Round and Round It Goes - Former US Secretary of Health and Human Services Joins Humacyte Board

anechoic effect conflicts of interest corporatism DHHS revolving doors

Round and Round It Goes - Former US Secretary of Health and Human Services Joins Humacyte Board

Unknown 9/04/2015 Komentar

The latest example of the health care revolving door was made barely public just before the US Labor Day holiday.  Per the Triangle Business Journal,

Humacyte Inc., a biotechnology company based in Research Triangle Park, has beefed up its board of directors by adding former U.S. Secretary of Health and Human Services Kathleen Sebelius and life sciences industry veteran Dale Sander.

The 11-year-old Humacyte develops novel human tissue-based investigational products that are being developed for potential commercialization for applications in regenerative medicine and vascular surgery. Sebelius adds a significant amount of heft to the company’s now eight-person board.

From 2009 to 2014, she served as the 21st Secretary of the HHS, leading the effort to pass and implement the Affordable Care Act. She’s also been named by Forbes as one of the 100 most powerful women in the world.

Prior to serving as secretary of HHS, Sebelius served as governor of Kansas, two terms as the Kansas insurance commissioner and four terms in the Kansas legislature.

'Secretary Sebelius is undoubtedly one of the most distinguished health care industry leaders of our time and we are honored to have her join our organization,' said Carrie Cox, chair and chief executive officer of Humacyte, in a statement. 'Her tenure in the public sector, and deep understanding of the rigors of the regulatory process and policy will provide unique perspective and insight to support our goals to improve care for Humacyte’s first application for patients with End Stage Renal Disease.'

Comments

I will just raise a tired, ironic eyebrow in response to a lawyer, politician, and government leader with no direct biomedical or health care training or experience, and no apparent health care industry experience being called a "distinguished health care industry leader."

The big issue here is, of course, the revolving door.

It now seems that any randomly selected top US government official who has responsibilities directly related to health care could turn out to be a past or future health care corporate lobbyist, consultant, board member, or executive.  The revolving door is now well established between the US government and the country's huge and growing corporate health care sector.  Recent (2015) examples include:
-  a former Director of the Center for Medicare and Medicaid Services who was a Columbia/ HCA executive and who became the CEO of America's Health Insurance Plans (a trade and lobbying group) (look here)
-  various officials involved trade agreements (that heavily affect health care) who came from or went to industry (look here).
-  some US Food and Drug Administration officials who were involved in the lax regulation of amphetamines in "natural" products who came from or went to the "natural" supplements industry (look here).
- Etc, etc, etc

But the latest example is a big one, since it involves the top US health care official, the Secretary of the DHHS.

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

This is at best crony capitalism, and makes a mockery of that famous sentence in President Lincoln's Gettysburg Address:

government of the people, by the people, for the people, shall not perish from the earth.

The revolving door is clearly a kind of conflict of interest.  Government officials who can look forward to extremely lucrative employment in health care industry (regardless of their actual experience in health care or the health care industry) may be much more inclined to seem friendly to the industry while in office.  Government officials who just came from industry are likely to maintain their industry mindset and be mindful of their industry friends.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Finally, the revolving door on its currently massive scale starts to look like corporatism (or corpocracy), "the organization of society by major interest groups."  One variant of corporatism prominent in the last century was fascism (on the model of Mussolini in Italy).  Of course, many of us in the US ought to see corporatism as antithetical to how our government and society is supposed to function - supposed to function.

Thus, the revolving door in health care seems like it ought to bear scrutiny.    Yet most examples of the revolving door are very anechoic, being noted mainly in the business media, and usually barely there.  I have seen almost no notice of it in the health care, health policy, or medical literature.  (For example, so far Ms Sebelius' new job has appeared in a corporate press release and a single article in a local business newspaper, as far as I can tell.)

So once more with feeling...  The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large

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

academic freedom anechoic effect bioethics censorship free speech mission-hostile management Northwestern University

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

Unknown 9/03/2015 Komentar

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.   

