Showing posts with label Northwestern University. Show all posts
Showing posts with label Northwestern University. Show all posts

Friday, April 10, 2020

A Pandemic of Silence: Hospital Managers Intimidate and Punish Coronavirus Whistle-Blowers

Under cover of a pandemic, managers and executives of hospitals, hospital systems, and other organizations that provide direct patient care are trying to silence health care professionals who point out leadership's failings.  We have seen a distressing parade of whistle-blowers intimidated and punished.



On March 25, an article in Medscape stated the basic problem.Per an anonymous orthopedic surgeon:

'It’s very clear; no one is allowed to speak for the institution or of the institution,' he said in an interview. 'We get a daily warning about being very prudent about posts on personal accounts. They’ve talked about this with respect to various issues: case numbers, case severity, testing availability, [and] PPEs.'

This clearly is not rare.

The silencing of physicians by hospitals about PPE shortages and other COVID-19 issues has become widespread, said Nisha Mehta, MD, a physician advocate and community leader who writes about PPE on social media. Physicians are being warned not to speak or post publicly about their COVID-19 experiences, including PPE shortages, case specifics, and the percentage of full hospital beds, Dr. Mehta said in an interview. In some cases, physicians who have posted have been forced to take down the posts or have faced retribution for speaking out, she said.

'There’s definitely a big fear among physicians, particularly employed physicians, in terms of what the consequences may be for telling their stories,' Dr. Mehta said. 'I find that counterproductive. I understand not inducing panic, but these are real stories that are important for people to understand so they do stay home and increase the systemic pressure to get sufficient PPE, so that we can preserve our health care workforce for a problem that is going to get worse before it gets better.'

Here is our round-up of specific cases, in the order that they came to light

Three Cases, Two Anonymous of the Silencing of Health Care Professionals who Blew the Whistle about Coronavirus Safety Issues

The Medscape article included:

an Indiana hospitalist who took to social media to ask for masks for hospitals in his area says he was immediately reprimanded by his management after the posts came to light.

Another frontline physician who works at a large New York hospital, said staff have been cautioned not to talk with the media and to be careful what they post on social media regarding COVID-19. The general rule is that only information approved by administrators can be shared

The Medscape article also detailed this case:

 [a] nurse, Lauri Mazurkiewicz, sent an email to staffers at Northwestern Memorial Hospital stating the surgical masks provided by the hospital were less effective against airborne particles than were N95 masks, according to a lawsuit filed March 23 in Cook County Circuit Court. Ms. Mazurkiewicz was terminated the next day in retaliation for her email, the lawsuit alleges.

In the short time since that article was published, more specific, and egregious examples have appeared

Emergency Physician Employed by TeamHealth, Owned by Private Equity Firm Blackstone, Fired at the Behest of PeaceHealth for "Inciting Public Fear"

Perhaps the best documented case is that of Dr Ming Lin.  As reported by the Seattle Times on March 29, 2020,

Dr. Ming Lin worked at PeaceHealth St. Joseph Medical Center for 17 years until he was removed on Friday by TeamHealth, a national staffing firm under contract to provide the hospital’s emergency department personnel. Lin became a national avatar for frustrated health care professionals during the COVID-19 outbreak by speaking up in the press and on social media with pleas for more medical supplies and stronger standards to protect health care workers combating the virus.

On March 16, Lin posted a letter on Facebook he’d sent to PeaceHealth St. Joseph’s chief medical officer, outlining how the hospital was mismanaging patient COVID-19 testing and exposing health care personnel and patients to unnecessary risks. He decried the hospital’s internal bureaucracy that prevented some doctors from ordering coronavirus tests, including a 'ludicrous' requirement that a flu test be completed before providing patients coronavirus screenings. Lin also criticized the hospital’s lack of a triage tent outside the emergency room to screen and test patients, to limit exposure of other patients and staff to potential infection.

'PeaceHealth is so far behind when it comes to protecting patients and the community, but even worse when it comes to protecting the staff,' Lin’s letter said.

The hospital's immediate response was to ask Dr Lin to "retract" or "recant" what he said.  When he refused, first

TeamHealth said Lin technically was not fired and remains employed by the company, but will no longer work at PeaceHealth St. Joseph Medical Center. A PeaceHealth St. Joseph spokesman on Friday confirmed Lin’s termination but declined to comment further because Lin was not directly employed by the hospital.

Note that:

TeamHealth was acquired by the Blackstone Group, a private equity firm, in 2016 for $6 billion. Since then, the company came under fire for a pattern of suing uninsured and low-income patients who were unable to pay their medical bills, but discontinued the practice after it gained public attention in the news.

