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

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.

How Institutional Conflicts of Interest Exacerbate the Anechoic Effect - the Example of ASCO Fearing "Biting the Hand that Feeds You"

As we recently discussed (here, here, here and here), in May, 2015, the New England Journal of Medicine, arguably the world's foremost medical journal, published an editorial and a three-part commentary arguing that current concerns about the effects of financial conflicts of interest (COI) on health care are overblown(1-4).  On June 1, the Wall Street Journal published a report on the 2015 meeting of the American Society of Clinical Oncology (ASCO) that provided a vivid example of why these concerns should not be dismissed.

Questioning Drug Prices at the ASCO Meeting

The main issue in the article was:

In a sign of growing frustration with rising drug prices, a prominent cancer specialist on Sunday sharply criticized the costs of new cancer treatments in a high-profile speech at one of the largest annual medical meetings in the U.S.

'These drugs cost too much,' Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, said in a speech heard by thousands of doctors here for the annual meeting of the American Society of Clinical Oncology.

The notion that health care prices are high and are rising continuously in the US should hardly be novel for regular Health Care Renewal readers.  We have been writing about it for a while, starting in 2005.

We first posted about high drug prices in July, 2005, with the example of BilDil.  This was a brand-name combination drug that included two compounds that were already cheaply available in generic form, advertised as a uniquely convenient therapy for congestive heart failure.  We were aghast that the price of the combination drug might be $5.40 - $10.80 a day (in 2005 dollars), over three times the cost of the two drugs in generic form.

But only a few days later we noted that three cancer costs had yearly costs in the five figures, and one, Erbitux, cost as much as $100,000.  Most amazingly we noted that Thalidomid was priced at $25,000  a year.  Yet it was just the infamous thalidomide, the drug initially marketed as a tranquilizer that caused severe birth defects after it was initially sold in Europe.  The drug was still available in generic form in South America for about seven cents a pill.

Since then, the ridiculously high prices of many tests and treatments, but most notably new drugs and devices, has been so widely covered our discussion has been limited to special cases.   For example, consider just a few headlines from April to May, 2015.

How Much Would You Pay for an Old Drug? If You Have MS, a Fortune (Bloomberg)

Pharmaceutical Companies Buy Rivals' Drugs, Then Jack Up the Prices (WSJ)

How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits (WSJ)

Runaway Drug Prices (NY Times)


Drug Prices as a Taboo Topic

However, despite this wide attention to the problem, the speech at ASCO was notable.  Back to the WSJ...

Dr. Saltz’s speech was unusual because it was made at the meeting’s plenary session, where the field’s most significant scientific research is presented and which all meeting participants are expected to attend. An estimated 25,000 doctors and scientists attended this year’s meeting.

One would think that the high price of drugs, especially cancer drugs, would be a fit subject for discussion at a plenary session of ASCO, however,

It is unprecedented for plenary speeches, which typically address scientific and medical issues, to substantially take on the topic of drug costs, said Alan Venook, a professor of medicine at the University of California San Francisco who planned the meeting’s scientific session and invited Dr. Saltz to speak.

The prominent venue for the speech was also unusual because, like many medical meetings, ASCO is sponsored by pharmaceutical companies and often focuses on highlighting advancements in drug development, said Dr. Venook. He said discussing drug prices there is 'uncomfortable' because it could be seen as 'biting the hand that feeds you.'

Doctors are also reluctant to antagonize the drug industry because they need pharmaceutical firms to invest in developing new medicines for patients, he said.

'It’s a tough balancing act for ASCO where the meeting is largely funded by pharma,' Dr. Venook said in an interview. 'You can’t have a [plenary] talk trashing pharma, but you can have a talk by a respected person questioning it.'

So because pharma gives ASCO a lot of money, at best, only the most distinguished ASCO members can gently question pharma, but cannot criticize, much less "trash" the source of their mammon.


This is thus a succinct example of why financial conflicts of interest in medicine and health care can be bad.  The incredibly high prices of cancer drugs should be a fit topic for discussion at a meeting run by a society of medical oncologists.  But those in charge of the meeting and the society are afraid to initiate such a discussion, and even more afraid of appearing to criticize the companies that charge these prices, because the society has become dependent on money from these very same companies.  So this is further an example of how conflicts of interest can create the anechoic effect - the notion that certain topics in medicine and health care are taboo, because discussing them might trouble the powers that be, and particularly the moneyed interests that now dominate medicine and health care. 

In a succinct response to the NEJM series (1-4) soft pedaling concerns about conflicts of interest, the British Medical Journal ran a commentary by a former NEJM national correspondent, and two former NEJM editors.(5)  It stated,

The NEJM has now sought to reinterpret and downplay the importance of conflicts of interest in medicine by publishing articles that show little understanding of the meaning of the term. The concern is not whether physicians and researchers who receive industry money have been bought by the drug companies, as Drazen writes, or whether members of guideline panels or advisory committees to the US Food and Drug Administration with ties to industry make recommendations that are motivated by a desire for financial gain, as Rosenbaum writes. The essential issue is that it is impossible for editors and readers to know one way or the other.

In this case, we seem not to be talking about the possibility that health care professionals "have been bought by the drug companies,"  but how drug companies essentially "buying" a professional organization has apparently heretofore prevented medical professionals from discussing a vital issue that could have major effects on patients.

Following the Money

In case there is any question about the money involved and its sources, one only needs to go to some publicly available in formation supplied by ASCO (mostly because of reporting requirements imposed on all US non-profit organizations of a certain size).  

The latest (2014) annual report from ASCO reveals that the organization only gets 16.1% of its revenue from member dues.  Thus a ostensible membership organization gets only about a sixth of its funding from members' dues.

Yet the organization has become quite wealthy.  Its most recent (2013) US Internal Revenue Service 990 Form reveals that it owns over $55 million in real estate, and has over $104 million in investments (presumably as an endowment.)  The organizations' leaders are also doing very well. Its CEO, Allen Lichter MD, got $804,775 in total compensation in 2012.  Eleven other managers, of which three are health care professionals (one MD, one RN, one PharmD), got at least $220,000 in total compensation.  Five of them got more than $300,000. 

The source of all that money seems mainly to be pharmaceutical and other health care corporations that sell goods and services for cancer care.  US non-profit organizations are not forced by law to reveal the details of their financial support.  However, the ASCO annual report does list 23 pharmaceutical and biotechnology companies, and one for-profit cancer hospital chain as contributing at least $1 million each in total to the non-profit over time.  The report lists 37 pharmaceutical, biotechnology, and medical device companies as current corporate donors, and also 10 other for-profit health care related corporations as current corporate donors.

