Are Million Dollar Plus Business Trained Managers the Right People to Lead Health Care in the Time of Ebola?

You can guess my opinion on the answer.

Introduction

News and opinions about Ebola virus are swirling around the US, fueled by a tragic epidemic in West Africa, and fears that more infections could appear here.  On October 6, 2014, I posted my concerns that despite a tremendous amount of confidence expressed by government officials and health care leaders, our dysfunctional health care system might have trouble containing Ebola virus.  Less than two weeks later, my concerns do not seem so extreme.  The first patient to be diagnosed with Ebola virus in the US has died.  Two nurses who cared for him now have the virus.

There seem to be millions of words on paper and on the internet about Ebola appearing every day.  So I certainly do not want to try to deal with the problem in all its aspects.  I do want to revisit a particular set of issues from my October 6 post: the hazards posed by generic management deluded by business school dogma running health care institutions in the time of Ebola.  In particular, my focus is the management of the US hospital at which one patient died, and two nurses were infected, based on what has come out since October 6.

The Incoherence of Hospital Leaders

On October 6, we noted that the hospital, Texas Health Presbyterian, part of the Texas Health Resources hospital system, had issued conflicting and confusing statements about why the first Ebola patient, Mr Thomas Eric Duncan, was sent home from the hospital when he first presented.  The first specific statement by hospital managers was that there had been a problem with the hospital's electronic health record (EHR), as had been suspected by my fellow Health Care Renewal blogger, InformaticsMD.  Then the hospital retracted that statement, but provided no explanation with which to replace it.

Since then, there have been more inconsistencies in statements made by hospital managers.

Fever or No Fever?

First hospital managers said Mr Duncan arrived without a fever, but then review of his medical records indicated his temperature was as high as 103 degrees F while he was in the hospital, a fever high enough that it might reasonably have prompted admission given his other symptoms, even if Ebola was not a concern.  (See this Dallas Morning News story.)

Readiness for Ebola Patients?

Hospital managers assured the public they were ready for Ebola virus patients, e.g., in the Dallas Morning News story of September 30, 2014, 

When Ebola arrived, they were ready.

The staff at Texas Health Presbyterian Hospital of Dallas did a run-through just last week of procedures to follow if the deadly virus landed in Dallas.

'We were prepared,' Dr. Edward Goodman, an epidemiologist at Texas Health Presbyterian, said Tuesday in a news conference. 'We have had a plan in place for some time now in the event of a patient presenting with possible Ebola. We are well-prepared to deal with this crisis.'

Presbyterian said it is following recommendations from the U.S. Centers for Disease Control and Prevention and the Texas Department of Health in responding to the patient, described as being 'critically ill' at the hospital in northeast Dallas.

All precautions are being taken to protect doctors, nurses and others in the hospital, officials said.

Sadly, this statement soon seemed, as one politician once said, inoperative. an October 14 Washington Post article described how hospital health professionals had to essentially make up their procedures as they went along.

The hospital that treated Ebola victim Thomas Eric Duncan had to learn on the fly how to control the deadly virus, adding new layers of protective gear for workers in what became a losing battle to keep the contagion from spreading, a top official with the Centers for Disease Control and Prevention said Tuesday.

'They kept adding more protective equipment as the patient [Duncan] deteriorated. They had masks first, then face shields, then the positive-pressure respirator. They added a second pair of gloves,' said Pierre Rollin, a CDC epidemiologist.

Also,

He said the hospital originally had no full-body biohazard suits equipped with respirators but now has about a dozen. Protocols evolved at the hospital while Duncan was being treated, he said: 'Collecting samples, with needles, then you have to have two people, one to watch. I think when the patient arrived they didn’t have someone to watch.'

Worse, in the last 24 hours, there have been reports by anonymous people said to be nurses at Texas Health Presbyterian that the hospital was clearly not ready, per the Los Angeles Times,

The nurses' statement alleged that when Duncan was brought to Texas Health Presbyterian by ambulance with Ebola-like symptoms, he was 'left for several hours, not in isolation, in an area' where up to seven other patients were.  'Subsequently, a nurse supervisor arrived and demanded that he be moved to an isolation unit, yet faced stiff resistance from other hospital authorities,' they alleged.

Duncan's lab samples were sent through the usual hospital tube system 'without being specifically sealed and hand-delivered. The result is that the entire tube system … was potentially contaminated,' they said.

The statement described a hospital with no clear rules on how to handle Ebola patients, despite months of alerts from the U.S. Centers for Disease Control and Prevention in Atlanta about the possibility of Ebola coming to the United States.

'There was no advanced preparedness on what to do with the patient. There was no protocol. There was no system. The nurses were asked to call the infectious disease department' if they had questions, but that department didn't have answers either, the statement said. So nurses were essentially left to figure things out on their own as they dealt with 'copious amounts' of highly contagious bodily fluids from the dying Duncan while they wore gloves with no wrist tape, flimsy gowns that did not cover their necks, and no surgical booties, the statement alleged.

'Hospital officials allowed nurses who interacted with Mr. Duncan to then continue normal patient-care duties,' potentially exposing others, it said.

In response, the official hospital statement (authored by one Wendell Watson, "a Presbyterian spokesman," according to the AP) contained vague assurances, but no specific responses to the allegations,

'Patient and employee safety is our greatest priority, and we take compliance very seriously,' the hospital said in a statement. 'We have numerous measures in place to provide a safe working environment, including mandatory annual training and a 24-7 hotline and other mechanisms that allow for anonymous reporting. Our nursing staff is committed to providing quality, compassionate care, as we have always known, and as the world has seen firsthand in recent days. We will continue to review and respond to any concerns raised by our nurses and all employees.'

So while hospital officials (and local and national politicians and government leaders) kept up reassuring statements that our sophisticated, high-technology hospitals were totally ready to deal with a disease like Ebola, the reality appeared far different. 

Other Inconsistencies

According to a USA Today story, other inconsistencies included hospital statements about the date Mr Duncan's diagnosis was confirmed, and whether or not the hospital was diverting ambulances.

Were Health Professionals Silenced?

Of course, given the suddenness of the arrival of Ebola in the US, the acuity of the first patient, and the general atmosphere of panic, initial confusion in public statements however critical the information they were meant to contain may be, is understandable.

However, there are now allegations that hospital management was not merely confused, but trying to keep critical information secret, and the allegations do not seem incredible.

In a Washington Post story on October 12, about how many US hospitals seem not well prepared for Ebola infected patients, appeared this from Bonnie Castillo, director of Registered Nurse Response Network, part of the union, National Nurses United,

Castillo said the union has been trying to contact nurses at Texas Health Presbyterian Hospital, where Thomas Eric Duncan, the Liberian man diagnosed with Ebola, died Wednesday.

'That hospital has issued a directive to all hospital staff not to speak to press,' Castillo said. 'That is a grave concern because we need to hear from those front-line workers. We need to hear what happened there. … They have them on real lockdown. There is great fear. This hospital is not represented by a union. Our sense is they are afraid to speak out.'

The Los Angeles Times story included,

The Dallas nurses asked the union to read their statement so they could air complaints anonymously and without fear of losing their jobs, National Nurses United Executive Director RoseAnn DeMoro said from Oakland.

The October 14 Washington Post story noted

the labor organization National Nurses United read a statement that it said came from nurses at the hospital who 'strongly feel unsupported, unprepared, lied to and deserted to handle their own situation.'

The AP story of October 15 stated,

The Presbyterian nurses are not represented by Nurses United or any other union. DeMoro and Burger said the nurses claimed they had been warned by the hospital not to speak to reporters or they would be fired.

The AP has attempted since last week to contact dozens of individuals involved in Duncan's care. Those who responded to reporters' inquiries have so far been unwilling to speak.

 Covering up information vitally needed by health care professionals, other institutions, the government, etc to better manage a potentially fatal disease that is already epidemic in other countries appears completely unethical.  Doing so to preserve the reputation of managers seems reprehensible.  But the implication of the recent stories is that is what happened. 

Why Hospital Managers May Not Deserve Our Trust

The US has had no recent experience with any disease like Ebola.  So that mistakes, sometimes very serious ones, were made in the management of the first Ebola patients is not a big surprise.
 
