Showing posts with label boards of directors. Show all posts
Showing posts with label boards of directors. Show all posts

Friday, July 31, 2020

The Remarkable Case of the CEO of the Brigham and Women's Hospital Who Renounced a Major Conflict of Interest

Introduction; a Conflict of Interest Affecting the Trial of Moderna COVID-19 Vaccine

On July 17, 2020, the Brigham and Women's Hospital, a prestigious teaching hospital in Boston, announced it would be a major center for the randomized controlled trial of Moderna's mRNA based vaccine for COVID-19.  This would be the first of several eagerly awaited major RCT's of newly developed vaccines for this dangerous pandemic.  The press release noted that the hospital would be:
a clinical research site as part of the COVID-19 Prevention Network (CoVPN), funded by the National Institutes of Health. In addition, Lindsey Baden, MD, an infectious diseases specialist at the Brigham and an expert in vaccine development for viral diseases, will serve as co-principal investigator for the study.

The press release also included this disclosure:
Dr. Betsy Nabel, the president of Brigham and Women’s Hospital, has been a member of the Moderna Therapeutics Board of Directors since 2015 and has a financial interest in the company. Since its inception, this personal relationship has been reviewed and approved in accordance with Mass General Brigham conflict of interest policy and procedure, including a recent review in connection with the Phase 3 Study, and has been disclosed to the NIH/NIAID.

Although Dr Nabel would not directly participate in the trial, Dr Baden would apparently indirectly report to her as hospital CEO even though she would simultaneously be a board member of the company whose vaccine the trial was assessing. 

Another Example of What Was Once a "New Species of Conflict of Interest"

Thus Dr Nabel appeared to have a severe conflict of interest, the latest example of what we once called "a new species of conflict of interest."

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 in 2006, we discussed a "new species of conflict of interest." 
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.

As Robert AG Monks put it, board members must "demonstrate unyielding loyalty to the company's shareholders" [Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  (Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.).

Dr Nabel's position on the board of directors of Moderna appears to be another example of this "board-level" conflict of interest.

Dr Nabel Does the Right Thing

On July 30, in the Boston Globe, Jonathan Saltzman reported that Dr Nabel had renounced her board position:
Dr. Elizabeth Nabel, president of Brigham and Women’s Hospital, said Thursday she was resigning from the Moderna board of directors after the Globe inquired about whether her position at the Cambridge biotech company conflicted with her hospital’s leadership role in a large study of Moderna’s experimental COVID-19 vaccine.

In fact Dr Nabel made the announcement while Mr Satzman was in the final stages of writing his article.  I know this because he had interviewed me about her conflict of interest earlier in the day.  So I got to unexpectedly make a new comment:

She did the right thing, It eliminates one issue that could have led to unfounded skepticism about this trial, and this is a trial where people have to trust the results.

In fact, this is the only case I can recall in which a top leader of a academic health care institution resigned from a for-profit health care corporate board after the conflict of interest presented by board membership was publicly pointed out.

Furthermore, the Globe article noted:

After Nabel announced her resignation, the Globe asked Brigham and Women’s whether she intended to keep the $6.5 million she collected in the recent sale of her Moderna stock.

Erin McDonough, a hospital spokeswoman, said, 'Dr. Nabel is considering a number of options, including charitable contributions.'


As we had previously discussed on Health Care Renewal, board level conflicts of interest can be extremely lucrative.  A typical board member of a large health care corporation makes hundreds of thousands of dollars in salary, and can collect stock options and other financial instruments worth millions.  Such compensation is obviously  a strong incentive to continue the conflict of interest.  Yet here a board member is quitting, and at least  considering giving away millions of dollars worth of stock to nullify her conflict.  That is truly remarkable.

Perhaps in this age of a dangerous pandemic, and its continuing reckless mismanagement by the US president (for example, look here), health care leaders are thinking more about what is really important. As Mr Saltzman wrote:

Medical ethics experts said it was worrisome that the head of the Harvard-affiliated teaching hospital had a financial stake in the vaccine, particularly given that many people are already skeptical of vaccines. Recent public opinion polls show up to half of Americans are reluctant to get a COVID-19 vaccine when one is approved.

'Anti-vaxxers, critics, and kooks will use any appearance of financial conflict to undermine trust in vaccines,' said Dr. Arthur Caplan, a professor of bioethics at New York University Langone Medical Center. 'It’s just hyper-dangerous now.'


So it seems that Dr Nabel recognized the danger to the public, and to reduce it was willing to take action which would involve at least some degree of personal sacrifice.

We can only hope that others will follow her.  
 



Friday, April 07, 2017

"A Radical Idea for Health-Care Reform: Listen to the Doctors" - Oops, I Mean Listen to the Corporate Executives, Directors, and Lobbyists

It has been the season for health care reform in the US since at least the Nixon administration.  We have endlessly discussed the unholy triad of health care dysfunction: rising costs, declining access, and stagnant quality.

These days, with all the furor over whether Obamacare should be repealed and replaced, let alone, or improved, it is still the season for health care reform.  Last week an article by David Ignatius in the Washington Post entitled "A Radical Idea for Health Care Reform: Listen to the Doctors," appeared.   Since on Health Care Renewal we are all about trying to uphold physicians' professional values, I thought this deserved a closer look, with the hope that it would provide some down-to-earth wisdom from physicians in the real clinical world.

Background - Doctors Views on the Causes of Health Care Dysfunction


As we recently discussed, we began the project that led to the establishment of Health Care Renewal because of our general perception that physician angst was worsening (in the first few years of the 21st century), and that no one was seriously addressing its causes.  Our first crude qualitative research(1) suggested  that physicians' angst was due to perceived threats to their core values, and in turn that these threats arose from the issues this blog discusses: concentration and abuse of power, health care leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, deceptive or dishonest, self-interested, conflicted, or outright corrupt, and health care governance that lacks accountability, and transparency, . We have found hundreds of cases and anecdotes supporting these proposed causes of health care dysfunction. 