An April 6, 2020 article in the Seattle Times disclosed the hospital's rationale for firing Dr Lin

Richard DeCarlo, chief operating officer of PeaceHealth, which operates Bellingham’s St. Joseph Medical Center, likened Lin’s public warnings about workplace coronavirus concerns to 'yelling fire in a crowded theater.'

that is,

allegedly inciting public fear by criticizing the hospital’s emergency precautions.

thus begging the question of what it was the public might fear.  Perhaps he was afraid they would fear going to his hospital, thus suppressing its revenues?

Note further that Mr DeCarlo, according to his official PeaceHealth biography, has no apparent experience of expertise in medicine, health care, or public health. The CEO apparently is a registered dietitian with no recent experience in medicine, health care, or public health.


NYU Langone Health Threatens to Fire Physicians who Talk to Press Without Authorization

The Wall Street Journal  reported on March 31, 2020 that after the head of the Department of Emergency Medicine at NYU Langone sent a message to physicians implying that they should consider withholding ventilators from some critically ill patients, the physicians

also got got a reminder not to speak to news reporters without permission from NYU Langone's Office of Communications and Marketing.

Kathy Lewis, executive vice president for communications and marketing, said in an email that NYU Langone's longstanding policy required faculty, residents and staff to forward all media inquiries to her.

'Anyone who does not adhere to this policy, or who speaks or disseminates information to the media without explicit permission of the Office of Communication and Marketing, will be subject to disciplinary action, including termination,' Ms Lewis wrote.

A blog post from the Foundation for Individual Rights in Education (FIRE) decried this threat to health care professionals' free speech about pandemic preparedness stated:

free speech and academic freedom do not become less important during a crisis, and that it’s critical that faculty members — many of them serving on the front lines of the pandemic — be able to share information with the broader public.

'It is precisely in times of crisis that it is most important that lines of communication to the public be open,' said Robert Shibley, FIRE’s executive director. 'These faculty members are there because they’re the experts. Inhibiting their ability to communicate important information about COVID-19 presents enormous risks.'

Consider also the source of the threat.  Note that according to her official bio,

Kathy Lewis, executive vice president for communications and marketing, is responsible for the advancement of NYU Langone Health’s unique brand identity as one of the nation’s premier centers for excellence in clinical care, biomedical research, and medical education.

Furthermore, Ms Lewis' qualifications to threaten physicians with termination appear to be limited to:

a BA from Montclair State University and an MA from Seton Hall University.

So the implication is that even in the midst of a deadly pandemic, the managers running NYU Langone think upholding the organization's brand identity comes before transparency and honest communication.

Note that this is not the first time Langone has put its brand identity ahead of transparency about disaster preparedness.  Back in 2012, after the medical center suffered a blackout and other problems due to super-storm Sandy, its board chairman, Mr Kenneth Langone, whose name the medical center carries, vociferously tried to avoid institutional accountability for poor disaster planning (look here.)  Mr Langone, a founder of Home Depot, who as described here had previously boasted

I am a fat cat, I'm not ashamed

is a big booster of President Trump (look here).

Other New York Hospitals Warn Health Care Professionals Not to Talk to Journalists

On April 1, 2020, Politico reported

As hospitals across New York City are filling up with patients gasping for air, health care executives are slapping gag orders on their workers to control the narrative amid the coronavirus pandemic.

Specific instances were:

Northwell Health recently sent medical professionals an email informing them all interviews with news media must first be cleared through the public relations department, a hospital employee told POLITICO.

Also,

Mount Sinai distributed its own set of guidelines discouraging speaking to the press and dictating social media policies as more health care professionals stepped forward to report problems in their hospitals. The guidance coincided with images shared on social media of employees wearing trash bags over their regular gear — an alarming picture from inside one of New York City’s premier and deep-pocketed health systems that has shaped public opinion of the shortage of personal protective equipment.

The email did not contain any reference to the ongoing pandemic or disciplinary action that could be taken, though some employees said the threat is present.

'I am very afraid I would be fired for [sharing the guidance with a reporter], which just makes me think they are more afraid of their image than actually having the patients cared for,' said one employee, who requested anonymity for fear of retaliation. 'I am a valuable asset, yet the fact that I am speaking up for my patients, colleagues and myself would have me terminated is not okay. It is an injustice that they overrule us with fear.'

A more recent New York Times article, from April 9, 2020, added:

'Do not respond or speak to any reporters, as well as current or former employees, regarding a pending news story,' wrote David A. Feinberg, the chief marketing and communications officer at the Mount Sinai Health System, in an email to all faculty and students on March 26.


In response,

health care workers on a coronavirus task force at Mount Sinai said they are demanding 'zero tolerance of employer retaliation or threats against those who are speaking up,' in a letter distributed among staffers and obtained by POLITICO.

Finally,

Eleven medical professionals across various health systems in New York City told POLITICO they signed nondisclosure agreements, had contracts that stipulated they not speak with the press without consent from their employer or feared losing their jobs if they spoke out publicly.

