At University of Miami, Faculty Without Confidence in their Hired Managers Afraid to Identify Themselves

The University of Miami has provided some vivid examples of the contrast between the power and privileges of the leaders of large health care organizations and the subservient role of faculty and staff. 

Background

Back in 2006, we noted that while the University of Miami was paying its janitorial support staff less than seven dollars an hour, and supplying them with no health insurance, its President, Donna Shalala, was living in a 9000 square foot official mansion, with staff hired to make her bed.  While Ms Shalala did not seem very perturbed about the living conditions of the lowliest University staffers, as a member of the board of directors of UnitedHealth, she approved the munificent compensation given to its then CEO, Dr William McGuire (look here), who was a billionaire until he was forced to give up  some of the backdated stock options she had approved (look here).  More recently, we discussed how Ms Shalala's "visionary" leadership included presiding over the hiring of Dr Charles Nemeroff, who had previously been forced to resign as chairman of psychiatry at Emory University for various unethical activities (look here).  Last year, while awaiting the construction of a new presidential mansion, Ms Shalala presided over layoffs of hundreds of faculty and staff, which may have been necessitated by bad spending decisions made by her or those who reported to her (look here). 

The Faculty Protest

All these shenanigans apparently finally succeeded in upsetting the faculty, as described in a new article in the Miami Herald.  The article's headline was about the resignation of the University of Miami Miller Medical School's second highest ranking executive in response to faculty anger:

Amid roiling faculty anger over drastic budget cuts, the University of Miami announced that the No. 2 executive at the Miller School of Medicine, Jack Lord, is 'stepping down.' 

Dr Lord was apparently taking the fall for the previous mass layoffs, some affecting faculty in 2012:

[Medical School Dean Pascal]  Goldschmidt defended his administration’s performance: 'Last year we had many challenging issues to fix, as do many medical schools in the U.S. Thanks to Jack Lord’s leadership and hard work by everyone at the Miller School, we have met those challenges and turned things around financially.'  The announcement comes after a tumultuous year in which the medical school suffered a severe financial crisis and its leaders responded with a major overhaul that included the layoffs last spring of over 900 full-time and part-time employees — moves that angered many professors.

In a letter to faculty sent on Wednesday, Goldschmidt insisted the problems have been fixed. Goldschmidt credited Lord for helping improve the medical school’s finances, which showed a surplus of about $9 million for the first six months of this fiscal year — compared to a $24 million loss for the first six months of the previous fiscal year.

Lord, a physician who had been an executive at Humana, became chief operating officer last March, as the restructuring plans started.

However, the faculty's anger was not just directed at Dr Lord, who as noted above seemed to have been hired to take responsibility for the layoffs:

The change, announced by Dean Pascal Goldschmidt, comes as a petition circulates among tenured medical school faculty expressing no confidence in both Goldschmidt and Lord.

In particular,

Meanwhile, several sources sent The Herald a copy of a petition being circulated among school faculty members who 'wish to express, in the strongest possible terms, the concern we feel for the future for our school of medicine.' The petition blamed 'the failed leadership of Pascal Goldschmidt and Jack Lord. ... We want to make clear that the faculty has lost confidence in the ability of these men to lead the school.'

Furthermore,

 Many faculty members, who had spent decades at the medical school without seeing mass layoffs, were angry that the cuts were made without consulting them. A report by a faculty senate committee said medical school professors described the layoffs as 'unprofessional,' 'graceless' and 'heartless.' 

Yet there is no hint that Dr Goldschmidt, or President Shalala to whom he reports are yet affected by this protest.  

Tenured Faculty Scared into Anonymity

In fact, while the faculty are upset, they are also afraid.

The report contended that the internal turmoil had prompted some faculty members to consider leaving and that 'fear is widespread.' It also cited instances of employees suffering retribution for criticizing the administration.

There is so much fear that the faculty constructed an elaborate mechanism to register protest while remaining individually anonymous.

A half-dozen people closely connected to the medical school who requested anonymity told The Herald that they’ve heard that between 400 and 600 of the school’s 1,200 faculty have added their names to individual copies of the petition.

The petitions are addressed to the chair of the faculty senate, Richard L. Williamson, a law professor. Williamson said last week he would not comment on how many had signed the petition because it was 'an internal matter' and may never become public. He said the number of those who know how many have signed is 'extremely small and none of them will talk.'

Three sources told the Herald that faculty are sending individually signed copies of the petition to the senate chair with the understanding that Williamson would not reveal their names to UM administrators. 

Summary

Read more here: http://www.miamiherald.com/2013/01/03/3166198_p2/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

 So, up to half of the University of Miami's medical faculty may be so upset with the current administration, apparently in part due to faculty and staff layoffs after questionable decisions by administrators some of whom may have lived large at university expense, that they essentially voted no confidence.  Yet the faculty are afraid to put their own names on their protest.

So this is not just a story about allegedly incompetent university executives, and about the contrast between the rewards such executives get and the results of their dubious management.  It is also a story about how the executives' power now threatens a bed-rock value of academia, the ability of faculty (and by extension, staff and students), to speak freely, even if that speech offends the university's management.  In this case, while apparently hundreds of faculty condemned the administration for autocratic, incompetent, self-serving actions, they all feared what that same administration could do to them if their identities were known.

In the last few years there has been a lot of prattle about the "flat organization," and there have probably been at least a few small high technology start ups that really were run on a collegial basis.  However, as we have shown again and again, throughout the corporate world, extending to health care corporations, and then to non-profit health care organizations, top management insiders have assumed more power and paid themselves better and better at the expense of all others (look here).  Even now in universities, which used to be examples of collegiality, and were run in somewhat democratically  by their faculties, faculty are obviously afraid to challenge the hired managers. 

Clearly, universities in which faculty cannot disagree with management are not going to be able to exercise the free enquiry that is core to their academic role.  In a health care context, why should anyone trust medical schools or academic medical centers run as tin-pot dictatorships by some hired executives?  Clearly, real health care reform would restore free speech and free enquiry to academic medicine.

Hat tip to Prof Margaret Soltan on University Diaries.

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Read more here: http://www.miamiherald.com/2013/01/03/3166198/um-medical-school-names-new-coo.html#storylink=cpy

Some Real-World Lessons for the Health IT Hyper-Enthusiasts

An article was published in Health Leaders Media yesterday by Scott Mace, senior technology editor entitled "Scot Silverstein's Good Health IT and Bad Health IT" at this link.

(Actually, the terms "good health IT" and "bad health IT" themselves came from Prof. Jon Patrick as a result of my discussions with him in Australia about my conviction, presented to the Health Informatics Society of Australia in my Aug. 2012 talk "Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step", that to be trusted and do no harm, health IT must be “done well".)

Scott Mace observes:

Inevitably, when the subject turns to the pitfalls of bad health IT, you will find Scot Silverstein, MD, ready to comment. He has been writing about health IT difficulties since 1998.

