Wednesday, October 17, 2018

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


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

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

Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.

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

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

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

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

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

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

As reported by Law.com,

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

Andrew Weissmann, the then-chief of the DOJ’s fraud section, told a health care conference in April 2016 that the section was placing 'a heightened emphasis' on corporate health care fraud investigations. He pointed to the recently established Corporate Fraud Strike Force that he said would focus resources in investigation and prosecution of larger corporate health care law violations, as opposed to smaller groups or individuals.
This little bit of progress was not to last.  Unfortunately, that strike force was downsized by the Trump administration as we noted in July, 2017.  Then as we noted in May, 2018, even the previously modest efforts by the US government to challenge corrupt acts by large US health care organizations were decreasing.  By that date, we found only one significant settlement made during the year.  That month, a report by Bloomberg, appeared with the headline, "White-Collar Prosecutions Fall to 20-Year Low Under Trump," on May 25, 2018.

Increasing Evidence of Corruption in the Trump Administration

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

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


The Global Anti Corruption Blog Update

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



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

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


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

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

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

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

The President shall, at stated Times, receive for his Services, a Compensation, which shall neither be encreased nor diminished during the Period for which he shall have been elected, and he shall not receive within that Period any other Emolument from the United States, or any of them.
This has been called the "domestic emoluments clause," and is supposed to prohibit a kind of conflict of interest, that is, a President getting paid by some part of the US government, or by state governments separate from his regular salary and benefits.  Nonetheless, Trump has been effectively paid, again and again, through the Trump Organization by the US government.


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

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

Albeit,

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

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

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

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

This has occurred on such a massive scale that

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

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

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

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

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



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

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



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

- Trump Organization seeking trademarks in China.

- Membership in Trump golf courses

-  Trump real estate transactions with secretive buyers

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

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

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

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

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

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

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

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

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




And still, corruption remains a nearly taboo topic. 

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

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

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

Wednesday, October 10, 2018

The Politicization of Pharma, and Other Health Care Corporations - Walk on the Dark (Money) Side

Introduction - Health Care Corporations Profess Social Responsibility

As we noted recently, large health corporations, which deal with patients, health professionals, and government regulators, usually profess their social resonsibility.  For example,

Giant health care insurance company Aetna advertises its social corporate responsibility, including

As a health care leader, we believe that our corporate responsibility starts with helping people live healthier lives. And that means using our resources to make the communities and world we live in better places.

and,

Our social responsibility efforts encompass how we treat our employees, improve the lives of customers, and effect positive change in community health.
Similarly, giant pharmaceutical company Merck advertises its corporate social responsibility,

Corporate responsibility is at the heart of our company's mission to discover, develop and provide innovative products and services that save and improve lives. It underscores our commitment to developing and rewarding our employees, protecting the environment, and operating with the highest standards of ethics and transparency.

Of course, in the policy arena, large health care corporations also tend to advocate for policies that are to their financial advantage.  Furthermore, top executives of large corporations have been known to donate to political candidates who favor their policy positions, although they often seemed to consciously spread their donations out to avoid any appearance of partisanship.

However, as the current US political chaos leads to more journalistic investigation, there is increasing evidence that large health care corporations have been secretly backing policy positions that do not correspond to their high-minded public statements about corporate social resonsibility, and are becoming quite political, even partisan in the process.  They do so through the use of dark money






Health Care Corporations Giving to Dark Money Organizations: Dark Money Illuminated

Dark money is meant to be secret, of course.  So it is not easy to find anything out about who gives to dark money organizations, and to whom they give in turn. 
 However, recently Issue One produced a report entitled "Dark Money Illuminated." It was based on an extensive attempt to pierce the veil hiding dark money. Its introduction states:

Dark money groups hold enormous sway over what issues are, and are not, debated in Congress and on the campaign trail. But the donors behind these groups rarely discuss their motivations for bankrolling these efforts, leaving the public in the dark about who funds these increasingly prominent and potent organizations.

To attempt to get the most accurate picture of the scope of dark money influence on US politics, its authors:

reviewed FEC filings, tax returns, annual reports submitted by labor unions to the Department of Labor, documents submitted to Congress by registered lobbyists, corporate filings, press releases and other sources.

This allowed them:

to be able to identify transactions — and donors — that have never previously been associated with these dark money groups.

So they were able to identify the 15 largest dark money groups in terms of donations received, and to get data on a substantial numer of donations to them, albeit likely only a fraction of the donations to dark money groups that have been made, from 2010 to 2017.  Health care corporations turned out to be major suppliers of funding to dark money group according to this data.  The report includes a summary of the top 67 donors to dark money groups, which included:

- Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry trade association, donated over $13 million.

- Aetna, a large for-profit health insurance company, donated over $8.5 million.

