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

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

Unknown 3/25/2016 Komentar

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

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

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

Unknown 2/12/2016 Komentar

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. 

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Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption

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Health Care Renewal Bloggers in Print on Conflicts of Interest and Health Care Corruption

Unknown 11/18/2015 Komentar

Not to toot our own horn too loudly, but in the last week, Health Care Renewal bloggers have appeared in print three times.

Prevalence of Board Level Conflicts of Interest

We recently posted on a British Medical Journal article on the prevalence of what we originally termed "a new species of conflicts of interest," that is, conflicts of interest involving membership in boards of directors of for-profit health care corporations.  A shortened version of this just appeared as a (not very) "rapid response" in the BMJ here.  (Note though that the official date of the response was October 3.)

The New England Journal Series Calling for Rethinking the Problem of Conflicts of Interest

After the New England Journal of Medicine published an editorial and three commentaries earlier this year suggesting that concerns about conflicts of interest in health care may have been overblown, we pointed out that many of their arguments were supported by logical fallacies.  The Canadian Medical Association Journal has been publishing a series of news articles about the issue.  The latest one, published on November 17, 2015, ended by quoting HCR blogger Roy M Poses MD.

Health Care Corruption

On November 16, 2015, the Corporate Crime Reporter published a front page interview, "Roy Poses on Corruption in American Healthcare,"  The interview is listed here,  and summarized here but the full transcript apparently is not available online, but only in print and via subscription.  (Link to interview updated on 19 November, 2015).  

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

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

Unknown 10/01/2015 Komentar

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

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

First Discovered Cases

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

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

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

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

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

Through more recent years,

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

Look here for even more

Our Early Cross-Sectional Study

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

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

We concluded:

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

More Modern and Complete Data

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

Methods

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

Results

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

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

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

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

Discussion

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

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

They also added the reminder that,

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

So,

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

Our Summary

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

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

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

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

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

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

References

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

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Turn That Door Around - A Physician Substantially Tied to the Pharmaceutical Industry Nominated to Run the FDA

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Turn That Door Around - A Physician Substantially Tied to the Pharmaceutical Industry Nominated to Run the FDA

Unknown 9/24/2015 Komentar

It seems to be the season of the revolving door in health care.  The latest version got some media attention, because it involves one of the most important health care leadership positions in the US government, the Director of the Food and Drug Administration (FDA).  However, the case actually seems much more serious than what the media has recently reported.

The Basics

For an introduction, we turn to the Wall Street Journal from September 15, 2015:

President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said Tuesday.

Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research.

The new nomination got some rave reviews. For example, from the WSJ article,

Francis Collins, director of the National Institutes of Health and a scientist who has worked with Dr. Califf for years, called this 'a fantastic nomination.'

Then this in the NY Times (Sept 15, 2015):

'He’s never forgotten that at his core he’s a doctor, and he cares deeply about providing evidence to help people take better care of patients,' said Dr. Robert Harrington, professor and chairman of the department of medicine at the Stanford University School of Medicine, who worked with Dr. Califf at Duke.

Also, a MedPage Today article was entitled, "Califf Nomination for FDA Chief Gets Most High Marks," and included such testimonials as,

'He has a very good understanding of industry and academia, and think that will serve him well,' Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today....

Also, this from Dr Harlan Krumholz,

He's a broad thinker and a very creative and visionary individual. He will be an outstanding choice.

And this from Dr Sanjay Kaul,

I can't think of a more qualified person than Dr. Califf to lead the FDA at the present time. He is an accomplished leader in cardiovascular disease research whose work has resulted in therapies that save lives and improve the quality of life for millions of patients.

Is it time to break out the confetti yet?

Conflicts of Interest a Fly in the Ointment?

The only fly in the ointment was the matter of Dr Califf's ties to industry. The WSJ article included,

Diana Zuckerman, president of the National Center for Health Research, a Washington-based group focusing on medical-product safety, questioned his ties to the drug industry.