Other research provided some corroboration.  Written comments from a 2001 survey of Massachusetts physicians made similar points about the causes of dissatisfaction, for example: "too much emphasis on the bottom line.  Taken over by large corporations.  Quality of care and interaction now subsumed by productivity and profit," and "the once most noble profession has become a factory job with a facade of ethics"(2)  Pololi and colleagues' qualitative interviews of young medical faculty included anecdotes of angst due to academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain.(3)  (Also, see our comments on this paper.)(4)  Pololi and colleagues' large survey of US medical faculty showed that over half thought that managers were only interested in them because of the money they brought in.(5)   We were able to show in a preliminary analysis of data from a physician survey that an instrument meant to measure physicians' perception of the integrity of the leadership of their organizations, which incorporated questions about whether leaders supported core values, put patient care ahead of revenue, supported transparency about quality issues, put patient care ahead of self-interest, and displayed honesty strongly correlated (negatively) with stress, intention to leave the practice, and burnout.(6)

The Latest Attempt to Listen to the Doctors about Health Care Reform


Ignatius' WaPo article was based on the pre-publication version of a new report by the National Academy of Medicine, (formerly the Institute of Medicine) made available on its website, entitled, Vital Directions for Health and Health Care.  According to Ignatius' interpretation, the basic problem health care reformers need to address is that America "squanders money on the wrong things - expensive procedures and tests rather than preventive care and social programs."  His summary of the supposed doctor recommended cures for this problem were: 

First, providers should be paid for value — for patient outcomes, not for the volume of procedures. Second, incentives should empower people to take better care of themselves through wellness programs or lifestyle changes. Third, better connectivity is needed among doctors, patients and others to encourage data-driven advances. Finally, the Academy argues for community strategies that target the highest-need patients, who are also most costly to treat.

It sounded good at first, but I quickly thought of questions: Does it make sense to pay for patients' outcomes, when those outcomes may occur regardless of what doctors do? What sort of incentives would be needed to make patients who are not taking good care of themselves change their ways?  Why would connectivity help when health care dyfunction has gotten worse as the world has become more connected?  How to you find patients with highest need, and how would you target such patients?  And above all, how would these cures, assuming one could figure out what they mean, prevent squandering money on the wrong things?

I left the Ignatius piece confused.  Perhaps the NAM publication on which Ignatrius' WaPo article was based would provide enlightenment.

What the National Academy of Medicine Wrought


So my next step was to quickly read the underlying report.  But that did not lessen the confusion.

The report did begin with sort of a definition of health care dysfunction

Health care today is marked by structural inefficiencies, unprecedented costs, and fragmented care delivery.

However it did not go on to providing an organized list of possible causes of these problems, with justifications for these diagnoses.  At best, it sort of alluded to the following as possible causes:

- the "rapidly aging population;"
- "persisting care fragmentation and discontinuity;"
- "costs associated with unnecessary services, inefficiently delivered services, excess administrative costs, prices that are too high, missed prevention opportunities, and fraud;" and
- "constrained innovation" due to "outdated regulatory, education and training models," particularly "uncertaintly and unpredictability around approval" of drugs and devices; and payment models that might place "excessive burden on manufacturers to demonstrate the value of their products."

"Rapidly again population" often appears as a postulated caused of health care dysfunction.  On Health Care Renewal we frequently discuss the problem of outright criminality and corruption in health care, including fraud; and the take over of health care by managers, which can result in "excess administrative costs."  However many of the other items were either too vaguely described to assess, or did not appear with clear justification. 


Furthermore, this list also raised some obvious questions.  For example, why are US costs so much higher than those of European countries whose populations are also aging?  Who sets criteria for how "high" prices should be?  What causes prices to be excessively high? Whose uncertainty and what unpredictability affect drug and device approvals?  How is the burden on manufacturers excessive?

Here was more confusion.  More was to follow. 

The bulk of the report is about "Vital Directions Issue Areas," again sort of a list of cures for health care dysfunction     

Vital Directions Issue Areas
Better health and well-being
Systems strategies for better health throughout the life course
Addressing social determinants of health and health disparities
Preparing for better health and health care for an aging population
Chronic disease prevention: tobacco, physical activity, and nutrition for a healthy start
Improving access to effective care for people who have mental health and substance use disorders
Advancing the health of communities and populations
 High-value health care
Benefit design to promote effective, efficient, and affordable care
Payment reform for better value and medical innovation
Competencies and tools to shift payments from volume to value
Tailoring complex care management, coordination, and integration for high-need, high-cost patients
Realizing the full potential of precision medicine in health and health care
Fostering transparency in outcomes, quality, safety, and costs
The democratization of health care
Workforce for 21st century health and health care
 Strong science and technology
Information technology interoperability and use for better care and evidence
Data acquisition, curation, and use for a continuously learning health system
Innovation in development, regulatory review, and use of clinical advances
Targeted research: brain disorders as an example
Training the workforce for 21st century science

However these apparent action items were not clearly associated with the causes of health care dysfunction they were supposed to address.  The discussions of these items raised yet more questions.  For example, the report discussed how to "drive health care payment innovation providing incentives for outcomes and value," presumably related to "payment reform" in the above list.  New payment and delivery models would have the "aim to reduce waste, increase value, and improve outcomes."  What was the evidence that they would be able to do so?  The next item was to "help clinicians develop the core competencies required for new payment models."  Would physicians be willing to accept a new payment system that would not work without subjecting the same busy clinicians to extensive new training? Etc, etc, etc

So in summary, the ful report did not give a clear definiton of the health care dysfunction, did not discuss the causes of the problem, and did not provide solutions keyed to either.  Furthermore, the report does did not provide clear justification for the action items it suggested.

Instead of a clear common-sense set of reforms, the new report just muddied the waters. Listening to the doctors was not helping at all. 


Listening to Not So Much Doctors as Health Care Corporate Executives, Directors and Lobbyists

The reason may be that the National Academy of Medicine report was written more by health care corporate executives, members of health care corporations' boards of directors, and lobbyists for health care corporations than by doctos.  The report's author list appeared thus on the NAM website:

Victor J. Dzau, National Academy of Medicine; Mark McClellan, Duke University; Sheila Burke, Harvard Kennedy School; Molly J. Coye, AVIA; The Honorable Thomas A. Daschle, The Daschle Group; Angela Diaz, Icahn School of Medicine at Mount Sinai; The Honorable William H. Frist, Vanderbilt University; Martha E. Gaines, University of Wisconsin Law School; Margaret A. Hamburg, National Academy of Medicine; Jane E. Henney, National Academy of Medicine; Shiriki Kumanyika, University of Pennsylvania Perelman School of Medicine; The Honorable Michael O. Leavitt, Leavitt Partners; J. Michael McGinnis, National Academy of Medicine; Ruth Parker, Emory University School of Medicine; Lewis G. Sandy, UnitedHealth Group; Leonard D. Schaeffer, University of Southern California; Glenn D. Steele, xG Health Solutions; Pamela Thompson, American Organization of Nurse Executives; Elias Zerhouni, Sanofi


Thus two physician authors were obviously employees of large health care corporations. Both in fact were high ranking executives. Dr Lewis G Sandy, is Senior Vice President, Advancement, for UnitedHealth Group; and Dr Elias Zerhouni, is President, Global Research and Development, for Sanofi.  Also, The Honorable Michael O Leavitt was the founder of Leavitt Partners, a business consulting group, whose clients include companies in the "pharmaceuticals and biopharmaceuticals, medtech and medical devices, health IT, diagnostics" and "commercial [health care insurance] plans," according to its website.

