Showing posts with label free speech. Show all posts
Showing posts with label free speech. Show all posts

Health Care Academics' Unrest and Bad Health Care Leadership?

Last month we discussed a recent, large scale study of physician burnout, and wondered whether it would finally inspire some discourse about why physicians are really so upset.  In particular, we hypothesized,  based on some real, if limited data, that physician angst, dissatisfaction, burnout, etc may mainly be a response to the problems with leadership and governance of health care organization we post about on Health Care Renewal.

After that post, one of our scouts found a very interesting and relevant article from earlier this year which got little attention at the time, but deserves more.  [Pololi LH, Krupat E, Civian JT, Ash AS, Brennan RT. Why are a quarter of faculty considering leaving academic medicine? A study of their perceptions of institutional culture and intentions to leave at 26 representative U.S. medical schools. Acad Med. 2012; 87: 859-69. Link here.]

Study Design

This was a cross-sectional survey of faculty at 26 medical schools in the US, selected to be similar to the general population of medical schools in the country.  At each school, 150 faculty were randomly chosen stratified by sex and age, and then the sample was enriched to include additional minority faculty and women surgeons, for a total of 4578.

The faculty were sent a multi item survey to assess their perception of the organizational culture of their institutions, and asked about their intentions to continue in or leave their current positions and academic medicine.  Responses to each survey item were allowed to be from 1 = strongly disagree, to 5 = strongly agree.  The items on the survey were combined into various scales.  A number of items on the survey seemed to be related to issues we frequently discuss on Health Care Renewal.  These items ended up in three different scales, entitled Relatedness/Inclusion, Values Alignment, and Ethical/Moral Distress.  The survey items are listed below, grouped by issue, with the scales into which they were combined noted.

Issue: Mission-Hostile Leadership

Administration only interested in me for revenue   (Reverse coded) (Values Alignment)
Institution committed to serving the public (VA)
Institution's actions well-aligned with stated values and mission (VA)
Institution puts own needs ahead of educational/clinical missions (RC) (VA)
My values well-aligned with school's (VA)
Institution awards excellence in clinical care (VA)
Institution does not value teaching (RC) (VA)
Have to compromise values to work here (Ethical/Moral Distress)

Issue: Deceptive, Unethical Leadership

Felt pressure to behave unethically (Ethical/Moral Distress)
Need to be deceitful in order to succeed (EMD)
Others have taken credit for my work (EMD)

Issue: Generation of the Anechoic Effect by  Suppression of Free Speech, Academic Freedom, Dissent, Whistle-Blowing,

Feel ignored/ invisible (RC) (Relatedness/Inclusion)
Hide what I think and feel (RC) (R/I)
Reluctant to express opinion/ fear negative consequences (RC) (R/I)

So in summary, the survey contained quite a few questions about mission-hostile management, comprising nearly all of the Values Alignment scale, some questions about deceptive or unethical leadership, all in the Ethical/Moral Distress scale, and some about generation of the anechoic effect by suppression of free speech, academic freedom, dissent, and whistle-blowing, all in the Relatedness/Inclusion scale.

Results

The response rate was 52% (N=2381.)

Unfortunately, the article did not include the distributions of the responses to individual survey items, and only included the mean and standard error of the scale scores.  The values for the scales of most interest were:
Relatedness/Inclusion  3.56 SE= 0.022
Values Alignment  3.25 SE=0.028
Ethical/Moral Distress 2.36 SE=0.022

Note that the article did not address the degree individual items, especially those listed above, contributed to variation in the scale scores.


A small majority of faculty indicated their intentions to stay at their institutions (57%).  Of the remainder, 14% were considering leaving their school due to dissatisfaction, and another 21% were considering leaving academic medicine due to dissatisfaction.  The remainder were considering leaving due to personal/ family reasons or to retire.

The authors did complex multinomial logit modeling to assess the relationships among the various scales, demographic factors, and intention to leave.  Most relevant to us, Relatedness/Inclusion was significantly related to intention to leave the institution due to dissatisfaction (Coefficient -0.69, p lt 0.001, OR =0.50), as was Values Alignment (-0.39, p=0.04, OR=0.68), but not Ethical/ Moral Distress.  Furthermore, Relatedness/Inclusion was related to intention to leave academic medicine due to dissatisfaction (-0.48, p lt 0.001, 0.62), as was Ethical/Moral Distress (0.60, p lt 0.001, OR =1.82). The article did not address whether individual survey items, including those of most interest listed above, were related to intention to leave.  The article also did not address whether responses to the survey or intention to leave varied across faculty characteristics, medical school characteristics, or individual medical schools. 

Summary and Comments

This very large survey of faculty from multiple US medical schools showed that more than one-third were considering leaving their institutions or academic medicine due to dissatisfaction, indicating a striking prevalence of faculty distress.  Their responses to questions about perceived organizational cultural and leadership problems, including those possibly related to leadership's perceived hostility to the mission, leadership's perceived dishonesty or unethical behavior, and leadership's suppression of dissent, free speech, academic freedom, and whistle-blowing were related to their intentions to leave due to dissatisfaction.

These results suggest the hypothesis that much of faculty angst may be due to the sorts of problems with leadership and hence organizational culture that we discuss on Health Care Renewal.  Since this was a cross-sectional survey, it certainly does not offer scientific proof of this hypothesis.  Note that there is other evidence from numerous cases discussed in Health Care Renewal, qualitative studies and our much smaller study published only in abstract form that also supports this hypothesis (look here). 

One part of the author's discussion of their findings was particularly relevant:


Our findings are congruent with metaanalyses of 25 years of organizational justice research outside medicine. These studies suggest that employee perceptions of organizational justice and an ethical climate are related to increased job satisfaction, trust in leadership, enhanced performance, commitment to one’s employer, and reduced turnover.

