The Big Spin Out: 2020 Revolving Door Update

In  2020, cases of the revolving door accumulated quickly. 

The Old School Outgoing Revolving Door

Let us begin with cases of the old fashioned outgoing revolving door, that is, of people leaving leadership positions in governmental bodies which regulate health care or make health care policy, then soon obtaining jobs in the health care industry, particularly organizations which they previously regulated or were affected by the policies they made.

Dr Vindell Washington from National Coordinator for Health Care Information Technology to Alphabet

Per FierceHealthCare, January 7, 2020:

Alphabet, the parent company of Google and Verily Life Sciences, continues to bolster its ranks of healthcare experts with the latest hiring of Vindell Washington, M.D.

Verily Life Sciences hired Washington as its new chief clinical officer as part of its health platforms team, Verily Life Sciences representative Kathleen Parkes confirmed to FierceHealthcare Tuesday.

Washington served as the national coordinator for health IT from August 2016 to January 2017.

As one of the highest health IT policy leaders, Washington brings to Verily a deep understanding of the industry. He is an emergency medicine physician by training.

So he moved from a position with significant influence over government health IT policy to a big IT company involved in health care.  Admittedly though, this moves comes three years after he left the ONC.

Dr Kate Goodrich from Chief Medical Officer of the Center for Medicare and Medicaid Services (CMS) to Humana Inc

Per Louisville Business First, January 17, 2020:

Humana Inc. has hired away a key regulatory insider from the federal government.

Dr. Kate Goodrich will leave the chief medical officer role at Centers for Medicare & Medicaid Services in February. Politico reported Thursday Goodrich will become a senior vice president for the company.

CMS is the agency that oversees both Medicare and Medicaid, the government-backed health plans. Goodrich was also director of the Center for Clinical Standards and Quality, the CMS website states.

Note that Humana's business is heavily influenced by the actions of CMS.

Humana's core business is providing Medicare Advantage plans, a private version of the federal health plan for seniors. It has about 4.1 million members in Medicare Advantage plans, according to its latest financial disclosure.

The Medicare Advantage segment brought in about $37.1 billion of revenue in the nine months ended Sept. 30, 2019.

Mary Sumpter Lapinski from Government Affairs at Bristol-Myers-Squibb to Counselor to the Secretary of the Department of Health and Human Services (DHHS) for Public Health and Science, then to Vice President of Global Governance Affairs for Greenwich Biosciences


Note that in this case, someone recently reported as transiting the outgoing revolving door has also had in the past transited the incoming revolving door.

Per a Buzzfeed News article, January 24, 2020 (which also discussed the larger revolving door problems involving the pharmaceutical industry and the Trump administration):

Mary-Sumpter Lapinski, who worked in government affairs for Bristol-Myers Squibb from 2002–2007, served as a counselor to the health and human services secretary for public health and science. As of April 2019, Lapinski is the vice president of global government affairs for biopharmaceutical company Greenwich Biosciences.

Again, most recently she moved from a senior position in DHHS affecting public health and science to a biotech company.

Roxana Weil, Lead Toxicologist from the Center for Tobacco Products at the Food and Drug Administration (FDA) and Gabriel Muniz who inspected tobacco manufacturers for the FDA to Juul Labs Inc

Per Bloomberg (via the Detroit News, February 5, 2020):

Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top U.S. e-cigarette maker.

So

Roxana Weil, formerly a lead toxicologist at the agency’s Center for Tobacco Products, joined Juul as principal scientific adviser in September. Gabriel Muniz, who worked in an FDA division that inspects tobacco manufacturers, joined Juul last month as a director of regulatory compliance.

Note that

The company and its peers must submit applications to the FDA by May 12 in order to continue selling their products. The deadline is a defining moment for the e-cigarette industry, which has been under fire following a surge in teen vaping and a lung-injury outbreak that sickened thousands and was later tied to THC.

For Juul, securing a swift clearance is critical. The company has seen its once-rich valuation drop since the broader vaping backlash began. Failing to win the FDA’s blessing could shut it out of a market it has dominated.

So they moved from regulating tobacco to a company essentially involved in selling tobacco analogues.  Note that the tobacco company Altria made a major investment in Juul (look here.)

The Au Courant Incoming Revolving Door

In the Trump era, many people have come through the incoming revolving door, that is, people with significant leadership positions in health care corporations or related groups have attained leadership positions in government agencies whose regulations or policies could affect their former employers.

There are two recent examples

Brad Smith, Chief Operating Officer of Anthem's Diversified Business Group to be Director, Center for Medicare and Medicaid Innovation (CMMI) at the DHHS

Per FierceHealthcare, January 6, 2020:

The Trump administration has selected Brad Smith to serve as the director of the Center for Medicare and Medicaid Innovation (CMMI), where he will oversee the creation and stewardship of value-based payment models.

Smith most recently was the chief operating officer of Anthem’s Diversified Business Group, a division of the insurance giant that includes provider services. He was also the co-founder and CEO of palliative care services company Aspire Health.

Anthem is a health insurer which provides Medicare supplements and Medicare Advantage programs, so its business is greatly affected by any changes in how Medicare or Medicaid makes payments.

Amanda Adkins, Executive for Cerner Corp, Now Running for the House of Representatives as a Republican

This could be called a running start that will likely lead through the incoming revolving door.

Per the  Kansas City Star, January 23, 2020:

Cerner executive Amanda Adkins has taken a leave of absence from the company to focus on her campaign to unseat Democratic Rep. Sharice Davids.

Adkins, a former Kansas Republican chair, launched her bid for Kansas’ 3rd congressional district in September, but initially planned to remain as Cerner’s vice president of strategic growth through the campaign.

But as of last week, according to a company spokeswoman, Adkins went on unpaid leave after from her role after 15 years with the health care IT giant.

Note that the Star article, unlike the others quoted above, provided at least a slightly detailed discussion of why this (potential) move poses a conflict of interest:

The Kansas City-based company is a major federal contractor with a $10 billion contract to design a new health care records system for the U.S. Department of Veterans Affairs. The new system is expected launch later this year.

Federal election rules prohibit federal contractors from giving directly to federal candidates. Craig Holman, a lobbyist for Public Citizen, a national group which advocates for tougher ethics standards, said Adkins’ unpaid leave protects Cerner from violating this rule.

But Holman said the fact that she can return from leave after the election still raises questions about a conflict of interest since she could end up on committees with oversight of the company’s contracts if elected to Congress.

'The conflict still persists,' Holman said in a phone call. 'The fact that she has not resigned and remains an employee of Cerner means that conflict of interest remains front and center.'

Summary

Sigh.  So while there is much discussion of corruption in high places, and its potential link to high crimes and misdemeanors, the revolving door quietly spins on well-oiled hinges, as it has for years, including many years before the current administration.  

So as we have repeatedly said,  most recently in October, 2019, ...

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

The ongoing parade of people transiting the revolving door once again suggests how the revolving door may enable certain of those with private vested interests to have disproportionate influence on how the government works.  The country is increasingly being run by a cozy group of insiders with ties to both government and industry. This has been termed crony capitalism. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

Remember to ask: cui bono? Who benefits? The net results are that big health care corporations increasingly control the governmental regulatory and policy apparatus.  This will doubtless first benefit the top leadership and owners/ stockholders (when applicable) of these organizations, who are sometimes the same people, due to detriment of patients' and the public's health, the pocketbooks of tax-payers, and the values and ideals of health care professionals.  

 The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

How Corporate Health Care Leaders Maintain Their Impunity: The Case of Purdue Pharma's Funding of the Washington Legal Foundation to Attempt to Weaken the Responsible Corporate Officer Doctrine

The ongoing epidemic of narcotic (opioid) abuse, and the resulting rise in the deaths due to overdoses, has focused attention on pharmaceutical companies' aggressive promotion of these drugs which minimized their substantial risk. A recent article in the Intercept showed how the leadership of one such company tried to insulate itself from responsibility for such actions even while such promotions were continuing.