The author information provided at the end of this version of the article also stated that "the Honorable Thomas A Daschle is Founder and CEO of The Daschle Group, a Public Policy Advisory of Baker Donelson.'  Note that Baker Donelson is a Washington, DC lobbying firm.  Furthermore the author information included the fact that The Honorable Willaim Frist is "chairman of the Executive Board of the health service private equity firm Cressey & Company." Finally, Leonard D Schaeffer was identified as "the founding Chairman & CEO of Wellpoint."

While most of the other authors were listed as affiliated with academic organizations, some searching reveals that most of them had major financial relationships with for-profit health care corporations, including some of the largest.  Many, in fact, had come to the attention of Health Care Renewal in the past because of their important conflicts of interest. 

When Dr Victor Dzau was proclaimed the new president of the then Institute of Medicine, there was little initial discussion of his major conflicts of interest.  At the time of the announcement, he was on the boards of directors of Alnylam Pharmaceuticals, device maker Medtronic, and sugary drink maker Pepsico (see our 2014 blog post).  At the time of the announcement, he owned millions of dollars of shares or share equivalents of the three companies.  In 2010, Duke University students had protested his multi-million dollar salary as Chancellor for Health Affairs (see our blog post).

We discussed in a 2013 blog post how Dr Mark McClellan transited the revolving door from his position as head of the Center for Medicare and Medicaid Services (CMS) in the Bush administration to positions as special advisor to private equity firm General Atlantic LLC, strategic advisory committee member for private equity firm Capital Royalty LP, on the advisory board for Castlight Health, and on the boards of directors of AvivReit and Johnson and Johnson.  In 2016 we discussed how Dr McClellan pretended to be an independent scholar for the Brooking Institution while he was still on the board of Johnson and Johnson.

Sheila Burke is a strategic advisor to Baker Donelson, the Washington, DC lobbying firm for which Mr Daschle also works. 

Dr Molly J Coye is currently on the boards of directors of health insurance company Aetna, and chairwoman of the board of Prosetta Biosciences Inc.

Former US Senator Thomas A Daschle's firm is actually a lobbying firm, and was officially registered as a lobbyist for Aetna in 2016 (per Politico).  His firm is now part of Baker Donelson, a larger Washington, DC lobbying firm (as noted above).

Former US Senate Majority Leader Dr William H Frist was a founder of the Hospital Corporation of America (HCA) and likely holds millions of shares of related stock (per Wikipedia), and currently serves on the boards of directors of Teledoc, and "publicly held companies Select Medical and AECOM. In addition, he serves as a board member for several of Cressey & Company’s privately-held portfolio companies." He had been on the board of the controversial diagnostic testing company Theranos (per this news release).

After Dr Margaret Hamburg was confirmed commissioner of the US Food and Drug Administration (FDA) in 2009 in the Obama administration, we discussed how she had to divest herself of shares of medical supply company Henry Schein Inc, on whose board of directors she formerly sat, and how she and her husband, a top hedge fund manager, had to divest themselves of various other holdings that entailed conflicts of interest.

We first discussed Dr Jane E Henney's multiple conflicts of interest in 2006.  Currently, she is on the board of directors of global pharmaceutical distributor AmeriSourceBergen and giant health insurance company Cigna. Recently, she had been on the boards of pharmaceutical companies AstraZeneca (through 2011), and Cubist (through 2014).

In 2011, we discussed how Michael D Leavitt, former US Secretary of Health and Human Services  under the Bush administration, transited the revolving door to a position on the board of directors of Medtronic.

Leonard D Schaeffer serves on the boards of Walgreens Boots Alliance, Quintiles Transnational Holdings, Inc. and scPharmaceuticals Inc

Dr Glenn D. Steele is on the boards of directors for medical app developer Ingenious Med; Director, PTC Therapeutics; Director, Stratus Video; biotechnology company Synaptive Medical; and again large for-profit health insurance company Wellcare Health Plans Inc (look here).

By the way, in 2010, we discussed how Dr Elias Zerhouni, former Director of the National Institutes of Health (NIH) in the Bush administration, transited the revolving door to positions on the board of directors of biotechnology company Actelion and of Danaher, which makes, among other things, medical devices, and then to a full-time position with global pharmaceutical company Sanofi.  In 2005 we discussed how Dr Zerhouni, as NIH director, lead a not very vigorous response to a series of scandals involving conflicts of interest at that august institution, after relevant government rules had been relaxed in the Clinton administration (see also this post and links backward).

Just to add to the confusion, while none of these relationships were noted in the version of the report on the NAM website, a few were listed in an online published version in JAMA.(7)  The JAMA version omitted those of Dr Dzau; all of the relationships of Dr McClellan, save an admission that he "received personal fees from Johnson & Johnson"; Ms Burke's position with Baker Donelson; Dr Coye's position on the board of Aetna; Mr Daschle's position as lobbyist for Aetna; Dr Frist's positions on the boards of Select Medical and AECOM, and former position on the board of Theranos, although the JAMA version added a position on the board of Aspire Health; Mr Leavitt's board membership; Mr Schaeffer's membership on the boards of Quintiles and scPharmaceuticals; and all of Dr Steele's board memberships.