 The scale of ethical/moral distress (see Table 1) reflects reactions to the prevailing norms and possible erosion of professionalism and increased organizational self-interest. There is a growing belief that organizations influence and are responsible for the ethical or unethical behaviors of their employees.To our knowledge, faculty perceptions of 'moral atmosphere' and 'just community' embedded in our survey have not been previously investigated in academic medicine, even though the ethical concepts of professionalism and justice can be used to guide the pursuit of excellence in the missions of medical schools. Several scholars have called for academic medicine to attend to its social justice and moral mission. Faculty perceptions
of organizational justice are pivotal to the critical issue of professionalism in medicine. The ethical/moral distress scale in the survey reported here included items such as 'the culture of my institution discourages altruism' and 'I find working here to be dehumanizing.' (See Table 1 for other items in this scale.) In that ethical/moral distress was more strongly related to intent to leave academic medicine entirely than intent to leave one’s own institution, these negative feelings among faculty must be particularly disheartening to them and may color major career decisions.
I believe that the study by Pololi et al adds to the evidence that physician distress is a symptom of a dysfunctional system in which major health care organizations have been taken over by leaders more devoted to self-interest and short-term revenue than the values prized by health care professionals and academics.  This applies obviously to academic medical institutions, but also to other organizations that might have been expected to defend such professional and academic values, such as professional associations, accrediting organizations, and health care foundations.  As we said before, if physicians really want to address what is making them burned out and dissatisfied, they will have to regain control of their own societies, organizations, and academic institutions, and ensure that these organizations put core values, not revenue generation and providing  cushy compensation to their executives, first.  

Using a "Professionalism" Initiative as a Speech Code to Punish Students' Criticisms of Administrative Authority?

The original impetus to set up Health Care Renewal was increasing evidence of external threats to physicians' professional values.  So it seemed to me that renewed interest in addressing professionalism in academic medicine might lead to more attention to these threats, and perhaps even real challenges to them. 

Instead, most academic professionalism initiatives seem to have steered away from this contentious area.  Worse, at times the academic medical concept of professionalism has been turned on its head. 

A Dispute Among Students at University of California - Davis

A recent post in the Torch blog from our friends at FIRE (the Foundation for Individual Rights in Education) provided a graphic example.  The case involved an apparently trivial dispute among two medical students:
[University of California - Davis medical student Curtis] Allumbaugh's ordeal began after he emailed the 'med2014' mailing list (or 'listserv') on July 19, 2010, regarding a party he was organizing. The listserv was widely used for a variety of non-academic purposes. Allumbaugh's email provided the address of the party, detailed the available space, and listed the variety of alcohol that would be available at the party. The email noted that others had signed up to bring snacks and mentioned that some things were still lacking for the party, such as music, fruit juice, and beer. Prior to Allumbaugh's message, others had sent similar emails using the same listserv about their own parties, such as a 'kegger' one student called 'CAMP MED.'

On July 20, 2010, a second-year student emailed Allumbaugh, notifying him that she had 'been placed on the class of 2014's listserve' and had monitored the class email. She criticized Allumbaugh's email for placing 'a heavy emphasis on alcohol.' In response, Allumbaugh emailed her directly on July 21, calling her a 'busy body' and telling her, 'You should really just mind your own business and let our class be.'

Note that the second-year student's email (available here) carried a suggestion that she had some sort of authority to monitor the extra-curricular actions of first year students as manifested on the list server, and perhaps even punish them for perceived misconduct:
I can tell you that as MS2s, we work and play hard, but we do it responsibly and always in the forefront of our minds we remember what image we are portraying in public and through the messages we send. I'd hate to see any one of you 2014ers get into any trouble right before you start an amazing period of your life.

Note that the exchange between the two students did not occur in an academic or clinical setting, and it was never clear why the second year student was "placed on" the list server, or why she should have any authority over the Allumbaugh. .

The School Administration Invokes "Professionalism"

The medical school saw fit to cast Allumbaugh's actions as violations of the school's standards of professionalism:
As a result of this email exchange, Associate Dean of Student Affairs and Graduate Medical Education James Nuovo sent Allumbaugh a letter on September 14, 2010, citing him for 'failing to demonstrate the highest standards of civility and decency to all' and 'failing to demonstrate courtesy, sensitivity and respect.' On November 3, 2010, Allumbaugh received a letter from the SOM Committee on Student Progress, punishing him with academic probation for the rest of his time in medical school and requiring him to undergo a psychological assessment to determine whether he was 'fit' to continue in medical school.

Finally, on November 19, 2010, SOM changed its rules to force all medical students to abide by the Principles of Community or else face academic probation.

The result was a series of interventions by FIRE:
In response, FIRE wrote UC Davis Chancellor Linda P.B. Katehi on August 3, 2011, noting that enforcing professional standards in truly professional settings differs greatly from enforcing workplace standards in other settings such as private conversations. FIRE also noted that it is blatantly unconstitutional to police student speech under the UC Davis Principles of Community because such a 'civility' policy violates the First Amendment right to freedom of speech when it is given disciplinary force.

When that letter had no effect, it took threats of litigation for the medical school to suspend Allumbaugh's punishment more than one year after it began:
SOM Associate Dean of Curriculum and Competency Development Mark Servis replied to FIRE on August 10, 2011, defending the policy. FIRE responded on November 23, 2011, reminding Katehi that 'violating well-established law regarding the First Amendment rights of students at public universities leaves you at risk of losing qualified immunity, thereby opening you and other administrators to personal liability' for the deprivation of students' First Amendment rights. Servis again defended the policy in a reply on December 5, 2011.