Silverstein is an adjunct professor at Drexel University who I recently interviewed for an upcoming HealthLeaders magazine story on physician resistance to health IT.

A recent Silverstein blog post caught my eye for the following statement: "It is impossible for people, especially medical professionals, to be 'ready' for a system that 'is not ready for them.'"

I wanted to learn about the good doctor's thinking and so I gave him a call. We spoke for two hours and it felt like scratching the surface of issues that healthcare will be facing for a good while to come.

Indeed, the issues we discussed were just scratching the surface.  The real world is ever so complex.

Also noted was my observation that:

... Silverstein says it is wrong to think of the tension in healthcare as being IT modernists versus Luddites ... [he says] "I believe the proper framing of this tension between technologists and physicians is that of technology hyper-enthusiasts, who either are unaware of or deliberately ignore the downsides and ethical issues of healthcare information technology in its present state, versus pragmatist physicians who just want to get a job done."

The hyper-enthusiasts largely ignore the real world. 

Two recent "real world" posts on other blogs by practicing physicians caught my eye, that help illustrate the concepts of health IT's disruption of clinicians and of clinical care.  These disruptions increase risk of error (even under normal circumstances; in an emergency scenario, I fear the disruptions will become far more destructive).

These disruptions need to be thrust in the face of the hyper-enthusiasts as characteristic of a very flawed approach to healthcare improvement.

The real-world observations, courtesy KevinMD blog (who reposted them from the source bloggers), with my comments are in [red italics]:

Information overload for doctors increases malpractice risk
Wes Fisher, MD
January 1, 2013

I have used the electronic medical record (specifically EPIC) since 2004.  I have grown accustomed to its nuances, benefits and quirks.  There are parts about it I really like.  There are parts of it I’d like to do without but accept that they are necessary evils in our current health care climate.  I know that there will always be parts of any modified computer system that will suffer growing pains.  For any new and adapting technology this is understandable.

But there is a little-appreciated issue that I see brewing: doctors (and maybe even patients) are quietly being buried by electronic information overload.  As a result, I believe doctors are being placed at an increased liability risk. [Not just doctors, but all clinicians, and the acquirers and implementers of the technology, and those who force the use of it on the clinicians - ed.]

Let me explain.

In the past era of medicine, nothing happened without a doctor’s order.  Nothing.  If you wanted a medication, lab test, invasive procedure, opportunity to participate in rehab classes – anything – you needed a doctor’s order.   For the years of paper records and independent doctors offices, this work flow assured that doctors (1) knew what was happening with their patients, (2) saw their patients, (3) prescribed the proper therapy, and (4) assumed the risk for the intervention or treatment prescribed.  Information proceeded in a logical linear fashion and the doctor was always at the head of the information line.

But we are no longer in the old days in medicine.  We are in the era of near-instantaneous information flow, multi-directional electronic communication, and geographically disparate order entry by “caregivers,” (think nurses, nurse practitioners, advanced practice nurses, clinic operators, registrars, etc.) who help us take messages, continue care, and order things.  In this electronic process, messages are no longer passed from just one individual to another, but rather are passed to two, three, four, or more individuals simultaneously from any one of several different clinical locations – some of which might be many miles apart.  There is an incredible amplifying effect of all of these messages, orders, and notifications — so much so that even the most tech-savvy doctors are struggling to keep up. [This observation about an "amplifying effect" gives life to my own observation that the terms "EHR" and "EMR" are anachronistic and suggest to the layperson an innocuous file cabinet, when in reality today's "EHR" is an enterprise healthcare resource and clinician control system, with all that implies in terms of potential adverse unintended consequences - ed.]

In fact, it is not uncommon for a doctor these days to work for two hours on a procedure and return to the computer to find twenty or thirty new notifications, e-mails, or orders have been deposited there.  Head back in for the next case and then another thirty items appear.  Pretty soon, it’s an avalanche of items.  Worse: doctors must click on each one of these notifications individually to “verify” he or she has looked at each and every single one.  [Looking at the computer has likely become a source of dread to many clinicians; I used to get the same feeling when facing up to a day's emails in Pharma, sometimes more than a hundred - ed.]

Doctors understand that the reason we have to click on all these orders is because (a) no one gets paid in our system unless a doctor orders whatever-it-is [not the best motivation - ed.] and (b) someone has to be the fall guy if there’s a problem with a nurse, medical assistant, or lab technician that “orders” something on behalf of the physician.  [Ditto; the "social issues" of health IT include factors like these  - ed.]  There is even a trend to auto-order things (like a pneumovax vaccine, for instance) that assure the hospital maintains excellent public reporting metrics whether the doctor ordered them or not with the order later appearing in our inbox to be clicked.  [This observation gives life to my own that the computer is increasingly becoming the intermediary between doctor and patient - ed.]

But worst of all are the silent notifications sent from fellow physician colleagues buried amongst the other notifications. They tell of an important story, one that needs fairly urgent attention, but because people no longer pick up the phone, are not immediately noticed or highlighted. It’s like a landmine sitting in a doctor’s inbox waiting to be stumbled upon.

* Click* *Click* *Click* * Click* *Click* *Boom*  [The "silent silo" syndrome, as I called it, also affects lab results reporting.  It should be clear that health IT does not "automagically" improve communications over Alexander Graham Bell's invention - ed.]

With all these people and devices ordering and sending, the limited number of doctors out there are being bombarded from multiple directions.   It is getting harder to keep up these days.  Orders and notices come to us on names we don’t recognize or have been long forgotten.  (Computers don’t forget that you saw the patient eight years ago).  [These observations should put an end, once and for all, to the oversimplifications of comparing health IT to, say, mercantile or banking IT - ed.] And once an order is placed and acted upon without our knowledge these days, we click on the order to clear our notices and thereby assume all the legal risk for the care. The legal buck still ultimately stops with us.

Doctors need to speak up about this problem.  [I could not agree more - ed.] We are not in the old days any longer.  We are in the fast-paced, electronic medical record era where things happen (literally) at the speed of light.  We need the electronic medical record companies, payors, hospitals and legal community to come together to help us find a solution to this current information overload crisis that maintains patient safety and improves efficiencies while limiting legal risks to the doctors who are doing their very best just to keep up.

Wes Fisher is a cardiologist who blogs at Dr. Wes.

The above "anecdote" (I use that term somewhat satirically, see here) is likely characteristic of the lives now lived by most clinicians using today's health IT.  Hyperenthusiasts, take note.