- Merck, a large pharmaceutical firm, donated over $4 million.

- Anthem, a large for-profit insurance company, donated $2 million.

Perusal of the whole data base revealed significant donations by many more health care corporations (list below includes the three companies listed above).


Aetna - $3.3 million to the American Action Network

Express Scripts - $75K to Americans for Tax Reform

American Healthcare LLC - $5K to Patriot Majority USA

Abbott Laboratories  - $500K to US Chamber of Commerce (USCC)

AbbeVie - $250K to USCC

Aetna - $5.3M to USCC

Allergan - $55K to USCC

Amgen - $302K to USCC

Anthem - $2M to USCC

Celgene - $262.5K to USCC

Cigna - $325K to USCC

CVS - $825K to USCC

Eli Lilly - $350K to USCC

Express Scripts - $150K to USCC

Gilead - $13K to USCC

Johnson & Johnson - $475K to USCC

Merck - $4.4M to USCC

Mylan - $210K to USCC

Procter & Gamble - $500K to USCC

UnitedHealth - $252K to USCC

Zimmer Biomet - $75K to USCC

Where Does the Money Go?

As is evident above, health care companies donated to a limited number of the big 15 dark money organizations, the American Action Network, Americans for Tax Reform, Patriot Majority USA, but mostly the US Chamber of Commerce.

The first two organizations were all identified by Issue One as affiliated with right-wing / Republican/ pro-Trump causes.

American Action Network

the American Action Network was not publicly rolled out by high-profile Republicans until February 2010 — one month after the U.S. Supreme Court’s Citizens United decision.
The self-described 'action tank' was founded by veteran Republican fundraiser Fred Malek, the former Marriott Hotels president and CEO who has helped raise campaign cash for a number of GOP presidential candidates over the years.

Former Republican Sen. Norm Coleman of Minnesota served as the American Action Network’s first CEO and is still the chairman of the organization’s board of directors.

Brian Walsh — the former political director for the National Republican Congressional Committee who helped Republicans win control of the U.S. House of Representatives in 2010 — served as the president of the American Action Network between 2011 and 2015.

The group’s current executive director is Corry Bliss, who managed Ohio Republican Sen. Rob Portman’s successful re-election campaign in 2016.  


Americans for Tax Reform

Originally founded in July 1985 to promote President Ronald Reagan’s proposal for tax reform, Americans for Tax Reform remains a powerful lobbying organization today that also frequently spends money in elections to aid Republican candidates. The group’s founder and president is Grover Norquist, a conservative activist who once boasted that his goal was to get government 'down to the size where we can drown it in the bathtub.'

In 1994, Norquist was one of the co-authors of the 'Contract with America,' the campaign platform that helped the GOP win control of the U.S. House of Representatives for the first time in more than forty years and helped elevate Rep. Newt Gingrich (R-GA), another co-author, to the position of Speaker of the House.

Americans for Tax Reform’s primary advocacy tool is its 'Taxpayer Protection Pledge,' which asks politicians at the local, state and national level to “make a written commitment to oppose any and all tax increases.”

The third group, to which only one donor gave only $5K, was identified with Democratic / left-wing causes.

Patriot Majority USA

Patriot Majority USA, a 501(c)(4) 'social welfare' organization that often spends money in elections to aid Democratic candidates, was founded in March 2011 by political consultant Craig Varoga, a Democrat with strong ties to former Senate Majority Leader Harry Reid (D-NV). To wit: Varoga led an independent group that helped Reid win his contentious re-election race in 2010.

The fourth organization, the one to which most of the health care corporate donors gave the most money, is in a class of its own.  The Issue One description of it was

US Chamber of Commerce

the U.S. Chamber of Commerce ranks as one of the nation’s largest and most powerful lobbying groups, with an ornate headquarters in Washington, D.C., just a block from the White House.

A trade association organized under Section 501(c)(6) of the tax code, the U.S. Chamber of Commerce mostly endorses Republican candidates, although it occasionally supports business-friendly Democrats. The group says it represents more than 3 million businesses across the country and has a membership of approximately 300,000.

The USCC has received much - probably unwanted - publicity about its efforts to help President Trump's controversial nomination of Brett Kavanaugh to the Supreme Court.  An October 4, 2018, article in the Intercept included:

Business groups with interests before the U.S. Supreme Court have orchestrated a multifaceted campaign to pressure the Senate to swiftly confirm Judge Brett Kavanaugh to the nation’s highest court. The advocacy reaches across the influence economy of Washington, D.C., with the largest corporate lobbying groups and billionaires working in concert with Republican operatives to elevate Kavanaugh to a lifetime posting atop the judiciary.

