Friday, August 31, 2012

Continuing Dissection of the Infamous Study 329

On the 1BoringOldMan blog, semi-anonymous blogger Mickey has been dissecting in detail the infamous Study 329 that GlaxoSmithKline used to promote Paxil (Seroxat, paroxetine) as safe and effective for children and adolescents, when the study data, rigorously analyzed, showed that was not the case.  Study 329 was an important part of the US Department of Justice case against GSK that resulted in a record $3 billion settlement (see this post). 

The posts so far are:
A Pretty Rotten Era  
A Movement
To Make Distortion Possible
The Lesson of Study 329: the Basics
The Lesson of Study 329: Efficacy Drifts to Trends and 2s
The Lesson of Study 329: Conventions and Protocols
The Lesson of Study 329: Uh-oh
The Lesson of Study 329: Data Transparency
The Lesson of Study 329: the Authors

This does not seem to be the end of the series, but the last post yesterday did have a striking conclusion:
But, for the moment, I am stuck on the piece that is, to me, the most fundamental lesson from this story, and unfortunately many similar stories in the industry-funded clinical trial literature that fills our journals. The authors of this study did not function as physicians, clinicians, scientists, or even authors. Some were there because of their previous credentials. Others were there to build up future credentials. But they weren’t there to do what they presented themselves as doing. Researchers are practicing medicine too. I might be seen as naive to see this as the center of this story. If that’s the case, I’ll go to my grave being naive. Medicine has been my life, and this isn’t Medicine.

There’s no place or tradition for physicians, particular physicians in high places, taking part in this kind of bullshit – particularly all the while claiming otherwise. The fact that it has been a widespread practice isn’t an excuse. That’s also an even stronger indictment. There are many principled neuroscientists working in this difficult area of medical science who’ve been tarnished by this kind of pseudoscience. There are many psychiatrists and other practitioners who’ve actually trusted these deceitful articles. And there are untold numbers of patients who’ve been medicated un-necessarily or even directly harmed by this and other capricious advise coming out of these studies – this one in particular. Rather than functioning as the advisers of ill people, these were physicians who actively participated in capitalizing on patients’ illness.
However, despite the seriousness of these concerns, and their corroboration in the Justice Department document that pushed GSK to settle for so much money, my alma mater, Brown University, where Dr Martin Keller, the lead author of Study 329, was Chair of Psychiatry, has consistently refused to revisit the study, and consistently failed to publicly refute the accusations against Dr Keller, nor to accept them and take appropriate action.  The University supposedly conducted an internal investigation of the matter, but has not seen fit to make it public.  When asked again about this, Brown's new President, Christina Paxson, referred the inquiry to the public relations people:
'The recent announcement by the U.S. Department of Justice did not suggest that any further reviews of the paper by the university are immediately warranted,' Darlene Trew Crist said in a written response. 'We have no further statement to make at this time.'

Given the seriousness of the allegations, and the University's mission:
The mission of Brown University is to serve the community, the nation, and the world by discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry, and by educating and preparing students to discharge the offices of life with usefulness and reputation.
the logic of the administration's refusal to have a public discussion of this case escapes me. As I have said before (in 2008!), the appearance of continued stonewalling, now going on for years, can easily be interpreted to imply that the institution has something really big and bad to hide.

Also see comments by Alison Bass on the Alison Bass blog, and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (4 September, 2012) - There have been two additional posts on the 1BoringOldMan blog on Study 329:
the lesson of Study 329: the hurdles…
the lesson of Study 329: naked Emperors, fractious Queens…

ADDENDUM (4 September, 2012) - See also this post on the Alison Bass blog.

ADDENDUM (5 September, 2012) - See this post on the retirement of Dr Keller by Ed Silverman on PharmaLot.

ADDENDUM (10 September, 201) - See the final two posts in the 1BoringOldMan series:
the lesson of Study 329: “we’re only as sick as our secrets”…
the final lesson of Study 329: epilogue…

His conclusion in the next to last post of the series:
Something terrible happened in psychiatry, an alliance between the pharmaceutical industry and a number of our leaders who allowed their academic credentials to be used for commercial purposes. It happened on a large scale, and in the process shamed all of us, whether we were involved or not. Many of the people we looked to to guide us fell into the role of key opinion leaders – a marketing term that meant that they could influence what we did and how we practiced. And in that new role, medical degrees, academic positions, the methods of science, and psychiatric experience became little more than marketing tools in a commercial campaign. Such was the case with Study 329 – an article that has become exemplary because it is now so painfully well known – a symbol for the failings of an era. It needs to be retracted simply because it was wrong on purpose – and we all know it. And yet no involved person, institution, or organization highlighted in that last paragraph has swallowed their pride, or guilt, or denial, or arrogance and called for retraction.
[Italics and bold typeface added for emphasis]

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own.

In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I documented at my post earlier today "Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?" (ghost writing, in effect, by those with obvious conflicts of interest):

  •  Is the MU Stage 2 Final Rule invalid due to the influence the industry had on the submitted "public" comments and opinions, supposedly by and of the submitters, which are now demonstrably tainted?
  •  Should an investigation be opened?

After all, as I pointed out on Aug. 29 in "The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology", not only is MU2 based on an admitted "nevertheless, we believe" justification (that is, lack of scientific rigor), but now it appears the legislation is based on stealth lobbying and resultant regulatory capture, ONC in essence doing the seller's bidding.

Tens of billions of taxpayer dollars are at issue here.

-- SS

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

-----------------------

From the Histalk blog in the 8/31/12 news at this link:

Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. David Clunie noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.