Background: Impunity of Top Leaders of Big Health Care Organizations

For years, we have railed against the impunity of top leaders of health care organizations.  We have noted that despite numerous legal settlements made by health care organizations of alllegations like fraud, bribery, and kickbacks, almost never do top leaders who presided over these actions face any negative consequences.  Lack of deterrence caused by such impunity appears to be a major cause of  the epidemic of continuing unethical behavior, crime and corruption on the part of large health care organizations. How executives got to the point of having such impunity has never been clear.

Timidity and lenience by regulatory agencies and law enforcement seem to be factors. For example, in 2014, we noted  that Attorney  General Eric Holder had previously been reluctant to go after big organizations because of the economic consequences of their failure:

The attorney general angered many last year when he reiterated those concerns at a congressional hearing, admitting 'that the size of some of these institutions becomes so large that it does become difficult for us to prosecute' because of the potential nasty economic effects of a major company failure.

In general we have seen much tougher enforcement directed against relatively small health care players than against bigger ones.  For example, we noted in 2014 that settlements by  Merck, Eli Lilly, Takeda, and Teva, all large pharmaceutical companies, allowed the companies to pay fines to settle allegations that they pushed dangerous products, while none of the executives who authorized, enabled, or directed these actions faced negative consequences.  In contrast, at that time, the CEO of a relatively tiny Sheffield Pharmaceuticals was convicted of a felonious wastewater discharge (see this post).

However, this rationale does not address the failure to pursue enforcement actions against organizational leaders who who enabled, authorized, directed or implemented misbehavior.  It is not that there are no good legal tools available to do so.  We wrote in 2012,

As we noted here, a Supreme Court case from 1943 empowered the government to seek penalties against responsible corporate officers (the "responsible corporate officer doctrine") who were in a position to stop a fraud that resulted in a guilty plea or conviction, particularly for the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act.    Despite a threat made in 2010 by the chief counsel of the Inspector General's office of the US Department of Health and Human Services to use such legal authority to "get high level executives out of companies," nothing of the sort has happened.

Later, in 2015, under the previous administration, there was a tiny sign of progress against impunity.  Then, Attorney General Holder authorized the creation of a Corporate Strike Force to take strong actions in response to health care corporate fraud.  However, last year the Trump administration gutted even that small effort  (look here).  The use of the Responsible Corporate Officer doctrine remains at best extremely rare.  Why?  


How Leaders of Purdue Pharma Tried to Undercut the Responsible Corporate Officer Doctrine

A recent article in the Intercept provided one explanation.  It provided a telling example of top health care corporate leaders who took active, but stealthy measures to preserve their own impunity by attempting to undermine the Responsible Corporate Officer Doctrine,

Executives at Purdue [Pharma]were once charged using the corporate office doctrine in 2007, in a case that found that the company had 'misbranded' its drugs as less likely to be abused than other narcotics. The company agreed to pay a settlement of $634.5 million.

As reported then by the New York Times, three corporate executives pleaded guilty of misdemeanor charges of misbranding Oxycontin.  It appeared that corporate leadership wanted to try to prevent further efforts to hold them accountable.

Purdue didn’t attach its name to the recent effort to weaken the responsible corporate officer doctrine. Instead, the company provided funding to the Washington Legal Foundation, a legal nonprofit that litigates in support of business interests, to petition the Supreme Court last year to accept a case that would give it the opportunity to weaken the RCO doctrine. The foundation closely protects the names of its donors and the drugmakers’ ties to the group were unclear until recently.

The legal strategy was confirmed by former staffers at the Washington Legal Foundation who spoke to The Intercept on the condition of anonymity. The foundation did not respond to a request for comment.

The effort revolved around a case known as DeCoster v. United States, one of the most significant challenges to the responsible corporate officer doctrine in four decades.

The lawsuit challenged the conviction of executives at Quality Egg LCC, an Iowa-based company, who were found guilty for shipping salmonella-tainted eggs that sickened 56,000 people. The federal prosecution shocked the business community because it represented a rare case of corporate executives held criminally responsible for actions committed by subordinates. The Department of Justice prosecutors relied on the RCO doctrine, which has historically been used for food- and drug-related offenses in cases in which companies have caused widespread health problems, to sentence executives at Quality Egg to three months in jail.

Business interest groups watched the case with interest, and the foundation filed a brief to overturn the decision after the case was upheld by an appellate court.

In its petition to the Supreme Court to take up the Quality Egg case, the Washington Legal Foundation called the responsible corporate officer doctrine 'a peculiar anomaly in criminal law' that allows imprisonment of corporate executives 'based on little more than his supervisory role in the company.' The foundation urged the Supreme Court to take up the case as an “opportunity to revisit the very notion of Park doctrine liability.”

"Little more than his supervisory role?"  Corporate executives command huge compensation specifically justified by their "supervisory" role.

The Intercept provided more detail about the role of Purdue Pharma leadership in this challenge,

According to a former Washington Legal Foundation official, an attorney with Purdue Pharma reached out to thank them for the work being done on the RCO doctrine. Another former foundation employee noted that the Washington Legal Foundation has long worked to weaken the doctrine, and that Purdue Pharma was one of several donors that had supported the effort.

While the foundation says all of its funding comes in the form of unrestricted grants, former employees told The Intercept that donors had effectively influenced briefs and others filings made by the Washington Legal Foundation. Connie Larcher, president of the foundation, has long coordinated the nonprofit’s legal strategy in close coordination with donors, the sources said. Some of the Purdue Pharma money was intended to promote the legal strategy around the RCO doctrine.

Asked for comment, Purdue Pharma did not speak directly to the relationship with the Washington Legal Foundation.

The Intercept also provided more details about the ongoing relationship between Purdue Pharma leadership and the Washington Legal Foundation,

Ties between Washington Legal Foundation and Purdue Pharma were reported by The Intercept in 2015 in a story detailing how the foundation had helped Purdue Pharma attempt to block the Centers for Disease Control and Prevention from issuing voluntary guidelines to discourage the overprescription of opioid narcotics.

Last week, Sen. Claire McCaskill, D-Mo., confirmed the prior relationship and released a report revealing that Purdue Pharma had donated $500,000 to the Washington Legal Foundation. The report noted that the foundation had taken the unusual step of lashing out at the CDC opioid guidelines.

Finally, the Intercept suggested that the Washington Legal Foundation

has long faced accusations in the past that the nonprofit operates as a legal front for corporations to undercut public health and safety standards.

The group figured prominently in the tobacco wars that raged throughout the ’90s. The group routinely filed briefs supporting the tobacco industry’s lawsuits challenging government regulations on tobacco products. A 1994 memo by Philip Morris executive Roy Marden noted that he was '[w]orking with the Washington Legal Foundation (WLF) in the development of a strategy to counteract and attack the efforts of the antis,' a reference to public health advocates. The group also sponsored advertisements criticizing 'anti-smoking zealots in government' without disclosing that the group was being funded by several major tobacco firms.

So this suggests that leaders of large health care corporations have actively attempted to preserve their impunity.  Furthermore, their methods have been aimed not just at increasing their personal impunity, but the impunity of all corporate leaders, which has implications beyond health care. In that they resemble efforts of leaders of other big corporations, like tobacco companies, to combat specific regulations by campaigning against regulation in general.  Finally, they have deliberately obscured their efforts to dodge responsbility by using third parties paid with concealed funds.

Summary

The Intercept noted that the strategy employed by Purdue Pharma and the Washington Legal Foundation to change the results of DeCoster vs United States failed.  However, this case raises the possibility that health care and other corporate leaders are using other deceptive strategies to preserve their own impunity in other contexts.  Furthermore, these strategies could have the effect of increasing impunity widely for other corporate and top organizational leaders, thus reducing deterrence of corruption.   If we ever want to have really responsible corporate leaders, we will have to uncover the schemes current leaders use to avoid responsibility and maintain impunity.

Meanwhile, there is justified public anger about the narcotic (opioid) epidemic, and in the works are multiple legal cases against the drug companies that sold and aggressively marketed these drugs.  Will any hold responsible the drug company executives who presided over these companies?  As the man said, we will see....

To conclude with the usual exhortation,

True health care reform requires well-informed leaders who uphold health care professionals' values, put patient's and the public's health ahead of all other considerations, avoid self-interest and conflicts of interest, are honest and ethical, and surely are not corrupt.  They need to work in the context of a government that is of, by and for the people, not of, by and for a demagogic leader.