By my count, a majority, 13 of 19 authors had major financial ties to large for-profit health care corporations.  The authors included three who worked for Washington, DC lobbying and consulting firms with major health care industry clients, including one who explicitly lobbied for for Aetna.  The authors included  top executives of UnitedHealth and Sanofi.  The authors included current or recent members of the boards of directors of Alnylam Pharmaceuticals, Medtronic(2), Castlight Health, AvivReit, Johnson and Johnson, Aetna, Prosetta Biosciences, Teledoc, Select Medical, AECOM, Theranos, Aspire Health,  AmeriSourceBergen, Cigna, AstraZeneca, Cubist, Walgreens Boots Alliance, Quintiles Transnational Holdings, scPharmaceuticals Inc, Ingenious Med, PTC Therapeutics, Synaptive Medical, and Wellcare.

The Washington Post article would better have been sub-titled, "Listen to Health Care Corporate Eexecutives, Directors, and Lobbyists." 

Summary

A recent report by the prestigious National Academy of Medicine, now published electronically in JAMA,  and an accompanying newspaper article promised common sense ideas for health care reform suggested by physicians.  On its website, the Academy did not disclose most of the multitudinous and serious conflicts of interest of its authors.  A version electronically published by JAMA disclosed a few more, but was still very incomplete.  Relationships that were not disclosed included positions on the boards of directors of for-profit health care corporations, from start-ups to some of the biggest such corporations in the US.  In my humble opinion, such incomplete and inconsistent disclosures was dishonest and deceptive.

The prevalence of health care corporate board members as authors of this report is particularly concerning.  In 2006, we first blogged about a "new species of conflict of interest" which involved health care organizational leaders who were simultaneously members of the boards of directors of for-profit health care corporations or other corporations which could strongly influence health care.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive, but also 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.]  So it should be no surprise that the NAM report did not really suggest any radical ideas for health care reform, despite Mr Ignatius' title.  Most of its authors were in a position to benefit from the status quo in health care.

Furthermore, it is no wonder the NAM report was confusing and muddled.  As Joe Collier  observed, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."(8)

In my humble opinion, the NAM report represents the sort of obfuscation that has been befogging discussion of health care policy for a long time.  Wendell Potter described how years of debate on health care policy that started during the Clinton administration was defined by concepts developed by for-profit insurance company public relations departments to steer debate away from ideas would threaten their profits.  In his book Deadly Spin, (p 64) he described a the AHIP (America's Health Insurance Plans, an insurance industry lobbying group) Strategic Communications Committee discourse on

the approach the industry would be taking when the reform debate heated up.  The goal would be to divert the public's and the media's attention from the uninsured and toward problems the insurers coudl insist were beyond their control.  The industry's spin, in other words, was going to be something like this: Health care costs are out of control because new treatments and technologies are more expensive than ever, the population's getting older and sicker, too many people are seeking care they don't really need, and health care professionals and providers are all too willing to provide the care that people don't need.

These putative causes of health care dysfunction, derived from an insurance industry organized public relations effort, have become the accepted wisdom.  Note that there were vestiges of them ("rapidly aging population") among the somewhat disorganized presentation of causes of health care dysfunction in the NAM report.  That there were not more of them may reflect the fact that the NAM report was not written just by people tied to the insurance industry.  It also included many people tied to biotechnology, drug, device, etc companies.  


Now during an era in which "fake news," propaganda and disinformation are in the headlines, we still see the terms of debate seemingly engineered by powerful health care organizations.

Physicians, other health care professionals, journalists, policy makers and the public at large should be extremely skeptical of apparently authoritative pronouncements on health care reform, especially when it is not clear what financial interests the authors of the pronouncements have, or when it is clear that the authors have important financial ties to large health care organizations, particularly large for-profit health care corporations.

At a minimum, media and certainly scholarly articles on health care reform and related policy issues should have at least as rigorous disclosure of conflicts of interests as clinical research articles.  

Real health care reform would start with honest debate in which the contestants at least make clear their underlying financial interests. 


References

1. Poses MD. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.
2. Massachusetts Medical Society. Physician satisfaction survey (2001). Link here.
3.Pololi L, Kern DE, Carr P, et al. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link here.
4. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here.
5. Pololi L, Ash A, Krupat E. Faculty values in the culture of academic medicine: findings of a national faculty survey. Link here.
6. Poses RM, Baier-Manwell L, Mundt M, Linzer M. Perceived leadership integrity and physicians’ stress, burnout, and intention to leave practice. J Gen Intern Med 2005; 20: S182. Link here.
7. Dzau DJ et al.  Vital directions for health and health care: priorities from a National Academy of Medicine initiative.  JAMA 2017; doi:10.1001/jama.2017.1964.  Link here.
8.  Collier J. The price of independence. Br Med J 2006; 332: 1447-9.  Link here

Thursday, February 09, 2017

More Health Care Professionals and Trainees Provoked to Resist - Dana-Farber Cancer Institute Protest of Leaders' Acquiescence to Trump's Muslim Travel Ban

The executive order by President Trump that temporarily banned immigration from seven predominantly Muslim countries provoked health care professionals and trainees to challenge another health care leader whom had not been so challenged previously.

We recently described how professionals and trainees protested the decision by Cleveland Clinic CEO Toby Cosgrove not to cancel a fund raising event a Mar a Lago, the resort owned by President Trump, even though Mr Trump's ban had resulted in the deportation (since reversed) of a Cleveland Clinic physician trainee, and Cleveland Clinic health care professionals and trainees had challenged the decision to continue with the event (look here).  Stories about major conflicts of interest affecting Dr Cosgrove had failed to inspire any protests, or even any real public discussion.

The Dana -Farber Cancer Institute and the Immigration Ban

Now a similar story is playing out at the Dana-Farber Cancer Institute, a major academic medical institution and a prominent affiliate of Harvard Medical School.

Here is a summary from the Boston Globe, January 31, 2017:

Hundreds of medical students, doctors, and other medical personnel opposed to President Trump’s immigration order are urging the Dana-Farber Cancer Institute to cancel a lavish fund-raiser at Trump’s Mar-a-Lago Club in Florida.

But even as the number of signatures on a circulating petition grew — rising to 1,206 caregivers in Boston and across the United States by 9:20 a.m. Wednesday — Dana-Farber said it would not risk losing money earmarked for cancer research and treatment by canceling the fund-raiser.

Donors are paying as much as $100,000 to attend the fund-raiser on Feb. 18 at the 20-acre seaside resort in Palm Beach. Dana-Farber raised $2.2 million at last year’s Mar-a-Lago gala, which featured a concert by James Taylor, according to a video on the hospital’s website.