From the primary source linked in the Histalk note:

Epic via University of Michigan Health System Meaningful Use Workgroup also the same Epic comments from University of Miami (who liked them so much they submitted it twice and then a third time and then a fourth and fifth time) and again from the Martin Health System and Metro Health Hospital and The Methodist Hospitals and Fairview Health Services and Sutter Health and Parkview Health System and the Everett Clinic and Dayton Childrens' and UMDNJ and NYU Langone Medical Center and Hawaii Pacific Health and finally as submitted by Epic themselves - others like the Community Health Network just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)

I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all.

Among other things, it represents taint of the submissions via ghostwriters (unattributed authors) with obvious conflicts of interests, topics often addressed at HC Renewal.

Here's an example I verified, the submission to the government from Dayton Children's Hospital:


"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations








Another example - University of Miami:


A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)

Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains.

I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine:


... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives.

Is this a tacit admission "certification" is a sham?  Is this in patients' best interests?

and

Informational Comments for Organizations Using Epic (remove before submitting to ONC)
We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification.

In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now."

Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?"

It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities.

I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call. 

While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (link), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley.

This May 2012 post might also be of interest:  Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?  ONC never responded to the questions I raised in the post.

Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"? 

Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted?

-- SS

Addendum:

I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  http://www.tinyurl.com/epic-stealth

Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html.

-- SS

Note:

** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

Thursday, August 30, 2012

Duchess of WellPoint Abdicates, Likely to Escape with Much Loot

A change in the leadership of one of the biggest health care organizations reveals a little more about how such leadership has become our new corporate royalty and nobility.

The Departure of WellPoint CEO Angela Braly

The basics of the story, as reported by the Anna Wilde Matthews in the Wall Street Journal,
Under pressure from investors unhappy with the health insurer's performance and direction, WellPoint Inc. Chief Executive Angela Braly resigned Tuesday, and the company's board said it would begin a search for a permanent replacement.

The abrupt shift came as the board's leadership had been meeting with major investors in the wake of a disappointing second-quarter earnings report that sharpened concerns about Ms. Braly and the company's strategy

Note that while this change was seemingly dramatic,
In its statement, the board signaled that WellPoint's direction might not change dramatically. Ms. Ward said that the board 'continues to believe that time will prove the wisdom of potentially transformative actions taken under Angela's leadership…But now is the right time for a leadership change.' She also said the board believes 'the remaining executive team is dynamic and strong, with great potential to drive WellPoint's future success.'

In addition, the Indianapolis Star suggested that Ms Braly would be richly rewarded for her departure:
Details about her exit package were not released Tuesday, but under her contract, she is entitled to at least $7.7 million if terminated without cause.

Furthermore, recall how much the board apparently thought of Ms Braly's leadership in the immediate past, as evidenced by the compensation she received. In 2011, her total compensation was a mere $13.2 million (see this article in the Indianapolis Star), just slightly less than that in 2010, $13.4 million (see this post). Such compensation, of course is gargantuan compared to that received by mere mortals such as primary care physicians (actually, conservatively it is at least 66, and probably more like 100 times that of primary care physician, and over 250 times the median US family income) Such compensation, and the likelihood of a rich severance package, suggests that either the board applauded Ms Braly's leadership right up until now, or perhaps that Ms Braly, despite being a hired employee, actually had more power than the board, sufficient to virtually set her own pay.

Was Financialization the Reason She Had to Go?

So why get rid of her now? Aside from references to recent issues with only short-term revenue, there were few hints in the media. The WSJ article did note
a series of stumbles over the past few years, including an unexpected earnings hit last year tied largely to problems with a Medicare plan in California. In 2010, the company scaled back a proposed rate increase in California that had become a lightning rod in the policy debate over a health overhaul, leading to a loss.

A Forbes post suggested that one problem was Ms Braly supported President Obama's health care reform legislation, the Patient Protection and Affordable Care Act (PPACA, or ACA):
Many blame Braly and her team for putting The Affordable Care Act over the top in Congress after Wellpoint’s Anthem Blue Cross plan in California two years ago raised rates nearly 40 percent on individual policyholders before the increase was tamed. Many at the time say that provided President Obama and Sebelius political momentum and ammunition to tell the story of excessive rate increases by the loathed insurance industry.

However, no media report so far has raised the issue of the ethics of past WellPoint behavior. In fact, as we have discussed, (most recently here), the company has made a lengthy series of ethical missteps, to put it kindly. (The complete list appears in an appendix at the end of this post.) These problems have been going on for quite a while, and if they were not a concern before, there is no hint that they became a concern within the company recently.

So, one explanation for the sudden leadership change is the dominance of financialization of for-profit health care insurance (and likely of all health care organizations.) The notion, pushed by a few economists in the 1980s, that the only thing that should matter to corporate leadership is short-term financial results may be that powerful (see this post). Of course, that is profoundly troubling for health care organizations, since it dismisses the importance of any long-term results, especially of results that affect patients' and the public's health, and the importance of values like honesty.

Corporate Leadership as Our New Royalty and Nobility

Another explanation, which need not contradict the one above, was suggested by Charles Ferguson in Predator Nation. He wrote that the leadership of big financial corporations, which became the dominant organizations in the US and, indeed, in the world,
became corporate royalty, with all the absurd arrogance, disconnections from reality, ego poisoning, and cults of personality thereby implied.

If the leadership of big financial firms became royalty, then the leadership of big health care organizations became nobility. The issues above only would affect nobility slightly less. In that sense, the departure of Ms Braly likely resulted from personal and political battles among royalty. The good thing is that in this somewhat more enlightened age, the results are merely abdication, probably with a huge severance payment. In the old days, the results would likely have been imprisonment in the castle dungeon, if not beheading.