Mississippi Physicians Fired After Speaking Out

Health care professionals outside of states with the highest current coronavirus prevalence are not necessarily protected from punishment if they speak out.  On April 5, 2020, Mississippi Today reported:

An Oxford doctor is one of at least two Mississippi physicians claiming they were terminated for speaking out about their employers’ safety measures during the coronavirus pandemic.

Dr. Samantha Houston says she lost her job of four years at Baptist Memorial Hospital-North in late March for 'disruptive' behavior. In the weeks prior, Houston, a hospitalist, used Facebook to organize a local donation drive for masks and baby monitors so that hospital staff could cut down on face-to-face interactions with patients.

Houston, 34, also says she sent several emails to colleagues raising concerns about the availability of personal protective equipment, or PPE, for some workers.

'Every idea I had was just shut down and dismissed, and I just got very frustrated,' Houston told Mississippi Today. 'I just feel like they were not advocating for our safety, and that was what was so frustrating for me. And it really wasn’t even my safety. I felt safe enough because I had an N95 mask and I was able to get in there, but I felt like the nurses were not as safe.'

Also

Dr. Jennifer Bryan, who chairs the Mississippi State Medical Association board of trustees, told Mississippi Today that she knows of at least one other doctor in the state who was also fired for advocating for stronger safety measures.

A Los Angeles and Another New York Health Professional Punished

An article in the New York Times, April 9, 2020 included:

'They’re very protective of their reputation in the community,' said Jhonna Porter, a nurse who was suspended from West Hills Hospital in Los Angeles after raising safety concerns in a private Facebook group and publicly on her own page, including appeals for equipment. 'If anything seems like it might make them look bad, they’re going to stomp on it quick.'

And,

A doctor at Lincoln Medical and Mental Health Center in the Bronx, Deena Elkafrawi, was reprimanded after the British publication Metro quoted her as saying, 'I am scared that going to work could kill me,' according to the Committee of Interns and Residents, a national association that represented her.

Reactions to Silencing Health Care Professionals

Physicians Societies

Two physicians' societies have condemned hospital managers threatening or punishing health care professionals who spoke out about problems with hospitals' responses to the coronavirus pandemic. Per an April 4, 2020 Medscape article,

'Physicians have a professional and ethical responsibility and need to be able to speak out on these types of issues,' Robert McLean, MD, president of the American College of Physicians, told Medscape Medical News

The ACP is one of several professional organizations that have come out against attempts to silence physicians in recent days. Earlier this week, the ACP released a statement supporting physicians who shared concerns about their workplace conditions and lack of adequate PPE, while also rebuking attempts by hospital systems to silence clinician complaints or activism.

'We as a college felt the need to speak out about that and indicate that this is completely wrong,' said McLean. 'Physicians who are speaking out to make people aware of issues of public health and of public health concern should not be at risk of having their employment terminated or otherwise disciplined.'

According to the ACP's ethics policy, physicians who are able should speak out about public health issues for their safety and the safety of their patients, he said. 'The benefit to patients is that problems are identified and not swept under the rug.'

On Wednesday, the American Medical Association (AMA) also put out a short statement in support of physicians' right to advocate for their patients in the current climate:

'In recent weeks, as physicians have battled the COVID-19 pandemic, the question of when and how to express concern about conditions and safety has become a flashpoint for physicians and their hospital employers.'

The hospital managers trade association responded by minimizing the problem.

When contacted by Medscape Medical News to comment on these reports, the American Hospital Association (AHA) referred to a letter sent by AHA President and CEO Richard Pollack on March 27 to the consumer advocacy group Public Citizen, in response to a complaint filed by the group on behalf of themselves and 54 other organizations.

'Outside of the anecdotal reports you shared, the AHA has not heard any reports of hospitals or health systems restricting the free speech of physicians, nurses, or others regarding the conditions related to COVID-19,' the letter reads.

I wonder if the AHA is now aware of all the cases listed above?

Frontline Health Care Professionals

An April 9, 2020, article in StatNews discussed widespread anger among health care professionals over responses to coronavirus from health care leaders, including local and national government leaders, but also hospital leadership.  In particular,

Among the physicians, there’s a growing fear that they’ll face repercussions if they speak out.

Specifically,

'The thought of being fired right now, when my patients need me the most, is even more terrifying than the idea of potentially getting ill from Covid-19,' the Los Angeles primary care physician said.

Whistleblower International Network

The Whistleblower International Network (WIN) wrote a protest letter saying the coronavirus pandemic has led to "the largest attack on whistleblower in the world."

