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.


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.


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 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.


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.


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.

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.


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.

Monday, September 03, 2018

Michael Fine's Health Care Revolt

Michael Fine, M.D., HealthCare Revolt: How to Organize, Build a Health Care System, and Resuscitate Democracy – All at the Same Time (Oakland, CA: PM Press, 2018).

Dr. Michael Fine is a man on fire. He’s on fire with anger about a healthcare marketplace that serves well to maximize the profits of investors and CEOs, but violates the values of many of those working in it. He’s on fire with enthusiasm about the potential of public health and prevention and about the value of integrated primary care. He’s on fire with determination to work to change our scattered health care marketplace into an actual health care system that could monitor and manage every citizen’s health. And he has concrete suggestions and a vision of how to work toward that end.

And, from what’s recounted here, Dr. Fine has an admirable practical record of implementing health care change on a local level in Rhode Island and in the Scituate area. In Scituate, he organized the non-profit Scituate Health Alliance and worked with residents and local officials to provide primary medical and dental care to all town residents. He envisions small local health care systems like his serving as a model that will show the feasibility of a better health system to both conservatives and liberals and eventually enable scaling up to a better national system. (This is quite reminiscent to me of how the great Nye Bevan, in the middle of the last century, successfully used the model of the Tredegar Medical Aid Society  and similar organizations to plan the NHS at its inception.)
What I liked best about the book is that Dr. Fine has an accurate gut understanding of just how much money we do spend on healthcare and of how harmful it is that we have let the “healthcare” sector balloon to such a large part of our economy. He realizes too how much of this - including many foolish things - is supported by public tax monies. And he really gets that this comes at a huge cost to the other things we could be spending that money on – and spending it on other things instead that are just as important to health would enhance people’s health, not diminish it. As he said in a related interview: “[To improve health,] we need to spend money on education … housing … community development … the environment. These …matter most for health. The paradox is that the more we spend on medical service expenditures that we don’t need, the less we spend on those things. In a certain way, healthcare is at war with health.”

I love Dr. Fine’s suggestion that one of the things we need to do to move toward healthcare improvement is to constantly highlight these costs and the damage done. Once we get to where everyone really understands this, we will have moved a big step forward. Working hard to publicize and delegitimize the cruelly extractive techniques of health care profiteers is worthwhile.

There’s all the difference in the world between making a living, including an excellent living, from people’s medical needs and making a killing from them – and in recent years the balance has shifted where we can fairly say that pharmaceutical companies, large hospital organizations, and many other medical sector big players are doing the latter.  I also like how he points out that “with …few exceptions, no health care market actor has a public portfolio (p. 84).” He’s right, and the corrupt marketplace – what Dr. Fine terms a “wealth extraction system” – has not gotten us to a good place for the public – at all.

So, in some ways, this book is inspiring – but in other ways, it is quite irritating. Dr. Fine is so wrapped up in his own perspective that he often is blind to and discounts the value of those parts of medicine that have not been his personal focus. Although I certainly agree with him that there are too many specialists and too much medical overuse, Dr. Fine seems insultingly unappreciative of valuable, needed services that specialists also offer, suggesting that one of the main ways generalists help their patients is by keeping them out of the clutches of specialists who may injure them. He seems, too, to class highly-paid specialists with high earners like CEOs where in my opinion this is ridiculous (specialists are after all basically pieceworkers and are not really similar to administrators, investors, and pharmaceutical executives – even if you think – and I do - they could rightly earn a bit less). Similarly, although I agree with him that the incorporation of a profiteering infrastructure into Obamacare and its lack of universality diminished its value, it’s unseeing to contend that it helped only a few people and that hardly counted. Dr. Fine grudgingly concedes that he likes that Obamacare funded more preventive services, ignoring the far more important benefits it provided to some of those MOST in need of medical care, those with clinical problems and issues. Dr. Fine should talk to some of the people who literally moved to Medicaid expansion states to save their lives first, before minimizing Obamacare’s benefits.

And, Dr. Fine doesn’t seem to have a grip on how unappealing many of us would find the world he dreams of. “Let’s close all center cities to private cars during normal working hours; let’s find ways to provide incentives for people who are not disabled to use the stairs rather than elevators (p. 71).”  He also suggests heavily taxing industrial food products, as well as the production of wheat, corn and sugar (p.70), oddly suggesting that we don’t need any of these crops any more for human consumption (which is news to me). Many readers, unlike Dr Fine, would have less than zero enthusiasm for living under such a heavy-handed, dictatorial regime and would (I believe fairly) consider some of their freedom lost.