Finally, on February 16, 2012, the Committee on Student Progress notified Allumbaugh that his probation had been dropped, but persisted in requiring him to adhere to the Principles of Community.
Note that Associate Dean Servis' letter stated that the email sent to Allumbaugh by the second year student was "a genuine suggestion of concern and an offer of albeit unsolicited friendly advice."  Thus, Servis seemed unaware that it could have been interpreted as an assertion of authority and a threat of punishment ("I'd hate to see any one of you 2014ers get into any trouble.")

Dean Servis also defended the use of probation to punish a student for failing to "work effectively with classmates." Yet the dispute that had nothing to do with (academic or clinical) work, and only involved a single student from another class.  Why that student was not equally to blame was not clear, unless it was because she had been granted special authority by the administration to monitor the actions of less senior students.  The implication appears to be that the punishment was in defense of a student who had been granted special authority by the administration, and hence was ultimately in defense of the administration's power. 

Summary

In this case, the medical school's professionalism policy seemed to be used by the administration primarily to control students' speech outside of the academic and clinical setting. Furthermore, the student's main offense seemed to be failure to kowtow sufficiently to another student who by implication had been given some sort of authority by the administration.  What the two students' dispute had to with professionalism is not  apparent.

On one hand, this seems like a case in which a speech code was mainly used to defend administrators from criticism and challenge.

On the other hand, this speech code was cloaked in the mantle of professionalism.  So this case seems to be an example of a professionalism initiative used as an excuse for the leadership to maintain its power.

It is beyond ironic that while this was going on, the University of California - Davis, and its Chancellor Linda Katehi were becoming briefly infamous for another effort, a more violent one, by the administration to prevent criticism and challenge. Chancellor Katehi had authorized university police to "clear" student demonstrators from an "occupation" of the campus which was protesting, among other things, rising tuition and economic inequality, and in doing so, the police used pepper spray on unarmed students (see this post.)

There are a lot bigger threats to physicians' and other health care professionals' professionalism than medical students' sarcasm or even rudeness in disputes about alcohol served at off-hours parties. Since many of these threats also generate personal benefits to academic leadership, it may not be much of a surprise that they have received little attention.  (See the list of threats appended below.  Note that we have discussed two of these threats in the specific context of the University of California - Davis.  Here we noted that Chancellor Katehi seemed to be re-imagining her medical school as a biotechnology company.  Here we noted that Chancellor Katehi was also on the board of a company with a medical education and communication company subsidiary.)

However, while they remain unaddressed, I submit that using "professionalism" to cloak increased social control of students to prevent them from looking too closely at what academic administrators are doing will eventually backfire. 

===
ADDENDUM: List of Threats to Professionalism


Instead, to really uphold professionalism, we need to defend it from its real threats, as listed in my 2010 post:


  • Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
  • Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
  • The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(1) wrote that research universities must respond to "societal demands that they become engines of economic development…."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
  • Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(2)
  • Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
  • Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(3)  See post here
  • Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
  • Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
  • Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
  • Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
  • Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
  • Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
  • Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 
References


1. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
3. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

SELF INFLICTED DAMAGE

SELF INFLICTED DAMAGE

The American Psychiatric Association (APA) is in the news again for bad public relations: worse than bad, actually – appalling. Locked in a bunker mentality, they have moved to stifle advance criticism of their flagship initiative, DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition), which is a work in progress. Lawyers for the APA have threatened the owner of a UK blog that served as a discussion forum for issues affected by DSM-5 and other, international psychiatric classifications. The blog, named dsm5watch was considered authoritative and accurate. If you go to this site now you will find that it has been deleted.

As recounted this week by Allen Frances, MD, the editor of the last published DSM edition, the blog’s owner, Suzy Chapman, told him, ”On December 22, I was stunned to receive two emails from the Licensing and Permissions department of American Psychiatric Publishing, claiming that the domain name my site operates under was infringing upon the DSM 5 trademark in violation of United States Trademark Law and that my unauthorized actions may subject me to contributory infringement liability including increased damages for willful infringement. I was told to cease and desist immediately all use of the DSM 5 mark and to provide documentation within ten days confirming I had done so."

"Given my limited resources compared with APA's deep pockets, I had no choice but to comply and was forced to change my site's domain name to dxrevisionwatch. Hits to the new site have plummeted dramatically and it will take months for traffic to recover - just at the time when crucial DSM 5 decisions are being made."

In effect, the APA, acting not through its medical or scientific officers but through its wholly owned publishing house, has attempted a SLAPP maneuver. SLAPP is the acronym for strategic lawsuit against public participation. What kind of leadership does this signal in a major professional organization?

The normal remit of professional medical societies is stewardship of professional values and ethics. That is why these societies are accorded deference and respect on matters of clinical guidelines, health policy and public education. Even when, like the Institute of Medicine of the National Academy of Sciences, they tolerate compromised members, they can generally hope to retain the public trust.

One reason for this assurance is that they are expected as a matter of professional duty to avoid conflicts of interest – personal and financial. The APA, however, has an enormous conflict in this case: it counts on millions of dollars in revenue from sales of the DSM volumes and it is under siege currently for perceived scientific and clinical weaknesses of the DSM-5 that is due to be released next year. Professional criticism is running so high that over 10,000 interested parties have signed a petition for the APA to reconsider planned changes. There is even talk of abandoning DSM-5 in favor of the ICD system (International Classification of Diseases), which is a WHO initiative.