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You Can Check Out Any Time You Like, But You Can Never Leave - Duke and UNC Allegedly Agreed Not to Hire Each Other's Faculty

antitrust corporate physician Duke University economism market fundamentalism medical schools University of North Carolina

You Can Check Out Any Time You Like, But You Can Never Leave - Duke and UNC Allegedly Agreed Not to Hire Each Other's Faculty

Unknown 8/28/2015 Komentar

We have intermittently discussed the worsening plight of physicians trying to provide clinical care as employees of large organizations.  Such corporate physicians are likely to be squeezed between professional values that put the patient first, and management that puts revenue first.   Physicians employed by large corporations may find their values increasingly at risk as these organizations adapt the tactics of the robber barons.

Now it appears that even ostensibly genteel academic medical institutions may be adapting these tactics.

Allegations of Anti-Competitive Faculty Employment Practices at Duke and University of North Carolina Medical Schools


The story first appeared with little fanfare in the (Duke) Chronicle in June.  An assistant professor at the UNC School of Medicine was interested in a position, also at the assistant professor level, at nearby Duke.

[Dr Danielle] Seaman had been in email communication with UNC’s Chief of Cardiothoracic Imaging beginning in 2011, when she expressed interest in a radiology position at the UNC School of Medicine, and the chief of the division encouraged her to apply, the case file describes. In 2012, Seaman was invited to visit the campus and toured the radiology department at UNC.

However,

When Seaman expressed interest in the assistant professor position again in early 2015, however, the chief responded in an email by saying he had just received confirmation that 'lateral moves of faculty between Duke and UNC are not permitted' as per a 'guideline' set by the schools’ deans.

In a later email, the chief also described to Seaman the reason the agreement was created—Duke had tried several years ago to recruit the entire bone marrow transplant team from UNC, and UNC was forced to pay them a large retention package to keep them.

Both emails are included in the filing by Dr Seaman's lawyers.


Imagine the nerve of medical faculty thinking they should be paid more by the current employer because another institution was willling to recruit them and pay them that much.
 
An Agreement Comfortable for the Deans, but Disadvantageous for Their Faculty

An August article in the Chronicle suggested that the top leaders of the two medical schools felt that the "no-poaching" agreement was mutually beneficial. 

According to the case file, Seaman became aware of the policy earlier this year, but the UNC chief of cardiothoracic imaging—who is unnamed in the file—believed the policy had been in place for several years after Duke had previously tried to recruit the entire bone marrow transplant team from UNC.

'The general rule was that we didn’t recruit there and they didn’t recruit at Duke—it certainly was in the years I was in the administration,' said John Burness, former senior vice president for public affairs and government relations from 1991 to 2008. 'I don’t know if it’s ever been a formal agreement, but it’s certainly been a practice over a long period of time.'

Burness—now a visiting professor of the practice in the Sanford School of Public Policy—noted that he could not recall an instance in which a faculty member from UNC was recruited to Duke during Nannerl Keohane’s tenure as president of the University from 1993 to 2004. Keohane also confirmed that during her time as president the University avoided poaching of UNC faculty.

Also,

'The question of whether Duke and UNC [or N.C. State] should attempt to recruit faculty from the other campus was always somewhat delicate,' Keohane, now Laurance S. Rockefeller distinguished visiting professor of public affairs at Princeton University, wrote in an email.

The Chronicle found a Duke Law professor who provided a comfortable rationale for the agreement between the two schools,

Despite the case file’s claims that such a policy is detrimental to faculty from both schools, Clark Havighurst—a former professor in the Duke University School of Law who taught healthcare policy and antitrust law for more than 40 years—also believes that this agreement would be beneficial to both institutions in the long run.

'You’d probably find relatively few instances where Duke and Carolina have poached each other’s faculty,' Havighurst wrote in an email. 'This is probably a matter of mutual restraint as much as explicit agreement, however, as each school or department would hesitate to irritate the faculty at the neighboring institution, thus undermining collegial and personal relations that are undoubtedly beneficial to each.'