Nonetheless, the notion that top corporate leaders, including leaders of for-profit and non-profit health care corporations, are becoming the new royalty and nobility should be profoundly disturbing in the US, which was founded after a revolution against royalty's excess power.  They should be no less disturbing in other countries which have overthrown their former royal leaders, or instituted constitutional monarchies in which the royals and nobles have little political or real power. 

Obviously, the growing power and decreasing accountability of hired managers of large health care organizations has become a major reason, if not the major reason for health care dysfunction.  True health care reform would decrease the size and scope of health care organizations, and make their leaders accountable to ownership, when appropriate, and to the community at large for patients' and the public health. 

Appendix: WellPoint's Ethical Misadventures
  • settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see 2005 post here).
  • subsidiary New York Empire Blue Cross and Blue Shield misplaced a computer disc containing confidential information on 75,000 policy-holders (see 2007 story here).
  • California Anthem Blue Cross subsidiary cancelled individual insurance policies after their owners made large claims (a practices sometimes called rescission).  The company was ordered to pay a million dollar fine in early 2007 for this (see post here).  A state agency charged that some of these cancellations by another WellPoint subsidiary were improper (see post here).  WellPoint was alleged to have pushed physicians to look for patients' medical problems that would allow rescission (see post here).  It turned out that California never collected the 2007 fine noted above, allegedly because the state agency feared that WellPoint had become too powerful to take on (see post here). But in 2008, WellPoint agreed to pay more fines for its rescission practices (see post here).  In 2009, WellPoint executives were defiant about their continued intention to make rescission in hearings before the US congress (see post here).
  • California Blue Cross subsidiary allegedly attempted to get physicians to sign contracts whose confidentiality provisions would have prevented them from consulting lawyers about the contracts (see 2007 post here).
  • formerly acclaimed CFO was fired for unclear reasons, and then allegations from numerous women of what now might be called Tiger Woods-like activities surfaced (see post here).
  • announced that its investment portfolio was hardly immune from the losses prevalent in late 2008 (see post here).
  • was sanctioned by the US government in early 2009 for erroneously denying coverage to senior patients who subscribed to its Medicare drug plans (see 2009 post here).
  • settled charges that it had used a questionable data-base (built by Ingenix, a subsidiary of ostensible WellPoint competitor UnitedHealth) to determine fees paid to physicians for out-of-network care (see 2009 post here). 
  • violated state law more than 700 times over a three-year period by failing to pay medical claims on time and misrepresenting policy provisions to customers, according to the California health insurance commissioner (see 2010 post here).
  • exposed confidential data from about 470,000 patients (see 2010 post here) and settled the resulting lawsuit in 2011 (see post here).
  • fired a top executive who publicly apologized for the company's excessively high charges (see 2010 post here).
  • California Anthem subsidiary was fined for systematically failing to make fair and timely payments to doctors and hospitals (see 2010 post here).
  • management was accused of hiding the company's political contributions from the company's own stock-holders (see 2012 posts here and here).
  • settled charges that its Anthem subsidiary cheated former policy-holders out of money owed when that company was converted from a mutual insurance company (see 2012 post here)

Clinicians: How to Document the EHR Screens You Encounter That Cause Concern

Healthcare IT "glitches" as reported on this blog should make any clinician - and patient - wary of the technology in its present state.

In the past, when camera film was the only image recording medium, it was often difficult to get high quality photographs of TV screens.  No longer.

Clinicians, here's a hint: it's now easy to photograph computer screens, either old CRT-based or newer flat panels, with a cellphone or other digital camera.

When you see something you are concerned about...you have the tools to document and share as necessary with the appropriate authorities, and to protect yourself.

Further, hospitals often claim they cannot show data as clinicians see it on-screen because of "print page" restrictions or due to the "oppressive burden" of someone having to do multiple screen dumps to a printer.

That excuse is no longer valid:


A screen shot of the very screen used to create this post, taken with an old 2 megapixel cellphone, default settings, no flash, ambient (dim) light, unremarkable flat screen monitor.  The same can be done for EHR, CPOE, etc.  Click to enlarge.


This example blows that Discovery-impairing excuse out of the water.

"Glitches" should be reported, and in a manner as I wrote at this post, reproduced below:

(Disclaimer:  The IT sellers and hospital corporate officials are likely to invoke IP rights regarding EHR screens and HIPAA regulations in the attempt to limit transparency about problems, for which I take no responsibility.  Use this technique with appropriate precautions with regard to information sharing.)

... 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 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.
  • As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:
"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

We hereby indemnify [Dr. Jones] for malpractice liability regarding patient care errors that occur due to EHR issues beyond his/her control, but within the control of hospital management, including but not limited to: [system downtimes, lost orders, missing or erroneous data, etc.] that are known to pose risk to patients. We assume responsibility for any such malpractice.

With regard to health IT and its potential negative effects on care, Dr. Jones has provided us with the Joint Commission Sentinel Events Alert on Health IT at http://www.jointcommission.org/assets/1/18/SEA_42.PDF, the IOM report on HIT safety at http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, and the FDA Internal Memorandum on H-IT Safety Issues at http://www.scribd.com/huffpostfund/d/33754943-Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-Technology.

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."
  • If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.
As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

Physicians can create health IT transparency; waiting for the industry or HHS to do so is, in my view, futile and not a patient advocacy stance.

-- SS

Aug. 31, 2012 Addendum:

I tried this method on a 20 year old, cathode ray tube-based Fisher 13" (appx.) color TV set.  Of course, this TV set is limited to a few hundred lines of resolution, and is interlaced (unlike most computer monitors after the early 1990's). Here's what I got.  Note that the picture was moving:


Old TV, old 2 MP cellphone, default settings.  Click to enlarge.