In addition to these apparently marked institutional conflicts of interest, ASCO leaders may have their own individual conflicts of interest.  I do not have the resources to search all relationships affecting meeting organizers and ASCO officers and trustees, and the organization does not post conflicts of interest affecting its leadership and governance in a prominent place. However, Dr Alan Venook, who confessed to his discomfort about inviting a talk that might be perceived as biting the hand that feeds the finances of ASCO, is or has been on advisory boards for Thershold Pharmaceuticals,  Mirna Therapeutics, and GlobeImmune.  For a 2014 presentation, he gave the following disclosures: "Research support from Genentech/Roche, BMS, Lilly, Novartis; H. Lenz: Consulting, advisory boards and research support from Genentech/Roche, BMS and Merck."  Furthermore, the current chair of the ASCO Board of Directors, Julie M Vose, MD, is also on the Medical Advisory Board of EmergingMed Inc, and the Clinical Advisory Board of Bullet Biotechnology.

Summary

The New England Journal of Medicine recently launched a counter-attack against the "pharmascolds" who are allegedly slowing the pace of medical progress by their excessive and puritanical concerns about financial conflicts of interest.  Yet the arguments that COIs could be bad for health care are logical, and based on at least some reasonably good evidence.  (See the article by Steinbrook et al in the BMJ mentioned above[4], the accompanying BMJ editorial[5] just to start and then the 2009 Institute of Medicine report.)

Moreover, we have encountered a lot of vivid cases suggesting that conflicts of interest can have adverse influences on health care.  In this most recent one, we see at least one prominent if conflicted organizational insider admitting that institutional, and perhaps individual conflicts of interest have made discussion of at least one big health care and health care policy topic taboo.  This seems to corroborate our previous discussion that the anechoic effect - that certain topics in health care are taboo - may be generated by conflicts of interest of the people who ought to discuss them, or of those to whom those people may have to answer.

True health care reform requires full disclosure of conflicts of interest for honesty's sake, and marked reduction of conflicts affecting those who make health care decisions on behalf of individual patients, and health care policy decisions that affect patients' and the public's health.  If we allow conflicts of interest to continue, we will have difficulty even discussing the most severe problems affecting health care, because those generating the topics are benefiting from the circumstances that enable such problems.

ADDENDUM (1 July, 2015) - This post was republished on 28 June, 2015, on the Naked Capitalism blog. 

ADDENDUM (20 July, 2015 ) - This post was republished on July 12, 2015 in OpenHealth News.

References

  1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.
5. Steinbrook R, Kassirer JP, Angell M.  Justifying conflicts of interest in medical journals: a very bad idea.  Brit Med J 2015; 350: h2942.  Link here. 
6. Loder E. Revisiting the commercial-academic interface in medical journals.  Brit Med J 2015; 350: h2957.  Link here.

Say It Ain't So, Again - a "Push Poll" to Minimize the Hazards of Conflicts of Interest ...in the New England Journal of Medicine?

The New England Journal of Medicine recently published a remarkable series of apologiae for conflicts of interest,(1-4) about which we have published three posts, here, here, and here.  Just to ice the cake, the NEJM also set up a reader poll on the subject. Its introduction stated,

we invite you to put yourself in the role of editor and help us decide about the suitability of three hypothetical potential authors of review articles for the Journal.

However, as noted first in a post on the HealthNewsReview.org blog, the poll had a curious design. 

Each of the three hypothetical experts has some type of financial arrangement with the pharmaceutical industry – either royalty payments, speaking fees, or commercially supported research at a university that covers everything except the researcher’s salary.

Noticeably absent was a 'Case #4' describing a potential author with no conflict of interest. 

IMHO, this seems like a biased survey design.  By failing to incorporate a questions about an unconflicted author, the numeric results of the poll could not show whether those answering it would actually favor authors without conflicts of interest.  Of course, the whole thrust of the three commentary(2-4) plus one editorial(1) NEJM series was that concerns about such conflicts are overblown.

Nonetheless, the poll allowed for comments, and as the blog post showed, this bias did not escape notice.  One commentator, Dr David Newman, wrote

The only reason to choose any of the individuals in these cases would be if there were no available alternatives.

This survey bias did not escape Dr Josh Farkas, who wrote this in a PulmCrit blog post,

Perhaps the most interesting component of the media campaign is the reader poll about the adequacy of various hypothetical authors for a review article.  Three potential authors are described, all of whom have significant COIs.  The design of this poll itself is biased, by presenting no authors without COIs.  A more transparent approach might be to simply ask readers 'do you think review article authors should be allowed to have COIs?'

Thus, the NEJM conflict of interest poll appears to be not an attempt at unbiased data collection, but a "push poll."  A "push poll," per Wikipedia, is:

an interactive marketing technique, most commonly employed during political campaigning, in which an individual or organization attempts to influence or alter the view of voters under the guise of conducting a poll.

By prominently publishing a poll with such a biased design, the NEJM has further supported my argument that its current editors are engaging in polemics rather than scholarly debate about the very important issue of conflicts of interest in medicine and health care.  Perhaps the current NEJM editors should consider joining the blogsphere in which polemics abound, while leaving the serious business of scholarly journal editing to those who are more dispassionate.   

References
1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.

Say It Ain't So: Logical Fallacies in Defense of Conflicts of Interest ... in the New England Journal of Medicine?

Introduction

We have been viewing with alarm the web of conflicts of interest draped over medicine and health care since we started Health Care Renewal.  We have been particularly concerned about how conflicts of interest may have led to threats to the integrity of clinical research, especially due to manipulation and suppression of clinical research studies.  We have also been concerned about how COIs have led to threats to the integrity of medical education, especially given how health care corporate marketers have paid influential health care professionals and academics to be "key opinion leaders," mainly to act as salespeople in disguise.  We have discussed individual and institutional conflicts of interest involving all sorts of health care organizations.

When we started writing about these issues, we did not find many who shared our concerns, but the topics have become better known.  The Institute of Medicine wrote an apparently authoritative report in 2009 on conflicts of interest which got some notice, but attracted few adherents.  There have been few changes on the policy front in the US regarding conflicts of interest, with the notable exception of the Sunshine Act incorporated into the Affordable Care Act which required increased disclosure of payments made to health professionals and organizations. 

So it was surprising that the New England Journal of Medicine, probably the most influential and important English language medical journal, recently published an editorial by Drazen (1) and three commentaries by Rosenbaum(2-4) about conflicts of interest, all suggesting that concerns about COIs are overblown, and that excess attention to COIs may be inhibiting medical progress.

