Health Care Renewal

The Texas TMAP Trials as Illustration of a Systematic Stealth Marketing Campaign

2012-02-10T17:12:00.000-05:00

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case here in 2006, and that this trial and the case was ably covered in detail on the 1BoringOldMan blog.)

Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., here), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care.

Evidence-based medicine may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values.

In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic.

Deception and Falsehoods: Suppression of Medical Research

A Bloomberg report of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research:

Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.

As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.

That study concluded Risperdal caused 'medically serious weight gain' that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.

In particular,

Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000.

The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.

Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends.
Deception and Falsehood: Ghostwriting

A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General published in the Houston Press provided this example of ghostwriting:

A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit.

Miller was a 'guest author' for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript.'

In addition, another article in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process:

As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles.

In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that 30 of the 145 articles to be published had authors listed as 'to be determined.'

Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters.

Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.''

The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.

This indicates the scope of this particular ghostwriting initiative: 145 articles were planned. Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal. Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work. Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers.

Deception and Falsehoods: Key Opinion Leaders
Emotional and Psychological Manipulation: Creation of Conflicts of Interest

An important element of most stealth marketing campaigns is the creation of key opinion leaders. These are academics or professionals who can promote products in the guise of unbiased expertise.

A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General published in the Houston Press provided the example of Dr Steven Shon:

As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing Risperdal was invaluable.

He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, 'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing.'

The company paid for his trips across the country, and even overseas, to promote Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.)

Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare.

Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP."

Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."

Similarly, a Bloomberg report of Dr Shon's trial testimony included:

Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.

Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.

Also,

Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.

Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company.

Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.

In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years.

Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive.

The Institute of Medicine report on conflicts of interest defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this.

However, conflicts of interest created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (see posts here and here). Such deliberately created conflicts may be deceptive, as noted above, and are particularly likely to lead to abuse of entrusted responsibilities. Given that the Transparency International definition of corruption is abuse of entrusted power for private gain, these conflicts of interest perhaps deserve such a more incisive name.

The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience.

Emotional and Psychological Manipulation: Intimidation

Another Bloomberg report included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated:

Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said.

Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said.

'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.'

Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said.

The state adopted the guidelines that favored Risperdal in 2003, Jones said.

Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility.

However, then

Jones said his boss told him to ease off his probe. He said he was told, 'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP.

Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.'

Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. He said he was fired for talking to the newspaper.

So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems.

Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission:

Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him.

In a sense, intimidation and created conflicts of interest are two sides of the same coin. Both involve the deliberate imposition of incentives, either positive or negative. These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science. Thus they are powerful tools of emotional and psychological manipulation.
Summary

Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of stealth marketing campaigns, including such examples as that of Neurontin here).

Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health.

There have been many calls (e.g., see recent posts here and here) for increased "collaboration" among health professionals and academics and industry. Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable." The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

2012-02-09T10:06:00.046-05:00

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:

Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164

The section I find most interesting is this:

We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) at two Australian teaching hospitals. In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and we compared before and after error rates. Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors (where system functionality or design contributed to the error) were calculated.

Here is my major issue:

Unless I am misreading, this research took place in hospitals (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) discharge prescriptions.

I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at discharge, or in outpatient clinic/offices to communicate with a pharmacy selling commercially and not involved in inpatient care.

From the U.S. Centers for Medicare and Medicaid Services (CMS), for example:

E-Prescribing - a prescriber's ability to electronically send an accurate, error-free and understandable prescription [theoretically, that is - ed.] directly to a pharmacy from the point-of-care

I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT.

This study appears to be of an inpatient Computerized Practitioner Order Entry (CPOE) system, not e-Prescribing.

Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via ONC-Authorized Testing and Certification Bodies) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you.

(This is not to mention the irony that one major aspect of Medical Informatics research is to remove ambiguity from medical terminology, e.g., via the decades-old Unified Medical Language System project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.)

I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE.

That said, looking at the nature of this study:

The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data:

Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards.

Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.

I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words, these were unintended adverse events as a result of the technology itself.

The authors conclude:

Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed.

The authors do acknowledge some limitations of their (CPOE) study:

Limitations included a lack of control wards at Hospital B and an inability to randomize wards to the intervention.

Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial.

Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in this comment thread).

In that thread I wrote to a commenter [a heckler, actually, apparently an employee of HIT company Meditech] with a stated absolute faith in pre-post studies that:

... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc.

There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here.

The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong.

Stated simply, in pre-post trials the results may be affected by changes that occur other than the intervention. HIT implementation does not involve just putting computers on desks, as I point out above.

In other words, the study was essentially anecdotal.

The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course.

Next, on ethics:

CPOE has already been demonstrated in situ to create all sorts of new potential complications, such in at Koppel et al.'s "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors", JAMA. 2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded:

In this study, we found that a leading CPOE system often facilitated medication error risks, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent.

CPOE technology, at best, should be considered experimental in 2012.

In regards to e-Prescribing proper, there's this: Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten and this: Upgrading e-prescribing system can bump up error risk to consider; in other words, the literature is conflicting, confirming the technology remains experimental.

This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards."

In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid.

Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones did not provide informed consent to the experimentation with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. This phenomenon is a pervasive, continual world-wide oversight with regard to clinical IT.

Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful.

What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this:

The impact of possible non-cybernetic interventions (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions."

Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like this affecting an entire country.

There is something very wrong with this, both scientifically and ethically.

-- SS

Note:

[1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment

Addendum Feb. 10, 2012:

An anonymous commenter points out an interesting issue. They wrote:

The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices.

Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.

I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant.

I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky.

-- SS

Health IT: Ddulites and Irrational Exuberance

2012-02-08T16:25:00.050-05:00

The title is not a typo.

I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially in the domain of health IT.

In face of the literature references provided throughout this blog, including at posts such as this reading list and at sites such as here, one would think rational people would temper their exuberance somewhat, at the very least towards rapid national rollouts - as opposed to constrained, controlled experiments until the industry learns how to get the technology "right."

However, more than a decade of writing has had little effect.

I've also attempted to explain the phenomenon of irrational exuberance on a belief in technological determinism, on industry propaganda, on unquestioning IT faith being a quasi-"religion", and on profiteering or other quid pro quo. (The latter, I'm certain, is operative to an extent.)

I have now come across a term, though, that I believe accurately encapsulates the phenomenon of unquestioning beliefs that health IT + clinician automagically --> a "revolution" in medicine.

It may be a character trait. The trait has been described by the term "Ddulite." (Pronounced, I would say, 'da-dew-light'.) It is obviously a play on "Luddite" with the fist four characters backwards.

Apart from its historical meaning, a Luddite is "one who is opposed to change, especially technological change" (Merriam-Webster).

A Ddulite, on the other hand, is the opposite of a Luddite. A Ddulite is:

A person who prefers new tech to old tech even when the old tech is better--more functional

or alternately:

A person with a preference for higher tech solutions even in cases where lower tech alternatives have greater and more appropriate functionality.

The Ddulite simply assumes if it's new technology, it has to be better, no matter the evidence because, well, it's new technology.

In other words, irrational exuberance in IT in general, and HIT specifically, is not merely a belief, it's a character trait, perhaps an ideology.

That could help explain why some otherwise very bright people, even people who promote evidence-based medical practice, seem to become blind and deaf in regard to HIT, as in the recent comment thread on my post "KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care."

When it comes to evidence-based IT practice, a Ddulite is eager to provide extraordinary special accommodation towards IT flaws, ethics, known dangers, etc. Someone of this ideology finds it exceptionally easy to dismiss or ignore any and all evidence that could contradict the technology's powers to "transform" medicine, and perhaps even worse (for patients), that could contradict its infallible beneficence.

Unfortunately, IT is not a magic bullet ... it can be just a bullet, period, unless "done well", an undertaking of almost wicked complexity.

Being a Ddulite can, in fact, lead to recklessness and negligence. A transition to IT must always respect the findings of Social Informatics (PDF): see especially Sec. 3.1 'Key Social Informatics Ideas' starting on pg. 117. The transition must be done - especially in a scientific domain - in a scientific manner.

In medicine, that means applying the rigors of medical research, medical science and medical ethics to the conception, design, implementation and lifecycle of health IT, with all that implies. This is certainly not the state of the HIT enterprise in 2012, which is largely based on a management information systems, i.e. merchant-computing, paradigm.

People who offer unquestioning loyalty to cybernetics, and who reflexively accuse those who are circumspect about commercial health IT of being "Luddites" who proffer "anecdotes", perhaps need to look in the mirror. They then need to think critically as to whether their reflection demonstrates Ddulite characteristics.

Unquestioning loyalty to the Empire: In A Mirror, Darkly

-- SS

More cybernetic miracles: 14,000 patients failed to receive follow-up outpatient appointments

2012-02-07T18:23:00.009-05:00

14,000 is a lot of patients to miss followup appointments. I do not think this feat could have been accomplished via paper:

Morecambe Bay missed 14,000 outpatients
E-Health Insider.com
7 February 2012
Lyn Whitfield

University Hospitals of Morecambe Bay NHS Foundation Trust is working through a backlog of 14,000 patients who failed to receive follow-up outpatient appointments because of administrative and IT problems.

And problems with disappearing ink and Fido, the office canine, chewing up charts, but mostly the IT.

The report of an investigation into the backlog paints a damning picture of failures at the trust, which became the first to introduce the Lorenzo electronic patient record system as part of the National Programme for IT in the NHS.

That would be, the failed National Programme for IT in the NHS, the NpfIT that went Pffft (perhaps the world's most expensive onomatopoeia, at a mere £12.7bn).

The report says the problems go back many years and have their roots in a ‘mismatch’ between demand and capacity at Morecambe Bay, as well poor management and risk practices and a culture of avoiding blame.

However, it also says the trust missed a big opportunity to identify and tackle the problems when it introduced Lorenzo [a health IT system - ed.] in June 2010, and that staff work-arounds contributed to the ultimate size of the backlog.

That is, workarounds to system flaws and 'glitches.'

Eventually, there were 37,000 access plans on the Lorenzo system for which a guaranteed access date had been missed. Many of these plans were duplicates or had not been closed.

However, 14,000 patients needed to be seen and were divided into cohorts so the trust could deal with them. All these patients should have been seen by the end of March.

For the future, the report says the trust needs to establish better systems, find ways to make sure that the board knows what is going on, encourage staff to take responsibility for dealing with problems, and curb the “mal-use” of Lorenzo by imposing “sanctions” on staff if necessary.

Once again, blaming the IT users and punishing them for not conforming to the diktats of the IT and its designers.

It also says the findings of the report, and the importance of “electronic, standardised and systematic management of outpatient follow-ups” should be shared with all providers, in case others are suffering the same problems on a smaller scale.

"In case?" It sounds like they don't even know.

... when a backlog was identified during the data cleansing process for the introduction of Lorenzo, the trust failed to recognise it as a clinical problem.

Instead, to try and solve another administrative problem – the constant cancellation of clinics – the trust introduced a ‘partial booking’ system. Patients who needed a follow-up in more than six weeks were asked to call for an appointment.

“No arrangements were made to account for the 1,000 or so calls that the clinical clerks would receive per week, whilst still trying to man the reception desk and administer the clinics,” the report says. “This created chaos and confusion for patients and staff alike.”

Sounds like a government operation to me.

Patients were often offered late appointments – “some of which arrived with the patient only after the clinic had taken place.”

All of this caused patient and GP complaints, but because they seemed to relate to administrative problems, their real, clinical nature was overlooked.

In the middle of all this, outpatient staff complained that Lorenzo was slow – although the report says there is no evidence that it was slower than the system it replaced [ignore the users - their complaints are all 'anecdotal' - ed.] – and that it was more complicated to complete a booking.

As a result, “many staff found ways around that were quicker, but these were responsible for patients having multiple access plans, which helped to label the problem as administrative.”

You never have to work around something that is not in your way.

Floor walkers initially monitored such “inappropriate” use, but this stopped once Lorenzo had stabilised. [The computer police...how charming. - ed.]

Morecambe Bay is the first and most prominent of the ‘early adopter’ sites for Lorenzo, which was due to be implemented in the North, Midlands and East by CSC [an American management consulting firm - ed.] as local service provider.

The problems at the trust, CSC’s failure to complete the ‘early adopter’ programme, and critical reports from watchdogs and MPs on progress, have thrown a new LSP deal into doubt.

I presume they mean critical reports from MPs like this, and other reports like this from Parliament's Public Accounts Committee a few years back that stated, among many other findings, that:

... The [NPfIT] Programme is not providing value for money at present because there have been few successful deployments of the [U.S. Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme.

Charming.

CSC announced last week that it was going to lay off 500 staff, including 46 from iSoft, which developed Lorenzo, and which CSC bought last year.

I'm sure that will help speed up software remediation.

-- SS

Perhaps Hospitals Don't Care Much That EHRs Can Be Dangerous, Because EHRs Lets them Attract 'Good Paying Customers' And Exclude the Old and Poor

2012-02-07T17:40:00.015-05:00

This comes as no surprise to me. I believe it may help explain hospital's cavalier attitudes towards the risks of today's commercial health IT.

It's all about money.

We already knew that (for example, see my Feb. 2011 post "Does EHR-Incited Upcoding (Also Known as 'Fraud') Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance?"), but the following news adds to the pecuniary motivations:

Kaiser Health News

Critics say hospitals cherry pick best-paying patients
By Phil Galewitz
KHN Staff Writer

Feb 05, 2012

When the oversized postcard arrived last August from Provena St. Joseph Medical Center promoting a lung cancer screening for current or former smokers over 55, Steven Boyd wondered how the hospital had found him.

Boyd, 59, of Joliet, Ill., had smoked for decades, as had his wife, Karol.

Provena didn't send the mailing to everyone who lived near the hospital, just those who had a stronger likelihood of having smoked based on their age, income, insurance status and other demographic criteria.

The nonprofit center is one of a growing number of hospitals using their patients' health and financial records to help pitch their most lucrative services, such as cancer, heart and orthopedic care. As part of these direct mail campaigns, they are also buying detailed information about local residents compiled by consumer marketing firms — everything from age, income and marital status to shopping habits and whether they have children or pets at home.

Hospitals say they are promoting needed services, such as cancer screenings and cholesterol tests, but they often use the data to target patients with private health insurance, which typically pay higher rates than government coverage. At an industry conference last year, Provena Health marketing executive Lisa Lagger said such efforts had helped attract higher-paying patients, including those covered by "profitable Blue Cross and less Medicare."

Not to mention helping exclude those covered by Medicaid, or the uninsured.

Strategy Draws Fire
While the strategies are increasing revenues, they are drawing fire from patient advocates and privacy groups, who criticize the hospitals for using private medical records to pursue profits.