Again, old 2 MP cellphone, ambient background, default settings.  I tried several shots, and all were of similar quality.

-- SS

A Tacit Admission That National Health IT is a Gargantuan Experiment

In my post yesterday "The Scientific Justification for Meaningul Use, Stage 2" I wrote:

There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary, there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program [starting at p. 18 in the Final Rule for Meaningful Use Stage 2 at this link - ed.] with the line:


"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."

I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.  [That is obviously satirical - ed.]

The Final Rule for MU Stage 2, via the admissions made by it regarding limited evidence, is in fact a tacit admission that the whole national health IT enterprise is a huge experiment (involving human subjects, obviously).  It is likely the most forthright admission we will get from this government on that issue.

With neither explicit patient informed consent nor a formal regulatory process to validate safety, but merely based on a "we believe" justification from the government, hospitals and practices are leaving themselves wide open to liability in the situation of patient injury or death caused by, or promoted by, this technology.

(Parenthetically, I note that I've already seen a claim in a legal brief that "certification" implies safety and a legal indemnification, and that the federal HITECH act - that as in this report merely provides statutory authority to the incentive program - pre-empts common-law i.e., state litigation over health IT.  The judge dismissed the claims.)

-- SS

Aug. 30, 2012 addendum:

A commenter pointed out that experiments on minors without consent might constitute an even more egregious action, subject to even more stringent laws (and perhaps penalties, I add) than on adults.   I cannot confirm that, but it is an interesting observation.  If you are an attorney, please comment, anonymously or otherwise.

-- SS

Wednesday, August 29, 2012

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

The Final Rule for Meaningful Use Stage 2 has been released.  It is at this link (PDF).  It is a mere 672 pages in length, a quick read during one's evenings of leisure.

Here is, from page 18 verbatim, the scientific justification for the program.  The finest scientific methods were used to achieve these criteria in justification of spending of $15 billion of taxpayer money in "incentives" (probably a low estimate), not counting the additional hundreds of billions the buyers themselves will spend that is diverted from your healthcare to the IT sector:

3. Summary of Costs and Benefits

This final rule is anticipated to have an annual effect on the economy of $100 million or more, making it an economically significant rule under the Executive Order and a major rule under the Congressional Review Act.

Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the final rule. The total Federal cost of the Medicare and Medicaid EHR Incentive Programs between 2014 and 2019 is estimated to be $15.4 billion (these estimates include net payment adjustments for Medicare providers who do not achieve meaningful use in 2015 and subsequent years in the amount of $2.1 billion).

In this final rule we have not quantified the overall benefits to the industry, nor to EPs, eligible hospitals, or CAHs participating in the Medicare and Medicaid EHR Incentive Programs. Information on the costs and benefits of adopting systems specifically meeting the requirements for the EHR Incentive Programs has not yet been collected and information on costs and benefits overall is limited. 

Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs, including reductions in medical recordkeeping costs, reductions in repeat tests, decreases in length of stay, increased patient safety, and reduced medical errors. There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs.

There's no truly robust evidence of generalizable benefit, no randomized trials, there's significant evidence to the contrary (that, incidentally, is deliberately being ignored), there's risk to safety that this disruptive technology causes in its present state (but the magnitude is unknown, see quotes from 2012 IOM study here) that MU and "certification" do not address, there's a plethora of hair-raising defect reports from the only seller that reports such things, but CMS justifies the program with the line:

"Evidence [on benefits] is limited ... Nonetheless, we believe there are substantial benefits that can be obtained by eligible hospitals and EPs ... There is evidence to support the cost-saving benefits anticipated from wider adoption of EHRs."

I am deeply impressed by the level of rigorous science here.  We are truly in a golden age of science.

I recommend NIH, NSF, FDA and all other research and regulatory agencies immediately adopt this rigorous HHS methodology (called the "NWB" methodology for "nonetheless we believe") in their professional pursuits and research grant approval processes.

-- SS

Tuesday, August 28, 2012

Parallels Between the Anechoic Effect in Finance and in Health Care: Predator Nation by Charles Ferguson

What has gone wrong with health care now seems to be the same as what has gone wrong with finance, and society at large.  This was not always obvious to those of us toiling in medicine, probably because we were so focused on medicine that we paid too little attention to the larger world around us.  The people I interviewed in preparation for writing A Cautionary Tale, [Poses MD. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here.] identified broad issues that helped characterize American health care dysfunction.  Neither they nor I, however, initially thought that these problems were tied to the broader society.  In fact, I often wondered back then why health care, and it seemed particularly academic medicine, was so uniquely cursed.

Now it seems obvious in retrospect that health care, finance, politics, and society are circling the same drain.  Now there has been enough time since the beginning of the great recession/ global financial collapse for some people to describe the larger problems.

The Anechoic Effect

We have frequently discussed what we called the "anechoic effect" in health care.  In short, this meant that discussing the big problems in health care, particularly those involving leadership and governance, was simply not done, particularly by the academics who could have addressed the problem.  Lots of examples of the anechoic effect are here.  We have postulated that this has to do with fear of offending the rich and powerful who now lead and govern health care organizations, and the benefits, which may be produced by conflicts of interest, of maintaining good relationships with these rich and powerful.

Charles Ferguson in Predator Nation on the Anechoic Effect

Meanwhile, the anechoic effect was a big reason that finance became such a big mess.  Charles Ferguson, as we have previously discussed, has been one of the most insightful commentators on the great recession/ global financial collapse, starting with his Academy Award winning documentary Inside Job.