It was more surprising, given the reach of this journal, that these articles featured a catalog of logical fallacies in support of their arguments.  We have noted that logical fallacies have been a stock in trade of those who actively defend laissez faire policies about conflicts of interest, and other kinds of interactions among health professionals and industry.  However, I would not have believed that the New England Journal of Medicine would go along with this sort of thing.

However, they did, and so we will endeavor to sort out their catalog, noting the most important uses of logical fallacies, in order of the chronological sequence of the publications....

Burden of Proof Fallacy: That All Physician - Industry Collaborations are Beneficial is Assumed, but Contentions that Financial Conflicts of Interest Affecting Physicians Must be Disclosed, Regulated or Banned Require Rigorous Proof  

"The burden of proof is a fallacy in which the burden of proof is placed on the wrong side," per the Nizkor Project definition.

The Assumption that All Physician-Industry Interactions are Good

The Drazen and Rosenbaum articles assert that the burden of proof rests on those who assert that conflicts of interest ought to be disclosed, regulated or restricted.  However, they take the benefits of all physician-industry interactions as given.  For example,

This partnership between an academic researcher and a drug company went on to alleviate substantial human suffering and should be a model for current behavior. Unfortunately, it is not.(1)

Simply put, in no area of medicine are our diagnostics and therapeutics so good that we can call a halt to improvement, and true improvement can come only through collaboration.(1)

the benefits wrought by interactions between physician-scientists and industry are ... clear.(2)

[Physician-industry] interactions [are] characterized by a shared mission to fight disease.(4)

life-saving therapies ... development requires the combined talents of clinicians and industry scientists.... (4)

The series of articles includes multiple assertions that physician-industry collaboration, which is not further defined, is necessary for the advancement of medicine.  The articles never explicitly exclude various kinds of "collaborations" that others may question, including for example, corporate marketers paying well known, often senior academic physicians to be "key opinion leaders" and thus act as salespeople; or paying physicians to give "drug talks" that are clearly marketing exercises, (e.g., the case of "Dr Drug Rep.")

The NEJM articles only supply anecdotal data at best to support this broad assertion.  Of the two anecdotes used by Drazen(1), one was about collaboration between Selman Waksman and Merck during the 1940s in the development of streptomycin.  The applicability of this anecdote, from long ago, done under the pressures of wartime, and long before the era of "shareholder value" theories of management that put short-term revenue ahead of all else (look here), was unclear.   The other "cogent example has been a vaccine against Ebola virus disease."  However, no such vaccine has been licensed for use or accepted as effective, yet.  In fact, society's failure to develop such a vaccine up to now has been attributed to pharmaceutical industry management's emphasis on the preeminence of revenue.  Until the recent epidemic, Ebola vaccine was not seen as a big money maker (look here).

In short, the series of articles accept the value of physician-industry collaboration, writ broadly, in the absence of clear evidence.

The Contention that the Burden of Proof is on Those Who Argue that COIs Should be Disclosed, Regulated or Restricted


On the other hand, regarding assertion that conflicts of interest ought to be disclosed, regulated, or restricted, Rosenbaum wrote

we still lack an empirical basis to guide effective conflict management.(3)

Equally unclear are the benefits and harms of regulations aimed at exposing or mitigating these conflicts.(3)

It remains unclear whether ... disclosures actually mitigate the risk of bias.(3)

conflict-of-interest policies have evolved not through careful data gathering and analysis.... (4)

In particular, most of Rosenbaum's three articles(2-4) focus on her general doubts about and perceptions of faults in the evidence-base about the harms of conflicts of interest, or the benefits of disclosing, regulating or restricting them. For example,

though considerable social science research suggests that even small gifts may influence physicians, it doesn't necessarily follow that greater financial stakes are more influential.(3)

Suggestive data may be worse than no data at all.(3)

It depends on how you define harm.  Consider pharmaceutical 'gifting,' a practice that smacks of bribery - which may be sufficient reason to prohibit it.  But does it actually harm patients?(4)

Furthermore, while decrying the lack of rigorous data in support of disclosing, regulating or restricting COIs, she raises doubts about such actions based on vague anecdotes and general, but unsubstantiated assertions, including

some of the young, talented physician-investigators I spoke with expressed worry about how any industry relationship would affect their careers.(3)

The proportion of physician-investigators who have such concerns was not stated.

A medical school dean probably won't lose her job if patents aren't produced under her tenure, but she will be taken to task if she appears to lax in regulating faculty-industry interactions.(4)

No further specifics about consequences to such academic leaders appeared. 

For many people, however, the medical-industrial complex elicits deeply negative feelings that make it tough to evaluate fairly any intervention aiming to mitigate industry influence.(4)

The evidence in support of this assertion was not apparent.

I think the desire for retribution against 'bad pharma' informs our management of industry interactions in a way that obscures the possibility that we are obstructing medical advances.(4)

The evidence in support of this thought was not apparent. 

Thus Drazen and Rosenbaum clearly believe that the burden of proof is entirely on those who advocate disclosing, regulating or restricting conflicts of interest.  Yet they never argue this point explicitly.  In my humble opinion, I see no reason that their beliefs should be considered a fundamental law of nature, while the beliefs of those who differ with them should be considered unproven hypotheses. The NEJM series of articles seem to be an extended exercise in the burden of proof fallacy.

Appeal to Authority: Important People and Organizations Agree with Us

The appeal to authority fallacy is that an argument supported by an authority must be true, as per Nizkor.  

Drazen and Rosenbaum corroborate their opinions with those of various authorities, but fail to identify any authorities who disagree with them.  In fact, as noted below, they often cite opinions with which they differ without noting who advanced them.  So, for example, 

The National Center for Advancing Translational Sciences of the National Institutes of Health, the President’s Council of Advisors on Science and Technology, the World Economic Forum, the Gates Foundation, the Wellcome Trust, and the Food and Drug Administration are but a few of the institutions encouraging greater interaction between academics and industry, to provide tangible value for patients.(1)

Shaywitz and Stossel, who have each written on the benefits of academic-industry collaboration and the challenges of bringing new products to market, are rare voices competing with a loud chorus of shaming.(3) 

Richard Epstein, a University of Chicago law professor who writes convincingly about the dangers of overregulating medical conflicts, questions certain limitations on the ties of FDA advisory-panel measures.(3)

Note that the authors of the NEJM articles do not discuss whether these authorities could have their own biases.  For example,while Drazen cited the support of the Gates Foundation above, Rosenbaum later acknowledged the current CEO of the Gates Foundation is a former Vice President of Genentech(4).  Neither noted that Dr Desmond-Hellmann was on record early as an apologist for the huge increases in drug prices that occurred starting in the first decade of this century (look here).  Dr Stossel has been known to deploy his own logical fallacies to defend physician-industry interactions (look here), as has Professor Epstein (look here).  Dr Stossel has been known not to disclose his own relationships with industry (look here).