The second real-world illustration of the naivete of the hyper-enthusiasts is as below.  I'd observed most of the points made in my own writings after my CMIO period in the late 1990's, which I highlight.   It is quite interesting to see these same points come from others without Informatics expertise, directly from the clinic:

Explaining the epic failure of EMRs
Kiran Raj Pandey, MD
December 19, 2012

It is no news a lot of doctors like to stick up a rather snotty nose to EMR. The defenders of the EMR tend to label such doctors as archetypal Luddites, sticking to their archaic ways and unbecoming of change and the new times. [In reality, the tension is between the hyper-enthusiasts or 'Ddulites' vs. pragmatist clinicians with real-world patient care responsibilities and obligations - ed.] But as is usually the case with any two heated but opposite arguments, the truth likely lies somewhere between the two extremes.

On an objective basis, there is no denying that automatisation of medical record keeping is the new way forward. In theory, if the machine could keep records for you and give it back to you when and where you want it, thus freeing up valuable time for the patient encounter, that should be winsome for everyone. That alas, is a vision of the EMR utopia [the path to Utopia usually has very bad unintended consequences, and Utopia never reached - ed.], and let alone being anywhere close to such utopia, it is difficult to ascertain if we are even set in the road leading us there. [As I've opined, we're on a speeding bullet train on a quarter-mile track - ed.]

Sometime ago, exasperated at the sheer waste of time that the clunky new discharge module was causing because it would not work the way it is supposed to (my hospital is means challenged, so they are building a patchwork of cheapskate EMR suite on top of their legacy system from the 90s, just to placate the gods of CMS [and the Lords of Kobol - ed.]), I complained to the IT guy that the thing barely works! The guy was sympathetic and said, “look I know the discharge module sucks, just bear with it until the end of the year when we should be able to weed out the bugs.” [Hospitals and clinics, as I've written, are NOT the proper place for software alpha and beta-testing - ed.]

But that’s not all, I said, even if it were working just the way it is supposed to, the discharge still takes me longer than what it used to with paper. “That’s something you will have to learn to live with,” he retorted. “Computer records do take a longer time than paper, and there is nothing I can do to change that.” [This reflects healthcare IT culture's of arrogant acceptance of bad health IT, largely ignoring ways to ease human-computer interaction - ed.]

Right there, I think is where EMR loses a lot of ground against paper records. At any practice, time is the most valuable resource, and anything that doesn’t offer a straight off benefit to save time will have a hard time being adapted. [The reverse is also true - ed.] Add to that the inertia people have about their old ways and you have a deal breaker right there.

That’s not all. Driven by the constant government whip to adopt EMR, and an EMR industry that is hell bent upon imposing itself on healthcare [long ago I began writing of a territorial invasion of healthcare by the IT industry - ed.], a lot of makeshift EMR adoption has taken place. So you have hospitals where one part is using one system while the other is using a completely different one. At one clinic I recently worked at, we had to switch between 3 different EMR systems, just to get the patients records. And there still was the paper records not to mention the dictation.The constant juggling not only made the patient encounters time consuming and cumbersome [and surely tiring - ed.], it literally made us curse at the computers and ruin an otherwise perfectly normal day at work. [And increase risk of cognitive overload and error substantially - ed.] Patient volumes have gone down from 15-16 patients per day to a half of that after EMR adoption.

What’s wrong with the current adoption of EMR? Why are even the converted like me questioning EMR? [Converted to what? - ed.]

I think there are two reasons for such seemingly epic failure. First, how we interface with an EMR. Second how the EMR tries to impose its will on to us instead of the other way around. [I've written that HIT should work like the clinicians work, not the other way around.  Again, the IT has become the cybernetic 'governor' or 'regulator' of care, and is not just an innocuous records system - ed.]  A keyboard and a point and click device may well have worked for many other interactions with the computer, but with an EMR it doesn’t always appear to be nifty.

... On the same note, no EMR is going to be see a faster adoption if something like writing a prescription takes a minute when in paper it barely takes 10 seconds. Right now doing something as simple as writing a prescription feels like running through a bunch of fire breathing hoops. Someone may argue, you can at least read it better [when bugs and 'glitches' due to sloppy industry practices don't cause faulty output such as occurred here - ed.] , but don’t get me started on how the EMR can come up with its own ludicrous set of errors, something that would never be possible with paper. ["not possible with paper" is a theme I've written about as well - ed.]

Trying to impose a ready made architecture on to health care will not work. “It works for retail and banking,” some people seem to offer cluelessly [Business/mercantile computing and clinical computing are two different subspecialties of computing, I've long observed - ed.]. But a patient encounter is no visit to your bank cashier. And human body is not your bank account, it is way more complicated and it is bound to generate way more complex information that is difficult to straight jacket into the rigid and rudimentary pipeline of set information pathways. An ideal EMR is supposed to be a seamless body-glove; today they feel like the hangman’s cloak, not only are they cumbersome, dark and dreary and suffocating, under their apparition, they force things you to do things you wouldn’t otherwise do. [Hyper-enthusiasts don't really seem to care; if it's a computer, it must be better - ed.]

Such forced behavior modification may make the administrator, the insurance company, and the government happy [it does - ed.] but I can’t understand how selecting a dozen pesky radio buttons while doing the discharge makes the patient lead a healthy life or make his doctor particularly enamored with the EMR, just because the government said so, or that it made the IT companies a few million dollars richer. [Doctors are just supposed to obediently accept this technology by the hyper-enthusiasts and profiteers - ed.]

Kiran Raj Pandey is an internal medicine resident who blogs at page59.

I feel "anecdote" #2 is also quite common, and the sentiments shared by a large number of clinicians forced into using this technology in its present state.

Hyper-enthusiasts and other health IT promoters and grandstanders need to read the above accounts well.  They need to understand that the real-world effects of the technology, recklessly pushed, can be toxic, and not result in the utopia of better care and cost-savings they naively believe will deterministically occur. 

-- SS

Why Did the "Dean of Health Care Economics" Urge Reforms that "Appeal to Some Special Interests?"

We have often discussed, some would say belabored, the importance of the "anechoic effect" in health care.  Particular issues which would make those who benefit the most from our current dysfunctional health care system uncomfortable are often considered not to appropriate for polite conversation. 

A prominent recent article in JAMA provided a great example of  how there are certain topics that health care, services, and policy experts avoid discussing.

Summary of the Article

The article was by Victor R Fuchs, who has been called the" dean of health care economics."  His topic was why US health care is so expensive compared to those in other countries, but provides little additional value for the extra expense.  [Fuchs VR. How and why US health care differs from that in other OECD countries.  JAMA 2013; 309: 33-34.  Link here.]

His explained the differences as follows:
-  "US individuals appear more distrustful of government...."  Thus presumably they shun government operation of health systems, which can lead to lowering administrative costs, and more effective negotiating "with drug companies and physicians and to control investment in hospitals and equipment."
-  "reluctance to achieve more equal outcomes for the population through redistributive public policy."  He attributed this to attitudes stressing personal responsibility for success, and the heterogeneity of the population leading to decreased sympathy to those who are unfortunate but "whose identity may differ greatly from one's own."
- "the opposition [to health care reform] of 'special interests,' such as pharmaceutical and device manufacturers, physicians (especially those in high-income specialties), and hospitals."  He noted that other countries have special interests, but attributed the power of US special interests to the country's system of government, especially "checks and balances," which provide "'choke points' for special interests to block or reshape legislation."

