who recruited Philipson to work for him, first at the FDA and later at the Centers for Medicare & Medicaid Services. 'Tom had a great background in health economics and wanted to do work that was very policy relevant. So it was a win-win.'

A health economist as the chief White House economic adviser sounds like a good idea on its face, but the reality is much more complex.  

Philipson's Career as a Master Stealth Health Policy Advocate

In February, 2017, months before Philipson ascended to the Council, a ProPublica article noted that Philipson was "the third co-founder of Precision Health Economics" (PHE).

As we said later in 2017, PHE was in the business of using its experts' academic credentials to help pharmaceutical and biotechnology companies influence public policy in their favor. From the ProPublica article

Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs.

So,

To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation’s top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb, and AbbVie.

Furthermore,

This is just an extension of the way that the drug industry has been involved in every phase of medical education and medical research,' said Harvard Medical School professor Eric G. Campbell, who studies medical conflicts of interest. 'They are using this group of economists it appears to provide data in high-profile journals to have a positive impact on policy.'

PHE has worked with some of the biggest pharmaceutical and biotechnology companies and trade groups. In particular,

The roster includes Abbott Nutrition, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Gilead, Intuitive Surgical, Janssen [a subsidiary of Johnson and Johnson], Merck, the National Pharmaceutical Council, Novartis, Otsuka, Pfizer, PhRMA, rEVO Biologics, Shire and Takeda.

ProPublica described some of the tactics PHE uses:

The firm participates in many aspects of a drug’s launch, both advising on 'pricing strategies' and then demonstrating the value of a drug once it comes on the market, according to its brochure. 'Led by professors at elite research universities,' the group boasts of a range of valuable services it has delivered to clients, including generating 'academic publications in the world’s leading research journals” and helping to lead “formal public debates in prestigious, closely watched forums.'

PHE has worked on campaigns to persuade the government and insurers to increase what they would pay for oncology drugs, and for Amgen's PCSK9 inhibitor (Repatha) for hypercholesterolemia.
 
Tomas Philipson was one of the principals of PHE:

Precision Health Economics may be well-positioned to influence the Trump administration. Tomas Philipson, an economist at the University of Chicago and the third co-founder of Precision Health Economics, reportedly served briefly as a senior health care adviser for the Trump transition team. He did not respond to requests for comment.

He has taken an active role in stealth health policy advocacy campaigns run by PHE.  For example, as part of the PHE campaign to advocate for generous government and commercial insurance payments for Repatha, Philipson disparaged an analysis by the Institute of Clinical and Economic Review which had suggested the drug was overpriced:

Philipson, the Precision Health Economics co-founder, and Jena wrote an op-ed in Forbes, citing the institute’s research and deriding its approach to value pricing as 'pseudo-science and voodoo economics.'

PHE and its principals, including Philipson, often failed to disclose relevant conflicts of interest.  For example, re the above Forbes article,

Only Philipson disclosed his ties to Precision Health Economics, and neither academic disclosed that Amgen was a client of the firm.

Failing to disclose the Amgen funding of their work in this context appeared deceptive.

Up to the time of his appointment to the Council of Economic Advisers, Philipson seemed to be enhancing his position at PHE.  In particular, in 2015, after PHE was bought out by a privately held biotechnology company, "Philipson ... [was] listed as chief economist and the chair of the strategy and innovation board."


However, Philipson's previous work on stealth advocacy campaigns for pharmaceutical and biotechnology companies did not prevent him from becoming a member of the Council of Economic Advisers.  Now that Philipson is likely to ascend to the chair of the Council, Philipson's previous record of stealth health policy advocacy has been anechoic.

Summary and Conclusions

The anechoic nature of this latest case shows how we are becoming numb to many common abuses in health care in the face of even worse abuses in the larger political economy, the ultimate defining down of deviancy.

Nonetheless, let me first emphasize that Philipson came through the revolving door from his role as a stealth health policy advocate to become a major Trump regime economic adviser.

We and others have said again and again that the revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  In particular, 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.

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.  Many examples, starting with Philipson's initial appointment to the Council, appeared here.  The more people transit the revolving door from the world of big corporations to government, the more government appears rigged to do the bidding of big corporations and their  munificently paid leaders.


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

Philipson is not merely an adviser to pharmaceutical and biotechnology companies.  He was an active participant and innovator in stealth health policy advocacy (or maybe stealth lobbying.)   Putting an innovator in stealth health policy advocacy and lobbying in the top economic position in the White House will only amp up the power of propagandists and disinformation purveyors in government.

Meanwhile, top health care (and other) corporate management is increasingly merging with the current administration in one giant corporatist entity which is not in the interests of health care. To derig 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. 

Despite Public Protestations of of Bipartisanship, Many CEOs of the Largest US Health Care Corporations Appear Partisan, and Mainly Republican

Leaders of big health care organizations clearly are interested in influencing public policy and government regulation in ways that favor their organizations, and often indirectly themselves. On the other hand, big health care organizations have traditionally been non-partisan.  While their leaders certainly may have political views, they used to keep them very quiet.

In this sense, the leaders of big health care organizations have seemed similar to the leaders of large businesses in general.  For example, a recent New York Times article noted,

The Business Roundtable, the top lobbying organization for industry in Washington, is often characterized as a nonpartisan or bipartisan organization.

Yet,  recently, especially in the US, we have seen evidence that some health care organizations have become partisan, albeit stealthily, throwing their support behind political candidates, parties and organizations that may support their policy and regulatory goals, even while they may also support positions that go against the health care and public health mission, or even may be frankly anti-democratic.  In the US, organizations and their leaders now may support partisan aims with dark money, funds whose origin is disguised.

The recent NYT article noted above summarized some newly released research showing how corporate leaders in general have become more partisan, and more partisan in a particular sense. 

Based on Disclosed Personal Contributions, Since 2000 Most Top Corporate Executives Became Very Republican

The NYT article summarized a study of disclosed personal political contributions made by S&P 1500 executives from 2000 to 2017.

To be counted a supporter of Republicans or Democrats, executives had to direct at least two-thirds of their donations to candidates affiliated with one party.

They only released aggregate data, not data on particular industries, much less particular companies.  The main findings were:

More than a quarter of the executives studied gave enough to both parties to be classified as 'neutral.'

But,

just 18.4 percent of the executives studied were designated as Democrats. The clear majority — 57.7 percent — demonstrated their affiliation through donations to the Republican Party. Indeed, 75 percent of donations from the median chief executive were directed to Republicans.