This year he published Predator Nation (Ferguson C. Predator Nation: Corporate Criminals, Political Corruption, and the Hijacking of America. New York: Crown Business, 2012.) a more complete account of our financial disaster.  It has a section on what we on Health Care Renewal would call the anechoic effect, and how it is driven by perverse incentives (pp 81-82) :
You see a horrific train wreck in the making, with all your coworkers contributing to it. But they are all making a fortune, and their manager - who is your boss too - is making even more money by keeping it going. Quite obviously, they're going to keep doing it whether you participate or not; so even if you refuse to participate, the firm will be dead anyway. You can try to stop it by going over your boss's head to the CEO; but your boss won't like that at all, and he and the entire department will tell the CEO whatever they need to tell him in order to keep it going. And if - speaking purely hypothetically - your CEO is an oblivious, selfish, obnoxious egomaniac nearing retirement age, heavily focused on his golf game and art collection, with a few hundred million in cash already stashed away, scheduled to rake in another $50 million this year, whose contract guarantees him another $100 million if he loses his job - well, then he probably won't be very sympathetic to you either. You could try going to the board of directors, but even if you could reach them, it will turn out that they are old pals of the CEO, often stunningly clueless, picked largely so that they won't rock the boat.

So if you try to stop the party, you'll probably get marginalized or fired, as happened to a number of serious, ethical people who tried to warn their management and curtail unethical and illegal conduct in Merrill Lynch, Lehman, Citigroup, AIG and elsewhere. So you'd gain nothing by acting ethically - quite the contrary, you'd ostracize yourself and lose your chance to build (or rather, transfer to yourself) some real personal wealth - possibly once-in-a-lifetime opportunity.

Summary: the Application to Health Care, and What Must be Done to Change Things

So consider how much of this might apply to a) serious, ethical employees of large health care corporations, and b) health care professionals who are employees of large health care non-profits, and/or have major financial relationships (conflicts of interest) with large health care corporations. 

Regarding the latter, think of the health care professionals who worked at the Allegheny Health Education and Research Foundation (AHEF) back in the 1990s, and who were told by their multi-millionaire CEO,  "Don’t cross me or you will live to regret it."  How inclined would they have been to blow the whistle on his supposedly "visionary" leadership?  On Health Care Renewal, we have posted lots of relevant newer examples of bad behavior by wealthy leaders of drug, device, biotechnology, health care information technology, and health insurance companies.  We have also posted lots of relevant newer examples of bad behavior within hospital systems and academic medical centers.  Yet most of these generated little resistance from within the organizations at the time they were occurring, and those who did try to blow the whistle often did not fare very well. 

The biggest issue is clearly that if you are in a system which may hugely award clueless, or bad behavior (i.e., that has perverse incentives), then those who might protest will be effectively silenced by those who are profiting from the status quo.

Combating this would require serious outside regulation to discourage perverse incentives and conflicts of interest, serious law enforcement to prosecute any resulting fraud, bribery, etc, and serious protection of whistleblowers, just for a start. All are currently lacking in finance, and in health care. But if we do not put such measures in place, the downward spirals in health care and finance will just continue.

Do not expect to see much discussion of these issues in health care or finance in the current political debate, unless those currently outside of the debate break the anechoic effect and inject them into the debate.

Monday, August 27, 2012

Health IT Amateurs, Logical Fallacy and Hospital Leadership: An Inhibitor to Good Health IT

An excellent three-part article on local providers' efforts to "join the electronic medical record/clinical IT movement", including a middle section "One doctor has reservations about EMR's design, usability", was published yesterday in the Dubuque (IA) Telegraph Herald.

I was cited as that doctor (subscription required).

The article began:

Dr. Scot Silverstein travels the country attending conferences [and other countries as well - ed.], speaking on panels and voicing concerns about health care's headlong rush into a reliance on electronic medical record systems.

"Headlong rush" is an accurate description of my beliefs, as in my "cart before the horse" posts here.

The newspaper reporter continues:

"Older and younger physicians alike are increasingly concerned about the poor design and poor usability of clinical IT," Silverstein said.  

Not only that, but so is ONC, the Institute of Medicine and the National Institute for Standards and Technology, among others, who I indicated were the source of my quotes.

The Drexel University College of Information Science and Technology faculty member calls "EMR" an anachronistic term from a time when the systems were merely storage tools for records.  "What is meant in 2012 is not just an innocuous 'filing cabinet,' but an enterprise clinical resource management and workflow control system - not just storing records, but regulating and governing all clinical behavior and action," Silverstein said.

That is, indeed, my own observation.

Silverstein contends such systems are inappropriate for some health-care environments, such as emergency rooms and intensive-care units.  "They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition," he said.

Again, not only me.  As I had written to the reporter:

... These devices are not appropriate for high-risk, high-intensity environments such as ED's, ICU's etc.  They slow down and distract clinicians due to their generally poor user interfaces, in the worst possible setting, and disrupt clinician cognition.  But don't take my word for it.  See the 2012 report from the Institute of Medicine on healthcare IT safety (I wrote about it at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html), the National Institute of Standards and Technology report on clinical IT usability (http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html) and the literature I collated at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist.

In fact, document image management systems and human data abstractors are a good tradeoff to meet the needs of the most time-pressed clinicians whose time is a hospital's most valuable asset, and to make patient charts available when and where needed.  This is as opposed to "digital data field and form-based" (i.e., conventional) EMR's that force the clinicians to waste their time in clerical functions and distract them from pressing clinical matters and informational accuracy. 

He then reports:

Silverstein defines such cognition as the decision making and problem solving necessary to provide quality health care.

Precisely.

