How to Reduce the Conflicts of Interests in Health Care in a Country Whose Leader Has Flagrant, Unconstitutional Conflicts of Interest?

Introduction: Conflicts of Interest in Health Care


Our first post about conflicts of interest appeared on December 22, 2004, and was about "senior NIH scientists [who] were collecting hundreds of thousands of dollars in consulting fees and stock from industry."  We were not the first to be concerned about the problems resulting from financial relationships among health care professionals, academic health care institutions, and other health care non-profits on one hand, and the commercial health care industry on the other.

In 2009, the US Institute of Medicine, now part of the National Academy of Medicine published a report entitled "Conflict of Interest in Medical Research, Education, and Practice" which included specific recommendations for reducing them.  Unfortunately, despite the prestige of the then IOM, the report seemed to vanish without much of a trace (look here)

A report from the IOM which recommended decreasing conflicts of interest affecting the production of clinical practice guidelines was similarly anechoic (look here and here). Egregious examples of conflicts of interest in medicine and health care continue to appear in the media. For example, per a Dec 6, 2019, ProPublica article, a newly disclosed US government database listed 8000 that shows that  disclosed "8,000 'significant' financial conflicts of interest worth at least $188 million since 2012" affecting researchers funded by the National Institutes of Health.  Moreover, the conflicts disclosed in such databases or discussed in the media may just be the tip of the iceberg.

It should be no surprise that conflicts of interest remain prevalent despite various reform efforts.  Such conflicts benefit the parties involved inthem but harms to other people may not be obvious.  Consider, for example, a pharmaceutical company paying a key opinion leader thousands of dollars to give talks and write articles that might help it market a particular product.  The key opinion leader makes more money.  The pharmaceutical company may sell more product.  Disadvantaged are the patients whose physicians were persuaded by this ploy to prescribe the drug when other drugs or approaches might have benefited those patients more.  But these patients and physicians may never connect their less than optimal outcomes with the conflicts of intereat that enabled their bad results.  Those who do not realize how conflicts of interest hurt them are not likely to campaign against these conflicts.  Howver, those who benefit from the conflicts are likely to resist any efforts to reduce them.

But if at first you don't succeed, try, try again...

The New BMJ Article

In December, 2019, the British Journal of Medicine published "Pathways to independence: towards producing and using trustworthy evidence" (Moynihan R, Bero L, Hill S et al.  BMJ 2019; 367: l6576. Link here.), with authors from eight different countries.  They argued that:

endemic financial entanglement is distorting the production and use of healthcare evidence, causing harm to individuals and waste for health systems. Building on the evidence and practical examples cited below, we propose pathways towards financial independence from industry across healthcare decision making.

The article provided a good quick summary of the reasons that various kinds of conflicts of interest can harm patient care, education, research, and health policy making, and proposed the following:

Research

Governments require independent production of evidence used for healthcare decision making, including the evaluation of new treatments, tests, and technologies

Governments require that public healthcare organisations, including regulatory and health technology assessment agencies, receive no industry funding and that their advisers have no financial relationships with industry

Groups conducting research synthesis, including systematic reviews, ensure reviewers have access to all information on study methods and all relevant study results, including clinical study reports, and are conducted without industry funding and by authors with no financial relationships with companies that could benefit from the outcomes

Education

Professional, advocacy, or academic groups engaged in educational activities for health professionals or the public or advocacy affecting regulatory or policy decisions, move to end reliance on industry funding and end financial relationships between their leadership and industry

National governments work with professional associations and licensing bodies to develop policies that ensure educational activity supported by industry cannot contribute to accreditation of health professionals

Medical journals and their editors move to end reliance on healthcare industry income

Practice

Professional groups, hospitals, health services, and governments prohibit marketing interactions between industry and decision makers, including practising professionals, and actively support development of healthcare information independent of commercial interests

Professionals, policy makers, and the public move to reliance on practice guidelines produced and written by groups that have no financial relationships with industry and that have access to evidence, including research synthesis, free of industry influence

Research funding bodies and academic institutions modify academic metrics and incentives explicitly to reward academic collaboration with public agencies and civil society groups as well as industry

These proposed pathways arise from our analysis of the relevant evidence and examples from around the world. The list is not comprehensive or definitive and is designed to inform intensified debate and development of detailed recommendations.

The authors did not claim their pathways were "comprehensive or definitive," but hoped they would "encourage development of more detailed practical recommendations for change."  Will this new push to challenge prevalent conflicts of interest in medicine and health care make a difference?  On one hand, the international approach could be more successful than the previous Institute of Medicine reports which focused only on the US.  On the other hand, since the IOM reports came out, the reign of conflicts of interest in the US has only gotten worse, especially within the US government.  Yet the new BMJ article depends on government to go down many of the proposed pathways.  

Emoluments from Home and Abroad

Concerns about conflicts of interest affecting the US government date back hundreds of years, but had largely been forgotten.  The actions of the current Trump administration have awakened interest in how the framers of the US Constitution tried to forestall conflicts of interest affecting the executive branch of government.The Constitution includes two clauses that appear to forbid certain specific conflicts of interest.  They had been largely forgotten, and their meaning obscured by their use of now archaic language.

Article I, Section 9 states:

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.

Article II, Section 1 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.

The word "emolument" is now rarely used  However, at the time of the writing of the Constiution its meaning was payment, thing of value, profit, advantage, or gain.  An NPR article described the efforts of one law professor, John Mikhail, a professor at Georgetown Law School, to research the meaning the framers would have understood.  He:

looked at all the known dictionaries between 1604 and 1806 that define emolument -- 40 books in all. He said only three gave definitions in ways favorable to Trump, 'kind of a narrow, even technical meaning, tied to the salary or official duties of an office,' while the other 37 used 'a broader meaning that would encompass sort of the profits of ordinary market transactions.'

Almost all of the dictionaries used the word profit in their definitions. The two other go-to words were advantage and gain.

The Foreign and Domestic Emoluments Clauses As Prohibitions of Conflicts of Interest Involving the US President and Other Government Officials

John Medwed, the WGBH legal analyst, explained the origin of the "foreign emoluments clause," (Article I, Section 9)  this way,

it emerged out of a fear that wealthy Europeans would ply American ambassadors with gifts and somehow curry favor and influence foreign policy. And back in the 1700s, that was a real concern. Benjamin Franklin famously received a diamond encrusted box from the king of France. And that caused titillation all through the upper crust, this concern that the French would dictate our foreign policy. That's what led to the emoluments clause.

So the foreign emoluments clause seems to forbid all officials of the US government from receiving any payments, gifts, or anything else of value from foreign governments. 



In Vox, Ian Milhiser, a senior legal correspondent with extensive legal background, put it this way:

There is a reason the Constitution singles out transactions with foreign governments as forbidden. As Alexander Hamilton explained in the Federalist Papers, 'one of the weak sides of republics, among their numerous advantages, is that they afford too easy an inlet to foreign corruption.' In a monarchy, the chief executive shares an identity with the state, so a king or queen 'has so great a personal interest in the government and in the external glory of the nation, that it is not easy for a foreign power to give him an equivalent for what he would sacrifice by treachery to the state.'

But in a republican state, where leaders serve temporarily and keep their finances separate from that of the nation, 'persons elevated from the mass of the community, by the suffrages of their fellow-citizens, to stations of great pre-eminence and power, may find compensations for betraying their trust.

The framers, in other words, believed that federal officials would be uniquely vulnerable to the corrupting influence of a foreign state. The foreign emoluments clause offers a shield against that corruption — assuming that it is enforced.