The APA doesn’t own psychiatric classification and diagnostic criteria. When the field allows the APA to take the initiative for revisions of the DSM, it is with the understanding that the work will be conducted in the public interest rather than in the commercial interest of the APA itself, which is said to derive over $5 million annually in profits from DSM sales. The public interest and the public trust are served by transparency and open discussion, not by contrived SLAPP threats.

It is bad enough that the APA resorts to this legal artifice to stifle public discussion. When they do it through their lawyers and business entities rather than through their medical and scientific officers, they sink to a lower level yet. The parallels with corporate sleaze that we have discussed so often on this blog are obvious. For shame.

The UC-Davis Pepper-Spray Case as Illustrative of Problems with the Leadership of Health Care

The aggressive actions by University of California-Davis police against unarmed, peaceful student protesters turn out to be the latest illustration of the problems with leadership and governance we discuss on Health Care Renewal

The University of California - Davis Pepper Spray Incident

To summarize the current episode, I start with quotes about its background from Reuters,
Student protesters at Davis had set up an encampment in the university's quad area earlier this month as part of the nationwide Occupy movement against economic inequality and excesses of the financial system.

Their demonstrations, which had been endorsed by a faculty association, included protests against tuition increases and what they viewed as police brutality on University of California campuses in response to recent protests.

The students had set up roughly 25 tents in a quad area, but they had been asked not to stay overnight and were told they would not be able to stay during the weekend, due to a lack of university resources, [university Chancellor Linda] Katehi said.

Some protesters took their tents down voluntarily while others stayed.

Then,
The pepper spray incident appeared to take place on Friday afternoon, when campus police moved in to forcibly evict the protesters.

Then, as per the (London, UK) Independent,
A police officer saunters up to a group of young protestors who are sat in a line on the ground, with their arms linked. Then he removes a canister of pepper spray from his belt, with a flourish, before casually proceeding to unload its contents into their faces.

The demonstrators remain silent and motionless, with their heads bowed. So the policeman carries on, methodically covering them, from point blank range. By the time he’s finished, their heads and faces are covered in a thick layer of the toxic red liquid.

The actual video is below:


The UC-Davis Chancellor's Defense of the Police Actions

The Independent's coverage emphasized that initially the leadership of the campus police defended the use of pepper spray on apparently unarmed, peaceful students:
Annette Spicuzza, the head of the UC Davis Campus Police, who were responsible for Friday’s incident .... told reporters that her officers had been 'forced' to use the pepper spray, after demonstrators surrounded them. Lt Pike gave his victims sufficient warning of the impending attack, she added, and emptied the canister with a sweeping motion, in keeping with official procedures.

'When you are encircled by 200 individuals, I don’t know if I want to say ‘afraid,’ but I think they were quite concerned about their safety,' she said, regarding the circumstances her officers faced. 'There was no way out of that circle... It's a very volatile situation.'

That coverage also made clear that the directive to clear the demonstrators came from the top:
Linda Katehi, the Chancellor of UC Davis ... had asked the police to clear demonstrators from her campus, a couple of hours north of San Francisco. In the aftermath of the incident, she had initially joined Spicuzza in defending the force's methods, saying that they had 'no option' but to adopt a hard line.

Ms Katehi later backed off, but only after her first response
sparked immediate outrage, and within hours, the university’s Faculty Association, representing Ms Katehi’s employees, issued a statement called for her resignation, saying that her authorisation of 'excessive' force had amounted to a 'gross failure of leadership.'

Nathan Brown, an assistant English professor who witnessed the incident, wrote in an open letter: 'Several of these students were hospitalized. Others are seriously injured. One of them, forty-five minutes after being pepper-sprayed down his throat, was still coughing up blood... You are responsible.'

Other comments likened the police actions to something "coming from some riot-control unit in China, or in Syria," [James Fallows in the Atlantic] called them indicative of "a police state in its pure form," [Glenn Greenwald in Salon], or otherwise denounced them as "outrageous" or "awful." (Clark McPhail, professor emeritus of sociology at the University of Illinois, and Greg Lukianoff, President of the Foundation for Individual Rights in Education, respectively, via Inside Higher Ed.)

This aggressive, violent response to peaceful protest seems to be the latest example of the arrogance of some current leaders of our important organizations.

Our Previous Discussion of the Chancellor in Health Care Renewal

This case appears directly related to the problems in leadership and governance we discuss on Health Care Renewal Ms Katehi has the distinction of having been already written up twice on Health Care Renewal for questions about her leadership.

On her arrival at UC-Davis in 2009, she promised to "help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market." This indicates at best ignorance of, at worst hostility to the fundamental university mission, which is hardly developing and particularly marketing products, but discovering and disseminating knowledge (see this post).

At that time, I called this an example of "how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions."

In 2011, Ms Katehi defended the payment to the medical center CEO, whom she called a "great CEO,' of nearly a million dollars yearly in compensation. However, that CEO was part of a group of top university leaders demanding large increases in their pensions at a time when the university was under great financial distress. For that, some called them not great leaders, but greedy and "despicable." Thus, Ms Katehi seemed to stand up for top leaders' privilege and exceptionalism, including their entitlement to huge compensation whatever the circumstance, even in a time of financial travail (see this post).

I could not have predicted that Chancellor Katehi would preside over the pepper spraying unarmed students for peaceful, legitimate protest. However, it is not surprising that a leader who does not understand the fundamental academic mission and who supports executive privilege and exceptionalism would foster an authoritarian climate in which such an incident could happen.

This example clearly illustrates the issues we have been discussing on Health Care Renewal for a long time. In particular, leaders who are more dedicated to their own and their fellow executives' privilege and exceptionalism than their organizations' missions are likely to end up promoting actions that threaten those  missions.

The Moral of the Story

Instead, as we have been preaching endlessly,... 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. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

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.