... Silverstein thinks current clinical IT programs focus too much on raw data and not enough on supporting a physician's decision-making abilities. "As a result, valuable time and energy is spent managing data as opposed to understanding the patient," he said. "Ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models that depict the health status of the patient, including information on how different organ systems are interacting, epidemiological insight into the local prevalence of disease and potential patient-specific treatment regimens."
 
Actually, it's not just that I think and said these things.  The quote came verbatim, as I had indicated, from the prestigious National Research Council of the United States and their 2009 study on health IT, led by healthcare IT pioneers Drs. Octo Barnett and William Stead.

Any time logically consistent, ethics-based, common sense observations and opinions are expressed about health IT, however, one can always rely on a pundit or hospital executive for a misdirecting, illogical, and/or impertinent comment.

The expected came from Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque:

 ... Kay Takes, vice president of patient care services at Mercy Medical Center-Dubuque, said the hospital finds electronic medical records a help in the critical environment of the ICU.

"Specifically in the ICU, in the last 13 months we've gotten enhancements that allow us to download values from the medical equipment - it's automatically pulled into the medical record," she said "It's been fantastic. The availability of the information is enormously valuable. It's been a lot more of a benefit than a hindrance."

I speak from experience, in having been involved in developing those exact same capabilities in the mid 1990's (or, most accurately, protecting patients from the dangers created by the IT department in the project), that they are a convenience to those who formerly had to collect the data manually and write it on the ICU flowsheet.

The capabilities are also a mild convenience to clinicians who view the data, although the surface area of a paper flowsheet is a great advantage in seeing more data in one's field of view at one time than the usual small computer screen (to illustrate see my Feb. 2012 post EHR Workstation Designed by Amateurs at this link and my Jan. 2012 post An 'Anecdotal Complaint' About An ICU EHR at this link).

From the latter post:

... And we do still talk to each other – but even that doesn’t always “work out”, because we’ve lost our operational minds (collectively) – the shared-by-all compact, visually all data in one place, and temporally arranged – i.e., the shared nurse/doc/resp flowsheet [traditionally in an ICU, a long tabular scroll of paper for "at a glance" patient status overview - ed.] – where everybody was looking at the same page, which we no longer are – as the team is slowly discovering.

And which required no logon for sign-over bedside rounding (~40 minutes for 20-30 babies was the allotted time). The flowsheet needed only a 10-15 second glance to spot developing problems; “the computer” is effectively inaccessible in the time allotted for the twice daily sign-n-out “rounds”.

Ultimately, though, Ms. Takes, if quoted accurately, commits the logical fallacy of ignoratio elenchi ("ignorance of refutation", missing the point) – an argument that may in itself be valid, but does not address the issue in question.

For this convenience does not at all justify the downsides of EHRs, especially in an ICU:  increased time for task completion, increased risk of errors of commission or omission, and the other risks as outlined in sources such as FDA's 2010 Internal Memo on H-IT Risks, and recently by AHRQ in their IT Hazards Manager project (Appendix B).

Let's review those risks and failure modes from the AHRQ report, all observed empirically in the real world.  From the report:

A health IT hazard is a characteristic of any health IT application or its interactions with any other health care system (e.g., the people, equipment and work spaces of an ICU) that increases the risk that care processes will be compromised and patients harmed.

The potential outcomes of these hazards include medical privacy breach/identity theft, medical misadventures such as errors of commission or omission resulting in "close calls" (errors barely averted), or patient injury, or death, stress on clinicians reducing their performance, and documentation errors or data corruption increasing the risk of errors in the short, medium or long term.  In short, nothing you'd likely desire to occur while you or a family member was a patient:

Usability
• Information hard to find
• Difficult data entry
• Excessive demands on human memory
• Sub-optimal support of teamwork (situation awareness)
• Confusing information display
• Inadequate feedback to the user
• Mismatch between real workflows and HIT
• Mismatch between user mental models/expectations and HIT

Data Quality
• IT contributed to entry of data in the wrong patient’s record
• Organizational policy contributed to entry of data in the wrong patient’s record
• Patient information/results routed to the wrong recipient
• Discrepancy between database and displayed, printed or exported data
• Faulty reference information
• Unpredictable elements of the patient’s record available only on paper/scanned documents
• Lost data
• Inaccurate natural language processing
• Virus or other malware

Decision Support
• Excessive non-specific recommendations/alerts
• Faulty recommendation
• Missing recommendation or safeguard
• Inadequate clinical content
• Inappropriate level of automation

Vendor Factors

• Sub-optimal interfaces between applications and devices
• Faulty vendor configuration recommendation
• Unusable software implementation tools
• Non-configurable software
• Inadequate vendor Testing
• Inadequate vendor software change control
• Inadequate control of user access
• Faulty software design (specification)

Local Implementation

• Faulty local configuration or programming
• Inadequate local testing
• Inadequate project management
• Inadequate software change control
• Inadequate control of user access
• Suboptimal interface management

Other factors
• Inadequate training
• Excessive workload (including cognitive)
• Inadequate organizational change management
• Inadequate management of system downtime or slowdown
• Unclear policies
• Compromised communication among clinicians (i.e., during handoffs)
• Interactions with other (non-HIT) care systems
• Physical environment (e.g., hardware location, lighting, engineering)
• Inadequately secured data
• Hardware Failure
• Use error in the absence of other factors

The convenience of automated data collection through an EMR system comes at, one might say, a slight cost that may not be realized by health IT amateurs.** 

Unfortunately, their lack of knowledge of these issues reduces the caution and "pushback" required for good health IT to become the norm, and permits bad HIT to be sold.


-- SS

** Amateurs in the sense that I am a radio amateur, not a professional, formally trained telecommunications engineer, and would never take a major role in an enterprise telecommunications project, especially a mission-critical one.