Coronavirus whistleblowers have been exposing inadequate health system capacity and delivery, public procurement problems, violations of health and safety and labor law, inequitable and ill-prepared global supply chains, unfair competition practices and market abuses, and large-scale violations of personal privacy rights. Employers and public authorities have responded to many of the doctors, scientists, and other frontline workers who told the truth by firing them. In countries like the US, UK, and Italy, such termination of employment is illegal whistleblower retaliation, but that hasn’t stopped employers. Other countries such as China, India, and Poland, employees don’t have any whistleblower rights on paper at all. In either scenario, employer retaliation chills others from engaging in public interest speech, which serves the overall mission of preventing the truth from getting to the community. The act of keeping the truth from the public during a pandemic is gross negligence, which is the deliberate and reckless disregard for the safety and reasonable treatment of others. Every time a whistleblower is retaliated against, the public’s rights are being trampled on too. Indeed, we are all victims in the wake of the largest attack on whistleblowers in the world.

The letter concluded:

Suppressing the truth is a clear and present danger to public health and safety that could turn the pandemic into a modern Black Plague. Employers and governments are silencing their early warning systems, but the effect is trans-national. The outrage must be as well.


Why Are Hospital Managers So Quick to Silence Health Care Professionals?

Thus threats against physicians and other health care professionals who blow the whistle about patient care and safety issues, and dangers to health care professionals in the era of the coronavirus pandemic are likely to continue. 

In medicine and health care, there is a long and sorry history of management trying to silence whistle-blowers who might put the leadership in a bad light.  As noted in the March 25 Medscape article,

John Mandrola, MD, a Louisville, Ky.–based cardiologist who has written about the recent muzzling of frontline physicians with respect to the coronavirus, said he is not surprised that some hospitals are preventing physicians from sharing their experience

'Before C19, in many hospital systems, there was a culture of fear amongst employed clinicians,' he said. 'Employed clinicians see other employed physicians being terminated for speaking frankly about problems. It takes scant few of these cases to create a culture of silence.'


We have been posting about problems with management and governance in health care for a long time.  Some of these problems seem to be grossly manifest in cases in which whistleblowers were threatened or punished to inspire silence, and may explain why the practice continues even in a time of pandemic.

Managerialism

In some cases above, the executives threatening to silence health care professionals were themselves not health care professionals, and seemed to have no direct medical, health care, or public health care experience. In two cases, executives in charge of  communications or marketing intimidated professionals to secure their silence. This implicates managerialism as a source of the problem.

Per an article from the June, 2015 issue of the Medical Journal of Australia (look here):
- businesses of all types are now largely run by generic managers, trained in management but not necessarily knowledgeable about the details of the particular firm's business
- this change was motivated by neoliberalism (also known as economism or market fundamentalism)
- managerialism now affects all kinds of organizations, including health care, educational and scientific organizations
- managerialism makes short-term revenue the first priority of all organizations
- managerialism undermines the health care mission and the values of health care professionals

Such generic managers, who have sworn no oaths to put patient care ahead of all other concerns, may have few qualms about silencing whistle-blowers to protect their organizations' and their own reputations. 

Putting Revenue Ahead of Patients' and Health Care Professionals' Safety

In several cases, hospital management seemed more concerned about loss of patients and revenue resulting from degradation of their hospitals' brand identity or reputation than about patients' and professionals' safety.

As noted above, managers of hospitals are increasingly from business, not health care backgrounds.  Whatever their background, they seem more likely to be influenced by currently fashionable management dogma.  A dominant dogma in management is that pursuit of shareholder value comes before all else.  Even though many, but not all hospitals are still ostensibly non-profit, many hospital managers have likely been influenced by this dogma.  As we posted here, quoting Lazonick:

in 1983, two financial economists, Eugene Fama of the University of Chicago and Michael Jensen of the University of Rochester, co-authored two articles in the Journal of Law and Economics which extolled corporate honchos who focused on 'maximizing shareholder value' — by which they meant using corporate resources to boost stock prices, however short the time-frame. In 1985 Jensen landed a higher profile pulpit at Harvard Business School. Soon, shareholder-value ideology became the mantra of thousands of MBA students who were unleashed in the corporate world.

Lazonick added:

When the shareholder-value mantra becomes the main focus, executives concentrate on avoiding taxes for the sake of higher profits, and they don’t think twice about permanently axing workers. They increase distributions of corporate cash to shareholders in the forms of dividends and, even more prominently, stock buybacks. When a corporation becomes financialized, the top executives no longer concern themselves with investing in the productive capabilities of employees, the foundation for rising living standards for all. They become focused instead on generating financial profits
So many hospital managers may have no qualms about punishing whistle-blowers to protect their organizations' revenues.


What Needs to Be Done?

In the short run, we must do all we can to protect health care professional whistleblowers, as suggested by the Whistleblower International Network above.

In the long run, hopefully assuming there is one, we further need to address the systemic features of our dysfunctional health care system that enabled the rise of leaders who are happy to silence health care professionals to preserve their organizations' reputations and revenue, no matter what.  We need leaders who put patient's and the public's health ahead of all else, and who understand and uphold health care professionals' values.  We need hospitals, hospital systems, and other organizations that provide direct patient care that are not responsible for producing profits for their owners or shareholders.