So there seems to be a very good argument that the framers of the US Constitution tried very hard to prevent a certain kind of conflicts of interest, those arising from a US government official receiving financial or material benefit from a foreign government.


Similarly, Milhiser succinctly wrote,

the domestic emoluments clause limits the president’s ability to profit off of either the federal government or a state government.

Thus the framers also sought to prevent the President and other officials form self-dealing, and from having conflicts of interest involving state governments.

President Trump's Numerous and Conspicuous Violations of the Emoluments Clauses, that is, Numerous and Flagrant Conflicts of Interest

The emoluments clauses remained largely obscure for over 200 years, probably because they were mostly respected, until the regime of Donald Trump.

We noted, most recently here, several well documented sources listing thousands of examples of Trump and cronies' conflicts of interest and corruption, including many instances about his conflicts of interest that seem to violate the emoluments clauses.

These conflicts largely arise from a historically unprecedented situation.  Trump is the only known president to have maintained ownership of extensive business operations while in office.  Per Wikipedia,

The Trump Organization is a group of about 500 business entities of which Donald Trump is the sole or principal owner. About 250 of these entities use the Trump name. The organization was founded in 1923 by Donald Trump's grandmother, Elizabeth Christ Trump, and father, Fred Trump, as E. Trump & Son. Donald Trump began leading it in 1971, renamed it around 1973, and handed off its leadership to several of his children in 2017.

The Trump Organization, through its various constituent companies and partnerships, has or has had interests in real estate development, investing, brokerage, sales and marketing, and property management. Trump Organization entities own, operate, invest in, and develop residential real estate, hotels, resorts, residential towers, and golf courses in various countries. They also operate or have operated in construction, hospitality, casinos, entertainment, book and magazine publishing, broadcast media, model management, retail, financial services, food and beverages, business education, online travel, commercial and private aviation and beauty pageants. Trump Organization entities also own the New York television production company that produced the reality television franchise The Apprentice. Retail operations include or have included fashion apparel, jewelry and accessories, books, home furnishings, lighting products, bath textiles and accessories, bedding, home fragrance products, small leather goods, vodka, wine, barware, steaks, chocolate bars, and bottled spring water.

Since Trump is the major owner of the Trump Organization, profits made by it largely go to him.  Thus a payment to that organization, less operating costs and whatever interest other owners, essentially his children, have, is a payment to him.

Emoluments from Foreign States

As summarized in the voluminous "Tracking Corruption and Conflicts in the Trump Administration" report section of the Global Anti-Corruption blog, the Trump Organization has been paid numerous times by foreign government.

Payments to Trump Organization Hotels

Attention has particularly focused on a single property, the Trump International Hotel in Washington, DC.  Per the report,

A number of concerns center on the Trump International Hotel in Washington, D.C., and in particular on whether foreign governments, or agents of foreign governments, may seek to curry favor with the Trump Administration by booking rooms and events at the hotel.

[Interior, Trump International Hotel DC]


In particular,

a leaked email from September 2017 indicated that, despite public assurances to the contrary, President Trump is 'definitely still involved' in the D.C. hotel’s business. Moreover, shortly after the election, the hotel hosted a promotional event aimed specifically at foreign diplomats, which almost 100 diplomats attended. Since then, there have been numerous reports of private companies and foreign governments paying for rooms and events at the Trump International Hotel, including in 2018 an Amazon subsidiary with billions of dollars in government contracts. As of May 4, 2018, the patrons at the hotel included 59 political groups, eight foreign governments, and 25 business interest events (industry or lobbying).

The report notes that the foreign governments that have "spent substantial sums at this D.C. hotel, with the possible intention to ingratiate themselves with the administration" included Bahrain, Azerbaijan, Saudi Arabia, Kuwait, Turkey, Malaysia, Philipines, Afghanistan, Iraq, Ukraine, and Romania.

More broadly, in the Citizens for Responsibility and Ethics in Washington (CREW) report on Trump's conflicts of interest:

Since President Trump took office, officials from 65 foreign governments, including 57 foreign countries, have visited a Trump property. Altogether, foreign officials account for 137 visits in total, 97 of which have been made to the Trump International Hotel in Washington, D.C.

Many of these visits have come from large events hosted by foreign governments, some of which switched venues to hold annual events at Trump properties after he became president. The embassy of Kuwait had, for example, typically held its annual national day celebration at the Four Seasons prior to President Trump’s election. The last three years, however, it’s held the event at the Trump hotel in D.C. In 2018, the Romanian consulate in Chicago moved its own national day celebration to the Trump hotel in Chicago after hosting it at the Chicago Cultural Center five years in a row.

While events like these are likely to be incredibly costly—and thus raise the likelihood of the president financially benefiting from payments made by foreign entities—neither the Trump Organization nor the Trump administration has released the financial details beyond an annual payment to the Treasury the Trump Organization claims represents profits from foreign government funds.

Turkish officials have made 14 visits to Trump properties, more than any other country. This can partially be credited to two annual conferences on U.S. relations with Turkey that have been held at President Trump’s D.C. hotel. This year, two advisors to President Recep Tayyip Erdoğan and the ministers of trade, defense, and treasury all attended the event.

Other events have drawn officials from countries that span continents or regions. In February, the Embassy of Kuwait in D.C. held a Kuwaiti independence day celebration at the Trump Hotel, with officials from all over the Middle East and North Africa in attendance. The 13 foreign officials in attendance included representatives from Kuwait, Yemen, Saudi Arabia, Oman, Iraq, Sudan, Yemen, and Libya.

Other officials have patronized Trump businesses around the time they met with President Trump. The Romanian President and Nigerian Vice President both visited the Trump hotel while in D.C. for meetings at the White House, and the Romanian Prime Minister is known to have stayed there.

[Trump Tower Chicago]



Payments Derived From Real Estate Transactions

If that were not enough, there are numerous instances of payments to or benefits received by the Trump Organization from foreign governments that do not involve its hospitality business. 

The Global Anti-Corruption Report noted that foreign governments and entities associated with them have rented and purchased Trump real estate.  These included "foreign government banks such as the Bank of India and Industrial & Commercial Bank of China."  Also,

the government of Qatar bought an apartment in one of President Trump’s New York towers for $6.5 million. As of June 2018, Qatar owned four units in the building for which it has paid a total of $16.5 million. Additionally, at least seven foreign governments—including Iraq, Kuwait, Malaysia, Saudi Arabia, Slovakia, Thailand, and the European Union—rented units at Trump World Tower in New York in 2017. (The Trump Organization does not own Trump World Tower, but it does manage the building, which means it benefits indirectly from renters in the form of management fees paid by those who own the units.) While most of the governments had also rented their units in 2015 and 2016, two of them—Iraq and Slovakia—only began renting in 2017.

Then again,

President Trump has a long history of lucrative financial dealings with Saudi Arabian partners, including those in or close to the Saudi government.