That strongly contrasts with the notion that big business and its leaders are non-partisan, although perhaps eager to be popular with people, particularly customers and politicians, with all sorts of political affiliations.

The study disclosed no information on any particular executive or company other than Tim Cook of Apple, one of the minority of apparently studiously bipartisan corporate leaders.


However, another article from October, 2018 in MarketWatch provided some particular information on how partisan leaders of health care corporations have become.


Many CEOs of Big Health Care Corporations are Very Republican

The MarketWatch article, which reported the journalists' own study, also opened with the notion that corporate executives have been known for being non- or bi-partisan,

Company executives often steer clear of any appearance of partisanship, in large part because they don’t want to alienate customers and investors who back the other side.

Their study focused on disclosed political contributions from CEOs of S&P 500 companies, the largest publicly traded companies in the US, from 2017 through August 31, 2018, that is, those relevant to the most recent US national election, the 2018 mid-term election.

They also found that many executives were heavily partisan based on their personal political donations.

MarketWatch’s analysis found that among the CEOs who did contribute to party-affiliated committees, nearly all leaned heavily blue or red, with few donating equally to the two main parties. More than 84% of the 261 CEOs who contributed to partisan committees donated 70% or more of their money to one party or the other. And about 100 of the CEOs spent above the median amount and contributed 75% of their money to one party.

Overall,

The chief executives contributed a total of $7.4 million to Republican groups, almost triple the $2.6 million contributed to Democratic committees.

The article presented a graphic showing the CEOs who were most partisan and contributed the most money.  It included several CEOs of big health care corporations.

The article included a database of CEOs ranked by amount contributed.  The amounts and proportions spent by the health care CEOs among the top 100 spenders were:

9. Timothy Wentworth, Express Scripts Holding: total contributions: $262,594, to Democrats, $10,000; to Republicans, $244,722

10. Robert A Bradway, Amgen: $235,800; D $41,000; R $194,800

13. Kenneth C Frazier, Merck: $196,961; D $48,500; R $140,000

14. Mark J Alles, Celgene; $195,682; D $15,000; R $173,600

16 Ian C Read, Pfizer; $181,833; D $25,800; R $145,400

23. David A Ricks, Eli Lilly; $128,020; D $23,300; R $89,500

25. Leonard S Schliefer, Regeneron Pharmaceuticals; $125,000; D $120,000; R $ 0

28. Marc N Casper, Thermo Scientific; $118,100; D $2,700; R $105,400

29. Brenton L Saunders, Allergan; $115,100; D $ 0; R $105,100

32 Michael F Nieidorff, Centene; $105,994; D $60,794; R $35,200

38 Miles D White, Abbott Laboratories; $90,400; D $ 0; R $90,400

39. Kent J Thiry, DaVita; $86,500; D $ 29,300; R $42,200

57. Clifford W Illig, Cerner; $47,000; D $0; R $42,100

70. Steven H Collis, Amerisource Bergen; $39,784; D $2,800; R $28, 100

85. Dow R Wilson, Varian Medical Systems; $30,800; D $0; R $15,800

88. Giovanni Caforio MD, Bristol-Myers Squib; $30,184; D $5,000 ; R $17,300

90. John F Milligan, Gilead Sciences; $30,000; D $0; R $20,000

92. Larry J Merlo, CVS;  $28, 733; D $0; R $15,400

93. Vincent A Forlenz, Becton-Dickinson; $28,700; D $11,500; R $0

100. George S Barrett, Cardinal Health; $27,168; D $13,900; R $5,000

So, there were 19 health care corporate CEOs among the top 100 of those giving disclosed political donations for the 2018 election.  Of those, 15 gave most of their donations to Republicans, 4 to Democrats.  Furthermore, note that many of the companies represented on the list have been Health Care Renewal "frequent fliers," often discussed because of problems with leadership, governance and/or ethics.  

Discussion

While publicly often non--partisan, it appears that the top leaders of the biggest US health care corporations (and other corporations) have become increasingly partisan, and and increasingly supporters of one US political party, the Republican.  This is important since, as the NYT article noted:

The opinions held by executives have always resonated beyond their own industries, but their importance is more pronounced today. Mr. Trump, for example, has not hesitated to equate economic policy with foreign policy.

Also, the authors of the research paper summarized by the article wrote:

Especially since the Supreme Court’s decision in Citizens United, which allowed corporations to make unlimited independent political expenditures, corporate political spending can substantially affect politics and policymaking

In particular,

These executives wield enormous influence over not just policy, but the inclinations of their own employees. One of the most fascinating revelations of the study was that it also looked at the conduct of the businesses themselves, and in the process discovered that disclosures of political donations were highly correlated with the political leaning of its chief executive.

Political contributions by public companies do not have to be disclosed to shareholders, although some of companies do it. So the researchers looked instead at the which companies disclosed the donations to shareholders. Using an index developed by the Center for Political Accountability, the professors found that there was'“a statistically significant association between having a Republican C.E.O. and a lower' disclosure score.

Also, in the era of Trump, the heavily Republican partisanship of top corporate CEOs seems at variance with how their corporations' claim to be socially responsible, and

given the outspoken positions a number of executives have taken in recent years on social issues like climate change, guns and immigration policies.

Furthermore, the heavily Republican partisanship of  CEOs of big health care corporations seems at particular variance with the health care missions espoused by these corporations. 

For example, in 2018 we discussed the case of CVS, which boasts a code of ethics including respecting the covenantal relationship between pharmacists and patients, promoting "the good of every patient," acting with "honesty and integrity," and serving "individual, community and social needs." It also has a social responsibility policy including "keeping the planet in balance," and making "quality health care more affordable, more accessible and more sustainable."  However, CVS was revealed to have been contributing to a "dark money" organization called America First Policies, 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.  Whether CVS made is making contributions to other such groups was unknown.  At the time, we speculated whether the contributions to AFP reflected the self-interest of CVS leadership.

Now we find out that CVS CEO Larry Merlo gave $15,400 to Republicans in the run-up to the 2018 election, but nothing to Democrats.  This increases suspicion that CVS corporate political action is more about its CEO's ideology than its professed mission. 

This anecdote, coupled with recent findings that big health care corporations' policies about political activities are lax at best (look here), and the evidence above, should prompt concern about the political actions of other big health care corporations, and their intent. 

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.

Meanwhile we are left with the suspicion that top health care corporate management is increasingly merging with the current administration 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.