Wednesday, September 02, 2015

Northwestern Upholds its "Brand," Never Mind Free Speech and Academic Freedom

Threats to free speech and academic freedom in health care were a major concern when we started Health Care Renewal.  Such threats may now be less anechoic, but do not seem to have diminished.

Censorship and the Resignation of Alice Dreger

The latest example was at Northwestern University. The basics of the case appeared in the Chronicle of Higher Education. Alice Dreger just resigned her position of 10 years as "a clinical professor of medical humanities and bioethics."

What prompted her departure was the fallout over an article by William Peace, who at the time was a visiting professor in the humanities at Syracuse University. Mr. Peace wrote an essay for an issue of the journal, Atrium, that Ms. Dreger guest-edited. The essay is a frank account of a nurse who helped Mr. Peace regain his sexual function after he was paralyzed.

According to Ms. Dreger, Eric G. Neilson, vice president for medical affairs and dean of the university’s school of medicine, tried to censor the essay. The essay is straightforward in its description of sex, and includes multiple mentions of 'the dick police,' but the purpose is to illuminate what went on in the era prior to disability rights and studies.

As Mr. Peace writes, the unconventional approach of the unnamed nurse 'injected a compassionate eroticism that made me a better man.'

In her letter, Ms. Dreger writes that the university allowed the essay to be published online only after she and Mr. Peace threatened to talk publicly about what they saw as censorship. She writes that she was 'disgusted that the fear of bad publicity was apparently the only thing that could move this institution to stop censorship.'

Now the essay is out there, for all to see, 'dick police' and all. So what does Ms. Dreger want?

She asked the university to acknowledge that attempting to remove portions of the essay was a mistake and to promise not to do so in the future. 'They never acknowledged that the censorship was real,' Ms. Dreger said in an interview. 'I wanted a concrete acknowledgment and assurance that my work would not be subject to monitoring.' That, she said, would have been enough for her to remain.

The idea that institutions must acknowledge wrongdoing is central to Ms. Dreger's academic work.

More details about university managers' alleged attempts to control the content of an academic journal emerged in an article in the local newspaper, that is, the Chicago Tribune.  The managers wanted to appoint their own oversight committee to control journal content.

The journal Atrium stopped publication after faculty objected to the new oversight committee, which [University spokesman Alan] Cubbage has described as 'an editorial board of faculty members and others, as is customary for academic journals.'

Note, however,  that editorial boards are usually appointed by journal editors, not managers or executives.

Also, as noted in an article in Inside Higher Ed,

Dreger, who guest-edited the 'Bad Girls' issue [in which the controversial article first appeared], said that soon after publication, medical school administrators asked Atrium’s editors to remove the essay from the web, because the content was considered inflammatory and too damaging to the new Northwestern Medicine 'brand.' (Northwestern Memorial Health Care recently acquired Northwestern’s Feinberg School of Medicine faculty practice and merged with Cadence Health to operate under the Northwestern Medicine banner.) The editor, another faculty member, refused to single out one article for censorship and took down the journal’s web archive instead.

Furthermore, the university administration's reaction to the publication of the article prompted another resignation,

The controversy prompted the resignation of Kristi Kirschner, a former clinical professor humanities and bioethics at Feinberg, in 2014. Kirschner, now an adjunct professor of disability and human development at the University of Illinois at Chicago, told Inside Higher Ed earlier this summer that the alleged censorship had a 'chilling effect, antithetical to the idea of the university.'

As for that "chilling effect,"

A university spokesman declined to comment on Dreger’s case on Tuesday, saying it was a personnel issue. He also declined to answer general questions about censorship or the status of Atrium, which recently had its funding reduced, causing the journal to be canceled.

Atrium’s editor, Katie Watson, an assistant professor of bioethics and medical humanities, declined an interview but said the funding cut was not related to the 'Bad Girls' issue or censorship.

She referred additional questions to a post she wrote for Peace’s blog, Bad Cripple, in June, in which she said that she was disappointed with Peace for taking certain details of the case public, and in which she confirmed that a university content oversight committee meeting had been 'disheartening.'

"[T]he medical school required me to allow a vetting committee to review my editorial choices and veto them if they were perceived to conflict with other institutional interests," Watson wrote.

So note that the allegations of censorship have come from at least three separate faculty members at Northwestern, and from the author of the censored article, a faculty member at another institution.  Furthermore, on university spokesperson has contradicted these charges.  

Previous Mysterious Events at Northwestern

Of further concern is that this case may be part of a pattern.

Two years ago we wrote (here and here) about another case, albeit mysterious and convoluted, at Northwestern in which a faculty member, Dr Charles Bennett, resigned after being accused of mismanaging the finances of a government grant.  However, although he was responsible for the scientific management of the project, university managers, nor Dr Bennet, were responsible for its finances.  While the university settled allegations of financial mismanagement, and a university staffer pleaded guilty to related charges, a university statement implied that it was mainly Dr Bennett's fault, per the Cancer Letter

'As the settlement makes clear, the covered conduct in the settlement involved allegations focused on Dr. Charles Bennett, and grants for which Dr. Bennett was the principal investigator,' Northwestern officials said in a statement.