'Dr. Califf’s expertise and his close ties to the pharmaceutical industry are both well-known,' she said. 'His ties to industry have been a source of great concern to public-health experts when he was previously considered for FDA commissioner, and those ties raise important questions about this nomination.'

The MedPage Today article noted that Public Citizen's Health Research Group stated,

'During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and device companies, including Amgen, Astra-Zeneca, Eli Lilly, Johnson & Johnson, Merck Sharpe & Dohme and Sanofi-Aventis, to name a few,' Michael Carome, MD, the group's director, said in a statement. 'Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.'

The MedPage Today article, however, then went on to undermine those concerns, implying that only fringe people like those at Public Citizen were really worried. 

Most experts contacted by MedPage Today seemed to think Califf would not have a problem getting Senate confirmation. 'I expect him to be confirmed," said [Dr. Steven] Nissen. 'He is very well liked by people ... in both parties, and I would expect the nomination to go well.'

'All signals suggest that Dr. Califf is well-respected on both sides of the political aisle,' Jay Wolfson, DrPH, JD, senior associate dean at the University of South Florida's Morsani College of Medicine, in Tampa, said in an email.

'There are some who believe his relationship with [the drug industry] may be a problem, but most see it as a value-added factor in building a functional, more streamlined relationship with the industry in order to improve the speed with which truly effective and quality drugs and devices are made available, mitigate the excessive costs associated with pharmaceuticals, and influence policies and practices intended to improve health status.'

Note that the experts were not all named, or their expertise described, the first two paragraphs were really about Dr Califf's political support, and the third paragraph clearly reflected the views of someone who thought that the FDA needs to have a lighter regulatory touch. 

There was additional reporting about Dr Califf's conflicts of interest, but again with the effect of minimizing their importance.  The Wall Street Journal published a second article on September 18, 2015 which first reported,

From 2009 through early 2015, Dr. Califf received consulting fees of roughly $205,000 from companies including Johnson & Johnson, Merck & Co., GlaxoSmithKline PLC and one medical-device maker, records show. The payments are documented by the federal Open Payments database, and PharmaShine, a database of pharmaceutical disclosures operated by Obsidian Healthcare Disclosure Services LLC. Drug makers spent an additional $21,000 on travel, meals and other expenses for Dr. Califf, data show.

But the article provided this counterpoint,

Kevin Griffis, a spokesman for the Department of Health and Human Services, said Dr. Califf had ceased all work with drug makers once he was hired by the FDA and that he has gone through a rigorous screening process for potential conflicts of interest. Mr. Griffis said Dr. Califf had donated all the consulting fees he has received since the mid-2000s to nonprofit groups.

'Dr. Robert Califf’s professional career has been dedicated to advancing biomedical research, including the rigorous evaluation of the safety, efficacy and appropriate use of both new medical products and those already on the market,' said Mr. Griffis, assistant secretary for public affairs at HHS.

Note that Dr Califf already is at the FDA, in a position that I do not believe required Senate confirmation.  It is striking, however, how the agency's own public relations people have jumped to his defense now as a nominee who has to be confirmed by the Senate.  However, I suppose that had Dr Califf donated all this fees to a local soup kitchen, they could not be called much of a conflict of interest.  But Mr Griffis said "nonprofit groups," without specification, not "soup kitchens." And continue reading to find out more. 

A simultaneous NY Times article enlarged a bit on Dr Califf's industry relationships,

He has written scientific papers with pharmaceutical company researchers, and his financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary, including Merck, Novartis and Eli Lilly. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.

However the NYT article also quoted Mr Griffis about the donations to "nonprofits," and added,

A résumé studded with industry funding is not unusual in academic medicine, Dr. Califf’s supporters note. Doctors are paid consulting fees all the time, and universities routinely conduct clinical trials on behalf of companies. Those contracts help support university researchers’ salaries, a standard practice. Many emphasize that it does not imply an inherent conflict.

His supporters contend that Dr. Califf’s vast experience in the clinical science world could be a major asset in his new post.

