Addressing threats to health care's core values, especially those stemming from concentration and abuse of power - and now larger threats to the democracy needed to advance health and welfare. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.
This is número cinco in our series of attempts to shed some of this dander. But it keeps on rising. Here are two recent reports both relating to the life-on-the-ground of North American rank and file physicians, especially as that life increasingly revolves around data entry and digital madness over and above everything else.
Are physicians suffering from acute, maybe by now chronic, PTSD? In the 20 March 2018 number of the important Boston Globe-affiliated newsfeed STAT, Elizabeth Métraux, a prolific staffer and author at the eminent organization Primary Care Progress, gives us another quite useful take on physician burnout. An Iraq War veteran herself, the author gives us a provocative title that
pretty much says it all: "I experienced trauma working in Iraq. I see it now among America’s doctors." Her diagnosis is stark.
[A]s a health care advocate who has struggled with PTSD, it’s clear to me that many of our country’s health care providers are struggling with trauma, as well. And we’re doing little to support them.
Here's another snippet of conversation she recently had with a phyhsician colleague who'd also served in Iraq.
You know, I’d go back to the field any day. Beats practicing in my clinic. ... I didn’t become a doc to put up with billing codes and power struggles. I thought that PTSD would hit when I came home from Fallujah. It’s so much worse when I come home from the office. Truth is, I’ve lost my sense of purpose.
In what she terms "tiny betrayals of purpose," the death of 1000 tiny cuts, she outlines the extent to which the endless obsession by bosses with data entry and charge capture, the eight-minute patient encounter, the constant deflection of attention away from the patient all the while marketing and admin people are trumpeting "patient-centered everything" to their "customers," all of these have taken their toll.
Unfortunately, the usual caveat applies: making the diagnosis is a lot more straightforward than establishing the right therapy for the PTSD viewed by every student who rotates through a preceptor's community office: rapidly driving the best and brightest young physicians away from primary care. The author suggests the patient turn around and ask the physician how she is doing. But much more structural reform will be needed to curb these excesses and reverse these trends. Higher pay would be a fabulous start, not to mention forgiveness of medical school loans.
Less empathic but no less important: revenge of the EHR--more paper records than ever, revealing private information. A fascinating research letter published the same day in JAMA (behind paywall), out of several hospitals in Toronto, Ontario, reveals still more new--but actually, hardly new at all--issues raised by perverse effects of Electronic Health Records. More, not less, paper documents are being discarded because of the EHR. The investigators spent about half a year auditing all the recycling-bound paper from five hospitals. The results are arresting. Here are the key take-aways. Bear in mind the context: these institutions had Protected (Personal) Health Information (PHI) policies; they also had recycling bins and shredders where they needed to be.
Nearly a ton of paper was examined including nearly 3000 discrete documents.
The study was multi-institutional.
Every hospital contained examples--lots of examples--of PHI discarded in both in- and out-patient settings.
Over 2500 documents containing PHI were found, including over 1000 with highly sensitivbe information (defined as including both diagnoses and descriptions of patients' conditions).
The vast majority of these documents were found in out-patient settings.
The highest proportion of PHI-containing documents was found in physicina offices--not hospitals or institution-bound clinics.
Paper records were impossible--in distinction to electronic privacy breathes--to trace with respect to identifying responsible individuals.
The authors reported no actual harms accruing to the documents' discovery.
The biggest drawback of this study was its focus on recycling materials, as opposed to other random discards. But recycling does not means properly-disposed-of, so the data are important. Most important is the Revenge Effect, to quote from Edward Tenner's important analysis of technology's impact, of the EHR.
To any of those of us who've lived this scenario, it all sounds drearily familiar. EHR allows managerialism to run rampant in terms of up-coding and adherent to more often than not perverse incentives around Meaningful Use of EHRs. Not to mention outright abuse. But it actually produces all sorts of other perverse effects. One near and dear to our hearts is the "credit" for printed "Clinical Summaries cited as "performed" in EHR databases, but actually abandoned on printers. And, when retried, lacking any information on the clinical plan--essentially only listing medication lists that are often dangerously erroneous.
Now, from Toronto, but we already knew this, we're reminded that EHR didn't do away with paper. Because so much paper comes in and gets scanned to EHR, it is rather more pervasive--but now discarded in the wrong palce--than ever.
Physician burnout is in the news again. Late in 2015, an article by Shaneyfelt and colleagues in the Mayo Clinic Proceedings showed an increase in the proportion of physicians reporting at least one symptom of burnout to 54.4% in 2014(1), up from the 45.5% they reported in 2012(2). A March 28, 2017, post in the Health Affairs blog based on the latest article warning about burnout and suggesting how to address it got considerable attention.
Background - Physician Burnout
However, physician burnout is hardly new. As we wrote in 2012 about the predecessor the 2012 Shaneyfelt article, this is just the latest in a long series of studies showing physicians'
growing angst, dissatisfaction, burnout, or whatever one calls it. In
1987, in an AMA survey of physicians over 40, 44% replied that were they
given chances to do it all over again, they would not go into
medicine.(3) In a 2001 survey of Massachusetts physicians, 62.3% were
dissatisfied with the practice environment.(4) In 2002, a national
survey by the Kaiser Family Foundation showed that 45% of physicians
would not recommend that a young person should go into medicine.(5) In
a survey of primary care physicians in 2007, 38.7% were somewhat or
very dissatisfied.(6) I have a 6 inch thick set of paper files
containing articles on the subject, although it is remarkable how many
research studies reported only average scores on instruments, and hence
did not report proportions of physicians who were burned out or
dissatisfied. Yet the 2017 Health Affairs post garnered headlines declaring physician burnout to now be a crisis.
Whether the current attention to burnout will lead to any real improvements is doubtful. In particular, I am concerned that the Health Affairs blog post that sparked all the attention was at best misdirected. It avoided discussing more than a few of the most immediate, proximate causes of burnout. It seemed more motivated more by concerns about money than about patients and the physicians that try to serve them. It read like a top down diktat uninfomed by the concerns of physicians or patients, maybe because all of its authors were CEOs of large health care organizations, all but one large hospital systems.