What the soothing words about mutual benefit and collegiality leave out is that while the school administrations benefit from less disruption, they also likely benefited by being able to pay their faculty, especially junior faculty less. As Dr Seaman argued in her filing, as per the June Chronicle article,

The suit—filed June 9 in the United States District Court for the Middle District of North Carolina—contends that the no-hire agreement had the “intended and actual effect” of suppressing competition and employee wages, therefore violating federal and state anti-trust laws.

An Aside, the Non-Poaching Agreement Defended by One of the Key Advocates for Market Fundamentalism in Medicine

As an aside, Professor Havinghurst turns out to be one of key architects of the transformation of the US health care from a regulated system emphasizing health care provided by individual professionals and small non-profit institutions to our current laissez faire commercialized system.  It is more than ironic that while Prof Havinghurst now scoffs at applying anti-trust law to alleged collusion by big employers, per M Gregg Bloche in the Stanford Law Review(1),

Since the mid- 1970s, market-oriented scholars have challenged a broad range of legal principles previously assumed to sustain the trustworthiness of physicians and health systems. Doctrines shielding physicians from antitrust law, insulating them from insurers' and hospitals' influence over clinical practice, and reinforcing the precept of undivided clinical loyalty to patients came under attack as protection for the medical profession at consumers' expense. These scholars, including Clark Havighurst, Richard Epstein, and Mark Hall, urge contractual ordering of clinical standards of care; relationships among physicians, hospitals, and health care payers; and physicians' conflicting obligations to patients, payers, and other third parties.

Again, Havinghurst appears to have been one of the principal, if not the principal advocate to use anti-trust law against small groups of physicians, and against the notion that physicians can promulgate their own codes of ethical conduct.  In an introduction to an article by Havinghurst in Health Affairs in 1983.(2)

For a decade or more, Clark Havighurst has been a philosophical thorn in the side of organized medicine, preaching a view of the health sphere that rejects decision making by professional self-regulation in favor of a system based on marketplace principles.

Note that in retrospect, this article seemed to stake out Health Affair's position as an important organ to promote market fundamentalism in health care. 

How convenient that Prof Havinghurst is still affiliated with Duke and in a position to defend his university's treatment of other faculty.


I urge you to scan Health Care Renewal to see how the change from professional self-regulation of ethics to the free rein of the laissez faire marketplace turned out. Look here for our first reporting on the late Dr Arnold Relman's discussion of how medicine was pressured to accept commercialization, and how that acceptance has since decimated our core values.  Look here for our discussion of the fallacy of the perfect market in health care.  Look here for a rebuttal from an authority we do  not often quote of the concept of health care as a commodity versus a calling. 

Summary

Note that the outcome of the lawsuit against Duke and UNC is unknown.  The allegations it makes are not proven.  However, I chose to discuss it because the evidence, particularly the emails reproduced in the court filing, seems pretty strong that the two schools did have an actual agreement not to compete in the hiring of faculty, and the argument that his suppressed faculty wages and opportunity is prety strong and obvious.

Academic physicians, particularly at elite institutions, may feel they are in a rarefied atmosphere separate from the hurley burley or everyday health care.  They may feel they are protected from, and can even ignore the health care dysfunction we discuss on Health Care Renewal.  They certainly may not think of themselves as "wage slaves" from the era of trusts, monopolies, and robber barons.

But this case exhibits that academic medical institutions are getting closer to the ruthless world of poorly regulated, commercialized, market fundamentalist health care.  Talk about collegiality is nice, but it seems pretty clear that the "non-poaching" agreement between Duke and UNC may have reflected collegiality among top medical school leadership, but limited their faculty salaries and individual faculty members' choices and opportunities.  This seems like another example, however soft spoken and genteel, of the leaders of health care organizations putting the interests of their own ingroup ahead of the interests of the larger organizations and the mission they are supposed to serve.