As I read this book, I couldn’t help but compare it to a book by another strong advocate of more primary care, Richard Young’s American Health$care: How the healthcare industry’s scare tactics have screwed up our economy – and our future. Dr. Young is the single other person I can recall being as angry and as perceptive as Dr. Fine about the damage done from monies that could and should be spent on other things for more benefit – including health benefit – but which instead are being sucked away by what he calls the “government-medical-industrial coalition.”

Both really believe in primary care. But Dr. Young also realizes, as Dr. Fine does not, that “prevention” – just as truly as medical care for the sick - has many limits and can itself be a waste of money and inordinately expensive. (His discussion of what costs vs. benefits would be of an imaginary Texas tetanus initiative is sound.) And to Dr. Young, the primary purpose of medical care is care for the SICK.  (No matter how much prevention we have, at some point sickness or injury will happen to all - and this is the crux of medicine.) I recommend reading these two books together, to understand how two capable, decent, intelligent, and sincere doctors can have so much agreement on some things and such intense lack of agreement on others.

I know one thing – if I had to choose one as my primary care doctor, I’d be very comfortable choosing Dr. Young and would absolutely avoid Dr. Fine. Clearly, Dr. Fine would have his own agenda for me (he sees primary care doctors as mostly health nags), but Dr. Young, by contrast, would be responsive to what matters to me and my agenda, so we would be able to work together to manage any ailments in a “minimally disruptive” way that would be actually helpful. And although I personally agree with Dr. Fine’s desire to have more publicly-run, genuinely non-profit healthcare such as community health centers (and ultimately nationalized health care) and to legally rein in health profiteers, there are some definite “stoppers” for me in buying off on his whole vision and signing up to his plan.

Fine’s insensitivity and rigidity in some areas and his impersonality is the reason that if I’m going to introduce a friend to the concept of health care revolt I’ll give them instead Victor Montori’s book: Why We Revolt: A patient revolution for careful and kind care. Dr. Montori’s down-to-earth compassion for the ill inspires more trust, and, like Dr. Fine, Dr Montori too insists on the role of patient as citizen in reforming health care to a system more consonant with patient and physician values, but in a more persuasive way that is more convincing in making me like his healthcare vision.

Sunday, September 02, 2018

Apologizing for Problems with Commenting

My apologies!

I discovered a few days ago that our Google overlords had stopped notifying me about pending comments some months ago.  No indicator of the number of pending comments appears on my Blogger dashboard. 

I just realized I had a large backlog of pending comments, most of which were spam, but some of which were not.  I just posted all those that were not obvious spam.  I am now getting notified of new comments again, so I hope that your submitted comments going forward will not be unduly delayed. 

Sorry again

EHR evidentiary mayhem

A short post.

I am encountering, in my legal work, electronic medical records systems that either allow ex post facto note alterations by clinicians - for example, after a catastrophe - and/or alteration of the apparent date/time a note was entered. The alterations (e.g., a version history) or fake times don't appear on the printed records, and usually are not in the audit trails as well.

Some of the systems don't even bother saving prior versions of edited notes, AND/OR defense attorneys make production of the the note version history and actual times of entry very difficult to obtain, AND/OR judges do not understand the issues and are not compelling the release of note edits and time-of-entry data.

Even *Facebook* retains edits of postings that you can view!

In the paper record world, the edits were inseparable from the records. Cross outs, comments over carat marks, erasures, ink color differences, spacing, etc. made them obvious. Attempts to conceal the edits in the paper world, if attempted, would have constituted evidence tampering and would have caused penalties and/or lost cases.

Electronic medical records are not entirely the patient's friend when mishaps occur, because of the evidentiary mayhem they can create.

This is another unintended consequence of the rush to EHR's in an unregulated industry.  As those in the field of Social Informatics long observed (see, for example Kling, Crawford, Rosenbaum, Sawyer, Weisband (2000). "Learning from Social Informatics: Information and Communication Technologies in Human Contexts" here), adoption of any new ICT - Information & Communications technology - will always create winners and losers [1].  (The citations refer to organizational "politics" as well as the governmental variety.)

In this case, unscrupulous clinicians and lawyers and the winners, and patients are the losers.

-- SS

[1] "It is common for ICTs to have systematic political repercussions with winners and losers"” (Danziger, Dutton, Kling & Kraemer, 1982; Markus 1981, 1983):

Danziger, James N., William H. Dutton, Rob Kling, and Kenneth L. Kraemer. Computers and Politics: High Technology in American Local Governments. New York: Columbia University Press, 1982.

Markus, M. Lynne 1981. Implementation Politics: Top Managment Support and User Involvement. Systems, Objectives, Solutions 1(4) (November): 203-215. 

Markus, M. L. 1983. Power, Politics, and MIS Implementation, Communications of the ACM, 26, 6 (June): 430-444.