Follow the Money: Nominee for Secretary of Health and Human Services Traded Health Care Stocks and Owned Tobacco Stocks While in Congress

At least the US president-elect seems to be making the problems of conflict of interests and health care corruption less anechoic.

Dr Price's Stock Portfolio

The latest relevant big story was first picked up by Sheila Kaplan writing in Stat. It seems that Dr Tom Price, once a practicing orthopedic surgeon, then a Congressman, and now Mr Trump's pick for Secretary of DHHS, owned and owns lots of health care related stocks:

his stock portfolio includes investments in pharmaceutical, medical device, and health insurance companies, the heart of the industries he would be overseeing as secretary.

In particular,

Among Price’s holdings are some in Innate Immunotherapeutics, Ltd., a biomedical company in which another lawmaker is a major shareholder. According to his financial disclosure statements, on Aug. 31 he bought between $50,001 and $100,000 worth of stock the firm.

Representative Chris Collins, a New York Republican, is a director of the company, which develops drugs to treat multiple sclerosis. He lists assets in the firm worth between $5,000,001 and $25 million. Price also purchased a smaller amount of stock in Innate Immunotherapeutics in 2015.

Collins is also a member of Trump’s transition team.

In March, Price invested between $1,001 and $15,000 in Amgen; Eli Lilly and Co.; Pfizer; Biogen; Bristol-Myers Squibb; Zimmer Biomet, a medical device company; Aetna; and Athenahealth. Also that month, Price sold the same amounts in Gilead, Abbott Laboratories, and Thermo Fisher Scientific.

So for readers of Health Care Renewal, this is very familiar.  We have discussed ad infinitum the conflicts of interest that may affect physicians, particularly due to financial relationships with big health care corporations.  The issue is that physicians swear oathes to put the health of their individual patients first, and to support the public health in general.  Yet the interests of, for example, drug, biotechnology, device companies may be at odds with this primary mission.  Such companies in this age of promoting "stock holder value" may primarily be about increasing revenue by selling as much of their products as they can, and let the Devil take the hindmost.  Yet physicians ought to use drugs and devices judiciously, and only when their benefits for individual patients outweigh their harms.  The concern is that physicians who have financial interests in such and other health care related companies may consciously or unconsciously allow their professional decisions to be influenced by their personal financial advantage.


Dr Price appears to be a member of the US House of Representatives full time, and no longer a practicing physician.  But he has not relinquished is Georgia medical license (look here).  So he should still be bound by his oath as a physician.

Dr Price's Active Stock Trading

But wait, there's more.  Last week, the Wall Street Journal noted that Dr Price was not simply a long-term owner of stocks, he was an active trader.   

President-elect Donald Trump’s pick to run the Health and Human Services Department traded more than $300,000 in shares of health-related companies over the past four years while sponsoring and advocating legislation that potentially could affect those companies’ stocks.

Rep. Tom Price, a Georgia Republican, bought and sold stock in about 40 health-care, pharmaceutical and biomedical companies since 2012, including a dozen in the current congressional session, according to a Wall Street Journal review of hundreds of pages of stock trades he filed with Congress.

In the same two-year period, he has sponsored nine and co-sponsored 35 health-related bills in the House.

His stock trades included Amgen Inc., Bristol Myers Squibb Co., Eli Lilly & Co., Pfizer Inc. and Aetna Inc.

This raises more issues.  First, that Dr Price was actively trading these stocks suggests that his financial holdings might have been more salient to him than, say, a long-term investor who just buys stocks and puts them away in a retirement portfolio.  This increases the likelihood that his stock holdings, and their recent performance, may well have influenced his decision making.

Moreover, this emphasizes that we should be concerned not so much about the effect of financial relationships on Dr Price's clinical decisions - in fact, it appears that he is a full time Congressman, and hence is not practicing - but on his decision making as a national legislator with considerable influence on health policy and the public health.  As a congressman, Dr Price also took an oath to "support and defend the Constitution of the United States against all enemies, foreign and domestic; that I will bear true faith and allegiance to the same; that I take this obligation freely, without any mental reservation or purpose of evasion, and that I will well and faithfully discharge the duties of the office on which I am about to enter."  So the concern is that the immediate profitablity of his actively traded stock portfolio might influence how Dr Price legislates.


As the WSJ article noted,

Mr. Price, an orthopedic surgeon who chairs the House Budget Committee, has played an influential role in shaping health legislation. He sits on the Ways and Means Committee’s health panel, which oversees Medicare. He also is a member of the Republicans’ Congressional Health Care Caucus that has called for repeal of the Obama administration’s landmark health overhaul.

Beyond just the issue of conflict of interest is that of Dr Price's apparent comfort with the ethical and sometimes criminal track records of the companies from whose stocks he appears to have profited.  We on Health Care Renewal have been documenting the ethical misadventures, and sometimes crimes committed by large health care organizations which claim they operate for the good of patients and the public, but seem more to operate for the benefit of their insiders, particularly top management.  Many of the companies held by Dr Price have lengthy lists of such bad behavior.  See the links above to some  individual companues for many more, sometimes sordid details.

If Dr Price, who is not only a physician but a legislator with significant influence on health policy, is unaware of these companies' track records shame on him.  If he owned these stocks with full knowledge of the companies' track records, more shame on him.

Dr Price's Tobacco Stocks

But wait, there's more. 

The WSJ article also noted:

Mr. Price also has traded in shares of ... tobacco stocks, including Altria Group Inc., whose products are regulated under the Food and Drug Administration, a part of HHS.

An article in Wired implied that Dr Price's tobacco holdings may have affected his legislative decision making.  Price voted against

a law that now requires the FDA to regulate tobacco as a drug.

That now goes beyond just a relatively simple set of conflict of interest issues. At least drug, biotechnology, and device companies make products meant to benefit patients and the public's health, if used properly and judiciously.  For that matter, insurance companies, like Aetna, are supposed to help patients afford needed medical care.

But tobacco companies are different.  Although they are legal in the US, there is overwhelming evidence that their products are harmful to health, and this harm is not outweighed by any health benefits, nor any benefits to society other than the money tobacco companies can make from them.  Most doctors now would recommend their patients stop smoking and, if they are not smoking, never start to smoke.  It is extremely hard to reconcile Dr Price's professional status and his ownership of tobacco stocks.

A physician legislator with a powerful role in health policy owning tobacco stocks may appear to be abusing his entrusted power for private gain.  That is the ethical definition of corruption used by Transparency International (although it is not a legal definition.)  No wonder that in a commentary in New York Magazine on Dr Price's stock holdings suggested that they mean in Dr Price's eyes

The appearance of corruption is totally fine.

Conclusions


Mr Trump's ongoing behavior does have some silver linings.  It is making the public more aware of the dangers of conflicts of interest and corruption, not just in health policy or health care. And it is also making the public aware how we have to follow the money, all the money that flows around our new plutocrat-in-chief to be, and his rich and well connected cronies.

If we cannot restrain the increasing pile of conflicted and possibly corrupt political appointments, we will be in for much worse than the health care dysfunction Health Care Renewal has been lamenting for more than 10 years.  

With 10 Health Care Executives on it Board, US Chamber of Commerce Defends Big Tobacco Abroad

Tobacco, especially smoked in cigarettes, is generally recognized by health care professionals as having health hazards that greatly outweigh its benefits to society.  Therefore, most health care organizations discourage tobacco use, and many have developed tobacco free policies.

However, the tobacco industry has its powerful supporters.  A recent NY Times investigative report, and a report entitled "Blowing Smoke for Big Tobacco," documented how the US Chamber of Commerce has defended the interests of tobacco companies overseas.  The apparent paradox here is that the leadership of the US Chamber of Commerce includes leaders of large health care organizations.  So far this paradox has not been explained by the parties involved.

How the US Chamber of Commerce Promotes Tobacco Interests Abroad

The NY Times Articles

On June 30, 2015, the NY Times published a wide ranging report on the pro-tobacco activities of the US Chamber of Commerce,

From Ukraine to Uruguay, Moldova to the Philippines, the U.S. Chamber of Commerce and its foreign affiliates have become the hammer for the tobacco industry, engaging in a worldwide effort to fight antismoking laws of all kinds, according to interviews with government ministers, lobbyists, lawmakers and public health groups in Asia, Europe, Latin America and the United States.