What may be a big surprise to many Americans is how untrustworthy health care leaders, and in particular the managers of Health Texas Presbyterian hospital and its parent system, Health Texas Resources now appear.  After all, USA Today published on October 14, "Texas Health Presbyterian was a respected, renowned hospital."  While even people at respected, renowned institutions make mistakes when confronted with sudden, unfamiliar problems, should not the institution's leaders at least be trusted to in their public pronouncements?

Instead, it appears that the leaders appeared tremendously overconfident, and worse, may have silenced employees from raising concerns that could have reflected badly on leadership.  This occurred in a context in which transparency was imperative so that other people who might have to deal with Ebola patients might be better prepared.


On the other hand, based on what we have been posting on Health Care Renewal for nearly 10 years, the conduct of the Texas Health Resources leaders should have come as no surprise.  On Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty. 

We have seen many examples of hospital executives who seemed vastly impressed by their own brilliance, egged on by board members who were themselves executives of other organizations, and by marketing and public relations functionaries dependent on these executives for their own career advancement.  In particular, we have posted examples of hospital CEOs and other top executives making millions of dollars a year based on their supposed "brilliance," or "visionary" capacity, at least according to the board members who supposed to be exercising stewardship over their institutions, and the public relations people they hired.  Such brilliance has often been asserted, but rarely been explained or justified  (The latest example was here, and much more discussion is here.)

Most such ostensibly "brilliant" hospital executives had no direct experience in clinical care, public health, or biomedical science.

Making hospital leaders feel entitled to make more and more money regardless of their or their institutions' performance seems to be a recipe for "CEO Disease," leading to disconnected, unaccountable, self-interested leaders.  Hospital leaders suffering from the CEO disease may be particularly willing to countenance suppression of any facts or ideas that might raise doubts about their brilliance.  

So the leadership of Texas Health Resources may in fact be very typical of that of large non-profit hospital systems.  THR is such a system.  A Dallas Morning News article about Mr Doug Hawthorne, the Texas Health Resources CEO who just retired in September, 2014, stated

In 1997, Doug Hawthorne helped reshape the health care industry in North Texas by leading the creation of Texas Health Resources, an alliance of Presbyterian Healthcare Resources, Harris Methodist Health System and Arlington Memorial Hospital.

By 2014,

 With more than 22,000 employees in fully owned and joint venture operations, Texas Health is one of the largest care providers in North Texas. For its 2012 fiscal year, it had $3.7 billion in total operating revenue and $5.3 billion in total assets.

For leading this system, Mr Hawthorne made a lot of money, although apparently no recent data is available on his compensation,

He was among the most highly compensated not-for-profit CEOs in the region. For 2012, the most recent information available, his base salary was about $1 million and his bonus was about $1.1 million.

It should be no surprise that to justify this compensation, Mr Hawthorne was proclaimed a visionary.  According to the Dallas/ Fort Worth Healthcare Daily, Mr Hawthorne was inducted in 2014 into the Texas Business Hall of Fame.  At that time, 

'A healthcare visionary, Mr. Hawthorne is at the helm of one of the largest faith-based, nonprofit health care delivery systems in the United States, Texas Health Resources,' the Hall said in a release announcing the induction.

Yet Mr Hawthorne had no direct patient care experience, public health experience, or biomedical or clinical science experience.  Mr Hawthorne is on the board of directors of the LHP Hospital Group Inc, a for-profit that provides capital and services to non-profit hospitals.  The official bio, posted by LHP stated his educational background only included

B.S. and M.S. degrees in healthcare administration from Trinity University in San Antonio.

Furthermore, as we mentioned earlier, the current CEO of Texas Health Resources, Mr Barclay E Berden, who has only been on the job since September 1, 2014, also was hailed by system board of trustees for his "unique leadership strengths."  His current compensation is unknown, but I would guess is likely over $1 million/year.  He highest degree is a MBA, and like his predecessor, had much experience in hospital management, but apparently none in clinical care, public health, or biomedical science. 

Summary

Texas Health Resources' recent CEOs have been paid millions, and hailed for their brilliance, despite a lack of any direct experience in health care, public health, or biomedical science.  Leaders convinced of their own brilliance may live in bubbles that prevent penetration of any ideas or facts that may challenge that brilliance, making them thus susceptible to hubris.

So should we have been surprised that the leadership of the first US hospital system to directly confront Ebola de novo seemed more concerned with polishing their supposed brilliance than with transparently providing the information that other people who have to confront Ebola in the future so greatly need?

No, but one tiny silver lining to the time of Ebola is that it may make it glaringly obvious that we need true health care reform that focuses on reforming the leadership of big health care organizations. In particular, we need leadership that is well-informed about health care and public health; that upholds the values of health care professionals, specifically by putting patients' and the public's health ahead of their own remuneration; is willing to be held accountable; and is honest and unconflicted.

Allowing the current dysfunction to continue, while it will be very profitable to the insiders who run the system, will continue to enable tragic outcomes for patients and the public.  

Retrospective on the Blumsohn - Procter and Gamble -Sheffield University Affair: the Unhappy Lives of Whistleblowers and the Anechoic Effect

Introduction - the Unhappy Lives of Whistleblowers

The UK Times Higher Education Supplement just published a feature on the unhappy fate of academic, including academic medical whistleblowers.

Whistleblowers in universities can hit the national headlines for shining light on issues of public interest, only for their careers to end up in very dark places.

Some of higher education’s most prominent whistleblowers paint a bleak picture about the impact on their subsequent careers. They talk about being persecuted by colleagues after coming forward. But even after leaving their jobs, some believe they still suffer a legacy. One talks about being 'effectively blackballed' from ever working again in higher education.

For other whistleblowers, exile is self-enforced.

It is noteworthy that the graphic for the article showed a whistleblower with a ball and chain, but the ball is in the shape of a whistle.

Summary - The Blumsohn - Actonel - Procter and Gamble - Sheffield University Case

The article focused on the case of Dr Aubrey Blumsohn, which we discussed recently, and have posted about since 2005 (here).  For all relevant posts, look here.

The Times provided a good summary.  It is worth quoting it here, as a reminder of a very important case which has had far too few echoes.

[The] case began in 2002, when he was working in the research unit led by Richard Eastell, professor of bone metabolism at Sheffield. The unit was researching the effects on patients of Procter & Gamble’s anti-osteoporosis drug Actonel.

Blumsohn raised concerns about abstracts for conference papers submitted by P&G, under his primary authorship, but without the firm having granted him full access to the drug trial data.

His concerns were first raised with senior colleagues and then reported in Times Higher Education in 2005.

The data analysis for the research was carried out by P&G, which paid for the research and which did not release key data to Eastell and Blumsohn. According to Blumsohn, this prevented honest publication of research.

After coming forward, Blumsohn has previously said, his other research work was used as the basis for a series of research grant applications that Eastell sponsored and signed off for a PhD student, without acknowledging Blumsohn’s input and despite his objections.

In 2005, he told the university that he was speaking to the media after losing faith in its internal systems for dealing with such allegations. He was subsequently suspended and told by Sheffield that he could lose his job over alleged 'conduct incompatible with the duties of office', including 'briefing journalists' and 'distributing information, including a Times Higher article, to third parties with apparent intent to cause embarrassment'.

He later reached a settlement with the university and it dropped all disciplinary charges. However, he left the university in 2006.

Blumsohn says of what happened afterwards: 'I withdrew from medicine completely, I withdrew from academia and ultimately withdrew my medical registration as well.'

Given the impact on his career, does Blumsohn regret coming forward with his concerns? 'I had to do that,' he says. 'As a scientist, I couldn’t just go along with having my name attached to manipulated publications, based on secret data ghost-analysed by pharmaceutical companies.'

Could Sheffield have dealt with his concerns more effectively? 'I don’t know how Sheffield could have done better, or indeed how any medical school could have done,' Blumsohn replies.

He clarifies: 'The problem these days is that some parts of universities – most notably medical schools but some other parts as well – have so many conflicts of interest and financial imperatives guiding what they do, I’m not sure other universities would necessarily have behaved differently from Sheffield. When millions of pounds are at stake both in private fees for academics and university funding, and a pharmaceutical company is wanting you to dance, the pressure to go along and to get staff to remain quiet is overwhelming.'