He ended with three policy prescriptions for more and better health care reform:


-  "government's role should be limited to what is necessary, not just desirable."
-  "provision of basic coverage for all should not require equality for obtaining additional coverage."
-  "reform should have features that would appeal to some special interests, or to some elements within each special interest group (for example, some physicians or some health plans."


I believe this essay, because it is in a prominent journal and by the supposed dean of US health care economists, provides a good example of some of the things that ail the discussion of health care policy. First, the author made rather cavalier use of evidence to support his points.  Second, he avoided even mentioning any of the unpleasant issues we discuss on Health Care Renewal.  Third, he not only failed to challenge any of those who benefit the most from the current system, but also suggested further appeasement at least of some of them.

Cavalier Use of Evidence

Prof Fuchs' justification for the role of distrust of government was based on a rather casual review of American history, and a single survey.  In fact, the proportion of people who appear to trust the government appears to depend on who asks the question and how it is asked.

For example, Gallup polling from 1998 to 2012 showed from 65% to 80% of people expressed “a great deal/ fair amount of trust in state and local government.”  Gallup polling from 1997 to 2012 showed from 51% to 83% of people had “a great deal” or “fair amount” of “trust in federal government to handle international problems.”  On the other hand, the Pew Research Center for the People and the Press showed public trust in government peaking at nearly 80% during the administration of President Johnson, then precipitously declining, rarely exceeding 50% over the ensuing years, and now around 20%. Furthermore, although Prof Fuchs argued that distrust of government is uniquely American, he provided no data comparing such poll results from the US with those from elsewhere.

Nor did he compare results of polls about trust of the government with those about trust of other organizations involved in health care.  However, while people in the US may be distrustful of government, polling shows even bigger distrust of health care special interests (like pharmaceutical companies and health insurance).    While Edelman marketing showed relatively constant trust in the pharmaceutical industry at around 50% from 2009-2012), a Harris Interactive 2010 poll showed that only about 10% of people thought the pharmaceutical industry was honest and trustworthy from 2003 to 2010, while health insurance companies and managed care companies were trusted by even fewer.

Avoiding Unpleasant Issues

While Prof Fuchs acknowledged the role of "special interests," he avoided mentioning how these special interests might negatively affect health care, and thus how their role could be altered or countered.

Some issues we discuss on Health Care Renewal, but which he ignored were:

Concentration of Power

We have frequently discussed how health care organizations have grown ever larger, increasing their market power, and hence their ability to command revenue.  Although we often hear arguments that larger organizations are more efficient, this historic excuse of monopolists has little evidence in support.  In fact, large organizations seem mainly efficient in extracting money for the benefit of their insiders.  For a recent discussion of the push toward monopolies that has some health care angles, see this post on Naked Capitalism.   


Commercialization of Health Care 

The US seems to be unique in that it allows a larger role for private, for-profit corporations in health insurance and the actual provision of health care.  In the US, many health insurance companies, some hospitals and hospital systems, and many other types of health care providers, like hospices and dialysis centers, are now for-profit.  Furthermore, the physicians who provide direct patient care are more frequently employed by corporations (rather than being in solo or small group practice), and these corporations are increasingly for-profit  (look here).

This increase in the provision of health insurance and direct health care by for-profit corporations is a historical change.  Through the 1970s, the American Medical Association declared "the practice of medicine should not be commercialized, nor treated as a commodity in trade." (Look here)   In most states, the corporate practice of medicine used to be banned.


Commercialization in an Age of Financialization -

This commercialization took place in an era in which economists were advocating that corporate leaders ignore all goals other than increasing "shareholder value" (look here).  This de facto meant increasing short-term stock price and/or revenue.  Clearly focusing only on short-term revenue increased the risk of management that ignored or was even hostile to the health care mission.  The focus on short-term revenue lead to strong incentives for employees to "make their numbers," that is, to achieve financial goals, no matter what it took (see examples here).  This likely lead to many examples of unethical behavior.  Furthermore, physicians were not immune to such requirements (look here).

 Abandonment of Government Regulation

As was noted in the comments on the post on Naked Capitalism,enforcement of anti-trust law that could prevent concentration of power has generally been abandoned by recent US administrations.  Furthermore, as we have discussed here, enforcement of laws against fraud, kickbacks, etc have lead to numerous legal settlements, but almost never any penalties against individuals who authorized, directed or implemented such actions within large health care organizations.  Thus, the leaders of health care organizations, particularly large health care corporations, have experienced impunity.  In some cases, there has been outright regulatory capture.  Conflicted regulators have proliferated, often through the mechanism of the "revolving door."

Executive Compensation 

Thus protected by such impunity, executives of large health care organizations often have become rich, and seem to be able to do so without any accountability for their organizations' actions.  As noted above, their incentives push them to put short-term financial goals ahead of the health care mission.  Furthermore, another currently fashionable business school doctrine is that health care managers may and perhaps should be generic, and thus need not know anything about health care, have experience caring for patients, or have sympathy for health care values.  All this has lead to health care management that ignores or even is hostile to the health care mission. 

Deception Undermining Clinical Research and Education 

Furthermore, this impunity and lack of accountability has been correlated with a rising tide of unethical behavior.  In particular, corporations that make drugs and devices have taken over clinical research meant to evaluate their own products.  They have often manipulated research to favor their products, and suppressed research that even when manipulated does not favor these products.  Thus they have corrupted the clinical research base on which physicians and patients rely to make the best possible health care decisions.  Marketers have launched stealth campaigns that have also included corruption of medical education.  In particular, they have paid influential health care professionals, called key opinion leaders, to support marketing under the guise of medical education.  Thus distorting health care and medical research and education decision making has distorted decision making, likely leading to increased costs and decreased quality.  

Other examples of poor, that is ill-informed, unaccountable, self-interested, conflicted and corrupt leadership are strewn around Health Care Renewal.  He have also shown how the governance of health care organizations often lacks accountability, integrity, transparency, and honesty.  All these problems can lead to increased costs, and decreased quality and access.  Yet almost never do any of these issues make it into polite discussion within health care research and policy circles.

Appeasement of Special Interests

Over eight years of  effort by a few dedicated academic researchers, health care professionals, investigative reporters, whistle-blowers, and watch dog organizations,  chronicled to some extent on this blog and by other bloggers and commentators, has shown bad leadership and governance of, and resulting unethical behavior by health care "special interests."  Yet, the example essay by Prof Fuchs failed to deal with any of these issues.  Instead of discussing how they might be approached, he suggested continuing appeasement of special interests, which would likely make our problems even worse.  Why he ignored all the privileges the leaders of special interest have, and felt the need to treat them even more nicely, remains unclear. 