Furthermore,

Supporters and former colleagues say Dr. Califf’s background makes him perfectly suited to the job of commissioner. He has spent years improving the way clinical trials are conducted, coming up with groundbreaking trial designs for medicines against blood clots.

'His integrity in scientific matters is impeccable, and his innovation in clinical trial design is legendary,' said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, who has been an outspoken critic of both the F.D.A. and drug companies.

Even better,

Dr. Califf is often in the gym on the StairMaster before 6 a.m., said a former colleague at Duke, Dr. Adrian Hernandez. He often invites younger doctors to join him in golf and has a passion for Duke basketball that he expresses by wearing the team colors on game days.

How could anyone criticize a man who is at the gym at 6 AM?

More seriously, note that while the recent reporting may bring up questions about Dr Califf's conflicts of interest in terms of financial relationships with drug, device and biotechnology companies when he was on the Duke faculty, all the reporting also included passages minimizing the importance of these conflicts.  To minimize the issue of conflicts of interest, articles cited unnamed experts, suggesting the logical fallacy of an appeal to authority; noted that the financial ties that were criticized are standard practice in academic health care, suggesting the logical fallacy of an appeal to common practice.  The articles also cited Dr Califf's positive attributes which may have been relevant to his work at the FDA, like knowledge of research, but were not related to the question of conflicts of interest. This suggests another appeal to authority, or something of a reverse ad hominem (pro hominem?) fallacy.  It seems odd that what appear to be straightforward journalistic reports of a presidential nomination included such attempts to defend the candidate.  Note further that many of these logical fallacies appeared not in quotes from Dr Califf's supporters, but in text apparently written by journalists (e.g., "industry funding is not unusual," "in the gym on the Stairmaster," etc.)

Nonetheless, this is the state of play as of this moment.  The thrust of the media coverage suggested that Dr Califf is a brilliant physician and researcher, and while he as some ties to industry, they do not amount to much of a problem, except in the eyes of the likes of Public Citizen.


If one digs deeper, however, there is more. When Dr Califf was appointed to his current FDA position in February, 2015, and years earlier when his name was first mentioned as a possible candidate to run the FDA, evidence appeared that his ties to pharmaceutical, biotechnology and device companies were much more serious than what the recent accounts suggested.  

Where Does the Money from Industry Sponsored Research Grants Go? 

The recent coverage of Dr Califf's nomination in the NY Times dismissed his multiple corporate research grants as common practice.  Yet in the TIME coverage of  his original appointment to the FDA in February, 2015, this reminder of the significance of corporate sponsored research grants appeared.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis.

Note that apologists for physician and academician interaction with industry often claim that industry funding of research grants that does not go directly to individuals does not cause important conflicts of interest. In one sentence, however, this article underlined how these grants support academic salaries, and hence lead to the dependency that is at the heart of conflicted relationships.

As we posted in 2007, academic medical institutions now depend on "external," including corporate research funding to support their research faculty's salaries, and via "overhead," their overall budgets.  Dr Lee Goldman, then Dean and Executive Vice President at Columbia University, called faculty who bring in a lot of grant money "tax payers," who earn gratitude, and likely bonuses and perks.  Thus Dr Califf's multiple large corporate research grants cannot be completely dismissed as conflicts of interest. 


A More Extensive List of Industry Relationships

Furthermore, a relatively obscure February, 2015, report from MDDIOnline noted that Dr Califf had more industry relationships than were reported this month,

Conflict of interest disclosures dating back to 2007 made public by the DCRI show that Califf has been paid for consulting or other services provided to a number of medical device pharmaceutical, and biotech companies, including Medtronic, Acumed, Bayer Healthcare, Merck, Novartis, Roche, GlaxoSmithKline, Bristol-Myers Squibb, Sanofi-Aventis, and Eli Lilly & Co. Califf also disclosed that he held equity in two pharmaceutical companies—Boulder-based N30 Pharmaceuticals and South San Francisco, CA-based Portola Pharmaceuticals—as recently as 2014. Califf retired from Portola’s board of directors January 26, according to a press release from the company.