A few comments are in order.  While universities appear to be places of free speech and open discussion, note that Sheffield apparently could punish Dr Blumsohn simply for talking to journalists, but particularly for simply saying things that might embarrass university leaders.  So university leaders wish not to be embarrassed seems to trump free speech and academic freedom.

Second, Dr Blumsohn rightly pointed out that the issue was really scientific integrity, not embarrassment.  He tried to stop what he perceived as manipulation of clinical research by a pharmaceutical company to support its vested interests in selling a particular drug.  Such manipulation threatened scientific integrity, and ultimately threatened patients' health.

Third, Dr Blumsohn also rightly pointed out in retrospect that what university managers really seemed to fear was not just personal embarrassment, but curtailment of money flows from industry to their institution that made them look good, and presumably become more wealthy.

Few Echoes in the Discussion of Whether the Former Procter and Gamble Executive on Whose Watch the Affair Occurred Should be US Veterans Affairs Secretary

As we discussed here, a top executive at Procter and Gamble whose remit at the time the affair occurred seemed to include Actonel and research related to it was nominated to run the US Department of Veterans Affairs, and hence the whole VA health system.  Only two blogs, including this one, raised the issue of the Blumsohn - Actonel - Procter and Gamble - Sheffield University affair as relevant.  There was no other public discussion of this connection.  The former Procter and Gamble executive was confirmed, and now runs the Department of Veterans Affairs.

Summary

This is another example of how leaders of big health care organizations remain unaccountable for their organizations' misdeeds.  The lack of any mainstream discussion of the Blumsohn - Actonel - Procter and Gamble - Sheffield University affair in connection to the VA nomination demonstrate the anechoic effect.  Even the most determined whistleblowers often do not get the public notice they deserve, and their revelations do not have the effects they ought to have, even after the whistleblowers have paid a very high price to try to spark public discussion.

So anyone thinking about trying to get public notice for some fact or issue that threatens the powers that be will think twice, both about the potential downsides to the whistleblower, and the potential ineffectiveness of these attempts.    

In the past two weeks, I have heard in confidence about three stories in which discussion of issues that might offend the powers that be, specifically, the leaders of big health care organizations, has been suppressed.  I am convinced that for every Dr Aubrey Blumsohn, there are dozens who are aware of deception, other unethical conduct, even crime and corruption that could harm patients and patient care, but are afraid to speak out.

Of course, as long as these issues remain hidden, the damage to patients and the public's health continues to be done.

We clearly need changes in public policy to protect whistleblowers and foster free speech about important issues in academics and health care.  We need health care professionals, health care researchers, health care policy makers, and those among the public who care about health care and health care need to organize to support free speech and academic freedom.  Otherwise, the anechoic effect will continue to befog all of health care.

Hat tip to Dr Carl Elliott writing for the Fear and Loathing in Bioethics blog.

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs

After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US Department of Veterans Affairs, the country's large government run health system, has had a massive leadership overhaul.  President Obama's nominee to head the agency is now Robert A McDonald, former CEO of Procter and Gamble.

The choice of a former CEO or a large corporation was called "unorthodox" by the Boston Globe, but many saw merit in a business leader running the VA.  As reported by the Globe, House Speaker John Boehner said that as a "private sector" leader,  Mr McDonald is the "kind of person who is capable of implementing the kind of dramatic systemic change that is badly needed and long overdue at the VA."  The Chairman of Boeing, also a member of the P&G board, hailed Mr McDonald as the person who "navigated Procter & Gamble through the difficult post-financial-crisis years, where he expanded business in developing markets and made substantial progress improving the efficiency of the company’s internal operations...."

On the other hand, a column in the Washington Post suggested that expertise in "selling Tide and Pantene" might not be relevant to fixing the VA. Yet aside from a single article on the Ring of Fire web site, all news coverage and discussion so far has ignored Mr McDonald previous experience in health care leadership, but also that his relevant track record ought to raise questions about his fitness for the VA position.

Procter and Gamble and Health Care

According to Mr McDonald's official P&G biograpy, after various roles in various countries, before becoming CEO, 

Bob returned to the U.S. as the Vice Chairman of Global Operations (2004 to 2007) and later P&G’s Chief Operating Officer (2007 to 2009).

Although not widely known as a pharmaceutical company, P&G actually had a subsidiary that made prescription drugs, which Mr McDonald sold off in 2009 (see this Wall Street Journal report.)  As we noted here, its products still include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just reported, it will soon sell this unit to private equity.  So during Mr McDonald's tenure, his company was to some extent a pharmaceutical company, and a health care provider.

The Blumsohn - Procter and Gamble - Sheffield University Case

Furthermore, on Mr McDonald's watch as Vice Chairman of Global operations and Chief Operating Officer, there was a case involving Procter and Gamble that raised multiple concerns about the ethics of its pharmaceuticals operations.  We first posted about the case in 2005 (here).  For all relevant posts, look here. In 2009 we described the case thus,

The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.

We previously summarized the case's events

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
  Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.

Although this case occurred in the UK, it involved actions by the US based Procter and Gamble.  While many of the events in the case occurred before 2004, from 2004 to 2009 it became clear that Procter and Gamble was not going to go easy on Dr Blumsohn.  For example, according to Dr Blumsohn, in 2006, P&G released some scientific data relevant to the case, but not complete enough data to be meaningful.  In 2007, there was still shady business going on involving scientific abstract submissions apparently made in Dr Blumsohn's name by P&G operatives.

Since Procter and Gamble never made any known attempt to apologize, explain its conduct, or ameliorate Dr Blumsohn's plight during 2004 - 2009, as one of the most senior leaders of Procter and Gamble, seemingly with direct authority over its pharmaceutical operations in the UK during that time period, Mr McDonald ought to be held accountable for the company's misbehavior described above.  To my knowledge, though, no one at P&G, including Mr McDonald, has ever admitted responsibility or been made accountable in any way.  

Summary

Since Mr McDonald recently was an executive of a company that sold prescription and non-prescription pharmaceuticals, and provided direct health care, confirmation as Veterans Affairs secretary could be regarded as a transit through the revolving door, and hence open to question.  Since Mr McDonald got $15,928,015 in total compensation during his last year as CEO (2012-13) (see the company's 2013 proxy statement), and had accumulated 2,247,593 shares of stock or equivalent by 2013, worth approximately $179 million at today's price of $79.67, his ability to understand the needs of the often poor veterans whom the VA serves is also open to question. 

More importantly, while Mr McDonald held high executive positions at Procter and Gamble, the company was involved in a dodgy affair involving conflicts of interest, manipulation of research, and attempted silencing of whistle blowers.  In my humble opinion, given that these events occurred directly on his watch, his fitness to run a huge health care system ought to be in question unless his responsibility for these events is disproved.

The widespread huzzahs for Mr McDonald as potential VA leader based mainly on his exalted status as CEO of a big corporation show that many in the US still see corporate CEOs as aristocracy.  True health care reform would hold health care leaders accountable, particularly for upholding the health care mission and putting patients' and the public's health ahead of revenue generation and especially personal profit.

ADDENDUM (7 July, 2014) - Link to McDonald's official P&G biography fixed. 

ADDENDUM (8 July, 2014) - This post has been re-posted on Naked Capitalism, and on Open Health News. 

CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.

The connotation, of course, is that these individuals are "snitches" and "non-team players", in other words, the "bad guys."  They are then punished for their good deeds.

(More on the term "whistleblower" below.)

Here's one "whistleblower" who punished back:

California Supreme Court upholds whistleblower protection for Modesto physician

By Ken Carlson
February 20, 2014
http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html

The California Supreme Court ruled Thursday that a Modesto physician who challenged the termination of his hospital privileges has whistleblower protections.

Dr. Mark Fahlen, a kidney specialist, filed a March 2011 whistleblower lawsuit in Stanislaus County Superior Court after Sacramento-based Sutter Health canceled his privileges to care for patients at Memorial Medical Center.

Fahlen’s lawsuit claims that Sutter Central Valley Hospitals and Steve Mitchell, then the chief operating officer of Memorial, persuaded the Sutter Gould medical group to fire him and terminated his hospital privileges because of his complaints about insubordination and substandard care by hospital nurses.

At least they didn't threaten to plaster his complaints to his forehead as occurred in Ohio (http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html).