Thus it appears that the anechoic effect is leading to failure to grapple with the real reasons for health care dysfunction, thus ensuring that health care costs will continue to rise while access and quality fall.

Real health care reform will first require honest, unflinching consideration of what has gone wrong.  As long as the conversation seeks to avoid offending those who benefit the most from the current system dysfunction, that dysfunction will only get worse. 

US President Theodore Roosevelt had the courage to challenge the "malefactors of great wealth" who engineered the first gilded age, at the expense of the public at large.  During this second gilded age, will we have the courage to take on the new malefactors of great wealth, including those who benefit from health care's dysfunction?

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]

I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-visibility release of the ONC report I'd written about in my Dec. 23, 2012 post "ONC's Christmas Confessional on Health IT Safety: HIT Patient Safety Action & Surveillance Plan for Public Comment."   (The ONC report itself is available at this link in PDF.)

The Boston Globe and Globe staff writer Chelsea Conaboy, however, have beaten me to the punch in the Jan. 3, 2013 article "Federal government releases patient safety plan for electronic health records", link below.

('Lords of Kobol', of course, is a pun.  They were fictional gods in a sci-fi series from the 1970's and a remake a few years ago, but in my circles the term is used satirically and derisively to reflect people expressing inappropriate overconfidence in - and perhaps worship of - computers.   Cobol, the COmmon Business-Oriented Language, is one of the oldest programming languages and was the major programming language of the merchant computing sector, including business, finance, and administrative systems for companies and governments.)

First, I do want to reiterate what I'd mentioned in my earlier post:  the new ONC report is a sign of progress, in terms of a government body explicitly recognizing the social responsibilities incurred by conducting the mass human subjects experiment of national health IT.  However, I also wrote:

... [The ONC report] is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk".

The Globe quoted a number of people involved the health IT debate, and I am now commenting on their Jan. 3 article:

Federal government releases patient safety plan for electronic health records
Boston Globe

01/03/2013 11:16 AM   

By Chelsea Conaboy, Globe Staff

The federal office in charge of a massive rollout of electronic health records has issued a plan aimed at making those systems safer by encouraging providers to report problems to patient safety organizations.

Though some in the field say it doesn’t go far enough, others said the plan is an important step for an office whose primary role has been cheerleader for a technology that has the potential to dramatically improve health care in the United States but that may come with significant risks.

A major issue at the heart of the controversy is the fact that, admittedly, nobody knows the magnitude of the risks - in large part due to systematic impediments to knowing.  This has been admitted by organizations including the Joint Commission (link), U.S. FDA (link; albeit in an "internal memo" never intended for public view, and discovered only through the hard work of Center for Public Integrity investigative reporter Fred Schulte when he was at the Huffington Post Investigative Fund), Institute of Medicine of the U.S. National Academies (link, quoted at midsection of post), and others. 

I have made the claim that when you don't know the level of harm of an intervention in healthcare, and there are risk management-relevant case reports of dangers, you don't go gung-ho and start a national-scale implementation with penalties for non-adopters, and then decide to study safety, quality, usability etc.  You determine safety first in more controllable and constrained environments.  Anything else is, as I wrote, putting the cart before the horse (link).

Things are a bit out of order here.

You also certainly don't dismiss risk management-relevant case reports from credible observers as "anecdotal", the common refrain of hyperenthusiasts and (incompetent) scientists who conflate scientific research with risk management - as a researcher from Down Under eloquently observed in the Aug. 2011 guest post "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things."

 Back to the Globe:

A year ago, the Institute of Medicine issued a report urging the federal government to do more to ensure the safety of electronic health records. It highlighted instances in which the systems were linked to patient injury, deaths, or other unsafe conditions.

The report suggested creating an independent body to investigate problems with electronic records and to recommend fixes, similar to how the National Transportation Safety Board investigates aviation accidents.

Instead, the Office of the National Coordinator for Health Information Technology delegated various monitoring and data collection duties to existing federal offices, including the Agency for Healthcare Research and Quality [AHRQ].

The problem is that AHRQ is a research agency (as its name suggests), has no regulatory authority nor any experience in regulation, and most clinicians have never heard of it.  In effect, this ONC recommendation is lacking teeth, even compared to the relatively milquetoast recommendations of IOM itself (as I wrote about in a Nov. 2011 post "IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency").

The [ONC] office has asked patient safety organizations, which work with doctors and hospitals to monitor and analyze medical errors, to add health IT to their agendas. Data from the organizations would be aggregated by the agency, but reporting by doctors and hospitals is completely voluntary.  [A prime example of what I term an extraordinary regulatory accommodation afforded the health IT industry - ed.]

Now we're into septic shock blood pressure-level weakness. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on mandatory, let alone voluntary reporting. From “Hospitals Are Not Reporting Errors as Required by Law", Philadelphia Inquirer, pg. 4, http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:
  

... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board.

He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.]

Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years.

Fixing this “is not a priority,” he added.

To expect hospitals to voluntarily report even a relevant fraction of mistakes and near-misses out of pure altruism, or permit their clinicians to do so, with the inherent risks to organizational interests such reporting entails, is risible.

The near-lack of reporting by most health IT sellers and hospitals in the already-existing FDA Manufacturer and User Facility Device Experience (MAUDE) database is substantial confirmation of that; the fraction of reports in MAUDE, however, are hair-raising.  See my Jan. 2011 post "MAUDE and HIT Risks: What in God's Name is Going on Here?" for more on that issue.

Here's an example of what happens to 'whistleblowers', even those responsible for system development and safety: "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge."

ONC's recommendations thus in my opinion reflect bureaucratic window dressing, designed to create progress - but progress that can probably be measured in microns.

“There was no evidence that a mandatory program was necessary,” Jodi Daniel, the [ONC] office’s director of policy and planning, said in an interview.

Really?  See the aforementioned Philadelphia Inquirer article “Hospitals Are Not Reporting Errors as Required by Law", as well as numerous articles on pharma and medical device industry reporting deficits such as starting at page 5 in my paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" at this link in PDF.

There is no evidence mandatory reporting is necessary ... to someone who's either naïve, incompetent - or persuaded, e.g. with money, to not find evidence or rationale.

The [ONC] office has been under pressure to roll out the electronic health records systems quickly while protecting patient data and making sure that the systems don’t cause problems in medical care, said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center. 

Under pressure by the health IT lobby, perhaps; but nobody else that I can think of.

“It’s this challenging chicken-and-egg problem,” he said.

No, actually, it isn't.  Patient safety must come first. This becomes clear when one considers the late 5th century BC ethical principle Primum non nocere ("first, do no harm" or "abstain from doing harm") versus the late 20th and early 21st century IT-hyperenthusiast credo I've expressed as "Cybernetik Über Alles"  ("Computers above all"). Under CÜA, the computer has more rights than the patients, and the IT industry receives extraordinary regulatory accommodation to sloppy practices that no other healthcare or mission-critical non-healthcare sector enjoys.