In addition,

The statement was signed by Northwestern President Morton Schapiro, Provost Daniel Linzer, and Vice President for Medical Affairs and Dean of the Feinberg School of Medicine Eric Neilson.

Note that the Vice President and Dean Neilsen above was the same Dean who Prof Dreger accused of trying to censor her journal.

Suspicions were raised at that time that the treatment of Dr Bennett might have been somehow related to how he made himself unpopular by authoring research that suggested Aranesp, a blockbuster Amgen epoetin drug, was much more dangerous than it seemed.  The Cancer Letter had interviewed one of Dr Bennett's collaborators,

[Michael]  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.'

And recently the editor of the Cancer Letter, and the author of the above article, has been fighting subpeonas from Amgen intended to make him reveal his sources of negative information about Aranesp, (look here and here).

As far as I can tell, the questions I raised about the case of Dr Bennett (look here and here) have never been answered.

Nonetheless, the case of Prof Dreger has also been rather anechoic.  It was also covered by the Times of London Higher Education Supplement, and inspired comment from FIRE, but has otherwise not gotten national media attention, or any apparent coverage in medical or health care journals.  

Sometimes you may be paranoid, and sometimes someone may be out to get you.
Summary and Comments

So, to summarize, multiple sources suggested that top Northwestern Medicine leadership attempted to censor an academic publication edited and led by university faculty.  After publication of an article apparently controversial for its sexual content, but which likely also brought up valid issues about compassionate treatment of disabled patients versus traditional ethical concerns about boundary issues for health professionals, university leaders imposed an oversight committee which apparently was more concerned about the instiution's "brand" and other "institutional interests" than about free discussion of important health care issues.  The chilling effects of this attempt at censorship seemed to include resignations by two faculty members, and the demise of the journal.

Thus it appears that the managers were putting public relations and revenue concerns ahead of the fundamental academic values of free speech and academic freedom, thereby threatening these values.  In a post on Bioethics.net, Craig Klugman reminded us,

 According to the American Association of University Professors (1940):
'Academic freedom is essential to these purposes [the search for truth and its free exposition] and applies to both teaching and research. Freedom in research is fundamental to the advancement of truth.'

Cary Nelson, president of the AAUP and an English professor says that academic freedom:
'Gives both students and faculty the right to express their views — in speech, writing, and through electronic communication, both on and off campus — without fear of sanction, unless the manner of expression substantially impairs the rights of others or, in the case of faculty members, those views demonstrate that they are professionally ignorant, incompetent, or dishonest with regard to their discipline or fields of expertise.'

Even the American Society for Bioethics & Humanities, which is known for not taking positions on 'substantive moral and policy issues,' does take positions to support academic freedom and has done so in the past.

Since 1940, the notion of academic freedom has been a core tenet of university and faculty life. The idea was born in response to centralized governments telling researchers what they could and could not study and what they should and should not teach.


So free expression and academic freedom remain under threat in academic health care institutions. These threats seem in part to stem from managers' continuing inclinations to put commercial concerns ahead of the academic mission, perhaps fueled by prodigious amounts of money waved around by health care corporations looking to make their marketing appear more scientifically based.  These threats may be partially enabled by the anechoic effect, a sort of second order self censorship, so that cases of censorship are another kind of recent unpleasantness that get little public attention.

Students, health care professsionals, and faculty members who care about medical education and research ought to be asking some hard questions about the leadership of their organizations.  It looks like Northwestern students, trainees, and faculty members could have lots of questions to ask.

As we have said until blue in the face, true health care reform would enable leadership of health care organizations that upholds and is willing to be accountable for putting patients' and the public's health first, and leadership of health care academic organizations that also puts honest, transparent research and education ahead of commercial interests.   

Tuesday, August 20, 2013

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 

Monday, August 05, 2013

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.

Friday, December 10, 2010

On the Interconnectedness of the Leadership of Health Care Organizations: the Abbott Laboratories Case

We just posted about some misbehavior by Abbott Laboratories: a physician Abbott paid as a "key opinion leader" to help market its cardiac stents was accused of inserting stents in many patients who had no need for them; Abbott settled for over $400 million a lawsuit alleging the company defrauded Medicare and Medicaid; and it settled an unrelated suit for over $40 million alleging the company paid kickbacks to physicians for prescribing its drugs.  I thus thought it would be interesting to see how well paid are the corporate leaders who presided over these activities, and who are the board members who were supposed to be providing stewardship of this company.