I don't recall anywhere on the releases at area hospitals saying they would be using their own clinical data for marketing purposes (which likely involve third party contractors). It might be in the fine print, however. I also don't recall any place to sign and give informed consent to the use of experimental medical devices such as the EHR's used to collect the marketing data, either, but that's addressed elsewhere on this blog such as here.

Doug Heller, executive director of Consumer Watchdog, a California-based consumer advocacy group, says he is bothered by efforts to "cherry pick" the best-paying patients.

"When marketing is picking and choosing based on people's financial status, it is inherently discriminating against patients who have every right and need for medical information," Heller says. "This is another example of how our health system has gone off the rails."

I would go beyond "off the rails." How about, straight to perverse? EHR data is used to attract paying customers and then expose them to risk of being maimed due to the disruptive nature of the HIT itself.

Deven McGraw, director of the health privacy project at the Center for Democracy and Technology in Washington, says federal law allows hospitals to use confidential medical records to inform patients about things that may help them.

"If it's technically legal, we can do it, and who gives a damn about the ethics?" is what is being expressed here.

"You want health providers to communicate to patients about health options that may be beneficial to their health," McGraw says. "But sometimes this is about generating business for a new piece of equipment that the hospital just bought."
Using such information for marketing "creeps closer to the line," between what is legal and what is not, she says.

And helping recoup the costs of that hundred-million dollar EHR setup, too.

... Tess Niehaus, vice president of marketing at St. Anthony’s Medical Center in St. Louis, says the approach has been quite successful and makes no apologies for going after the most lucrative business.

"We are here to serve everybody but we market for good paying patients because it preserves our ability to serve everyone," she says. [And the ability to proffer generous executive salaries and raises - ed.]

"Good paying patients?" Does that imply there are bad paying patients? (Might those "bad paying patients" be predominantly the elderly and/or minorities?)

While the practice is legal, most people would be shocked to know their records may be shared with nonmedical personnel and outside firms to help hospitals attract business, says Pam Dixon, executive director of the World Privacy Forum, an advocacy group based in California. "I am really bothered by the overabundance of information that is flowing that is unnecessary and risky," she says.

As I've written before, don't worry, your most sensitive data's safe in the hands of the extremely skilled health IT professionals at most hospitals.

While hospitals may profit from offering cholesterol tests and mammograms, the big payoff is in what those screenings may lead to – additional tests and procedures, including surgery.
"It's all about downstream revenue," says Patrick Kane, senior vice president of marketing at Cape Cod Healthcare in Massachusetts who used such approaches at Wellmont Health System in Kingsport, Tenn. "The old adage in business is that it’s easier to sell an existing customer new services, rather than find a new customer."

So much for medical professionalism and conservatism. At least Mr. Kane admits it's all about money.

... Provena's Lagger says the approach boosted the system's bottom line so it could serve people regardless of insurance status. "This is a means to an end," she says.

The ends don't always justify the means, but that may be a hard concept for some in today's amoral culture to understand.

... Much of the expertise for such campaigns is provided by three consulting firms -- CPM Marketing of Madison, Wis., Medseek of Birmingham Ala. and New York-based Thomson Reuters. They typically charge hospitals $100,000 a year or more.

CPM, which merged in November with Denver, Colo.-based HealthGrades, a health ratings firm, added 100 new hospitals last year to give it a total of 400. Medseek works with more than 250 hospitals and Thomson Reuters, with 150.

Remember Darrin Stevens on Bewitched? "Larry, I've got a great idea for a new campaign! Let's troll for patients using their private data! Never mind that I have donkey ears today... that darn mother in law of mine, Endora!"

The targeting worked in the case of Boyd, who called the number on the back and scheduled the CT scan a few days later. The $169 test showed his lungs were clear, but found potential blockages in coronary arteries that his Provena-affiliated doctor is monitoring.
"In hindsight, I’m glad I had the test," he says.

No mention of patients who had unnecessary testing and interventions that led to bad outcomes ... or patients injured by the very EHR systems that make such marketing possible.

-- SS

Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

2012-02-07T12:21:00.000-05:00

A case, reported by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the state of the academic medical mission.

Litigation Involving the Abramson Family Cancer Research Institute and Dr Craig B Thompson

Here is how the Times outlined the story:

The president of Memorial Sloan-Kettering Cancer Center in New York is in a billion-dollar dispute with his former workplace, a cancer institute at the University of Pennsylvania, over accusations that he walked away with groundbreaking research and used it to help start a valuable biotechnology company.

In a lawsuit, the Leonard and Madlyn Abramson Family Cancer Research Institute at Penn described its former scientific director, Dr. Craig B. Thompson, as 'an unscrupulous doctor' who 'chose to abscond with the fruits of the Abramson largess.'

In particular,

In the suit, the Abramson cancer institute, which has received more than $100 million from the philanthropist Leonard Abramson and his family, says that Dr. Thompson concealed his role in starting Agios, which has attracted investors with a potentially new way to treat cancer. The institute says Dr. Thompson’s actions deprived it of proceeds that could support future research, causing it damages that could exceed $1 billion.

So presumably the Abramson Institute is alleging that Thompson took its intellectual property and put it into Agios, and the Institute therefore wants compensation. Note that the Institute does not appear to be alleging either that Thompson was supposed to be its employee, but actually was working for Agios at the time he was supposed to be working for the institute; or that Thompson hid a a conflict of interest created by his financial relationship with Agios that could have affected how he fulfilled his professional responsibilities there.

Note further that certain other parties declared that they are not part of this dispute. These included Dr Thompson's current employer:

Sloan-Kettering declined to comment, saying it was not a party to the lawsuit....

These also included the University of Pennsylvania:

Susan E. Phillips, senior vice president for Penn Medicine, said that the suit had been filed not by the university but by the research institute, a separate entity. She said the university was investigating the accusations.

The nature of this dispute ought to generate several kinds of cognitive dissonance.

Protecting Intellectual Property vs Upholding the Academic Mission at the University of Pennsylvania

On one of its web pages, the Abramson Family Cancer Research Institute describes its history:

The Abramson Cancer center of the University of Pennsylvania provides each patient with exemplary care though a comprehensive team approach, personalized service, education and outreach, and nationally recognized cancer research programs.

The web page describes the institute as simply part of the larger University of Pennsylvania cancer center, which came to be named for the Abramson family:

Penn's Cancer Center was renamed in 2002 as the Abramson Cancer Center of the University of Pennsylvania, recognizing the Abramson family's $100 million commitment to support comprehensive cancer research and care.

Thus it seems that the Abramson institute is simply a piece of a traditional academic medical center.

The academic mission is traditionally described as the creation and teaching of knowledge. Thus, if an academic institution creates new knowledge, its should then disseminate it, not own it. Of course, in the US, since the Bayh-Dole act was passed, academic institutions were given the ability to patent their discoveries, and began to protect and sequester the knowledge they contained, rather than disseminating it.

In this case, however, one part of a large university and a large academic medical center seems to be concentrating entirely on its right of ownership of intellectual property, not the traditional academic mission. The fact that this dispute has lead to litigation suggests that the academic organization is now intent on protecting, rather than disseminating knowledge. The dispute appears to be between a commercial research company and its allegedly errant former hired manager.

The Abramson Institute: Part or Independent of the Academic Medical Center?

A little more digging suggests that the nature of the Abramson institute is not as clear as is described in its web-page. A GuideStar search revealed that the institute is actually legally independent from the university. It filed its own 990 form (latest version, covering 2009-2010, here.)

The filing did list various entities, including the Clinical Care Associates of the University of Pennsylvania Health System, and the Trustees of the University of Pennsylvania as "related tax-exempt organizations."

However, this filing should create cognitive dissonance about what the underlying nature of the Institute? Is it part of the University of Pennsylvania and its medical center, or is independent but cooperating?

This dissonance is only enhanced by the ambiguous response of the University of Pennsylvania to the lawsuit. If the Institute is part of the University, then the University ought to be party to the lawsuit, it would seem.

This filing with the US government did underline the Institute's commitment to disseminating research. A description of its tax "exempt purposes" included:

Education - scientists at the Institute actively share their discoveries with the research community, physicians, and students.

As above, this statement of purpose appears not to fit with the filing of a lawsuit to obtain damages due to the alleged taking of intellectual property. If this really were the Institute's mission, would not they want the intellectual property liberated so it could be actively shared? The cognitive dissonance about the mission of the Institute and of the University versus the protection and sequestration of intellectual property is thus increased.

Upholding the Academic Mission vs Staying Uninvolved at Memorial Sloan-Kettering Cancer Center

As an aside, note that Dr Thompson is now not just working for Agios. In fact, he has been President of the Memorial Sloan-Kettering Cancer Center since 2010 (look here). Just like the Abramson Cancer Center, Sloan-Kettering is an academic medical center with the traditional mission of teaching, research, and patient care. Here is its mission statement:

As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs.

So one would think that people there ought to be concerned by allegations that its current president took intellectual property without authorization, and that he is "an unscrupulous doctor." If these allegations were to be proven false, they seemingly would represent a major, unwarranted slur on its and his reputation. If they were to be proven true, they would indicate that current leadership might not have the character to uphold the mission. Either outcome would be serious and have serious implications. However, at the moment, this noted academic medical institution has expressed neither outrage about possibly false accusations nor resolve to investigate the matter and then weed out any leaders not devoted to the mission.

Thus, the apparent intention of the leadership of Memorial Sloan-Kettering to stay uninvolved with this case ought to generate more cognitive dissonance.

Summary

The cognitive dissonances evoked by the case of the Abramson Institute vs Dr Thompson ought to inspire questions about what our academic medical institutions have become. While they proclaim their devotion to research and teaching to improve health and health care, and advance science, they may increasingly act like commercial research organizations whose main goal is to generate increased revenue from products and services, and in this case, from intellectual property.

It is hard to see how this emphasis on holding onto rather than disseminating new knowledge will be good in the long run for science, learning, or patient care.

We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals. Squabbling among top researchers and leading academic medical institutions over the ownership of intellectual property for the sake of revenue, not dissemination, is the latest symbol of the decline of our health care.

I can only hope that all the parties involved suddenly remember that they are supposed to be creating and disseminating knowledge, not just getting rich.

Just Business - Employee Control Fraud, Gresham's Dynamic, and the Race to the Bottom in Health Care

2012-02-03T14:00:00.000-05:00

Since Enthoven called for the break up of the physicians' "guild," and handing over its supposed power to managers, (see post here) managers have taken over from physicians and other health care professionals as leaders of health care organizations. Unfortunately, most of these managers are generic, often lacking knowledge and experience in health care, and understanding of its core values. Instead, such generic managers may rely on the current management dogma. The perils of doing so are illustrated by an analysis of the recent expose of conditions at Apple manufacturing plants in China.

The Apple Expose

The New York Times summarized in a landmark article how bad it is to work in factories building Apple products under contract in China. Workers endure harsh conditions, toiling up to six days a week, 12 hours a day. Meanwhile, banners remind them to "work hard on the job today or work hard to find a job tomorrow." Workers may be exposed to hazardous, even poisonous materials (like n-hexane used to clean components). Workers have died in explosions due to inadequate control of combustible dust. Over 18 workers at one factory attempted or committed suicide within two years.

The article suggested that while Apple managers may be well-intentioned, and "want to improve conditions in factories," the bottom line is more important:

that dedication falters when it conflicts with crucial supplier relationships or the fast delivery of new products.

In fact, because of its rigid insistence on cost control, its suppliers are sorely tempted to push their workers too hard:

Apple typically asks suppliers to specify how much every part costs, how many workers are needed and the size of their salaries. Executives want to know every financial detail. Afterward, Apple calculates how much it will pay for a part. Most suppliers are allowed only the slimmest of profits.

So suppliers often try to cut corners, replace expensive chemicals with less costly alternatives, or push their employees to work faster and longer, according to people at those companies.

'The only way you make money working for Apple is figuring out how to do things more efficiently or cheaper,' said an executive at one company that helped bring the iPad to market. 'And then they’ll come back the next year, and force a 10 percent price cut.'

So,

'You can set all the rules you want, but they’re meaningless if you don’t give suppliers enough profit to treat workers well,' said one former Apple executive with firsthand knowledge of the supplier responsibility group. 'If you squeeze margins, you’re forcing them to cut safety.'

William Black's Analysis: Employee Control Fraud and the Race to the Bottom

Writing in the Huffington Post, William K Black showed how Apple executives' relentless focus on cost could drive a race to the bottom. He began by analyzing Apple executives' explanation for out-sourcing their production:

'We shouldn't be criticized for using Chinese workers,' a current Apple executive said. 'The U.S. has stopped producing people with the skills we need.'

He noted that it is absurd to suggest that the US does not have workers with the technical skills necessary to build Apple products. He suggests, however, that these are not the skills that matter.

The suppliers want engineers and managers who will selectively apply their substantive skills. American engineers and managers cannot be counted on to provide the necessary selectivity. Apple's suppliers' often seek managers willing to order their workers to exceed the lawful workweek, to refuse to pay them for significant portions of the wages they have earned, to unlawfully employ child labor, and even to coerce abortions.

So, in the n-hexane example,

The engineer did not order the workers to use the nerve poison because he hated the workers. It was 'just business.' The nerve poison reduced cleaning time, so an engineer knowingly ordered the workers to use it and scores of other engineers did nothing to prevent the usage.

Note that Black calls this employee control fraud, deceiving the employee that he or she is working in a reasonably safe environment, and that employee health and safety is a concern, when in truth the only concern is the bottom line.

So what Apple executives, and by analogy, other multi-national corporate executives want are underlings, particularly middle and line managers who will do anything, anything to cut costs and improve the bottom line. This will produce the race to the bottom:

What we are observing is the essence of a Gresham's dynamic in which bad ethics drives good ethics out of the market.

Two aspects of this Gresham's dynamic are obscene, and both are produced by neoclassical economics dogma. Calling this process 'creative destruction' is baseless and dishonest. It is the fraudulent destruction of honest businesses, professions, and labor.

Black concluded:

firms that are anti-employee control frauds are likely to commit other forms of control fraud. Apple and its Western counterparts have driven the creation of an Asian network of fraudulent firms that has distorted international trade, hollowed out U.S. manufacturing, and created a bizarre hybrid: quasi-communist crony capitalism. It boggles the mind that theoclassical economists celebrate the corrupt result as the essence of creative destruction. The network is corrupt. It will not play by the rules. Firms like Apple help create the perverse incentives that encourage the network to cheat. Surviving U.S. manufacturing firms are whipsawed by the powerful Gresham's dynamic that the frauds produce. U.S. firms and workers are constantly pressured to reduce wages and workforce to try to compete with the foreign frauds. This is the 'Road to Bangladesh' strategy that has caused U.S. working class wages to stall for decades. Europe is retreating along this same road at an even more rapid rate. The Gresham's dynamic tilts the world in favor of fraudulent firms operating in fraud-friendly nations.