Furthermore, while Rosenbaum attributed a stance in favor of disclosing, regulating or restricting COIs  to former NEJM editor Dr Arnold Relman, it was in the context of doubting his approach, rather than supporting his authority.(3)  Most of the views she cited as opposing hers were not attributed.


Ad Hominem Fallacy: People who Advocate Increased Disclosure, Regulation, or Restriction of COIs are "Pharmascolds"

The ad hominem fallacy is that a posited defect in the character, abilities, competence etc of a person making an argument means the argument is false, see Nizkor.  Rosenbaum wrote,

Physicians know that 'pharmascolds,' as physician-scientist David Saywitz and Tom Stossel have dubbed them, will 'vilify the medical products industry and portray academics working with them as traitors and sellouts.'(3)

The wording thus gives credence to the idea that anyone who advocates for disclosure, regulation or restriction of conflicts of interest is such a "pharmascold."  The articles by Rosenbaum never seeks to balance that assertion with any epithets that might be applied to people who advocate for unrestricted physician-industry interaction.  The implication is that "pharmascolds" are at best excessively sensitive, or worse, engaged in witch hunts. Thus this appears to be at least a back-handed use of the ad hominem fallacy.

Appeal to Pity Fallacy: People Who Advocate a Lenient Approach to Conflicts of Interest are Besieged by a Monolithic Force of "Pharmascolds"

The appeal to pity is an attempt to make an argument more convincing by making the person making it worthy of pity, see Nizkor.  

Rosenbaum started her second article(3) thus,

In 1980, the Journal’s editor Arnold Relman wrote an editorial entitled, 'The New Medical-Industrial Complex' Although it’s hard to pinpoint the moment when a culture forever changed, the editorial represented a seminal event.

She further stated, "In the ensuing decades, endless attention has been paid."  Her examples of this endless attention were two books, the report by the Institute of Medicine, "new rules," and the "recent passage of the Physician Payment Sunshine Act."

Rosenbaum opened her third article(4) thus,

Although I probably couldn’t have explained its rationale, I never questioned the anti-pharma animus that pervaded my medical education. The message I received from certain outspoken classmates and fellow trainees was that interacting with pharmaceutical reps was simply wrong.

She noted that

I suspect my experience was not unique. Indeed, the American Medical School Student Association (AMSA) now grades medical schools on their creation of a 'pharma-free' environment, issuing annual report cards on conflict-of-interest policies and curricula.

As mentioned above, she cited with dismay her interpretation of a single medical student's opinion that a biased lecture caused "violation."  She later cited a Wall Street Journal article and a British Medical Journal article which she thought were too critical of industry.

Near the end of the article was this personal anecdote,

Recently, for the first time, I was asked to consult for a medical products company. My first thought was, 'This would be fascinating.' My second was, 'There’s no way.' I would have to disclose the relationship, my credibility would suffer, and I would be defenseless. That I immediately succumbed to this fear reflects our failure to manage industry relationships effectively.

So the evidence for a huge, powerful, monolithic movement of "pharmascolds" presented was minimal.  Rosenbaum cited a 1980 article and asserted it changed the world, without any real documentation of that.  Otherwise, she cited a few books, a society of medical students, and some personal anecdotes about medical students.  The most telling anecdote was about the author's person perception that her credibility would suffer - presumably unfairly in her eyes - were she to consult on a "fascinating" project, never mind what she would have been paid to do that.  So at the very end, this ostensibly scholarly article concludes with an apparent appeal to pity its poor author for having to give up this wonderful opportunity.  That seems like the essence of an appeal to pity fallacy.

Furthermore, while the evidence of a powerful army of pharmascolds was lacking, the author did not address the evidence that the majority of academic physicians have conflicts of interest, as do the majority of department chairs(5,6).  While she speculated how a medical school dean might be oppressed by the pharmascolds, she did not address how many medical school deans, leaders of academic medical centers, and other top leaders of academic medicine have conflicts (look here).  Finally, she neglected to mention that conflicts of interest mainly come out of corporate marketing and public relations budgets that total billions in US dollars yearly nationally.

So the image of the poor pitiful defenders of the laissez faire approach to industry relationships seems a bit overdrawn.  


Straw Man Fallacies Industry Critics Claim to be Free of Bias, Equate COIs with Rape and Child Abuse, Use Flawed Reasoning, Believe All Physician-Industry Interactions Constitute Fraud

Per Nizkor, "the Straw Man fallacy is committed when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position."  Rosenbaum attributes to all or most supporters of disclosing, regulating, or restricting conflicts of interest all sorts of statements or beliefs without evidence that anyone, or more than a few people actually hold such beliefs, viz...

But couldn't industry critics blind spots leave them unjustifiably confident that despite their industry aversion, they are bias free?(3)

There was no documentation that industry critics claim they are free of all biases.

The application of language associated with rape and child abuse to the circumstances of education about effective drugs reveals a feature of the conflict-of-interest movement that has fed its contagion and rendered it virtually unassailable....(4)

Note that this was based on a single Harvard Medical student saying a single lecture lead him or her to feel "violated."  There was no documentation that anyone actually made a comparison to rape or child abuse, much less that such ideas are widely held.

Such flawed syllogistic reasoning has become the norm.(4)

Note that this refers to a "narrative" that someone who works with industry must have a favorable view of industry and therefore must make decisions based not on "clinical and research expertise but a desire for financial gain."  That in turn was derived from a single article in the news media.

'If post-Hart political journalism has a motto,' writes [journalist Matt] Bai, 'it would be: 'we know you're a fraud somehow.  Our job is to prove it.'  A similar motto could apply to much reporting on physician-industry interactions.'(4)

Furthermore,

the climate is so permeated with assumptions of fraudulence that treatments ... that have revolutionized our ability to prevent and treat disease become pawns in the hunt for wrongdoing.(4)

The few examples Rosenbaum supplied of supposedly faulty journalism did not seem to discuss fraud at all.