Few businesses, however, have stamped their names on the effort. Most major corporations and wealthy donors are instead using 501(c) nonprofit groups that do not require donor transparency to air upward of $15 million in reported advertising spending in order to convince the public to support Kavanaugh’s nomination. Other conservative groups contributing to the ad war have not disclosed how much they are spending, likely bringing the total much higher.

Among the groups publicly campaigning for Kavanaugh to be confirmed are the giants of pro-business lobbying — organizations like the U.S. Chamber of Commerce and the Koch brothers-funded Americans for Prosperity. Lesser-known, business-funded political groups, such as the Republican Attorneys General Association, are also spearheading campaigns.

The article also said this specifically about the US Chamber of Commerce

The powerful lobby announced in August that it would mobilize support for Kavanaugh, claiming it would score support for Kavanaugh as a 'key vote' in evaluating members of Congress. The Chamber spends tens of millions of dollars every election cycle against lawmakers who cross them on major votes.

One wonders whether patients or health care professionals who must deal with large health care corporations have any idea that these companies are promoting partisian causes, mostly right-wing/ Republican/ pro-Trump causes?  One wonders whether the employees and small stockholders of these corporations likewise have any idea about this?

Summary and Discussion

This is now the fourth time we have discussed the role of dark money in health care.  In 2012 we discussed a case of "dark money" being used to conceal sources of support for particular health policy and political positions.  Earlier 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." (Note that these CVS dark money contributions were separate from those discussed above.)  Ten days ago we discussed how the pharmaceutical trade organization, PhRMA, and some large drug companies donated money to a dark money organization to combat a state initiative to limit pharmaceutical prices, but also to the American Action Network (see above) to "repeal and replace" the Affordable Care Act (ACA, "Obamacare") despite their previous support for and then current neutrality on the ACA.

Now it appears that health care corporations often donate large amounts to dark money organizations, and as best as we can tell now, nearly all the donations and all the money go to organizations that support right-wing/ Republican/ and now pro-Trump causes.  Many of these causes seem to openly conflict with the corporations' promises of social responsibility.  The slanting of these efforts towards one end of the political spectrum, one party, and now the current president suggest that these corporations may have partisan agendas.

Note that without the various ongoing investigative efforts mainly inspired by the actions of the Trump administration, we would have little idea that this was going on.

I hope that such investigations continue.

Furthermore, the increasing knowledge of these corporate actions raises a big question: cui bono? who benefits?

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

It is not obvious why it would want to consistenly support actions by one party, or by people at one end of the political spectrum.

The obvious hypothesis is that these donations, 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.

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. 

===

Musical interlude: "On the Dark Side," Eddie and the Cruisers




Friday, October 05, 2018

New York Times Remembers Dr Bernard Carroll, the "Conscience of Psychiatry"

We at Health Care Renewal miss Dr Bernard Carroll, who we were proud to count among our bloggers.



The New York Times just published a kind obituary, which called him "the conscience of psychiatry."

It opened:

Dr. Bernard J. Carroll, whose studies of severe depression gave psychiatry the closest thing it has to a 'blood test' for a mental disorder, and who later became one of the field’s most relentless critics, helping to expose pervasive corruption in academic research, died on Sept. 10 at his home in Carmel, Calif. He was 77.

It described how he started his "second career":

He and a lifelong friend, Dr. Robert Rubin, a professor of psychiatry at the University of California, Los Angeles, dissected psychiatric studies as they appeared, flagging sloppy work and sniffing out conflicts of interest. They then broadcast their findings to former colleagues and allies through various email lists, often taking their findings to the news media.

'He never stopped; he was up at all hours,' said Dr. Allen Frances, a former Duke colleague. 'I mean, I’m an early riser. I’d get up and there’d be a bunch of emails from Barney.'

In the 2000s, Dr. Carroll and Dr. Rubin worked with Paul Thacker, then a staffer for Senator Charles Grassley of Iowa, to help expose huge undeclared payments to top academic researchers at Harvard, Emory University and other institutions. He knew very well how this world operates; he had consulted widely with drug makers himself.

Dr. Carroll concluded that the psychiatric drug literature had become so polluted as to be virtually meaningless; he called most drug trials “infomercials.”

'We weren’t after anyone, nor did we care how much money people were making — we were concerned about how corrupt the science had become,' Dr. Rubin said in a phone interview. 'The tragedy in all this was that the corrupt science was affecting countless people’s lives.'

Dr. Carroll’s work ethic and vast connections helped convert many younger researchers to his cause; they now view the published psychiatric science with his skeptical eye.

'He was the conscience of psychiatry,' Dr. Frances said, 'and he spawned a generation of future consciences along the way.'