It is time for even academic physicians to realize that they are not protected from the troubles of the larger world.  If they truly believe in their professional values, if they really care about patients' and the public's health, and about medical and health care science and education, they will have to start speaking up, or they will end up wage slaves of the new health care robber barons along with nearly everyone else.   

To lighten things up at the end, the Eagles doing Hotel California live in 1977 -



"We are all prisoners here, of our own device"

References
1.  Bloche MG. Trust and betrayal in the medical marketplace.  Stanford Law Review 2002; 55: 919-954.  Link here.
2.  Havinghurst C. The doctors' trust.  self-regulation and the law.  Health Affairs 1983; 2: 64-76.  Link here.

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The Real Dark Side of Health Care: Health Care Corruption

anechoic effect Annals of Internal Medicine health care corruption medical journals professionalism

The Real Dark Side of Health Care: Health Care Corruption

Unknown 8/26/2015 Komentar

The editors of the prestigious Annals of Internal Medicine just stated they they were shocked, shocked to find out that physicians occasionally express disrespect for patients when the patients cannot hear or see them.  The occasion was an editorial signed by three editors whose title included the phrase, "shining a light on the dark side of health care."(1)  The editorial referred to an anonymous narrative that recounted two incidents from the past.(2)

Two Alleged Incidents of Physicians' Expression of Disrespect for Patients

The first incident, discussed second hand, was of a obstetrician who made a sexist comment about a patient, who was under anesthesia, presumably unconscious, and being prepared for surgery.  The second incident, presumably less recent, was of an obstetric/gynceology resident who, after performing an emergency procedure that saved a woman from potentially fatal acute hemmorhage, performed an impromptu dance routine that appeared to disrespect the patient's ethnicity, until stopped by the anesthesiologist who issued a profance rebuke.

The names of the people involved, the hospitals in which these incidents occurred, and even the years when they happened are unknown.  The Annals did not publish anything suggested their veracity was corroborated.

There was no apparent harm to or direct effect on any patient as a result of either incident.  Of course, both alleged incidents suggested very disrespectful expression by the two physicians.  Their actions appeared unprofessional.

The Editorial Reaction

As noted above, the editorial called the incidents examples of medicine's "dark side."  It further said they may make "readers' stomachs churn," referred to "medicine's dark underbelly," and "repugnant behavior," and characterized the narrative as "disgusting and scandalous," and having the potential to "damage the profession's reputation."  The editorial characterized the the behavior of the obstetrician in the first incident as "highly disrespectful," and said it "reeked of misogyny and disrespect," while the second "reeked of all that plus heavy overtones of sexual assault and racism." 

That is certainly extreme language.  The editors appeared shocked, shocked that any physician could ever express disrespect for a patient, even when the patient could not possible be aware of that.  Nonetheless, of course, the behavior alleged to have occurred was certainly inappropriate and unprofesional, and cannot be condoned.

The Media Reaction

The two articles got considerable publicity, and media coverage also made the incidents out to be extremely sordid, using words like,"disturbing," "astonishing," "unsavory," (albeit also "boorish,") (LA Times); "criminal," "vulgarity," (MedPage Today); "appalling," "troubling," (NY Times); and  "misogynistic," "abhorrent," (US News and World Report).  I must note that some of the news coverage did reflect doubts that the two Annals of Internal Medicine articles represented some horrendous catastrophe, raising issues such as the humanness of doctors, so that some may be "prone to sociopathy and criminality;" the stress of some medical emergencies leading to letting off steam, or poor attempts at humor; and doubts about the representativeness and validity of the two alleged anecdotes.

Nonetheless, it seemed to me that the Annals articles and the media coverage did suggest an impending crisis due to the sordid behavior of perhaps numerous doctors, and at least the tone of the media coverage they provoked suggested the need for immediate action.