I sent Dr. Halamka a set of arguments such as I make here, and a picture of a health IT 'chicken', my deceased mother in her death robes.

I received back a "thank you for the views" message - but no condolences.  (It occurs that I have rarely if ever received condolences from any senior HIT-hyperenthusiast Medical Informatics academic or government official to whom I've mentioned my mother.  Not to play amateur psychologist, but I believe it reflects the level of disdain or even hatred felt by these people towards health IT iconoclasts/patient's rights advocates.)

The plan, which is subject to public comment through Feb. 4, “is a reasonable start,” in part because it puts more pressure on hospitals and doctors to monitor safety, Halamka said.

As I expressed to Dr. Halamka, we are in agreement on that point.

The government would have risked stifling innovation in the industry if it had opted instead to require the kinds of tests and review by the Food and Drug Administration that new medical devices and drugs must go through, he said.

To that, I mention here (as I did in my email to him) my response to this industry meme, as I had expressed it at Q&A after my August 2012 keynote address to the Health Informatics Society of Australia:

... I had a question from the audience [after my talk], from fellow blogger Matthew Holt of the Health Care Blog.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post here.)

Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article here), that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003).

His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations.

The audience was visibly unsettled.  Someone even hollered out their disapproval of the question.

My response was along the lines that:

• VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;
• That I'm certainly not against innovation; I'm highly pro-innovation;
• That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation.  It is exploitation.

I stand by that assessment.

More from the Globe article:

There is little good research into how the systems improve health care and there are big obstacles to fixing even the known problems, said Ross Koppel, a professor of sociology at the University of Pennsylvania who studies hospital culture and medication errors.

Some developers require providers to sign nondisclosure agreements before using their systems, and the safety plan does not prohibit such gag clauses.  [Note: I wrote on this issue here, and in a published July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" here - ed.]  While the plan addresses reporting of known problems, Koppel said it will not help researchers and developers understand problems that go unnoticed but that may be causing real patient harm. 

“We only know the tip of the iceberg” about how electronic health records affect patient care, said Koppel, who was an official reviewer for the Institute of Medicine report.

As per the title of this blog post, we are in a dark place, ethically, when a PhD sociologist who's never taken the Oath of Hippocrates (to my knowledge) appears to express more concern for patient safety and patient's rights than a Harvard physician-informatics Key Opinion Leader such as Dr. Halamka.

Koppel said the mantra of the Office of the National Coordinator has been that more health IT leads to better health care. “It probably is better than paper,” he said, “but it could be so much better than it is.”

I agree, but with caveats.  I opine that bad health IT is likely worse for patients than a good, well-staffed paper based system.  For instance, the former can cause systematic dangers that even a bad paper system cannot, such as tens of thousands of prescription errors (see my Nov, 2011 post "Lifespan Rhode Island: Yet another health IT 'glitch' affecting thousands - that, of course, caused no patient harm that they know of - yet") or mass privacy breaches (see the current 30 or so posts on that issue at this blog query link: http://hcrenewal.blogspot.com/search/label/medical record privacy).

On good health IT and bad health IT from my teaching site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/:

Good Health IT ("GHIT") is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes. 

Bad Health IT ("BHIT") is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. 

The Boston Globe article concludes:

Ashish Jha, associate professor of health policy at Harvard School of Public Health and a member of the panel that drafted the Institute of Medicine report, said he wants doctors to be able to report problems -- errors in medication lists, for example -- in real-time so they can be found and fixed quickly. The safety plan does not require systems to have that capability, but Daniel said her office could soon add such a requirement for products that receive federal certification.

The bigger problem is that health care as a whole needs a better way of tracking patient safety, Jha said. Monitoring issues caused by electronic health records “should be a part of it, and then we can actually know if this is a small, medium or large contributor to patient safety issues,” he said. “But we don’t know that.”

I agree with Dr. Jha, but the IT sellers and healthcare organizations will (legitimately) claim that adding real-time error reporting/forwarding to their products will be extremely resource-intensive.

I have an alternate approach that will require little effort on the part of the sellers and user organizations.

• Post a message at the sign-in screen of all health IT along the lines that "This technology is experimental, adopted willingly by [organization] although not rigorously vetted for safety, reliability, usability, nor fitness for purpose, and thus you use it at your own risk.  If problems occur, report them to the following" ...

"The following" could include a list of alternatives such as I wrote in my Aug. 2012 post "Clinicians: How to Document the EHR Screens You Encounter That Cause Concern."

... When a physician or other clinician observes health IT problems, defects, malfunctions, mission hostility (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting):

• Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "disruptive physician" and/or or being subjected to sham peer review (link).

• Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks at this link. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger Dr. Scott Monteith in a comment to me about this post.)

• Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at http://www.jointcommission.org/report_a_complaint.aspx . Also consider writing the JC senior officers (link to officer's list), whose awareness of HIT issues I can personally attest to via our correspondences.

• Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. An example of such an adverse event report I filed myself (when the involved hospital refused) is at this link in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.

• Inform the State Medical Society and local Medical Society of your locale.

• Inform the appropriate Board of Health for your locale.

• If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "Quality Insights of PA."

• Inform a personal attorney.

• Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.

See the actual post for an idea about clinicians seeking indemnification when forced by healthcare organizations to use bad health IT.  I can attest to actually seeing HIT policies that call for "human resources actions" if clinicians refuse to use HIT, or cannot learn to use it at a sufficient pace.

(Left out of this reiteration is the demonstration on photographing problematic EHR screens.  See the post for the details - it is easy to do, even with a commodity cellphone.)

HHS should be promoting laws on protection from retaliation upon clinicians reporting problems in good faith.

Thus, physicians, nurses and other clinicians can create needed health IT transparency and help our society discover the true level of risks of bad health IT.  They simply need the right information on what to do and where to report, bypassing the ONC office and, in the spirit of medicine, taking such matters into their own hands in the interests of patient care and medical ethics.

I also made recommendations to the Pennsylvania Patient Safety Authority on how known taxonomies of health IT-related medical error can be used, and need to be used, to promote error reporting in common formats.  Slides from my presentation to the Authority entitled "Asking the Right Questions:  Using Known HIT Safety Issues to Improve Risk Reporting and Analysis", given in July 2012 at their invitation, are at http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt

Finally, another sign of progress:  unlike the HITECH Act, this new ONC plan is open to public comment.

-- SS

Addendum Jan. 8., 2012:

Dr. Halamka has put more details regarding his views in his blog.  The entry is entitled "Electronic Health Record Safety" at this link:  http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html .

He writes:

... Some have questioned the wisdom of moving forward with EHRs before we are confident that they are 100% safe and secure.   [That, of course, is not my argument - nothing is ever 100% safe and secure.  However, we don't yet know just how safe and secure - or unsafe and insecure - HIT is.  That is the issue I am concerned about - ed.] I believe we need to continue our current implementation efforts.