You heard it here first on Health Care Renewal .

Keep your eye on Health Care Renewal for continued discussion of parallels between problems in health care and in the larger political economy.

Embedded Networks of Influence in Health Care: An Illustrative Case

At the 12th International Anti-Corruption Conference (IACC), sponsored by Transparency International, one of the plenary sessions was devoted to the topic of "embedded networks of influence."  The session description included this description of the topic as:
the major stumbling block in the fight against corruption, namely, the power of 'embedded networks' in advancing personal or group interests through state institutions. The extent of their power can create what is known as “state capture” meaning democratic governance failure. It will take a close look at the influential role of private sector, especially of the multinational private sector.
A recent investigative report in the Chronicle of Higher Education illustrated a striking case of how one key individual has affected health care through multiple connections to what can be regarded as embedded networks of influence, thus tying in to many of the topics we have discussed on Health Care Renewal.

The article focused on the University of Miami and its current President, Donna Shalala. Let me summarize the set of relevant topics in roughly chronological order and note how the article links them to President Shalala.

Speech Codes and Restrictions on Free Speech within Academia

As I wrote in my 2003 article, (Poses RM. A cautionary tale: the dysfunction of the American health care system.  Eur J Int Med 2003; 14: 123-130.  Link here), speech codes and other restrictions on free speech within academia created the framework for the suppression of clinical research that may offend those with vested interests:
Failure of universities to champion the academic freedom of their clinical researchers may stem from their abandonment of their own academic core value of free enquiry. There is abundant evidence that universities may restrict expression and limit academic freedom. In The Shadow University, Kors and Silverglate charged that 'universities have become the enemy of a free society.' Universities have punished faculty and students who raised unpopular viewpoints.

In the Chronicle,
Ms. Shalala, ... was previously president of Hunter College of the City University of New York and chancellor of the University of Wisconsin at Madison....

The Shadow University, the pioneering work on challenges to individual rights by leaders at academic institutions, dealt with Ms Shalala's role as a leading early proponent of silencing speech that offended academic leaders.
Wisconsin chose to enact a speech code. On March 29, 1990, the Wisconsin ACLU joined a suit against the university, announcing that the important moral goals of toleration and equal opportunity 'can be accomplished through means other than the creation of rules which infringe upon the fundamental freedom to express ideas.'

The speech code was drafted with the help of UW-Madison Law School professors Richard Delgado, Gordon Baldwin, and Ted Finman.... On June 9, 1989, upon recommendation by Chancellor Shalala, it was adopted by the Board of Regents...."
The speech code was soon declared unconstitutional by a federal court, which held:
the policy was unconstitutional precisely because 'the UW rule regulates its speech upon its content.'
Ms Shalala then:
recommended a new code to the regents in the spring of 1992, which they adopted in March.
However,
Faced with another lawsuit, the regents reversed themselves
For these and similar efforts, as discussed by Evans and Novak in 1993, Ms Shalala was dubbed "the Queen of PC" [political correctness].

Speech codes and other restrictions on free speech in the academic setting seem mainly to be used to target speech that administrators find offensive, including speech critical of management practices. This is echoed in the Chronicle story, which suggested how fearful University of Miami faculty now are of criticizing Ms Shalala:
Others, including several current and former faculty members, outline their complaints in far more detail. But they do so anonymously, saying they don't want to tangle head-on with such a politically powerful president.
Ms Shalala's prominence in academics, probably more due to rather that in spite of her hostility to free speech and free enquiry, may have enabled her to join another and even more powerful network of influence, this one at the center of the US political world.
 
The Rise of Commercial Health Insurance 

In Deadly Spin, former CIGNA executive Wendell Potter documented how clever and unscrupulous use of public relations and marketing techniques enabled commercial health care insurance and managed care companies to increase dominance of US health care, while allowing health care costs to soar, and denying access to larger numbers of patients. 

The Chronicle article briefly alluded to Ms Shalala's role in the rise of for-profit health insurance.  Despite being labelled "farthest to the left and most controversial of all President-elect Clinton's Cabinet appointments," again per Evans and Novak, Ms Shalala departed the University of Wisconsin in 1993 to become US Secretary of Health and Human Services. In that role, she presided over the administration's failed attempt at health care reform, as Potter wrote,
When President Bill Clinton was forced to give up on comprehensive health care reform in 1994, the damage was far more extensive than anyone could have imagined - the administration's defeat emboldened health insurance companies to totally redefine the mission and methods of an industry that now strands nearly fifty million people without insurance.

As I outlined..., insurers knew after the Clinton disaster that the coast was clear for them to abandon nonprofit practices, long-standing commitments to public service, and traditional insurance models and turn instead to satisfying Wall Street investors' desire to make money, by limiting spending on health care.
Note that my only quibble with what Wendell Potter wrote is that it may be that the insurance companies' top executives, rather than their stockholders who benefited the most from these changes, as we will address below.

Ms Shalala remained Secretary of HHS until 2001, but after the failure of the health care reform proposal in 1994, her department apparently did nothing to try to ameliorate the changes to health care that Potter described above.

Bloated Executive Compensation Disproportionate to Any Measure of Organizational Performance

We have frequently discussed how health care leaders now seem entitled to get huge amounts of compensation disproportionate to their organizations' performance and their responsibility for it. 