The Race to the Bottom in Health Care
Note that we have written about numerous examples of executives of US health care organizations putting revenue ahead of the health care mission, ahead of workers' morale, ahead of patients' and the public's health. Some of these examples involve executives of nominally non-profit organizations that are supposed to have charitable purposes. (Look under our heading of mission-hostile management.)

In fact, just yesterday, Dr Carl Elliott, writing for the Chronicle of Higher Education, summarized how pharmaceutical companies have out-sourced clinical research. The resulting commercial clinical research have generated conditions as bad for the research subjects as those endured by the Chinese electronics workers above:

If the past decade had an emblematic moment for clinical research, it was probably November 12, 2005, the day when Bloomberg Markets published its cover story, “Big Pharma’s Shameful Secret.” In that issue, Bloomberg reporters laid out the story of SFBC International, a contract research organization in Miami that was paying undocumented immigrants to test the safety of new drugs in a seedy motel. The SFBC owners had converted the lobby into a large waiting area with plastic chairs, and they were housing their research subjects six to a room. The medical director of the research site was unlicensed to practice medicine; the Institutional Review Board that approved many of the studies was owned by the wife of the company vice-president; and the converted motel, which had been cited for fire and safety violations, was eventually demolished. Nonetheless, SFBC had become an astonishingly successful enterprise. Just a few years before the Bloomberg Markets report, Forbes had named SFBC one of the most admired small businesses in America. Virtually every major pharmaceutical company had tested drugs with the company. In fact, with 675 beds, the converted motel was the largest research facility in North America.

Note: see our relevant posts here on SFBC International, and on contract research organizations.

Moreover, such out-sourcing has produced the sort of race to the bottom described by Black, but this time involving one of the US most important health care institutions, academic health care:

the more important reason is money. In medical schools, faculty members are often expected to generate their own salaries, either by seeing patients or getting grants and contracts. Likewise, academic departments are often expected to be financially self-sufficient, with as little support as possible from central administration. 'Eat what you kill' is the phrase used, without irony, by medical school deans and department heads. And if you are not killing it with NIH grants, you probably need to be killing it with AstraZeneca or Pfizer.

This system has not been good for human subjects, but it has not been good for academic physicians either. According to a recent study of over 5,000 faculty members at U.S. medical schools, 51 percent of respondents said that the administration is only interested in me for the revenue I generate.' Thirty-one percent said that their institution discourages altruism; 27 percent said that it does not reward clinical excellence; and over half said that it does not value teaching. Nearly half of respondents were considering leaving their current jobs; almost a third were considering leaving academic medicine altogether. Asked if their values lined up with the medical schools where they worked, over half said no. And just in case you are wondering why these physicians are not standing outside the building with picket signs, protesting the injustice of the system, the survey offers another clue. Thirty percent of respondents agreed with the statement, 'I am reluctant to express my opinion for fear of negative consequences.' [This was from an abstract by Pololi L et al. See our relevant post here.]

Of course, this survey does does not exactly match up with the happy propaganda disseminated by the media-relations offices at most medical schools. Instead, it offers a picture of alienated, demoralized physicians, unhappy in their jobs, pressed to work according to values that repel them in order to prop up an institution that views them primarily as instruments to generate profit. In this environment, contract research makes perfect sense. It may not require much intellectual work, but it pays the bills and keeps the authorities happy. And if medical schools don’t really value intellectual work anyway, that may well be enough.

So the pressures on medical school faculty are little different from those on corporate middle management. Their only role is to make money, mainly so that the top leaders can become multi-millionaires, and woe unto them if they object.
Summary

What is missing in all this is any organized opposition to the race to the bottom. As long as top executives can make nearly unlimited money, as long as they can do so by making their subordinates put revenue ahead of all else, as long as there are no countervailing forces, the race to the bottom will continue.

To stop it, we need some combination of efforts by honest government regulators, professional and trade organizations, civil society organizations including non-profit organizations and NGOs that really care about patients' and the public's health, and finally an activated, and properly outraged public.

As long as we think that a laissez faire policy allowing continual market dysfunction to continue, the good times for executives will keep rolling, over all of the rest of us.

Siemens Healthcare on solving EHR usability problems: you can just call up your pal at the next hospital

2012-02-02T17:01:00.021-05:00

In my Aug. 2009 post "Why Siemens Healthcare Fails", I wrote:

I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain.

My admiration fell another notch. I now see this, in a Feb. 1, 2012 article from HealthData Management entitled "User Unfriendly" on the flaws in commercial health IT that present a poor user interface/user experience (at the expense, ultimately, of you, the patient). The article's browser title bar somewhat subliminally reads "Physicians gripe that EHR's are not easy to use but improvements are coming":

... There's also no mechanism for publicizing problems with EHR interfaces, unlike the FDA's process for issues with medical devices. [User interface expert Prof. Ben] Shneiderman describes a case where a physician found a bug in an EHR that created a danger to patients. "He contacted the supplier because he thought it was something other users should know about, and the response was, 'Oh, we know-we're working on it,'" Shneiderman says. "The physician said, What? You know about it and you haven't notified everyone?' Contrast that with the Federal Aviation Administration, where problems with airplanes are publicized within hours."

The IOM report calls for substantial loosening of those contractual restrictions. "The committee views prohibition of the free exchange of information to be the most critical barrier to patient safety and transparency," the report says. "The committee urges the [HHS] Secretary to take vigorous steps to restrict contractual language that impedes public sharing of patient safety-related details. Contracts should be developed to allow explicitly for sharing of health I.T. issues related to patient safety." The report also says there should be a central place to report and publicize known issues with EHR software.

Siemens apparently has a different idea on taking responsibility for the user interfaces of their products:

Siemens Healthcare Chief Medical Officer Don Rucker, M.D., says the secrecy issue is overblown. "There are trailer loads of information out there on each of these big systems, and there are so many end users that you can just call up your pal at the next hospital."

There are trailer loads of information out there, and it's up to the end user physician to find the information and sort through it?

... Sounds perfectly reasonable to me. /not/

There are so many end users that you can just call up your pal at the next hospital [for guidance on user interface complexities and errors]?

Also sounds perfectly reasonable. /not/

... Except, I think most EMR vendors and user-organizations sort-of disable Remote Assistance, Remote Desktop and similar programs. Even "print screen" is usually either disabled or forbidden from sharing with that "pal at the other hospital." Might have something to do with security and IP protection.

Ever try to guide someone through a complex computer interface over the phone, blind, with no real-time mutually viewed visuals? It's not easy, but ... physicians and nurses have PLENTY of time for such fritter, what with the little other work they have to do.

I also think saying busy physician, nurse and other clinical customers should "depend on their pals at the next hospital" for information on health IT difficulties is a rather condescending and patronizing statement to make (to be charitable), a backyard-mechanic attitude, but that's just me.

Why does Siemens fail?

This type of statement is a very good clue.

-- SS

KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care

2012-02-02T13:00:00.015-05:00

Reposted from KevinMD blog on another aspect of the health IT mission hostile user experience. Emphases and comments in [red italics] are mine:

How algorithm driven medicine can affect patient care
by Jeffrey Parks, MD

Whenever someone is scheduled for an operation, the assigned nurse is required to fill out a “pre-op checklist” to ensure that all safety and quality metrics are being adhered to. Before the patient is allowed to be wheeled into the OR we make sure the surgical site is marked, the consents are signed, all necessary equipment is available, etc. One of the most important metrics involves the peri-operative administration of IV antibiotics. SCIP guidelines mandate that the prophylactic antibiotic is given within an hour of incision time to optimize outcomes. This has been drilled into the heads of physicians, health care providers, and ancillary staff to such an extent that it occasionally causes total brain shutdown.
Let me explain. For most elective surgeries I give a single dose of antibiotics just before I cut. For elective colon surgery, the antibiotics are continued for 24 hours post-op. This is accepted standard of care. You don’t want to give antibiotics inappropriately or continue them indefinitely.
But what about a patient with gangrenous cholecystitis or acute appendicitis? What if, in my clinical judgment, I want to start the patient on antibiotics right away (i.e. several hours before anticipated incision time) and then continue them for greater than 24 hours post-op, depending on what the clinical status warrants? I should be able to do that right? [No - wrong - the idiots who designed your CPOE/Pharmacy IT system forgot that robotic medicine is bad medicine - ed.]
Well, you’d be surprised. [No, actually, I'm not. I'd have been more surprised to see a system not impeding critical medical decisions tailored to the individual patient - ed.]
You see, at two different, unaffiliated hospitals I cover, the surgeons have seen that decision-making capability removed from their power. If a young patient comes in with acute appendicitis and I feel that it would be prudent to continue the Zosyn an extra couple of days, an automatic stop order is triggered [presumably cybernetically - ed.] in the department of pharmacy and the antibiotic is stopped after 24 hours, no matter what. Unless the surgeon specifically writes “please do not stop this antibiotic after 24 hours; it is being administered for therapeutic purposes, not prophylaxis [that sounds a bit like begging - ed.] ,” the antibiotic will not be sent to the patient’s floor for administration. As a result, patients end up being treated sub-optimally, and potentially harmed, due to an over-emphasis on “protocol” and “quality care metrics.”
Similarly, the 60-minute timeline for pre-operative antibiotic administration can be problematic. I have had patients come into the ER with appendicitis or cholecystitis and, in my pre-op orders, write for Zosyn or whatever, to be started ASAP, no matter what time the operation is scheduled. Not too long ago, I admitted a gallbladder over the phone at 2am. I gave the nurse admitting orders which included one for a broad spectrum antibiotic.
When I saw the patient in the morning, I added her on to the OR schedule. By the time a room opened up, it was about 10:30am. The OR nurse asked me if I wanted to give an antibiotic for the case. I told her that the patient was already on antibiotics as part of her admit orders for treatment. The nurse shook her hand. It had never been given; the floor nurse held it so that it wasn’t administered until 60 minutes before the scheduled OR time, just like the algorithm dictates — despite the fact it had been ordered nearly 8 hours prior to the case, not for peri-op prophylaxis, but for treatment of an established pathology. [This is how EHR-induced malpractice occurs, readers. Guess who bears liability? - ed.]
And there it was, the cefotetan, hanging on her IV stand. Now nothing bad happened [this time, due to luck - ed.], but here you have a situation where health care providers are so terrified of violating Quality Assurance Protocol that they end up withholding necessary treatment. It’s just astounding. [It's astounding the surgeons don't simply use a scalpel on the computer terminal network and power cables to protect their patients - ed.]
As surgeons, we have bitched and moaned. You would think that these issues would be quickly rectified. But no. It is the responsibility of the surgeon to write qualifying statements [a workaround to a 'feature' that turns medical judgment on its head - ed.] for therapeutic antibiotics because the default mode is to override a licensed physician’s clinical judgment. [Not mentioned is who is overriding that judgment through cybernetic proxy - ed.]
This is what I’m talking about when I say that blind allegiance to a top-down, systems analysis-driven algorithm can turn everyone involved in health care into a bunch of mindless drones.
Jeffrey Parks is a general surgeon who blogs at Buckeye Surgeon.

I will simply add that these issues sound like poor IT/protocol design and implementation, getting in a physician's way regarding tailoring of care to the individual patient.

An inviolable rule in health IT is - or needs to be -

"You should not have to work around something that is not in the way."

There is nothing to debate or discuss on this issue.

-- SS

Feb. 3, 2012 addendum:

Some IT person (anonymously, of course) tried to argue and debate anyway; however, they did not even do basic homework. See their comments in the comments box.

Feb. 5, 2012 addendum:

More in the comments section by someone saying they made the aforementioned comments, stating they are a hospitalist, and still trying to advance the same arguments in favor of physicians adapting to mission-hostile HIT and/or protocols rather than 'protesting too much.'

EHR Workstation Designed by Amateurs

2012-02-01T13:15:00.016-05:00

Below is an actual workstation, in an ICU of a major regional hospital, to permit interaction with an already mission-hostile EHR system:

How many things are wrong here? (Click to enlarge)

I can charitably say this workstation, in this recent picture, was designed by amateurs. Less charitably, I would use the words 'glaring incompetents.'

How many things are wrong here? For starters (commenters are welcome to suggest additions to the list):

Small square (4x3) monitor, when large 16x9 monitors are available quite cheaply, even at retail let alone in bulk;

Monitor in front of window so on sunny days, glare causes eye strain;

Monitor forces user to look away from the patient, with their back facing the patient behind them;

Standard keyboard and mouse to help spread infection, not medical-specialty devices such as membrane-based or membrane-covered keyboards and easily cleanable trackpads;

Very slow, small, toy-ish nettop computer, to facilitate responsiveness delays;

Height of ledge with keyboard/mouse and of elevated monitor on ledge does not facilitate comfortable ergonomics when sitting, note chair in background (or standing as is intended, either, although I don't recall ever making entries in the permanent paper chart on my feet). It seems nobody ever heard of an appropriate moveable workstation desk;

Tangle of wires behind setup facilitates "accidents."

There are probably a few more "issues" I'm missing.

There is nothing to argue here and nothing to debate. Combined with the mission hostile virtual user interfaces presented by health IT software itself, this is inexcusable.

Apart from designers, any physicians (and nurses) who would accept such poor choices - and the cause of this workstation's problems were, in fact, deliberate choices - are either weak-kneed victims of "physician's learned helplessness" themselves, or enjoy EHR-induced medical errors and lawsuits.

The workstations are poorly designed like this all throughout this hospital, including the ED.

This is not the first time I've observed this type of amateurism in hospitals. I observed similar issues in another ICU - over a decade ago.

Hospitals are truly an IT backwater.

-- SS

What is Life is Really Like in Pharma? - These xtranormal Video Cartoons Come Close.

2012-02-01T01:35:00.011-05:00

Sadly, the 'xtranormal' video cartoons at the following URL capture all too well what life is like in the pharmaceutical industry - buzzwords, neologisms, nouns turned into verbs, new paradigms, team players - and per the site, endless inane "initiatives" and related threats to sanity.

I've been there; while a parody, these videos are uncomfortably close to reality.

http://www.youtube.com/user/ZombieSymmetry/feed

"I'll have to ideate on that for awhile, Mike"

Even sadder are managers who believe their own babble.