Also

He worked until the end, Sylvia Carroll said, finishing a last paper and, as ever, expanding his electronic presence. His email lists were active; he had started tweeting (he was terrible at it, Dr. Frances said); and he contributed to various blogs, including Margaret Soltan’s 'University Diaries,' for which he sometimes wrote limericks under the name Adam, like this one:

And then we have just across campus

The medical guys playing scampers.

They’ve learned to beguile,

To increase their cash pile

Once grant funds are safe in their clampers.

— Adam.

Dr Carroll was  was with us at Health Care Renewal since 2005, contributing insightful, pithy, provocative and important posts.  He also authored some of our most widely read posts.  Most viewed was: JAMA Jumps the Shark.   His most recent post was Corruption of Clinical Trials Report: A Proposal.   All his posts can be found here. We all miss him.


Sunday, September 30, 2018

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.

Thursday, September 20, 2018

The Mystery of the Ownership of the Trinity School of Medicine

Trinity School of Medicine Vice President Boasts that It Is "Not the Same" As Most Offshore Medical Schools

A post promoting the Trinity School of Medicine just appeared on the KevinMD blog. It was entitled "Addressing the 'ugly truth' about Caribbean medical schools: Why they’re not all the same." Its purpose seemed to be to persuade the reader in particular that the Trinity School of Medicine, (located conveniently in St Vincent and the Grenadines, "high on a hillside in the Ratho Mill district of Kingstown, the capital of St. Vincent and the Grenadines," conveniently near the Young Island Resort and "Living the Dream" sailboat cruises, per Google) is not the same as, and in fact is superior to other offshore medical schools.

In particular, Stacy Meyer, Vice President for Enrollment, asserted that the school would address the problem of huge attrition rates at offshore schools by embracing "a principle of mutual support," seek out faculty who would actually spend time with students, and would actually have "office hours," and provide tutoring and an "Academic Progress Committee." She promised to provide good housing with "privacy, a full kitchen, air conditioning and high speed internet."  She stated that the school would deal with the stress of medical training by providing "on-campus access to professional help and a culture of openness." She concluded with "better support, better quality of life for the students?  It will only mean better doctors."

It sounds nice, but her post was remarkable for what it left out.  Does that extras "support" translate into an attrition rate lower that other comparable schools?  Is there any data that the doctors produced are "better?" What about the school's curriculum, the quality of its faculty, and the accountability of its leadership?


In fact, review of the school's website provides little hard information.  While the school aims to attract US and Canadian students, I could not find a single member of its regular faculty who has a medical degree from a US or Canadian school.  Its faculty is tiny, 22 regular faculty members plus 3 deans and a chancellor, much smaller than the faculty of a conventional US or Canadian school.  Information about its curriculum is fragmentary.  The school claims an 85% match rate, but provides no information about attrition, and hence the denominator for that rate.

What Is Trinity School of Medicine?  Who Runs It?  Who Benefits From It?

Even more curious, I could find very little information, and that which I found was rather contradictory, about who actually is accountable for the operations of Trinith School of Medicine, and who, if anyone, owns it.

The school's website, including its "about" page, say nothing about the nature of its organization, basically whether it is a for-profit company, or not for profit organization. Wikipedia simply says the school is "private."  Although the school is located in St Vincent and the Grenadines, its website lists its address as 925 Woodstock Road, Suite 200, Roswell, GA 30075.  On the other hand, the Manta database says the school is located in Alpharetta, GA, and is a "single location business" with 10 employees.

The school's website"administration" page has a headline next to a picture of Steven R Wilson stating he is "CEO and President."  However, accompanying text states that he is the president and CEO of "Trinity LLC."  I can find no further explanation on the website of "Trinity LLC."  (Note that the website has no search function.)

There is a Hoover's profile on a Trinity LLC located in Atlanta GA, listed as a private company, but it appears to be a "site preparation contractor." 

Mr Wilson apparently is a businessman who

served as President and CEO of several highly regarded institutions over the past 22 years. Prior to Trinity School of Medicine, Mr. Wilson was President of TSYS Loyalty, Inc., a wholly owned subsidiary of TSYS, TSS on the NY stock exchange from 2003 until 2006 when he left to pursue the start-up of Trinity School of Medicine. Prior to TSYS, Mr. Wilson was President and CEO of Enhancement Services Corporation from 1998 to 2003, an institution that provided loyalty transaction processing and fulfillment services to the world's largest financial institutions. Mr. Wilson was also the President and CEO of Business Travel, Inc. from 1986 to 1997.

Although his background seems to have no relevance to biomedical science, medicine, or health care, his official profile states

Mr. Wilson's background and experience are a vital element in Trinity's success as it endeavors to become one of the finest Caribbean medical schools available to students from North America and around the globe.