Summary

The series of articles about conflicts of interest that just appeared in the New England Journal, while ostensibly scholarly, published by the journal's "national correspondent" in the Medicine and Society section, appear to be polemical.  They deployed a substantial number of logical fallacies to make the point that medicine and society have gotten too tough on conflicts of interest.  They are notably short on logical, dispassionate discussion of the evidence.  Thus, they seem more like posts on a very opinionated blog site rather than commentaries in a scholarly medical journal.

By publishing this series of high visibility articles, the New England Journal of Medicine seems to have deliberately muddied the waters of discussion about conflicts of interest.  This is sad, because the journal was once considered the foremost English language scholarly medical journal, but it now seems to be publishing polemics.

This latest publishing phenomenon, or debacle, should be a reminder why conflicts of interest, if unhindered, become so prevalent.  They are relationships that benefit both parties involved.  For example, a pharmaceutical company marketing department presumably benefits from the increased revenue generated by increased sales generated by prominent key opinion leaders touting its products in the guise of professional and/or academic experts.  The KOLs, on the other hand, benefit from their generous payment.  Who loses?  - physicians who are increasingly regarded as pharma shills; physicians, whose decision making on behalf of patients may be hindered by constant exposure to marketing and public relations drowning out logical, evidence based discussion;  patients, who need to worry whether the tests and treatments they get were ultimately too influenced by conflict of interest fueled marketing and public relations, and not enough by evidence and logic.

As we said many times before, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  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. 

ADDENDUM (21 May, 2015) - See also detailed comments by Larry Husten on Forbes.and by Dr Susan Molchan on the HealthNewsReview blog.  Both delve into the details of some of the cases and data that Dr Rosenbaum does cite, and thus raise questions about the facts she chose to use, and how she chose to interpret them. Also, corrected citation for "pharmascolds."

ADDENDUM (26 May, 2015) - See additional posts here, here, here and here by Micky on the 1BoringOldMan blog.

ADDENDUM (29 May, 2015) - See posts in the Lown Institute blog by Shannon Brownlee, Dr Vinay Prasad, and Dr Vikas Saini. 

ADDENDUM (8 June, 2015 - See also comments by Dr Steven Reidbord in the KevinMD blog. 


References
1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.
5.  Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
6.  Campbell EG, Weissman JS, Ehringhaus S et al.  Institutional academic-industry relationships.  JAMA 2007;298(15):1779-1786. doi:10.1001/jama.298.15.1779.  Link here.

BLOGSCAN - New England Journal of Medicine Scoffs at "Pharmascolds"

The venerable New England Journal of Medicine has now published an editorial,(1) and two commentaries(2-3), with one more promised, hailing physician industry "partnership," as per NEJM editor Jeffrey Drazen,(1) and deploring the "pharmascolds,"(3) who might question the glorious innovations that could arise when industry pays academic and practicing physicians.   

In a tweet, Dr Harlan Krumholz said he was "shocked" that a NEJM commentary would "give credence to the 'pharmascold' narrative.  

So far, the only more detailed questions about this new direction for the Journal came in a guest blog by Dr Susan Molchan in the HealthNewsReview blog, which responded only to the editorial(1) and the first commentary(2).  Dr Molchan wrote, 

Dr. Rosenbaum makes a nice try at reinterpreting financial conflicts between physicians and pharma, but however one twists and turns it, the dots still reconnect into dollar signs. She asks, “Have stories about industry greed so permeated our collective consciousness that we have forgotten that industry and physicians often share a mission — to fight disease?” Is Dr. Rosenbaum’s consciousness so clouded as to think that pharmaceutical companies don’t exist first and foremost to make money? That their primary responsibility is not to their shareholders?  It’s true that a means to this end is fighting disease, (including new “diseases,” tailored to one’s drug), but this should not be confused or conflated with the primary mission of (hopefully most) physicians.

I and many others suggest that the 'stories about industry greed' have not permeated enough, and that this problem has polluted much of medical research and medical practice, to the point where trust of the medical research enterprise has been eroded....

The airtime the NEJM is giving this issue, including publishing three - count them - strongly opinionated but hardly journalistic commentaries by their ostensible"national correspondent," suggest a major push against the "pharmascolds."  Again, note this this inflammatory and ad hominem term was used in a supposedly serious article on "Medicine and Society."  I strongly doubt we have heard the last of this.  Stay tuned. 

ADDENDUM (20 May, 2015) - See also comments by Mickey on the 1BoringOldMan blog.  

References
1.  Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854.  Link here.
2.  Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015;  372:1860-1864.  Link here. 
3.  Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here. 

Innovations form the Safra Center Ending iCorruption Conference

I had the pleasure of attending the Ending iCorruption Conference, the capstone conference for the Edmond J Safra Research Lab on Institutional Corruption, held at the Harvard Law School on May 1-2, 2015.  The conference included much material relevant to health care corruption and related topics, and provided some innovative approaches that could be used to address these issues.  I list these below, with citations or links when available.  At some point in the future, all conference proceedings should be available on video from the Safra Center.

Uncovering Data on Conflicts of Interest

Unearth: Using PubMed to Uncover Conflicts of Interest Affecting Clinical Research

Unearth is a browser extension now available for Google Chrome, and soon to become available for other browsers, e.g., Firefox.  It works on PubMed searches, scraping funding and conflict of interest data from the body of articles and adding them to abstracts.  We have often discussed such conflicts of interest, and their relationship to manipulation of clinical research.  Unearth could make such conflicts more salient, making it easier to discriminate unconflicted from conflicted research.  (See this post on the Bill of Health blog.)  This application was developed during the Safra Center Hacking iCorruption Event.

Open Think Tanks: Uncovering Think Tank Funding

Think tanks often publish findings on and make recommendations about health care.  However, think tanks are often opaque, and any institutional conflicts of interest they have may not be easily apparent.  Open Think Tanks currently shows donations from government entities outside the US to US based think tanks.  Enhancements to include various kinds of private donations are likely in the future. This application was also developed during the Hacking iCorruption Event.

Finding Unconflicted Academics

As we have discussed, the majority of medical academics have conflicts of interest, which may affect their research, teaching and patient care.  Yet these conflicts are not always disclosed.  Furthermore, finding experts without conflicts is not easy.  ProfessorCert is a website that allows academics who have no conflicts of interest to register as such.  The website was developed by the Academic Independence Project. 