8/27/12  Addendum:

A typical, anonymous, irrational response of the type we've seen on this blog before (as for example here and here) has been posted as a comment to the newspaper story:

"nemesis" posted at 1:19 pm on Mon, Aug 27, 2012. 

He travels the country complaining about existing systems? Perhaps the good prof could spend a little time designing the ideal interface/system and see if he can get anyone interested. Surely his design would win them all over.

The problem with this type of comment, of course, is that it's logically fallacious (a form of ad hominem and an odd "appeal to perfection") and irrelevant.  It is no way responds to or refutes the issues I raise in the article.   

It likely comes from a health IT pundit of some sort, but hopefully not someone in a position of authority.  In medicine, the rule of thumb is simple:  "Critical thinking always, or your patient's dead."

-- SS

Thursday, August 23, 2012

Will Another Study on Physician Burnout Finally Lead to Addressing its Causes?

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).

Similar conflicts may affect accrediting organizations, health care foundations, and especially academic medical institutions, as we have profusely discussed.  (Look at our posts on conflicts of interest, and institutional conflicts of interest.)

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.

From the University of Chicago EHR Helpdesk Call Line

I was alerted this morning (Aug. 23rd) to this message currently in the telephone message of the CBIS [Chicago Biomedicine Information Services] Service Desk at University of Chicago Medical Center:

"Thanks for calling the CBIS Service Desk.  Your call is very important to us. We are currently experiencing troubles with our Citrix logon.  It may log you on under a different profile.  Please check before you go any further when you're logging in to Citrix."

Citrix is a computer program that allows remote access to information systems.

I imagine the meaning of "log you on under a different profile" means "logging you on as a different user."

The chances of a security breach (ability of unauthorized user to peer into patient's charts they have no business seeing), unauthorized history/order manipulation, or even misidentification error (e.g., a clinician inadvertently acting upon a patient of some other clinician who has a similar name to their own patient) and other distracting work disruptions due to the inconveniences this "trouble" creates are worrisome.

One wonders how every user is being informed of this problem, as not everyone makes it a habit to call the service desk before logging in to clinical systems...

But, alas, this is just a "glitch" (the euphemism used by technophiles for malignant software defects), and, of course, patient safety is never compromised by "glitches."


Patient Safety Will Not Be Compromised, We Predict ... So Say Us All.


-- SS

8/29/12 Addendum:

Apparently the problem was finally solved between 5:30 PM and 9 PM CST on August 27.   I first became aware of it at around 8 AM EST August 23.  Brings to life the line "either you are in control of your information systems, or they are in control of you."

Also, see the comment thread to this post here, specifically the comments starting at August 28, 2012 12:16:00 PM EDT, to see yet another demonstration of the illogic, unserious attitudes and feelings of entitlement towards patient risk and transparency characteristic of the health IT industry.  The anonymous commenter also alleges to have firsthand knowledge of the problem, suggesting they are from U. Chicago, but this cannot be confirmed.

-- SS

Wednesday, August 22, 2012

BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and as a guest blogger on KevinMd.  The post was about other physicians can become big-time KOLs by using social media, and refers to another post which indicates that pharmaceutical companies look for physicians who are big prescribers of their products and have a lot of influence to, guess what, help market their products.  Although the blogger refers to ethics more than once, how it is ethical to trade on the trust physicians get for their professional vows to put patients first to market products (that may not always be good for patients) remains beyond me.

ADDENDUM (27 August, 2012) - See also comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.  

An Even Bigger Golden Parachute for Captain Outrageous

In 2009, I first posted about the amazingly colorful leadership and governance problems at a small hospital system in Massachusetts. 

Background: Northeast Health System

The story of Northeast Health System then included  leaders who solicited money from the community but concealed what they were doing from the same community, an adolescent pregnancy pact after the hospital system refused to provide confidential birth control information at the high school clinic it ran, a hospital vice-president accused of art theft, various cuts, some concealed, of medical services, accusations of conflicts of interest affecting the board of trustees, and no-confidence votes by nurses and physicians. Finally, Stephen Laverty, the CEO held responsible for much of the mess, resigned and things quieted down a bit.  However, he left a system in deficit, leading to further lay-offs, (e.g., see this story in the Boston Globe).  And the vice-president accused of art theft was also "arraigned on bribery and larceny charges" (also per the Boston Globe.)

Nonetheless, in 2010, it was revealed that Mr Laverty left with a golden parachute worth more than $1 million.  But wait, now there is more.

A Guilty Plea
In May, 2012, per the Salem News,
A former associate vice president at Beverly Hospital pleaded guilty yesterday to soliciting bribes and kickbacks from hospital contractors and stealing valuable paintings and other antiques while overseeing a $50 million renovation of the facility.

Paul Galzerano, 60, was sentenced to serve 18 months of a two-year jail term on four larceny counts and two years of probation on two counts of commercial bribery during a hearing yesterday at Salem Superior Court.

Yet More Severance Payments


But wait, there is even more. Yesterday, the Gloucester Times reported about Mr Galzerano's former boss,
Nearly four years after he resigned under fire, former Northeast Health System CEO Stephen Laverty is still collecting big paychecks from his former employer.

Laverty was paid $573,348 in severance in 2011, the second year in a row he has received buyout money from Northeast, the parent nonprofit corporation to Beverly Hospital and Gloucester’s Addison Gilbert Hospital, and a corporation that was essentially merged with Lahey Clinic to become the new Lahey Health System under an agreement that gained the necessary state approvals earlier this year.