A somewhat more obscure commentary by Martha Rosenberg in OpEdNews provided even more extensive listings of Dr Califf's industry relationships. And it suggested having a look at the disclosures he has made in the past in medical journal articles. A statement in a 2013 JAMA commentary was particularly telling,

Dr Califf receives research grants that partially support his salary from Amylin, Johnson & Johnson, Scios, Merck/Schering-Plough, Schering-Plough Research Institute, Novartis Pharma, Bristol-Myers Squibb Foundation, Aterovax, Bayer, Roche, and Lilly; all grants are paid to Duke University. Dr Califf also consults for TheHeart.org, Johnson & Johnson, Scios, Kowa Research Institute, Nile, Parkview, Orexigen Therapeutics, Pozen, WebMD, Bristol-Myers Squibb Foundation, AstraZeneca, Bayer/Ortho-McNeil, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Gilead, GlaxoSmithKline, Li Ka Shing Knowledge Institute, Medtronic, Merck, Novartis, sanofi-aventis, XOMA, University of Florida, Pfizer, Roche, Servier International, DSI-Lilly, Janssen R&D, CV Sight, Regeneron, and Gambro; all income from these consultancies is donated to nonprofit organizations, with most going to the clinical research fellowship fund of the Duke Clinical Research Institute. Dr Califf holds equity in Nitrox LLC, N30 Pharma, and Portola.

These lists of corporations from which Dr Califf got salary support and consulting fees are much longer than previous lists.  He acknowledged 13 commercial research sponsors, and consulted for 32 organizations, most of which were pharmaceutical companies.  Again, given that the salary support and overhead likely supplied by corporate research grants do suggest conflicts of interest, Dr Califf may have had many more of these sorts of conflicts than current reports implied  

A Seat on a Pharmaceutical Company Board of Directors

Note that the MDDIOnline article mentioned that Dr Califf was a member of the board of directors of Portola Pharmaceuticals. That was a significant source of income.  According to the Portola Pharmaceuticals 2015 proxy statement, Dr Califf received $259,623 in cash and stock options from the company in 2014.  I cannot find anything to suggest that this payment did not go directly to him.  This position, and the money it paid were not mentioned in the recent coverage. That payment alone seems to represent a major conflict of interest.

However, being on the board of directors of a health care corporation presents a deeper conflict than that produced by a simple payment of money or stock options, no matter how large. In 2006, we discussed corporate directorships as a new and important species of conflict of interest for medical academics.  As we have previously posted, corporate directors have fiduciary responsibilities to the company and its shareholders to support its financial success.  They are supposed 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 corporate directors have a much more significant commitment to the corporation than do corporate consultants, or researchers supported by corporate grants. 

Where Did Those Donated Consulting Payments Go?

Also note that the disclosure statement in the JAMA article mentioned that most of the consulting payments Dr Califf received went to the clinical research fellowship of the Duke Clinical Research Institute (DCRI).  Dr Califf was the first director of DCRI, 

So, while Dr Califf apparently did donate the consulting fees to a non-profit organization, that organization actually was part of Duke, and an organization that Dr Califf once led. It appears likely that Dr Califf benefited at least indirectly in terms of institutional gratitude and reputation from these consulting fees that he donated to his own institution.  So it appears that Dr Califf's donations of his consulting fees did not reduce the conflicts of interest generated by these fees to the extent suggested by the current FDA spokesperson and current media reports. 