His attorney said the court decision guarantees that physicians have the same protections as hospital employees if they report problems that threaten to harm patients.

That "guarantees protections" and "report problems that threaten to harm patients" have to appear in the same sentence at all is symptomatic of the most severe form of patient-be-damned dysfunction in this industry.

It’s “the biggest victory for patient rights since California’s health care whistleblower law was adopted in 1999,” said attorney Stephen Schear of Oakland. “In a hospital environment dominated by corporate giants too often more focused on protecting their marketing and brand name than patient health, today’s ruling will finally unshackle doctors from fear of retribution so they can protect patients.”

Ditto my prior comment.

In a case closely watched by the hospital industry, the American Medical Association supported Fahlen with a “friend of the court” brief. The California Hospital Association and groups such as Kaiser Foundation Hospitals, Scripps Health and Dignity Health filed briefs on behalf of the defendants.

That is rather indicative of the mindsets of those who filed briefs on behalf of the defendants.

... After he was given staff privileges at Memorial in 2004, Fahlen complained to administrators that nurses refused or failed to follow his patient care instructions. According to facts in the case, Fahlen had six clashes with nurses about patient care from August 2007 to April 2008. He told supervisors and administrators that nurses were insubordinate and that their care was substandard.

One complaint was regarding a nurse’s refusal to transfer a patient to intensive care, delaying for five hours the appropriate level of care for the patient, the doctor said.

What if the patient had died, I ask?

Mitchell, the chief operating officer, blamed Fahlen for his conflicts with nursing staff and contacted Sutter Gould’s medical director about Fahlen’s conduct. Sutter Gould cut ties with Fahlen in May 2008, causing his malpractice insurance to be canceled. Fahlen decided to start his own practice and arranged a meeting with Mitchell to talk about his hospital privileges.

Mitchell wrote in an email to Memorial’s chief executive officer that Fahlen “does not get it,” meaning that he was going to lose his privileges. The CEO replied that it “looks like we need to have the medical staff take some action on his MedQuals!!! (or medical qualifications). Soon!”

According to the lawsuit, Mitchell told Fahlen at the meeting that he should resign and leave town, or the hospital would report him to the Medical Board of California. Fahlen charged that a subsequent in-house investigation, and an executive committee decision not to renew his privileges, occurred in retaliation for his complaints about patient care.

In other words, the doctor was a "disruptive physician" - a bad schoolboy who needed to be spanked - which was, of course, more important to the executives than maimed or dead patients.

Fahlen asked for a hearing, resulting in an October 2009 to May 2010 review by a six-physician committee at Memorial. The panel concluded that the evidence did not show he was incompetent or that his behavior had endangered patients. [But] Memorial’s board of trustees overruled the panel in early 2011.  [It's not hard to imagine that few if any on that board were themselves medical professionals - ed.]

It's more likely in my view that this physician was ultra-competent.

Sutter attorneys argued that the doctor first needed to exhaust other legal remedies before bringing the whistleblower lawsuit. The Supreme Court dismissed a previous expectation that doctors exhaust other remedies before filing suit with claims of retaliation. Such conditions would “seriously undermine the Legislature’s purpose to afford a whistleblower on a hospital medical staff the right to sue,” the Supreme Court’s opinion said.

Next, a typical circular argument:

Attorney Lowell Brown, who handles physician disciplinary cases for hospitals, said Thursday’s ruling will “change the rules of the game,” though additional court decisions will be needed to clarify issues. He predicted doctors will be reluctant to serve on hospital panels that review the competency or behavior of physicians.

“The doctor can claim the action is being taken because he or she is whistleblowing,” Brown said. “No one ever produces evidence that a sham peer review has taken place. What we will see is sham whistleblower complaints about peer reviews.”

Since sham peer review (see more at http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html) is done secretly and behind closed doors, with protections, it's pretty hard to produce "evidence" of the type required in court.

... Fahlen said the ruling means that “doctors no longer have to choose between speaking out for their patients or continuing with their careers.”

Again, this is an absolutely perverse choice foisted upon clinicians by corporatized, financialized medicine and its leadership.

------------

More on the term "whistleblower" itself.

My attitude about that term is clear - the people who use it are attempting an ad hominem attack in one word.  It is a bad term, with bad connotations, and does not actually describe what the individual is attempting to accomplish.

AHIMA's  Kim Baldwin Stried-Reich has a similar view, and a suggestion for replacement of that term with a more descriptive and non-abusable term:

"Changing Perception of ‘Whistleblowers’"

From  http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/

... According to Kim Baldwin Stried-Reich, the former Speaker of the AHIMA House of Delegates, the new amendment to the HITECH-HIPAA Omnibus rule demonstrates both the increasing importance and value HIM professionals have today in ensuring both integrity and compliance with rules, regulations, and laws governing access and disclosure of health information within their organizations. Baldwin Stried-Reich is a privacy and compliance officer with the Lake County Physicians Association, in Waukegan, IL.

She notes that while the new provision provides specific protections against disclosures reported to an oversight agency by whistleblowers and workforce members who are victims of a crime, she’s not so sure this new rule will encourage individuals, such as HIM professionals to speak-up and speak-out when or if they see evidence of systematic and ongoing non-compliance with federal mandates.

One reason for this is the widespread use of the word “whistleblower,” which often carries negative connotations. She prefers the term “corporate integrity advocate.”

"Corporate Integrity Advocate" clearly and unequivocally describes what the individuals - including those who write for blogs such as this one - are trying to accomplish.

It is also a term that is rather hard for malfeasance-doers to use as ad hominem..

“Perhaps if Health and Human Services had utilized another term, such as ‘corporate integrity advocate’ more individuals would understand what the intent of this new law is and that it is meant as an avenue individuals can choose to pursue if their professional integrity and ethics are not in alignment with the corporation’s any longer,” Baldwin Stried-Reich says.

"Not in alignment with the lack of the corporation's integrity and ethics" is a more direct, and likely more accurate, way to put it.

A relevant example of this is evident in the settlement that Shasta Regional Medical Center (SRMC) entered into with the Department of Health and Human Services (HHS) following an investigation concerning the breach of PHI after senior-level executives intentionally disclosed protected information to the media on at least three separate occasions.

The Shasta case demonstrates how and why corporate integrity advocates or whistleblowers are needed to facilitate change within their organizations when it is warranted, Baldwin Stried-Reich explains.

That example is but the tip of the iceberg.  There are many posts on this blog alone dealing with the issues of whistleblowers Corporate Integrity Advocates (see the query link http://hcrenewal.blogspot.com/search/label/whistle-blowers).

The term "whistleblower" needs to be retired ASAP.

-- SS

No Dogs to Bark - Failure to Connect the Events Foreshadowing the Fall of the Upstate President

In Silver Blaze, Sherlock Holmes noted the important clue of the watchdog that did not bark.  In health care, nowadays watchdogs are absent, so who is expected to bark?  So, when cases of failed leadership of health care organizations appear, in retrospect they often appear to have been foreshadowed by various events which caused no reaction.. 

Last week we posted about the president of the State University of New York (SUNY) - Upstate Medical University who resigned his job after revelations that he was receiving hundreds of thousands of dollars in income from outside organizations which he had not properly disclosed, and which could have constituted conflicts of interest. 

Only days later, on November 20, 2013, James T Mulder, the Syracuse Post-Standard journalist who had done much of the relevant reporting, published an article summarizing previous events that in retrospect should have suggested that there were serious ongoing problems within SUNY - Upstate leadership. 

Claims that the University Fired Physician Whistle-blowers - the Case of Dr Stewart

According to the summary article,

Critics of [SUNYH - Upstate Medical University President Dr David R] Smith ... [said]  he ruled with an iron first and did not tolerate opposing views.

'It became clear once he knew who dissenters were, things would happen,' said Dr. James Holsapple, a former Upstate neurosurgeon who now practices and teaches in Boston, Mass.'Dissidents would not be tolerated.'

Holsapple cited the case of Dr. William Stewart, a neurosurgeon fired by Upstate in 2011. Stewart contends he was fired because he filed a complaint with the state Health Department, alleging misconduct by two other Upstate doctors. That complaint led to an investigation by the state which issued a report critical of Upstate.