I will venture to go through the issues point by point in the hope of sparking a discussion more focused on the physicians subject to or at risk of burnout, and ultimately the effects of their burnout on their patients.
For the Love of Money
While the blog post began with a nod towards improving the quality of, lowering the cost of, and improving access to health care, there was a subtext. Consider some quotes, first, stating that one cause of burnout is,
profound inefficiencies in the practice environment
Also,
The experience from Atrius Health suggests that replacing a physician who retires early or leaves to pursue other career opportunities can cost between $500,000 and $1 million due to recruitment, training, and lost revenue during this time.
Also,
Professional satisfaction for physicians is primarily driven by the ability to provide high-quality care to patients in an efficient manner.
Also,
As leaders, we must recognize burnout in physicians and other health care workers as a serious problem and respond vigorously. This is especially true if we want to maximize the effectiveness, productivity, and longevity of clinicians.
Also,
More than words are needed. Leaders of health care delivery organizations must embrace physician well-being as a critical factor in the long-term clinical and financial success of our organizations. We must make both the prevention of burnout and the restoration of the joy of a career in medicine core priorities, and address this issue with the same urgent methods we would use to solve any other important business problem: commit to measurement, develop strategy and tactics, and allocate the resources necessary to achieve success.
I would suggest that to a business CEO, efficiency refers to a state in which goods and services are produced with a minimum of costs. Furthermore, many business managers follow the business dogma first called the shareholder value theory, which seems mainly to be interpreted to mean managers should maximize short-term revenue as their first priority (look here). This is part of the larger financialization of all spheres of life, including hospital systems.
The focus on relentless revenue maximization may be reinforced by large incentives for top managers, particularly CEOs, based on revenue and other financial, not clinical outcomes. Such perverse incentives have resulted in huge increases in executive compensation for hospital CEOs. For example, as we recently discussed, author Dr John Noseworthy, CEO of the Mayo Clinic, received more than $2.3 million in total compensation in 2013, and was just reported to have received more than $2.5 million in 2015. Author Dr Delos (Toby) Cosgrove, CEO of the Cleveland Clinic, received more than $4.8 million in 2015 (look here).
Thus, too a hospital CEO, efficiency might mean the ability to provide services as cheaply as possible, and such efficiency is likely to be a top priority. The quotes above suggest that hospital CEOs mainly want to combat burnout to increase efficiency. One quote above refers directly to the monetary costs, again presumably
to the hospital, of losing physicians to burnout. One quote refers to
burnout as hampering physician productivity, which to a hospital CEO
might mean the ability to produce maximum billing, that is revenue, in
the minimum amount of time. Finally, one quote suggests that to the
authors, burnout is a business problem, not a human problem, or a
clinical problem.
Even stranger, two quotes suggest that the CEO authors believe inefficiency might cause burnout. That would appear very strange to employed physicians who may be increasingly pressured by top management to be more efficient, and thus to increase revenue. I would guess that many employed physicians would attribute their burnout to this relentless push for productivity and efficiency by top management.
So reading not between the lines, but the lines themselves suggests that the CEO authors might be more interested in reducing burnout to increase hospital revenues, and thus their total compensation, rather than to make physicians happier or more fulfilled, much to less improve patient care. Such a focus on revenue might not be reassuring to burned out physicians, especially those who feel forced to shortchange time spent with individual patients to fuel revenue. The repetitive discussion of efficiency and productivity in the Health Affairs blog post should worry any physician who feels his or her first responsbility is to take the best care of each individual patient.
Hear No Evil,...
Proximal Versus Organizational, Leadership and Governance Causes of Burnout
Here is what the blog post said about the causes of burnout:
The spike in reported burnout is directly attributable to loss of control over work, increased performance measurement (quality, cost, patient experience), the increasing complexity of medical care, the implementation of electronic health records (EHRs), and profound inefficiencies in the practice environment, all of which have altered work flows and patient interactions.
We dealt with the curious citation of inefficiencies as a cause of burnout above.
The rest of the items seem more plausible. However absent from the post is consideration of why physicians lost control over work, have been subject to performance measurement (often without good evidence that it improves performance, and particularly patients' outcomes), and have been forced to use often badly designed, poorly implemented EHRs. Particularly absent was any consideration of whether the nature or actions of large organizations, such as those led by the authors of the blog post, could have had anything to do with physician burnout.
Contrast this discusion with how we on Health Care Renewal have discussed burnout in the past. In 2012, we noted the first report on burnout by Shanefelt et al(2). At that time we observed that the already voluminous literature on burnout often did not attend to the external forces and influences on physicians that
are likely to be producing burnout. Instead, burnout etc has been addressed as if it were lack of resilience, or even some
sort of psychiatric disease of physicians.
In fact, we began the project that led to the
establishment of Health Care Renewal because of our general perception that physician angst was worsening (in the
first few years of the 21st century), and that no one was seriously
addressing its causes. Our first crude qualitative research(8) suggested hypotheses that physicians' angst was due to
perceived threats to their core values, and that these threats arose
from the issues this blog discusses: concentration and abuse of power, leadership that is ill-informed, uncaring about or hostile to the values of health care professionals, incompetent, deceptive or dishonest, self-interested, conflicted, or outright corrupt, and governance that lacks accountability, and transparency, . We
have found hundreds of cases and anecdotes supporting this viewpoint.
We found some corroboration of these hypotheses from other research. Written comments
from the 2001 Massachusetts survey made similar points about the causes
of dissatisfaction, for example: "too much emphasis on the bottom line.