The Trinity website includes a listing of the members of its "board of trustees." Non-profit institutions generally have boards of trustees whose role is be stewards of the organizations.  However, Trinity appears to be a privately held business.  Such businesses may have "boards of directors," but the power of such boards in closely held private businesses may be negligible. 

The website does not explain the actual relationship of the "board of trustees" to the school. The board has only four members, one of whom is a physician, and three of whom are business people.  There qualifications to be stewards of a medical school, if that in fact is their role, are not evident.

So what exactly is the Trinity School of Medicine?  Who is accountable for how it operates? Who, if anyone,exterts stewardship over it?  Who benefits from its operation?  Given its opacities, is it a shell company?  These are all mysteries.

We need Sherlock Holmes.



Why Should We Care?

As we have said a few times before, most recently here, this is not just about the leadership, governance and ownership of the Trinity School of Medicine.  It is about off-shore medical schools, and ultimately about the leadership and governance of health care in the US.

As we most recently noted here,

Admission to US medical schools is increasingly difficult.  So many who seek medical careers may be tempted to apply to schools outside the US.  In the last 30 years, American entrepreneurs have opened offshore medical schools, mostly in the Caribbean, that cater to US students.  They teach in English, and do not require immersion in an unfamiliar culture, so may be more attractive than medical schools in other countries whose mission is to educate physicians to practice in those countries. In 2010, Eckhert documented that the number of offshore medical schools, "for-profit institutions whose purpose is to train U.S. and Canadian students who intend to return home to practice," but not to train physicians to practice in the countries in which these schools are located, was rapidly growing.(1)  By 2010, there were 33 such schools, 20 of which were new since 2000.

Such offshore medical schools exist in a grey area.  The small countries or colonies in which they are located usually do not seek to regulate them, since the physicians they produce are going to practice elsewhere. There is no requirement that these offshore medical schools be accredited in the US.  Such  accreditation is currently not required for individual graduates of such schools to be admitted to US house-staff programs or for US licensure.  So perhaps it is not surprising that little is known about these schools.

How they choose students, the qualifications or even names of their faculty, their curriculum, how they supervise clinical training (which is mostly done by affiliated North American hospitals), and what happens to their graduates are obscure.  Eckhert attempted to describe what is known, but noted "variability exists in the availability of information on faculty; where data exists, it is noted that most of the permanent on-site basic science faculty are internationally trained, many have no documented medical education experience in the United States, and it is not uncommon for them to be OMS [offshore medical school] alumni."

As we also noted, most recently here,

 Even less is known about who leads these schools, who if anyone is responsible for their stewardship, and even who owns them.

For comparison, most US schools provide extensive information about their leadership.  Just as an example, see the introductory page on the Dean of the University Washington medical school.

Many US medical schools have their own boards of trustees who are supposed to provide stewardship. For example, the UW board is here.  Their membership is generally known.  Furthermore, most US medical schools report to university leadership, again whose identity is known, and are subject to governance by a university board of trustees.  We have certainly criticized the leadership and governance of US academic medicine.  At least, however, it is possible to find out the names of the people responsible.

While Eckhert wrote in 2010 that the increasing presence of offshore medical graduates in the US "obligates U.S. medicine to take a closer look at these educational programs," no such scrutiny has occurred since then.  While offshore medical schools account for the training of an increasing proportion of US (and presumably Canadian) physicians, we know next to nothing about their leadership and governance.  This seems to be just another part of the decreasing accountability of the leadership of US health care, and the increasing opacity of the governance and stewardship of US health care organizations.  True US health care reform would make leadership transparent and accountable.

This case also illustrates why we must reexamine our fascination for "market based" approaches to health care, when almost nothing about any part of health care resembles, or could resemble a free market (see this post).  We need to make health care more transparent, and shine more sunshine on the nooks and crannies, like off-shore but US corporate owned medical schools. 

Finally, as an aside, in this day and age, the possibility that Trinity School of Medicine is actually owned by an anonymous LLC is particularly alarming.  Such anonymous shell companies have been implicated in global corruption.  Transparency International says this about shell companies

A shell company or corporation is a limited liability entity having no physical presence in their jurisdiction, no employees and no commercial activity. It is usually formed in a tax haven or secrecy jurisdiction and its main or sole purpose is to insulate the real beneficial owner from taxes, disclosure or both.

We really need Sherlock Holmes.

Friday, September 14, 2018

Remembering Dr Bernard Carroll



Dr Bernard Carroll passed away on September 10, 2018.  Dr Carroll had a distinguished career, so it was a surprise and delight that he also chose to be a stalwart Health Care Renewal blogger.  He was with us since 2005, contributing insightful, pithy, provocative and important posts.  He also authored some of our most widely read posts.  Most viewed was: JAMA Jumps the Shark.   His most recent post was Corruption of Clinical Trials Report: A Proposal.   All his posts can be found here.