Upstate contends Stewart was let go because he refused to cooperate with an investigation into a breach of confidential information, including patient records.

Holsapple calls the incident a ' ... clear example of Smith taking out a critic.'

In a pending lawsuit in federal court, Holsapple has accused Upstate of retaliating against him for speaking out against what he calls dangerous medical practices and other unethical activities at the Syracuse teaching hospital. Upstate has denied his accusations and called them 'baseless.'

In fact, Mr Mulder's article from April, 2011 about Dr Stewart's case noted that Dr Stewart

said his complaint ' ... made me an enemy of the regime.'

Although Upstate accused Dr Stewart,

 ... because he refused Upstate’s request that he cooperate in an investigation into an intentional breach of confidential information, including private patient care records.

Dr Stewart contended that he knew how to handle confidential information,

Stewart served 20 years as a member of the state Board for Professional Medical Conduct, which takes disciplinary action — including license revocation and suspension — against doctors. He chaired that board for three years in the late 1980s.

Stewart said he never disclosed any private patient information. 'I took the Hippocratic oath when I graduated from medical school,' he said.

Stewart said physicians are required by state law to report suspected cases of medical misconduct. Failure to do so is considered misconduct under the law.

Stewart said that’s why he filed a complaint with the Health Department, alleging that a resident neurosurgeon training at Upstate was allowed to perform complex spine surgery without proper supervision because the neurosurgeon who was supposed to be doing the operation was in another operating room with a different patient.

Furthermore, Dr Stewart alleged that Upstate sought to intimidate him,

Stewart said two private investigators hired by Upstate visited his office in December, but he refused to talk to them.

Claims that the University Fired Physician Whistle-blowers - the Case of Dr Holsapple


The case that caused Dr Holsapple to file a lawsuit against Upstate had some interesting similarities, but also some uniquely colorful aspects, as documented in an article from February, 2011, by Mr Mulder.  Dr Holsapple also alleged a major quality of care problem at Upstate,

 The suit charges Holsapple’s problems began in 2007 when he objected to a plan to have a single neurosurgeon supervise two spine surgeries in separate operating rooms at the same time. Holsapple thought the plan was risky for patients. At the time death rates following spine surgery at Upstate were five times higher than normal, the suit said.

The suit contends Dr. Ross Moquin, a neurosurgeon no longer at Upstate, was overseeing the two surgeries, according to the suit. While Moquin was with one patient, Dr. Walter Hall, then chair of the department of neurosurgery, and a resident doctor in training, began surgery on the second patient, the suit says. Neither Hall nor the resident were qualified to finish the operation, but Hall told the resident to complete the surgery because Moquin was busy with the other patient, according to the suit. Holsapple’s suit contends the patient suffered complications. It also accused the hospital of creating fraudulent documentation about the operation and billing fraud. 

Some of these charges appear to have been independently corroborated, at least,

That same two-room spine surgery case was cited in a recent state Health Department investigation. In a 68-page report issued in August, the Health Department said Upstate did not provide surgical services in a way 'that assures protection of the health, safety and rights of patients ... .'

Nonetheless, Dr Holsapple argued that the hospital punished him for his whistleblowing,

The suit says Hall stripped Holsapple of his job as residency coordinator in 2007 without any explanation, cutting his annual pay by $82,500. Hall also removed Holsapple as the department’s quality officer, according to the suit.

Dr Holsapple also contended that the hospital attempted to harass him after he left, and did so, as Dr Stewart also argued, using private investigators,

Holsapple contends Upstate continued the retaliation after he left. He said Upstate sent two investigators to his home in South Boston in November to intimidate and harass him and his wife.

The lawsuit suggested that Dr Holsapple was qualified to complain about quality issues,

Upstate hired Holsapple as an assistant professor of neurosurgery in 1994 after he completed his residency training there. In his suit he says he served as the quality improvement officer for the neurosurgery department, on the SUNY faculty senate and on the hospital’s medical executive committee alongside top Upstate executives, department chairs and other officials.

It also suggested that perhaps Dr Hall, the chairman of neurosurgery whose conduct figured in Dr Holsapple's complaint, was not so qualified to sit in judgment of Dr Holsapple,

The following year nursing staff discovered images of Nazi artifacts within the computerized medical records of Hall’s patients, the suit says.

Holsapple said in an interview the images were photographs of tank medals and other Nazi paraphernalia displaying the swastika.

The suit says a hospital investigation confirmed the Nazi images belonged to Hall and he was forced to resign as chair of the neurosurgery department.

Holsapple said in an interview Hall told hospital officials he bought and sold the Nazi memorabilia and stored the images on his computer. 'Some of the Jewish faculty were disturbed these icons were finding their way into the computer system,' Holsapple said.

A Cheating Scandal and Probation by an Accrediting Agency

Mr Mulder' November 10, 2013, summary article also reported,

The medical school was embroiled in a cheating scandal in 2011. An Upstate investigation found more than 100 fourth-year medical students cheated on quizzes in a medical literature course.

Last year the medical school was placed on probation by the Liaison Committee on Medical Education, an accrediting group. That group criticized the school for having an erratic learning environment. It also said the medical school's curriculum was out of sync, student complaints were being ignored and the dean was ineffective. Upstate fixed the problems and was taken off probation earlier this year.

Mr Mulder's article jogged by hazy memory into the recollection that I had seen several other examples of problems at SUNY - Upstate, but since the articles that illustrated them seemed to appear in isolation, I had just dumped them into the pile of  documents to be filed. A hurried search then revealed articles on the two whistle-blowers, and the cheating and probation issues above, and...

A Costly Merger?

I found a story from February 21, 2011, also authored by Mr Mulder, that suggested a merger proposed for Upstate University Hospital would lead to a big increase in health care prices,

 The cost to replace a hip, treat a heart attack and provide many other routine hospital services covered by Medicare is about 46 percent higher at Upstate University Hospital than at Community General Hospital.

Some experts fear a proposal to merge Upstate and Community into one hospital with one payment rate will raise Community’s prices to Upstate’s level and increase overall health care costs in Central New York. 

So,

MVP Healthcare, a health insurer, is worried about potential price increases at Community.

'We need to know if the charges for services provided by Community General Hospital would increase as a result of the merger,' said Gary Hughes, a spokesman for the insurer. 'If the rates increase, we would be concerned how the merger would affect health care costs in the region, how that would affect the business community and individuals.'

At a recent public forum on the proposed acquisition, Dr. Douglas Tucker, of MVP, said blending Upstate’s high rates with Community’s could be 'catastrophic,' especially for patients with high-deductible plans who have to pay big upfront costs before their insurance coverage kicks in.

SEIU Local 1199, the union representing Community General workers, shares that concern. The union wants Community General to remain as a lower cost, private sector community hospital. The union also wants to remain at Community to preserve its members pensions and benefits. It does not want to see Community workers become state employees, who are represented by different unions.

Note that although the merger did occur in 2011, I could not find any documentation about its effects on costs since.


Summary


In the last two years, SUNY - Upstate Medical University has been accused of seeking a merger mainly to drive up its prices, and of independently driving out and attempting to intimidate two separate physicians for blowing the whistle about health care quality concerns.  The department chairman whose work was criticized by one of the physicians, and who subsequently drove him to leave was himself forced out of his leadership position over allegations of Nazi photographs found within his computerized patient files.  University students were involved in a big cheating scandal, and the university was placed on probation by its accrediting agency.  These stories generated lots of concerned and sarcastic comments online.  However, I could find nothing to suggest that they lead to any official investigations by SUNY leadership, state government, accrediting agencies (other than as listed above), Medicare, medical societies, etc  I could find nothing to suggest that any actions were taken by students or faculty at the school, or by independent watchdogs or other members of civil society. 


Yet in retrospect the sequence of events suggested major problems with the leadership of SUNY - Upstate Medical University.  The existence of these problems seems to have been confirmed by the revelations that the university president was accepting hundreds of thousands of dollars of outside income which he failed to properly disclose to the university, and which could have constituted major conflicts of interest.  The seriousness of the leadership problems was just underscored by the recent decision of the state Comptroller to audit the institution's contracts (look here for AP story), and the sudden resignation of the university senior vice president for administration and finance who apparently was receiving pay, admittedly which he had disclosed, from the same organizations who were paying the president (see story by Mr Mulder here.)