The objections to the fund-raiser are an example of the fallout over Trump’s order restricting travel from seven Muslim-majority countries — restrictions that have prompted protests across the country.

Six medical students and one doctor e-mailed a letter Sunday to Dana-Farber president Dr. Laurie Glimcher and development head Susan Paresky. They said Trump’s immigration order threatens the medical school’s research program, poses a risk to overseas patients who need cancer treatment at Dana-Farber, and 'is a direct threat to the health and well-being of thousands of refugees worldwide who are fleeing violence and persecution.'

Two Iranian medical researchers headed for Brigham and Women’s Hospital were barred from entering the country after the ban went into effect. And the medical school’s teaching hospitals are scrambling to determine whether patients from the seven targeted countries will be able to keep appointments for medical care. When the group did not get a reply to their letter, they began circulating a petition on social media at 6 p.m. Monday, said organizer George Karandinos, a Harvard medical and doctoral student.

'Given the events of recent days,' he said, 'we are asking Dana-Farber to take some moral leadership on this.'

The response was that it was too late to cancel the event. Although CEO Glimcher and Josh Beckstein, the Chair of the Dana-Farber board of trustees, said they sympathized with the petitioners' concerns, they asserted:

contracts have been signed, and a large number of people have committed to attend. Cancelling the event outright would only deny much-needed resources for research and care

An article in the Atlantic posted on February 9, cited questions about Dr Glimcher's and Mr Beckstein's response

It noted that Dana-Farber leadership used a logical fallacy, an appeal to common practice to justify their decision:

Dana-Farber, which brands itself as a pioneering, trailblazing institution, closed its public statement with the argument that 'Other organizations find themselves in a similar position this year and have made a similar decision.'

Meanwhile, the protesters thought the Institute could have done better:

'This was covered in the press as an issue in September,' said George Karandinos, a Harvard medical student among those leading the backlash. 'Partially because this has been brought up before, we're less sympathetic to the argument that the fundraiser is so close' In light of the fact that President Trump has 'sent out a message of exclusion, discrimination, and hate,' Karandinos said, this response 'felt very weak.'

And the number of signatures on the petition continues to rise. It is now greater than 2000. It is likely the protests will get stronger:

Because Dana-Farber has opted to proceed with the Mar-a-Lago gala—has not committed to distancing itself from the Trump Organization in the future—the Harvard students, doctors, and patients are elevating the stakes. This coming Saturday, they plan to rally on the quad of Harvard Medical School, in the shadow of the cancer institute. In the spirit of evidence-based effective protest, their request is clear and concrete: 'We call on the Dana-Farber to relocate its fundraiser away from President Trump’s Mar-a-Lago this year and in all subsequent years.'
Maybe it should have been no surprise that Dr Glimcher was not sympathetic to arguments that the Mar a Lago fund raising event posed a conflict of interest for the Dana-Farber, notwithstanding the conflicts of interest created for President Trump by his continuing business ownership.  Dr Glimcher actually has a long history of her own conflicts of interest.

Dr Glimcher's Conflicts of Interest

As in the case of the Cleveland Clinic, the strong response to Dr Glimcher's refusal to cancel the Mar a Lago fundraiser could be contrasted with the lack of response to what could have been considered questionable actions by Dr Glimcher in the past.  Dr Glimcher accepted leadership positions at the Dana -Farber, and before then at Weill Cornell Medical School, despite severe conflicts of interest.

As we noted in 2011, at the time Dr Glimcher left Harvard to become Dean of the Weill Cornell Medical School, she was already the longest serving member of the board of directors of pharmaceutical giant Bristol-Myers-Squibb.  At that time, she was paid over $240,000 a year for her services on the board, and owned more than $1.4 million of BMS stock units. 

At that time, Dr Glimcher was also on the board of directors of the Waters Corporation, which makes laboratory equipment used in pharmaceutical research.

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 other conflicts of interest afflicting health care that were then starting to be discussed.  This new species  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.

Furthermore, even in 2011, BMS had a track record that included settling allegations that the company gave kickbacks to physicians to promote its products.  These actions would have been taken place while Dr Glimcher was responsible for the governance of the company.

At that time, appointing a member of the boards of Bristol Myers Squibb and Waters Corporation to be dean of  Weill Cornell Medical School incited no public discussion, much less protest.  I know of no more public discussion or protest ensuing after Dr Glimcher became CEO of Dana-Farber. 

She is still on the boards of these two corporations.  The most recent (2016) BMS proxy statement  noted that Dr Glimcher's yearly compensation is now $300,000 and she now owns 88,190 share equivalents, worth more than $4.5 million at today's price.

Furthermore, Bristol-Myers-Squibb has continued its ethical misadventures under Dr Glimcher's watch.  Last year we discussed yet another settlement it made of allegations of giving kickbacks to doctors to induce them to prescribe its medication.  Prior to that, but still on Dr Glimcher's watch, we noted the following:

- In 2003, for $617 million, BMS settled suits alleging it tried to prevent competition from low cost generic versions of its products Taxol and Buspar (per the NY Times).
- In 2004, for $150 million, BMS settled suits by the SEC alleging accounting fraud (per the NY Times here).
- In 2007, BMS paid a $1 million dollar penalty while pleading guilty to lying to federal agents about a deal with the Canadian drug company Apotex (per Law360).   In 2009, it paid additional financial penalties in response to a US Federal Trade Commission charge about this case (per the FTC).
 - In 2007, for $515 million, BMS settled a suit alleging it used kickbacks to induce use of Abilify for dementia and by childeren, despite evidence that the drug was not suitable for either.  The settlement included a five year corporate integrity agreement.  (Look at our post here).
 - In 2014, BMS settled allegations its subsidiary Lantheus Medical Imaging Inc evaded state taxes (per the Corporate Crime Reporter)
 - In 2015, Bristol-Myers-Squibb settled allegations by the US Securities and Exchange Commission (SEC) that it bribed physicians in China to induce them to prescribe its drugs.  (Look at our post here).

Maybe those who protest Dr Glimcher's current actions will note that these actions were presaged by her publicly known but largely ignored past actions.

Summary

Donald Trump's campaign, his election, and the beginnings of his administration have evoked tremendous controversy.  Of many questions raised, those about his voluminous conflicts of interest, and whether has background as a corporate leader is suitable for leadership in other spheres, particularly the political, have been salient.  One unanticipated effect of his early decisions as president seems to be to raise questions about his relationships with leaders in other spheres with their own conflicts, and own doubtful qualifications for their leadership roles. 