His obituary just appeared in the British Medical Journal. It began

A pioneer in biological psychiatry, more recently Bernard Carroll (‘‘Barney’’) became a withering critic of its compromised ethics and corruption by industry.

He was a scientific skeptic

A rigorous scientific sceptic, even about his own work, he refrained from claiming that the DST explained the aetiology of melancholia. He was critical of ill informed challenges to its clinical uses but opposed exaggerated claims for its role as a screening test.

He was a renowned teacher, mentor, and academic leader

Barney was a great clinical teacher and mentor, who never hesitated to say: 'I don’t know the answer to that—let’s look into it.' No one had a better command of the scientific literature or was better able to translate it to the complex exigencies of clinical practice. By his quiet example, Barney influenced hundreds of psychiatrists, psychologists, social workers, and nurses, as well as basic neuroscientists, to become better clinicians, researchers, and educators. He was rigorous and demanding, but in the most nurturing and affable way.

In 1983 Barney accepted the chair of psychiatry at Duke University. He turned a respected department of psychiatry into a great one—recruiting new faculty members, increasing external grant support 10-fold (raising it to sixth in the US), improving clinical services, and forging research and residency training partnerships with the public sector. I followed Barney as chair and found it to be one of the easiest jobs in the world. All I had to do was coast on his coat tails.

He was a campaigner for accountability, integrity, transparency, honesty and ethics

During the past 20 years, Barney became a critic of weak science, of ethical lapses, and of industry’s corruption of the research enterprise. He coined the term 'experimercial' to describe clinical trials that were really disguised exercises in marketing. He relentlessly exposed undisclosed conflicts of interest, hidden commercial promotions, inadequate research designs, biased analyses, misleading conclusions, exaggerated claims, and ghost writing.

Barney became the conscience of psychiatry. With the frequent collaboration of Robert Rubin, he outed many high profile academic opinion leaders who had been co-opted by commercial interests.

Barney never flinched in his David and Goliath battle to restore truth and integrity to the psychiatric research enterprise. His exposés comprised ethics critiques as well as aesthetic disapproval of degraded standards and tawdry behaviour.

Barney’s 'right' prevailed against institutional and commercial 'might.' He helped to force the current upgrades of editorial oversight and full disclosure now demanded by Nature Publishing Group, by AMA journals, and most journals. The publicity surrounding Barney’s exposés triggered the conflict of interest inquiries conducted by Charles Grassley, chair of the US Senate Finance Committee, which had a profound impact on recalibrating ethics standards in all medical specialties. As he left us, Barney was encouraged by current trends towards improving transparency and increased integrity.

He persisted

Looking to the future, on the scientific side Barney cautioned against the loss of independent investigators and the diversion of research resources by 'big science' consortiums. On the ethics side, Barney’s main unfinished work is an ongoing petition to Congress to update US Food and Drug Administration oversight of analyses and reporting of clinical trials.

Barney is remembered as a fair and generous colleague, an honest broker in review committees, a generative and avuncular mentor, a constant source of good ideas, a meticulous academic craftsman, and a tireless servant to the field. He did endless pro bono advocacy, editorial and committee work, and served as president of three professional societies. Barney was a great raconteur, a jolly companion, a dedicated writer of limericks, a courtly gentleman, a devoted husband and father, a wonderful friend, and a man for all seasons. He died as he lived—with grace, courage, and fortitude. Barney leaves his wife, Sylvia; a daughter; and a son.

Bernard J Carroll (b 1940; q 1964; MD, PhD), died from cancer on 10 September 2018

Investigative journalist Paul Thacker provided these memories:

Since Barney retired as Chair of Psychiatry at Duke, he became a very important resource to a small number of reporters and experts trying to understand corruption in medicine. I was just watching the documentary 'Bleeding Edge' about the medical device industry, and one of the devices profiled was the Vagal Nerve Stimulator (VNS). I was watching the documentary thinking, 'God, that VNS crap made it on the market. Barney blew it up in the Wall Street Journal back in 2006.' Barney was critical to a lot of movement in trying to fix things behind the scenes.

A couple years back, I was talking with Barney and asking him why he thought so many people in medicine behaved the way they did, doing things when it was obvious patients were either going to harmed or given some treatment that was likely pointless but expensive. Barney always had a colorful way of explaining these things.

"When you get old, much of what you'll have are memories of what you did, and what you added during your time here. These people won't have s* but f* money. They didn't add a f*ing thing!'

I think Barney added a lot. He was a great guy, who added a whole lot to our understanding of medicine while retired.

 We will all miss him.