-- SS

How the Anechoic Effect Is Institutionalized - A Hospital Policy Against Unsupervised Discussion with the Media

2012-01-31T14:58:00.000-05:00

In a single sentence, a short, obscure article in the Worcester (MA) Business Journal on life at a community hospital after a for-profit corporate take-over:

Several Nashoba employees, who didn't want their names used because it's against hospital policy to talk to the media without authorization, said they're happy with the new insurance plan.

We have often discussed the anechoic effect, how cases involving or discussions of the topics we address on Health Care Renewal, the concentration and abuse of power in health care, fail to produce any responses, or echoes. It was almost an aside, but the sentence above provides evidence of the existence of apparently blanket hospital policies against unsupervised discussion with the media. Here is an example of the institutionalization of the anechoic effect.

This example raises three immediate questions. How prevalent is this? How long has it been going on? What is it meant to hide?

Prevalence

This article is only about a single hospital. However, the context of the article is the take-over of Nashoba Hospital by Steward Health Care. Steward Health Care is a for-profit health care corporation that grew out of the take-over of the formerly not-for-profit Caritas Christi health system by the private equity firm Cerberus Capital Management. Steward Health Care now comprises eight hospitals, and also owns physician practices (apparently including over 2000 doctors based on a quick search using its "doctor finder" function.) Thus it is likely that the policy at Nashoba Hospital that prevents unsupervised discussion with the media also applies at seven other hospitals, and perhaps to the practices of over 2000 doctors. Thus it is very likely that this hospital gag policy is not unique, and may be widespread. However, recursively, the existence of such gag policies will make it hard to determine their own prevalence.

Note that we have posted a few times about confidentiality clauses mainly within physicians' contracts here.

Duration

This policy is likely relatively new, since the take-over of Caritas Christi by Cerberus occurred in 2010. My guess is that the rise of such policies may parallel the resurgence of for-profit hospitals and hospital systems, and perhaps the new involvement of private equity firms in such organizations.

In my humble experience, gag policies and confidentiality clauses at least within non-profit teaching hospitals were virtually unheard of from the time I began medical school (1974) to when I left my last full-time academic medical position (2005).

Note that we recently found out (because of investigative journalism about presidential candidate Mitt Romney's previous involvement with private equity firm Bain Capital) that such firms are generally rebranded leveraged buy-out firms. They have become known for their secretiveness. Therefore, maybe it should not be surprising that they have imposed such secretiveness on hospitals and health care professionals.

Rationale

The big question is why should hospital employees not be allowed to talk to the media without management supervision? I can only speculate.

In this case, perhaps such secretiveness is just the habit of the private equity executives who now run the hospital system. Even if this is the reason, they ought to reconsider. Hospitals and health care professionals due have a solemn obligation to keep confidential their patients' medical information. However, otherwise health care organizations and health care professionals ought to be as transparent as possible.

Maintaining such a level of secrecy could lead to some suspicions, for example, that the generic managers of the organization distrust the professionals they hire who actually provide patient care; worse, that the managers fear discussion that might question their actions or abilities; worse, that the managers want to silence whistle-blowers; or even worse, that the managers have something unethical or illegal to hide. That is all speculation, of course.

On the other hand, we have discussed again and again how the anechoic effect has stifled discussion of what is wrong with health care, and hence prevented meaningful health care reform. Gagging hospital employees is an obvious extension and institutionalization of the anechoic effect. It should not be done, because we need honest discussion of what is really wrong with health care so we can come up with some real solutions.

Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail

2012-01-30T13:26:00.012-05:00

From the Washington Post:

FDA staffers sue agency over surveillance of personal e-mail
Ellen Nakashima and Lisa Rein
January 29, 2012

The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they [the scientists - ed.] warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show.

The surveillance — detailed in e-mails and memos unearthed by six of the scientists and doctors, who filed a lawsuit against the FDA in U.S. District Court in Washington last week — took place over two years as the plaintiffs accessed their personal Gmail accounts from government computers.

While accessing Gmail from government computers was not a wise idea, since all traffic over an institutional PC and network can be monitored, these Gmails were apparently to members of Congress.

Copies of the e-mails show that, starting in January 2009, the FDA intercepted communications with congressional staffers and draft versions of whistleblower complaints complete with editing notes in the margins. The agency also took electronic snapshots of the computer desktops of the FDA employees and reviewed documents they saved on the hard drives of their government computers.

See sample emails at link above.

Information garnered this way eventually contributed to the harassment or dismissal of all six of the FDA employees, the suit alleges. All had worked in an office responsible for reviewing devices for cancer screening and other purposes.

That's very unfortunate.

It will be far more unfortunate if the warnings of the six, as in this whistleblower case, went unheeded, and patients are injured or die as a result. In that case, FDA bureaucrats might have been accessories to those injuries or deaths.

“Who would have thought that they would have the nerve to be monitoring my communications to Congress?” said Robert C. Smith, one of the plaintiffs in the suit, a former radiology professor at Yale and Cornell universities who worked as a device reviewer at the FDA until his contract was not renewed in July 2010. “How dare they?”

I, on the other hand, would have expected it. It would have been far more prudent to send such emails from a private home computer and ISP.

The scientists and doctors denied sharing information improperly. The HHS inspector general’s office, which oversees FDA operations, declined to pursue an investigation, finding no evidence of criminal conduct. It also said that the doctors and scientists had a legal right to air their concerns to Congress or journalists.
FDA officials sought a second time that year to initiate action against the scientists and doctors. “We have obtained new information confirming the existence of information disclosures that undermine the integrity and mission of the FDA and, we believe, may be prohibited by law,” wrote Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, on June 28, 2010.
The inspector general, after consulting with federal prosecutors, declined the second request, as well.

The IG office seemed to find the behavior legal, but FDA bureaucrats apparently did not like non-team players.

The FDA scientists and doctors, all of whom worked for the agency’s Office of Device Evaluation, said they first made internal complaints beginning in 2007 that the agency had approved or was on the verge of approving at least a dozen radiological devices whose effectiveness was not proven and that posed risks to millions of patients. Frustrated, they also brought their concerns to Congress, the White House and the HHS inspector general.
Three of the devices risked missing signs of breast cancer, the scientists and doctors warned, according to documents and interviews. Another risked falsely diagnosing osteoporosis, leading to unnecessary treatments; one ultrasound device could malfunction while monitoring pregnant women in labor, risking harm to the fetus; and several devices for colon cancer screening used such heavy doses of radiation that they risked causing cancer in otherwise healthy people, the FDA scientists and doctors said.

Permit me to wonder if regulatory capture played a role in these decisions.

One might also wonder if complaints about electronic health records or other clinical IT, admitted by FDA to be a medical device "political hot potato" they elected to not regulate, were also involved.

... The first documented FDA interception was of an e-mail dated Jan. 29, 2009, shortly after the letter from Ferry. In it, device reviewer Paul T. Hardy asked a congressional aide, Joanne Royce, for assurances that “it is not a crime to provide information to the Congress about potential misconduct by another Agency employee.”
Royce replied: “[Y]ou and your colleagues have committed no crime. . . . you guys didn’t even provide confidential business information to Congress.”

The only 'crime' was apparently not being a 'team player', which on Healthcare Renewal has been defined as someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness.

Hardy, who is among the six employees who filed the suit, was fired in November after a negative performance review; an internal FDA letter obtained in separate litigation quoted managers saying they did not “trust” him. Of the other five scientists and doctors, the suit says two did not have their contracts renewed, two suffered harassment and werepassed over for promotions, and one was fired.

Trust him to do - what, I ask?

Read the whole WaPo article.

Plaintiff's lawyers need to be aware of this event, and I intend to make them aware.

-- SS

Elephants We Can Notice But Cannot Name

2012-01-27T15:30:00.001-05:00

We have often discussed the anechoic effect, how cases involving or discussions of the topics we address on Health Care Renewal, the concentration and abuse of power in health care, fail to produce any responses, or echoes.

Last month, an article with the provocative title, "Elephants in Academic Medicine," by Souba et al addressed the anechoic effect, but was unable to discuss what people in academic medicine cannot discuss.(1)

"Organizational Silence"

In summary, the authors surveyed chairs of departments of medicine and surgery at all accredited US medical schools to ask about the "elephants in their living rooms." By this they meant the problems which people are unwilling to discuss at their medical schools. Their goal was to assess "organizational silence" in academic medicine, as they discussed in their introduction:

Morrison and Milliken popularized the term 'organizational silence,' which refers to the collective-level phenomenon of doing or saying very little about the problems facing an organization. Organizational silence derives both from people's fears of negative feedback and from a set of behavioral cues adopted by supervisors that lead to structures, procedures, and processes that discourage speaking up. Two common structural features of organizations that foster organizational silence are centralized decision making and a lack of formal feedback mechanisms.

Some organizations face an apparent dilemma in which employees know the truth about specific problems within the organization yet dare not speak that truth to their superiors. A key factor that fosters the creation of a climate of organizational silence is senior leaders' fears of receiving criticism, especially from subordinates. The unwritten message from the top is 'No bad or unpleasant news.' Fearing retaliation or the label 'not a team player' if they speak their minds, subordinates become silent; even if they do speak up, they may discover that their feedback is disregarded. A culture of silence becomes ingrained.

Methods

The investigators sought to learn from these academic leaders:

(1) What are the major elephants in your AHC [academic health center]? (2) What do you believe to be the most prevalent reasons people do not speak up? and (3) What are the consequences of remaining silent?

The survey response rate was 55%. The major elephants, in the order that they were ranked by the participants, were
- misalignment between goals and available resources
- ignoring information that clearly indicates a performance problem
- unwillingness to give up on a failed strategy
- unwillingness to speak up about inequities (e.g., pay, space, favoritism, special deals)
- failure to deal with disruptive behavior

The wording of these items were chosen by the investigators. The survey allowed for respondents to write in additional items, but the paper did not discuss any such responses. Its discussion of the results did not further define the nature of any elephants.

In addition, survey results suggested that more open discussion is unlikely to be in the offing.

- The majority of respondents thought that the elephants were someone else's problem:

Both chairs of surgery and of medicine believed that elephants are more commonly ignored by deans and hospital leaders than by other department chairs or themselves. Surgery chairs were more likely to say that hospital leaders ignore elephants, whereas medicine chairs were more likely to say that deans disregard elephants.

- The majority thought that other leaders did not encourage discussion of elephants:

Only 52 of the chairs (37%) said that elephants are usually discussed in an appropriate venue, whereas 87 (63%) said that elephants are discussed in less constructive venues or not discussed at all. Less than a quarter of the chairs (32; 23%) reported that the top leaders at their institutions actually encourage people to call out and deal with elephants. More commonly, the chairs (77; 55%) reported that the top leaders of their institutions say they want people to be frank about elephants, but their actions or nonverbal cues indicate otherwise. A higher percentage of medicine chairs than of surgery chairs (16 of 53 [30%] versus 16 of 86 [19%]), said that top leaders pretend that elephants do not exist.

- An important minority did not think the elephants were a problem at all:

nearly a fifth (26 of 139; 19%) agreed that, indeed, some issues are best left undiscussed.

- While the majority favored discussing elephants, they did not think it would be easy to do so:

two-thirds (92 of 137; 67%) felt that creating a culture in which elephants are openly discussed would be very or moderately difficult.

Their and Our Discussion

It was particularly striking that an article about elephants in the living room did not more fully describe what sorts of elephants they were. The descriptions of elephants above, taken verbatim from the survey instrument, were vague. They were not clarified in the discussion section of the article.

Particularly lacking were the sort of nasty elephants described by Pololi et al in a qualitative study of barriers to the advancement of primary care faculty.(2) As we summarized in our letter,(3) these elephants included academic leaders who put revenues ahead of patient care, teaching, and research; and who allegedly used deception for personal gain. Also lacking were nasty elephants we have discussed on Health Care Renewal. We have discussed examples of self-interested, conflicted, and corrupt leadership of health care organizations, including academic medical institutions.

I am glad that Souba et al brought up the topic of elephants in academic medicine's living room. However, I am disappointed that these elephants were never clearly identified. It seems that while we are getting to the point of being able to say there are things we cannot say, we are not yet at the point of saying what those things are. The strength of the anechoic effect is demonstrated by cases in which we cannot talk about what we cannot talk about.

Souba et al concluded:

We believe that AHCs are designed, often subconsciously, to keep the range of conversation limited to a few voices, usually the voices of those in power. The powerful silence the voices of others because they consider others' views to be either contrary to the status quo or of limited value.

We would add that those in power often may value the status quo not merely because of philosophical conservatism, but because maintaining the status quo supports their self interest. In particular, it has become increasingly lucrative to be in a leadership position in a health care organization, even in a non-profit academic institution. Executive compensation at these institutions has been rising inexorably, driven by increasing institutional relationships with corporate health care. Individuals in leadership positions in academic medicine frequently have their own, increasingly lucrative financial relationships with the health care industry. (A study by Campbell et al showed that the majority of department chairs, like those who answered the survey above, have such relationships.[4]) Ever increasing hunger for institutional and personal revenue may lead to a variety of practices that are hostile to the academic and professional mission. Discussing any of these aspects of the status quo may offend and threaten those who are profiting from it.

However, as long as we cannot even talk about such problems, the problems will only get worse.

References

1. Souba W, Way D, Lucey C, Sedmak D, Notestine M. Acad Medicine 2011; 86: 1492-1499. Link here.
2. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med 2009; 24: 1289-95. Link here.
3. Poses RM, Smith WR. Faculty values. J Gen Intern Med 2010; 25: 646. Link here.
4. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786, link here.]

Wikipedia page on EHR's: ==Disadvantages== material seems to keep disappearing

2012-01-27T12:42:00.043-05:00

It's interesting how most of the information below seems to have a hard time "staying put" on the Wikipedia page for "Electronic Health Record" at http://en.wikipedia.org/wiki/Electronic_health_record

The information is presented in a neutral fashion from impeccable sources. Yet several Wikipedia "editors" take issue with it and, rather then editing it or refuting it (and stating their rationale and sources!), they keep deleting it. (The most recent edit history comments follow this "disappearing" information, at the bottom of this post):

==Disadvantages==

===Software quality and usability deficiencies===
EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials.http://en.wikipedia.org/wiki/Validation_%28drug_manufacture%29 Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.http://www.faa.gov/regulations_policies/advisory_circulars/index.cfm/go/document.information/documentID/1019261http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf.

As a result, EHR software quality and usability is often suboptimal. For example, in "A study of an Enterprise Health information System", March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR adoption rates "have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available."http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf

Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html

The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.http://www.nist.gov/healthcare/usability/upload/Draft_EUP_09_28_11.pdf

===Unintended adverse consequences===
EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandumhttp://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fundhttp://web.archive.org/web/20110425002322/http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA).