The Trump Organization is currently developing a luxury resort on the Indonesian island of Bali. The Bali local government provided public land for the project, granted numerous licenses and permits, and is planning to build (at government expense) a toll road extension that will substantially shorten the drive from the airport to the Trump resort—a decision that has raised concerns that the government may be deliberately undertaking an infrastructure project to curry favor with the U.S. president. (On August 13, 2019, Donald Trump Jr. attended an event in Indonesia to celebrate the development of two Trump properties in the country. Though the event was not affiliated with the United States government, pictures of the event reveal that several Indonesian government officials)

In addition,

The Trump Organization developed a luxury hotel in Panama City, and the Panamanian government has stepped in to aid the project in various ways, including government-funded repair of privately-owned sewage and drainage systems, use of the hotel for various government functions, and favorable permitting and tax decisions—decisions that, while not illegal or necessarily improper, raise significant concerns about conflicts of interest. The drama concerning this property continued in February 2018, as the building’s majority owner, Orestes Fintiklis, tried to fire the Trump Organization for mismanaging the hotel’s finances, but the Trump Organization refused to leave, instigating a standoff in which the police were called; the Panamanian government is currently investigating whether there was 'punishable conduct' by the Trump Organization.

Other Payments to the Trump Organization by Foreign States

Other Trump Organization operations have benefited from the actions of foreign governments, in particular,

in February 2017 President Trump reaffirmed the U.S. commitment to the so-called 'One China Policy.' Within a week of this announcement, the Chinese government granted the Trump Organization long-coveted Chinese trademarks for the 'Trump' brand. As of June 2017, the New York Times reported that President Trump had 123 trademarks registered and provisionally approved (meaning they would be approved within three months if there were no objections) in China.

Emoluments from the US Government

Independent of the salary and benefits President Trump receives from the government, the Trump Organization has received payments made by the US government.  The Global Anti-Corruption blog report noted in general that

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.

Specific instances it listed included:

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.

Department of Defense at Trump Tower: The Department of Defense has followed its standard practice of setting up a separate headquarters near the President’s private residence—in this case also in Trump Tower.

Trips to Mar-a-Lago and other Trump Properties: As of September 3, 2019, President Trump had spent 293 days at properties owned by the Trump Organization, with the bulk of that time at the Trump National Golf Club in Bedminster (90 days) and Mar-a-Lago resort in Florida (99 days).... On these visits, the Secret Service must pay the Trump Organization directly for any costs related to protecting the president. In fact, a Government Accountability Office report concluded that the Secret Service paid about $60,000 to the Mar-a-Lago resort for four trips between February and March 2017 alone

Trump Properties Abroad: If President Trump or his immediate family travel abroad and choose to stay at a Trump property, the U.S. government will pay the Trump Organization to rent space for the Secret Service and any additional necessary support. For example, the State Department paid at least $60,000 to the Trump Organization’s golf resort in Scotland when President Trump stayed there in July 2018.

Emoluments from US States

Payments by state governments to Trump via the Trump Organization have not been tracked so assiduously, but the Global Anti-Corruption Blog report noted,

At least 33 state-level officials also visited Trump properties, including nine governors, two lieutenant governors, and 15 members of state legislatures.... If these visits are taxpayer funded—and ongoing public records requests are seeking to find out—officials could be diverting public funds into the president’s private trust. This concern appears to have been borne out in a recent investigation by the Portland Press Herald, which found that former Maine Governor Paul LePage and his staff spent at least $22,000 in Maine taxpayer money staying at the Trump International Hotel over a two-year period—an amount far in excess of the state spending limit for this type of expense.

Furthermore,

Public pension funds in California, New York, Texas, Arizona, Montana, Michigan, and Missouri—with more than five million members—have millions of dollars invested in The CIM Group, a Los Angeles-based investment group that owns The Trump SoHo Hotel and Condominium. Through 2017, the CIM Group paid Trump International Hotels Management LLC 5.75% of Trump SoHo’s operating budget, resulting in millions of dollars in payments. Thus, these state pensions paid millions of dollars almost directly to the Trump Organization through the CIM Group.

Also,

In 2017, the Trump Organization announced a new mid-priced hotel chain, Scion (soon followed by another chain, American Idea). The first Scion hotel was granted a tax break in 2018 worth over $6 million from the Mississippi Development Authority.

Summary

The article by Moynihan et al in the BMJ is the latest effort to challenge conflicts of interest affecting health care professionals and academic health care organizations.  There are many barriers to the success of such reform efforts, most notably resistance from people who are directly benefiting from ongoing conflicts: in this case, health care professionals and management of the commercial firms making the payments to them that generate the conflicts.

In the US, we now have a particular barrier to addressing conflicts of interest in health care. Moynihan et al call on national governments to take various actions to reduce such conflicts.  However,  the US government is now led by a President whose personal conflicts of interest are voluminous, severe, and brazen.  Many of them appear to directly violate provisions of the US constitution that forbid emoluments (payments, gifts, or transmission of other things of value) to the President by foreign states, the US government, or state governments.  The government under Trump has shown little interest in challenging conflicts of interest or corruption unless doing so would politically benefit the president. So once again, it is difficult to see how we might meaningfully challenge conflicts of interest affecting American health care without challenging the monstrously conflicted executive branch of our own government.

That will not be easy.


Discussion of Trump's conflicts of interesti the media, and several civil lawsuits targeting them have not discouraged the President from continuing to enrich himself from foreign, the US, and state governments.

It is not obvious how these presidential conflicts of interest could otherwise be reduced or eliminated.  While the US House of Representatives has recently focused on possible impeachment of President Trump, unconstitutional conflicts of interest have not been a focus.  A New York Times op-ed just noted his continuing conflicts of interest, but lamented

The Democratic-controlled House has done an especially poor job of calling attention to this corruption. It hasn’t even conducted good oversight hearings — a failure that, as Bob Bauer, an N.Y.U. law professor and former White House counsel, told me, 'is just astonishing.'

It is possible that Trump will lose the next election.  However, that would leave him, unconstitutionally conflicted, in office until 2021, if he does not attempt to ignore such electoral results, as he has threatened.  He has already threatened to ignore election results he deems illegitimate (look here).

So it seems that we in the US are stuck with the continuing prevalence of conflicts of interest and corruption adding to health care dysfunction, unless health care professionals and the public band together to do something more direct to challenge them. 

From Russia with Money - Harvard Medical School Accepts $200 Million from Russian Emigre with Ties to Russian Oligarchs and Putin, and Who Is Under Investigation for US Election Meddling

On Health Care Renewal we have frequently written about individual and institutional conflicts of interest.  The landmark but often ignored 2009 report by the Institute of Medicine on Conflicts of Interest in Medical Education, Research and Practice defined institutional conflicts of interest as arising when

an institution's own financial interests or those of its senior officials pose risks of undue influence on decisions involving the institution's primary interests.

We have written about institutional COIs affecting academic medical institutions, medical societies and patient advocacy organizations.  Typically, the COIs arise from industry (that is, usually pharmaceutical, biotechnology medical device, and sometimes health insurance corporate funding) that might be seen as influencing the institution's decisions about medical care, health care policy, teaching and/or research.  For example, most recently we wrote about systematic research on institutional conflicts of interests affecting patient advocacy organizations, and on organizations writing clinical practice guidelines. 

But now things are different.

We present a big case of what looks like an entirely new, and very troubling variation on an institutional conflict of interest.

A "Transformative" Gift to Harvard Medical School

On November 8, 2018, Felice Freyer, writing in the Boston Globe, documented a huge new gift to Harvard Medical School.

Harvard Medical School has received a $200 million donation — the largest in its history — to support research into fundamental questions about human illness and health.

The pledge, from the Blavatnik Family Foundation, will enable the school to hire researchers, add to its advanced technology, and a build an 'incubator' in the Longwood area to help bring research findings to market.

The gift is so large that Harvard will rename many of the school's components after Blavatnik.