Payments for "Educational Activities" 

Finally, perusal of disclosures of Dr Califf's commercial relationships made by the Duke Clinical Research Institute for the years 2010-2015 showed that he received payments for "educational activities" in 2011 from Amylin.  Information about earlier years is not available on this site, but in 2009, Dr Daniel Carlat wrote this about Dr Califf's then rumored candidacy for leadership of the FDA in the Carlat Psychiatry Blog,

look at these industry disclosures. He took money—lots of money--from 18 different pharmaceutical or device firms. Most of this was not for research, but for consulting and speaking, including CME. If Dr. Califf believes that it is ethical for physicians to help drug companies market their products, that’s his own business. But to elevate him to a position in which he is the country’s chief watchdog over unsafe medications and foods seems a dangerous move. With money from 18 drug companies padding his bank account, he will presumably spend most of his FDA career recusing himself from crucial decisions. Not a good idea.

There has been no mention of Dr Califf being a paid speaker for pharmaceutical companies in any of the recent reporting.  Dr Carlat implied that Dr Califf was paid to speak to further marketing objectives of pharmaceutical companies, that is, was giving "drug talks."  Since the publication of "Dr Drug Rep" in the New York Times in 2007, authored by Dr Carlat, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.)

Paid speakers may be regarded by pharmaceutical companies as paid "key opinion leaders," KOLs, who serve a marketing function in the guise of academics. As noted here and here, the companies buying their services may believe they have bought the services of sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how company keaders view key opinion leaders as marketers.

So the revelation that Dr Califf received corporate payments for "education" suggests a bigger commitment to corporate marketing objectives than has previously been revealed.  

Summary

So, looking at not only current media reports, but media reports from earlier this year, and also proxy statements, the fine print of journal articles, and old blog posts, it appears that Dr Robert Califf really did have very substantial financial interactions with the drug, device and biotechnology industry.  These interactions likely underwrote his salary and his standing with the leaders of his former employer, Duke University.  Dr Califf seemed to be a paid speaker for drug companies on at least two occasions, suggesting that the companies may have put him in a covert marketing role, or viewed him as a paid key opinion leader.  Finally,  Dr Califf served on the board of directors of one drug company, a much deeper commitment than being a sponsored researcher or consultant.

Thus Dr Califf really appears to be one of the most, if not the most drug, device and biotechnology industry connected individual ever nominated to lead the agency that is the most important regulator of the US drug, device and biotechnology industry.  Some of his connections, particularly his previous membership on a pharmaceutical company board, and his previous roles as a paid pharmaceutical speaker, suggested not only financial relationships, but commitments to companies' financial and marketing goals.  These appear to be major conflicts of interest vis a vis Dr Califf's current leadership position at the FDA, and his nomination to be the ultimate leader of this regulatory agency.  This is the revolving door writ large.

As we have said very recently,  the revolving door can be veiwed as a species of conflict of interest.  Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who just came from industry are likely to maintain their industry mindset and be mindful of their industry friends.

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.

Furthermore, the ongoing and increasing revolving door phenomenon clearly suggests excess coziness between industry and government, now to the extent that industry and government leaders of health care are becoming interchangeable.  This suggests that health care is increasingly run by this cozy ingroup, who very likely put their own interests ahead of those of patients and the public.

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.

ADDENDUM (28 September, 2015) - This post has been republished on the Naked Capitalism blog,  and OpEdNews.

ADDENDUM (28 September, 2015) - See also more detail on Dr Califf's activities on the Portola board on the PEU Report blog. 

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Who Benefits? - Rising Generic Drug Prices and the Case of Mylan's Conflicted Property Purchases

boards of directors conflicts of interest executive compensation mission-hostile management Mylan perverse incentives

Who Benefits? - Rising Generic Drug Prices and the Case of Mylan's Conflicted Property Purchases

Unknown 7/09/2015 Komentar

Rising Generic Drug Prices

Health care costs in the US continue their seemingly inexorable rise.  Even the parts of health care that used to seem reasonably priced now are affected.  As Ed Silverman discussed on PharmaLot

prices for many generic drugs have been climbing, prompting concerns that a low-cost staple of the U.S. health care system might soon strain budgets.

Generic drugs, like practically every other part of US health care, have become big business.  As a Forbes article pointed out, the industry is becoming more consolidated, and more likely to suffer from manufacturing and regulatory issues.  However, there may be other reasons for increasing generic drug costs.