The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A "Examples of potential harm presented by health software."http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf.

Also, in "Research in Ambulatory Patient Safety 2000–2010: A 10-year review", Dec. 2011http://www.ama-assn.org/resources/doc/ethics/research-ambulatory-patient-safety.pdf, the American Medical Association reports:

:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers." Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).

In the U.S., FDA's MAUDE (Manufacturer and User Facility Device Experience) databasehttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFMreveals many reported EHR problems, some of which could result in patient injury or death http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html. Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauseshttp://jama.ama-assn.org/content/301/12/1276.extract and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues{{cite web | last=Silverstein| first=Scot| year=2012 | url=http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}.

The literature is conflicting on benefits and harms of EHRs http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html, and as in the Jan. 2009 U.S. National Academies study "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS", EHR's ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572

===Regulatory controversy===
FDA's Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device.http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives.http://www.lakemedelsverket.se/upload/foretag/medicinteknik/en/Medical-Information-Systems-Report_2009-06-18.pdf. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjectshttp://ohsr.od.nih.gov/guidelines/index.html and the World Medical Association Declaration Of Helsinkihttp://ohsr.od.nih.gov/guidelines/helsinki.html restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study "Health IT and Patient Safety: Building Safer Systems for Better Care"http://www.modernhealthcare.com/Assets/pdf/CH76254118.PDF, there are calls for formal governmental regulation of the technology.

The edit-history comments are quite interesting, where a poster who uses the ID "Barek" keeps deleting all or most of the information on EHR disadvantages, despite indications the material is impeccably sourced and does not draw its own conclusions. Read from bottom to top:

17:29, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (67,826 bytes) (please discuss on talk page, as you are approaching WP:3RR)

17:28, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,232 bytes) (clarifying that information comes from the cited sources.)

17:26, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (→Unintended adverse consequences)

17:24, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,151 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:23, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,137 bytes) (If you have factual disageements, let them be known and document the source of your information.)

17:18, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (Undid revision 473542684 by Barek (talk). Barek may have a conflict of interest regarding exposure of health IT difficulties.)

17:14, 27 January 2012‎ Barek (talk | contribs)‎ m (67,826 bytes) (Reverted edits by InformaticsMD (talk) to last version by Barek)

17:14, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,122 bytes) (→Regulatory controversy)

17:12, 27 January 2012‎ InformaticsMD (talk | contribs)‎ (76,217 bytes) (The added information is factual, well-referenced from impeccable sources, and does not draw conclusions.)

17:08, 27 January 2012‎ Barek (talk | contribs)‎ (67,826 bytes) (→Disadvantages: restore some content after purging WP:SYNTH material)

17:06, 27 January 2012‎ Ohnoitsjamie (talk | contribs)‎ (65,826 bytes) (rv per WP:SYNTH)

17:01, 27 January 2012‎ 108.16.62.235 (talk)‎ (76,341 bytes) (Undid revision 473539844 by Barek (talk))

16:57, 27 January 2012‎ Barek (talk | contribs)‎ (65,826 bytes) (rv - some of that content is usable - but most is pure WP:SYNTH, attempting to draw conclusions rather than simply stating what's in the sources - requires a total re-write to be encyclopedic)

... 20:22, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,058 bytes) (→Unintended Adverse Consequences: actually, remove whole section - BAD HANDWRITING can result in patient injury and death)

20:21, 26 January 2012‎ SarekOfVulcan (talk | contribs)‎ (65,860 bytes) (→Unintended Adverse Consequences: If it's unknown, we don't need to report it. If it's not a RS, we don't need to report its conclusions. And "a researcher says" isn't notable enough to mention without establishing authority in the subject) (undo)

I note that the logically fallacious "Bad handwriting can cause patient injury and death, so remove whole EHR Unintended Adverse Consequences section" and "if it's unknown, we don't need to report it" [regarding the referenced FDA and IOM observations that the true extent of EHR adverse consequences is unknown -- which is on its face a matter critical to public health and policy - ed.], coming from an editor who ironically calls him/herself "Sarek of Vulcan", offers a prime example of how the utopian concept of tapping "community wisdom" can fall flat on its face.

WP:SYNTH is Wikipedia-talk for "Synthesis of published material that advances a position", i.e., "drawing conclusions." Apparently, when it comes to EHR, citing the work of governmental regulatory and healthcare agencies, expert researchers, etc. is "drawing conclusions."

Wikipedia is essentially open to all, including the HIT industry and its pundits.

It is possible that the Wikipedia editors who keep deleting the material could have some sort of conflict of interest. COI could cause them to find easily-verifiable information from impeccable sources on the Wikipedia EHR page (viewed 22924 times in the last 30 days as of this morning) that refutes common cybernetic legends to be "inconvenient." We've certainly seen that type of person before (link).

This affair may also be another example of the "anechoic effect", the notion we discuss often on this blog that certain topics in medicine and health care 'just aren't talked about', in action.

The 'disadvantages' material, revised, will be re-posted again soon, after my being blocked (for 'reverting', i.e., restoring the material three times in 24 hrs.) expires tomorrow. It will be revised to have as neutral a tone as possible, with exact page numbers where possible, in accordance with written Wikipedia examples. If the additions still disappear, that will be revelatory.

-- SS

Unequal Justice Under Law - Comparing Cases of Alleged Misbehavior by Large Health Care Organizations and Individuals

2012-01-25T15:05:00.000-05:00

How the wealthy and powerful have become able to play by a different set of rules than those affecting ordinary people may be the defining issue of our time. Yesterday, President Obama's State of the Union message asked for an economy in which "everyone plays by the same set of rule." We posted about how this issue, which got national attention due to the Occupy movement, affects health care here.

We have previously posted again and again about how the penalties for misbehavior by large US health care organizations seem to be so minimal as to be incapable of deterring future bad behavior (e.g., see posts about legal settlements). At most, corporations often pay fines that are no more than a cost of doing business. They rarely have to admit guilt, and when they do, it is usually to a relatively trivial charge. The people who authorized, directed, or implemented the bad behavior almost never suffer any negative consequences. Thus, the leaders of large US health care organizations seem to have impunity.

Similar complaints have been made about the lack of accountability of the leaders of the finance firms that lead us into the global financial crisis, or great recession.

However, while I have reviewed now hundreds of stories about such minimal organizational punishments, I have also seen hundreds of stories discovered by my automatic news searches of much more severe penalties paid by individuals who have been accused of similar misbehavior. I have never previously made an explicit comparison of how health care corporate and individual misbehavior are handled.

A recent set of examples of organizational misbehavior invites such a comparison. Here they are, in chronological order.

KV Pharmaceutical

On December 6, 2011, the St Louis Post Dispatch reported:

KV Pharmaceutical Co. has agreed to pay $17 million to federal and state authorities to settle Justice Department allegations that it defrauded federal health care programs.

The settlement resolves allegations that KV, as the Bridgeton-based parent company of now-defunct Ethex Corp., misrepresented the regulatory status of two of its drugs that did not qualify for coverage under federal health care programs, the Justice Department said today.

The Justice Department alleges that Ethex submitted false quarterly reports to the federal Centers for Medicare and Medicaid Services related to the two drugs: nitroglycerin extended release capsules and hyoscyamine sulfate extended release capsules.

Company leadership made the usual sort of comment. CEO Greg Divis said:

The closure of this matter is another step forward as KV moves ahead as a women's healthcare focused branded specialty pharmaceutical company.

Corporate leaders seem to love putting such unpleasantness in the past and moving on, especially when they personally are not held accountable for the previous misbehvior.

Note that this is just the latest settlement for KV Pharmaceutical:

KV shut down Ethex after the subsidiary pleaded guilty in March 2010 to two felony counts of criminal fraud for failing to report to the Food and Drug Administration that it was making oversize drugs - and drew $27.6 million in fines and restitution.

Catholic Healthcare West, Sutter Health

On December 8, the Sacramento Bee reported:

Two of Sacramento's biggest health care players paid a combined $2.3 million to the federal government to settle allegations that 61 of their hospitals double-billed Medicare for therapies and services, U.S. Department of Justice officials announced Wednesday.

Catholic Healthcare West paid more than $875,000 and Sutter Health nearly twice that – more than $1.43 million – for alleged duplicate charges for infusion therapies and treatments to break up kidney and bladder stones, in what Lauren Horwood, a spokeswoman in the Sacramento U.S. attorney's office, called 'a significant settlement.'

As usual,

Officials at the two health networks admitted no wrongdoing in agreeing to the settlement, Horwood said. No charges will be filed.

Again, however, this was not the first such issue to affect these large non-profit organizations:

In 2006, Sutter Health agreed to grant discounts and refunds to uninsured patients the network was accused of overcharging, stemming from a 2004 class-action lawsuit.

Blue Shield (California)

On December 29, 2011, the Los Angeles Times reported:

More than a year after the healthcare reform law sought to prevent sick patients from losing medical coverage, insurers are still paying for their alleged abuses.

Blue Shield has agreed to pay $2 million to resolve accusations that the company improperly dropped policyholders after they got sick and needed expensive treatment.

The settlement, announced Wednesday by Los Angeles City Atty. Carmen Trutanich, ends an investigation into more than 1,000 so-called rescissions by Blue Shield, a San Francisco-based not-for-profit company.

As usual, there was no admission of guilt, and a company spokesperson claimed that while the company decided to pay out the money in response to the allegations, it, of course, was blameless:

Blue Shield spokesman Steve Shivinsky said the firm settled to avoid litigation.

'Our process meets or exceeds all legal and regulatory requirements,' Shivinsky said in a statement. 'In every instance, we provide immediate notice, ensure multiple layers of review, involve a medical director in the decision, give members an opportunity to provide additional information before we take any action, and follow the guidance of an independent third party review.'

Note that rescission is now against US federal law:

President Obama made rescission a central theme in his push for a healthcare overhaul. In September 2010, a ban on rescissions for unintentional application errors became one of the first pieces of the healthcare law to take effect.

GE Healthcare

On December 29, 2011, the Detroit Free Press reported (via USA Today):

Pharmaceutical giant GE Healthcare will pay $30 million to the U.S. Department of Justice to settle claims in a case filed by a Michigan salesman, alleging one of its companies marketed a diagnostic drug used in cardiology tests as one that could be diluted and stretched to more patients than intended.

Not surprisingly,

GE admitted no wrongdoing in the settlement.

This was despite the fact that the actions alleged may have harmed patients as well as defrauding the government:

For patients, the diluted product resulted in more false positives during cardiology tests and exposed them to additional and unnecessary testing....

We have posted previously about some previous questionable behavior by GE in the health care sphere.
Actavis

On January 3, 2012, Bloomberg reported:

Two units of Actavis Group Hf will pay $84 million to settle a lawsuit over drug pricing, Texas officials said, less than half the amount an Austin jury said the company should pay.

The state accused Actavis Mid-Atlantic LLC and Actavis Elizabeth LLC, subsidiaries of the Iceland-based company’s U.S. division, of inflating billings to the Texas Medicaid program by falsely reporting drug prices. The state court jury in February ordered the units to pay the state $170 million.

The settlement resolves that litigation, Texas Attorney General Greg Abbott said today in a statement.

Note that Medicaid is a joint federal-state insurance program for the poor.

The company's statement had a familiar ring to it:

'Actavis denies any and all wrongdoing, and denies that it has any liability relating to the Texas judgment,' the company and the state said in the settlement agreement. The parties reached a settlement 'to avoid the delay, uncertainty, inconvenience and expense of continuing the litigation.'

Nothing to see here, just move along.

Denver Health Medical Center

On January 5, 2012, the Denver Post reported:

Denver Health Medical Center will pay $6.3 million to federal and state officials for overbilling Medicare and Medicaid, state and U.S. attorneys said.

After investigating a whistleblower's lawsuit, government officials said Denver Health was classifying patients with an "inpatient" status when it should have been listing them as 'outpatient' or under 'observation' status, which paid less under government rules.

Oops, missing from this story was the pro forma denial of blame, wrongdoing, misconduct by organizational leadership. However, the Denver Business Journal was able to add that:

Denver Health, in a statement, said it and the government agreed to the settlement to avoid 'protracted litigation' over the allegations. It did not admit guilt in agreeing to the settlement.

Of course, again despite having to pay millions, the organization asserted that it is fine and upstanding:

'Denver Health has, and will continue to, strive to ensure that its billing systems are accurate,' the hospital said in a statement, adding that the hospital has implemented a system to correct and improve billing accuracy.

Whoever wrote the statement seemed to overlook the implication that flowed from the need to "correct" the system.

CVS Caremark

On January 12, 2012, the Baltimore Sun reported:

The Federal Trade Commission announced that CVS Caremark Corp. agreed to pay $5 million to settle a complaint that it misinformed seniors about the price of certain Medicare Part D prescription drugs sold through CVS and Walgreens pharmacies.

The action by the company, according to the FTC, caused seniors and consumers with disabilities to pay significantly more for drugs. It also pushed them more quickly into the so-called 'doughnut hole,' in which drug costs aren’t covered by the federal program.

Despite its multimillion dollar payment, the company admitted no guilt, of course, and asserted its exemplary corporate citizenship:

CVS Caremark released a statement:

'During the course of this two year investigation, our company cooperated fully with the FTC and provided to the government millions of documents as well as access to numerous members of our management team who participated in voluntary interviews and depositions,' said Douglas A. Sgarro, Executive Vice President and Chief Legal Officer of CVS Caremark.

He also took comfort from the fact that there were not even more charges:

It is important to note that, at the conclusion of this comprehensive investigation, the FTC made no allegations of antitrust law violations or anti-competitive behavior associated with any of our business practices, products or service offerings.

Stryker Corp

On January 18, 2012, Bloomberg reported:

A Stryker Corp. (SYK) unit agreed to plead guilty and pay a $15 million fine while the medical-device maker was on trial on charges it marketed an unapproved mixture of products for strengthening human bone growth.

The unit, Stryker Biotech, and three Stryker sales representatives were on trial in federal court in Boston on a 13-count criminal indictment claiming conspiracy and wire fraud. The trial began Jan. 9 with jury selection.

Stryker Biotech agreed to plead to one misdemeanor count of misbranding a medical device, according to a letter dated yesterday from the U.S. Attorney’s Office in Boston and filed with the federal court.

This did involve an admission of guilt, but to what amounts to a financial violation when there were allegations that patients may have been harmed:

The U.S. had charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux. Some patients suffered adverse side effects and required more surgery, the U.S. said.