Despite Ms Shalala's reputation in the 1990s as an extreme leftist, upon leaving her role in the Clinton administration, she almost immediately embraced the for-profit corporate model of health insurance. In a notable example of what now is called the "revolving door" that went unnoticed at the time,  Ms Shalala went from would be regulator of commercial managed care to leader of commercial managed care.  As noted by the Chronicle:
Debates over ethical boundaries are not new to those involved in the university's growth surge. Ms. Shalala was on the compensation committee of the board of the health insurer UnitedHealth Group when it was caught in one of the nation's largest-ever stock-options scandals. She also received low-cost loans in 2002 as part of a favors-for-politicians scandal at Countrywide Financial Corporation.

Both Ms. Shalala and [University of Miami medical school dean] Dr. Goldschmidt have served on the boards of companies directly or indirectly affected by the university's business decisions. The university had $30-million in annual business with UnitedHealth Group when Ms. Shalala was on its board.
Note that Ms Shalala served as Secretary of Health and Human Services from 1993 to 2001, (see this list), then joined the board of UnitedHealth Group within months (see this article.)

We discussed in considerable detail the ethical failings of UnitedHealth Group while Ms Shalala had fiduciary responsibility as a board member for its conduct. A particularly striking failing was how the board of directors granted sufficient back-dated stock options to the company's former CEO to make him a billionaire on paper.  The resulting scandal was followed by his resignation.  Later, Dr McGuire was forced to give back some the options.  The final settlement of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options.  As we most recently summarized here, former CEO William McGuire was one of the top 10 best compensated CEOs of the first decade of the 21st century, despite the company's multiple ethical failings. 

Conflicts of Interest, Especially Involving Key Opinion Leaders who Promote Marketing Objectives Cloaked in Academic Respectability

We have extensively discussed the web of conflicts of interest that now pervades health care. For academic health care leaders, the most intense kind of conflict of interest may be created by service on the board of directors of a for-profit health care corporation.  Note that corporate directors, as we have discussed previously, have a fiduciary duty to exhibit "unyielding loyalty" to the stockholders of the company and their interests  [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.].  We first started to discuss the intense conflicts of interest generated when leaders of academic medicine are also members of boards of directors of for-profit health care corporations in 2006.  The issue really made the big time in 2010 when the New York Times published a front page article in its Sunday Business section about whether university presidents who also were corporate directors were part of an "academic-industrial complex."  As we noted above, Ms Shalala's service on the board of UnitedHealth Group created such a conflict, and she apparently presided a similar board level conflict of interest affecting her medical school dean. 

A particularly pernicious kind of conflict of interest may be created when a company selling health care goods or services pays an academic to become a "key opinion leader."  Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

The Chronicle recounted how Ms Shalala also was linked to one of the better known examples of industry paid KOLs:
Dr. Goldschmidt did not fully report the income from such corporate associations on the medical school's financial-disclosure Web site, even while promoting the site as evidence of his faculty's commitment to openness. He also brought to Miami a repeat violator of financial-conflict-of-interest standards, Charles B. Nemeroff, to serve as a professor and chairman of the department of psychiatry and behavioral sciences.
In a companion article, the Chronicle summarized Dr Nemeroff's career thus:
Dr. Nemeroff had quit as chairman of Emory University's psychiatry department in December 2008 after the university received complaints about his secretly receiving money from GlaxoSmithKline and other pharmaceutical companies while helping promote their products.
We (Dr Bernard Carroll more than yours truly)  have posted previously about Dr Nemeroff's exploits, including those at the University of Miami, numerous times

The Fall of Municipal Hospitals, the Rise of For-Profit Hospitals

We have frequently discussed how the leaders have undermined health care organizations' core missions, and particularly how hospitals and hospital systems have strayed from their patient care mission to make more money. The Chronicle suggested how Ms Shalala's leadership of the University of Miami has enriched the institution's teaching hospital at the apparent expense of the local municipal hospital system:
Another set of problems, cited by current and former university faculty and Jackson staff members, stems from the 2007 takeover of a facility that became the University of Miami Hospital, across the street from Jackson. The purchase has greatly expanded the university's ability to direct many of the area's most profitable patients and procedures to the new facility and to other university-owned hospitals, further worsening Jackson's own considerable budget woes.
In addition,
The university's patient-enrollment practices were part of the problem. The inspector general of the U.S. Department of Health and Human Services and the U.S. Attorney's Office for the Southern District of Florida are looking into the question of whether university doctors routinely enrolled Jackson patients in research projects without telling the hospital.

In a 2008 letter from Jackson officials to university leaders, Nathan Anspach, who was vice president for physician services at the hospital, described a series of failed efforts 'to stop new clandestine research' at Jackson by university doctors.

Meetings with university officials aimed at stopping the practice 'went badly,' Mr. Anspach wrote, and Dr. Goldschmidt, the medical-school dean, was 'outwardly annoyed' by Jackson's requests for information that would help it identify research patients in the building.

Ms. Shalala was copied on at least some of the correspondence, including a 2006 letter in which Marvin O'Quinn, then-president and chief executive of the Jackson Health System, which runs Jackson Memorial, warned Dr. Goldschmidt about the legal risks of submitting claims for patient care that should be covered by a medical study.

The current director of compliance at Jackson Health System, Diana Salinas, said the allegations are a matter of investigation by the two federal agencies. Ms. Shalala and Dr. Goldschmidt told The Chronicle that they were unfamiliar with the matter. 'This must not be a very big issue,' Ms. Shalala said, 'because none of the Jackson senior leadership has ever brought it up with me.'
Finally,
And the departing chief executive of the Jackson Health System, Eneida O. Roldan, whose appointment two years ago was supported by the university, said medical-school officials made clear from the start 'that they were going to take cardiology across the street.'

Ms. Dixon-Shim, of the support-workers' union, is among those who say they've seen it happen. 'Most of the indigent patients, they're staying at Jackson,' she says. 'But most of the private patients, the physicians are taking them over to their area' at the university-owned hospitals.
Note that we previously discussed how Jackson's financial troubles lead to a bid by for-profit Steward Health Care to take it over.