It is ironic that Mr Trump has pledged to stand up for working people and the middle class, while his affinities seem to be almost entirely for the rich and conflicted.

Dr Toby Cosgrove of the Cleveland Clinic and Dr Laurie Glimcher of the Dana-Farber Cancer Institute seem relatively untroubled about their institutions' financial arrangements with Mr Trump's ongoing businesses, despite the conflicts that these businesses pose for a sitting president.  Furthermore, both Dr Cosgrove and Dr Glimcher have had and continue to have major conflicts of interest affecting their own leadership positions, conflicts which have been largely anechoic up until now.

The protests of President' Trump's dubious actions may shed needed light on the large, complicated network of insiders which has disproportionate influence on health care, public policy, and politics.

So here goes again, for the umpteenth time...

 I now believe that the most important cause of US health care dysfunction, and likely of global health care dysfunction, are the problems in leadership and governance we have often summarized (leadership that is ill-informed, ignorant or hostile to the health care mission and professional values, incompetent, self-interested, conflicted or outright criminal or corrupt, and governance that lacks accountability, transparency, honesty, and ethics.)  In turn, it appears that these problems have been generated by the twin plagues of managerialism (generic management, the manager's coup d'etat) and neoliberalism (market fundamentalism, economism) as applied to health care.  It may be the many of the larger problems in US and global society also can be traced back to these sources.

We now see our problems in health care as part of a much larger whole, which partly explains why efforts to address specific health care problems country by country have been near futile.  We are up against something much larger than what we thought when we started Health Care Renewal in 2005.  But at least we should now be able join our efforts to those in other countries and in other sectors.  

 True health care reform would restore health care leadership that understands health care and medicine, upholds the health care mission, is accountable for its actions, and is transparent, ethical and honest.

Wednesday, August 10, 2016

How the System is Rigged - Johnson and Johnson Board Member Pretends to be Independent Brookings Institution Scholar

Fears that "the system is rigged" may cause the lack of trust marring this year's political season. These fears are not baseless.

Dr McClellan of the Brookings Institution on Drug Prices

A recent series in the New York Times focused on the biases of the think tank "independent scholars" whose work is used to justify much policy making.  An article entitled "Think Tank Scholar or Corporate Consultant? - It Depends on the Day" actually provided a health care example that was much worse than what the title implied.

It noted that

Dr. McClellan, a former commissioner at the Food and Drug Administration who until January was a senior fellow at Brookings, has been a go-to expert for the federal government as it debates how to cope with surging costs of prescription drugs.

In particular, Dr McClellan has opined on the increasingly recognized problem of ever-rising drug prices, and on one class of drugs that we have discussed on Health Care Renewal.

At public events, Dr. McClellan emphasized the extraordinary progress by the pharmaceutical industry in coming up with treatments for diseases like diabetes, H.I.V. and hepatitis C.

'Lots of diseases have been transformed,' Dr. McClellan said at a hearing in November sponsored by the Department of Health and Human Services. He ran through a series of slides prominently stamped with Brookings’s name. He also argued that even though these drugs were very expensive, they were worth it given the improvement in a patient’s quality of life.

'They are, over all, a pretty good deal,' Dr. McClellan said, referring to treatments for hepatitis C. One such drug, manufactured by Johnson & Johnson, generated $2.3 billion in sales in its first full year, representing about 7 percent of the company’s overall drug sales in 2014. The pills cost $66,000 for a standard 12-week regimen.

Little Evidence that New Drugs for Hepatitis C Represent "Extraordinary Progress?"


Note that despite Dr McClellan's enthusiasm, there is no good data from clinical trials that show that the new drugs for hepatitis C have long-term clinical benefits.  As we wrote here last month....

In fact, starting in March, 2014, we have posted about the lack of good evidence from clinical research suggesting these drugs are in fact so wondrous.  The drugs are now touted as "cures," at least by the drug companies, (look here), and physicians are urged to do widespread screening to find patients with asymptomatic hepatitis C so they can benefit from early, albeit expensive treatment.

However, as we pointed out (e.g., here and here)
-  The best evidence available suggests that most patients with hepatitis C will not go on to have severe complications of the disease (cirrhosis, liver failure, liver cancer), and hence could not benefit much from treatment.
-  There is no evidence from randomized controlled trials that treatment prevents most of these severe complications
-  There is no clear evidence that "sustained virologic response," (SVR), the surrogate outcome measure promoted by the pharmaceutical industry, means cure. 
-  While the new drugs are advertised as having fewer adverse effects than older drugs, it is not clear that their benefits, whatever they may be, outweigh their harms.

Furthermore, health care professionals and researchers with heftier credentials in clinical epidemiology and evidence based medicine than mine have since published similar concerns.  These included
- a report from the German Institute for Quality and Efficiency in Health Care (the English summary is here)
- an article in JAMA Internal Medicine from the Institute for Clinical and Economic Review (1)
- a report from the Center for Evidence-Based Policy (link here)
- an article in Prescrire International (2)

These publications and your humble scribe noted that the clinical trials or other types of clinical research about new hepatitis C treatment published in the most prominent journals had numerous methodologic problems that all seemed likely to make the new drugs look better, perhaps intentionally.  (See posts here,  here, and here.)

In July, 2016 we had written about the enthusiasm for these drugs expressed by Mr Bill Gates, chairman of the Gates Foundation.  Maybe one can somewhat excuse Mr Gates, who is hardly a clinical research expert, for this unjustified enthusiasm.  (Although maybe someone at his foundation, given its emphasis on global health, should have briefed him to the contrary.)

Why Was Dr McClellan So Unjustifiably Enthused?

Give Dr McClellan's background, why was he not more skeptical about the the supposed miraculous properties of hepatitis C drugs?.  His biography, provided for the US Department of Health and Human Services Pharmaceutical Forum, suggested he ought to know something about clinical research.  It stated,  

Mark McClellan, MD, PhD, is a senior fellow and director of the Health Care Innovation and Value Initiative at the Brookings Institution. Within Brookings, his work focuses on promoting quality and value in patient centered health care, and he leads the Richard Merkin Initiative for Payment Reform and Clinical Leadership.

A doctor and economist by training, he also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These include the Medicare prescription drug benefit, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. Dr. McClellan chairs the FDA’s Reagan-Udall Foundation, is co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine, and is a research associate at the National Bureau of Economic Research. He previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and was an associate professor of economics and medicine at Stanford University.