'That mixture was never studied clinically,' Assistant U.S. Attorney Susan Winkler told the jury in her opening statement on Jan. 12. 'They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.'

Interval Summary

We have presented eight cases in which major US health care organizations settled cases involving allegations of financial gain under false pretenses. Nearly all involved US federal charges, and the others included alleged misbehavior that affected a federal program or that now would be illegal under federal law. All the cases were resolved with fines over $1 million. However, while these fines may seem big to most people, they were trivial compared to the revenues of the organizations. None of the settlements involved any penalties to actual people who authorized, directed, or implemented the misbehavior. No individuals at any of the involved organizations admitted any mistakes, much less wrong doing.

While the volume of such settlements indicates the prevalence of misbehavior by large health care organizations, it is not clear that their results, which amount to slaps on corporate wrists, have any deterrent effect.

In comparison, see what happens when little people obtain money from the government under false pretenses. I found a convenience sample of such cases reported in the last month through a Google search.

Vasquez

On January 9, the San Francisco Chronicle reported:

A Los Angeles woman who pleaded guilty to committing $6.2 million in Medicare fraud has been sentenced to 5 years in prison.

Federal Health and Human Services officials say 47-year-old Carolyn Ann Vasquez has also been ordered to pay $6.2 million in restitution.

Vasquez admitted to conspiring with others to use a series of fraudulent Los Angeles-area medical clinics to defraud the federal health care insurance program for people over age 65 and the disabled.

Between 2007 and 2008, Vasquez obtained a physician's personal information and Medicare provider number and used it to print prescription pads.

She then had a physician's assistant, David Garrison, write fraudulent prescriptions for pricey medical equipment.

Curtis

On January 7, 2012, the [Jacksonville] Florida Times-Union reported:

A federal judge sentenced the would-be owner of a Brunswick prosthetic business to three years and six months in prison for his organization and leadership of a scheme that defrauded Medicare of more than $250,000.

Also,

In addition to prison, Wood sentenced Curtis to repay $254,750.94 to Health and Human Services and serve three years’ probation. She dismissed eight other counts as part of his plea agreement.

In stark contrast to the stories above about cases of fraud involving large health care organizations:

Samuel Curtis III, who had submitted false claims from Preferred Prosthetics and Orthotics in Brunswick and Team Orthotics and Prosthetics of Houston, had pleaded guilty in July to conspiring to commit health care fraud.

Curtis, 38, apologized and asked U.S. District Judge Lisa Godbey Wood for leniency during his sentencing hearing Friday.

Popov

On January 12, 2012, the Sacramento Bee reported:

A Los Angeles physician who assumed the role as co-owner of a Sacramento medical clinic has been sentenced to federal prison for his participation in a Medicare fraud scam.

Alexander Popov, 47, was sentenced today by U.S. District Judge Morrison C.England Jr. to eight years and one month in prison for committing health care fraud and conspiring to commit health care fraud, according to a federal Department of Justice news release. He was found guilty by a jury in July.

In sentencing, Judge England found that Popov was responsible for more than a million dollars in fraudulent billings submitted to Medicare and more than $600,000 in payments made on false claims.

Evidence at trial showed that Popov gave false testimony and manufactured evidence at trial, amounting to an obstruction of justice, officials said.

Also,

Vardges Egiazarian previously pleaded guilty in the case and is serving 78 months in prison.

Applebaum

On January 20, 2012, Medscape reported:

A former Idaho psychiatrist was ordered to pay nearly $95,000 in a legal judgment this week, adding to a prison sentence of up to 5 years, which he received in November for obstruction and falsifying records relating to Medicaid fraud.

The judgment, obtained by the US Attorney's Office against Michael Applebaum, MD, of Nampa, Idaho, involved a civil lawsuit in which he was accused of submitting false Medicare and Medicaid claims for undocumented and ineligible services from 2004 through 2009.

Prosecutors claimed Dr. Applebaum failed to properly document services for approximately 502 claims, including falsifying service dates on 49 claims to make them appear eligible for reimbursement under Medicaid's rule of submitting claims within 12 months of the date of service.

Summary

As we noted above, if a large organization, such as a hospital system, pharmaceutical company, or health insurance company is accused of fraud against the government, the outcome is likely to be a large fine that is nonetheless small compared with the organization's revenue, no admission of guilt or responsibility, and no penalties for any individuals who authorized, directed or implemented the misbehavior. However, if an individual or small business is accused of such fraud, the results are likely to include fines sufficient to bankrupt either, admissions of guilt, and years of jail time.

Yet such actions by large organizations are likely to be more harmful to individuals and society than those of individuals or small businesses.

This seems like a glaring, stark example of unequal justice in health care. If an individual does something bad in a health care context, the punishment is likely to be severe and life altering. If an individual who is a leader of a large health care organization does something equally bad, he or she is likely to receive no punishment at all.

This is an example that ought to unite the left and the right, liberals and libertarians in outrage. Liberals are supposed to believe in the rights of the individual and economic justice. Libertarians are supposed to believe in economic freedom and the economic rights of the individual. In this example, the government and large corporations seem to have gotten together to let corporate leaders play by different rules than individuals. Corporate leaders seem to be above the law, the same law that can ruin individuals who violate it.

If we really want to reform health care, we need to make sure that its rules apply equally to all individuals, whether humble or rich, whether they are individual professionals of corporate CEOs. As long as the rich and powerful can play by different rules, we only fuel cynicism and anger. Down that road lies disaster.

London Ambulance Service: Would You Like Some Death And Mayhem With Your American Healthcare IT?

2012-01-25T10:56:00.027-05:00

It seems American companies are good at producing really noisome commercial healthcare IT and foisting it on other countries, such as outlined at "Is clinical IT mayhem good for [the IT] business? UK CfH leader Richard Granger speaks out" and at "Cerner's Blitzkrieg on London: Where's the RAF?".

Yet another example: Software for the London Ambulance Service (LAS). From Wikipedia:

The London Ambulance Service NHS Trust (LAS) is the largest "free at the point of contact" emergency ambulance service in the world. It responds to medical emergencies in Greater London, England, with its ambulances and other response vehicles and over 5,000 staff at its disposal.

Thanks to the U.S., the inhabitants of London are now the unconsenting subjects of an American IT beta-testing experiment that could cost them their lives.

From E-Health Insider.com:

LAS plans for IT go-live and failure
E-Health Insider.com
25 January 2012
Shanna Crispin

London Ambulance Service NHS Trust may terminate its contract with American supplier Northrop Grumman if a second attempt to go-live with a new dispatch system fails.

The trust initially attempted to launch the CommandPoint computer aided dispatch system in early June last year.

However, the technical switch-over to the new system had disastrous effects; with the system failing, staff having to use pen and paper, and then finally aborting the go-live by reverting to the old CTAK dispatch system.

Health IT can kill you ever before you ever reach the hospital...

An investigation into the incident has found the response to calls was delayed by more than three hours in some cases. One patient has lodged a legal claim for the delay he experienced, and the service has received four additional complaints.

A patient died in one of the calls affected. However, a separate investigation concluded that it could not be determined whether they would have survived if the response had been faster.

In other words, the patient very well might have survived without long delays for the ambulance to arrive.

Board papers drawn up for a board meeting next week say an investigation into the 8 June go-live attempt concluded that critical configuration issues were not identified during the testing phase.

It also found there were no operational procedures in place in the event of a critical system failure and that the product failed to deliver the system, technical and operational functionality expected.

At least in this case an absolution for the software itself was not made. One wonder if the vendor was "held harmless" contractually for this somber outcome.

The trust has since been working to further test the system, and is planning to go-live again on 28 March.

However, the trust’s director of information management and technology, Peter Suter, said if that go-live failed then “the contract with Northrop Grumman would need to be reconsidered.”

That will make two chances to get it right. In life-critical IT, I would only have given one.

A defective first-responder system is, on first principles, a public health menace. There is nothing to argue here, nothing to discuss on that point.

I note that disrupting the first-responder system in London would be the envy of terrorists, especially at the time of the London 2012 Olympic Games. However, who needs them when you have U.S. IT personnel who create a system as described?

The trust completed testing the software prior to Christmas, when it began training staff. Leading up the March go-live, the software will be subjected to four separate live runs, with the system staying live for progressively longer periods of time.

If the system fails to go live in March, the trust will abandon any further attempts to go-live before the Olympics in July.

That's still very tight timing to discover all the bugs in an IT system, in preparation for expected increased need during the Olympics...

Instead, it will keep operating the current CTAK system. However, the trust decided to procure a new system in 2007 because CTAK was deemed ‘unstable’ and in need of replacement.

An analysis of the CTAK system has now determined it is stable enough to handle the increased pressure during the Olympics, which is estimated to be an increase of 5.6% to 8.9% on top of the usual volume for this time of year.

One wonders if the "new system" was not needed at all, but was instead sold as vaporware by impressively attired, good-haired, shiny-toothed, fast-talking salespeople to hapless decision-makers with all sorts of promises of cybernetic and financial miracles.

(I've been in that game before from both sides - as a potential customer, and as part of a health IT sales team.)

One also wonders if, should the system be dismantled due to a second failure, the British taxpayers who paid for it will get their tax dollars refunded.

-- SS

"Conspiracy Theory" Proven - Taking UCSF Private

2012-01-22T23:49:00.001-05:00

Students and faculty at the University of California have come up with a vivid, and prescient example of how the hired executives and bureaucrats have taken over higher and health care education.

"Run in the Interests of the Administration"

Two weeks ago, the Orange County Register reported:

Over the past few months, the University of California has raised undergraduate tuition by 18 percent, awarded raises of as much as 23 percent to a dozen high-ranking administrators and announced a possible 81 percent tuition increase over the next three years.

Students haven't taken the news well.

At campus rallies across the state, thousands of students and their faculty supporters have decried the actions, staging raucous rallies and 'Occupy'-style sit-ins that in some cases have ended in clashes with law enforcement. They've also descended en masse on UC regents' meetings, disrupting proceedings and even forcing officials to retreat to a private room.

Behind the angry chanting and acts of civil disobedience is a growing sense that the 10-campus UC system is no longer a public institution accessible to the middle class, but rather a sprawling bureaucracy of hospitals and auxiliary research institutions buffeted by an ever-expanding roster of administrators.

The problem, as the student activists see it, is that none of these functions translates directly into expanded course offerings or improved student-to-faculty ratios, even as their tuition dollars help sustain the system.

'The university is now being run in the interest of the administration,' said UC Irvine student activist Anne Kelly, a Ph.D. candidate in earth system science. 'They're promoting their own internal growth, asking us to sacrifice with higher tuition – but administrators have had raises.'

In higher education, as well as in health care education and in health care in general, the pattern is the same: rising costs without any obvious increase in quality or quantity of services. As in health care, however, the pain never seems to extend to administrators/ managers/ bureaucrats/ executives. Worse, as their numbers grow, these insiders seem to run organizations more for their own benefit, and less for the mission.

One Manager Per Faculty Member

Furthermore, UC faculty have data:

The students' growing frustration is fueled by UC employment data that show that almost three-fourths of UC's 152,500 employees last year were designated 'non-academic personnel,' according to an annual UC employment report.

In the report, UC characterizes the growth in its non-academic staff as the inevitable byproduct of 'an increasingly complex university system that 'requires greater professionalization of its staff, who must meet higher technical and competency standards.' Non-academic personnel includes everyone from custodians and food-service workers to accountants and plant operators. [The question begged is whether it was the managers and executives that caused this complexity - Ed.]

UC Davis horticulture researcher Richard Evans, who has independently analyzed UC personnel data, offered a different take on the data, publishing a tongue-in-cheek piece for UC faculty in 2010 entitled 'Soon every faculty member will have a personal senior manager: Is this a good way to spend money?'

'Data available from the UC Office of the President shows that there were 2.5 faculty members for each senior manager in the UC system in 1993,' Evans wrote in his piece. 'Now there are as many senior managers as faculty. Just think: Each professor could have his or her personal senior manager.'

In his analysis, Evans compared the number of UC employees classified as either 'senior management' or 'managers and senior professionals' with the number of tenure-track UC faculty members.

As of spring 2011, UC employed 8,144 senior managers, managers and senior professionals, and 8,521 tenure-track faculty members, according to the latest available UC data.

This pattern is similar to that seen in some data we discussed a long time ago about the ever rising numbers of administrators/ managers/ bureaucrats/ executives in health care. In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). Health care went from being controlled by clinicians to controlled by a growing volume of managers. Most of these managers were generic, in that they had little if any knowledge of, experience in, or sympathy to the values of health care. These generic managers have used the same techniques advocated for the management of supermarkets or automobile manufacturers to manage health care organizations, despite all the obvious differences in context, goals, values, and people involved.

A "Conspiracy Theory" About the Privatization of the University

At the University of California, the Register reported that there is a "conspiracy theory" about the next step to increase the domination of the managers:

The salaries and size of UC's administrative staff, in particular, have fueled conspiracy theories among students and faculty that the system has deliberately sought to 'privatize' itself – in other words, to compete with private universities on all fronts, from the scope of its non-instructional programs to executive compensation to the amount of tuition that students pay.

Three years ago, the head of a UC faculty group advanced the privatization theory in a multi-part series called 'They Pledged Your Tuition.'

Of course, the administrators denied, sort of, anything so far-fetched:

For its part, UC denies all such allegations, saying that while the university has arguably become privatized, outside influences beyond its control are entirely to blame.

"It is not something we advocate, not something we want,' Klein said. But, 'he added, 'times have changed; the economic model has changed.'

Not Just a "Conspiracy Theory" - UCSF Chancellor Advocates Privatization

It only took two weeks, however, for the notion of administrators taking the university private to go from "conspiracy theory" to official plan. Yesterday, the San Francisco Chronicle reported,

UCSF Chancellor Susan Desmond-Hellmann told the regents, delicately, that she wants out.

Under her proposal, UCSF's medical school, hospital, clinics and research facilities would remain a public university connected to UC, the chancellor assured the regents. But the tendrils connecting the two entities should be thinner than they are today.

Desmond-Hellmann said she envisions a relationship like those of UC Hastings College of the Law, Lawrence Livermore National Laboratory and Lawrence Berkeley National Laboratory, which contract with UC for health and pension services. While ultimately accountable to the regents, they are autonomous with their own boards of directors.

Referring to 'alternative governance models' and 'examining UCSF's financial relationship with UC,' the chancellor and campus executives talked of their ambition to become the world's leading innovator in the health field - a goal better achieved, they hinted, without the rest of the university weighing it down.