 One obvious conclusion is that bad leadership leads to lots of bad consequences.

Another is that here in these United States we lack any effective watchdogs who can spot major leadership problems at important health care organizations before they lead to bad outcomes. 

  In particular, our the leadership of our academic medical organizations do not seem to get any organized scrutiny from student, faculty or alumni groups, from government agencies, from accrediting organizations, from medical societies, or from community based civil society organizations  or health care watchdog groups.  Hoping that overworked local reporters or volunteer bloggers will not only be able to spot evidence of trouble in a timely way, and then make it visible enough to generate action is whistling past the cemetery. 

 
 IMHO, concerned citizens, hopefully including those in and in training for the health professions, need to set up organized civil society watchdog groups to hold health care leadership accountable, and to push for involvement by government, accrediting organizations, medical societies, etc. 

The Mystery of the Northwestern Settlement - the Plot Thickens

A few weeks ago, we wrote about this curious case.

How the Case Stood

Northwester University, a prominent research university, settled charges it had mismanaged US government grant funds.  While it did not admit guilt, and specifically exonerated the faculty leader on whose watch the mismanagement allegedly occurred, the settlement and most of its coverage strongly suggested wrongdoing by the faculty member in charge of the scientific conduct of the grants, Professor Charles L Bennett.  While the alleged financial mismanagement was of funds in the mere millions, a relatively small amount as federal fraud cases go, and there were no allegations of anything harmful to patients, or of any research misconduct, the investigation involved multiple federal agencies, including the Federal Bureau of Investigation.  The settlement of charges of financial mismanagement, not research misconduct,  included unfavorable references to Dr Bennett, who as Principal Investigator should have been in charge of the scientific conduct of the grants, but not of their financial management.  Much bigger cases of alleged fraud, involving hundreds of millions of dollars, and potentially harm to patients due to overuse of dangerous drugs or devices, have not involved the FBI, and not included any disparagement of individuals who could have authorized, directed, or implemented the alleged misbehavior.

None of the initial press coverage noted the peculiarity of these aspects of the case, nor provided any explanations for them.      

Days later, the Cancer Letter published a long article in this case, which is now available without a subscription.  This article includes even more curiosities that raise even more questions.

Dr Bennett Found Irregularities, Sangoleye Pleaded Guilty, Nobody Noticed

In the original media coverage, Dr Bennett was accused based on complaints by a whistle blower.  For example, in an article in the Chicago Sun-Times,

 A whistleblower suit filed under seal in 2009 by former Lurie Cancer Center worker Melissa Theis first alleged the wrongdoing by Bennett.

However, the story in the Cancer Letter suggests Dr Bennett had tried to blow the whistle himself.  First,

Bennett said the allegations that he spent NCI money on dinners and vacations were inaccurate. He said he had encountered administrative irregularities at Northwestern and reported them to compliance officials.

In addition,

'I reported administrative issues by Northwestern University with my grants to the university compliance officer in 2006, just prior to my long-term bout with cancer that was diagnosed there,' Bennett said to The Cancer Letter. 'I have never had a single administrative discussion about the matter with anyone.'

Specifically,

Bennett’s statement about lax administration of grants at Northwestern appears to be bolstered by an aspect of the scandal that has escaped media attention even as multiple news stories in Chicago and national outlets focused on the settlement.

The Cancer Letter has learned that days before the settlement with Northwestern was announced, a former research administrator at the Division of Hematology and Oncology at the university’s medical school pled guilty to felony charges stemming from administration of Bennett’s NCI grants.

According to documents filed in the U.S. District Court for the Northern District of Illinois, Feyifunmi Sangoleye, the rogue administrator, set up an elaborate scheme to divert $86,000 to her personal accounts.The proceeds financed a wedding and a honeymoon in Europe, court documents say.

The article later included more detail,

Bennett said that he saw irregularities in the actions of the research administrator who handled his Research for Adverse Drug Events and Reports and that he has alerted the administration of the Division of Hematology and Oncology.

That same administrator, Sangoleye, pled guilty to larceny and theft, admitting to having embezzled NCI funds from Bennett’s program into a checking account created in the name of a fictitious contractor.

According to court documents, Sangoleye created a vendor code for a fictitious entity she called ATSDATA.

Then she created 10 false invoices from that entity and paid them with Northwestern’s checks.

The checks were sent to the ATSDATA post office box, which Sangoleye had rented, and placed into a bank account she created.

Between June 29, 2007, and July 29, 2008, ATSDATA received eight Northwestern checks that added up to $86,000. 'Sangoleye converted the proceeds of the ATSDATA checks to her own use and to the use of another' individual, the plea agreement states.

'I knew nothing about ATSDATA,' Bennett said in response to questions from The Cancer Letter. 'The administrator told me that ATSDATA was the billing address for the University of Illinois Survey Research Laboratory, a formal subcontractor. I did not know that the Survey Research Lab had any particular billing name. I have documented this to Jonathan Licht [chief of Northwestern’s Division of Hematology/Oncology] in 2008.'

So in summary, Dr Bennett, who was responsible for the scientific integrity but not the financial management of his grants, reported financial irregularities to Northwestern managers.  These reports lead to a guilty plea by a former Northwestern manager who admitted embezzling money.  However, this guilty plea was anechoic.  It did not appear in any media accounts.  The settlement negotiated between Northwestern University and the government did not acknowledge it.   


According to the Cancer Letter, Northwestern managers did not want to discuss the crimes of Sangoleye when the Cancer Letter brought it up,

 Northwestern officials declined to discuss Sangoleye, saying only that she had been employed by the university as a research administrator from February 2006 through August 2009.

The Cancer Letter suggested why the university might have had an interest in keeping the Sangoleye crimes and its settlement of the allegations about Dr Bennett apart.

Legal experts say that the final plea agreement between Sangoleye and the government would have weakened Northwestern’s position in negotiating the settlement. The final version of the plea agreement with Sangoleye was filed on July 25, just five days prior to the announcement of the government’s $3 million settlement with Northwestern.

Northwestern University might have had an interest in keeping the Sangoleye criminal case and its civil case separate.  However, the government did not obviously have such an interest.

Why did the government not address Sangoleye's crimes in the settlement it made with Northwestern University?

The Ambiguities of the Named Whistle Blower's Work

As we noted in our earlier post on this case, the role of the named whistle blower, Melissa Theis, was unclear, especially vis a vis Dr Bennett.  Although Dr Bennett as Principal Investigator of some of the grants involved ought not to have had any direct control of the financial management of the grants, Ms Theis apparently worked in some financial management capacity.  Yet Ms Theis apparently blew the whistle on the university, and on Dr Bennett for alleged financial, not research mismanagement.

The Cancer Letter raised new doubts about Ms Theis' role,

Several observers were surprised to see that the relator, Theis, was never employed by the cancer center.

According to her 2009 suit, Theis came to Northwestern as a temp two years earlier, in 2007, serving as a purchasing coordinator for the Division of Hematology and Oncology. The division, which is separate from the cancer center, administered all but one of the grants in question, the NIH database shows.

After a year, in 2008, Theis was hired as a fulltime employee of the Northwestern Medical Faculty Foundation. The foundation, which runs the medical practice, is also separate from the cancer center. She left Northwestern in October 2008.

'Theis specifically noted that invoices were submitted for consultants and services that were never included in the initial grant budget,' the complaint states. 'Invoices were submitted for consultants and services that were significantly in excess of the amount budgeted for the grant, and many of the consultants and vendors failed to provide detailed information about the actual services rendered.'

Again, in the usual practice, such invoices might have been requested by a grant investigator, but the requests would have to have been vetted and then the invoices would have to have been generated by managers, not scientists or physicians. 

Who really administered these grants, and why did the settlement minimize the responsibility of university managers while apparently blaming scientists for bad financial management?

Dr Bennett's Supporters and Enemies

In our first post on this case, we had contrasted how the settlement and media coverage of it appeared to heap blame upon Dr Bennett alone, while not attaching any responsibility to his academic supervisor on one hand, or any university managers on the other.  We noted that Dr Bennett, after having been a consultant for Amgen,  had become known as a "pharmascold," a skeptic of pharmaceutical industry practices, and the author of research that suggested one Amgen product was more hazardous than had been previously thought.  His supervisor, on the other hand, had multiple ongoing financial ties to the pharmaceutical industry.