The U.S. Chamber’s work in support of the tobacco industry in recent years has emerged as a priority at the same time the industry has faced one of the most serious threats in its history. A global treaty, negotiated through the World Health Organization, mandates anti-smoking measures and also seeks to curb the influence of the tobacco industry in policy making. The treaty, which took effect in 2005, has been ratified by 179 countries; holdouts include Cuba, Haiti and the United States.

Facing a wave of new legislation around the world, the tobacco lobby has turned for help to the U.S. Chamber of Commerce, with the weight of American business behind it. While the chamber’s global tobacco lobbying has been largely hidden from public view, its influence has been widely felt.

Letters, emails and other documents from foreign governments, the chamber’s affiliates and antismoking groups, which were reviewed by The New York Times, show how the chamber has embraced the challenge, undertaking a three-pronged strategy in its global campaign to advance the interests of the tobacco industry.

In the capitals of far-flung nations, the chamber lobbies alongside its foreign affiliates to beat back antismoking laws.

In trade forums, the chamber pits countries against one another. The Ukrainian prime minister, Arseniy Yatsenyuk, recently revealed that his country’s case against Australia was prompted by a complaint from the U.S. Chamber.

And in Washington, Thomas J. Donohue, the chief executive of the chamber, has personally taken part in lobbying to defend the ability of the tobacco industry to sue under future international treaties, notably the Trans-Pacific Partnership, a trade agreement being negotiated between the United States and several Pacific Rim nations.

'They represent the interests of the tobacco industry,' said Dr. Vera Luiza da Costa e Silva, the head of the Secretariat that oversees the W.H.O treaty,...

The NYT asked the Chamber of Commerce for a response, and got only

The U.S. Chamber issued brief statements in response to inquiries. 'The Chamber regularly reaches out to governments around the world to urge them to avoid measures that discriminate against particular companies or industries, undermine their trademarks or brands, or destroy their intellectual property,' the statement said, adding, 'we’ve worked with a broad array of business organizations at home and abroad to defend these principles.'

The chamber declined to say if it supported any measures to curb smoking.

"Blowing Smoke for Big Tobacco"

Two weeks after the first NY Times article, a group of nine organizations including Campaign for Tobacco Free Kids, Corporate Accountability International, and Public Citizen released a report on the US Chamber of Commerce pro-tobacco actions. A summary article in the Huffington Post written by representatives of the latter two organizations included,

Our report and a two-part New York Times investigation shows that, while the Chamber throws its weight around in many Global South countries to protect its corporate members' interests, Big Tobacco has also pushed it to adopt particularly aggressive and radical positions in order to undermine the cascade of public health laws being passed as a result of the success of the global tobacco treaty.

In particular,

For tobacco control advocates familiar with this deadly industry's tactics, the Chamber's work in this space comes as no surprise. Internal documents tell us that as the tobacco industry lost its public credibility, it began to use third parties to advocate on its behalf.

Case studies in our report, from Africa to Latin America, make it clear that Big Tobacco is doggedly pursuing this strategy with the U.S. Chamber and its affiliates in Global South countries. In countries the tobacco industry has targeted around the world, the Chamber is delivering threatening letters that cast doubt on the science behind tobacco control, exaggerating exaggerate the economic impacts repercussions of proven measures like tobacco taxation and crying wolf about explosions in illicit trade. In pursuing these actions, the Chamber and its AmCham affiliates are exporting well-documented tobacco industry tactics to block health laws around the globe.

And as the New York Times points out in its investigation, (and then advocates that countries resist in their recent editorial: Tarred by Tobacco), these tactics are in some cases drafted by Big Tobacco executives themselves.

Who Runs the US Chamber of Commerce?

A 2010 MotherJones article noted that the US Chamber of Commerce as having a "name that evokes Main Street and Little League teams," and its history of "taking a moderate, nonpartisan approach."  So who is responsible for the US Chamber of Commerce becoming a tobacco advocate, at least outside of the US?

First, the Chamber has become more the creature of the biggest corporations than small businesses.  The MotherJones article noted that recently

The Chamber's politics became synonymous with its biggest corporate donors.  [Chamber President Tom] Donohue established special accounts for companies that feared taking controversial public stands, allowing them to anonymously funnel money to the Chamber, which advocated on their behalf.

Furthermore,

The Chamber claims that 96 percent of its members are small businesses, yet its self-seleted board includes just 6 representatives from small businesses, 1 from a local chamber, and 111 from large corporations.

Among these large corporations, tobacco corporations seem to be particularly influential.  The NY Times article noted,

The increasing global advocacy highlights the chamber’s enduring ties to the tobacco industry, which in years past centered on American regulation of cigarettes. A top executive at the tobacco giant Altria Group serves on the chamber’s board. Philip Morris International plays a leading role in the global campaign; one executive drafted a position paper used by a chamber affiliate in Brussels, while another accompanied a chamber executive to a meeting with the Philippine ambassador in Washington to lobby against a cigarette-tax increase. The cigarette makers’ payments to the chamber are not disclosed.

Yet the Chamber's governance also ostensibly includes health care viewpoints.  Its current board includes 10 member who are executives of large health care organizations:

- Richard Bagger Senior Vice President, Corporate Affairs & Strategic Market Access, Celgene Corporation, [biopharmaceutical company] Summit, NJ
- John Cannon Executive Vice President & Chief Administrative Officer, Health Care Service Corporation, [health insurance company] Chicago, IL
- Ken W. Cole Senior Vice President, Government Relations, Pfizer, Inc., [pharmaceutical company] Washington, DC
- Wayne S. DeVeydt Executive Vice President and Chief Financial Officer, Anthem, Inc., [health insurance company, formerly Wellpoint] Indianapolis, IN
- Ralph de la Torre, MD Chairman and CEO, Steward Health Care System LLC, [for-profit hospital system, owned by Cerberus Capital Management] Boston, MA
- Fuad El-Hibri Executive Chairman, Emergent BioSolutions Inc. [biopharmaceutical company] Gaithersburg, MD
- Daniel F. Evans, Jr. President & Chief Executive Officer, Indiana University Health, [non-profit hospital system] Indianapolis, IN
- Gregory Irace President and Chief Executive Officer, Sanofi US Services Inc., [US subsidiary of French pharmaceutical company] Bridgewater, NJ
- Paul J. Klaassen Founder, Sunrise Senior Living, Inc., [for-profit provider of nursing care, hospice care, etc] Arlington, VA
- Elaine R. Leavenworth Senior Vice President, Chief Marketing and External Affairs Officer, Abbott Laboratories, [pharmaceutical and device company] Abbott Park, IL

These organizations ostensibly are all about promoting or sustaining individual or population health.  Executives of these organizations serving on the board of the US Chamber of Commerce are responsible for the governance and stewardship of the Chamber.  How could they square the missions of the organizations which the lead, and their responsibility for the Chamber's pro-tobacco stance?

The Health Care Organizations Dodge the Question

The answer to that question is elusive.

The NY Times article stated,

It is not clear how the chamber’s campaign reflects the interests of its broader membership, which includes technology companies like Google, pharmaceutical giants like Pfizer and health insurers like Anthem.

An accompanying NY Times editorial added,

Health insurance and hospital companies that are members of the U.S. Chamber of Commerce find themselves in an uncomfortable situation. Publicly, these companies support policies designed to reduce smoking, but the chamber, as Danny Hakim recently reported, has opposed anti-smoking measures around the world.

The controversy appears to have surprised health-related businesses like Anthem, one of the nation’s biggest health insurers, and Steward Health Care Systems of Boston, which have executives on the board of the chamber. 'If the chamber is in fact advocating for increased smoking, we do not agree with them on this public health issue,' a spokeswoman for Steward said in a statement to The Times.

In an article in the Indianapolis Business Journal, J K Wall recounted how he tried to get a substantive response to the NY Times article from Indiana University Health, whose President is on the Chamber board,

Indiana University Health CEO Dan Evans is one of the most anti-smoking health care executives I know.