Taken over by large corporations. Quality of care and interaction now
subsumed by productivity and profit," and "the once most noble
profession has become a factory job with a facade of ethics"(4) Pololi
and colleagues' qualitative interviews of young medical faculty included
anecdotes of angst due to academic leaders who put revenues ahead of
patient care, teaching, and research; and who allegedly used deception
for personal gain.(9) (Also, see our comments on this paper.)(10) Pololi
and colleagues' large survey of US medical faculty showed that over
half thought that managers were only interested in them because of the
money they brought in.(11) We were able to show in a preliminary
analysis of data from a physician survey that an instrument meant to
measure physicians' perception of the integrity of the leadership of
their organizations, which incorporated questions about whether leaders
supported core values, put patient care ahead of revenue, supported
transparency about quality issues, put patient care ahead of
self-interest, and displayed honesty strongly correlated (negatively)
with stress, intention to leave the practice, and burnout.(12)
Yet at best most studies of physicians' burnout, angst, or dissatisfaction
only vaguely allude to "system factors" and not greedy, money-focused,
preversely incentivized, self-interested, or corrupt leadership, etc as its causes. "System factors" such as bad EHRs and performance measures suggested by the Health Affairs bloggers were more likely to have been imposed on physicians by bad organizational leadership than by the physicians themselves. Of course, the CEO authors of the post likely would be made very uncomfortable with the notion that bad health care leadership, including of hospital systems like their own, might be a major cause of burnout.
Furthermore, there clearly have been leadership problems at many of the blog post authors' institutions that could have made them more uncomfortable. Cases involving some of the authors' institutions have appeared on
Health Care Renewal.
Most recently we noted that Mayo Clinic CEO Dr
Noseworthy had raised questions of mission-hostile management by suggesting that the Mayo Clinic should give some patients with commercial health care
insurance priority over those with less well paying government health
insurance (look here).
Not long ago we noted the controversy generated by Cleveland Clinic
CEO Dr Cosgrove's lukewarm approach to the Trump administration's
"Muslim ban," even though that ban had affected one of the Clinic's own
house-staff, while the Clinic was planning a fund raising event at
Mr Trump's Mar a Lago resort, raising yet more conflict of interest
questions (look here).
Finally, several of the Health Affairs authors have "board level" conflicts of interest. In 2006, we first blogged about a "new species of conflict of interest" which involved health care organizational leaders who were
simultaneously members of the boards of directors of for-profit health
care corporations or other corporations which could strongly influence health care. We posited these conflicts would be particularly
important because being on the board of directors entails not just a
financial incentive, but also requires board members
to "demonstrate unyielding loyalty to the company's shareholders" [Per
Monks RAG, Minow N. Corporate Governance,
3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]
Two Health Affairs blog authors have such conflicts. Dr Paul Rothman is on the boards of Merck and of Cancer Genetics, a biotechnology company specializing in DNA based testing. Dean M Harrison is on the board of Northern Trust,
a wealth management firm. He was on the board of Ikaria Inc, a
biotechnology company now part of Mallinckrodt, and incidentally is a special advisor
to Merrick Ventures, a private equity firm (look here).
Thus, how can one regard as credible an article on physician burnout which ignores how large organizations' nature or actions might be the major cause of such burnout, and which was written by the top leaders of such organizations?
Corporate Employment as a Cause of Burnout
Finally, the Health Affairs post mention of "loss of control over work" deserves special attention. It could represent a catch-all of more "system factors" as noted above. However, the biggest cause of physicians' loss of control over work may be the rising power of large health care organizations, in particular the large hospital systems that now increasingly employ physicians, turning them into corporate physicians.
In the US, home of the most commercialized health care system among
developed countries, physicians increasingly practice as employees of
large organizations, usually hospitals and hospital systems, sometimes
for-profit corporations. The leaders of such systems meanwhile are now often generic managers, people trained as managers without specific training or experience in medicine or health care, and "managerialists"
who apply generic management theory and dogma to medicine and health
care just as it might be applied to building widgets or selling soap.
We have also frequently posted about what we have called generic management, the manager's coup d'etat, and mission-hostile management.
Managerialism wraps these concepts up into a single package. The idea
is that all organizations, including health care organizations, ought to
be run people with generic management training and background, not
necessarily by people with specific backgrounds or training in the
organizations' areas of operation. Thus, for example, hospitals ought
to be run by MBAs, not doctors, nurses, or public health experts.
Furthermore, all organizations ought to be run according to the same
basic principles of business management. These principles in turn ought
to be based on current neoliberal dogma,
with the prime directive that short-term revenue is the primary goal.
Again, the authors of the Health Affaris post included some generic managers: Mr Edgeworth, whose highest degree was an MBA, and who had a long career
as a hospital manager; Ms Krevans, and MBA with an MPH, who also had a
long career as a hospital manager; and Mr Harrison, an MBA, who also had
a career in hospital management. Doubtless all of the authors lead organizations whose upper management is frequently generic and managerialist. It is likely that the hospital systems they lead increasingly employ physicians, who thus have become corporate. So the Health Affairs blog authors might not be comfortable with the notion that a major cause of burnout may physicians' new status as hired employees sometimes of their own hospital systems, rather than autonomous practitioners.
To repeat, how can one regard as credible an article on physician burnout which
ignores how large organizations' nature or actions might be the major
cause of such burnout, and which was written by the top leaders of such
organizations?
Summary
I am glad that physician burnout is getting less anechoic. However, in my humble opinion, the last thing physicians at risk of or suffering burnout need is a top down diktat from CEOs of large health care organizations. The CEOs who wrote the Health Affairs post may not have any personal responsibility for any particular physician's burnout. However, the transformation of medical practice by the influence of large health care organizations run by the authors' fellow CEOs, particularly huge hospital systems, often resulting in physicians practicing as hired employees of such corporations likely is a major cause of burnout. If the leaders of such large organizations really want to reduce burnout, they should first listen to their own physicians. But this might lead them to realize that reducing burnout might require them to divest themselves of considerable authority, power, and hence remuneration. True health care reform in this sphere will require the breakup of concentrations of power, and the transformation of leadership to make it well-informed, supportive of and willing to be accountable for the health care mission, honest and unconflicted.
Physicians need to join up with other health care professionals and concerned member of the public to push for such reform, which may seem radical in our current era. Such reform may be made more difficult because it clearly would threaten the financial status of some people who have gotten very rich from the status quo, and can use their wealth and power to resist reform.