Harvard Medical School is keeping its name for now. But a large portion of the school will be renamed. The 10 academic departments in science and social science — as distinguished from the affiliated hospitals where postgraduate training takes place — will be called the Blavatnik Institute at Harvard Medical School.

Per the Harvard's in-house publication, the Gazette,

Announcing the donation, Harvard President Larry Bacow described it as an 'unprecedented act of generosity and support,' and thanked Blavatnik for his faith that HMS — and the region’s broader life sciences community — can make dreams of dramatic progress in human health become reality.

'It’s one thing to dream for oneself, for one’s family and friends, even for one’s community. It’s another thing to dream for all people, to dream for a future in which more lives are improved and saved through the creation and application of knowledge through science,' Bacow said.

HMS Dean George Q. Daley called the donation 'a transformative opportunity' for the School and said it will enable a new generation of scholars and scientists to emulate those who made key discoveries in every area from organ transplants to polio vaccines to gene therapy.

The Gazette described the donor, Len Blavatnik, thus

The foundation is led by Blavatnik, who graduated from Harvard Business School (HBS) with an M.B.A. in 1989, founded Access Industries, and became one of Britain’s wealthiest men.

What could possibly go wrong?

The Russian Connection

Actually, while he may currently operate out of Britain, Blavatnik came from Russia.  Per the Globe,

Blavatnik made his fortune in aluminum, oil, and gas after the fall of the Soviet Union and in 2011 bought the Warner Music Group. His philanthropy has sometimes raised eyebrows because of his alleged connections to Russian oligarchs.

His connections to these (other) oligarchs should raise some eyebrows, and concerns. 

The Access-Alfa Renova Consortium, Alleged Russian Sponsored Harassment of BP, and FSB Active Measures

Blavatnik's recent generous donations to Oxford sparked protests, and provided documentation of some relevant issues. Per the Globe

When Oxford University in England named a school of government after Blavatnik in 2015, some 20 critics wrote to chide the school for 'selling its reputation and prestige to [Russian President Vladimir] Putin’s associates,'

Their letter, published in the Guardian in 2015, stated that Blavatnik belongs

to a consortium of Russian billionaires called Access-Alfa-Renova (AAR). The consortium has long been accused of being behind a campaign of state-sponsored harassment against BP. In 2008-09 dozens of British and other western managers were forced out of Russia. As part of this campaign, Vladimir Putin’s FSB intelligence agency fabricated a case against two Oxford graduates. According to evidence from its jailed owner Sergei Bobylyov, Alfa-Bank oligarchs also raided a retail company called Sunrise.

The spy case and the attack on Sunrise involved the participation of Russian officials who are listed as gross human rights violators by the US Treasury in line with the Sergei Magnitsky Rule of Law Accountability Act of 2012.

These corporate abuses took place in Russia with active official support. There was a backdrop of state-sponsored propaganda. Russian state media broadcast libellous assertions against western and Russian citizens. AAR went on to make billions from a highly controversial deal with Rosneft.

The letter writers asserted

Oxford University apparently failed to investigate these facts, AAR’s track record from the beginning, and its close ties with the Kremlin.

A 2015 Guardian article described the background of the letter's signatories, including

Pavel Litvinov, one of eight people who in 1968 protested on Red Square against Moscow’s invasion of Czechoslovakia. He was exiled for five years to Siberia. Another is Vladimir Bukovsky, jailed by the KGB. Bukovsky, who lives in Cambridge, exposed the Kremlin’s use of psychiatric treatment against dissidents.

Others include former Oxford academics and graduates, members of Russia’s democratic opposition and human rights activists. One is Vladimir Milov, a colleague and friend of Boris Nemtsov, the opposition leader shot dead in February outside the Kremlin. The letter was organised by Ilya Zaslavskiy, a TNK-BP employee and Oxford graduate who ran Moscow’s Oxford alumni association.

In 2008 Putin’s FSB spy agency arrested Zaslavskiy and his brother Alexander in Moscow and accused them of being 'western agents'. Russian state TV claimed the FSB had exposed a major spy ring. The case against them was 'fabricated', the letter says.

Despite their credentials suggesting that the letter writers knew whereof they spoke, Oxford apparently has not done any further investigation.   However, per the Globe again, 

Last year, after Blavatnik donated $1 million to Donald Trump’s inauguration committee, an Oxford professor quit in protest, the Guardian reported.

In fact, according to contemporaneous (2017) coverage in the Guardian, Professor Bo Rothstein

a specialist on corruption, called the donation 'incomprehensible and irresponsible' in his resignation letter.

The academic subsequently told the Guardian he had received hundreds of messages of support about his decision, adding: 'I’m not going to be the Blavatnik chair of government and public policy because I’m not going to give legitimacy and credibility to this person. $1m is a sizeable amount of money. In my book by donating to the inauguration of Donald Trump you are supporting Donald Trump.'

The 2017 Guardian article expanded on the allegations made by the 2015 letter writers

Access began making investments in Russia after the fall of communism as the energy and aluminium groups of the former Soviet Union were broken up. Eventually Blavatnik combined assets with Viktor Vekselberg and Mikhail Fridman to form AAR. Their partnership with BP ended in acrimony.

In 2008, Bob Dudley, then the chief executive of TNK-BP and now the boss of BP, left Moscow after what the British company described as an 'orchestrated campaign of harassment'. Armed police also raised TNK-BPs office and more than 100 BP managers had to leave Russia after the authorities refused to renew their visas.

US diplomats alleged that at least one individual in AAR, German Khan, was involved in a state-sponsored campaign against BP to try to force them out of Russia. However, AAR and lawyers for Blavatnik have denied any involvement, including that of Khan, in a plot against BP.

In the end, both BP and AAR were bought out of the venture by state-backed Russian energy company Rosneft. The $55bn (£42bn) deal in 2013 handed the oligarchs, including Blavatnik, $28bn. It was signed off at a meeting with Putin.

The cash from the sale of TNK-BP pushed him to the top spot of the Sunday Times rich list in 2015. By this stage Access had already diversified beyond Russia and the energy sector.

However, note that the 2017 Guardian article's addendum included

Sir Leonard Blavatnik’s lawyers have informed the Guardian that the term 'oligarch' in his view does not apply to him. [But] The Guardian editor-in-chief disagrees.

So to recap, Blavatnik made a lot of money from aluminum, gas and oil in Russia after the collapse of the USSR.  He banded together with other very rich Russians in a consortium, AAR, that was accused by multiple people of dirty tricks meant to drive the UK oil firm BP from the Russian market.  There were allegations that this trickery involved Russian state agencies, and was likely to have been condoned by Putin.  The people behind AAR eventually netted a lot of money from the resulting buyout of their firms and of BP, a deal that apparently did involve Putin. 

Blavatnik's Changing Pattern of Political Contributions Raise Question about Foreign Influence on the US Election

While giving a lot of money to various educational and cultural institutions, Blavatnik was giving modest amounts of money to politicians. 

However, his pattern of political giving apparently changed greatly upon Trump's advent on the scene.  A May, 2018, Dallas News op-ed article by Professor Ruth May of the University of Dallas on Russian oligarchs' affinity for Trump's campaign stated,

Data from the Federal Election Commission show that Blavatnik's campaign contributions dating back to 2009-10 were fairly balanced across party lines and relatively modest for a billionaire. During that season he contributed $53,400. His contributions increased to $135,552 in 2011-12 and to $273,600 in 2013-14, still bipartisan.

In 2015-16, everything changed. Blavatnik's political contributions soared and made a hard right turn as he pumped $6.35 million into GOP political action committees, with millions of dollars going to top Republican leaders including Sens. Mitch McConnell, Marco Rubio and Lindsey Graham.