Just a few months after I started covering health care for IBJ in 2007, Evans told me in an interview that Indiana employees 'should snatch the cigarettes out of their co-workers mouths and say, ‘Hey, you’re costing me money!’'

However, Evans was not available, and the only response was this statement from a spokesperson

We are proud of the many programs we have in place for smoking prevention and cessation, as well as health promotion and screenings for our team members, patients and members of the community. IU Health has been and will continue to be a leader in Indiana to prevent and curtail the use of tobacco products.

IU Health is a member of many diverse state and national organizations to support our public policy goals including the U.S. Chamber of Commerce and the Indiana State Chamber of Commerce. We are talking with U.S. Chamber leadership about the facts surrounding recent stories in the NY Times and will strongly encourage the U.S. Chamber to review its international programs to ensure they are consistent with its own stated policy to oppose smoking and promote wellness.

Similarly, a follow up story in the New York Times documented this response from Anthem, (formerly Wellpoint), whose Executive Vice President and CFO is on the Chamber board,

Anthem said it was 'dedicated to helping people quit smoking and has led the charge to end tobacco use.'

'Anthem has shared its strong, longstanding position with the chamber and will continue to address our concerns with the chamber directly,' the statement said.

Likewise, the Times noted this response from

Greg Thompson, a spokesman for the Health Care Service Corporation, said in a statement last week: 'We are convinced that ending smoking may help people live longer, enjoy a better quality of life and reduce costs in our health care system.'

'This is a point of view we have advocated for decades and made clear to organizations that we support.'

Those seem to be the only public responses from companies whose leadership is represented on the Chamber of Commerce board. They all ignored the main issue.  None of them seemed informed by the role their companies' executives on the Chamber of Commerce board play.  None of the executives or the companies for whom they worked acknowledged any accountability for the Board's vigorous foreign campaign of pro-tobacco activities.

The Times did note that Chamber of Commerce member CVS, which is not specifically represented on the Chamber board, and which recently stopped selling tobacco products, withdrew from Chamber membership. But as a simply a member of the Chamber, it had little direct responsibility for the Chamber's actions.

Discussion

US health care is increasingly dominated by large organizations.  Most of these organizations like to portray themselves as warm and fuzzy supporters of individual and population health.  For example, Pfizer has a statement of responsibility which begins

As a member of today’s rapidly changing global community, we are striving to adapt to the evolving needs of society and contribute to the overall health and wellness of our world.

Anthem's statement includes

Anthem is dedicated to delivering better care to our members, providing greater value to our customers and helping improve the health of our communities.

Yet on Health Care Renewal, we have documented actions by leaders of health care organizations that directly contradict their lofty mission statements, and may have threatened patients' or the public's health.

In its aggressive international promotion of tobacco interests, the US Chamber of Commerce appears to be promoting the use of products that directly threaten individual's and the public's health.  Even though the Chamber protested that it was merely reaching out

to governments around the world to urge them to avoid measures that discriminate against particular companies or industries, undermine their trademarks or brands...

their protestation ignored how tobacco is a different product than that of nearly all industries.  It seems inherently dangerous to patient's the and public's health even when used as intended, and has no known health or societal benefits that even partially compensate for its risks.  Therefore, what is the argument not to discriminate those who make and promote such an inherently dangerous product from those who make products that do not threaten health, or provide obvious benefits that may compensate for their risks?

It is obvious why tobacco companies might want the Chamber's support.  What, however, could be the rationale for executives of corporations pledge to promote health to preside over the international promotion of tobacco?

The executives on the Chamber board, and their companies have not as yet even tried to provide an answer.

Thus, in the absence of better responses, in my humble opinion the presence of health care executives on the US Chamber of Commerce board is another example - an important one - of mission-hostile actions by top leaders of US health care organizations.

As we have said far too many times - without much impact so far, unfortunately - true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.

Smart ALEC's Strange Bedfellows

 A number of articles in the Nation, plus posts by some of our blogging colleagues discussed the American Legislative Exchange Council (ALEC) and its role in policy, including health policy advocacy.  The lead article, "ALEC Exposed," in the Nation, characterized ALEC as:

a critical arm of the right-wing network of policy shops that, with infusions of corporate cash, has evolved to shape American politics. Inspired by Milton Friedman’s call for conservatives to 'develop alternatives to existing policies [and] keep them alive and available,' ALEC’s model legislation reflects long-term goals: downsizing government, removing regulations on corporations and making it harder to hold the economically and politically powerful to account. Corporate donors retain veto power over the language, which is developed by the secretive task forces. The task forces cover issues from education to health policy.

ALEC and Health Care Reform
Wendell Potter contributed an article about ALEC's position on health care reform. First,

ALEC crafted the Freedom of Choice in Health Care Act, which, despite its Orwellian name, was written to deny the citizens of any state that passed it the freedom to set up such a system. By declaring that Congressional attempts to regulate health insurance at the federal level would be unconstitutional, it would effectively ban not only a federal single-payer proposal but also a federally created health insurance exchange and a federally operated public insurance option.

ALEC

adopted a strategy to shape rather than stop reform. Its top five goals became:

§ Keeping single-payer proposals off the table;

§ Ensuring that the final bill contain a clause requiring all Americans not eligible for an existing federal program to buy coverage from a private insurance company; [note that thus the "mandate" that pseudo-conservative groups like the Tea Party hate seems to have been pushed by big commercial insurance firms, and by some of the Tea Party's backers, not by the "big government" the Tea Party also loves to hate]

§ Preventing the new law from establishing a government-run plan (the 'public option') that would compete with private insurers;

§ Making sure that the reform law is implemented primarily at the state level, to keep the federal government from assuming any significant new oversight of private insurers’ business practices; and

§ Keeping any new regulations and consumer protections to a minimum.

Insurers achieved their first four goals, with ALEC playing a key role in a well-coordinated effort to keep the most progressive proposals from being enacted at the state or federal level.

Corporate Funders and Influencers
The articles in the Nation suggest that ALEC's health policy advocacy is shaped only by commercial health care insurance. However, it appears that ALEC is supported by a much broader spectrum of health care corporations and other corporations whose products affect health care. It's "Private Enterprise Board" includes Mrs Sandra Oliver, First Vice Chairman, Bayer Corp; Mr John Del Giorno, Second Vice Chairman, GlaxoSmithKline; Mr David Powers, Treasurer, Reynolds American; and Board Members Mr Don Bohn, Johnson and Johnson, Mr Jeffrey Bond, PhRMA, and Mr Michael Hubert, Pfizer.

A PRWatch special report on its funding noted:

98% of ALEC's funding comes from corporations like Exxon Mobil, corporate 'foundations' like the Charles G. Koch Charitable Foundation, or trade associations like the pharmaceutical industry's PhRMA and sources other than 'legislative dues.'

In more detail,

Other current ALEC corporate leaders have given an undisclosed sum to ALEC this year and before.

These companies include: CenterPoint 360 (a firm that helps companies 'manage legislation'), Altria (formerly Phillip Morris tobacco), the American Bail Coalition (the trade group for for-profit bail bonds), AT&T, Bayer (aspirin), Coca-Cola, Diageo (Crown Royal and other liquor), Energy Future Holdings (Texas electricity), ExxonMobil, GlaxoSmithKline (Tums and other brands), Intuit (Quickbooks), Johnson & Johnson (lotion), Koch Industries (Georgia Pacific paper products and other brands), Kraft Food (Macaroni and Cheese dinners), Peabody Energy (the largest private coal company in the world), Pfizer (Viagra), PhRMA (the pharmaceutical trade group), Reed Elsevier (Lexis/Nexis legal research), Reynolds American (tobacco), Salt River Project (energy), State Farm Insurance, United Parcel Service, and Wal-Mart (world's largest retailer).

So ALEC supporters include some very strange bed fellows.

Commercial Insurance in Bed with Pharma
ALEC has championed health care positions that seem designed to favor commercial health insurance.  However, it is supported by many corporations with which commercial health insurance ostensibly negotiates at arms length, and whose prices commercial health insurance ostensibly wants to lower.  These include pharmaceutical companies, Bayer, GlaxoSmithKline, and Pfizer, and pharmaceutical/ biotechnology/ device conglomerate Johnson and Johnson, all represented by PhRMA. 