From time to time, McClellan advises U.S. government officials on health care policy issues. In his capacity as a health policy expert, he is the co-director of the Bipartisan Policy Center’s Leaders’ Project on the State of American Health Care; co-chair of the Robert Wood Johnson Foundation Commission to Build a Healthier America; and chair of the FDA’s Reagan-Udall Foundation. McClellan is also co-chair of the Quality Alliance Steering Committee, sits on the National Quality Forum’s Board of Directors, is a member of the Institute of Medicine of the National Academy of Sciences, and is a research associate at the National Bureau of Economic Research.

McClellan holds an MD from the Harvard University–Massachusetts Institute of Technology (MIT) Division of Health Sciences and Technology, a PhD in economics from MIT, an MPA from Harvard University, and a BA from the University of Texas at Austin. He completed his residency training in internal medicine at Boston’s Brigham and Women's Hospital, is board-certified in Internal Medicine, and has been a practicing internist during his career.

However, that biography left out one important item.  Per the NY Times article,

There was no mention in a video of the event that Dr. McClellan joined Johnson & Johnson’s board of directors in October 2013, or that he earned nearly $530,000 over the past two years in overall compensation from the company. That is in addition to his salary at Brookings, where he is one of the top-paid scholars, with $353,145 in wages and other compensation from the think tank in 2014, tax records show.

I suspect that most attendees at the conference had not read our 2013 post on Health Care Renewal that noted Dr McClellan's transit through the revolving door that ended up with his position on the Johnson & Johnson board.

Dr McClellan's Chronic Failure to Disclose His Johnson and Johnson Board Membership

Despite the fact that Dr McClellan's position on the Johnson & Johnson board of directors is public, as are the identities of all the members of US publicly held corporations, Dr McClellan has seemingly made a point of avoiding its mention when he assumes the persona of health care policy expert.

For example, he did not disclose it in some recent publications on aspects of health policy that likely would relate to Johnson & Johnson's interests.  These included:
- a 2014 Brookings report entitled "Improving Health Care While Reducing Cost Growth: What is Possible?"(3) in which he is only described as "Director, Health Care Innovation and Value Initiative, Senior Fellow, Economic Studies; The Brookings Institution."
- a 2014 article on "Health Reform and Physician-Led Accountable Care" in JAMA(4) which simply noted Dr McClellan came from the Brooking Institution, and which contained the assurance that all authors completed "the ICMJE Forum for Disclosure of Potential Conflicts of Interest and none were reported."
- a 2015 article on increasing "pharmaceutical innovation" in Health Affairs(5) which similarly only described Dr McClellan as "senior fellow and director of the Health Care Innovation and Value Initiative at the Engelberg Center for Health Care Reform at Brookings."

Furthermore, Dr McClellan's new employer, Duke University, currently provides a biography which also omits any mention of his position on the Johnson & Johnson board.

Dr McClellan Denies any Conflict of Interest

The NY Times article suggested that Dr McClellan may think his position at Johnson & Johnson is irrelevant to his day job as health policy expert.

Dr. McClellan, in a statement, disputed any suggestion that he might have had a conflict.

'My entire career in academics, government and public policy has focused on evidence-based ways to improve health and restrain costs for consumers, and my extensive track record speaks for itself,' he said.

I suppose that Dr McClellan might have justified his failure to disclose his membership on the Johnson & Johnson board of directors by his perception that this membership caused no conflict of interest.

How Board Membership May Cause Severe Conflicts of Interest

I will omit detailed discussion of all the evidence that even receiving small gifts may affect thinking and actions through the social obligation to reciprocate.  Yet Dr McClellan did not just receive small gifts.  He is a member of a corporate board of directors.

 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.

As Robert AG Monks put it, board members must "demonstrate unyielding loyalty to the company's shareholders" [Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  (Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.)  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of not only academic medical institutions, but of think-tanks professing to provide unbiased policy relevant research.

Presumably, were Dr McClellan in a situation in which he had an opportunity to promote Johnson & Johnson's interests, such as speaking at an influential conference about drug prices, and failed to uphold the company's interests, stockholders could consider legal action against him for failing in his fiduciary responsibilities.  Thus the mind boggles at how Dr McClellan could believe that his role as a corporate director does not pose a conflict of interest for him in his better publicized role as think tank and now academic health care policy expert.

Discussion

It is hardly news that US health care is broadly dysfunctional, that it suffers from ever rising costs, and questionable quality, while access has only somewhat improved after the 2009 Affordable Care Act.  The big question is why these problems seem so intractable.

Our latest case illustrates that the problem may be that health policy making is dominated by people with conflicts of interest.  In the current case, one of the more influential voices on health care policy turns out not to have just a garden variety conflict of interest.  He actually has a duty to uphold the corporate interests of one of the biggest US drug, biotechnology and device companies.  Could one really expect such a man would have a serious interest in controlling health care costs, especially those driven by the prices charged by drug, biotechnology, and device makers?

A system in which the top "independent" health policy experts may have conflicts of interest, may even be members of boards of directors of health care corporations, certainly suggests a system that has been rigged. 

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.


 References

1. Ollendorf DA, Tice JA et al. The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection. JAMA Intern Med 2014;174(7):1170-1171. Link here.
2. Sofosbuvir (Sovaldi), active against hepatitis C virus, but evaluation is incomplete. Prescrire Int 2015; 24: 5- 10. Link here.
3.  McClellan M, Rivlin AM. Improving Health Care While Reducing Cost Growth: What is Possible?
Engelberg Center for Health Care Reform at Brooking; 2015.  Link here.
4.  Mostashari F, Sanghavi D, McClellan M. Health reform and physician-led accountable care: the paradox of primary care physician leadership. JAMA 2015; 311: 1855-56.  Link here.
 4.  Daniel GW, Caze A, Romine MH, Audibert C, Leff JS, McClellan M. Improving pharmaceutical innovation by building a more comprehensive database on drug development and use.  Health Aff 2015; 34: 319-327.  Link here.


Friday, March 25, 2016

Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing Doctors

Umpteenth verse, same as the first...