To Health Care Renewal readers, that UCSF would be proposed as the first part of the University of California to privatize should not come as a shock. After all, Chancellor Desmond Hellmann came not from academia, but from the world of for-profit biotechnology. She was a former president for drug development for Genentech.

Two and one half years ago I suggested that "hiring a lavishly compensated top executive from a biotech firm known for its high drug prices to run a public health sciences university does considerably blur the line between academic medicine and the health care industry." Furthermore, three months ago I noted that Dr Desmond Hellmann seemed be advocating that the university's focus turn to product development, so that it would start to emulate a contract research organization. Now it appears that Dr Desmond Hellmann wants to traverse the line between government and the private sector, so that the organization could "make a ton of money," and "focus on spinning innovations into business deals," according to the San Francisco Chronicle.

What any of this has to do with the university's fundamental mission to discover and disseminate knowledge, and with this health care university's mission to take the best possible care of its patients is not clear.

Summary

Turning UCSF into a private, quasi contract research organization might conceivably yield some good research and drug development. Why a formerly academic organization would be better at this than a purpose-built CRO is hardly proven. Whether UCSF recast as a CRO would yield better research, leading to better patient outcomes than would have resulted if it continued as a state government sponsored health care university is also hardly proven.

Turning UCSF into a quasi CRO, however, would likely be very much in the self-interest of its administrators/ managers/ bureaucrats/ executives who would be freed from any constraints on their incomes, and the disclosure of same that were previously obligated by the messy representative democracy to which they formerly had to answer.

On the other hand, it is hard to conceive of how such a privatization would be good for students or patients. In fact, it is not the least bit clear why a medical, nursing, or other health professional student would want to study within what would basically be a contract research organization. It is also unclear whether patients seeking care from such an organization could trust it to put their interests, rather than the organization's revenue and the self-interest of its administrators/ managers/ bureaucrats/ executives first.

We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals. Turning one of our once proud and prestigious state government sponsored academic medical institutions into a private contract research organization would be a powerful symbol of our final national health care decline.

Let us hope that the students and faculty whose "conspiracy theory" about privatization proved true will now mount a more effective protest before UCSF falls into the muck.

Hospital IT Department Attitudes on Clinicians

2012-01-20T17:37:00.008-05:00

A quasi-satirical but actually quite serious post:

As exemplified by my posts at my 12-year-old HIT difficulties site at this link, and much feedback from clinicians, informaticists, and others, the picture below speaks for itself about the apparent attitudes of health IT vendor and hospital IT departments towards clinicians. (And, by implication, towards patients - you - and patient safety):

(Click to enlarge)

Enough said.

-- SS

A Letter to the Joint Commission on Their EHR-Related Investigations

2012-01-20T16:02:00.023-05:00

After a U.S. Joint Commission (JC) evaluation of a complaint involving an EHR-related mishap that affected a relative of mine, I sent the following letter to Mark Chassin, MD, President of the Joint Commission; and the same letter, personalized, to Paul Schyve, MD, Senior Advisor, Healthcare Improvement, to Anita Giuntoli, Director, and to Shirley Legaspi, RN, MSN, Patient Safety Specialist, JC Office of Quality Monitoring.

Joint Commission hospital accreditation is advertised to consumers by the JC itself and by accredited hospitals and other healthcare organizations as an assurance of quality and safety.

For example, prominently displayed on the JC website here is the following:

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

Our Mission: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

Vision Statement: All people always experience the safest, highest quality, best-value health care across all settings.

And here:

What's the Word on Accreditation
"Joint Commission accreditation puts us ahead of the curve when it comes to quality and safety. We are confident, based on how we operate our business, that we are Joint Commission-ready at all times."

Dee Weigel, R.N., B.S. - Quality Assurance and Risk Manager Algonquin Road Surgery Center, L.L.C.

The letter below should help prevent future public misunderstandings of the Joint Commission's stance on faulty electronic medical records and related clinical IT systems, or on policies or procedures surrounding use of same.

Scot M. Silverstein, MD
Medical Informatics Specialist
Plaintiff’s Expert Witness in EHR-Related Medical Malpractice
[address redacted]
[phone redacted]
[email redacted]

January 20, 2012

Mark R. Chassin, M.D., F.A.C.P., M.P.P., M.P.H.
President, the Joint Commission
One Renaissance Blvd.
Oakbrook Terrace, IL 60181
Via email and postal mail

Dear Dr. Chassin,

This letter is to put on the record facts about the Joint Commission’s (JC) evaluation activities of complaint/ incident #XXXX-YYYY-ZZ [actual code redacted].

The information transmitted to the JC included, but was not limited to documentary proof of:

• A warning letter I submitted to the CEO and CMO of the hospital system that was the subject of the complaint evaluation activities, warning about EHR deficiencies that could cause patient harm a month prior to actual harm occurring;
• Evidence an EHR permitted an RN to discontinue at triage a longstanding critical cardiac medication the patient had been on for approximately 8 years;
• A failure of mechanisms, both cybernetic and human, for clinical staff in the continuum of care (ED/ICU/specialty floor), including those explicitly informed of the medication by the patient’s relative, himself a physician and family member, to be aware of or alerted to this discontinuation;
• Resultant severe, debilitating patient harm that ultimately led to death;
• A medication reconciliation H&P ICU page (handwritten) that was left blank;
• A non-dated, non-timed chart alteration adding the missing medication as if to appear contemporaneous with the H&P;
• A finding by Medicare’s state QIO after their investigation that the care provided did not meet accepted professional standards of healthcare, and that the deviations led to the patient harm and subsequent complications.

In response to the above materials and documentation, and despite hearing my opinion (which, in fact, is supported by reports and research from the Joint Commission itself, the National Research Council, the Institute of Medicine, the National Institute of Standards and Technology, the American Medical Informatics Association, the ECRI Institute, and others) that such deficiencies pose a risk to the public of further EHR-related near-misses and actual patient injuries and deaths, the JC decided that:

• "The standards areas in which requirements for improvement were issued as a result of complaint evaluation activities" was "None.”

In effect, the Joint Commission’s officers and investigative personnel, who have a fiduciary responsibility to the public to assure hospital operational safety, believe hospitals with deficient EHRs and other clinical IT systems and policies and procedures that can create scenarios such as this are in compliance with all JC standards, and can advertise to the public they are JC accredited for safe operations.

Sincerely,

Scot Silverstein, MD

The Joint Commission's Dec. 11, 2008 Sentinel Events Alert on Health Information Technologies is at this link (PDF): http://www.jointcommission.org/assets/1/18/SEA_42.PDF

In that Alert it states (emphases mine):

As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission.

These unintended adverse events typically stem from human-machine interfaces or organization/system design. The overall safety and effectiveness of technology in health care ultimately depend on its human users, ideally working in close concert with properly designed and installed electronic systems. Any form of technology may adversely affect the quality and safety of care if it is designed or implemented improperly or is misinterpreted. Not only must the technology or device be designed to be safe, it must also be operated safely within a safe workflow process.

-- SS

The Very Latest Health IT "Glitch" - Britsh MP Says No to Cerner

2012-01-19T16:24:00.012-05:00

It's just a glitch:

Bacon calls for halt on Millennium
e-Health Insider.com
19 January 2012

Conservative MP Richard Bacon has called for a halt to all Cerner Millennium deployments following appointment problems and delays at the latest trusts to go-live with the system - North Bristol and Oxford.

Bacon, who has followed the progress of the National Programme for IT in the NHS [NPfIT - ed.] for many years, said the two hospitals had been “brought to their knees” by the implementation of the new electronic patient record system.

“These deployments need to be stopped until we are sure that they can be managed safely,” he said; adding that the system should be "switched off" if it was not working for patients.

North Bristol NHS Trust and Oxford University Hospitals NHS Trust said they are working through some deployment issues, but denied that patient safety has been compromised.

[There's that 'safety has not been compromised by major IT system disruptions' line again - see here - ed.]

However, Oxford University Hospitals told eHealth Insider that it has had to bring in extra staff to help it overcome some “temporary problems while the new system beds in.”

Bacon said local news reports indicated that the trust was having serious difficulties booking patients in for treatment.

The Oxford Mail has reported that problems were so bad before Christmas that the trust had to suspend its parking charges as clinics over-ran by hours.

... Bacon, who was instrumental in triggering last year’s National Audit Office and Commons’ public accounts committee inquiries into the programme, said the NHS should never have been locked into buying software that was “unreliable” and “unreasonably expensive."

“Effective, affordable and robust IT systems are vital to the future of the NHS, but it is clear that the fiasco that is the national programme cannot deliver them,” he said this morning.

He called for “a halt” to new Cerner Millennium deployments, including that at Imperial College Healthcare NHS Trust, which is being undertaken by BT as the local service provider for London, and that at Royal Berkshire NHS Foundation Trust, which went outside the national programme more than two years ago.

[More typical hospital executive-style excuses and spin control follow]

Readers, I won't bore you with the rest of the excuses, pleadings for special accommodation, etc. You've heard them all already on this blog.

However you can read them at the link above if you so desire.

-- SS

Harvard Psychiatry Fails Again

2012-01-19T00:09:00.000-05:00

HARVARD PSYCHIATRY FAILS AGAIN

About a year ago I remarked upon the ethical tone deafness that characterizes Harvard psychiatry. It is bad enough that Harvard-MGH is the home of Joseph Biederman, MD, with whom Senator Grassley had so much fun a while back. Biederman is still in the news. It is also the home of Andrew Nierenberg, MD, who was rash enough to take on Marcia Angell in the New York Review over her well founded criticisms of the hyping and misuse of psychiatric drugs. In response, Dr. Angell handed Dr. Nierenberg his head.

Biederman and Nierenberg are not the only ones. When I called one of the senior Harvard professors, Carl Salzman, MD, to task for signing up a pair of compromised key opinion leaders as speakers in his annual Psychopharmacology Master Class last spring, I hoped the ensuing negative publicity would persuade him to go in a different direction next time.

No such luck! Today I saw the flyer for the 2012 Harvard Psychopharmacology Master Class. The list of speakers is virtually unchanged from a year ago. There is Charles Nemeroff. There is Alan Schatzberg. Both were outed by Senator Grassley’s investigation in 2008, and both were subjected to major administrative sanctions, by Emory University and by Stanford University. Other people now occupy the departmental leadership chairs they held in 2008. There also is a group of other key opinion leaders who appear content to endure the taint of sharing the podium with the compromised Nemeroff and the compromised Schatzberg. What are they thinking?

For that matter, what is the course director Carl Salzman thinking? A year back he said Nemeroff and Schatzberg would give great talks and that he would ensure they were objective and impartial. That’s not the point. The point is that they brought dishonor on our field, and for Harvard Medical School to give them this platform amounts to compartmentalizing information in service of their public rehabilitation. To repeat what I said a year ago, Adolph Hitler also gave a lot of speeches that received rave reviews, and compartmentalized information was widespread in the nation of Germany between 1928 and 1945. The best one can say about the upcoming course is that Biederman and Nierenberg are not on the program.

The Augean stables of psychiatry, at Harvard and nationwide, will not be flushed clean by the Carl Salzmans of our field, quibbling over legal technicalities while failing to see the ethical elephant in the living room.

For how long will the grownups at Harvard Medical School allow this farce to continue?

EHR Lowers Costs By 33% ... Oh ... Wait A Minute ... We Retract That Statement

2012-01-18T18:12:00.008-05:00

There's this:

Blue Cross Blue Shield of RI Pilot Lowered Monthly Costs By Up to 33% Through EHRs
December 13, 2011
Becker's Hospital Review.com
Sabrina Rodak

Health plan members that received care from physician practices using electronic health records had an average of 17-33 percent lower monthly healthcare costs compared to members receiving care at non-EHR physician practices, according to a news release by Blue Cross & Blue Shield of Rhode Island.

BCBSRI conducted a three-year pilot program that partially funded 79 primary care physicians to purchase and use EHRs.

Then, there's this:

Blue Cross backtracks on claim that EHRs lower care costs
December 22, 2011
FierceEMR.com
Dan Bowman

A week after reporting that use of electronic health records lowered the cost of care for its customers between 17 and 33 percent, Blue Cross Blue Shield of Rhode Island has backtracked on those claims. In an email sent to FierceEMR, BCBS/RI says that while the program significantly improved healthcare quality, its cost data had not been risk adjusted and did not include costs related to infrastructure spending. "At this time we are unable to accurately ascertain the cost implications of the pilot and are retracting the news release," the email reads. BCBSRI updated its announcement, which can be found here.

I note the following:

Healthcare organizations, HIT pundits and vendors seem happy to promote EHR's as saving a great deal of money. I do not believe they ever will. (I have company, such as at Wharton.)

One can only wonder what led to the retraction of a press release based on a curbstone data analysis, as cited above. Internal dissent, perhaps?

Healthcare IT, as in this pilot study, can improve healthcare quality metrics (outcomes is another matter as yet undecided as illustrated by this reading list) - but only if done well, a remarkably complex undertaking. That undertaking starts at conception and design, to production, to implementation, to customization, to maintenance of software and hardware during the system lifecycle. See this report by the U.S. National Research Council.

When healthcare IT is done poorly, it will neither reduce costs, nor improve outcomes, and will increase risk to patients.

The current ecosystem of commercial health IT and its lack of true regulatory framework for these experimental devices can be counted upon to "do health IT poorly."

-- SS

"Barbarians at the Gate" - Making Private Equity Less Private, and Understanding Its Effects on Health Care

2012-01-18T14:23:00.001-05:00

One good byproduct of the tumultuous everlasting 2012 campaign for the US presidency has been to shed light on a number of political and economic issues that had previously been ignored, especially those relating to the global financial crisis or great recession. In turn, many of these issues may be relevant to our understanding of our ongoing health care dysfunction.

The latest issue to achieve prominence was the nature of private equity firms. Current presidential contender Mitt Romney used to work for Bain Capital, a private equity group. As we discussed here, Bain Capital owned a variety of companies, including some important health care corporations. More importantly, attacks on Mr Romney's record at Bain by other candidates have lead to a broader discussion of the nature of private equity. This discussion is very relevant to health care, since private equity firms have taken over a number of important health care corporations, and more recently, have begun to take over formerly non-profit health care organizations.

Therefore, we will summarize what has become known about private equity, and then consider its implications for health care.

Understanding Private Equity as Re-Branded Leveraged Buy-Out Firms

- Private Equity Firms are Just Re-Branded Leveraged Buyout Firms

The first good statement to this effect I found was by Merrill Goozner in the Fiscal Times(1):

Private equity is actually a misnomer, since the modus operandi of those investors is no different than the leveraged buyout firms that pioneered junk-bond financing in the 1980s.