It is very curious, to say the least, that such companies are helping to fund a set of policy objectives all designed to further the interests of commercial insurance companies as listed above.  Perhaps the leaders of drug companies think that commercial insurers are likely to be easier negotiators than would be some future hypothetical "public option," (government run insurance company).  Perhaps the leaders of commercial insurance companies realize that they can more plausibly raise their administrative costs, and the amounts they pay to top executives, when overall health care costs, fueled by pharmaceutical and device prices, are rising.

A UK Company in Bed with American State Legislators

ALEC is supposed to be directed at American state legislatures, and be a membership organization for American state legislators.  It literally includes a graphic of a waving American flag on its home page.  However, it is supported by at least one foreign (UK) pharmaceutical company, GlaxoSmithKline. 

It is very curious that a British company seems to be seeking to influence the US state legislative process. The appropriateness, and the legality of a British company seeking to influence American state legislatures I leave to be judged by others. 

Pharmaceutical Companies (Including Those that Make Smoking Cessation Products) in Bed with Tobacco Companies

ALEC is supported by pharmaceutical companies that all promise to improve health care.  These particularly include those that make or sell products that are designed to improve health by aiding smoking cessation, (GlaxoSmithKline, Johnson and Johnson, and Pfizer).  However,by their side stand two tobacco companies, Reynolds America and Altria, whose products the pharmaceutical companies' products are designed to counter. 

It is very, very curious that smoking cessation product manufacturers would team up with tobacco companies.  Perhaps cynics among the leadership of the drug companies realize that the market for smoking cessation products increases with tobacco sales.  Perhaps cynics among the leadership of tobacco companies think that the knowledge that there are treatments, albeit not very effective ones, to aid in smoking cessation may encourage people to start or continue smoking (an interesting but rarely discussed example of the "moral hazard" that free market economists love to otherwise discuss).  

Summary

So in my humble opinion, the strange bedfellows among health care related corporations funding ALEC suggest 1) how little the health care system functions like anything resembling an ideal free market; and 2) how top organizational leaders may have feel they have more in common with each other than they do with their more lowly employees, customers, clients, and the public at large.

True health care reform would require decreasing the size and power of large health care organizations, and ensuring that their leaders put their mission, and their patients' and the public's health ahead of their personal enrichment.

Hat tip to Naomi Freundlich's post on the Health Beat blog.

Where There's Smoke? ... A University President Who Simultaneously Lead a Failed Financial Company and a Tobacco Company Which Apologized for International Bribery

A long time ago, in 2006, we first blogged about a "new species of conflict of interest" which we thought might prove to be even more important than those afflicting health care that were then starting to be discussed.  This involved health care organizational leaders who were simultaneously members of the boards of directors of for-profit health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   Thus, for example, the conflict posed by the president of a university, to whom a medical school and academic medical center report, who also is the director of a pharmaceutical company, would be extreme.

Since then, we noted yet another variant on this theme, university presidents who were supposedly the top leaders of failed financial firms, and then who did various dances to try to avoid accountability for these firms' fates.  That theme recently made it to the big time, a front page article on the Sunday Business section of the New York Times.

The most extreme version was the case of that of Eugene Trani, the former President of Virginia Commonwealth University ( full disclosure: I spent 7 years on the faculty of its medical school, and am still an adjunct faculty member).  Trani turned out to be on the board of a tobacco company, and soon after this was revealed, retired from the presidency (see most recent blog post here).

Now a Washington Post blogger has yet another twist on this case:

Eugene P. Trani left the presidency of Virginia Commonwealth University in 2009 after improving the school and expanding its presence in downtown Richmond. But Trani was also a director of LandAmerica Financial Group, a Richmond-area title insurer that went belly-up in 2008, taking with it millions in investors' money.

Today, Trani is on the board of Richmond-based Universal Corporation, a global tobacco marketer. Universal's subsidiaries have just agreed to pay $8.98 million in a tobacco bribery scandal that stretches from Brazil to Thailand to Africa. The firm has issued a public apology. Trani received $159,032 in total compensation for his board service.

So Trani was not only on the board of directors of a tobacco company, he was on the board of directors of a tobacco company that was forced to settle charges of international bribery and issue apologies for same, and just to ice the cake, was on the board of a failed financial company whose failure affected residents of the locality which his university served.

As the saying goes, "the fish rots from the head down."  How can academic leaders expect integrity from their faculty when they willingly take on such grotesque conflicts?  Leaders who thus try to serve two, or many masters are likely to run health care organizations that do not serve their primary constituents, patients who expect good care, learners who expect honest, competent teaching, and the public who expects important, unbiased research, well.  If we really want to reform health care, we need leaders who put the mission, not their own pocketbooks, prestige, and cronies, first.

"Smoke Detector" - Medical Center Leader (and Former Biotech CEO) Outed as Tobacco Investor

Last year we posted about the seemingly incongruous choice of a wealthy biotechnology executive with little academic or practice experience to run the prestigious University of California - San Francisco, a health oriented university housing a respected medical school.  We wondered whether her corporate background would make it difficult to uphold the university's academic and patient care missions.

In line with our concerns, Duff Wilson, writing in the New York Times, reported:

When Dr. Susan Desmond-Hellmann was named chancellor of the University of California, San Francisco, last summer, she took over a medical institution focused on world health generally and tobacco control in particular.

But she forgot one thing in adjusting to her new role: personal stock holdings listed last year in the range of $100,000 to $1 million in Altria, owner of Philip Morris USA, the maker of Marlboro cigarettes. Altria has been blamed for thousands of deaths and repeatedly criticized by the Center for Tobacco Control Research and Education at the university.

Last week, a day after The New York Times inquired about the Altria stock, Dr. Desmond-Hellmann and her husband, also a doctor, ordered it to be immediately sold and imposed 'values screening' on their personal investments.

Experts on tobacco control were aghast:

Dr. Stanton A. Glantz, director of the university’s tobacco control center, said he was unaware of Dr. Desmond-Hellmann’s Altria stock, which was contained in a university filing but not made public until now, after a public records request by a former student who passed it on to The Times.

“I do find that kind of shocking, but at least she got rid of it,” Dr. Glantz said on Monday, adding that Dr. Desmond-Hellmann had been very supportive of the center.

Dr. Kenneth E. Warner, dean of the school of public health at the University of Michigan and a national antitobacco leader, said, “I find it frankly a bit appalling that the chancellor of a major medical center would have held such stock. It strikes me as unthinking, frankly.”

We should give Dr Desmond-Hellmann credit for selling her Altria stock as soon as its connotations were made plain to her. (And at least she was not on the board of a tobacco company, to our knowledge, as was one former president of a university and large health sciences center.)

However, this little incident underlines the clash between the culture that dominates large health care corporations and the mission of medical schools and academic medical centers. In the last 30 years, academic medicine has rushed to embrace the reigning corporate culture, not to mention corporate money. I submit that this embrace has been at the peril of the fundamental academic and patient care missions.

Academic medical leaders need to promote better patient care, and honest, responsible teaching and research. To do so, they may have to give up some of the glitz, glamor, and cash proffered by industry. If they do not make this sacrifice, they risk losing the trust of an increasingly skeptical, if not cynical public.

After Controversy Over Tobacco Money Funding Medical School, University President Steps Down

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) We later observed how little attention this subject has gotten in Richmond's major news outlet. Then, we noted that some university leaders were willing to open a public dialogue about the issue, thus exhibiting more transparency under criticism than has been shown by many other organizations. Most recently, we discussed how the Dean of the university's Medical School had allegedly actively sought grant support from Philip Morris for a center for research on women's health.

Today, the Richmond Times-Dispatch reported that VCU President Eugene Trani will step down next year. The article hailed Trani for his efforts to enlarge and expand the University. It also noted, however,

Trani was so intent on unifying the university in a shared mission that he forbid the mention of the Medical College of Virginia, renaming it the VCU Health System.

Furthermore, although the Times Dispatch has not published much about the controversy over the relationship between VCU and Philip Morris (see post here), it did acknowledge

But collaboration between VCU and Philip Morris also has stirred controversy because of the tobacco company's apparent level of control over research it sponsors through the university.