Wednesday, September 05, 2018

Fake Reform Foisted on Us by Those who Benefit Most from the Current Dysfunction



Introduction - No Funding for You

To better understand health care dysfunction, I interviewed doctors and health professionals, and published the results in Poses RM.   A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14(2): 123-130. (link here).  In that article, I postulated that US physicians were demoralized because their core values were under threat, and identified five concerns:
1. domination of large organizations which do not honor these core values
2. conflicts between competing interests and demands
3.  perverse incentives
4. ill-informed, incompetent, self-interested, conflicted or even corrupt leadership
5.  attacks on the scientific basis of medicine, including manipulation and suppression of clinical research stuides

After that my colleagues and I have tried to raise awareness of these and related issues, now mainly through the Health Care Renewal blog.  We also set up FIRM - the Foundation for Integrity and Responsibility in Medicine,  a US non-profit organization, to try to provide some financial support for the blog.

Since we were mostly health care academics, we assumed we could get some financial support for the blog and FIRM from foundations with interests in improving health care.  Had we not identified important causes of health care dysfunction that had been largely anechoic, but once identified could be addressed, thus presumably improving health care costs, quality, and access?  It seemed reasonable at the time.

However, we failed to find any prominent foundations willing to help.  We have occasionally gotten small amounts of money from a few small foundations, but not recently.  Meanwhile we have not seen any major health care foundations supporting any iniatives by anybody meant to address any of the issues we discuss on Health Care Renewal.  In particular, while outright health care corruption seems one of the most outrageous issues we discuss, we have never found a foundation willing to take that on - at all.

 We should not have been surprised.  We later discovered that the leaders of many health care foundations had conflicts of interests which likely decreased their enthusiasm for even considering issues such as ... conflicts of interest and their risk of generating health care corruption.  (See below for further discussion.)  Recently, however, we have found some enlightenment on how such foundations, and other change agents and do gooders working the health care sphere, have managed to ignore such important problems

Why Expect Those Who Profit from Current Dysfunction to Lead Real Reform?


Last week, the New York Times published an essay by Anand Giridharadas, author of  the just published Winner Take All: Elite Charade of Changing the World.  The author's thesis was that society has handed over the responsibility for reform to those who benefit most from the status quo.

'Change the world' has long been the cry of the oppressed. But in recent years world-changing has been co-opted by the rich and the powerful.

He posited,

America might not be in the fix it’s in had we not fallen for the kind of change these winners have been selling: fake change.

Fake change isn’t evil; it’s milquetoast. It is change the powerful can tolerate. It’s the shoes or socks or tote bag you bought which promised to change the world. It’s that one awesome charter school — not equally funded public schools for all.

He suggested that the very wealthy seduce us with their dedication to change, even while sponsoring

world-changing initiatives funded by the winners of market capitalism do heal the sick, enrich the poor and save lives. But even as they give back, American elites generally seek to maintain the system that causes many of the problems they try to fix — and their helpfulness is part of how they pull it off. Thus their do-gooding is an accomplice to greater, if more invisible, harm.

What their 'change' leaves undisturbed is our winners-take-all economy, which siphons the gains from progress upward.

They have

a strong interest in convincing the public that they can help out within the system that so benefits the winners.

After all, if the Harvard Business School professor Michael E. Porter and his co-author Mark R. Kramer are right that 'businesses acting as business, not as charitable donors, are the most powerful force for addressing the pressing issues we face,' we shouldn’t rein in business, should we?

This is how the winners benefit from their own kindness: It lets them redefine change, and defang it.

In a 2017 essay in Medium which previewed the ideas that would appear in the book, Giridharadas had summarized the problem thus

change-makers [focus] on the difference they make to those they choose to help. Yet they risk avoiding the causes of the disease and remedies that would actually cure it. And they avoid these things in part because facing them could implicate powerful people, or perhaps even themselves.
This is a powerful idea.  As a society, at least in the US, we have abandoned true reform, including reform of health care, for faux reform controlled by those who would lose the most were true reform to take place instead.  We have handed the problem of excessive drug prices over to the executives of pharmaceutical companies who benefit most from currently outrageous pricing.  We have handed the problem of a dysfunctional health care insurance system over to executives of insurance companies who benefit most from high cost commercial insurance plans that cover as little as possible.  We have allowed corporations accused of unethical and criminal practices to make lax legal settlements that pretend they will be able to improve themselves without penalties accruing to the managers on whose watch the bad behavior occurred.  And we have let health care foundations led by top health care corporate managers and their cronies to sell change that matters. 

Broadening Understanding of the Conflicts of Interest Affecting Leadership of Health Care Foundations

Gridharadas has given us a broader view that explains why many big foundations fail to fulfill their glorious mission statements.

Example: the Robert Wood Johnson Foundation

For example, the Robert Wood Johnson Foundation boasts,

The inspired vision of our founder, General Robert Wood Johnson II, was to improve health and health care in America, especially for those most in need. Energized by our legacy of taking on challenging issues, we are dedicated to building a Culture of Health that provides everyone in America a fair and just opportunity for health and well-being.