Summary

So, through her mutiple roles that allowed her to serve at several key nodes of networks of influence in health care, one person has been linked to multiple dysfunctional aspects of US health care that arguably have been responsible for our increasing costs, declining access, and poor quality.  Note that these multiple roles seem to have been logically and even ideologically inconsistent, suggesting that multiplying her roles within the  networks may have been more compelling to her than logical or ideological rationales for particular actions.

We have discussed before, the leadership of health care organizations has become incredibly interrelated, interlocked, and incestuous. 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.  It now appears reasonable to characterize the relationships among health care leaders as embedded networks of influence. 


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.

Who Is Really "Bullying?" - Academic Leaders and the Stifling of Critics of Conflicts of Interests

Universities, which are supposed to discover and disseminate knowledge, ought to be the foremost defenders of free speech and a free press.  However, in the past decades, university executives have become notorious for trying to control speech that offends their political sensibilities (for numerous examples, see the FIRE - Foundation for Individual Rights in Education web-site.) 

It seems that academic leaders get even more upset when their or their faculties' conflicts of interest are criticized, as demonstrated by updates about two important cases we have discussed.

Columbia University

We recently posted about reactions at the university to revelations in the movie "Inside Job" that the Dean of the Business School and one of its prominent professors failed to disclose pay they received that might have motivated their enthusiastic promotion of economic policies that helped contribute to the Great Recession. 

These reactions occurred six months after the movie came out.  A Columbia Spectator student columnist asked why it took so long:
Why have students waited until April to address the consequences of “Inside Job” when the film was released in October? Why has our reaction been delayed by seven months?

Her postulated answer:

Why should Columbia need an outside documentary to point out its ethical failures?

Embedded in the Spectator news article about the film—published April 15— is a quote from University Senator Liya Yu that offers a frightening answer to our question about the delayed student reaction. 'I think people in the Business School haven’t responded because they are afraid,' Yu was quoted saying. 'If you are the dean of a school, obviously all the students are going to be dependent on you for their careers and futures. It’s hard for them to do anything.' I think this explanation extends to students beyond those currently enrolled in the Business School. In fact, its implications pose a threat to student journalism as a whole. For the first time in history, everything that a student journalist writes during his or her time in college is published on the Internet. This is a good thing for many reasons: It increases readership, allows writers to cross-reference easily, etc. But it also creates a permanent, compromising memory that is available forever to anyone who seeks it.

From the moment the college application process began, we were told that the content of our Facebook profiles could be used against us in admissions. We have learned to censor our traceable online behavior so as not to compromise our professional or educational prospects. Unfortunately, this has led to journalistic over-caution. We fear that anything we say now will be used against us later. And maybe it’s true. After all, not enough time has passed for us to take a careful account of the degree to which students’ first publications can affect their futures. Even editors have advised me to mitigate the strongest claims in my columns for fear of consequences to come. Perhaps they are right. But the most insidious kind of censorship—the hardest to recognize, the hardest to combat—is self-censorship, the persistent imaginative failure that prevents us from even recognizing what we should be writing about.

In the Internet age, bravery in student journalism is not trailing a military unit on the Iraqi front lines. Rather, it is the willingness to address controversial issues as they surface, not once these points of view have become popular. Our brand of fear—which is frankly selfish—censors our thoughts almost unnoticed. Next time, let’s skip the delayed reaction. I for one hope to do better.

So students may fear challenging conflicted faculty or administrators for fear of immediate academic punishment and future harm to career prospects in a society in which criticism of acquisitive leaders is decreasingly tolerated.

University of Minnesota

Earlier this year we posted about the troubling case of the death of an ostensibly voluntary participant in a clinical trial at the University of Minnesota years ago.  A particular concern was whether the money they received from the trial's sponsor influenced faculty and university leaders to overlook problems that might have put patients at risk in a trial whose main goal was marketing, not science.

The case got recent attention in an article by Dr Carl Elliott, a university professor of bioethics, and a letter he signed with other faculty requesting a new university inquiry into the case.  Not only did the university administration rebuff this request, but it now seems to be looking for ways to deter any future criticism of the institution's human research.  As reported in the Chronicle of Higher Education,
At the prompting of the University of Minnesota's general counsel, a committee of the University Senate has taken up the question of how faculty should collectively respond to "factually incorrect attacks" on particular faculty research.

Some faculty members say that direct appeal from the general counsel, Mark B. Rotenberg, is an attempt to quiet some faculty members' criticism of drug trials conducted at the university, including one seven years ago in which a participant, Dan Markingson, committed suicide. Before they took up the general counsel's question at a meeting this month, members of the university's Academic Freedom and Tenure Committee were provided with copies of material related to that case, including a letter sent by eight bioethicists to the Board of Regents last fall, asking it to appoint a panel of outside experts to examine the ethical issues raised by the death.

Committee members discussed with two administrators who attended that meeting, on April 8, whether faculty members have a responsibility to respond to attacks on fellow faculty members, according to minutes from the meeting; failure to do so, one professor said, could be seen as parallel to 'bullying.'

Professor Carl Elliott, who wrote the Mother Jones article that brought the recent unpleasantness of the Markingson case back into the public view, was concerned:
In an interview, Mr. Elliott said the general counsel's actions are troubling. Instead of fostering an open discussion about research practices, Mr. Rotenberg, and by extension the university administration, is attempting to use the faculty senate as a 'stalking horse' for intimidation and punitive action, Mr. Elliott said.