Laverty's total severance payments have reached "more than $1.56 million over those two years." Whether the payments have ended is not clear. Attempts to discover why payments continued and became so large revealed only,
Beverly Hospital released a statement Monday saying, 'We cannot comment on Mr. Laverty or the terms of any agreements between the company and past employees.'
Summary

For a relatively small hospital system, Northeast Health System has produced an enormous example of the perverse incentives given to top executives of health care organizations. Mr Laverty has been made a millionaire despite what the Gloucester Times called in its news article a "tenure plagued by acrimony and controversy," and leadership previously described in a Gloucester Times editorial as "arrogant, dictatorial," and a history of what only can be described as outrageous management failures. Furthermore, the money he received came not from rich stockholders, but from a struggling community hospital system.

The ability of top executives of many, probably most health care organizations to collect bloated paychecks out of proportion to, if not despite their performance attracts the wrong people to lead these organizations, and provides incentives for even the right people to lead badly. 

Until we make health care leaders accountable, and until their incentives reflect their ability to uphold the health care mission, expect more unaccountable leadership that subverts the health care mission, and hence continually rising costs, declining access, and deteriorating quality. 

Tuesday, August 21, 2012

Pfizer's Pforeign Pfiasco

Quelle surprise.  Giant international pharmaceutical company Pfizer managed to go for nearly 10 months without announcing a major legal settlement.  However, this month, as reported by Bloomberg, it was time for Pfizer to settle again.  The basics were:
Pfizer Inc., the world’s biggest drugmaker, agreed to pay $60.2 million to settle foreign bribery cases it brought to U.S. authorities involving alleged payments paid by employees and agents of subsidiaries.

Pfizer entered into two agreements with the Securities and Exchange Commission and the New York-based drugmaker reached a deferred prosecution accord with the Department of Justice, according to filings today in federal court in Washington.

Bribery

This case is worth perusing because of how it documents what the US government called not merely deceptive, but corrupt practices used by Pfizer to sell drugs. The practices were widespread around the world:
The settlements announced today include Pfizer operations in eight countries: Bulgaria, Croatia, Kazakhstan, Russia, Italy, China, the Czech Republic and Serbia. The Wyeth settlement, over its nutrition business, was for China, Indonesia, Saudi Arabia and Pakistan.

The practices involved, not to put too fine a point on it, bribing doctors. Furthermore, as part of the settlement Pfizer apparently admitted to some of the specific practices alleged by the government:
In Bulgaria, local representatives spent $28,000 to invite government doctors on 'incentive trips' to Greece, as a reward for the physicians who were the biggest prescribers of Pfizer’s products, Pfizer admitted according to the Justice Department filing. They also paid $17,000 to send doctors to medical conferences, again in exchange for commitments to prescribe Pfizer drugs.

In Croatia, the unit there had used a consulting agreement with a government doctor to help influence which drugs were allowed to be sold in the country, paying the physician in cash and travel expenses, Pfizer admitted.

Pfizer also admitted to what was called the 'hospital program,' in Russia, where doctors were given a 5 percent kick- back on certain drugs prescribed.

'Pfizer Russia used the Hospital Program to make cash payments to individual government healthcare professionals to corruptly reward past purchases and prescriptions of Pfizer products, and to corruptly induce future purchases and prescriptions,' the Justice Department said in the filing. Pfizer’s Russian unit also used intermediary companies to pay off doctors and government officials, the company admitted.

No Individual Penalties

Despite the shamefulness of these practices, as is now distressingly usual (look here), no individual seems to be obligated to suffer any penalty or negative consequences as a result of this settlement. While the US government alleged criminal behavior, beyond the fines imposed on the company, further prosecution will be deferred:
The Justice Department charged the Pfizer HCP Corp. unit with two criminal counts, conspiracy to violate the Foreign Corrupt Practices Act and a violation of the FCPA’s anti-bribery provisions. Prosecutors agreed to defer prosecution and drop the charges after two years if Pfizer continues to cooperate and take remedial steps.

The article contained a curious statement seemingly asserting that the payments were somehow made independent of any actions by individuals at Pfizer:
The SEC said the payoffs were made 'without the knowledge or approval of officers or employees of Pfizer, but the inaccurate books and records of Pfizer subsidiaries were consolidated in the financial reports of Pfizer.'

So were the payments made by machines acting autonomously? or by ghosts? Maybe this was just a typo. However, note that the de rigeur statement by Pfizer's internal counsel was phrased so as to imply the actions somehow occurred outside of the organization:
'The actions which led to this resolution were disappointing, but the openness and speed with which Pfizer voluntarily disclosed and addressed them reflects our true culture and the real value we place on integrity and meeting commitments,' Amy Schulman, Pfizer’s general counsel, said in an e-mailed statement.

Summary

This latest settlement reaffirms the poor ethical culture now prevalent in major health care organizations throughout the world.  It also affirms how deeply unethical the culture has become at some of our largest and most prominent and influential health care organizations.  This settlement is only the latest evidence of ethical missteps by Pfizer's leadership.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,
October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.

May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.

April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).

Thus, it appears on 10 separate occasions between 2002 and 2012, Pfizer settled allegations of, pleaded guilty to, or was convicted for actions that represented seriously unethical behavior.  Note that these included a conviction that found the company to be a racketeer-influenced corrupt organization.

Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences.  In fact, last year its CEO made over $18 million, up from over $6 million the year before (see this post).   

So obviously it is not just that one company's culture has become seriously corrupt.  We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations.  Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong."




Unless we hold leaders of health care organizations accountable for bad behavior and corruption, expect bad behavior and corruption to get worse.  Until we have political leaders with the courage to stand up for honesty and the law, expect continued dishonesty and the law to continue to be trampled by the rich and powerful.