Pharma's Dark Money: Touting Corporate Responsibility and Non-Partisanship, But Using Dark Money to Promote Self-Serving Policies and Partisan Causes

Health Care Corporations Promote Their Social Responsibility

The US health care system's extreme dsyfnctionality is now a cliche.  So it's no wonder that everyone seems to want to make things better.  Big health care corporations in particular tout their socially responsible ideas for health care reform.

For example, PhRMA, the trade organization for drug and biotechnology firms, describes its mission thus:

PhRMA is committed to advancing public policies in the United States and around the world that support innovative medical research, yield progress for patients today and provide hope for the treatments and cures of tomorrow.

Amgen states simply its mission is "to serve patients."

Biogen published a "Corporate Citizenship Report" which included

our commitment [is] to positively impact our communities, to inspire the next generation of scientists, to solve social and environmental challenges and to create a diverse and inclusive workforce that thrives professionally and personally.

Giant pharmaceutical/ biotechnology/ device company Johnson & Johnson has its famous "credo" which starts with

We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services.

Furthermore,

We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens – support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education.

 
With all that positivity supporting better health care, one would think that health care dysfunction should be soon gone. But maybe under all this talk about corporate responsibility lies something darker.

An Early Case of Dark Money in Health Care

Back in 2012 we discussed a case of "dark money" being used to conceal sources of support for particular health policy and political positions.  The case was of the Center for Protection of Patient Rights, an obscure group whose mission was to "protect the rights of patients to choose and use medical care providers."  The CPPR financed the US Health Freedom Coalition, led by Dr Eric Novack, which received nearly its entire budget — $1.7 million — from the center to help pass a state ballot measure that aimed to block President Obama's healthcare overhaul.  The Center ultimately transferred $55 million to Republican candidates in the 2010 election.  Its money came from the equally obscure Americans for Job Security, and was conveyed by groups such as the American Future Fund. The people who gave the money to the Americans for Job Security remained unknown, save for one wealthy Alaskan "landowner."  

Do Health Care Corporations Put Their Money Where Their Mouths Are?


This year, we discussed the case of huge pharmacy chain CVS,which proclaims its "social responsibility," and its policy of only making charitable contributions to improve "health and healthcare nationwide."  Yet CVS was donating to America First Policies, a supposed non-profit group devoted to promoting the partisan agenda of President Trump, including "repealing and replacing Obamacare," and immigration policies such as building the "wall" and deporting  "illegal immigrants."  America First Policies appears to be yet another dark money organization.  CVS only decided to stop contributing when journalists revealed that America First Policies staffer had made flagrantly racist and pro-Nazi comments.

This suggested that it is possible that health care corporations which promote themselves as socially responsible and non-partisan may actually be secretly promoting political agendas that might shock some of their consumers and/or patients, employees, and health care professionals who must deal with them. 


We have  now found some more cases that reinforce this suspicion, showing how pharmaceutical and biotechnology companies have funneled funds through more "dark money" organizations to support policies that do not fit so well with the image they want to convey.

The PhRMA Backed Dark Money Campaign Against an Ohio Initiative to Control Drug Pricing

In August, 2017, the International Business Times revealed how the pharmaceutical/ biotchnology industry had set out to defeat a 2017 Ohio initiative meant to hold down drug prices without revealing who was funding it.

PhRMA had already succesfully defeated a similar initiative in California in 2016.  However, industry support for this campaign, while obscure, was not a secret. 

PhRMA set up ... Californians Against the Misleading Rx Ballot Measure, which raised over $111 million for its campaign against a California initiative that ... would have blocked that state from paying higher drug prices than those negotiated by the Veterans Affairs Department. The trade group set up a political action committee in California to which pharma companies donated directly — so PhRMA had to disclose these donors. Merck, Pfizer and Johnson & Johnson gave over $9 million each; Amgen gave $7.6 million; and 19 other drug companies gave $1 million or more. The PhRMA-run committee spent nearly all of the millions it raised, and the measure failed to pass, with 53 percent of voters shooting it down. All donors except for Genentech and Gilead Sciences are PhRMA members, and only a handful of companies out of more than 30 total corporate donors are headquartered in California.

Somehow, with all the news coming out about the 2016 US elections, this generated little interest.  However, in Ohio in 2017, PhRMA was able to do something similar while keeping the corporate sources of the money hidden.  Their target was:

Issue 2, the Ohio Drug Price Relief Act — a citizen-initiated ballot measure designed to prevent state agencies, including the state Department of Medicaid, from purchasing drugs at rates any higher than the lowest amount paid by the federal Department of Veterans Affairs, which negotiates with drug companies and saves between 20 and 24 percent on drug costs.

This time:

Pharmaceutical Research and Manufacturers of America (PhRMA), the biggest trade organization in the U.S. representing major drug companies, created a political action committee on May 1 called Ohioans Against the Deceptive Rx Ballot Issue. On the same day, PhRMA also founded a limited liability corporation of the same name and registered at the same address; under normal circumstances, it would not be required to disclose its donors. Campaign finance reports document only one donor to the ballot measure committee: the linked LLC.

So contributions from corporate donors to the LLC to financeed the political action committee were concealed.  So,

'Certainly, setting up an LLC to launder drug company money into fighting the ballot measure looks like an effort to evade Ohio's transparency and disclosure laws,' Brendan Fischer, director of federal and Federal Election Commission reform at the nonpartisan Campaign Legal Center, told International Business Times in an email.

Also,

The Campaign Legal Center contends that hiding donors this way at the federal level violates the Federal Elections Campaign Act, which prohibits 'straw donors.'

There were only two flies in the ointment.  Two companies did disclose donations to the LLC:

According to the Columbus Dispatch, California-based Amgen gave $6.3 million from 2016 through June 2017, and Biogen, headquartered in Massachusetts, gave $1.5 million last year. This accounts for roughly half of the $15.8 million total that PhRMA’s LLC raised in just May and June to fight Issue 2.

Who donated the rest, amounting to some $58 million, remains unknown.  And the effort to defeat Issue 2 was succesful, as reported by Cleveland.com in November, 2017.

Issue 2 also now holds the distinction of being the most expensive ballot issue in state history, with more than $74 million raised over the course of three years, topping the $64.4 million spent on Issue 6 in 2008, which sought permission for a casino in Wilmington, Ohio. Issue 6 also failed at the ballot.

Big Pharma accounted for more than $58 million of the total raised.

Furthermore,

Because the drug companies passed the money through a limited liability company created with the intention of funneling cash to the opposition campaign, it's currently impossible to tell which companies actively spent money combating the initiative in Ohio.