Case: Mylan Purchased Properties Developed by its Own Board Vice Chair

A recent Wall Street Journal scoop on the big generic pharmaceutical company Mylan suggested that maybe such companies are now suffering from the same leadership and governance ills we have been finding throughout US - and indeed global - health care.  Furthermore, to understand the impacts of such health care dysfunction, one must consider the incentives that underlie them, that is, who benefits?

The story concentrated on some dodgy deals involving the company and firms linked to the Vice Chairman of its board of directors.  The first part of the story was:

Generic-drug maker Mylan NV moved into new headquarters in December 2013 after buying vacant land in an office park near Pittsburgh and erecting a five-story building for about 700 employees.

The company hasn’t publicly disclosed that the office park’s main developer is Rodney Piatt, Mylan’s vice chairman, lead independent director and compensation-committee chief. The new headquarters was a big boost for the mixed-use real-estate development, called Southpointe II, where all the land has been sold and some of the last buildings are now rising.

Securities regulators require public companies to tell shareholders about any significant transactions with directors, executives or other 'related persons.' Members of boardroom compensation committees have special duties under securities and tax laws to avoid dealings that compromise their independence.

Mylan, now fighting a three-way takeover battle in the pharmaceutical industry, says there was no need to disclose Mr. Piatt’s connection to the $60 million real-estate project because he and the company avoided any direct dealings with each other.

The day before Mylan announced plans to build the new headquarters, a company managed and partly owned by Mr. Piatt sold a 7-acre site for $1 to an entity owned by a business partner in Southpointe II, according to property records reviewed by The Wall Street Journal. The partner’s firm sold the same land to Mylan for $2.9 million later the same day.

Also,

Real-estate records show a similar transaction in May. Mylan paid $9.2 million to buy an adjacent 11 acres from Mr. Miller, whose firm previously bought the land for $10 from a company partly owned by Mr. Piatt.

'Mr. Piatt was not a party to either transaction' involving Mylan and 'had no direct or indirect material interest in the transactions,' says a Mylan spokeswoman.

She adds that Mr. Piatt didn’t make a profit on either sale to Mylan because Mr. Miller separately arranged to buy out Mr. Piatt at cost and then sold the land directly to Mylan. Mr. Piatt didn’t return calls seeking comment.

Note however that

Securities rules require disclosure of any transaction of more than $120,000 where a related person will have a direct or indirect material interest, regardless of whether the person makes a profit.

In the case of compensation-committee members, related-party transactions can jeopardize the independence required of them under tax and securities rules. That can threaten the tax-favored status of some executive-pay programs and require executives to disgorge some of their gains on stock sales.

Some securities-law and corporate-governance experts say Mylan should have been more transparent about the real-estate transactions or handled them differently.

'The optics are terrible,' says Charles Elson, director of the John L. Weinberg Center for Corporate Governance at the University of Delaware and a director at HealthSouth Corp. and Bob Evans Farms Inc. 'Pittsburgh is a big town with no shortage of real estate. Either they could have gone somewhere else, or [Mr. Piatt] could have relinquished the directorship and eliminated the conflict.'

Just to emphasize the questions about Mr Piatt's independence,

The new headquarters is named the Robert J. Coury Global Center, after Mylan’s executive chairman. Mr. Coury, 54, was chief executive from 2002 to 2012.

A few months after the project’s approval by local officials, Mr. Piatt signed a pension amendment that increased the value of Mr. Coury’s promised benefits by 40%. His overall pension of $48.8 million is 11th-largest among executives at U.S. publicly traded companies, according to Standard & Poor’s ExecuComp.

Further muddying the waters,

During construction, Mylan hired project-management firm RIZ Consulting & Management Inc. to oversee the general contractor and architect. RIZ has the same business address and phone number as Mr. Piatt’s real-estate company, and he is listed as the contact person for RIZ in the local chamber of commerce’s membership directory.