Improving Integrity

Putting Consumers in the FDA and Other Regulatory Agencies

We have frequently discussed regulatory capture, how government health care regulatory agencies, like the US Food and Drug Administration (FDA),  often seem to end up more concerned about the financial health of those they are supposed to regulate than patients' and the public's health.   Harvard Prof Daniel Carpenter, collaborator in Safra Center research,  talked about the problem of  "cultural capture" of regulatory agencies, in which the regulators' thinking is influenced by outside vested interests.  He proposed that regulatory agencies need to put consumers, or presumably other stakeholders like unconflicted health care professionals, "into the room."  

Putting Ethicists in the C- Suite

We have frequently criticized the leadership of hospitals and hospital systems.  In particular, we have discussed instances in which these leaders seem to have gone directly against the mission of their own organizations, which we termed mission hostile management. Safra Lab Network Fellow James Corbett, now Senior Vice President for Centura Health, proposed that ethicists who also understand the language of finance and management be present among the top leadership of hospital systems.  

Licensing Executives

As noted above, a major theme of the Health Care Renewal blog is the shortcomings of the leadership of large health care organizations.  Top leaders often have business training, but may be ill-informed about health care, and ignorant or unsupportive of  or even hostile to its values.  Wellesley College Professor Emerita Ann Congleton's 2014 article in the Journal of Business Ethics, entitled Beyond business ethics: an agenda for the trustworthy teachers and practitioners of business, proposed requiring that corporate executives, including executives of health care corporations, be licensed in order to lead their organizations.  I proposed licensing of leaders of large health care organizations as early as 2008 (here).    

Pharmaceutical Research Uninfluenced by the Pharmaceutical Industry

Because clinical research meant to evaluate drugs or devices sponsored by  manufacturers of the relevant products has shown to be frequently manipulated, or even suppressed, many people have suggested banning such sponsorship and direct influence of such manufacturers.  (For example, see the book and blog, both entitled "Hooked," written by Dr Howard Brody, and see Health Care Renewal blog posts, e.g., here.)
Safra Center Network Fellow and Rowan University Professor Donald Light's book in press, Good Pharma, basically offers proof of the concept that high quality clinical research on pharmaceuticals can be accomplished without industry money or influence, albeit in Italy, at the Mario Negri Institute. 

Summary

The project on institutional corruption at the Safra Center produced a burst of innovation meant to address this pervasive project, and thus provided much of value to those who want to challenge health care corruption.  I hope this innovation will turn out to be truly disruptive.  It is regretful that this project has come to an end.  We can only hope others pick up the banner.  

"God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door

Who is watching the watchers?  A story this week involving "speed" like drugs added to "dietary supplements" suggests how far the once respected US Food and Drug Administration has fallen.

An Amphetamine-Like Drug Spiking "Nutritional Supplements"

The story began with a paper by Cohen and colleagues published a relatively obscure medical journal, and then picked up by the news media.(1)  The main points of the article were:

BMPEA (beta-methylphenylethylamine) is a compound first synthesized in the 1930s as a "potential replacement" for amphetamines.  Animal tests revealed amphetamine-like properties.  The compound was never tested on humans, and never marketed.

But,

BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labelled as containing ‘Acacia rigidula’, even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.

However,

More than two years after the FDA's discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.

So Cohen et al undertook to identify "nutritional supplements" said to contain acacia rigidula and test them for BMPEA.  They found 21 such supplements, all of which tested positive. The authors then recommended,

that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.

Note that while the power of the FDA to regulate "nutritional supplements" is limited by a 1994 law, Cohen and colleagues wrote that it

is tasked with identifying and removing mislabelled, adulterated, and dangerous dietary supplements from the marketplace.

Since BMPEA is apparently not found in nature, and was not sold prior to 1994, putting BMPEA in a "dietary supplement" appears to be adulteration. 


The Risks of BMPEA in Nutritional Supplements

The study was then picked up by the media.  In the Los Angeles Times, Pieter Cohen, the lead author of the journal article,

said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA's failure to act is 'completely inexcusable.'

Furthermore, in a CBS report,

BMPEA has not been tested in humans, but led to increased blood pressure in cats and dogs.

'These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,' Cohen said.

The point is that while it has never been tested fully on humans, there is every reason to suspect that BMPEA acts very similarly to amphetamine, colloquially called "speed."  Amphetamines, as we discussed here, have dangerous side effects, including severe blood pressure elevations, and increased risks of stroke, myocardial infarction (heart attack), and other cardiac events.  The drugs also have a high potential for abuse. 


Why Did the FDA Do Nothing? 

Despite the likely riskiness of BMPEA, the FDA did nothing when it found it in numerous dietary supplements in 2013, and has not indicated that it will do anything now.  According to the LA Times,

FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.

'While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,' she said.

In a Consumers Report item, Dr Cohen responded to that,

'It’s mind boggling,' said Pieter Cohen, M.D., the Harvard physician who is the lead author of the new study, published online in the journal Drug Testing and Analysis. 'The companies think they have complete impunity. They assume the FDA will do nothing about it. And they’re right.'

A post in the NY Times Well blog reiterated, 

Under federal law, dietary supplements — with some exceptions — can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.

Yet while the FDA had authority to do something, it did nothing.

Was the Revolving Door the Reason?

Back in 2014, we posted about two transitions through the revolving door by the FDA official in charge of the regulation of nutritional supplements.  We reproduce the relevant section of the post below:

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.

But,

The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.

While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not then question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

In 2014, the Times drew no conclusions about Mr Fabricant's career trajectory.  However, this time

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.

Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group.

'To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,' said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Also, the new Well blog post noted 

Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency’s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.

Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency 'has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.'

Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had 'an excellent safety record.'

'The industry itself supports and has implemented strong self-regulatory mechanisms,' she said in an industry news release at the time.

Summary

To summarize, from 2011 to now, the leadership of the part of the FDA that is supposed to regulate dietary supplements was dominated by former top executives of the Natural Products Association, the trade organization for dietary supplement manufacturers.  In 2013, FDA scientists found that multiple dietary supplements contained BMPEA, a compound closely related to amphetamines, and hence potentially dangerous and addictive, although it had never been tested on or previously used by humans.  Although the FDA had authority to do something about this apparent adulteration of these products, it so far had done nothing.  Thus it appears that the currently legal revolving door that allows government regulation to be run by people who come directly from the industries that government is supposed to regulate could be responsible for exposing people to dangerous, addictive drugs.

Remember, BMPEA is a first cousin of amphetamine, amphetamine is "speed," and as the drug epidemics of the 1960s and 1970s showed us, "speed kills."  So a plausible argument is that the revolving door, as relevant to FDA, has enabled manufacturers of nutritional supplements to become the "pusher man," a la the Steppenwolf sound track of Easy Rider,


As we noted here, some experts consider the revolving door per se to be corruption, not merely conflict of interest.  The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy.  Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.   