A proponent of Issue 2 charged:

'The onslaught, the bombardment of television advertising that was misleading, lying and negative led to tremendous confusion,' he said.

Uncertainty from the public about the effects of the bill coupled with the ugliness of the campaign likely led to Issue 2's defeat. Voters were often confused and felt both sides were of zero help in explaining the issue.

And by August 25, 2018, the Columbus Dispatch reported that all legal compaints against the PhRMA dark money campaign were dismissed.

Think of the campaign to defeat Issue 2 as a proof of the concept that health care corporations can finance campaigns against policy measures using dark money organizations to hide their support.

But no one would be surprised to find out that pharmaceutical companies were against a policy measure that would restrict the prices they charge.  Our next case shows how the dark money ruse can be used by corporations to support partisan policies that conflict with their proclaimed social responsibility and non-partisan nature.  

The PhRMA Backed Dark Money Campaign to "Repeal and Replace" the Affordable Care Act (ACA)

Investigative journalism from Kaiser Health News appeared in the New York Times and the Washington Post in late July, 2018 showing how PhRMA again used dark money, but this time to advocate for "repealing and replacing" the Affordable Care Act (known informally as "Obamacare"), which PhRMA had previously supported, and about which it was then ostensibly neutral.  The article began,

In 2010, before the Affordable Care Act was passed by Congress, the pharmaceutical industry’s top lobbying group was a very public supporter of the measure. It even helped fund a multimillion-dollar TV ad campaign backing passage of the law.

But last year, when Republicans mounted an aggressive effort to repeal the law, the group made a point of staying outside the fray. 'We’ve not taken a position,' Stephen Ubl, head of the organization, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, said in an interview in March 2017.

This was deceptive.

That stance, however, was at odds with its financial support of another group, the American Action Network, which was heavily involved in the effort to repeal the act, often referred to as Obamacare. The network spent an estimated $10 million on an ad campaign designed to build voter support for its elimination.

'Urge him to repeal and replace the Affordable Care Act now,' one ad running in early 2017 advised viewers to tell their congressman. That and similar material (including robocalls) paid for by the American Action Network ran numerous times last year in 75 congressional districts.

PhRMA was one of AAN’s biggest donors the previous year, giving it $6.1 million, federal regulatory filings show. And PhRMA had a substantial interest in the outcome of the repeal efforts. Among other actions, the Republican-backed health bill would have eliminated a fee the companies pay the federal government, one estimated at $28 billion over a decade.

But there was no way the public could have known at the time about PhRMA’s support of the network or the identity of other deep-pocketed financiers behind the group.

The KHN report went on to explain how this works

Unlike groups receiving its funds, PhRMA and similar nonprofits must report the grants in their own Internal Revenue Service filings. But the disclosures don’t occur until months or sometimes more than a year after the donation.

The conservative-leaning AAN has become one of the most prominent nonprofits for routing what is known as dark money — difficult-to-trace funds behind TV ads, phone calls, grass-roots organizing and other investments used to influence politics. Such groups have thrived since the Supreme Court’s Citizens United decision in 2010, which loosened rules for corporate political spending, and amid what critics say is nonexistent policing of remaining rules by the I.R.S.

Generally speaking, dark-money groups are politically active organizations, often nonprofit, that, under I.R.S. regulations, are not required to disclose the identities of their donors.

Such groups are often chartered under Section 501(c)(4) of the tax law, which grants a tax exemption to 'social welfare organizations.' For those seeking to influence politics but stay in the background, 501(c)(4) designations offer two big advantages: tax exemption and no requirement to disclose donors.

The AAN seems to be an obviously partisan, right-wing, pro-Republican group.

PhRMA’s $6.1 million, unrestricted donation to AAN was its single-biggest grant in 2016, dwarfing its $130,000 contribution to the same group the year before. Closely associated with House Republicans — AAN has a former Republican senator and two former Republican House members on its board — the group backed the failed G.O.P. health bill intended to replace the Affordable Care Act. It also supported the successful Tax Cuts and Jobs Act of 2017, which reduced corporate taxes by hundreds of billions of dollars over a decade.

So far in this election cycle, AAN has given more than $19 million to the Congressional Leadership Fund, a Republican super PAC with which it shares an address and staff, according to the Center for Responsive Politics. The fund recently ran ads opposing Democratic candidates in high-profile special congressional elections in Georgia and Pennsylvania.

In fact, PhRMA made a variety of contributions to dark money groups associated with right-wing and/or Republican party backed causes, while it presumably maintained a non-partisan public stance.

PhRMA gave nearly $10 million in 2016 to politically active groups, including AAN, that do not have to disclose donors, its most recent filing with the I.R.S. shows. By contrast, PhRMA and its political action committee made only about $1 million in political donations in 2015 and 2016 that were disclosed to regulators and reported by the Center for Responsive Politics.

PhRMA’s 2016 political activities included support for the Republican National Convention. Rather than directly support the Cleveland convention, which several companies pulled out of after it became clear that Mr. Trump was going to be the nominee, PhRMA routed $150,000 through limited liability companies with names like Convention Services 2016 and Friends of the House 2016.

Like 501(c)(4)s, LLCs do not have to disclose their donors. PhRMA’s support was revealed in I.R.S. filings more than a year later. (Donations by PhRMA and other groups to Friends of the House, which financed a luxury lounge for convention dignitaries, were first reported by the Center for Public Integrity last fall.)

PhRMA’s surge in donations to AAN coincides with the arrival of Mr. Ubl, who took over as president and chief executive in 2015 and has longstanding ties to Norm Coleman, a former United States senator from Minnesota who is now the network’s chairman. Mr. Ubl once ran the lobby for manufacturers of knee implants, heart stents and other medical devices, one of which, Medtronic, is based in Minneapolis.

Also,

PhRMA’s 2016 dark-money contributions included $150,000 to Americans for Prosperity, a conservative group associated with the billionaires Charles and David Koch. Their group has already signaled it will be active in November’s elections, running attack ads against Senator Jon Tester, a vulnerable Montana Democrat, for not supporting a repeal of the Affordable Care Act.

PhRMA also gave $50,000 to Americans for Tax Reform, run by the conservative anti-tax activist Grover Norquist.

In contrast, PhRMA gave lesser amounts to groups identified as centrist or left-leaning.

Mostly smaller amounts went to centrist and liberal groups. Center Forward, which claims to seek bipartisan, common ground on drug policy and other issues, received $300,000 directly from PhRMA and another $179,000 from a PhRMA-backed group called the Campaign for Medical Discovery, according to tax filings.