Was the Outrage Justified?

However, first keep in mind that these two incidents involved two individual doctors, one a trainee.  There are approximately 800,000 physicians in the US.  They are human.  Is it any surprise that some are "bad apples," and that others occasionally behave badly?  There is nothing in the two articles to suggest that these incidents reflected more organized, systemic actions.

Furthermore, the articles seemed to ignore the fact that mechanisms, perhaps not flawless, are already in place to address unprofessional behavior by physicians, even if no one involved in the published narrative may have used them.  In the US, physicians are subject to discipline from state licensing boards.  They may be reported to those boards for unprofessional behavior.  The boards can sanction physicians in a variety of ways, up to and including permanent loss of license.  Both alleged incidents apparently occurred in teaching hospitals.  Attendings and residents at teaching hospital must answer to department chairs, medical school deans and hospital staffs.  So mechanisms for policing such behavior exist, even if they may have not been used in this case.  A look at state medical board websites reveals that that physicians are often sanctioned for bad behavior that disrespects or even endangers patients. 

Finally, the Annals of Internal Medicine used very strong language, involving churning stomachs, reeks of misogyny, sexual assault, and racism, dark underbellies, etc.  Was this a proportionate response to two anonymous cases that did not involve allegations of direct patient harm?

The Real Dark Side

Readers of Health Care Renewal know that we often discuss systemic problems in health care, often involving the leadership of large health care organizations, that may produce real harms to patients' and the public's health, but for which no good policing mechanisms seem to exist.  Worse, these problems seem to be a taboo topic in health care policy discussions, and in medical journals, like the Annals of Internal Medicine.

In my humble opinion, the Annals' editorial outrage would ring less hollowly if it was accompanied by even greater outrage at such more extreme problems. 

Let me start with a recent example.

Example: the Anechoic AllTrials US Launch

Very recently we discussed how the launch of new US AllTrials initiative got almost no notice.  Specifically, even though a sponsor of the initiative is the American College of Physicians, that organization's publication, the Annals of Internal Medicine, did not comment on it.  (A search of the journal using the term AllTrials produced no results.)

However, the AllTrials initiative means to tackle the problem of suppressed clinical research.  We have long discussed how research may be systematically suppressed when its results do not please its commercial sponsors.  Particularly, trials of drugs or devices that do not produce favorable results may be suppressed by their sponsors, usually the companies that make the drugs or devices.  Such suppression breaks trust with and therefore hugely disrespects the patients who volunteered to participate in the trials, who believed they were contributing to science and public health.  Suppressing data that drugs and devices may be ineffective and harmful may endanger patients by letting them be treated by such drugs and devices in the illusory belief that they are safe.  Yet where is the outrage about such dishonest behavior by large and powerful health care organizations that disrespects, and more importantly, endangers patients?

Health Care Corruption

When a pharmaceutical, biotechnology, or device company withholds results of a clinical trial to makes its product look better and enhance its revenue, that is an example of health care corruption.

Transparency International defines corruption as

Abuse of entrusted power for private gain

When health care corporations run clinical trials, we entrust them to do honest research and be worthy of the trust of their research subjects.  Withholding the results to enhance revenue is therefore abuse of that entrusted power for private gain.

Health Care Corruption as a Taboo Topic

This blog focuses on the US, and we  now have in our archives some amazing stories that document various forms of health care corruption in the US, including numerous allegations of misbehavior by large health care organizations ending in legal settlements, and examples of outright fraud, bribery, kickbacks and other crimes.  Some large and profitable health care corporations have made numerous such settlements over recent years.  (For example, see the track record to date of Pfizer Inc here and that of Johnson and Johnson here.)

Much of this bad behavior was meant to sell drugs, devices, or clinical services, often in situations in which their benefits did not outweigh their harms.  For example, we just discussed the latest settlement by Amgen of allegations that it promoted an epoetin (Aranesp) "off-label" for cancer patients not on chemotherapy.  Such "misbranding" was not merely a technical violation, since it has been shown that use of the drug in this situation increases mortality.   Such bad behavior thus likely harmed numerous patients.