According to the company's 2010 proxy statement, the five highest-paid executives were:

Miles D White, Chairman of the Board and CEO - $26,213,966 total compensation
Thomans C Freyman, Executive Vice President, Finance, and CFO - $9,561,227
Olivier Bohuon, Executive Vice President, Abbott Pharmaceutica Group - $5,232,589
Laura J Schumacher, Executive Vice President, General Counsel, and Secretary - $5,724,060
James V Mazzo, Senior Vice President, Abbott Medical Optics - $10,394,085

Now, let us turn to the company's board of directors.  Note that I looked for board members who also held leadership positions in other health care organizations whose interests may not be aligned with the corporation.  I also looked for those who held leadership positions in the discredited financial services corporation who helped usher in the global financial collapse.  (I  used similar methodolgy here.)

Abbott currently has 12 board members, including
  • Robert J Alpert MD - Ensign Professor of Medicine, Professor of Internal Medicine, and Dean of the Yale School of Medicine.  He also "serves as a Director on the Board of Yale-New Haven Hospital."
  • Roxanne S Austin - President and Chief Executive Officer, Move Networks Inc, and President, Austin Investment Advisors
  • William M Daley -"Vice Chairman and Head of the Office of Corporate Responsibility and Chairman of the Midwest, JP Morgan Chase & Co."  He is the board of directors of  "Loyola University of Chicago and Northwestern University."
  • W James Farrell - Retired Chairman and Chief Executive Officer of Illinois Tool Works Inc
  • H Laurence Fuller - Retired Co-Chairman of BP Amoco, former chief executive officer of Amoco
  • William A Osborne - Retired Chairman and Chief Executive Officer of Northern Trust Corporation and the Northern Trust Company.  He is "Chairman of the Board of Trustees of Northwestern University."
  • Rt Honorable Lord Owen - Chairman of Europe Steel Ltd
  • Roy S Roberts - Managing Director, Reliant Equity Investors.
  • Samuel C Scott III - Retired Chairman,  President and Chief Executive Officer of Corn Products International.  He "currently serves on the board of directors of Bank of New York Mellon Corporation."  He also is on the board of "Northwestern Healthcare."
  • William D Smithburg - Retired Chairman, President and Chief Executive Officer of Quaker Oats Company.  He is on the "board of trustees of Northwestern University."
  • Glenn F Tilton - Chairman, President and Chief Executive Officer of UAL Corporation and United Airlines Inc.  He is on the "board of directors of Northwestern Memorial Hospital."
  • Miles D White - Chairman of the Board and Chief Executive Officer, Abbott Laboratories, "is on the board of trustees of "Northwestern University." 

Of Abbott's 12 directors, seven have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities (Northwestern University, its medical school and teaching hospitals, in particular, are stewarded by six Abbott directors). 

Two have leadership positions in  financial services corporations that were implicated in the global financial collapse.  (Note that JP Morgan Chase staffers helped to invent some of the kinds of financial derivatives widely viewed as causative of the collapse, but the firm itself did not fail. [See Tett G. Fool's Gold.]  Through TARP, the US government took preferred equity stakes in both JP Morgan Chase and Bank of New York Mellon.  [See Ritholtz B.  Bailout Nation. p. 222]) 

Two more are leaders of financial services firms.  All but one are current or former high-level hired executives (seven are or were CEOs), or chairpersons or co-chair persons of corporations (the one exception is a dean of a medical school.) 

Note how similar our findings were here to those found after our perusal of the boards of Genzyme and Medtronic (see post here).   So we find again that executives of health care organizations who preside over various questionable activities not only rarely pay any penalty, but usually become extremely wealthy in the process.

We also find how interconnected is the leadership of health care.  The boards and leadership of drug and device companies overlap with the boards and leadership of medical schools, teaching hospitals, and their parent universities. 

Yet, as we have noted before, there are obvious conflicts.  In particular, teaching hospitals and medical schools are supposed to provide unbiased teaching, including about issues relevant to drug and device corporations, such as choice of diagnostic strategies and treatments, and relevant health policy.  They are supposed to perform unbiased research, including research that evaluates drugs and devices.  They are supposed to provide the best possible patient care at a reasonable cost, which relates to choices of and prices paid for drugs and devices. 

On the other hand, drug and device companies are supposed to put making a profit for their share-holders first.  The directors of such companies, like the directors of all for-profit corporations, are supposed to show an unyielding loyalty to their companies' financial health and profits, although contemporary corporate directors have been accused of acting more like cronies of the hired management.  (See this post.)

Also, we note that the vast majority of people chosen as stewards of a given health care organization are current or former top hired executives of other corporations.  The board members, that is, stewards of health care organizations, to whom the top hired executives reports, are usually not people with large ownership interests in the organizations (in the case of public, for-profit corporations.)  For the most part, they also do not seem to be people with clearly demonstrated devotion to the values of health care, in particular, putting the care of individual patients first, and advancing health care teaching and research.  Instead, they seem to be people with the perspective of hired executives, who may be prone to putting the interests of hired executives, rather than patients, doctors, teachers, scientists or the public at large, first.