I realize it is a controversial statement for me to make, but let me use an analogy.

When cars were first invented, seat belts, air bags, and anti-lock brakes did not exist.    Manufacturers tried to create very functional cars, learned from experience how to make them better, then innovated to create new safety technologies. many of which are now required by regulation.

Writing regulation to require seat belts depended on experience with early cars.

My grandmother was killed by a medication error caused by lack of an EHR.  My mother was incapacitated by medication issues resulting from lack of health information exchange between professionals and hospitals.   My wife experienced disconnected cancer care because of the lack of incentives to share information.     Meaningful Use Stage 2 requires the functionality in EHRs which could have prevented all three events.

I express my condolences on those events.

I disagree, however, with continuing national implementation efforts at the current rate, with penalties for non-adopters.  I opine from the perspective of believing health IT has not reached a stage where it is ready for national rollout and remains experimental, its magnitude of harms admittedly unknown and information flows systematically impaired.  I recommend and prefer great caution under those circumstances, and remediation of those circumstances before full-bore national implementation.

I will leave it to the reader ponder the two views.

-- SS

BLOGSCAN - When Private Equity Owns Hospitals

On his Not Running a Hospital blog, Paul Levy discussed reasons for concern when private equity firms purchase and operate hospitals.  He used the example of Steward Health Care, now a for-profit hospital system (which also employs physicians to provide direct patient care), which in turn is owned by Cerberus Capital Management.   The issue is pertinent due to recent discussion in the media about Cerberus' newly stated intention to sell the large firearms and ammunition business it assembled, Freedom Group.  This intention was only stated after the tragic multiple murders of children and teachers by gunfire from a weapon manufactured by Freedom Group at a Connecticut elementary school.  We have previously posted about questions raised when private equity buys hospitals and employs physicians, specifically about Cerberus and Steward Health Care, and have questioned whether a private equity group is a suitable owner and operator of hospitals and physicians' practices when said private equity group also owns a large firearms and ammunition business, and, for that matter, a military contracting company which has been accused or providing "mercenaries" (look here and here).    

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first discussed the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the irrationality of health care prices in the US, and of the failure of the organizations that ought to resist outrageous pricing in our mixed, pseudo-market based health care system to do so.  A recent New York Times article has updated this case.

Background

As we wrote in 2007, ACTH (adrenocorticotrophic hormone) is a naturally occurring hormone that stimulates the activity of the adrenal gland, which produces cortisol and other glucocorticoid and mineralocorticoid hormones.   ACTH produced from pigs' adrenals was first marketed as a biologic agent in the 1940s.  It was used for some conditions that appear to benefit from the effects of increasing cortisol production induced by ACTH.

It has been traditionally used to treat infantile spasms, a rare but distressing condition, and exacerbations of multiple sclerosis (MS).  However, since the drug was introduced so long ago, it was never subject to rigorous controlled trials to assess its efficacy and adverse effects for these indications.  Furthermore, since the 1940s, synthetic glucocorticoid hormones have become widely available as generic drugs.  Yet these slightly newer drugs have never been rigorously compared to ACTH for infantile spasms or MS.  The most recent review (edited in 2009) by the Cochrane Collaboration found that steroids and ACTH have some evidence in their favor for the treatment of acute MS, but found no evidence showing that ACTH was superior.  [Filippini G, Brusaferri F, Sibley WA, Citterio A, Ciucci G, Midgard R, Candelise L. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD001331. DOI: 10.1002/14651858.CD001331].  Also, the most recent review (edited in 2009) of treatment of infantile spasms concluded, "it is not clear which treatment [including ACTH] is optimal." [Hancock ED, Osborne JP, Edwards SW. Treatment of infantile spasms.  Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No. : CD001770. DOI: 10.1002/14541858.CD001700.pub2.]

The Pricing of H P Acthar

Possibly because some physicians thought ACTH might be useful for some patients with two conditions, infantile spasms and acute exacerbations of MS, ACTH has remained on the market.  It was manufactured by a single company, Aventis, (now part of Sanofi-Aventis), the successor to Rhone-Poulenc-Rorer.  In 2001, Aventis sold the rights to manufacture ACTH, with the trade name H P Acthar, to a new, small biotechnology company, Questcor.  In 2007, Questcor raised the price of ACTH from $1650 per vial to more $23,000 per vial.  That got the attention of the Philadelphia Inquirer, on whose article we based our commentary. We used the price increase as an example of how pricing in health care has become untethered from any sort of clinical reality, and wondered why insurance companies and the US government seemed willing to pay this outrageous price for an old drug with little evidence from clinical research to support its use.  But the issue then seemed, like many others we have discussed , to become anechoic, until the very end of 2012.


Now the  New York Times story has provided an example of how health care corporations can do very well without doing anyone, except corporate insiders, much good.  It included instances of many of the kinds of ethically questionable practices we have discussed over the years on Health Care Renewal.

Deceptive Marketing

Per the NY Times,

Questcor did almost no research or development to bring Acthar to market, merely buying the rights to the drug from its previous owner for $100,000 in 2001. And while the manufacturing of Acthar is complex, it accounts for only about 1 cent of every dollar that Questcor charges for the drug.

Moreover, the tiny 'orphan' market soon became much bigger. Before long, Questcor began marketing the drug fo multiple sclerosis, nephrotic syndrome and rheumatologic conditions, even though there is little evidence that Acthar is more effective for those other conditions than alternatives that are far cheaper. And the company did so without being required to prove that the drug actually works. That is because Acthar was approved for use in 1952, before the Food and Drug Administration required clinical trials to show a drug is effective for a particular disease. Acthar is essentially grandfathered in. 

Today, only about 10 percent of the drug’s sales are for infantile spasms. The new uses, Mr. Bailey has told analysts, represent multibillion-dollar opportunities for Acthar and Questcor, its sole maker. 

The results have been beyond even the company’s wildest dreams. Sales of Acthar, which accounts for essentially all of Questcor’s sales, totaled nearly $350 million in the first nine months this year, up 145 percent from the period a year earlier. In the same period, Questcor’s earnings per share nearly tripled, to $2.12. In the five years after the big Acthar price increase in August 2007, Questcor shares rose from around 60 cents to about $50, in one of the best performances of any stock in any industry. 

So Questcor leadership was clever enough to use loopholes in the law to promote ACTH for particular kinds of patients without any good evidence that it did those patients any good.  Furthermore, Questcor used several questionable tactics 

in this promotion.

Manipulated Research

Apparently Questcor leaders decided they needed some sort of minimal research results to promote their products, so as the Times reported,

Because Acthar was approved for these conditions decades ago, Questcor has not had to do large clinical trials to show that the drug works. It has paid for some small studies, mainly by individual doctors, who then publish a paper that the sales force can present to doctors. 