In 2017, donations continued, with $41,000 going to both Republican and Democrat candidates, along with $1 million to McConnell's Senate Leadership Fund.

A Vice News article April 2018, provided more detail,

according to the Wall Street Journal, Blavatnik gave $12,700 in April 2017 to a Republican National Committee fund that was used to help pay for the team of private attorneys representing Trump in the probe of Russian interference in the 2016 election. He’d given the RNC legal fund $100,000 in 2016, the Journal said.

The problem is that, as stated by Represenative Adam Schiff (D-CA), likely now incoming chair of the House Intelligence Committee,

'Unless the contributions were directed by a foreigner, they would be legal, but could still be of interest to investigators examining allegations of Russian influence on the 2016 campaign. Obviously, if there were those that had associations with the Kremlin that were contributing, that would be of keen concern.'

Under federal law, foreigner nationals are barred from contributing directly or indirectly to political campaigns in local, state and federal elections.

Note that according to an April, 2018, Mother Jones article, the 

the question of possible illegal foreign donations from Russia is also under scrutiny by the FBI and the Federal Election Commission. 

Apparently because of these allegations that Blavatnik was helping to channel Russian money to influence the 2016 election, per the Globe

Although no wrongdoing has been alleged, ABC News reported in the spring that special counsel Robert Mueller is looking into Blavatnik’s donation to the inauguration as part of an inquiry into foreign financial support for Trump.

So to recap, Blavatnik became a dual UK-US citizen, and for quite a while made political donations in a style similar to that of many rich businesspeople at the time, giving amounts to both parties, presumably to enhance access whoever was in power.  However, when Trump became a presidential candidate, Blavatnik began making much bigger donations, and only to Republicans and Trump-related causes.  Then he gave a million dollars to Trump's inagural.  Given the known scheme  by Russia to meddle in the US election to benefit Trump (see the 2018 Senate committee report as discussed here), this raised suspicions that Blavatnik, was helping to also influence the election on Russia's behalf. 

Blavatnik's Sanctioned Associates

Moreover, perhaps Mueller is also interested in Blavatnik's ties to other Putin-linked oligarchs.  A profile in Forbes from October, 2018, stated

Blavatnik still retains a few Russian assets. He and Vekselberg, along with [Oleg] Deripaska, are key investors in Rusal, one of the world’s largest aluminum producers.

Note that

His former business partners are now facing U.S. sanctions. They include Viktor Vekselberg (net worth: $13.1 billion) and Oleg Deripaska (net worth: $3.3 billion), two of seven Russian oligarchs that the U.S. Treasury and State departments identified in the April sanctions. Allegations made against the sanctioned oligarchs include interference with the 2016 presidential elections and financially profiting from a Russian government that engages in 'destabilizing activities.'

To recap, Blavatnik has ongoing business relationships with other oligarchs who have been sanctioned for meddling in the 2016 US election.


Blavatnik's Former Lobbyists Spin Through the Revolving Door into the Trump Administration

Furthermore, the April, 2018, Vice News article documented apparent ongoing ties between Blavatnik operators and the Trump administration.

Two senior Trump administration officials were once registered as lobbyists for an investment company controlled by a Soviet-born industrialist who made billions doing business with newly sanctioned Russian oligarchs.

Makan Delrahim is now the assistant attorney general for the Antitrust Division in the Department of Justice, after rising from his original appointment as deputy White House counsel and deputy assistant to the president. David Bernhardt is the No. 2 official in Trump’s Department of the Interior.

Both men registered as lobbyists in 2011 and 2012 for Access Industries, a holding company controlled by billionaire Leonard Blavatnik, according to public filings reviewed by VICE News. And though they are far from the only D.C. lobbyists to get plum jobs in the Trump administration, the connection to Blavatnik, long in business with billionaire associates of Russian President Vladimir Putin, reveals yet another link between Russia and senior Trump officials.

The article noted,

As of the fourth quarter of 2017, the lobbying firm that Delrahim and Bernhardt worked for was still on Access Industries’ payroll, according to public records. Bernhardt told the Senate during his confirmation hearing that despite filing the paperwork, he never actually did any lobbying for Blavatnik’s firm.

Delrahim, may have been in a particularly fraught position,

Both wound up on the Trump transition team. One, Makan Delrahim is now the assistant attorney general for the Antitrust Division in the Department of Justice, after rising from his original appointment as deputy White House counsel and deputy assistant to the president. David Bernhardt is the No. 2 official in Trump’s Department of the Interior.

The problem is while

Neither Delharim nor Bernhardt, who registered to lobby for Blavatnik and Access Industries in the past, currently has a job with direct oversight of issues related to the Russian economy or the Russia probe.... Delharim might have been involved when he was in the White House counsel's office, a position he left in September for the DOJ.

Richard Painter, former White House ethics lawyer under President George W. Bush, said that in his view, Delrahim would have needed to recuse himself from any work at the White House involving the investigation into Russia’s role in the 2016 election due to his previous work for Access Industries.

'I think that if I were in the White House Counsel’s Office, I’d say, ‘This guy needs to stay away from the entire Russia thing,'' Painter told VICE News.

To recap, former lobbyists for Blavatnik's firm served on the Trump transition team, and then were appointed to responsible federal offices, suggesting at the least, conflicts of interest.


Harvard Officials See No Evil

Nonetheless, Harvard officials had nothing but praise for Len Blavatnik, their generous donor.  Per the Globe,

[Lawrence S] Bacow, Harvard’s president, stood by the donor, calling him a 'distinguished alumnus' and 'somebody that we know very well.'

'We’re very comfortable with who Len is,' Bacow said. 'Len is well-known to the medical community here at Harvard and has been very supportive of science at Harvard and elsewhere. . . . He’s also somebody who is intensely curious, who believes in the power of science to improve the human condition, and he also believes in backing really talented young scientists.'

Were they totally unaware of all the accusations against, suspicions of, and likely investigations of their very wealthy donor?  Or did they just not want to look this very generous gift horse in the mouth? 

Not With a Bang,...

As noted above, there were vigorous protests of Blavatnik's much smaller gift to Oxford in 2015, and then in 2017 after Blavatnik's million dollar gift to the Trump inaugural was announced.  Yet so far, there has been little media discussion, and no protest of Blavatnik's "transformative" gift to Harvard, and the naming of a good chunk of the Harvard Medical School in his honor.

Blavatnik's story seems to be anechoic so far.  It has gotten little public coverage.  A Bloomberg article and a tiny AP story made no mention of Russia, oligarchs, Putin, etc.  Not surprisingly, coverage by Harvard's public relations did not bother either, (see the Harvard Gazette as above, and Harvard Magazine.) The only media coverage beyond the Boston Globe that said anything about the questionable aspects of Blavatnik's background was by the Harvard Crimson and WBUR.   


Summary and Discussion

Len Blavatnik  has been accused of acting in association with other Russian oligarchs, and with the Putin regime's FSB to use unethical means to push UK oil interests out of Russia.  Blavatnik has been accused of helping Russia to influence the 2016 US elections.  Some of Blavatnik's business associates have already been sanctioned by the US government for election meddling and profiting from "destabilizing activities."  And Special Counsel Mueller and other federal authorities are apparently in the midst of investigating Mr Blavatnik.