Despite the fact that the current US president has stated he is for the "forgotten people" rather than the elites, do not expect such reform from him. He has sought advice on health care policy from the same people who wrote the Health Affairs post, as per the Washington Post, December 28, 2016:
On Wednesday, his guests were health-care executives, many of whom represent companies or institutions that have a big stake in the outcome of Trump’s ambitions to dismantle the Affordable Care Act. According to a pool report, the group, all men, met with him at 11 a.m. at the Mar-a-Lago estate in Palm Beach, Fla. They included John Noseworthy of the Mayo Clinic, Paul Rothman of Johns Hopkins Medicine, David Torchiana of Partners HealthCare and Toby Cosgrove of the Cleveland Clinic.
We truly live in interesting times.
References
1. Shanafelt TD et al. Changes in Burnout and Satisfaction With Work-Life Balance in Physicians and the General US Working Population Between 2011 and 2014. Mayo Clin Proc 2015; 90: 1600-1613. Link here.
2. Shanafelt TD, Boone S, Tan et al.
Burnout and satisfaction with work-life balance among US physicians
relative to the general US population. Arch Intern Med 2012; available
online here
3. cited in Schroeder SA. The
troubled profession: is medicine's glass half full or half empty? Ann
Intern Med 1992; 116:583-592.
4. Massachusetts Medical Society. Physician satisfaction survey (2001). Link here.
6. Kaiser Family Foundation. National survey of physicians - part III: doctors' opinions about their profession. Link here.
7. Merritt Hawkins & Associates. 2007 survey of primary care physicians. Link here.
8. Poses MD. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here.
9.Pololi L, Kern DE, Carr P, et al. 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.
10. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here.
11. Pololi L, Ash A, Krupat E. Faculty values in the culture of academic medicine: findings of a national faculty survey. Link here.
12. Poses RM, Baier-Manwell L, Mundt M, Linzer M. Perceived leadership integrity and physicians’ stress, burnout, and intention to leave practice. J Gen Intern Med 2005; 20: S182. Link here.
Musical Diversion
"For the Love of Money" by the O'Jays, used as the opening theme for (now President) Donald Trump's Celebrity Apprentice
Monday, May 18, 2015
Why is the New England Journal of Medicine Scolding "Pharmascolds"?
I, a normally quiet blogger on this site, was disquieted by what may be a backlash aimed at quashing the anti-conflict-of-interest movement.
Lisa Rosenbaum just published her second of three treatises in the highly prestigious New England Journal of Medine, scolding "pharmascolds" (see Conflicts of Interest: Understanding Bias — The Case for Careful Study). "Pharmascolds" is the term Rosenbaum and others use for those of us at Health Care Renewal, the Institute of Medicine, and countless medical journals and institutions. Why? Because we dare assert there is great danger when providers practice though saddled by (potential) conflicts of interests in medicine. Such conflicts are created when physicians (up to 94% of us, according to Rosenbaum's research), other health care providers in practice, and health care organizations accept, not only gifts and trinkets, but also large, sometimes clandestine consulting fees and other arrangements from pharma and device companies, all the while providing direct patient care using the companies' products.
Rosenbaum and others say we pharmascolds are essentially self-righteous and obstructionist, holding back the progress of medical science. In this article, she seems to claim that not proving direct patient harm from a specific questionable financial arrangement with a company whose product we may therefore more likely prescribe, speak well of, or publish (pseudo)evidence supporting the use of, is enough of a reason to justify the arrangement.
Wouldn't that be the same as saying, "Until you actually crash into another car while texting, it's ok to text while driving, even if it's distracting."?
Rosenbaum uses mainly anecdote to prove her point, and appeals to a little-quoted, but still important, heuristic/bias called "moral liscensing." Rosenbaum describes the phenomenon correctly: "once disclosure [of a conflict of interest] gets the weight [of guilt] off your chest, you feel liberated and may feel licensed to behave immorally." True. But then Rosenbaum seems to support non-disclosure of acts that create conflicts of interest, because disclosure doesn't decrease the acts themselves.
Rosenbaum goes further. At the same time as she supports non-disclosure of conflicts, she attempts to paint those who accept conflict-generating arrangements and keep them clandestine as victims--afraid to "come out of the closet" because doing so is socially taboo, though the activity is not wrong.
I beg to differ. For certain acts, potential conflicts, and actual conflicts, it seems to me that mere disclosure of the act or conflict shouldn't relieve one of the guilt associated with the act or conflict. It also seems disclosure of a conflict should not make a speaker seem more credible to his/her audience because of its disclosure, though some research Rosenbaum quotes seems to show that disclosure improves credibility.
Perhaps the stronger argument for disclosure is to disqualify people from activities that should be prohibited for people in conflict, as well as to warn people away from engaging in questionable activities that would result in conflicts.
In an unbelievable twist of logic, Rosenbaum seems to be arguing in this article for more, not less of these questionable activities, in the interest of advancing science, until we prove patients are directly hurt by them, i.e., we have a "wreck." Heck, let's get rid of traffic lights too, while we're at it. People have eyes. We should trust them. They should be able to avoid accidents voluntarily, on their own.
In short, how could Dr. Rosenbaum not see that the best solution for the "problem" of conflicts of interests is avoidance when possible? One can't help but wonder if she and the Journal aren't blinded by the shimmer and pull of powerful, influential organizations, ones so shiny, so strong, and so ubiquitous that resistance is just too hard for her, the Journal, and for 94% of us.
Conflicts of interest should be avoided. Society has accepted that improved health will result not just from secondary prevention (e.g., not texting while driving after one has had an accident from the activity), but also from primary prevention (not texting while driving, even before an accident occurs).
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.
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)
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.
We have frequently discussed how perverse incentives are spread around health care. In the US, the physicians are paid according to a system that provides strong incentives for doing procedures, (see our posts about how the RUC has encouraged this bias towards procedures.) Since physicians are the most influential "deciders" about the care of individual patients, these incentives encourage overtesting and overtreatment with the highest technology, driving up costs and subjecting patients to increased risks of adverse events. The recent health care reform law, however, essentially encouraged a version of capitated payment, which might very well provide incentives for undertreatment and undertesting. For years, Dr Robert Centor has argued logically and forcefully for paying physicians for the time they spend on behalf of payments, very analogous to how lawyers and many other professionals are paid. This might provide much more neutral, less perverse incentives than would existing or other proposed physician payment schemes. Dr Centor argued again for this seemingly reasonable and logical idea on his DB's Medical Rants blog. The big question is why this idea has been so anechoic?