The study that justified calling on rheumatologists involved five patients with rare conditions, all of them treated by a single doctor. All the patients had much improvement on Acthar after failing to benefit from more standard therapies, the doctor, Todd Levine, said in a Questcor conference call.

Too call the research Questcor sponsored minimalist would be too polite.  A case series of five patients, lacking any control group proves almost nothing.  It proves less when the research is done in an unblinded  fashion by a single doctor who presumably was invested in the outcome being favorable for his sponsor's product.  (I suppose some might quibble with calling this research manipulated, but I contend but doing such crude research when it would be possible to do something much more credible amounts to manipulation.)

Suppression of Research

Moreover, it seems that even such rudimentary studies sometimes failed to produce the wanted results.  In these cases, the Times reported that Questcor simply suppressed them.

Still, it appears that at least a couple of small studies that may have raised questions about the drug have been suspended. 

'From my standpoint it just didn’t work,' said Dr. Sungchun Lee, a Phoenix nephrologist who stopped a small study testing Acthar as a treatment for nephrotic syndrome. 'I think they were O.K. with me stopping because we weren’t getting the results,' he said. 

Another study that was terminated sought to determine whether multiple sclerosis patients who did not have a good response to steroids should be treated with either another round of steroids or with Acthar. The study was halted midway through 'to analyze data,' according to the summary of the trial on the federal clinical trial database. 

Use of Paid Key Opinion Leaders

Despite the lack of good clinical evidence in support ACTH, there are some physicians who defend its use.  One example in the Times article was a physician who is paid by Questcor

But some doctors say Acthar can be effective in cases that are not well treated by steroids. They say that there is emerging evidence that Acthar does more than just stimulate the body to produce its own steroids. 

'It really looks like the ACTH does bring something different to the table that standard steroids don’t,' said Dr Ben W Thrower, director of the multiple sclerosis institute at the Shepherd Center, a hospital in Atlanta. Dr. Thrower, who is a paid speaker for Questcor, said his institute had tried Acthar for about 60 of its 3,000 patients, ones who did not respond to steroid treatment. Acthar made the symptoms subside in about half of them.

Where to begin?  Just because ACTH is different does not mean it is better.  Since MS is a disease whose symptoms wax and wane, patients who fail standard treatment may get better on their own, and without a control group, it is impossible to say whether the ACTH given to such patients was the reason they got better. 

Creation of Institutional Conflicts of Interest for Disease Specific Foundations

Questcor's ACTH also has support from a disease specific foundation, but one that Questcor has also supported financially.

Dr Lawrence Brown, a neurologist at the Children's Hospital of Philadelphia, and the president of the Child Neurology Foundation, says of Questcor: 'They have gone out of their way to help every kid who needs the medicine to get it quickly and efficiently.'

This year, the foundation awarded its first corporate citizenship award to Questcor. Dr. Brown says Questcor’s donations — the amount has not been disclosed — to the foundation didn’t influence the award.

Who could be so naive to think that giving an organization funding might influence its actions?  After all, human response to financial incentives is the basis for most current economic thinking.

Insiders Get Rich

Admittedly, these questionable tactics did lead to an increase in "shareholder value,"  As the company's proxy statement boasted in 2011,

While we generated strong financial returns in 2011, we are most proud of our patient focus and investments in Questcor which we believe will generate sustainable value to our shareholders, employees, patients and all of the communities that we serve. We believe that our patient focus and commitment to generating sustainable value to all of our constituencies results in strong value creation for our shareholders.

However, as of today, Qustcor's share price has dropped to $26.74 from a peak of 53.42 in June, 2012, with most of the drop in December, 2012, around the time the Times article came out, according to Google Finance.  So whether share holder value will turn out to have increased in the long run is not clear. 

Meanwhile, some Questcor employees did very well.  The largess started with some drug representatives,

Questcor sales representatives who are lucky enough or skillful enough to have a big prescriber in their territory can reap bonuses of $50,000 a quarter, according to former employees of the company.

More highly placed corporate insiders did even better.

Executives are paid well, too. In 2009, Mr. Bailey, [the CEO]  hired his daughter Kirsten Fereday as director of business analytics and evaluation, a job that paid $275,000 in cash and stock last year. 

 Left out of the Times article, somewhat surprisingly, was what the top executives make.  Information from up to 2011 is publicly available, however, in proxy fillings.

In the company's 2012 proxy statement, we find the following figures for total compensation:
Don M Bailey, President and CEO - $4,546,230, up 192% of his compensation in $1,554,503 in 2009
Michael H Mulroy, Senior Vice President, Chief Financial Officer and General Counsel -  $1,749,891 (his first year)
Stephen L Cartt, Chief Operating Officer -  $2,298,308, up 168% from $855,460 in 2009
David J Medeiros, Executive Vice President and Chief Technical Officer - $1,232,556, up 78% from $692,188 in 2009
David Young Pharm D, Chief Scientific Officer - $1,948,804 up 182% from $1,066,159 in 2009

In addition, by 2011, Mr Bailey, the CEO, had acquired 1.92% of the company's total stock, 3,834,910 shares, today worth $102,545,490.

Finally, per the Times,

one group of shareholders has done pretty well for itself. Over the last two years, as the company’s share price mainly soared, Questcor insiders have sold more than $100 million of stock. 

Summary

 So, in summary, a small biotechnology company drastically increased the price of its only product, a drug which has never been subject to modern clinical trials, and whose efficacy has never been proven.  Its marketing tactics have included manipulation and suppression of research, and payments to physicians and non-profit organizations.  Although its most breathtaking price increases were made in 2007, they attracted little public attention until five years later.   Meanwhile, corporate insiders, from drug representatives to top executives and their relatives, have done very well for themselves.

In the US, there a lot of people who advocate free market based health care for its efficiency and innovation.  For example, see "Yes, Mr President, a Free Market Can Fix Health Care," published by the Cato Institute, in which its Director of Health Policy Studies proclaimed, "The great advantage of a free market is that innovation and more prudent decisionmaking means that fewer patients will fall through the cracks," and then "a free market can and would control costs, expand choice, improve health care quality, and make health coverage more secure." [italics added for emphasis]

Unfortunately, the case of Questcor's ACTH makes it seem that in the current US system, which is supposedly more market based than systems in many other countries, the efficiency and innovation is characteristic of the marketing of corporate health care, not of the health care itself.  Here is a stellar example of how clever, and not always very scrupulous marketing can be used to sell a very old drug with little demonstrated clinical value for a stratospheric price, enriching corporate insiders, perhaps enriching stockholders (although, not so much lately, and we will see how they do in 2013), at the expense of the public who pays taxes and insurance premium.  This case suggests a need for more attention to market failures and less insistence on market fundamentalism.  Of course, it also suggests the continuing need for health care professionals, policy makers, patients and the public to be extremely skeptical about heavily promoted commercial health products.