Furthermore, efforts to police these kinds of corruption have been weak and scattered.  Most cases have ended with legal settlements that at most involve fines to corporations, yet the fines are rarely big enough to significantly affect their overall revenues.  While the corporations themselves may be thus punished, the people who actually authorized, directed or implemented the bad behavior are usually unscathed.  So as we have discussed frequently, such attempts at justice are unlikely to deter future bad behavior.

In fact, people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, the Transparency International Global Corruption Report focused on health care corruption, and asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  It also noted how diverse is health care corruption:

In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.

It further stated how serious the consequences of corruption may be for patients and public health:

Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly....

The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services.

Corruption affects health policy and spending priorities.

Occasionally, something is published about health care corruption in the US in the medical literature.

- In 2009, qualitative interviews by Pololi et al in the Journal of General Internal Medicine produced many striking anecdotes suggesting corruption in US academic medicine. Four of the interviews were with faculty whose leaders allegedly used deception for personal and professional gain (i.e., “a situation of major unethical use of funding,” “fraudulently creating data for a research project,” “we’re lying to the people who are doing our school evaluations, we’re putting things on paper that we do that we don’t do,” “that’s what I think he felt he had to do—hide money, lie about money, or at least cook the books a little bit.”)(4)  These results produced few echoes, particularly not any strident editorials about the need to address corruption.
- In 2011, an article in the Lancet suggested that "there is more corruption in the G8 countries than in the whole of Africa," but for any health care professional to acknowledge that would be "professional suicide" (see this post).(3)
- Finally, in 2013, a Transparency International survey showed that 43% of Americans believe their health care system is corrupt.  Yet this received no media attention, and to my knowledge has never been mentioned in a major US medical journal.  (Look here.)

So health care corruption remains a largely taboo topic.  (On Health Care Renewal, we call corruption "anechoic," since evidence of health care corruption produces few echoes.) 

The Annals of Internal Medicine, like most major medical journals, has long avoided discussion of health care corruption, and how systemic corruption harms patients' and the public's health.

Of course, the unwillingness to discuss global health care corruption, health care corruption in the US, and the relationship of health care corruption in the US to corruption in other sectors may arise from the fear, as stated by one person interviewed in Charles Ferguson's documentary Inside Job, that discussion could lead to investigation, and investigation could "find the culprits".

Summary

It is perfectly fitting and proper for the Annals of Internal Medicine to call attention to various kinds of unprofessional behavior by physicians and health care professionals, such as sexist, disrespectful expression, even if such behavior is already subject to sanctions by medical boards, accrediting organizations, etc. In my humble opinion, however, if such disrespectful comments by physicians should generate outrage, corrupt behavior by large health care organizations that may harm patients and the public health, and which often goes largely unchallenged by civil authorities, should deserve more outrage.

Of course, it is one thing to criticize individual physicians, and ask physicians to "call out our colleagues" who behave unacceptably.

It is another to call out large, powerful, wealthy organizations and the executives who have become rich running them.  Such executives command well funded marketing and public relations departments, and corps of attorneys ready to take on perceived critics.

But if we really want better health care and public health, we all have to step up.  In particular, I urge the editors of the Annals of Internal Medicine, and other major health and medical journals to take on health care corruption as vigorously as they would take on physicians' expressions of "misogyny and disrespect."

ADDENDUM (26 August, 2015) - This post was republished on the Naked Capitalism blog. 

References
1.  Laine C, Taichman DB, LaCombe MA. On being a doctor: shining a light on the dark side.  Ann Intern Med 2015; 163: 320.  Link here.
2.  Anonymous.  Our family secrets.  Ann Intern Med 2015; 163: 321.  Link here.
3. Horton R. Offline: ten commandments, G8 corruption, and OBL. Lancet 2011; 377: 1638. Link here.
4. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med. 2009;24:1289–95. Link here.