'The events of the summer are unfortunate,' [Professor of Political Science and Public Administration Blue] Wooldridge said, 'and would be a stain on [Trani's] legacy that didn't need to be there.'

A former president of the faculty senate, Wooldridge said he admires much of what Trani has done -- from building the engineering school to forging 15 alliances with universities in other countries -- especially while maintaining his own scholarship as a historian.

However, too often Trani hasn't considered the full costs to the university of his ambitions or listened to the informed opinions of others, Wooldridge said.

'I don't think the faculty has had their voices heard as much as they should.'

I hope that the impending retirement of President Trani will lead the VCU administration to rethink its apparent infatuation with cultivating tobacco as a source of funding for the medical school. The medical school's mission of promoting the health of individual patients, and the health of the public through teaching and research is ill served by financial arrangements with companies whose products only promote ill health.

Courting Tobacco Money

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) We later observed how little attention this subject has gotten in Richmond's major news outlet. Most recently, we noted that some university leaders were willing to open a public dialogue about the issue, thus exhibiting more transparency under criticism than has been shown by many other organizations.

This week's Richmond (VA) Style Weekly reported that there were plans for even greater ties between VCU and Philip Morris,

Virginia Commonwealth University officials have repeatedly denied the existence of a proposal to create a women’s health center funded by Philip Morris USA, but a draft copy of the proposal shows the idea did — and in some iteration still does — exist.

A copy of a working paper titled 'Proposal to Create the VCU Center for Health Pregnancy and Neonatal Outcomes,' obtained by Style Weekly, shows plans for a center focused on treatment and research into preventing defects, early birth and mortality.

Furthermore, it appeared that VCU leadership, not Philip Morris, initiated these plans,

In part, the memo obtained by Style reveals a plan for how VCU could solicit money from Philip Morris.

The seven-page proposal includes various attachments and is detailed down to budget projections for such specifics as bus and cab fare for participants. It concludes with a subheading titled 'Why Philip Morris USA should support this initiative.' The rationale for the pitch? 'Philip Morris USA will be investing in the future of the Richmond community,' and 'giving new meaning to ‘being well-born’.'

Pam Lepley, a university spokeswoman, says she was unaware of the proposal until contacted about it last week. During a July 16 community forum held on the medical campus, Dr. Francis L. Macrina, the school’s vice president for research, repeatedly denied knowledge of the proposal, saying that no proposal has ever existed.

Lepley now says the proposal is a working paper developed by the dean of the medical school, Jerry Strauss, but adds that it was not specifically aimed at attracting the financial support of Philip Morris.

'This is a draft proposal that Jerry Strauss was working on for any number of potential philanthropic providers,' Lepley says, calling it a working proposal that remains internal to the school. 'This is an initiative of Jerry Strauss’.'

The Richmond-based tobacco company is the only private corporation mentioned in the proposal and the only entity mentioned that is not the university or one of various governmental service providers foreseen as partners.

The assertion that the proposal has yet to see the light may not be worth a pack of smokes, either.

'This was a proposal that the dean of medicine shopped with Philip Morris,' says a medical school faculty member, speaking on condition of anonymity. 'Since all this has broken, [Strauss] has said [in meetings] that Philip Morris did not accept it or they did not fund it.'

We have previously discussed how medical school and academic medical center leaders often seem to care more about financial goals than the fulfillment of their clinical and academic missions. This can lead to pressure on faculty to raise research money from commercial sponsors, such as drug, biotechnology and device companies who have vested interests in having the research results favor their products. Medical schools and academic medical centers often seem so eager to get such money that they let the research sponsors control many aspects of the research, making it easier for them to manipulate the research to favor their products (see post here). Faculty pushed to work with commercial sponsors may be prone to become "key opinion leaders" who help the sponsors market their products.

All that is bad enough, but at least drug, biotechnology and device companies make products designed to treat, prevent, and sometimes even cure disease. In my humble opinion, medical school leaders fundamentally violate their institution's mission when they solicit money from a company whose products cause disease without providing any clinical benefits.

A Town Meeting About Tobacco-Funded Research in Academic Medicine

We have posted about the controversies arising from recently revealed research agreements between Richmond, Virginia based Virginia Commonwealth University (VCU) and tobacco company Philip Morris. These were first publicly discussed in May in a New York Times article. As we posted here, the main issues were that the research agreements themselves were secret; the agreements apparently gave Philip Morris control over all publications arising from the research, since they defined all products of the work as proprietary information belonging to Philip Morris; and that research for hire on behalf of a tobacco company, given that tobacco products have known severe health risks and no health benefits, seems to go against the mission of a medical school and academic medical center. We also noted that the university administration's apparent lack of qualms about its relationship with Philip Morris might have been related to its president's role as a leader of a tobacco company. (He sits on the board of Universal Corp, a tobacco buyer, processor, and distributor.) Finally, we just observed how little attention this subject has gotten in Richmond's major news outlet.

VCU just held a "town meeting" that allowed faculty and students to comment on or question this recent unpleasantness. The meeting was covered by Richmond.com, the Associated Press, and, to its credit, the Richmond Times-Dispatch. According to the latter,

Francis Macrina, vice president of research at Virginia Commonwealth University and chairman of a task force on corporate-sponsored research, told a gathering tonight that the university made a mistake in its deal with cigarette giant Philip Morris.

Macrina said a confidentiality clause in the deal appeared to offer secrecy to the company.

'It won't happen again,' he said during the town-hall meeting at the Kontos Building on the university's MCV campus. 'We will not enter into any agreements that support secrecy.'

An estimated 75 attended the meeting, and about 20 spoke, many declining to give their names.

'Transparency at VCU is pathetic,' said one speaker who did not identify herself.

Another speaker, a faculty member in the pharmaceutical sciences, defended corporate research in general.

'I've never had a situation in which I felt my integrity was endangered,' he said.

Some wondered how a confidentiality agreement could be reached with a corporation without halting the publication of research information.

'That's a good question,' [Associate Dean of the School of Social Work Kia] Bentley said. The task force will address that, she said.

First, for what my opinions may be worth, I commend VCU for setting up this meeting, and setting up a task force to consider issues raised by the Philip Morris contracts. Second, I commend the Richmond Times-Dispatch and other media for covering it.

But I do wonder about how, at least according to the media reports, this meeting seemed to skirt some some of the issues involved. First, Vice President Macrina seemed not to be acknowledging just how comprehensive the secrecy provisions of the contract were. According to the original NY Times article,

The contract bars professors from publishing the results of their studies, or even talking about them, without Philip Morris’s permission. If 'a third party,' including news organizations, asks about the agreement, university officials have to decline to comment and tell the company.

Second, at least the Richmond Times-Dispatch coverage seemed to soft-pedal Philip Morris' control over publication of research results. Again, according to the NY Times,

Philip Morris alone decides whether the researchers can publish because the contract defines 'without limitation all work product or other material created by V.C.U.' as proprietary information belonging to the company.

Finally, it is not clear whether the issue of the VCU President's simultaneous responsibilities to the share-holders of a tobacco company was even mentioned.

Perhaps these are quibbles, given that this university was at least willing to have a public discussion of this problem. Many of the issues involving mismanagement by and conflicts of interest affecting leadership of academic medicine that we have mentioned on Health Care Renewal have never been discussed in anything like a town meeting at the relevant institutions.

So I hope that VCU is making some progress towards making its clinical and health related research transparent in all respects, its design, implementation, analysis, reporting, and who funds it and under what agreements. It would be nice if some other academic medical institutions also could show some progress.

VCU, Philip Morris, and the "Recent Unpleasantness"

While I lived in Richmond, Virginia from 1987 to 1994, one could still find some people who referred to the US Civil War as the "recent unpleasantness." Similarly, we have noted the "anechoic effect," how cases involving deficient ethics, poor leadership, and flawed governance in health care occurs produce few echoes. Many important cases and issues that have been discussed on Health Care Renewal have never appeared in medical or health care journals. Many specific cases have never been publicly discussed at the institutions in which they originated. Some specific cases have never appeared in the national news media. Some specific cases have not been covered even in the relevant local news media.