And the groups to which they donated were also pursuing narrower issues that supported the industry's economic interests, not broadly partisan (and in this case, prro-Democratic) issues. For example,

Center Forward worked to preserve a tax credit for researching rare-disease medicines known as orphan drugs. PhRMA took a similar stance, encouraging Congress “to maintain incentives” for rare-disease drugs.

The KHN article noted that there is evidence that individaul pharmaceutical companies hide their political advocacy, possibly mainly their advocacy of right-wing and/or Republican backed causes, in similar ways.

Johnson & Johnson gave $35,000 that year to the Republican Main Street Partnership, a 501(c)(4) that describes itself as a coalition of lawmakers committed to 'conservative, pragmatic government,' the C.P.A. data shows.

But the center’s research also shows that many pharmaceutical companies don’t disclose donations made to 501(c)(4) organizations, nor are they legally required to do so.

Corporations 'could dump millions into one of these (c)(4)s and nobody would ever know where it came from,' said Steven Billet, a former AT&T lobbyist who teaches political action committee management at George Washington University.

Summary and Discussion

So in three cases, health care corporations, and/or their trade associations, made significant financial contributions to dark money organizations, thus avoiding reporting of such fund transfers.  In two cases, these fund transfers went to organizations with clearly partisan, right-wing, pro-Republican and/or pro-Trump agendas.  Yet the corporations and their trade association had publicly committed themselves to social responsibility, putting patients and health care ahead of all other concerns, and had never advertised themselves as partisan, explicitly politically conservative, and/or Republican.

This is a new dimension of stealth health policy advocacy or stealth lobbying.  Most of the previous, at least pre-2016 campaign, examples we had found of these involved corporations promoting measures that would improve their revenue (and consequently their top managements' pay).  They did not involve explicitly siding with a single political party or political philosophy.

Patients, consumers, health care professionals, and the public at large might not be pleased but would probably not be too suprised that health care corporations and their management pursue financial self-interest, but prefer doing so without much publicity.  However, I suspect most people would be unpleanatly shocked to find out that well-known health care corporations have been actively siding with a single political party and that party's ostensible political philosophy, but keeping that support very quiet.

Since such dark money support is by definition secret, who knows how many health care organizations have been doing this?

As an aside, I wonder if this hidden support from large corporations has pushed one political party to more extreme actions despite such actions' popular disfavor?  But that is for more politically attuned people to ponder.

In any case, as we have said again and again,...

There are myriad ways corporate and political insiders push health policy agendas because of self-interest, regardless of their effects on patients' and the public's health.  Health policy in the US has become an insiders' game.  Unless it is redirected to reflect patients' and the public's health, facilitated by the knowledge of unbiased clinical and policy experts rather than corporate public relations, expect our efforts at health care reform to just increase health care dysfunction. 

Physicians, public health advocates, whatever unbiased health policy experts remain must educate the public about how health policy has been turned into a corporate sandbox.  We must try to somehow activate the public to call for health care policy of the people, by the people, and for the people.

Pontifications About Health Care Reform Written by Insiders Who Benefit from the Status Quo - Worse Than We Think

Perceptions that the US health care system is dysfunctional and needs major reform go way back.  A timeline from the Tampa Bay Times noted President Theodore Roosevelt's proposal for a national health service in 1912.  Nonetheless, as we have discussed endlessly, most attempts at reform failed, and health care dysfunction seems to be getting worse.

One big problem may be that we don't understand how much discussion of health care reform is driven by those who benefit from the status quo. 

A Personal Anecdote

When I began my academic career in 1983, I was often in the audience for talks about how to fix health care by people billed as experts.  Often these talks seemed oddly disconnected from the realities on the ground for a junior assistant professor with a lot of clinical and teaching responsbilities.  Worse, many of the solutions they offered seemed to entail greater burdens for health care professionals, with no obvious compensation other than the warm feeling that we would be benefiting society.  Who else these solutions might benefit was not discussed. 

One talk given a bit later stands out in my memory. On November 29, 2001, one Dr John W Rowe gave the prestigious Levinger Lecture at Brown University entitled "Good Health: Can we Afford It?" (referenced here, see items for 11/14 and 11/16)  As I recall, Dr Rowe spent considerable time scolding us hard working physicians for overuse of medical interventions leading to endless increases in health care costs, and promising more burdensome bureaucratic interventions to rein in our follies.  While promising more burdens on physicians, Dr Rowe did not dwell on how the resulting cost savings might benefit him in his role as CEO and Chairman of Aetna Inc.  Aetna had purchased the notoriously physician-unfriendly US Healthcare, and thus had become a big for-profit health care insurer already known for imposing bureaucratic burdens on physicians in hopes of decreasing their utilization, while increasing the company's revenues (look here).  Were Dr Rowe's pontifications really about improving health care for all Americans, or about justifying his previous management behavior, and perhaps supporting the price of his shares in Aetna? Why was Aetna's public relations given the patina of an academic lecture?

These days, health care professionals continue to be exhorted about health care reform.  Many such pontifications may be not so much about true health care reform as about preserving the fundamental status quo which has benefited and enriched so many insiders. The interests of the pontificators are often less obvious than those of Dr Rowe.  Maybe that is so why there has been so little real reform, and what little reform there has been seems to be under continuous attack.

Two Examples of How Hard It Is to Discover the Interests of Health Care Policy Pontificators

In the last few weeks I posted about two recent ostensibly authoritative pontifications.  One was about ways to address the worsening problem of physician burn-out (see this post). It was written by the CEOs of large, non-profit hospital systems, joined by the CEO of the American Medical Association.  The other was about a health care reform proposal from the prestigious National Academy of Medicine (see this post).  A rather uncritical article in the Washington Post hailed it as a "radical idea" because it was written by "doctors." In both cases, I was skeptical, mainly because many of the proponents had conflicts of interest, mostly undisclosed, that suggested they were already benefiting mightily from the current system.

However, it gets worse.  While I thought my posts were based on reasonable efforts to find undisclosed conflicts of interest affecting the authors of these exhortations, within a few weeks I realized I had missed one important item affecting each.  The lesson is that the web of conflicts of interest that ensnares the insiders who run most of US health care is even more complex and adherent than any of us realizes.