The latest article on physician burnout has actually attracted some media attention. e.g., here and here.
The Latest Article
The article was a survey of physicians in all specialties with over 7000 respondents (unfortunately a less than 27% response rate.)(1) Its most notable findings were:
- The rate of burnout among physicians was 45.4%
- Physician specialties with higher than average rates were emergency medicine, general internal medicine, neurology, and family medicine.
- The proportion of physicians who may have been depressed, (using the Primary Care Evaluation of Mental Disorders screening instrument,) was 37.8%
So almost half of all physicians, and more than half of the front-line physicians who treat adults appear to be burned out, while more than one-third of physicians may be clinically depressed. So it is not surprising that the authors called the rate of burnout "alarming."
They also commented on the implications of their data,
Unfortunately, little evidence exists about how to address this problem. Although extensive literature suggests that contributors include excessive workload, loss of autonomy, inefficiency due to excessive administrative burdens, a decline in the sense of meaning that physicians derive from work, and difficulty integrating personal and professional life, few interventions have been tested. Most of the available literature focuses on individual interventions centered on stress reduction training rather than organizational interventions designed to address the system factors that result in high burnout rates.
Previous Studies of Burnout and Dissatisfaction
This study, in fact, is just the latest in a long series of studies showing physicians' growing angst, dissatisfaction, burnout, or whatever one calls it. In 1987, in an AMA survey of physicians over 40, 44% replied that were they given chances to do it all over again, they would not go into medicine.(2) In a 2001 survey of Massachusetts physicians, 62.3% were dissatisfied with the practice environment.(3) In 2002, a national survey by the Kaiser Family Foundation showed that 45% of physicians would not recommend that a young person should go into medicine.(4) In a survey of primary care physicians in 2007, 38.7% were somewhat or very dissatisfied.(5) I have a 6 inch thick set of paper files containing articles on the subject, although it is remarkable how many research studies reported only average scores on instruments, and hence did not report proportions of physicians who were burned out or dissatisfied.
The Causes of Dissatisfaction and Burnout
What is most remarkable about this voluminous literature is its relative lack of attention to the external forces and influences on physicians that are likely to be producing burnout, and the general aversion to promoting any interventions that could conceivably affect these external threats. Instead, burnout etc has been addressed as if it were some sort of psychiatric disease of physicians. This was noted above by Shanafelt et al.
In fact, the reason that we did the crude qualitative literature that lead to my articles on health care dysfunction (6), and to the establishment of Health Care Renewal was a general perception that physician angst was worsening (in the first few years of the 21st century), and that no one was seriously addressing its causes.
Our first crude research suggested that physicians' angst was due to perceived threats to their core values, and that these threats arose from the issues this blog discusses: concentration and abuse of power, bad governance and leadership of health care organizations, and the rise of various dishonest and unethical practices that affect physicians. We have found hundreds of cases and anecdotes supporting this viewpoint.
There is some corroboration of these assertions. Some written comments from the 2001 Massachusetts survey made similar points about the causes of dissatisfaction, for example: "too much emphasis on the bottom line. Taken over by large corporations. Quality of care and interaction now subsumed by productivity and profit," and "the once most noble profession has become a factory job with a facade of ethics"(3) Pololi and colleagues' qualitative interviews of young medical faculty included anecdotes of angst due to academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain.(7) (Also, see our comments on this paper)(8) Pololi and colleagues' large survey of US medical faculty showed that over half thought that managers were only interested in them because of the money they brought in.(9) We were able to show in a preliminary analysis of data from a physician survey that an instrument meant to measure physicians' perception of the integrity of the leadership of their organizations, which incorporated questions about whether leaders supported core values, put patient care ahead of revenue, supported transparency about quality issues, put patient care ahead of self-interest, and displayed honesty strongly correlated (negatively) with stress, intention to leave the practice, and burnout.(10)
Yet at best studies of physicians' burnout, angst, or dissatisfaction only vaguely allude to "system factors" and not greedy, money-focused, self-interested, or corrupt leadership, etc at its causes. And again as noted above, most interventions meant to improve burnout have treated it like a psychiatric illness, not a rational response to a badly lead, dysfunctional health care system.
Why Has Nothing Changed?
The real question is why so little has changed given this now 20 plus year history of the documentation of burnout, and why there has been such avoidance of what appears to be the real causes of the problem. One question worth raising again at this time is why the organizations one might think would be interested in helping physicians address causes of burnout have not done so.
One might think that medical societies, foundations interested in improving health and health care, bodies that accredit physicians, and academic medicine in general would all be interested in addressing the causes of physician burnout, dissatisfaction, and angst. However, I am aware of no significant action on their part. (There have bee some some marginal actions by the smallest of these organizations, e.g., the Society of General Internal Medicine's call to "chuck the RUC," see this post)
We should not be surprised, since most of these organizations have become more creatures of health care corporations than noble proponents of physicians' core values. Most of these organizations have substantial institutional conflicts of interest, and are often lead by individuals with their own individual conflicts of interest.
Medical societies, in particular, now often get significant financial support from industry (pharmaceutical, biotechnology, medical device and even health insurance companies). The societies' leaders are often full-time executives, not necessarily physicians, who may look to their industry sponsors to continue to provide the funds that support nice salaries and luxurious offices. The society's officers and boards are often dominated by physicians with their own conflicts of interest. (Look here for more examples, and see, in particular, the case of the AAOS).
So 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.
References
1. Shanafelt TD, Boone S, Tan et al. Burnout and satisfaction with work-life balance among US physicians relative to the general US population. Arch Intern Med 2012; available online here. 2. cited in Schroeder SA. The troubled profession: is medicine's glass half full or half empty? Ann Intern Med 1992; 116:583-592. 3. Massachusetts Medical Society. Physician satisfaction survey (2001). Link here. 4. Kaiser Family Foundation. National survey of physicians - part III: doctors' opinions about their profession. Link here. 5. Merritt Hawkins & Associates. 2007 survey of primary care physicians. Link here. 6. Poses MD. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130. Link here. 7.Pololi L, Kern DE, Carr P, et al. 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. 8. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here. 9. Pololi L, Ash A, Krupat E. Faculty values in the culture of academic medicine: findings of a national faculty survey. Link here. 10. Poses RM, Baier-Manwell L, Mundt M, Linzer M. Perceived leadership integrity and physicians’ stress, burnout, and intention to leave practice. J Gen Intern Med 2005; 20: S182. Link here.