So here is another admittedly limited case study of the board of directors, that is, the ostensible stewards of a health care corporation, selected this time because of its history of ethical missteps, which showed  - that the leadership of health care organizations is incredibly interrelated, interlocked, incestuous.  Again, it appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.

So to repeat-

I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Monday, July 17, 2006

How Hospital CEOs Get Paid Tens of Thousands to Advise Hospital Suppliers

The New York Times just reported on the activities of an organization called the Healthcare Research and Development Institute (HRDI).

Despite its name, HRDI is a "for-profit company owned by about three dozen hospital executives, but underwritten by 40 or so of its handpicked corporate members, all suppliers to hospitals." These "executives benefit from payments made by companies their hospitals do business with." HRDI industry members are limited to "only two competing companies in any specific field."

The purpose of the organization is apparently to give hospital suppliers access to the CEOs of large not-for-profit hospitals. "Last May, more than 130 representatives from 40 health care companies were scheduled to attend confidential consulting sessions at the Broadmoor, a Colorado Springs hotel. When not attending the sessions, hospital chief executives and suppliers mingled at company-sponsored tennis, golf and social events. Each year, H.R.D.I. holds two gatherings like the one in Colorado, where each corporate member gets a meeting of up to three hours with five or six chief executives, according to [HRDI CEO]Mr. Mecklenburg." "'The typical organization is paying $40,000,' Mr. Mecklenberg said. 'It can be more, but that would not be typical.' Additional access to hospital executives and their institutions can cost companies $55,000 a year or even more. For example, a special two- to three-day visit to a specific hospital costs $2,000 a person, according to H.R.D.I., which says most of that money is eventually passed on to the hospital."

"It is unclear exactly how much hospital executives, who are the shareholders of the healthcare institute, earn annually for consulting at the two conferences. Asked to verify a report that some members earned as much as $50,000, Mr. Mecklenberg initially denied it. 'Our observation and recollection is $20,000 to $30,000 a year,' he said. 'It may be more than that but we don’t have data in front of us, but it’s certainly not $50,000.'

Mr Mecklenberg himself has an interesting history. He is "a former chairman of the American Hospital Association, the industry’s largest trade group." Furthermore, now he "not only runs a large nonprofit hospital, Northwestern Memorial in Chicago, but he also serves on the board of Becton, Dickinson and Company, a major supplier of medical devices to hospitals around the world, including his own. Becton, Dickinson pays the institute for marketing advice, and the institute pays Mr. Mecklenburg $50,000 a year, mostly for participating in two national conferences, according to the group."

HRDI is now under the scrutiny of Connecticut Attorney General Richard Blumenthal, who "is investigating whether the organization allows certain vendors to buy access to hospital leaders who are in a position to influence what supplies or services their institutions purchase. As a result, Mr. Blumenthal said, hospitals may not be getting the best deals, either in terms of cost or quality. 'At the very least it suggests insider dealings — an insidious, incestuous, insider system,' said Mr. Blumenthal...." He is also investigating whether the limitation on HRDI membership to only two companies from each sector violates anti-trust regulations. Mr Blumenthal recently testified that HRDI is a "secretive" network of "ethically questionable business arrangements." Note that until recently, the organization did not allow public access to its web-site, and did not list its members, although its current membership list and list of corporate sponsors are currently on the web.

The Times' investigative reporting has opened yet another window on the pervasive web of conflicts of interest that entangles health care. The report reveals problems at multiple levels:
  • Hired leadership of not-for-profit hospitals seem to be personally profiting from their positions of trust
  • Hospital leaders not only have cozy relationships with at least some suppliers, but are paid handsomely by these same suppliers for their supposed market advice, raising questions about how effectively their hospitals will negotiate with these suppliers
  • The leader of the organization that makes these cozy relationships possible is simultaneously a not-for-profit hospital CEO and a member of the board of directors to a major hospital supplier, and hence has a fiduciary duty to that organization that seemingly clashes with his duty to his main employer
You just can't make this stuff up.
And people wonder why health care is so expensive? And think that the only solution to the rising cost of health care is to keep cutting physicians' fees for "cognitive services?" (See post here.)
Note that the well-publicized article by Brennan et al that castigated physicians for accepting so much as a coffee mug with a company logo from a drug or device company would have put academic medical center administrators in charge of enforcement of this stringent policy, the same administrators who may personally get paid tens of thousands of dollars to sit give market advice to the companies whose logos are on the coffee mugs. LOL. (See post here.)
Instead, as we have said before, there needs to be a broad, impartially enforced policy that bans major conflicts of interest affecting all decision makers in health care.
And we need some of leaders of large health care organizations, not just pharma and device companies, but also managed care organizations and insurance companies, hospitals, academic medical centers and health care systems, and medical schools and universities, to to look in the mirror to see who has been dodging responsibility for rising costs, declining access, stagnant quality, and demoralized providers.