So Blavatnik's huge gift to Harvard Medical School seems likely to generate a new version of an institutional conflict of interest.  Consider a typical insitutional COI: a medical school getting a big donation from a pharmaceutical corporate foundation.  The concern in that case might be that the people running the school would be unduly inclined to support research that might boost the company's products, or support teaching that would again favor its products, or favor pharmaceutical therapy over other approaches.  Perhaps the students and professionals at that school might feel they are supposed to help hype the company's products, or avoid criticizing them.  All that would be highly concerning.

However, in the current case the issue is not how the school, its officials, its faculty, its health professionals and/or its students would favor Mr Blavatnik's corporate products and avoid criticizing them.  It is that they all are being pushed to cozy up to an oligarch, and thus might be pushed to favor the authoritarian government to which Mr Blavatnik appears tied, its anti-democratic practices, its corruption, and its apparent attempts to meddle in US elections, undermine US democracy, and support a particular candidate who may be beholden to it.

The protesters at Oxford in 2015 wrote

We insist that the university should stop selling its reputation and prestige to Putin’s associates.

Now Harvard University and its medical school appear to be "selling its reputation and prestige to Putin's associates."  This endangers Harvard, and the rest of us. Yet no on at Harvard appears to be protesting.  The silence is deafening.

Patient or Corporate Advocacy Organizations? - New Studies Shed Some Light

Introduction

On Health Care Renewal we frequently discuss how people and institutions entrusted to promote patients' and the public's health instead promote commercial interests. 

For example, health care corporations, particularly drug/ biotechnology/ device companies may enlist key opinion leaders (KOLs).  These are nominally learned academics and distinguished professionals, but who have been paid to market the companies' products.  KOLs often fail to disclose their financial relationships and hence loyalties to these companies.

We have also noted that top leaders of academic medical institutions often serve on the boards of directors of big health care corporations.  In that capacity, they have fiduciary responsibilities to the companies and their shareholders.  They thus are expected to be loyal to these companies, even when corporate interests conflict with their academic organizations' missions.  Again, these relationships may not be well publicized.

Health care leaders and institutions may profess lofty goals, while they cultivate financial relationships that lead to personal gain, but leave them divided and conflicting loyalties.  Furthermore, individuals and institutions may fail to fully disclose these relationships, and thus may deceive health care professionals, patients and the public about the nature of their loyalties.

Institutional Conflicts of Interest and Patient Advocacy Organizations

In the last month, two scholarly articles that show the prevalence of such conflicts of interest (COIs) affecting patient advocacy organizations (also called disease advocacy organizations) were published.

McCoy et al. Conflicts of Interest for Patient-Advocacy Organizations(1)

Published today, March 2, 2017, the article's introduction gives this excellent overview:

Patient-advocacy organizations are nonprofit groups whose primary mission is to combat a particular disease or disability or to work toward improving the health and well-being of a particular patient population. As political actors, such organizations play an influential role in shaping health policy, pursuing agendas that include expanding coverage for drugs, devices, and diagnostic procedures; increasing support for medical research; and streamlining approval of experimental therapies.

Reports by media and watchdog groups have drawn critical attention to financial relationships between patient-advocacy organizations and drug, device, and biotechnology companies. Industry support can be an important resource for patient-advocacy organizations but can also give rise to institutional conflicts of interest, which exist when 'an institution’s own financial interests or the interests of its senior officials pose risks to the integrity of the institution’s primary interests and missions.' In the context of organization–industry relations, concerns have been raised that industry-supported patient-advocacy organizations have spoken out for access to drugs with questionable therapeutic benefit and remained silent on policy proposals, such as drug-pricing reforms, that might benefit their constituents.

This study analyzed public records (US Internal Revenue Service form 990 tax reports, annual reports and website) on the largest US based patient advocacy organizations, that is, those with revenues of at least $7.5 million.  Its goal was to determine how well these organizations disclose conflicts of interests, and how they have COIs, and what policies they have to mitigate their effects.

Its main results were that:

- Disclosure was modest.  88% of organizations disclosed their donors, 52% disclosed approximate amounts of donations, but only 5% disclosed exact amounts.  74% provided some information about the employment of their board members.

- COIs were common.  83% got funding from drug, device, or biotechnology companies.  Of the 57% of organizations that disclosed any information about the amount of funding, 39% received at least $1 million a year.   Furthermore, at least 39% of the companies had at least one current or former drug, device, or biotechnology executive on their own board of directs.

- Policies governing conflicts of interest were infrequent and weak.  Only 26% had publicly available COI policies, and and only 12% of these policies addressed the organizations' instutional conflicts of interest.


Rose SL et al. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest(2)

This study, published online on January 17, 2017, surveyed "a nationally representative sample of 439 PAO [public advocacy organizations'] leaders," from September 1, 2013 to June 30, 2014.  The survey response rate was 65.8%.  Its main results were that:

COIs were common.  Of the 245 organizations whose leaders responded, 67.3% received industry funding; 33.8% received more than one quarter of their funding from industry, and 11.9% received more than half from industry.  Of those receiving funding, a median of 45% of that funding was from drug, device or biotechnology companies.

Policies governing conflicts of interest were common, but often did not require public disclosure of conflicts.  63.9% of the organizations said they had policies, but only 25.7% had policies that required public disclosure.  The number of organizations that made their policies public was not clear.

So in summary, there is new data obtained systematically from observational studies suggesting that most patient advocacy organizations get substantial funding from health care corporations, especially drug, device or biotechnology companies.  These companies may be marketing drugs and devices for use by patients with the diseases for which the organizations advocate.  Furthermore, many organizations may also be governed by boards which include leaders of these companies.  Finally, disclosure of these COIs may be unreliable.  So health care professionals, patients and the public may not understand where these organizations' loyalties lie. 

Putting Patients and the Public, or Corporate Interests First?

Patient advocacy organizations, like many other kinds of health care organizations claim to put patients and the public's health first.  However such organizations frequently have large institutional conflicts of interest, and may not be at all transparent about such conflicts. 

Such conflicts of interest clearly raise the risk that the organizations may be influenced to put their financial sponsors' interests ahead of those of patients and the public.  However, the articles discussed above were not designed to discover how often such conflicts actually lead to abuse of these organizations' power.  Such abuse could be health care corruption, since corruption is defined by Transparency International as abuse of entrusted power for private gain.

In a New York Times article discussing the most recent study, representives of patient advocacy organizations denied that they possibly could be affected by all those dollars flowing into their coffers.

'Patient advocacy organizations are driven by their missions — putting patients first,' said Marc M. Boutin, the chief executive of the National Health Council, an umbrella group for patient-advocacy groups. 'To say otherwise negates the extraordinary work achieved by these organizations on behalf of their patients.' The health council had previously said that pharmaceutical companies accounted for 62 percent of the council’s $3.5 million budget in 2015.

Furthermore, while "researchers pointed to the National Hemophilia Foundation as one group that is vague about its funding,"

the hemophilia foundation said it never allows its corporate sponsors to influence its decision-making, and that it also does not endorse specific products or favor certain companies.

But  as Joe Collier wrote, "In my experience, people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(3) 

Furthermore, commonsense, history, and anecdotal evidence suggests that the conflicts of interest affecting patient advocacy organizations could influence their actions, and could at times lead to health care corruption.  For example, looking through our files, I found....

- Drug companies recruited patient advocacy organizations to advocate for less clinical trial transparency.  In a 2013 news article in the British Medical Journal, "a leaked memo sent to several drug companies from two trade association bodies ... showed that there were plans to recruit patient groups to resist moves that would force the companies to publish more raw trial data."