Dr John Noseworthy, Author of the Health Affairs Post on Reducing Physician Burnout: CEO of the Mayo Clinic, But Also Now Nominated to be a Director of Merck

Dr Noseworthy, CEO of the Mayo Clinic, was the lead author of a post in HealthAffairs about reducing physician burnout.  (Oddly enough, none of the proposed action items seemed to involve increasing physician autonomy by reducing the power of managers over health care professionals.)

Two weeks after Noseworthy and colleagues' post appeared, an article on the Minnesota Public Radio website reported that Dr Noseworthy has just been nominated to a seat on the Merck board of directors.  Presumably the possibility of this nomination had been known at the time the post was published.

I had previously written that two of the authors of the Health Affairs post were on corporate boards.  One, Dr Paul Rothman, was already on the board of Merck.  As corporate directors, they have fiduciary responsibilties to promote the revenues of their corporations.  Now it turns out there were at least three such board members among the health system CEOs who had pontificated to physicians about how to reduce their burn-out.

Yet the power of such health care systems, whose management is often mission-hostile, and who often put revenue ahead of physicians' professional values (per the shareholder value theory), is arguably a major cause of physician burnout.  Furthermore, Merck, in particular, has had its share of management misbehavior as demonstrated by a recent $830 million settlement for deceiving shareholders, a mere $5.9 million 2015 settlement for deceptive marketing, and multiple setttlements, cumulatively totaling more than $1 billion, plus one guilty plea for the historic deceptive marketing of Vioxx (see this post).

So to what extent are the authors of this pontification about reducing physician burnout (without really giving physicians much new autonomy) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Mr Leonard Schaeffer, Author of National Academy of Medicine Article on Health Care Reform: Member of the Boards of Wahlgreen Boots, Quintiles, scPharmaceuticals, but Also Long-Term Director of Amgen

Mr Schaeffer was an author of the National Academy of Medicine article, now published online in JAMA, about health care reform.  (Oddly enough, none of the "vital directions issue areas" mentioned in the article involved real challenges to the power of large health care organizations, particularly for-profit corporations, or increased autonomy for health care professionals.)

The version of the article published online by the NAM did not include any explicit disclosures of conflicts of interest.  It did note that two authors were full-time employees of health care corporations, one was a consultant to health care corporations, one was a lobbyist for health care corporations, and one was on the boards of health care corporations.  The online JAMA version added more disclosures, but these were incomplete.  In my post, I noted that fully 13 of the 19 authors had major ties to large health care corporations, as employees, lobbyists, consultants or  board members.

In particular, Mr Leonard D Schaeffer was listed in the NAM version as simply affiliated with the University of Southern California, but I found was actually on the boards of Wahlgreens Boots Alliance, Quintiles Transnational, and scPharmaceuticals Inc.  That was still an incomplete picture of his conflicts of interest.

A ProPublica article from February, 2017 recounted how big pharmaceutical companies engaged Precision Health Economics to wage public relations campaigns to try to justify high pharmaceutical prices.  The article noted the following about Mr Schaeffer.  

Amgen has ties to all three founders of Precision Health Economics. Working for other firms, Philipson has twice testified as an expert witness for Amgen, defending the company’s rights to drug patents, according to his curriculum vitae. The other two founders, Goldman and Lakdawalla, are principals at the Leonard D. Schaeffer Center for Health Policy and Economics at USC, which received $500,000 in late 2016 from Amgen for an 'innovation initiative,' according to public disclosures. Goldman said the funds were unrestricted and could be used at the center’s discretion. Robert Bradway, the CEO and chair of Amgen, is on the advisory board of the university center, and Leonard Schaeffer, a professor at USC and the namesake of the center, sat on Amgen’s board of directors for nearly a decade.

With funding from Amgen, the Schaeffer Center hosted a forum in Washington, D.C., in October 2015 on the affordability of specialty drugs. Before a panel focused on the new cholesterol treatment, Goldman cautioned against lowering drug prices.

So Mr Schaeffer, in addition to his current board positions, turns out to have had a long relationship with Amgen.  Given that according to the 2013 Amgen proxy statement, Mr Schaeffer retired from the board with at least 28,277 shares of Amgen stock and options for 15,000 more, he may have current financial ties to the company. 

So once again, to what extent were the authors of the 2017 NAM report on health care reform (which did not challenge the influence of large health care corporations over the health of US citizens) insiders benefiting from the status quo in health care?  It may be more than what we think, even now.

Summary

Health care professionals, policy makers, and the public are constantly harangued by apparently unbaised experts about health care reform.  Yet many of these authorities are insiders who benefit from the status quo.  Many of their financial connections to the corporations that make the most money from the US commercialized health care system are not disclosed.  It may take considerable investigation to determine their involvement in a web of conflicts of interest that drapes over the US health care system.

Meanwhile, audiences should demand that those who lecture us about health care reform disclose all their financial conflicts of interest.  Any whiff of deception about their personal interests should suggest intense skepticism. 

True health care reform requires honest discussion of the issues.  Honesty in this case entails complete and detailed disclosure of the discussants' conflicts of interest. Until such honesty is the rule, be very, very careful about taking sanctimonious spiels at face value. 

Once More with Feeling - Amgen Again Settles Allegations of Misbranding, But Why Bother?

The Latest Settlement

Biotechnology giant Amgen has just reached another settlement of allegations that it unfairly, deceptively or misleadingly marketed its drug. Per the Los Angeles Times,

Amgen Inc. has agreed to pay $71 million to settle allegations by 48 state attorneys general that it improperly marketed two of its blockbuster drugs.

That is,

The states, including California, alleged that Amgen violated consumer protection laws by promoting the use of its anemia drug Aranesp for longer periods than the Food and Drug Administration had approved and by encouraging its use to treat anemia caused by cancer without FDA approval.

In addition, Amgen was accused of promoting its drug Enbrel as a treatment for mild plaque psoriasis even though it was approved only for severe plaque psoriasis, and for overstating the length of time that Enbrel effectively treats the disease.

This is the second settlement Amgen has made for improper marketing of Aranesp.

Three years ago, Amgen pleaded guilty to a single misdemeanor in federal court in New York for improperly marketing Aranesp. The drugmaker agreed to pay $150 million in criminal penalties and $612 million to resolve broader civil lawsuits, including allegations that Medicare, Medicaid and other government insurance programs were improperly billed.

At the time, federal prosecutors called the settlement 'the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.'

Although doctors can prescribe medications for off-label uses, drug companies are banned from promoting uses that aren't approved by the FDA, which has been at odds with some drugmakers over the issue.