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Once More with Feeling - Amgen Again Settles Allegations of Misbranding, But Why Bother?

Amgen bribery deception kickbacks legal settlements marketing

Once More with Feeling - Amgen Again Settles Allegations of Misbranding, But Why Bother?

Unknown 8/21/2015 Komentar

The Latest Settlement

Biotechnology giant Amgen has just reached another settlement of allegations that it unfairly, deceptively or misleadingly marketed its drug. Per the Los Angeles Times,

Amgen Inc. has agreed to pay $71 million to settle allegations by 48 state attorneys general that it improperly marketed two of its blockbuster drugs.

That is,

The states, including California, alleged that Amgen violated consumer protection laws by promoting the use of its anemia drug Aranesp for longer periods than the Food and Drug Administration had approved and by encouraging its use to treat anemia caused by cancer without FDA approval.

In addition, Amgen was accused of promoting its drug Enbrel as a treatment for mild plaque psoriasis even though it was approved only for severe plaque psoriasis, and for overstating the length of time that Enbrel effectively treats the disease.

This is the second settlement Amgen has made for improper marketing of Aranesp.

Three years ago, Amgen pleaded guilty to a single misdemeanor in federal court in New York for improperly marketing Aranesp. The drugmaker agreed to pay $150 million in criminal penalties and $612 million to resolve broader civil lawsuits, including allegations that Medicare, Medicaid and other government insurance programs were improperly billed.

At the time, federal prosecutors called the settlement 'the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.'

Although doctors can prescribe medications for off-label uses, drug companies are banned from promoting uses that aren't approved by the FDA, which has been at odds with some drugmakers over the issue.

This settlement seems to be just the latest in a very long procession of legal settlements  of allegations of apparent misbehavior by large health care organizations.  We have previously discussed many such settlements, how they serve as markers of ethical lapses by leaders of large organizations, and also how the failure of most of these settlements to provide meaningful penalties to those who presided over, directed, or implemented the bad behavior allows continuing impunity and fails to deter future bad behavior.  Many large organizations have made multiple such settlements in recent years, but have these settlements seem to have not promoted honest, transparent, accountable health care.   

Yet continuing government efforts to provide even these weak challenges to continuing bad behavior now appear under threat.

Is Misbranding a Crime?

The fundamental allegations in the original large Aranesp settlement were of misbranding (although the settlements with state government just announced were of violations of state laws prohibiting, as in the case of Connecticut, "unfair, deceptive or misleading" marketing practices.)  Marketing a drug or device for uses other than those approved by the US Food and Drug Administration (FDA) may be called "misbranding."

Whether misbranding should be considered a crime has lately become controversial.   Recently, an appeals court agreed with the notion that such marketing is constitutionally protected speech, as long as it is "truthful." (See discussion by Shannon Brownlee on the Lown Institute blog, and the NY Times news article.)  I am not a lawyer, so I will try not to deal with this constitutional argument at this time.  But most of the public discussion has focused on the narrow issue of whether misbranding is in fact protected free speech.

However, the case of the 'misbranding allegations agains Amgen suggest other issues worthy of consideration.

Promoting a Not Merely Ineffective, but Dangerous Drug

As we discussed here in 2012, Amgen pleaded guilty to one count of illegally marketing Aranesp, and agreed to pay a penalty of $762 million.  As we noted, the misbranding in this case was promotion of Aranesp for patients with cancer who were not receiving chemotherapy.  However, a growing collection of evidence suggested that epoetin drugs, a class in which Aranesp resides, increase the death rate in patients with various kinds of cancer.  On the other hand, Aranesp was never meant as a possible cure for cancer.  At best, its benefit is improvement of anemia, which might, just might improve how some patients feel in the short-term.  So it appears Amgen was promoting a dangerous drug without any evidence that the drug provided benefits that balanced the danger.  This appears very bad for patients.  The misbranding here was not some technical violation, but likely a deceptive effort that could have hurt patients, while profiting Amgen and its top executives.  The ethics here look much worse than the single guilty plea suggested.