So it is surprising that today (13 April, 2015), the New York Times published an editorial inspired by the BMPEA case, which concluded

consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

As a minimum, that would be a good start.  Unfortunately, even a NY Times editorial hardly guarantees action.  At least, however, the problem of the revolving door as a danger to patients has gotten a little less anechoic.

As we last wrote, 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 that have lead to government of, for and by corporate executives rather than the people at large.

ADDENDUM (20 April, 2015) - This post was republished on Naked Capitalism. 


Reference

1.  Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamins isomer whose efficacy and safety in humans has never been studied, beta-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.  Drug Testing Analysis 2015; DOI: 10.1002/dta.1793  Link here.

The Troubles at Cooper Continue, Lately Gruesomely, But Will Its Leadership and Governance Change This Time? - Part II: the History since 2005

In our most recent post, we noted the latest tragic, and gruesome development at Cooper Health System, the largest hospital system in southern New Jersey.  Months after the system CEO, John F Sheridan, and his wife Joyce were found dead after a fire in their home, local law enforcement concluded that Mr Sheridan murdered his wife, set fire to the house, then committed suicide.  It turns out this is just the latest, albeit possibly most tragic and grisly, troubling news from that health care system.

Our last post summarized the history from 1978, including:
-  Seven people, including the hospital system chief financial officer, confessed to and/or found guilty of participating in an embezzlement scheme that cost the hospital more than $21 million
-  An internal investigation was suppressed for years, but later revealed several severe management problems
-  The media revealed multiple conflicts of interest affecting the system's board of trustees, including members of the committee that performed the investigation
-  One member of the board of trustees who participated in the internal investigation was later convicted of arranging his wife's murder
-  Resulting financial losses caused layoffs and service reductions, some of which affected the hospital system's charitable mission
-  The stories received little attention outside the region, and apparently did not result in any fundamental changes in governance or the structure of leadership.

Since 2005, there have been other troubles at Cooper.

Conflicts of Interest Involving Local and State Politics

Board Chairman George E Norcross III

In 2006, the Philadelphia Inquirer found close ties between NJ politicians and hospital leaders (see this post).  In particular, the story noted "the board of South Jersey's major hospital, Cooper University Hospital in Camden, is chaired by the region's most powerful political figure, Democratic power broker George E. Norcross III."

In 2012, as we posted here, Mr Norcross' relationships became more evident.   The New York Times reported that a story about his conflicts of interest had been held from publication by the Inquirer because Mr Norcross was part of a business group seeking to purchase that newspaper.  When the Inquirer story finally came out, it stated firms with financial relationships to the hospital under Norcross had donated generously to Norcross' political allies, and that Norcross had influenced the creation of relationships with these firms.  It suggested that Norcross' political influence had resulted in an unusual level of state financial support for the hospital system.  It noted that the law firm for which Cooper CEO John F Sheridan had previously worked did lobbying for the hospital.  It noted that the hospital did millions of dollars of business with firms tied to hospital trustees, including Mr Norcross.

Trustee Emeritus Peter Driscoll

Recent reporting after Mr Sheridan's death suggested the rehabilitation of former board chairman Peter Driscoll under Chairman Norcross.  Mr Driscoll was the former board chair who resigned in 1999 after the embezzlement scandal report and revelations about conflicts of interest affecting the board were finally made public, and the hospital system was in financial difficulty.  However, by 2014, he was identified by the board as a "trustee emeritus."  Per the Philadelphia Inquirer, after the fire at the Sheridan house was attributed to arson,

'If they had died because the house was on fire, that would be a terrible, terrible tragedy,' said Cooper Health System trustee Peter E. Driscoll, a senior member of the Haddonfield law firm of Archer & Greiner. '. . .I don't know what to make of it. I can't imagine anybody that would want to do something like this.'

New Vice President Kevin O'Dowd and his Family

Also after Mr Sheridan's death, the hospital system hired a new top manager with his own extensive political connections and conflicts of interest.  Per the Inquirer,

Gov. Christie's chief of staff, Kevin O'Dowd, will step down this month to work for Cooper University Hospital in Camden, nearly a year after the governor named O'Dowd his pick for attorney general.

O'Dowd, whose selection as attorney general never moved forward after controversy arose over lane closures on the George Washington Bridge, will serve as senior executive vice president and chief administrative officer at Cooper, where he will focus on business development, Christie officials said. He will start at Cooper in January.

The conflict was

 O'Dowd's wife, Mary, serves as commissioner of the state Department of Health.

A NJ.com story made that more explicit,

 State Health Commissioner Mary O’Dowd will refrain from making decisions that would directly affect Cooper University Hospital in Camden after her husband accepted a senior management job there, officials said Friday night.

The move was made to avoid any conflicts of interest as the state Department of Health licenses and inspects hospitals, and doles out money to compensate them for treating uninsured charity care patients. Cooper will receive $37.3 million in charity care payments from the state this year, the fifth highest amount in the state.

A story in the NJ Spotlight suggested that would not solve the problem,

The question that the O’Dowds will have to face is whether they can overcome even the perception of a conflict of interest when their jobs so pervasively present opportunities for such a situation.

'It’s a very, very tenuous situation,' said William Schluter, a former longtime member of the State Ethics Commission and state senator.

He noted that nearly everything that senior hospital executives do in their jobs is influenced by state regulations.

'It’s a situation that I sure as heck wouldn’t want to be in,' said Schluter, adding that he expects second-guessing in the media and by elected officials as the state handles issues affecting Cooper.

Just to ice the cake for Mr O'Dowd, the Courier-Post noted that Mr O'Dowd's job at Cooper could be considered an example of the revolving door, albeit delayed,

O'Dowd, previously the governor's deputy chief counsel, also worked under Christie at the U.S. Attorney's Office for New Jersey.

During seven years as an assistant United States attorney, O'Dowd oversaw a securities and healthcare fraud unit. He also prosecuted cases ranging from child pornography distribution, cybercrime and drug trafficking.

O'Dowd served earlier as a state Deputy Attorney General, where his responsibilities included providing legal counsel to the state Department of Health.

As US Attorney, Christie, possibly with the aid of Mr O'Dowd, pursued a deferred prosecution agreement for UMDNJ, then Cooper's primary academic affiliation, for a complicated set of allegations that we discussed extensively in the past (look at this post and follow links backward).  