This settlement seems to be just the latest in a very long procession of legal settlements  of allegations of apparent misbehavior by large health care organizations.  We have previously discussed many such settlements, how they serve as markers of ethical lapses by leaders of large organizations, and also how the failure of most of these settlements to provide meaningful penalties to those who presided over, directed, or implemented the bad behavior allows continuing impunity and fails to deter future bad behavior.  Many large organizations have made multiple such settlements in recent years, but have these settlements seem to have not promoted honest, transparent, accountable health care.   

Yet continuing government efforts to provide even these weak challenges to continuing bad behavior now appear under threat.

Is Misbranding a Crime?

The fundamental allegations in the original large Aranesp settlement were of misbranding (although the settlements with state government just announced were of violations of state laws prohibiting, as in the case of Connecticut, "unfair, deceptive or misleading" marketing practices.)  Marketing a drug or device for uses other than those approved by the US Food and Drug Administration (FDA) may be called "misbranding."

Whether misbranding should be considered a crime has lately become controversial.   Recently, an appeals court agreed with the notion that such marketing is constitutionally protected speech, as long as it is "truthful." (See discussion by Shannon Brownlee on the Lown Institute blog, and the NY Times news article.)  I am not a lawyer, so I will try not to deal with this constitutional argument at this time.  But most of the public discussion has focused on the narrow issue of whether misbranding is in fact protected free speech.

However, the case of the 'misbranding allegations agains Amgen suggest other issues worthy of consideration.

Promoting a Not Merely Ineffective, but Dangerous Drug

As we discussed here in 2012, Amgen pleaded guilty to one count of illegally marketing Aranesp, and agreed to pay a penalty of $762 million.  As we noted, the misbranding in this case was promotion of Aranesp for patients with cancer who were not receiving chemotherapy.  However, a growing collection of evidence suggested that epoetin drugs, a class in which Aranesp resides, increase the death rate in patients with various kinds of cancer.  On the other hand, Aranesp was never meant as a possible cure for cancer.  At best, its benefit is improvement of anemia, which might, just might improve how some patients feel in the short-term.  So it appears Amgen was promoting a dangerous drug without any evidence that the drug provided benefits that balanced the danger.  This appears very bad for patients.  The misbranding here was not some technical violation, but likely a deceptive effort that could have hurt patients, while profiting Amgen and its top executives.  The ethics here look much worse than the single guilty plea suggested.

Misbranding just refers to promoting a drug or device for uses that the FDA did not approve.  Some cases of misbranding could cause little more than inconvenience and added expense, but others could result in serious harm to patients.  Treating them all as misbranding removes important distinctions.

Allegations of Kickbacks

Furthermore, as discussed here in 2013, the 2012 settlement was not just about misbranding.  It was about kickbacks, that is bribes given to doctors by Amgen to induce them to prescribe a dangerous medication.  The settlement was arranged that Amgen did not admit to the alleged kicbkbacks.  But neither did it deny them, and the company apparently thought it was worth $762 million to avoid further dealing with these accusations, which nonetheless hang in the air.  So the ethics here now look even worse, invovling promoting a dangerous drug allegedly with bribery.


Furthermore, after news of the original Aranesp settlement came out, other stories of other settlements by Amgen appeared.  As we noted here,  in 2013, Amgen settled allegations that it also paid kickbacks to Omnicare and PharMerica to promote Amgen use in nursing homes and hospital.  It also settled charges that it inflated pricing data to obtain larger payments from Medicaid in multiple states for a variety of its drugs, including Aranesp.   Later in 2013, as we noted here, Amgen settled yet more charges that it gave kickbacks to doctors to promote one of its products, this time anti-cancer drug Xgeva.

Organizations accused of misbranding often are also accused of much worse conduct, yet very often, their cases are settled with the emphasis on the misbranding, leaving more serious allegations neither proven nor denied.  Focusing on misbranding may distract from more serious ethical, moral and legal violations.


Discussion

In the case of Amgen, the large 2012 settlement for misbranding resulted in the only guilty plea made and the largest fine paid by the company.  From my informal perusal of legal settlements made by drug, biotechnology and device companies, misbranding seems to be one of the more frequent allegations, and often the only one resulting in admissions of guilt.  It may be that it is easier to prove misbranding than other charges, and companies may admit to misbranding in settlements because the charge is not well understood by the general public and hence may carry less of a stigma than other charges, for example, kickbacks or fraud.

Yet as noted above, while misbranding seems to connote a mere technical violation, in health care misbranding can mean patients hurt by dangerous treatments that did them little if any good.  Furthermore, companies that settle allegations of or even admit to misbranding often have been charged with lots of other bad behavior, but settlements are often set up so none of these other allegations is ever confirmed or refuted.  So settlements that focus on misbranding again may nullify questions about worse ethical problems.

Now whether misbranding is itself really a transgression seems to a legal question.  But perhaps the legal challenges to misbranding as a crime ought to evoke more than just a narrow defense of the legal concept.  Of course, declaring misbranding unconstitutional could result in even weaker enforcement actions against large and powerful health care corporations,  However, maybe the inherent weakness of misbranding charges ought to inspire some rethinking of what bad behavior in health care really deserves attention.

Should not aggressive marketing of a drug as tremendously effective and safe in situations in which the drug is either minimally or not at all effective (especially in terms of improving patient-centered outcomes) or not very safe be considered possible fraud, and prosecuted as such?  Should not alleged kickbacks and bribes given to health professionals and care giving organizations be prosecuted, rather than treated as civil disputes and settled?  Should not the people who actually appeared to have committed fraud, or given bribes be prosecuted, rather than just letting their employers escape with civil monetary penalties?  Should not the leaders of big organizations on whose watches fraud and bribery allegedly occurred be charged as responsible corporate officers (look here )?

If civil authorities were willing to stop regarding big health care organizations and their leaders as "too big to jail,"  maybe less mischief would be going on in health care.  And maybe that would lead to better care for patients and better health for the public. 

ADDENDUM (21 August, 2015) - This post was republished on the Naked Capitalism blog.

What Big Drug and Biotechnology Companies Will Not Tell Us - Transparency International on Corporate Reporting

Drug companies are entrusted to provide pure, unadulterated medicines.  Increasingly drug companies are now entrusted with doing research, including experimental studies, on human beings, and providing education to doctors and patients.  Ordinarily, trust requires confidence in transparency. However, a new report suggests that large multinational drug and biotechnology companies are not very transparent.