Misbranding just refers to promoting a drug or device for uses that the FDA did not approve.  Some cases of misbranding could cause little more than inconvenience and added expense, but others could result in serious harm to patients.  Treating them all as misbranding removes important distinctions.

Allegations of Kickbacks

Furthermore, as discussed here in 2013, the 2012 settlement was not just about misbranding.  It was about kickbacks, that is bribes given to doctors by Amgen to induce them to prescribe a dangerous medication.  The settlement was arranged that Amgen did not admit to the alleged kicbkbacks.  But neither did it deny them, and the company apparently thought it was worth $762 million to avoid further dealing with these accusations, which nonetheless hang in the air.  So the ethics here now look even worse, invovling promoting a dangerous drug allegedly with bribery.


Furthermore, after news of the original Aranesp settlement came out, other stories of other settlements by Amgen appeared.  As we noted here,  in 2013, Amgen settled allegations that it also paid kickbacks to Omnicare and PharMerica to promote Amgen use in nursing homes and hospital.  It also settled charges that it inflated pricing data to obtain larger payments from Medicaid in multiple states for a variety of its drugs, including Aranesp.   Later in 2013, as we noted here, Amgen settled yet more charges that it gave kickbacks to doctors to promote one of its products, this time anti-cancer drug Xgeva.

Organizations accused of misbranding often are also accused of much worse conduct, yet very often, their cases are settled with the emphasis on the misbranding, leaving more serious allegations neither proven nor denied.  Focusing on misbranding may distract from more serious ethical, moral and legal violations.


Discussion

In the case of Amgen, the large 2012 settlement for misbranding resulted in the only guilty plea made and the largest fine paid by the company.  From my informal perusal of legal settlements made by drug, biotechnology and device companies, misbranding seems to be one of the more frequent allegations, and often the only one resulting in admissions of guilt.  It may be that it is easier to prove misbranding than other charges, and companies may admit to misbranding in settlements because the charge is not well understood by the general public and hence may carry less of a stigma than other charges, for example, kickbacks or fraud.

Yet as noted above, while misbranding seems to connote a mere technical violation, in health care misbranding can mean patients hurt by dangerous treatments that did them little if any good.  Furthermore, companies that settle allegations of or even admit to misbranding often have been charged with lots of other bad behavior, but settlements are often set up so none of these other allegations is ever confirmed or refuted.  So settlements that focus on misbranding again may nullify questions about worse ethical problems.

Now whether misbranding is itself really a transgression seems to a legal question.  But perhaps the legal challenges to misbranding as a crime ought to evoke more than just a narrow defense of the legal concept.  Of course, declaring misbranding unconstitutional could result in even weaker enforcement actions against large and powerful health care corporations,  However, maybe the inherent weakness of misbranding charges ought to inspire some rethinking of what bad behavior in health care really deserves attention.

Should not aggressive marketing of a drug as tremendously effective and safe in situations in which the drug is either minimally or not at all effective (especially in terms of improving patient-centered outcomes) or not very safe be considered possible fraud, and prosecuted as such?  Should not alleged kickbacks and bribes given to health professionals and care giving organizations be prosecuted, rather than treated as civil disputes and settled?  Should not the people who actually appeared to have committed fraud, or given bribes be prosecuted, rather than just letting their employers escape with civil monetary penalties?  Should not the leaders of big organizations on whose watches fraud and bribery allegedly occurred be charged as responsible corporate officers (look here )?

If civil authorities were willing to stop regarding big health care organizations and their leaders as "too big to jail,"  maybe less mischief would be going on in health care.  And maybe that would lead to better care for patients and better health for the public. 

ADDENDUM (21 August, 2015) - This post was republished on the Naked Capitalism blog.

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