RIZ’s president also is a top executive at Mr. Piatt’s company, and some employees of Mr. Piatt’s company worked for RIZ on the project, according to state records, construction documents and the minutes of permit meetings. RIZ’s president didn’t return calls seeking comment.

'They set it up that way because [Mr. Piatt] sits on the board of Mylan,' says Jeff Yates, a project manager with PJ Dick Inc., the general contractor for the Mylan headquarters project. 'It was kind of a conflict of interest, [so] RIZ was a separate company set up to be the owner’s rep.'

We often discuss how health care is tangled in a vast web of conflicts of interest.  The kinds of apparent conflicts of interest in play in this case are somewhat different from those we frequently discuss, but still seem part of this web.

In the last few days, other Pittsburgh newspapers have jumped into the fray, and found their own experts to question these deals.  Per the Post-Gazette,

'It doesn’t pass the smell test'” said Mel Fugate, a management professor at Southern Methodist University.  Mr. Fugate said that while the SEC places legal requirements on which transactions must be disclosed, the legal obligations are 'the lowest hurdle of them all.'

'This smells bad … even if they can prove legally there are no conflicts' he said.

Again, as noted above the law in certain instances may define conflicts of interest more narrowly than ethical definitions.  For example, the Institute of Medicine defined conflicts of interest in medicine: occurring "when an individual or institution has a secondary interest that creates a risk of undue influence on decisions or actions affecting a primary interest."

The Tribune weighed in,

'The whole thing stinks,' said Douglas Branson, a University of Pittsburgh law professor and an expert in corporate governance. 

Board members'have to serve the best interest of the corporation,' he said. 'You can't be both a seller and buyer — that's the classic definition of conflict of interest.

So here we see serious allegations of conflicts of interest affecting the Vice Chair of the Mylan board, and perhaps affecting another board member and former CEO.  These conflicts suggest that company operations could have been manipulated for these individuals' benefits.

Other Questions about Mylan's Leadership and Governance

Yet these are not the only examples of questions about Mylans' leadership and governance, questions which suggest that managers and board members may have been putting personal gain ahead of the larger interests of the corporation, its shareholders, and the patients who take its drugs


A Pittsburgh Business Journal article noted the "allegations of impropriety" raised by the current case, but also hinted at larger problems with the leadership and governance of Mylan.


Current CEO's Invalid MBA

Per the Pittsburgh Business Journal

Mylan (Nasdaq: MYL) has had ethics questions in the past. An MBA awarded to CEO Heather Bresch was withdrawn in 2008 following an investigation that found she didn’t complete the necessary course credits.

However, that finding did not apparently affect her ongoing career trajectory at Mylan

Former CEO's Use of Company Jet to Help Son's Rock Music Career

The Pittsburgh Business Journal also stated,

And in 2012, the Wall Street Journal found that [former CEO] Coury transported his son to rock concerts on the corporate jet, which was allowed as part of his employee benefits package.

That WSJ article emphasized,

 Nina Devlin, a spokeswoman for Pittsburgh-based Mylan, said Mr. Coury's employment contracts have allowed outside personal activities, 'including those related to his son Tino's career.' She said Mr. Coury isn't required to use the corporate jets but his employment contracts for the past decade have allowed personal use by him and his family.

Thus these contracts apparently allowed valuable Mylan resources to be expended in support of the former CEO's son's career, even though Tino did not apparently have any direct role in the company. Note that these revelations also apparently did not affect Mr Coury's career trajectory with the company, nor did those below.

Transactions Between Former CEO's Brothers and Mylan

That same WSJ article also found,

 This wasn't the only business relationship between the elder Mr. Coury and his brothers. Coury Investment Advisors, a company in which two of his brothers, Gregg and Paul, are principals, has served as a broker for Mylan's employee-benefit plans. Various insurers paid them $597,000 in the past three years for Mylan-related business, according to U.S. Labor Department filings.