With desultory interest, I picked up a 1993 novel at the library, The Surgical Arena, by Peter Grant, M.D., “a former navy pilot who became a surgeon.” The following snippet, on page 18, says a lot in a nutshell:
“We’ve got one shot at getting into medical school and that means getting our grades into the top twenty.”
“Why don’t we all just quit and take some gut courses that will prepare us to be brokers,” said Beckwith, one of the veterans. “We can sit on our asses and make a lot of dough.”
“You have to be a crook to be successful in that field,” said Norman. “Besides, you’ll never get any satisfaction out of life unless you put something worthwhile back into it. I didn’t fight in the infantry to come back and become a broker.”
1993 was the same year that a short-sighted Congress cancelled the Texas supercollider project. It’s been correctly noted that had that not happened, the recent Higgs-Boson particle observation might have occurred here rather than in Switzerland. A number of the now-unemployed physicists involved were hired by Wall Street firms.
Although basic banking DOES perform a socially useful function -- firms and individuals DO need capital -- it is very questionable what if anything “banking innovations” (CDOs, derivatives, very rapid short-term computerized trading, etc.) that have proliferated since 1993 have contributed to society. As Roger Bootle wrote:
For m]uch of what goes on in financial markets . . . [t]he gains to one party reflect the losses to another, and the vast fees and charges racked up in the process end up being paid by Joe Public, since even if he is not directly involved in the deals, he is indirectly through the costs and charges that he pays for goods and services.
In 1995, the assets of the six largest bank holding companies was no more than 17% of GDP, but at the end of 2010, the assets of the six largest bank holding companies were valued at just over 63 percent of GDP. This financialization of the economy has been at the expense of the rest of us. And finance is now the top area where graduates of Ivy League universities find jobs.
As Dale Carnegie points out, all people – even gangsters like Al Capone – think of themselves as “good guys”. Lloyd Blankfein, Goldman Sachs’ CEO, is probably sincere when he says he is “doing God’s work”. But many of us do not agree. Things work as well as they do only because many people are actually still working hard at useful jobs that do contribute to society. My thanks go to those – and not to the so-called “wealth creators.”
We have frequently posted, first here in 2007, and more recently here and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC.
Since 1991, Medicare has set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort they expend, and the resources they consume on particular patient care activities. Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1) A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, and understanding patients' values and preferences when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients.
As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.
To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95 (although now with the notation that the product has been "discontinued.") However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership is at best relatively opaque.
To expand on the ultimate point, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."
The fog surrounding the operations of the RUC seems to have affected many who write about it. We have posted (here, here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until 2010, after the US recent attempt at health care reform, the RUC seemed to remain the great unmentionable. Even the leading US medical journal seemed reluctant to even print its name.
That changed in October, 2010. A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser Health News yielded two major articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted by Kaiser Health News.) The articles covered the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc.
So the RUC became less anechoic. Now, four months later, there is more news. A new site called "Replace the RUC!" has now appeared, with the following introduction:
This site has been developed - see here for our backgrounds - to help primary care physicians and other interested individuals obtain verifiable background from reputable sources on:
* The evolution and structure of the US' medical payment system.
* How it came to devalue primary care and favor specialty services.
* How that has translated to lower quality care at far greater expense in the US.
We believe the overwhelming majority of American primary care physicians are deeply frustrated with the differences in how primary and specialty care are valued by the current system, and the havoc that system has wrought throughout health care and the nation.
The first step to remedying this situation is for the primary care medical societies to visibly and loudly withdraw from participation in the RUC, de-legitimizing the process.
That said, this effort is most decidedly NOT primarily about getting primary care physicians more money, but bringing our health system back into homeostasis.
We have previously noted that there are many unanswered questions about the RUC:
How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
How did the RUC become de facto in charge of this process?
Why does the AMA keep the membership of the RUC so opaque, and give no input into the RUC process to its general membership?
Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?
We welcome this new site as a way to answer these questions, and more importantly, as a way to develop more rational incentives within the health care system.
Note that "Replace the RUC!" will be added to our link list.
References
1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.) 2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)
We have frequently posted, first here in 2007, and most recently here and here, about the little-known group that controls how the US Medicare system pays physicians, the RBRVS Update Committee, or RUC.
Since 1991, Medicare as set physicians' payments using the Resource Based Relative Value System (RBRVS), ostensibly based on a rational formula to tie physicians' pay to the time and effort the expend, and the resources they consume on particular patient care activities. Although the RBRVS was meant to level the payment playing field for cognitive services, including primary care, vs procedures, over time it has had the opposite effect, as explained by Bodenheimer et al in a 1997 article in the Annals of Internal Medicine.(1) A system that pays a lot for procedures, but much less for diagnosing illnesses, forecasting prognoses, deciding on treatment, understanding patients' values and preferences, when procedures and devices are not involved, is likely to be very expensive, but not necessarily very good for patients.
As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.
To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership as at best relatively opaque.
To expand on the ultimate point, as Goodson(2) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."
The fog surrounding the operations of the RUC seems to have affected many who write about. We have posted (here, here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. Up until now in 2010, after the US recent attempt at health care reform, the RUC seems to remain the great unmentionable. Even the leading US medical journal seems reluctant to even print its name.
That has just changed. A combined effort by the Wall Street Journal, the Center for Public Integrity, and Kaiser yielded two major articles about the RUC, here in the WSJ (also with two more spin-off articles), and here from the Center for Public Integrity (also reprinted by Kaiser Health News.) The articles cover the main points about the RUC: its de facto control over how physicians are paid, its "secretive" nature (quoting the WSJ article), how it appears to favor procedures over cognitive physician services, etc.