Late CEO John F Sheridan and Family


Apparently only after Mr Sheridan's death did the media report extensively on his political connections.  The earliest report I found was in the Philadelphia Inquirer from September 28, 2014.  He served

on Gov. Christie's health-care transition subcommittee in 2010.

The statement said he was New Jersey commissioner of transportation under Gov. Thomas H. Kean and served as New Jersey deputy attorney general and assistant counsel for the New Jersey Turnpike Authority, and was counsel for the New Jersey Senate majority.

Also,

 his son Mark - a prominent lawyer ... has represented Christie in the Bridgegate scandal 

NJ.com added,

John Sheridan Jr., the CEO of Cooper University Health System ... previously spent 40 years in New Jersey government

Also,

He has held positions on Gov. Thomas Kean's cabinet as transportation commissioner and chairman of the New Jersey Transit board, as well as held roles on transition teams for Gov. Chris Christie and Gov. Christine Todd Whitman. 

Furthermore,

 Earlier in his career, he served as Deputy Attorney General of the State of New Jersey, Assistant Counsel to Gov. William T. Cahill, General Counsel to the New Jersey Turnpike Authority and Counsel to the New Jersey Senate Majority.

Finally, his son

Mark Sheridan, a partner at Squire Patton Boggs, acts as general counsel for the New Jersey Republican State Committee.

 So, in the years since conflicts of interest at the board of trustees level were noted as part of the investigation after the management embezzlement scandal at Cooper, many more apparent conflicts affecting top managers and board members have appeared, most recently in late 2014. 


Settlement of Allegations of Kickbacks

In 2013, the media reported that Cooper settled federal allegations that it gave kickbacks to doctors to induce referrals.  As reported by the Inquirer,

The Cooper Health System in Camden has agreed to pay $12.6 million to settle a whistle-blower lawsuit alleging that it made improper payments to doctors in an effort to build its cardiology business, the U.S. attorney for the District of New Jersey said Thursday.

From October 2004 through 2010, local doctors were paid $18,000 to attend four meetings of the Cooper Heart Institute Advisory Board in any given year under 'consulting' and 'compensation' agreements, in possible violation of antikickback laws, state and federal law enforcement officials contended.

The whistle-blower was South Jersey cardiologist Nicholas L. DePace. He attended an advisory board meeting in 2007 and was convinced that the board's purpose was not to provide advice to Cooper, but to be a source of patient referrals to the Heart Institute, according to a lawsuit he filed in 2008.

'He was invited to be a member of the advisory board. He attended a meeting and it quickly became apparent to him what the advisory board really was. It was sitting and listening to lectures and not providing advisory services,' said Michael A. Morse, a partner in Pietragallo, Gordon, Alfano, Bosick & Raspanti L.L.P. in Philadelphia, one of DePace's lawyers.

As is typical of legal settlements involving prominent health care organizations,

Cooper admitted no liability.

'After more than three years of extended discussions with government lawyers, we decided, in the best interests of Cooper, to settle our dispute without the admission of wrongdoing to avoid the burdens and uncertainties of a protracted litigation,' Cooper president and chief executive officer John P. Sheridan Jr. said. 'This allows us to focus our full energies on serving our community.'

In a note to Cooper employees, Sheridan said the board was established to 'improve the quality and responsiveness of our cardiac programs' and 'was reviewed by outside legal counsel before it began operations.

However, given that the Inquirer reported that "the $12.6 million penalty is financially significant for Cooper," one wonders why it was made if hospital leadership felt that the case against it was poor.  

So years after the embezzlement scandal, another scandal involving allegations of illegal behavior was settled.  This time, there was no trial, but since the settlement was financially burdensome for the hospital, it is plausible that it resulted from managers' realization that they would not have a good defense against the charges at trial. 

The Death of the Sheridans

Mr Sheridan became CEO of Cooper in 2008.  As noted in the Gloucester County Times,

On Feb. 7 John P. Sheridan Jr., was appointed president and chief executive officer of The Cooper Health System by the Cooper Board of Trustees. Sheridan joined Cooper as senior executive vice president in July 2005 and has served as president of Cooper University Hospital since September of 2007.

'Cooper has grown dramatically in recent years and is positioned as the academic medical leader of South Jersey,' said George E. Norcross III, chairman of the Board of Trustees at Cooper.  'John Sheridan is a proven leader. He has the skills required to build-out our $500 million health care campus in Camden, implement our suburban strategy and achieve our vision of creating the premier academic health care system in South Jersey and the Delaware Valley.'

As of early 2014, he was getting substantial compensation typical for a hospital system CEO, per NJBiz, "John T. Sheridan Jr. (of the $913 million Cooper Health System) received $963,433."

In late September, 2014, Mr Sheridan and his wife were found dead in a house fire.  Initial reports suggested the fire was accidental.  Then it was declared to be arson.  Then Joyce Sheridan's death was found to be the result of a homicide.  Finally, as we posted here, law enforcement declared that Mr Sheridan killed his wife, set the fire, and then committed suicide.

That news was so horrendous that it dumbfounded Cooper insiders.  As reported by the Inquirer,

 'It's not something I can imagine,' said Peter Driscoll, a Cooper Health System trustee emeritus and a senior member of the Haddonfield law firm Archer & Greiner. 

Also,

In a brief statement, Cooper University Health Care called the prosecutor's findings 'unfathomable to us.'

I can only hope that they will get over their shock and realize that the institution really has some big problems. 

Summary

Since 1978, there have been multiple stories about mismanagement, conflicts of interest affecting managers and board members, and crimes committed or alleged to have been committed by management and at least one trustee at Cooper Hospital/UMC which then became Cooper Health System.  Despite these often lurid stories, there is no indication that there has been a fundamental change in the governance of the institution.  While managers have come and gone, sometimes under difficult circumstances, there is no indication that how managers were hired has changed.  Since the early 1990s, there has been no obvious effort made by management or board members to change, at least not one announced publicly.  There has been no outside investigation.

Given that the hospital system has long enjoyed a cozy relationship with state government, including both the legislative and executive branch, maybe it has been easy to go along to get along.  More cozy relationships, including some with ownership of the news media, may have helped to keep this story anechoic outside of the region.

Yet the cumulative story is so striking that it should prompt national attention, and inspire some real hard thought about how health care leadership and governance has gotten so bad.

To repeat what I have said all too often, and I admit with little impact so far....

True health care reform requires governance that is accountable, transparent, true to the organization's mission, and honest, ethical, and without conflicts of interest; and leadership that understands health care, upholds its values, is honest, ethical, and without conflicts of interest, is transparent and open, and is willing to be accountable and subject to appropriate incentives.