It defies common sense that Dr Elliott, representing only his own intellect and knowledge of ethics, was the "bully" in this case, while Mr Rotenberg, representing the university hierarchy, and the faculty members who ran the trial in which Mr Markingson died were the victims. As University of Minnesota faculty member Karen-Sue Taussig, a medical anthropologist, said per the Bioethics Forum:
I was worried the committee might be being used to intimidate a member of the faculty who was critical of the University. It seemed to me that there was a logical inconsistency in the University counsel's position: he did not provide any evidence that any individual faculty member felt chilled by Carl's work, yet his bringing up the issue clearly posed the threat of chilling Carl's speech. . . . In short, I was concerned about the possibility of an Orwellian attempt to invoke academic freedom in order to chill academic freedom.

By the way, there is also nothing to suggest that Dr Elliott's work was "factually incorrect."  Per the Bioethics Forum:
Philosopher and historian of science Ken Waters, who also attended the second meeting, was just as concerned. 'The University's general council planted a false question, the implicature of which [the committee] seemed to be uncritically accepting (that Carl was advancing factually incorrect claims),' he wrote to me in an e-mail. 'And in planting the question, the counsel was trying to turn the tables and squelch my colleagues' academic freedom by somehow suggesting that they were impinging upon the academic freedom of others.'

In the 1980s and 1990s, university administrators tended to attack speech they felt was hurtful to minorities and women, using speech codes (again as has been amply demonstrated by FIRE). Now they seem most sensitive to speech critical of their own exercise of power, and of the cozy financial relationships that generate conflicts of interest and threaten the academic mission.  Furthermore, now that it has become fashionable to decry "bullying," "anti-bullying" initiatives may become the chief way to quell criticism that make academic leaders uncomfortable.

Summary

At one time, university administrators and favored faculty justified attacks on free enquiry, a crucial part of the academic, by claiming a higher political or social purpose.  Now they seem to be willing to trash the core values of academia to stifle critics of their own actions, especially those involving lucrative conflicts of interest.   Such actions may be a major cause of the anechoic effect.
Increasingly, academic institutuions seem to be run more for the personal benefit of their leaders and their cronies than to discover and disseminate knowledge.  True health care reform would return academic medicine to its fundamental purpose, and return its leadership to those who would uphold the mission rather than fill their pockets.  

Hat tip to Ed Silverman in the PharmaLot blog re the University of Minnesota case.  See also comments by Prof William Gleason in the Periodic Table blog, e.g., here and here, and by Gary Schwitzer in the HealthNewsReview blog.

No Free Speech for Comparative Effectiveness Researchers?

We have repeatedly argued why comparative effectiveness research, under ideal circumstances, would be a good idea.  As I said before:
Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compared individual treatments to placebos, and when even those were restricted to narrow patient populations unlike those patient usually seen in daily practice, physicians are left juggling oranges, tomatoes, and carburetors.

Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients.

Because I believe that comparative effectiveness studies could be very useful to improve patient care, it upsets me to see this particular kind of clinical study get caught in political, ideological, and economic battles.
However, when comparative effectiveness research was proposed as an element of US health care reform, it was attacked as a vehicle for the dreaded rationing of health care (even though in the US health care is already rationed, especially to those without generous insurance or the means to pay for expensive tests and treatments), using arguments based more on emotions, or outright fallacies than on logic and evidence. For example, see our blog posts here, here, here, and here.

Those opposed to the sort of comparative effectiveness research I described above then seemingly decided, "if you can't beat 'em, join 'em."  Thus, a provision appeared in a recent version of health care reform legislation proposed in the US Senate for comparative effectiveness research to be sponsored by an "independent" institute whose board of directors would have to include a substantial minority of representatives of industry (that is, drug, biotechnology, device, health insurance corporations, and other corporations as "payers.")  This would seems to be a fairly shameless form of "regulatory capture," that is, an instance in which a government agency whose mission seems to be to improve health care is "captured" by those with vested interests in promoting certain health care products and services.  (See post here.)

My concern has now seemingly gone mainstream, in that it was addressed in a commentary published on-line in the prestigious New England Journal of Medicine.  [Selker HP, Wood AJJ.  Industry influence on comparative-effectiveness research funded through health care reform.  N Engl J Med 2009.  Link here.]

Selker and Wood addressed the issue of regulatory capture thus.
Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research.

The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee

Note that the situation is worse considering that the insurance industry and other "payers" also have seats on the board.

However, Selker and Wood discovered an even more outrageous provision:
The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome.

As Selker and Wood noted, it is unprecedented for a US government agency that is meant to sponsor science to be empowered to punish researchers for conclusions or opinions with which the agency disagrees. This suggests that the new agency would be meant to produce only results that support the vested interests of its leadership, that is, that favor the latest, and most expensive drugs and devices. The research sponsored by such an agency would not only be biased, it would likely be of poor quality, because researchers of integrity would likely avoid sponsorship by an agency that would be so threatening to their scientific independence.

This part of the bill does not promote health reform, but blatantly attempts to serve health care corporations while sacrificing the interests of patients and doctors.

As Selker and Wood politely put it:
If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected.

It seems to be almost gilding the lilly to note that the provision cited above seems to violate the free speech and free press provisions of the 1st amendment of the US Constitution, since they threaten government punishment of private citizens (e.g., by withdrawal of existing funding) purely for speech that the government does not like.

So I ask the anonymous Senate aide who drafted this provision, and the anonymous lobbyist(s) who influenced him or her, have they no shame? 

Finally, I have yet to see coverage of the Selker and Wood article in the mainstream media.  I hope they will eventually conclude that this attempt to co-opt clinical science and mock the 1st amendment is actually news and comment worthy. 
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