Has the foundation ever really addressed ill-informed, incompetent, self-interested, conflicted or even corrupt health care leadership, or attacks on the scientific basis of medicine, including manipulation and suppression of clinical research studies?

Should we expect anything more - or less - from a foundation whose current 15 person board of trustees is chaired by:
- a retired corporate vice president and general counsel of Johnson & Johnson

and which otherwise includes:

- a retired corporate compliance officer and vice president, Technical Resources, of Johnson & Johnson

-   a surgeon who was  founder of the for-profit Columbia/ HCA, now HCA hospital system

- a retired vice president of government affairs and policy responsible for federal, state, and international relations for Johnson & Johnson.

- a retired vice president, chief information officer, and a member of and the first woman to serve on the Johnson & Johnson Executive Committee.

- and another retired retired corporate vice president of Johnson & Johnson

Example: the Bill and Melinda Gates Foundation

The Gates Foundation boasts

We see equal value in all lives. And so we are dedicated to improving the quality of life for individuals around the world.

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

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

Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.
Has the Gates Foundation ever addressed health care corruption and the conflicts of interest that are risk factors for corruption?  Should we expect more, or less from foundation that is now run by a multi-millionaire former pharaceutical executive as foundation CEO?

As we noted here, Dr Susan-Desmond Hellmann, the CEO of the Gates Foundation was previously President of Drug Development at Genentech, Dr Desmond-Hellmann had defended the then sky high pricing of bevacizumab.  Of course, Dr Desmond-Hellmann, as a top executive, personally profited from such pricing.  In her last year at Genentech while the company was still independent, her total compensation was over $8,000,000.  As we discussed in 2014, while she was the Chancellor of UCSF, questions arose about her committment to public health when it was revealed she and her husband had large stock holdings in the tobacco company Altria.  Yet she continued to dismiss the importance of her many apparent conflicts of interest.And there have been many accusations that the foundation she runs is more about promoting corporate interests in health care than actually promoting health, see the 2016 Global Policy Forum report per this Guardian article, this article in the Independent that accused the foundation of having a

ideological commitment to promote neoliberal economic policies and corporate globalisation

and  a PLoS Medicine article [Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020.  doi:10.1371/journal.pmed.1001020.  Link here. ]

'There is a revolving door between the Gates foundation and pharmaceutical corporations. Many of the foundation’s staff had held positions at pharmaceutical companies,' the report adds.
For more details about Dr Desmond-Hellmann, look here.  

As we noted, in 2012,  the Global Fund to Fight AIDS, Tuberculosis, and Malaria as struggled with corruption issues, but even after these wake up calls, the Gates Foundation, one of its major donors, has done nothing to address corruption beyond its doors.  Likewise, while the Health Alliance International  has also struggled with corruption, the Doris Duke Foundation has shown no interest in health corruption initiativies (look here).

Other Foundations

As we noted in 2011, uninterested in health care conflicts of interest and corruption are the Ford, Rockefeller, Kellogg and Robert Wood Johnson Foundation which were noted to have significant holdings in Coca-Cola, Kellogg, PepsiCo, Pfizer, GlaxoSmithKline, McDonalds, Nestle, NovoNordisk, YumBrands, Pizza Hut, KFC, Johnson & Johnson, and Sanofi-Aventis, while the Ford Foundation held shares in a tobacco company, Lorillard, and the Kellogg and Rockefeller Foundations "were indirectly invested in tobacco corporations through conglomerate equity funds...."

So health care interested foundations, which may derive financial benefit, and may be led or governed by people who mightily benefited from the dysfunctional health care status quo, are likely to continue fake reform to appear socially responsible, but avoid challenging their and their cronies sources of wealth.

Conclusion

Giridharadas suggested in an interview in New York Magazine,

What all that does is create this moral glow. And under the haze created by that glow, they’re able to create a probable monopoly that has harmed the most sacred thing in America, which is our electoral process, while gutting the other most sacred thing in America, our free press. And they do it under the cover of changing the world.

Unfortunately, he apparently has not come up with what to do about this problem.  The best conclusion I can reach derives from the end of a review of his book by Joseph Stiglitz in the New York Times,

Democracy and high levels of inequality of the kind that have come to characterize the United States are simply incompatible. Very rich people will always use money to maintain their political and economic power. But now we have another group: the unwitting enablers. Despite believing they are working for a better world, they are at most chipping away at the margins, making slight course corrections, while the system goes on as it is, uninterrupted.

So I say first, beware of fake reform pitched by those who benefit most from the current dysfunction, call it out, and whatever you do, do not continue enabling it.