As just reported by Bloomberg,

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker’s Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group’s recreational activities such as a Niagara Falls excursions, $150 in 'walking around' money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club.  It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without "admitting or denying the findigs." In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

'The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,' Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case.  Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders.  Yet this evidence remains anechoic, even given the apparent recidivism involved.  For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership.  At that time, our post included these section headings covering 2014-15:

-  Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
- Novartis Executive Pleads Guilty to Bribing Polish Official
- Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
- Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
- Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis' previous record.   In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also,  in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here)   Other Novartis misadventures from 2010 and earlier appear here.  So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers.  Meanwhile, Novartis executives continue to be paid handsomely.  The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty.  Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7  million in 2013-14 just to US physicians.    The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University,  Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School.   I am unaware that anyone of them have publicly raised any concerns about Novartis' recent misadventures, although I am also unaware whether anyone has publicly asked them such questions. 

No wonder that ordinary US (and other countries' citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders.  No wonder that someone of them are seeking the protection of some of those powerful insiders.  But I digress...

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first...

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care.  There are calls to avoid unnecessary, and sometimes harmful care.  Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction.  Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients' and the public's health ahead of personal gain.

Our musical interlude ("second verse, same as the first,") Herman's Hermits, Henry VIII



Thursday, February 11, 2016

Bio-Tech U, Version 2 - Current Board Member of Four Biotechnology Companies, Fomer Pfizer Director, Former Genentech Executive to be President of Stanford

Stanford University will soon have a new president.  According to the New York Times,

Stanford University’s incoming president, Marc Tessier-Lavigne, has developed a career that successfully melds science, business and academia.

Although he is now coming off a stint as president of Rockefeller University in New York starting in 2011,  his business connections are extensive.

A Genentech Executive

The NYT noted,

He may be best known, though, for his work at Genentech. As the No. 2 executive in research, he oversaw 1,400 scientists in one of the most innovative and successful companies in the biotech industry, known for the groundbreaking cancer drugs Avastin, Rituxan and Herceptin.

To expand that, his brief CV on the Rockefeller University website included,

1991 - 2001  increasingly senior faculty positions at UCSF
2001 - 2003  professor at Stanford

2003 - 2008  senior vice president, research drug discovery, Genentech Inc

2008 - 2009  exectuive vice president, research drug discovery, Genentech

2009 - 2011  chief scientific officer, Genentech

Member of Multiple Biotechnology Corporate Boards of Directors, Chairman of One

However, his involvement with the pharmaceutical and biotechnology industries hardly ends there.  He currently is on four biotechnology corporate boards of directors.  These include:

Agios 

For which he received compensation of $374,926 in 2014, according to the 2015 proxy statement.  His holdings in the company were then 130,122 shares.

Juno Therapeutics Inc

For which he received compensation of $30,000 in 2014, according to the 2015 proxy statement.  His holdings in this company were then 175,000 shares Series A2 convertible preferred.

Regeneron Pharmaceutical

For which he received compensation of $1,764,032  in 2014, according to the 2015 proxy statement.  His holdings in this compary were then 34,716 shares.

Pfizer, then Denali Therapeutics

Also, in 2011, he became a member of the board of directors of Pfizer, Inc.  He left in 2015 when he co-founded, and became chairman of the board of a new biotechnology company, Denali Therapeutics.  In 2014, according to the Pfizer 2015 proxy statement, he received compensation of $300,000.  His holdings in the company then were 104 shares of stock, and 24,307 stock units. 

He remains as chairman of the board of Denali, according to the company website.  Since this company is privately held, I could not find any information about the compensation or holdings of board members.

Discussion

To summarize, the incoming president of Stanford, on of the most prestigious American universities, one of the foremost US sites for biomedical research, and home to an equally prestigious medical school and academic health center, spent most of the last 15 years heavily involved with the pharmaceutical and biotechnology industries.  He was a top Genentech executive for eight of those years, served as a director of the then biggest US pharmaceutical company, and currently is a member of the boards of directors of four biotechnology companies, and is chairman of one of them.  He earned nearly $2.5 million dollars from these directorships in 2014, the last year for which such data is public, and owned hundreds of thousands of shares of stock in these companies.

How he had the time to executive all his fiduciary responsibilities as a director of four health care corporations while being the president of Rockefeller University, and apparently continuing to do his own research boggles the mind.  

However, Stanford's incoming president is a perfect example of how health care is now run by an interlocking group of insiders who have personally profited massively from their situated influence.   

So in whose interests will he act as president of Stanford?  The New York Times cited those who hailed his scientific prowess.

According to Susan K. McConnell, a professor of biology at Stanford, Dr. Tessier-Lavigne was responsible for a 'long list of amazing discoveries' involving identifying molecules that guide the growth of nerve connections in the developing brain.

On the other hand, he had important affiliations with two biotechnology companies that were known for leading the charge for stratospheric drug prices as much as they were known for developing innovative drugs.  By coincidence, or not, he was a top executive for the same company, Genentech, as was Dr Susan Desmond-Hellman, who later became the leader of the University of California - San Francisco.  As we noted here, Dr Desmond-Hellman was a public defender of such pricing, in particular, of the then (2007) stratospheric $55,000 a year price of bevacizumab (Avastin).

Prof Tessier-Lavigne also is currently on the board of Regeneron, which became known for charging $1850 per montly dose of Eylea, a drug for macular degeneration, while paying its board members and executives proportionately large amounts.  As we noted above, Professor Tessier-Lavigne got over $1.75 million in 2014 for his board service, and in 2014, the company's CEO received over $36 million.

In an interview with the NY Times, professor Tessier-Lavigne said,

We do have to ensure access [to Stanford], broadly, both in terms of access for people who are disadvantaged socioeconomically and, of course, diversity

But how easy would it be for a man with his biotechnology corporate connections and the riches they produced for him to step into the shoes of disadvantaged, diverse students (or patients)? 


When asked about his corporate background, he told the NY Times,

that before taking the reins at Stanford in September, he will review all his corporate relationships with the board to determine whether any conflicts of interest exist.

That suggests doubt about the existence of such conflicts. But as we first wrote in 2006,

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.

Last year, Anderson et al documented the prevalence of such board level conflicts of interests, and wrote,(1)

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.

If Professor Tessier-Lavigne has doubts whether his current service on four biotechnology boards of directors, as chairman of one of these companies, as former board member of Pfizer, and as former executive of Genentech could create any conflicts of interest, the students, faculty, patients and alumni of Stanford should be very wary of what direction he will take their university.

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.

Reference
1.  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.