The Cancer Letter suggested others were trying to connect related dots. First, in general,

Making enemies is an exhaustively studied side effect of probing the safety of cancer drugs, and during much of the period in question, Bennett was producing more than his standard quota of foes.

In particular,

Now, researchers who worked with Bennett on the ESA issues are puzzled by his legal problems.

'Charlie has been an important voice in raising concerns regarding the use of erythropoietin in patients with cancer,' said Anthony Blau, co-director, Institute for Stem Cell and Regenerative Medicine at the University of Washington. 'In particular, his 2008 metaanalysis, published in JAMA, heightened awareness of the issue and helped to reduce the indiscriminate use of erythropoietin in cancer patients.'

Blau is a co-author on the JAMA paper [as noted in our previous post.]

'This doesn’t really fit in his picture,' said Michael Henke, a radiation oncologist in Freiburg, Germany, who was the first to stumble across potential problems stemming from overuse of ESAs.

'You might recall, we got in contact in 2003 when our group communicated potential dismal effects of erythropoietin on cancer patients—a story not really appreciated these days because of economic interests,'  Henke said referring to the pioneering paper in The Lancet. Henke was the senior author on the JAMA paper.

'However, Dr. Bennett and we consistently gathered additional data that were finally reported as a meta-analysis in 2008. Consequently, erythropoietin prescriptions dramatically decreased, eventually prolonging or even saving lives of cancer patients.'

'While collaborating, I did learn him as extraordinarily active, alert-eyed colleague who strictly adhered to serious scientific conduct and to the wellbeing of patients.'

Henke confesses to wondering whether the many powerful enemies Bennett made in the pharmaceutical and biotechnology industries have struck back.

'We shouldn’t feed paranoia,' Henke said.  'However, given the exclusively positive experience when collaborating with his group, makes me wonder whether this litigation might follow some very particular other issues.'

Did Dr Bennett's transformation from a consultant to to a fierce scientific skeptic of the pharmaceutical industry influence the handling of this case, and its media coverage?

Summary

The coverage by the Cancer Letter underscores our previous concerns, so I will simply repeat the summary from my last post.

The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the march of legal settlements whose continuation we have frequently discussed.

The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know.

ADDENDUM (27 August, 2013) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.


Roy M. Poses MD in Health Care Renewal 

The Mystery of the Northwestern Settlement

Watson, quick, the game's afoot.  We have discussed a large number of legal settlements by large health care organizations that serve as markers of misbehavior and often lack of leaderships' responsibility for same.  These settlements often follow a common pattern.  Yet this week a settlement appeared that was quite different, and hence raised some important questions.

The Basics of the Settlement

I will summarize the settlement as described by the Wall Street Journal.  The basic points were:

Northwestern University agreed to pay nearly $3 million to settle claims that a former cancer researcher fraudulently used federal grant money for personal expenses, including food, hotels and airfare for family trips between 2003 and 2010.

The settlement in the civil suit was unsealed Tuesday by the U.S. Attorney for the Northern District of Illinois, which investigated claims brought by a whistle blower under the False Claims Act.

The settlement seemed to be more about the researcher, Dr Charles L Bennett, than Northwestern,

At the time of the alleged fraud, Dr. Bennett was the principal investigator on research funded by the National Institutes of Health, studying adverse drug events, multiple myeloma, a blood disorder known as thrombotic thrombocytopenic purpura, and quality of care for cancer patients.

According to the settlement agreement, he allegedly billed federal grants for family trips, meals and hotels for himself and friends, and for 'consulting fees' for unqualified friends and family. Northwestern also allegedly improperly subcontracted, at Dr. Bennett's request, with various universities for services that were paid for by the NIH grants.

'Allowing researchers to use federal grant money to pay for personal travel, hotels, and meals and to hire unqualified friends and relatives as 'consultants' violates the public trust and federal law,' U.S. Attorney Gary S. Shapiro said in a statement.

Meanwhile,

 Northwestern, which is in Evanston, Ill., cooperated with the investigators and didn't admit to any wrongdoing, according to a statement by the university.

The settlement was the result of the actions of a purported whistle-blower,

The whistleblower, Melissa Theis, worked as a purchasing coordinator in the Feinberg school's department of hematology and oncology, processing invoices when she 'noticed some red flags,' according to her attorney, Linda Wyetzner, of the Evanston firm Behn & Wyetzner Chartered.

The federal False Claims Act allows private citizens who allege government programs are being defrauded to file actions on behalf of the government and receive a portion, usually 15% to 30%, of any recovered damages. Ms. Theis will get $498,100 in settlement proceeds, according to the agreement.

The settlement resulted from the efforts of multiple federal agencies,

 The allegations were investigated by the NIH, Federal Bureau of Investigation, U.S. Department of Health and Human Services Office of Inspector General and the U.S. attorney's office.

Curious Aspects and the Questions They Raise

So here is yet another settlement by a large health care organization, in this case, the prestigious academic medical center of a well known university.  This one, however, does not follow the usual pattern, and includes some quite curious aspects.

Media Attention vs Severity

The settlement so far has generated articles in the WSJ (above), the Chicago Tribune, the Chicago Sun-Times, Crains Chicago Business, Medscape, Modern Healthcare, UPI, Bloomberg, other local Chicago and university publications, and local outlets in South Carolina, the state in which Dr Bennett currently works.
 
The amount of the grants that Dr Bennett allegedly misused was $8 million, according to the University Herald.

There are no allegations that any activities of Dr Bennett or the university affected the quality of clinical research, clinical teaching, or patient care.

Contrast that substantial media attention to that generated by another recent settlement we just discussed, that of Pfizer misbranding of Rapamune (look here.)  This involved the excess promotion of a relatively dangerous drug that likely resulted in harm to many patients.  The over-promotion may have caused up to 90% of the drug's $200 million yearly sales.  The settlement itself was for $491 million.  Yet while it got more coverage, mainly from local media outlets which covered it because the settlement will result in payments to individual states, only four big national outlets have covered it so far, again the Wall Street Journal, and  the New York Times, Reuters and Businessweek.

Why did a relatively small settlement of alleged financial misbehavior without clinical implications get nearly as much attention as a settlement fifty times bigger that involved actions that likely harmed patients?

Intensity of the Government Response

Dr Bennett's alleged misuse of grant funds required investigation by four different federal agencies, including the FBI.  Pfizer's misbranding of a dangerous drug seemingly was handled only by one, and the FBI was not obviously involved.  In fact, the FBI rarely has rarely been mentioned in the media coverage of most of the legal settlements we have discussed.

Why did again a case of relatively small alleged financial misbehavior require such massive federal resources when much bigger cases which had implications for clinical care, policy, or research seemed to command lesser resources?

Naming and Shaming

The settlement did not involve any admission of any wrongdoing by Northwestern.

In contrast, nearly all the news coverage of this settlement emphasized the role of Dr Charles L Bennett.  The coverage seemed to be following the lead of the Department of Justice press release, which included,

 Northwestern allegedly allowed one of its researchers, Dr. Charles L. Bennett, to submit false claims under research grants from the National Institutes of Health. The settlement covers improper claims that Dr. Bennett submitted for reimbursement from the federal grants for professional and consulting services, subcontracts, food, hotels, travel and other expenses that benefited Dr. Bennett, his friends, and family from Jan. 1, 2003, through Aug. 31, 2010.

Yet Dr Bennett appeared not to be a party in this settlement, and it was unclear whether he had a direct opportunity to respond to it.  The Wall Street Journal did note that after it was announced,

 James M. Becker, an attorney for Dr. Bennett, said, 'We deny the allegations.…We are actively engaged in discussions to resolve the allegations.'

We have discussed numerous legal settlements by large health care organizations, often involving hundreds of millions or even billions of dollars, sometimes involving guilty pleas by the companies involved or their subsidiaries.  Almost never do these settlements name or involve in any way persons who authorized, directed, or implemented the misbehavior.  In fact, we have commented again and again about the impunity of health care organizational managers and executives.  For example, the recent $491 million Pfizer settlement did not name or punish any individuals.  Furthermore, Pfizer's $2.3 billion settlement for deceptive marketing of a drug later pulled from the market (Bextra) did not name much less penalize any responsible individuals (look here.)  Also, GlaxoSmithKline's $3 billion settlement of numerous unethical practices did not name much less penalize any responsible individuals (look here).