So the RUC has suddenly become less anechoic.
However, despite the best efforts of some very good investigative reporters, there still are important unanswered questions, questions we have raised before:
How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
How did the RUC become de facto in charge of this process?
Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?
Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them? If we do not fix them, do we really think we can "bend the cost curve?" If we do not control our costs, do we really think that we will be able to make good health care accessible for all? At least now I can say that the issue may really be in play for health care professionals, health care policy experts, and the public at large.
See also comments on other blogs: DBs Medical Rants, GoozNews, and Managed Care Matters.
References 1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.)
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)
The parade of legal settlements marches on. The latest story is about Forest Laboratories and its marketing of Celexa (citalopram ) and Levothyroid (l-thyroxin). Here is the most complete version, courtesy of Natasha Singer reporting for the New York Times. First, the lead sentence:
A unit of Forest Laboratories, the maker of the antidepressant Celexa, agreed on Wednesday to pay more than $313 million to settle criminal and civil complaints, including a claim that it had illegally promoted the drug for use in children.
Here are the charges:
Among the criminal charges was one that the subsidiary, Forest Pharmaceuticals, marketed Celexa, which was approved only for adult depression, to treat children and adolescents. The government also claimed that, in conjunction with the company’s off-label promotion, Forest publicized the positive results of a study on Celexa in adolescents while failing to tell doctors about a similar study that had negative results.
'Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the F.D.A. and the American public,' Carmen Ortiz, the United States attorney for the District of Massachusetts, said in a statement Wednesday.
In addition, federal prosecutors accused Forest of paying doctors to induce them to prescribe Celexa and another antidepressant, Lexapro. The remuneration included 'cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services,' the government said in its civil complaint.
Among the items that Forest sales representatives gave to doctors from 1998 to 2005, the complaint said, were tickets to St. Louis Cardinal games, which were to be 'leveraged and sold as a reward for prescriptions'; a $1,000 gift certificate to Alain Ducasse, a gourmet French restaurant, for a high-prescribing child psychiatrist; a deep-sea fishing trip off Cape Cod for a doctor and his three sons; $400 in Broadway theater tickets for a doctor and his wife; and Red Sox tickets worth $2,276 to be used for doctors in the Boston area.
So we not just off-label marketing, but suppression of clinical research (of course, a study whose results were not favorable to the product being marketed), and payments to doctors as an "inducement to prescribe."
But wait, there is more:
As part of the criminal settlement, Forest Pharmaceuticals, which is based in St. Louis, agreed to plead guilty to one felony count of obstructing justice, acknowledging that employees had lied to F.D.A. officials during a plant inspection in 2003.
The company also agreed to plead guilty to two misdemeanors, one of which covers the company’s misbranding of Celexa by marketing the antidepressant for use in children from 1998 to 2002.
The other misdemeanor covers the illegal distribution from 2001 to 2003 of an unapproved drug, Levothroid, to treat a thyroid hormone deficiency. Such thyroid pills, made by various drug makers, had been sold in the United States since the 1950s without F.D.A. approval. But in 2001, the agency told drug makers that they needed to reduce their distribution of such medications until the companies obtained agency approval to market the pills.
The criminal charges accused Forest of making a deliberate decision to continue distributing the drug in quantities exceeding the F.D.A.’s directive. After the agency sent a warning letter to Forest, the company directed employees to work until 1 a.m. to continue shipping as much Levothroid as possible, according to the criminal complaint.
So there was also obstruction of justice in the form of lying to the FDA, and selling drugs that the FDA had ordered not to be sold.
So what are the penalties?
The criminal settlement calls for the company to pay a $150 million fine and to forfeit an additional $14 million in assets. Forest will also pay more than $88 million to the federal government and more than $60 million to the states to resolve a civil complaint that its actions caused false claims to be submitted to federal health care programs. In addition, two whistle-blowers will split $14 million from the federal share of the settlement.
Forest has also entered into a five-year corporate integrity agreement, requiring an independent expert to review the company’s compliance with drug marketing regulations.
So here we go again. A large drug company was up to no good, suppressing research, paying doctors for their prescriptions, lying to the FDA, and disobeying its orders.
The penalty seemed large, over $300 million. However, Celexa was a big revenue generator at the time the events above occurred, topping $1 billion in revenue first in 2002 (per Forbes here). Furthermore, as noted by Ed Silverman on Pharmalot, it seems no individual will suffer any negative consequences for authorizing, directing, or implementing the conduct described above. Finally, as best I can tell, despite the fact that a Forest subsidiary will plead guilty to a felony, the company is not going to be barred from doing business with the government.
So, despite pleading guilty to a felony and three misdemeanors, neither Forest as a company nor any individual working for the company will really suffer very much. On the other hand, the leaders of Forest have been doing very well. The company's CEO, Howard Solomon, was number 18 on Wall Street Journal list of the 25 highest paid CEOs over the last decade. His total realized compensation was over $385 million over the last 10 years. According to the company's 2010 proxy statement, his total compensation in 2009 was $8,267,236. The four other highest paid executives made from just over $2.5 million to $5.3 million.
So here we go again. Another large health care organization has been found to have done wrong, but the only penalty is a fine that whose impact will be diffused across the whole company, and ultimately be paid by its employees, its customers, including patients, and its stockholders. Meanwhile, the people who authorized, directed, or implemented the wrong doing apparently will pay nothing and receive no negative incentives. Furthermore, the top leaders of the company, whose huge compensation in the past was increased by the results of the wrong doing, will continue to prosper.
As we have said again and again, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.
By the way, the current case offers an avenue for those who do not like what Forest did to ask those who are supposed to be ultimately responsible for its behavior how this was allowed to happen. The board of directors of the company is supposed to be ultimately accountable for the company's actions. As we have noted before, these directors are supposed to "demonstrate unyielding loyalty to the company's shareholders." [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]
The current directors of Forest Laboratories, according to the company's 2010 proxy statement, include Dr Nesli Basgoz, "Associate Chief for Clinical Affairs, Division of Infectious Diseases, Massachusetts General Hospital (MGH)," and "Associate Professor of Medicine at Harvard Medical School." Also, it includes Dr Lester B Salans, "Clinical Professor" at Mount Sinai Medical School, not to mention Dr Peter J Zimetbaum, "Director of Clinical Cardiology" at Beth Israel Deaconess Medical Center in Boston (BIDMC), and "Associate Professor of Medicine at Harvard Medical School." Maybe some enterprising student journalist will get to ask the good doctors how they let things at Forest get so ethically out of hand.