- Patient advocacy organizations advocated for pharmaceutical company donors' drugs. There are many anecdotes involving patient advocacy groups which receive money from specific drug companies strongly advocating for those companies' products. 

In 2014, a British Medical Journal article showed how two multiple sclerosis charities in the UK advocated that the British National Health Service pay for drugs manufactured by companies which contributed to those charities.

In 2016, two news articles (USA Today, NY Times) noted the curious silence of disease advocacy organizations on the then burning question of high and rising prices of drugs used for their diseases, but manufactured by their sponsors.  Yet the same organizations were quite vocal about the need for insurance companies to pay for these medications.

Furthermore, the NY Times article suggested that patient advocacy organizations which tried to protest high prices on behalf of patients might fight themselves in trouble:

And for patient groups, loudly addressing the issue can be perilous, as Cyndi Zagieboylo, the chief executive of the National Multiple Sclerosis Society, recently discovered.

She said members of her group, one of the most influential patient charities, had identified cost as a priority. The average annual cost for multiple sclerosis medications is $78,000 today, nearly 400 percent higher than the $16,000 average in 2004, the group says.

But as soon as Ms. Zagieboylo started discussing a plan — a modest proposal that involved bringing together drug makers, insurers and others to find solutions — she said she encountered resistance. Other patient groups would not join her, and she said she was told by members of Congress, as well as some of the pharmaceutical companies that donate to her group, to tread carefully.

'We were warned, you know, in a number of ways, just sort of to be careful about this,' Ms. Zagieboylo said. 'A couple of pharmaceutical companies mentioned, ‘Boy, we support you, why are you doing this to us?'

- Donors to patient advocacy organizations think they are buying influence.  An 2016 investigation by the Project on Government Oversight (POGO) showed that companies that fund patient advocacy organizations may think they are thus buying influence.  For example, the report noted vis a vis the National Health Council (whose CEO Marc Boutin was quoted defending its purity above):

In a filing with the Internal Revenue Service, the organization says its mission is 'TO PROVIDE A UNITED VOICE FOR PEOPLE WITH CHRONIC DISEASES AND DISABILITIES.' The filing says National Health Council is a tax-exempt 501(c)(3) corporation, otherwise known as a charitable organization.

The website of Pfizer, a big drug company, shows how Pfizer has categorized it.

Pfizer discloses its membership in National Health Council on a page headed 'Lobbying & Political Contributions,' listing National Health Council under 'Trade Association Memberships,' along with groups such as PhRMA, BIO, U.S. Chamber of Commerce, and Business Roundtable.

So while leaders of patient advocacy organizations may implausibly deny that they possibly could be influenced by corporate donations, there is certainly anecdotal evidence to suggest they may be very much influenced.  He who pays the piper....

Summary

We have often talked about the huge and complex web of conflicts of interest that binds many of the important decison makers and leaders in health care to each other, and to other large health care organizations, so that health care in the US has largely become a game for insiders.

This month, we see how frequently institutional conflicts of interest affect patient advocacy organizations, even though such organizations "wrap themselves in white as if they are pure," (per Dr Ezekiel Emanuel, author of the latest study, quoted in the NY Times).  Furthermore, there is ample reason to think that these conflicts often may influence these organizations to put their commercial sponsors' interests ahead of the patients for whom they ostensibly advocate.  Thus in some cases these conflicts may lead to health care corruption, keeping in mind that Transparency International defines corruption as abuse of entrusted power for private gain. 

Compounding it all is the propensity of these organizations to hide the details of their corporate funding.  It's not the crime, it's the coverup.....


Now we live in an era when conflicts of interest and corruption are in the headlines every day.  Maybe here in the USA we are starting to realize that conflicts of interest and corruption are not just some tiresome  concern of party poopers, wet blankets and curmudgeons.  We all have to wonder: are the people and institutions we think are sworn to uphold our interests are actually upholding someone else's interests?


As we have said again and again,...  The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system.  True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.


References

1.  McCoy MS, Carniol M, Chockley K et al. Conflicts of interest for patient advocacy groups.  N Engl J Med 2017; 376: 880.  Link here.
2. Rose SL, Highland J, Karafa MT et al.  Patient advocacy organizations, industry funding, and conflicts of interest.  JAMA Intern Med 2017; doi:10.1001/jamainternmed.2016.8443.  Link here. 
3.  Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.

Clinical Practice Guidelines: Still Conflicted After All These Years

Background: Untrustworthy Clinical Practice Guidelines

Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes.  When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines.  We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.

That approach, however, failed to yield ways to improve adherence.  After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them.  We learned that integrity of  the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.

Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest.  No wonder physicians were suspicious of guidelines, and resisted adhering to them.

In 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link here.)  We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect.  The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.

These included in particular:
- Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2)
- The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4)
- Funders should have no role in guideline development (2.4)

This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.

Article Summary

Below I summarized the article, but presented results somewhat differently than did the authors.

Design

Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations.  They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.

Study Population

The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%.  The organizations were primarily professional societies (67%) or disease advocacy groups (21%).

My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.

Industry Funding

63% of organizations reported receiving funds from biomedical companies.  (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)

My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.

Conflict of Interest Policies

Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs.  In most cases, I simply did subtractions to emphasize the negative.  Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.

20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them.  A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.

My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.

Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest

The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.

Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies:
98% required committee members to disclose conflicts of interest;
90% required review of conflicts of interest before guideline publication; 
68% required that a majority of guideline committee members be free of conflicts of interest;
92% reported publishing committee members' conflicts of interest within guidelines;
78% did not allow direct industry funding of guideline development
82% did not allow industry participation in selection of committee members
67% did not allow industry to review guidelines prior to publication.

That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.

Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:

38% did not require CPG committee members to disclose conflicts of interest
43% did not require review of committee members' conflicts of interest prior to guidelines development
57% did not require that a majority of guideline committee members be free of conflicts
44% did not report publishing committee members' conflicts of interest within guidelines
48% did not report preventing direct industry funding of guidelines
51% did not report preventing industry participation in selection of committee members
61% did not report preventing industry review of guidelines prior to publication.

My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.

Disclosure of Conflicts of Interest Within Guidelines

Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.

Of the 290 guidelines reviewed:
65% "included disclosure statements regarding direct funding and support"
37% specifically disclosed the absence or presence of direct funding from biomedical companies
However,
49% did not disclose committee members' financial relationships
99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole

My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them. 

Did the Guidelines Follow the Organizations' Stated Policies?


The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices.  They found:

16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure

61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members

6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.

My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.

Authors' Conclusion

Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.

Editorialists' Conclusion

The editorial by Bastian(2) was sharper in tone.  It included an observation that reinforced my confession of naivete above:

With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development

She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:

Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients’ organizations.

She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem.  The rate of failure to report found by Campsall et al was

about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.

Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:

Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it’s a case of caveat lector: let the reader beware.

My Summary

So should physicians trust clinical practice guidelines?  At least this article suggests they ought to be very very skeptical of them.  The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach.  The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low.  Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices.  Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.

The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment."  I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.

The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system.  True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.

Musical Interlude

To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:





References

1.  Campsall P et al.  Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study.  PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029    Link here.

2.  Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016;  DOI;10.1371/journal.pmed.1002030  Link here.

Academic Medical Leaders as Directors of For-Profit Health Care Corporations: the Prevalence of This "New Species" of Conflict of Interest Documented in the BMJ

The important conflicts of interest generated when academic health care leaders also serve on the boards of directors of for-profit health care corporations is suddenly less anechoic, thanks to some intrepid researchers and the British Journal of Medicine.