So why was naming and shaming Dr Charles L Bennett such an important part of the relatively small Northwestern settlement, when much larger settlements, many involving unethical behavior that could have harmed patients or distorted medical research, and some of which involved corporate guilty pleas to criminal charges did not involve naming and shaming any responsible person?    
 
How Accountable was Dr Bennett?

As in the Wall Street Journal version, the settlement implies that Dr Bennett was the person most responsible.  The Chicago Sun-Times put it this way,

 Dr. Charles L. Bennett allegedly took his wife on personal trips, then illegally billed the flights, hotels and meals to the National Institutes of Health, claiming it was part of his cancer-fighting work. And he allegedly submitted phony bills for his work over a seven-year period beginning in 2003.

Here I will have to interject a bit of information about how federal grants work.  As I learned when I was a young faculty member, and as I confirmed with several other experienced researchers who have run and reviewed federal grants, these grants are made to institutions.  In the current case, the grant apparently went to Northwestern University.  The institution that receives the grant is responsible for making all payments and disbursements related to that grant.  The grant's Principal Investigator is responsible for the scientific conduct of the grant, but NOT payments, disbursements, business management or accounting.  The Principal Investigator can request that payments be made for various things, including travel expenses and consulting work.  But the Principal Investigator cannot directly authorize or make these payments.  They are authorized, signed, and made by institutional administrators, usually in grants and contracts offices or the equivalent, and usually only after copious paperwork to justify the payments.

So Dr Bennett may have requested reimbursement for travel expenses, or requested the university to hire a consultant.  But university managers must have made those payments, unless the university's grants administration mechanism had completely broken down.  Note that given the usual ways grants are administered, it would appear that Ms Theis, the ostensible whistle-blower, who will receive nearly one half of a million dollars from this settlement, actually may have had more direct responsibility for making the payments in question than did Dr Bennett.

Presumably, that is why the settlement was made by Northwestern.

Why then did the settlement, the DOJ press release, and the media coverage so emphasize Dr Bennett's responsibility, and so minimize the role of the university?  

Was Anyone Else Accountable?

The DOJ press release, and all the media articles on the case,  save one, mention only Dr Bennett as the person at fault.  Crain's Chicago Healthcare Daily, however, suggested someone else was responsible,

Northwestern University's nearly $3 million settlement of fraud claims by the federal government protects the director of the school's cancer center, who allegedly failed to supervise a researcher who used grant money to cover personal expenses over a seven-year period.

Dr. Steven Rosen, director of the Robert H. Lurie Comprehensive Center for Cancer, and Dr. Charles L. Bennett, a researcher who is no longer with the center, were both named in a whistleblower complaint unsealed on Tuesday, when the settlement was announced.

Dr. Bennett used federal grant money for family trips and fraudulent consulting fees for his brother and cousin from 2003-10, the government alleges.

Dr. Rosen 'failed to exercise appropriate responsibility,' Randall Samborn, a spokesman for the U.S. Attorney's office said. 'It was a supervisory function that he didn't adequately fulfill.'

When the settlement was announced, Mr. Samborn said the agreement did not cover either doctor. On Wednesday, he corrected himself, saying that settlement covered Dr. Rosen, but not Dr. Bennett.

As I noted above, the way federal grants work, it was the university, and its managers and leaders, who were responsible for making all payments on this and other federal grants.

Why did the government press release and the media coverage emphasize Dr Bennett's alleged role, while ignoring any possible responsibility of anyone else, especially his supervisor?


Backgrounds of the Principles

Dr Bennett and Dr Rosen, who seemingly were treated so differently in this settlement, travel in very different circles.

Most media articles described Dr Bennett as a prolific researcher and medical academic.  Although some described his areas of interest in hematology and oncology, only Medscape described one particular project of his.  

Dr. Bennett's research efforts included a 2008 study on which he was the first author (JAMA. 2008;299:914-924). The study was the first meta-analysis to identify an increased mortality risk in cancer patients associated with erythropoiesis-stimulating agents.(1)

In fact, as we discussed here,  Dr Bennett was the first author of a meta-analysis that was the first to show that epoetins increased the rates of adverse effects and death for cancer patients.  This evidence lead to reduced use of some very expensive drugs made by Johnson and Johnson and Amgen, and hence reduced revenues for both companies.

The JAMA article noted that at the time he wrote it, Dr Bennett had financial relationships with Amgen.  He and a coauthor "reported serving as consultants to AMGEN and Dr Bennett reported he has received grant support from AMGEN previously."

Note that Amgen pleaded guilty to misbranding its epoetin, Aranesp, and therefore paid fine and a civil settlement totaling $762 million.  Given the data on this drug class' adverse events, as shown by Dr Bennett and others, it is likely that the misbranding lead to patients being harmed by the drug without receiving any benefits (look here.) 

After writing that article, Dr Bennett became known as a strong skeptic of the pharmaceutical industry.  Just before the JAMA article was published, he coauthored an editorial which wondered if conflicts of interest would ever prove to be acceptable once sufficient research was done.(2)  In that article, he disclosed consulting for, and receiving honoraria and research grants from Amgen.  In 2010, he published research showing the effects of conflicts of interest on reporting of possible adverse effects based on basic science research about epoetins.(3)  By then he apparently no longer had financial relationships with Amgen.  In 2011, he reported a survey of major cases of pharmaceutical fraud resulting in legal actions.(4)

Dr Bennett became known for skepticism about the practices of pharmaceutical companies, and for publishing about the harms of specific drugs, despite his previous financial relationships with Amgen. 

However, Dr Rosen apparently has continued to work closely with industry.  His faculty disclosure page revealed  the following industry relationships

Consulting / Related Activities
Faculty member engaged in activities such as speaking, advising, consulting, or providing educational programs for the following companies or other for-profit entities:

• Allos Therapeutics, Inc.
• Carden Jennings Publishing Co., Ltd.
• Cerner Corporation
• Dava Oncology, LP
• Elorac, Inc.
• Envision Communications
• Health Practices Consulting - unverified entity
• Plexus Communications
• Prostrakan, Inc.
• Seattle Genetics, Inc.
• Studio ER Congressi (Triumph Group, Inc.)
• The Medal Group Corp.

In addition, faculty member received compensation for medical record consultation and/or expert witness testimony.

Ownership or Investment Interests
Faculty member had an ownership or investment interest in the following companies:

• AuraSense, LLC
• Nanosphere, Inc.

Royalty Payments and Inventor Share
Faculty member has the right to receive payments or may receive future financial benefits for inventions or discoveries related to the following companies or other entities:

• Nanosphere, Inc. 

We have seen various important effects of individual and institutional conflicts of interest in health care.  We have seen corporatism and regulatory capture affecting government and its dealings in health care.  

Did Dr Bennett's break with a powerful industry make it easier to set him up as the villain in this story?

Summary   

The settlement by Northwestern University, which was mainly about allegations made against Dr Charles L Bennett, who was not a party to the settlement, was very different that the vast majority of the march of legal settlements whose continuation we have frequently discussed.

The settlement and its media coverage raised important questions whose answers would be important to the assessment of  our current regulatory and legal response to misbehavior by and within large health care organizations.  Health Care Renewal is about raising such issues by commenting on public information, media reports, and research.  I hope those with capacity to investigate will consider these questions.  Inquiring minds want to know.

Roy M. Poses MD in Health Care Renewal 

References

1.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin adminstration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924.
2.  Djulbegovic B, Angolotta C, Knox KE, Bennett CI. The sound and the fury: financial conflicts of interest in oncology.  J Clin Oncol 2007; 25:3567-3568.  Link here 
3.  Bennett CI, Lai SY, Henke M et al.  Association between pharmaceutical support and basic science research on erythropoiesis-stimulating agents.  Arch Intern Med 2010; 170: 1490-1498.  Link here.
4.  Qureshi Z, Sartor O, Xirasagar S, Liu Y, Bennett CI.  Pharmaceutical fraud and abuse in the United States, 1996-2010.  Arch Intern Med 2011; 171: 1503-1506.  Link here.