Last week, the influential New England Journal of Medicine published an article by Bruce Vladek entitled "Fixing Medicare's Physician Payment System."(1) Although only identified as working for Nexara, a health consulting business, Mr Vladek was a former administrator of what was then called the Health Care Financing Administration (HCFA) of the US Department of Health and Human Services (DHHS), the part of the department that then ran the US Medicare program. Vladek thus can reasonably be viewed as an expert on Medicare.
Vladek identified two main problems with the current way physicians are paid by Medicare. First,
Medicare is captive to an arbitrary, if elegantly conceived, formula for total payments to physicians — the sustainable growth rate (SGR). In the alternate reality of the Congressional budget process, the SGR will reduce Medicare's physician payments, which already trail those from private insurers, as far into the future as the eye can see.
Second,
there is widespread consensus that the relative fees in the current system are a significant cause of the growing imbalance in supply and utilization between primary care and specialty services in the U.S. health care system. That imbalance, in turn, is widely perceived as a major cause of both excessive costs and inadequate quality of care. This is not just a Medicare problem: the Medicare Resource-Based Relative Value Scale is used by most private insurers to set relative prices for physicians.
Vladek expanded on the second point as follows
the basic mechanics of the Medicare Physician Fee Schedule, which was supposed to change physician payment to increase rewards for primary care services at the expense of procedural and interventional services, appears to have gone totally off track. For various reasons, the fee schedule, which originally did increase the prices of evaluation and management services relative to those of surgery or invasive procedures, turned in the other direction through the process of annual updating of relative value units. Surgeons, radiologists, and some medical specialists are now paid two to three times as much per hour as providers of cognitive services, which is about where we began 20 years ago; this was the situation that the fee schedule was supposed to fix.
The question of the relative virtues of primary versus specialty care can be debated ad nauseam, but in other wealthy countries that serve their populations at least as well as we do, the ratio of primary care physicians to specialists is much higher than in the United States, and the gap in compensation is much smaller or the poles even reversed. Young physicians, burdened by increasing educational debts, may well choose a career path on the basis of a major difference in compensation, especially when the better-compensated positions require less ongoing responsibility for patients and offer better working hours.
This is about all that Vladek wrote about how the imbalance between how Medicare pays for primary care and other "cognitive services," and for procedures came about. Vladek, and many others have argued that this imbalance has lead to strong financial incentives that have been slowly destroying primary care, and strong incentives that have lead to the use of too many procedures, both strong drivers of rising costs in the most expensive health care system in the world.
Vladek noted vaguely that "through various reasons," the incentives were imbalanced by "the process of annual updating of relative value units."
However, as we have discussed in several blog posts, a lot more is known about how this process got "totally off track."
In fact, in 2007, an article by Bodenheimer et al in the Annals of Internal Medicine explained the problems in considerably more detail.(2) As we wrote then, Its main points included
Proceduralists are often able to learn how to do their procedures more quickly, and thus increase the volume of procedures done, while office and hospital visits can only be sped up so much.
The process used to update the RBRVS system is biased towards procedures for three main reasons: 1. "specialty society influence in proposing RVU [relative value unit] increases," 2. the specialist-heavy RUC [Relative Value Scale Update Committee] membership," and 3. "the desire of RUC specialists to avoid increases in evaluation and management [that is, cognitive, or non-procedural] RVUs."
Medicare now uses a formula to limit increases in overall spending. The use of this formula leads to across the board cuts in all reimbursements. Since cognitive services reimbursements were never high to begin with, and have rarely been individually increased, these cuts tend to have disproportionate decreases.
Private insurers and managed care organizations tend to follow Medicare's lead in their reimbursement procedures, but tend to tilt the playing field even more in favor of procedures versus cognitive services. Several studies showed that such payers paid more for procedures than did Medicare, but about the same for office and hospital visits.
The role of the RBRVS Update Committee (RUC) is complex and in many ways mysterious. As we wrote before, to update the system, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee. The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are opaque, and the proceedings of the group are secret.
To expand on the penultimate point, the current page on the AMA web-site that describes the RUC only lists its members in terms of their specialties and organizational affiliation. Their names do not appear. A response to a previous post by me on the subject by the then Chair and Chair-Elect of the RUC suggested that the RUC membership is not quite secret. They stated that "a list of the individual members of the RUC is published in the AMA publication, Medicare RBRVS 2009: The Physicians Guide." This publication is available from the AMA here for a mere $71.95. However, the book is not on the web, or in my local or university library, and I have no other way to easily access it. Thus, the RUC membership as at best relatively opaque.
To expand on the ultimate point, as Goodson(3) noted, RUC "meetings are closed to outside observers except by invitation of the chair." Furthermore, he stated, "proceedings are proprietary and therefore not publicly available for review."
The fog surrounding the operations of the RUC seems to have affected many who write about. We have posted (here, here, and here) about how previous publications about problems with incentives provided to physicians seemed to have avoided even mentioning the RUC. In 2010, post the US recent attempt at health care reform, the RUC seems to remain the great unmentionable. Even the leading US medical journal seems reluctant to even print its name.
Thus, as we noted before, however, the mysteries about it remain:
How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry.
Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC?
How did the RUC become de facto in charge of this process?
Why does the AMA keep the membership on the RUC so opaque, and give no input into the RUC process to its general membership?
Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers?
Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures?
Without discussing how the incentives for physicians became so unbalanced, do we really expect we can fix them? In this case, the persistence of the anechoic effect seems to be doing real damage to the discussion of the critical issues we in the US face today. References
1. Vladek B. Fixing Medicare's physician payment system. N Engl J Med 2010; 362:1955-1957. (Link here.) 2. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. (Link here.) 3. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. (Link here.)