Here is a case in point, from Richmond, Virginia. The Richmond Times-Dispatch, the only major newspaper in that city, just reported that the President of Virginia Commonwealth University (VCU), Eugene P Trani, is recovering from coronary artery bypass grafting (CABG) surgery. We wish President Trani a speedy recovery. But buried in that article is the only mention that has ever appeared in the Richmond Times-Dispatch of the recent unpleasantness about research contracts between VCU and tobacco company Philip Morris. Here it is:

Trani was scheduled to be on a two-month sabbatical at Harvard University's Taubman Center for State and Local Government through mid-August. In his note to the university community, he said he returned to Richmond after his first month because the university was 'experiencing a number of recent challenges.'

Recent controversies have brought VCU some unwelcome attention.

There have been questions about whether a research agreement with Philip Morris USA was in accordance with traditional accepted research guidelines and policy.

A university Task Force on Corporate Sponsored Research will hold a town-hall meeting tomorrow to hear from faculty and students on the research issue.

We have discussed this "recent challenge" on Health Care Renewal. Briefly, the New York Times reported last month that VCU has been doing research under contract with Philip Morris USA. Contract provisions forbade the university from even revealing the existence of the contract itself. By classifying all products of the research as "proprietary," the contract seemed to bar university faculty from publishing or publicly discussing the research without permission from Philip Morris. Such provisions apparently violated not only the university's stated policies, but its fundamental mission. Furthermore, it appeared that the university's coziness with Philip Morris might relate to its President's leadership role for a company in the tobacco industry. President Trani, it turns out, is on the board of directors of Universal Corp, which buys, processes, and ships tobacco. For a university President who also leads a medical school and academic medical center simultaneously to be responsible to the stock-holders of a tobacco company seems quite a major conflict of interest, given that tobacco products clearly cause much disease, disability, and death in the absence of any health benefits.

But to the Richmond Times-Dispatch, all this seems just to be some recent unpleasantness.

The cone of silence that seems to confine much unethical behavior, poor leadership, and poor governance in health care has disabled medicine's and society's ability to address these problems.

Key Opinion Leaders, Drugs for Smoking Cessation, and Transparency as a Cause of "Confusion"

A perspectives article from the April 1 issue of the Annals of Internal Medicine has provoked a slowly growing controversy. (1) Let me summarize the main points of the article before getting to the controversy.

As the title, "the case for treating tobacco dependence as a chronic disease," suggests, the authors argue "for some smokers, long-term pharmacotherapy [which] is the difference between tobacco abstinence and lifelong smoking," based on the argument that smoking is like a chronic disease.

They called for long-term use of pharmacologic treatments for tobacco addiction, including nicotine replacement therapy (NRT), buproprion, and verenicline, asserting that these drugs are safe and effective, and have "proven benefits." Such proven treatments, therefore, ought to be used long term.

Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed.

Rather than considering cessation medications as a short-term aid in smoking cessation, these medications should be covered in the same manner as the treatment of other long-term illnesses and conditions, such as asthma, depression, and diabetes....

However, their enthusiasm for pharmacologic treatment for smoking cessation, even in the short-term, seems to go beyond the evidence. That evidence shows that the "proven benefits" of these treatments do not accrue to the majority of patients receiving them. For example, in one widely disseminated study comparing verenicline, buproprion and placebo, the proportions of patients who were abstinent for one year (the duration of follow-up) were 21.9% for verenicline, 16.1% for bupropion, and 8.4% for placebo. Although the most effective drug, verenicline, more than doubled the continuous abstinence rate compared to placebo, the large majority of patients treated with that drug, 78.1%, did not achieve continuous abstinence, even for one year.(2) In another recent study, patients given verenicline were somewhat more likely to be abstinent at the end of a year (26.1%) than those treated with nicotine patches (20.3%), although the difference did not reach statistical significance.(3) However, again the great majority of patients treated with either medicine were not continuously abstinent, even for one year.

Thus, most smokers treated with drugs will not remain abstinent from smoking, even for one year. Furthermore, I am aware of, and Steinberg et al did not cite any data from controlled trials about the safety or effectiveness of any pharmacologic treatments of tobacco addiction for patients followed for more than one year. There is no reason to suspect that these drugs' effectiveness over the long-term would be any better than their rather marginal effectiveness when when used short-term.

In my humble opinion, Steinberg et al might have been able to make a case for controlled trials of these drugs' use that would follow patients for more than one year. But they presented no evidence to support the clinical use of these drugs, much less insurance company reimbursement for them, for time periods longer than those found in the published trials.

So why did these authors make arguments that went beyond the evidence?

Soon after the article came out, Adriane Fugh-Berman and Douglas Melnick, writing in the Bioethics Forum, noted:

The most important section of this article is the conflict of interest statement. The two authors who have advanced degrees are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline, and Celtic Pharma. Pfizer makes varenecline (marketed under the brand name Chantix) and Nicotrol, a nicotine nasal spray. GSK makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (buproprion, which GSK also sells as an antidepressant under the name Wellbutrin). Novartis makes Thrive, a nicotine chewing gum ('thrive,' which means to prosper or flourish, seems a rather peculiar association for a delivery system for an addictive drug.) And Celtic Pharma is developing TA-NIC, a nicotine vaccine.

Furthermore, last week, an article in BusinessWeek provided more information about the financial ties of two authors of the Steinberg et al paper.

In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix. The company also selected Foulds and Steinberg to be 'key opinion leaders,' sending them to talk to doctors about Chantix over fancy dinners and paying them each $900 per presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.

Steinberg received a $30,000 grant from Pfizer in April 2007 to study the effect of Chantix on patients forced to forgo cigarettes while hospitalized for other illnesses. He says this was his first research grant from a drug company. (The Robert Wood Johnson Foundation separately provided $300,000 for the hospital study.)

Steinberg, according to BusinessWeek, denied that he is influenced by his ties to Pfizer:

Adamant that his work for Pfizer and other drug companies poses no problem, he adds: 'We look at the data, and we look at our own clinical experience.'

While the authors disclosed the nature but not the effect size of their financial relationships in the Annals of Internal Medicine article, they were not so forthcoming to their patients. Per BusinessWeek,

Both doctors stress that it's not standard practice to tell patients about potential conflicts.

On the Web site for UMDNJ's smoking clinic, it's not easy for a layman to find disclosures. There is no clearly labeled list of companies that pay Foulds and Steinberg that is directly accessible from the home page. There are links to journal articles, some of which reveal industry ties. But getting the information takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix.

Foulds includes a broadly worded disclosure on his blog, but doesn't name companies for which he consults.

Finally, neither author saw the need to provide more disclosures to patients.

Telling patients more about industry ties 'would just puzzle them,' Foulds says.

Steinberg sees no need to be more forthcoming. His passion for helping people quit is fueled by treating numerous cases of high blood pressure and other problems precipitated by smoking.

To add a final touch, Cathryn M Clary, vice president for external medical affairs for Pfizer, "fears too much transparency will cause confusion,"

The more information that's out there, the more difficult it will be for patients to process

There has been a good deal of discussion about drug, biotechnology and device companies paying "key opinion leaders" to help market these products (for example, see these posts here and here). And there has been a good deal of indignation that it is an affront to physicians to judge the content of medical education they provide based on who paid for it (see this link.)

Although the case of the Annals article is essentially only an anecdote, it does suggest an association between payments to key opinion leaders, and opinions that are more enthusiastic about the payers' products than the evidence seems to warrant.

Furthermore, it suggests that key key opinion leaders and the companies who sponsor them may dismiss transparency about their financial relationships as a cause of "confusion." If patients really are too naive to understand the implications of payments by drug and other commercial firms to key opinion leaders, would the KOLs and their patrons prefer that government step in to protect these poor, naive patients from such relationships they cannot understand? That is what their attitude seems to invite.

References

1. Steinberg MG, Schmelzer AC, Richardson DL, and Foulds J. The case for treating tobacco dependence as a chronic disease. Ann Intern Med 2008; 148: 554-556. Link here.
2. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al. Verenicline, and alpha-4-beta-2 nicotinic acetylcholine receptor partial agonist, vs sustained release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006; 296: 47-55. Link here.
3. Aubin HJ, Bobak A, Britton JR, Oncken C et al. Verenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax 2008. Link here.