That appeared to be another conflict of interest, benefiting different members of the former CEO's family.

However, that is still not the whole story.  A quick look through our magic files, and Google, revealed some other pieces.

Mylan Settled Allegations of Inflated Pricing

In 2010, we briefly posted about a settlement by Mylan of charges it falsely inflated prices for several drugs.
As is usual in such settlements, none of the people who authorized, directed or implemented the actions leading to this settlement apparently suffered any negative consequences, including the top managers on whose watch they occurred. 

Mylan Fired Executive Allegedly for Filing Whistleblower Lawsuit Against Another Company

In June, 2014, the Pittsburgh Tribune reported,

 When Mylan Inc. learned that its vice president of marketing had filed a whistleblower lawsuit against his previous employer, it fired him, the man alleged in a federal lawsuit filed Tuesday.

Note that the lawsuit was against Cephalon, not Mylan.  Rocking the boat, or blowing the whistle apparently are not rewarded at Mylan.

Current CEO Named US Patriot of the Year, then Moved Mylan to Netherlands

In 2014, some wondered how Heather Bresch, still the Mylan CEO, could have claimed to be ultra-patriotic while she was planning to move her company out of the US.  In 2011, Esquire listed Ms Bresch in an article on "Americans of the Year: Patriots." They were apparently particularly impressed that she had called for more inspections on foreign drug companies whose products are imported into the US. However, in 2014, per Ron Fournier in the National Journal.

This story is about a gilded class of people and corporations enriched by the new American economy while the rest of its citizens pay the tab. The protagonists could be any number of institutional elites, but this column happens to be about a Democratic senator from West Virginia, Joe Manchin, and his daughter, Heather Bresch, the chief executive of Mylan, a giant maker of generic drugs based outside Pittsburgh.

Her company's profits come largely from Medicaid and Medicare, which means her nest is feathered by U.S. taxpayers. On Monday, Bresch announced that Mylan will renounce its United States citizenship and instead become incorporated in the Netherlands – leaving this country, in part, to pay less in taxes.

This is the sort of story that makes blood boil in populists – voters from the Elizabeth Warren wing of the Democratic Party to libertarians who follow Rand Paul and including tea party conservatives. These disillusioned souls, growing in numbers, hate hypocrites who condemn the U.S. political system while gaming it.

Later, Ms Bresch's father, Senator Manchin, said what his daughter did should be illegal, again per another Ron Fournier article in the National Journal, whose title says it all:

Senator Manchin: What My Daugher Did Should be Illegal

Nonetheless, late in 2014, Bloomberg reported that not only would Mylan go ahead with the inversion, but it would pay the excess taxes personally incurred by its own executives due the transaction.  Such taxes were meant as a negative incentive to discourage such maneuvers.  Even so, top managers seemed to be able to pay themselves to avoid the effect of these incentives, and of course any resulting personal financial losses.


Summary

 The latest story about Mylan seemed to show a leading board member financially benefiting from transactions between the company over which he was supposed to exercise stewardship and his own company.  Other stories showed Mylan executives seeming to gain outsized benefits for themselves or their family members from Mylan beyond conventional salaries and corporate benefits packages. Of course, since Mylan is not just any company, but a very large generic drug company, putting top hired managers and boards of directors first may mean putting patients second.  The cost of these managers' and boards' interests may be at the expense of patients, and the public at large.

Thus perverse incentives enable mission-hostile management and ultimately health care dysfunction.

So once again, when considering how US, and global health care has become so dysfunctional, it makes sense to think about who is benefiting from the current dysfunction.  It very often is organizational insiders, particularly top hired managers, and sometimes those who are supposed to keep an eye on them. 

 Thus, like hired managers in the larger economy, health care managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money. 

One wonders how long the people who actually do the work in health care will suffer the value extraction to continue?
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.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.

As Robert Monks said in a 2014 interview,

People with power are very reluctant to give it up. While all of us recognize the problem, those with the power to change it like things the way they are.

So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

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