Background: Academic Health Care Leaders Also Serving as Directors of For-Profit Health Care Corporations

First Discovered Cases

In 2006, we first noticed that leaders of academic medicine also were serving as board members of large for-profit health care corporations.  The first example we discussed was that of Marye Anne Fox, Chancellor (equivalent to president) of the University of California - San Diego, and hence the person to whom the University of California, San Diego School of Medicine and its academic medical center report. The conflict was between this position, and her service as a member of the board of directors of Boston Scientific, a medical device manufacture, and the board of directors of Pharmaceutical Product Development Inc., a contract research organization.

Later that year, we discussed a "new species of conflict of interest."  At that time we wrote:

Medical schools and their academic medical centers and teaching hospitals must deal with all sorts of health care companies, drug and device manufacturers, information technology venders, managed care organizations and health insurers, etc, in the course of fulfilling their patient care, teaching, and research missions. Thus, it seems that service on the board of directors of a such public for-profit health care company would generate a severe conflict for an academic health care leader, because such service entails a fiduciary duty to uphold the interests of the company and its stockholders. Such a duty ought on its face to have a much more important effect on thinking and decision making than receiving a gift, or even being paid for research or consulting services. Furthermore, the financial rewards for service on a company board, which usually include directors' fees and stock options, are comparable to the most highly paid consulting positions. What supports the interests of the company, however, may not always be good for the medical school, academic medical center or teaching hospital.

Since 2006, we continued to find colorful examples of such conflicts of interest, e.g.,

- In 2006, the UnitedHealth board included multiple academic leaders, at least one of whom seemed partly responsible as a member of the board compensation committee for allowing the then UnitedHealth CEO to collect many backdated stock options (look here)
- In 2009, some attributed the problems at George Washington University's medical school that caused it to be put on probation to the conflict of interest of its provost and vice president for health affairs,  who also sat on the board of Universal Health Services, which owned the university hospital (look here)...

Through more recent years,

- In 2014, members of the AMA committee that has an outsize role in how the government fixes the pay of US doctors wer also found to be members of boards of directors of such companies as Kindred Healthcare, Hanger Inc, and Sante. (Look here.)
- In 2015, the academic physician and research unit leader nominated to be the new head of the US Food and Drug was a director of Portola Pharmaceuticals (look here)...

Look here for even more

Our Early Cross-Sectional Study

In 2007, we did a somewhat rough and ready research project based on 2005 data to determine the prevalence of such conflicts.  The results were presented in abstract form,(1) but not published as an article:

In 2005, there were 164 US health care companies in the 2005 S&P 1500, and 125 US medical schools. We identified 198 people who served on the companies' boards of directors who had faculty or leadership positions at these medical schools. Of the 125 medical schools, 65 schools had at least one faculty member and/or leader who also served on a health care corporation's board of directors. 15 schools had more than five, and 4 had more than 10 such individuals. Of the 125 schools, 7 reported to university presidents who were also directors of health care corporations, and 11 schools reported to vice-presidents for health affairs who were also such corporate directors. Four schools were lead by deans who were also health care corporate directors, and 10 schools had academic medical center CEOs who were such directors. 22 schools had at least one top leader who was also a director of a health care corporation. 36 schools reported to university boards of trustees which each included at least one director of a health care corporation, and 12 schools' own boards of trustees included at least one such director.

We concluded:

more than one-half of US medical schools had a leader or faculty member who also was a director of a major US for-profit publicly traded Bpure^ health care corporation, more than one-sixth of schools had a top leader who was also such a director, and more than one-fifth reported to boards of trustees which included such directors.

More Modern and Complete Data

Unfortunately, we never wrote a full paper about this work, although the likelihood we could have gotten it published around 2007 was very small.  It is fortunate that Anderson and colleagues did a more complete and current version of this project, which was published online this week by the British Medical Journal.(2)

Methods

Their methodology was similar to our earlier work, but more sophisticated.  They obtained data on the 2013 board members of 446 public for-profit US companies listed on New York Stock Exchange or NASDAQ and classified as in the healthcare sector, including pharmaceutical, biotechnology, medical equipment and supply companies and health care providers from the companies' 2014 proxy statements.

Results

Their results were striking, suggesting even a greater prevalence of conflicted academic leaders than our preliminary results suggested

Directors were affiliated with 85 geographically diverse non-profit academic institutions, including 19 of the top 20 National Institute of Health funded medical schools and all of the 17 US News honor roll hospitals. Overall, these 279 academically affiliated directors included 73 leaders, 121 professors, and 85 trustees. Leaders included 17 chief executive officers and 11 vice presidents or executive officers of health systems and hospitals; 15 university presidents, provosts, and chancellors; and eight medical school deans or presidents.

The new study also described the direct financial relationships among the academic leaders, professors and trustees and the corporations on whose boards they served.

The total annual compensation to academically affiliated directors for their services to companies was $54 995 786 (£35 836 000; €49 185 900) (median individual compensation $193 000) and directors beneficially owned 59 831 477 shares of company stock (median 50 699 shares).

Discussion

As we have suggested, Anderson et al stated that being on the board of directors of a for-profit health care corporation creates conflicts of interest beyond those created by simply having a financial relationship with a health care company, e.g., by participating in a commercially sponsored research project or acting as a consultant to a company.

Similar to individuals engaging in consulting relationships, directors on industry boards enter a formal contract with the company and receive financial payment for services; however, they are subject to two important differences. Firstly, unlike consultants who are compensated to provide expertise on a specific issue, directors are subject to a fiduciary responsibility to company shareholders to advance the general interests of the company and increase profits. Secondly, directors are reimbursed both through larger cash fees than typical consulting contracts and through stock options, the value of which is directly tied to the financial success of the company.

They also added the reminder that,

Though the missions of academia and for profit companies can overlap, they may also diverge, specifically when the for profit mission of industry competes with the non-profit taxpayer funded clinical and research missions of academic medical and research institutions.

So,

previous guidelines have emphasized the relationships of clinicians and researchers with industry, but institutional conflicts of interest, which arise when administrators, including executive officers, trustees, and clinical leaders have a financial relationship with industry, are increasingly recognized and pose a unique set of risks to academic missions. 

Our Summary

We have written again and again on the problem of conflicts of interest affecting health care professionals, academics, and policy makers.  The worst such conflicts may occur when individuals are simultaneously leaders of large mission-oriented health care non-profit organizations, such as teaching hospitals, medical schools, or research institutes, and board members of for-profit health care corporations.  Despite our attempts to raise such issues as important, and probably important causes of health care dysfunction, they have remained anechoic.

Now a broadly based study of this no longer so "new species" of conflict of interest has appeared in one of the biggest and most prestigious medical journals.  Let us hope it will bring this issue to the forefront, and also partially counter those who have been preaching that concerns about conflicts of interest in health care are overblown.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.

ADDENDUM (16 November, 2015) - Note that an abbreviated version of this post has appeared as an electronic "rapid response" to the article by Anderson et al (link here), although the published form has on it our original submission date.   

References

1. Poses RM, Smith WR, Crausman R, Maulitz R. Selling them the rope: prevalence of for-profit health care corporate dirctors among academic medical leaders. J Gen Intern Med 2007; 22 (Suppl 1): 98.
2.  Anderson TS, Good CB, Gellad WF.  Prevalence and compensation of academic leaders, professors and trustees on publicly trade US healthcare company boards of directors: cross sectional study.  Brit Med J 2015; 351:h4826.  Link here.