Transparency International just released a report on the transparency, or lack thereof, of the 124 biggest multinational corporations.  The report detailed how well these companies disclosed their internal anti-corruption programs, their subsidiaries, affiliates, and joint ventures, and their financial data broken down by the countries in which they operate.  In summary, the overall results for disclosing anti-corruption programs were mediocre, and for disclosing organizational structure and country-by-country financial data, they were dismal.

The report is highly relevant to health care.  It included the biggest multinational health care corporations, all drug and/or biotechnology companies: Abbott Laboratories, (based in the US), Amgen (US), AstraZeneca (UK), Gilead Sciences (US), GlaxoSmithKline (UK), Johnson and Johnson (US), Merck and Co (US), Novartis (Switzerland), Novo Nordisk (Denmark), Pfizer (US), Roche Holding (Switzerland), Sanofi (France), Teva Pharmaceutical Industries (Israel).

The report has so far received little media coverage.  In the US, several news services provided brief  summaries.  Somewhat more substantial articles came from Reuters, the Wall Street Journal's Risk and Compliance Journal, and CNBC.  None gave specifics about health care.  Coverage from other countries, e.g., Germany by Deutsche Welle, and the UK by the Guardian, was more detailed but also did not specifically mention health care.

Therefore, I will summarize the rationale and assessment methods used by Transparency International for its three dimensions of transparency, and then show results from the 13 health care corporations.

Disclosure of Anti-Corruption Programs

The rationale for addressing this area was:

Global companies have legal and ethical obligations to conduct their business honestly. This requires
commitment, resources and the ongoing management of a range of risks – legal, political and reputational – including those associated with corruption. The implementation of a comprehensive range of anticorruption policies and management systems is fundamental to efforts to prevent and remediate corruption within organisations.

Transparency International believes that public reporting by companies on their anti-corruption programmes allows for increased monitoring by stakeholders and the public at large, thereby making companies more accountable

Evaluation of disclosure of anti-corruption programs was

based on 13 questions, which are derived from the UN Global Compact and Transparency International Reporting Guidance on the 10th Principle against Corruption. This tool, based on the Business Principles for Countering Bribery, which were developed by Transparency International in collaboration with a multi-stakeholder group, includes recommendations for companies on how to publicly report on their anticorruption programmes.

Note that the project addressed only reporting of anti-corruption programs, not their implementation or effectiveness.

For this and the other two dimensions of transparency, responses were converted into a 0% to 100% scale, with 100% being the best possible result.

Organizational Transparency

The rationale was:

As many of the recent corporate scandals have shown, acts of corruption are very often aided by the use of opaque company structures and secrecy jurisdictions.  But the use of offshore companies and their lack of transparency are posing increasing risks for global companies as well as for their shareholders, employees and local communities.

So,

Companies can mitigate the risks posed by lack of transparency and ownership arrangements by shedding more light on their corporate structures and by making basic financial information public on a country-by-country basis. This allows stakeholders to have a clearer understanding of the extent of a company’s operations and makes the company more accountable for its activities in a given country, including assessing whether it contributes financially in a manner appropriate to its level of activity.

The measurement strategy was,

Transparency International researchers consulted publicly available documents such as annual reports and stock exchange filings for information about company subsidiaries, affiliates, joint ventures and other holdings. The information sought included corporate names, percentages of ownership by the parent company, countries of incorporation and the countries in which the companies operate.

Country-by-Country Reporting

The rationale included:

The importance of country-by-country reporting was first recognised in the extractive sector as a way to ensure that revenues from natural resources are used to foster economic and social development rather than line the pockets of kleptocratic elites.

So,

country-by-country reporting ... [is] a recognised building block for corporate transparency and as a tool for countering tax avoidance.

In addition, country-by-country reporting provides investors with more comprehensive financial information about companies and helps them address investment risk more effectively.

The items measured were disclosure of revenue/sales, capital expenditures, pre-tax income, income tax, and community contribution in each country in which the company operated.

Results for Health Care Corporations

Company                      Total  Anti-Corruption P  Org Structure  by-Country

Abbott Laboratories    40             81                           38                3
Amgen                          37             85                           25                0
AstraZeneca                37             88                           19                3
Gilead Sciences           26             54                           25                0
GlaxoSmithKline          52            96                           50               11
Johnson and Johnson  26           65                           13                0
Merck and Co               42           77                            50                0
Novartis                        38            77                           38                1
Novo Nordisk               39            81                           38                0
Pfizer                             35            92                           13                0
Roche Holding              33            62                           38                1
Sanofi                            38            77                           38                0
Teva Pharmaceutical  35            85                            19                0

Again, only one company, GlaxoSmithKline, achieved an overall score of barely better than 50%.  All the others had lower scores.  Only two companies achieved a 50% score on disclosure of organizational structure, and only one achieved a score of better than 10% for disclosing country-by-country results.  The Transparency International report noted that the health care companies got particularly bad scores for disclosing organizational structure, averaging 31%, the third worst performance by economic sector.


Summary

 The drug and biotechnology companies generally did a fairly good job disclosing what their anti-corruption programs were supposed to do.  However, note that the Transparency International report did not assess how well these programs were implemented or enforced.  That this concern is not academic is underscored by some of these companies disreputable track records.  Some have long histories of legal actions, including billion dollar plus legal settlements, some of which were of allegations of fraud or kickbacks, and some have been convicted of crimes.  See the records of, for example: Abbott Laboratories (look here and here), Amgen (here), AstraZeneca (here), GlaxoSmithKline (here), Johnson and Johnson (here), Merck (here), Novartis (here), Novo Nordisk (here), Pfizer (here), Roche (here), Sanofi (here), and Teva (here).

Moreover, the companies did not do a good job disclosing their organizational structures, and hardly any bothered to report any financial results broken down by country.

We have frequently discussed health care corporations' deceptive marketing, induction of conflicts of interest, including those of supposed "key opinion leaders" who often are marketers in academic or professional clothing, and manipulation and suppression of clinical research.  There has been an ongoing procession of legal settlements involving health care corporations, often involving allegations of, and sometimes convictions for fraud, kickbacks, bribery, or other crimes.  There have even been some cases in which drug companies have failed to assure that their products are pure and unadulterated, their most basic mission.  Thus many are distrustful of drug and biotechnology companies, and large health care organizations in general.

So, as Transparency International's report noted, to rebuild trust,

integrity must be central to these efforts. Those efforts, in turn, can only become fully credible if they are undertaken with a sustained commitment to ethical behaviour and transparency across companies’ operations.

In my humble opinion, a basic premise of true health care reform would be that health care organizations become sufficiently transparent to restore basic trust in them.