As reported by the Los Angeles Times(2):

'Being known as a leveraged-buyout-deal shop wasn't the most attractive label out there,' said Colin Blaydon, director of the Center for Private Equity and Entrepreneurship at Dartmouth's Tuck School of Business. 'Private equity has a much nicer ring to it.'

In fact, according to Forbes columnist Robert Lenzer,(3) the famed investor Warren Buffet called this re-branding

'Orwellian': Buffett wrote that 'private equity' is a 'name that turns facts upside-down: A purchase of a business by these firms almost invariably results in dramatic reductions in the equity portion of the acquiree’s capital structure compared to that previously existing.'

I must admit I always thought private equity firms simply collected large amounts of capital from investors, then used the pooled capital to buy out troubled firms. I assumed that because these investors therefore had a large personal stake in these firms, they would want to increase at least their financial value. I also thought that leveraged buy-out firms ceased to exist after all the bad press they got in the 1980s. It turns out I was wrong on all counts. Probably, a lot of other peoples' beliefs about private equity were similarly wrong.

Once the equation of private equity and leveraged buyout firms is made, understanding what they do and its implications are easier.

- Leveraging the Buy-Out

The modus operandi of leveraged buyout firms is to make their purchases of troubled corporations mainly with borrowed money. As Merrill Goozner put it(1),

Private equity firms generally finance anywhere from 60 to 90 percent of their purchases with borrowed cash.

Note that,

Interest payments on those debts are treated just like any other expense, and are therefore deductible from earnings.

- Then Leveraging the Acquired Company

If this leveraging were the only leveraging done in a leveraged buy-out, the implications might not be that big, except for the acquiring firm. After all, when the leveraged buy-out firm borrows the money, it then becomes obligated to pay it back. However, then comes the tricks.

One important trick was described in the following example by economist Dean Baker on the Beat the Press blog(4),

To take a simple example, suppose a public company (let's call it Gingrich Inc.), has $1 billion a year in profits. If Gingrich Inc. paid taxes at the full 35 percent rate (fat chance), it would have $650 million [thanks Robert] a year to either keep as retained earnings or to pay out as dividends to its shareholders.

Now suppose that a PE company (we'll call it Romney Capital) steps in. The current price to earnings ratio in the stock market is around 14, so Gingrich Inc. would have a pre-takeover market value of approximately $9.2 billion (14*$650 million). Romney Capital then arranges for Gingrich Inc. to borrow $6 billion which it pays out as a dividend to itself. This means that the Romney Capital has just gotten back almost two-thirds of its investment.

A somewhat less vivid description of the process appeared in a post by Robert K Lifton on the Huffington Post(5):

Most often, in order to increase the return on capital invested by the fund, the fund will borrow a significant portion of the purchase price of the business. And sometimes, if it can, the fund will take back as a distribution immediately upon closing the purchase of the business, a portion of its investment in the purchase price, reducing its own investment and enhancing its return on the investment left in the business. This distribution may come from the company's existing cashable assets or from money that the company is caused to borrow.

Thus, it appears that while the leveraged buy-out (or private equity) firm borrowed money to finance the purchase of a company, it can almost immediately get out of its obligation to pay off that loan, by making the acquired company its own loan, and using proceeds from that to end the LBO firm's debt. The leverage, and the obligation to pay back a debt has almost magically been transferred from the LBO or private equity firm to the acquired company. That has big implications, as Lifton wrote(5):

This additional leverage also creates additional risk; if things don't go right the business will not be able to pay the carrying costs of the debt, the lender will take over the business and the fund will lose its investment. Sometimes, that results in the acquired company placed in bankruptcy proceedings either to liquidate its assets to pay off the debt or to restructure, a process Bain also experienced.

- Selling Assets to Further Reduce the Private Equity Firm's Debt

LBO firms have another trick up their collective sleeves. As Dean Baker continued his example(4),

Now suppose that the Romney Capital arranges to sell off some of Gingrich Inc.'s assets, such as real estate or a highly profitable subsidiary, and then uses the proceeds to make a payment to the Romney Capital rather than leaving the money under the control of Gingrich Inc. Such sales may allow Romney Capital to recoup the rest of its investment and possibly more.

Of course, the result is

Gingrich Inc. is then left as a highly indebted company with few assets.

In this story, Romney Capital may have earned a substantial profit on a limited investment (it recouped most of its money almost immediately when it loaded Gingrich Inc. with debt), without doing anything to improve the operation of Gingrich Inc. If Gingrich Inc. manages to stay in business and generate profits, then this will increase the return. Romney Capital may be able to resell the company and treat the whole sale price as profit.

On the other hand, if Gingrich Inc. goes bankrupt, this will primarily be a problem for creditors, since Romney Capital has already gotten its investment back. In effect, Romney Capital might have secured large gains entirely by financial engineering, while creating no value whatsoever.

Let me underscore that. The LBO model (now also the private equity model) enables the acquiring LBO firm to avoid any losses, by shifting all the risk and obligations to the acquired firms. This puts these firms at considerable jeopardy.

- Tactics to Prepare Acquired Firms for Sale

Of course, LBO/ private equity firms want to do more than not lose money. To make real money, they must be able to sell off the firms they acquire. To do so, they must make these firms, or their components, seem attractive, at least in the short term. To do this, they employ a standard set of tactics out of the generic management playbook.

So, per the LA Times(2),

layoffs are part of the playbook that elite investment firms use to squeeze cash out of struggling companies.

Also, per Lifton(5),

To increase the profits of the acquired company, the fund may reduce the number of employees, reduce pay levels or curtail work time.

In addition, per Josh Barro writing for the Forbe blog(6), other tactics can include

downsizing, increased automation, offshoring, and the like.

- The Private Equity/ Leveraged Buy-Out Version of the Anechoic Effect

It is striking that while Mitt Romney worked at Bain Capital in the last century, and private equity has been around, if not growing, since then, the current presidential campaign seems to be the first occasion which prompted any real public discussion about the nature of private equity, and its significance for the larger political economy. Thus private equity/ LBO seem to have been anechoic for a very long time (like much about how our current health care system operates seems to be anechoic.)

This version of the anechoic effect seems to have been deliberately created by the private equity/ LBO firms.

A Washington Post commentary(7) quoted Mitt Romney,

You know I think it's fine to talk about those things in quiet rooms,...

As a New York Times story(8) put it, these firms are lead by

a group of Wall Street executives who prefer to operate out of the spotlight

A story in Politico(9) called private equity/ leveraged buy-out firms

one of the most secretive redoubts of the American economy

The article went on to suggest that these firms may well have something to hide:

Josh Kosman, author of 'The Buyout of America: How Private Equity Is Destroying Jobs and Killing the American Economy.' [said] 'Most private equity firms are because once you look behind the numbers, there is much they don’t want you to see.'

Furthermore,

Private equity companies often tend to have confidentiality agreements with their investors (Bain would not comment on what agreements it has). Several equity experts interviewed for this story thought any disclosures from Bain were likely to spook its investors.

The private equity business model is based on taking companies out of the public markets, where reporting requirements are strict and investors punishing, making changes that will hopefully make them more profitable and then selling them or taking them public through an IPO.

The part that happens behind the curtain is not always pretty, and private equity firms have learned over the years that it’s hard to tell a complicated story in the media. The goal of private equity is to keep things private.

'It’s had very little consciousness in the political realm until Romney came along because these guys are smart enough not to try to become Treasury secretaries,' said Bill Cohan, a former Wall Street banker-turned-investigative journalist who wrote 'Money and Power: How Goldman Sachs Came To Rule The World.'

In addition, Dean Baker suggested that the confidentiality is used to hide how private equity/ leveraged buy-out firms remove capital from acquired companies(4),

The sort of asset stripping described here, which harms creditors by taking away potential collateral for their loans, violates the law. However it is extremely difficult to prevent, especially with private equity companies that have to make few public disclosures.

Thus secrecy/ confidentiality/ deception should be regarded as one of the main tactics used by private equity/ leveraged buy-out firms.

Implications for Health Care

Mitt Romney's candidacy has generated a surprising amount of discussion about the effects of private equity/ leveraged buy-out firms on the political economy. Many are worried that despite his claims, such firms cause more job loss than job creation. In the Huffington Post(10), Robert Creamer wrote that private equity/ LBOs have contributed to the sense that ordinary people who play by the rules suffer while well-connected insiders prosper:

It just doesn't make sense to them that a relatively tiny number of people -- who don't build a product or create a service -- can make massive amounts of money, while ordinary people who work hard and play by the rules see their incomes flat-line.

Their view is simple. They create cars, or food, or houses or computers -- or they provide police protection, or care for sick people, or teach our kids. Why should they be asked to sacrifice when guys who basically gamble for a living -- as Wall Street speculators -- make incomprehensibly large sums of money?

There seems to be a good argument that the tactics used by private equity/ leveraged buy-out firms might be bad for the general political economy.

Moreover, these firms often take over health care corporations, drug and device companies, health care information technology companies, health insurance companies, for-profit hospital chains, etc. There is reason to think that their standard tactics used on such targets are likely to be particularly bad for health care.

Many health care corporations depend on a long-term view to be successes. To develop new products, drug, device, and health care IT companies must pursue research and development projects that take years. All health care companies depend on highly trained, specialized workers and professionals. To sustain these sorts of employees requires a long-term attention to their development. So private equity/ leveraged buy-out firms' short-term focus, transfer of debt and risk to the acquired companies, and emphasis on short-term generic management cutting costs techniques including lay-offs, outsourcing, etc clash with the sophisticated long-term focus these companies require.

These health care organizations often require the complex interplay of many components. Private equity/ leveraged buy-out firms' efforts to sequester and sell particular assets may disturb this complex system.

Health care quality, and successful research and development require transparency. Extreme emphasis on secrecy by private equity/ leveraged buy-out firms threatens such transparency.

Even more pointed concerns may arise when private equity/ leveraged buy-out firms endeavor to take over non-profit health care organizations. We plan to discuss these in a subsequent post.

The NY Times(g) noted that in the 1980s, leveraged buy-out firms

were branded as 'barbarians at the gate' - the title of a book [by Burrough and Helyar, link here] about the takeover of RJR Nabisco by Kohlberg Kravis Roberts.

Now 30 years later we are finally having a conversation about the role of these firms in the greater political economy. We in health care should be having a parallel discusion about their role in our sphere. I submit that their role was not likely productive. Since health care should not merely be looked upon as a means to make money, but as a public good, we ought to be talking about how to restrain private equity/ leveraged buy-out firms from doing it more damage.

References

1. Goozner M. Private equity's edge: buy now, deduct taxes later. Fiscal Times, Jan 9, 2012. Link here.
2, Hamilton W. Private equity industry: a bad rep, but is it deserved. Los Angeles Times, Jan 12, 2012. Link here.
3. Lenzer R. Why Warren Buffet disdains the private equity crowd. Forbes, Jan 14, 2012. Link here.
4. Baker D. NPR does fluff piece for private equity. Beat the Press, Jan 13, 2012. Link here.
5. Lifton RK. Mitt Romney and Bain Capital: understanding the reality. Huffington Post, Jan 13, 2012. Link here.
6. Barro J. The discussion we should be having about Bain. Forbes, Jan 12, 2012. Link here.
7, Robinson E. Reexamining the myth of no-fault capitalism. Washington Post, Jan 16, 2012. Link here.
8. Lattman P, Lowrey A. As Romney advances, private equity becomes part of the debate. New York Times, Jan 10, 2012. Link here.
9. Hagey K. Mitt Romney's Bain Capital days: a black box. Politico, Jan 11, 2012. Link here.
10 Creamer R. Why the Bain Capital controversy is so damaging to GOP chances this fall. Huffington Post, Jan 16, 2012. Link here.

An "Anecdotal Complaint" About An ICU EHR

2012-01-15T11:18:00.028-05:00

An "anecdotal complaint" (see health IT-specific definition of 'anecdotal' at this link) from a practicing medical informaticist on an EMR system being rapidly rolled out - in a neonatal ICU, where a single slip is an ended life or lifelong crippling injury, and a multimillion dollar lawsuit, in the making:

... Having just exited a 4 week “Night call” rotation of q3 nights (16 hours in house) or weekend days (16-26 hour shift in house) call / attesting/checking and signaturing horror show, my first with our “New” {#$@#**%%$@!*&!!*} charting and attesting, etc system [symbolic praise in the original - ed.], I can 100% attest that everything [another colleague -ed.] said is exactly why I’m scared to death of all the UCs [unintended consequences - ed.] of this current effort, when adult outpatient systems hit quaternary NICUs of 50-60 patients, with untested crash [i.e., artificially rushed - ed.] rollouts.

Dozens and dozens>>>>thousands of examples of each and every comment [made by the other colleague on EHR problems - ed.], plus more is exactly what I’m personally suffering. The more is bilateral horrible carpel tunnel flare ups (7-10 clicks and scrolls to get an “overview” of anything) so right now both my hands are numb.

Plus, one to two minute logons, is a lifetime when a baby is suddenly crashing. This is a “coding horror” and a safety nightmare. I live in constant fear of somebody screwing up something important, and perhaps uncorrectable. We do our work in real-time, most of the time. Where is the FDA when you need them? [Scared of hot potatoes as I wrote here - ed.]

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”.

A traditional ICU flowsheet (click to enlarge)

One wonders how often this scenario - what I now call a "But ... patient safety is not compromised" scenario in the words of the typical hospital administrator - is being repeated around the country.

Of course, the problem just can't be the software (as in the post at this link). It's those dullard clinicians and hospital IT staff who have misconfigured the cybernetic miracle.

This is certainly an example where the customs, traditions and methodologies of business IT (e.g., implement on-time and on-budget, at all costs, according to a strict timeline with benchmarks) are highly ill-suited for medicine. That assumes that there are not kickbacks or other financial 'incentives' or COI's in play, of course.

In fact, it would not surprise me if the IT vendor, a major company, has insulated itself from liability through a "hold harmless " clause. If so, as I have written in 2009 in JAMA at this link in response to an article by Koppel and Kreda [1], and at my Drexel Univ. health IT difficulties site at this link, having signed such a clause would represent a breach of hospital governance's fiduciary responsibilities to their clinical employees and agents (in effect, laying the liability for EHR-induced malpractice solely on them), and to patients.

I advised this doctor to 'be safe', as I would not want to have to be expert witness for a plaintiff whose child they injured or killed due to EHR-mediated obstacles to accepted professional standards of healthcare.

Finally, if this doctor were to resign, perhaps a case could be made for constructive discharge.

-- SS

[1] Health Care Information Technology Vendors' “Hold Harmless” Clause Implications for Patients and Clinicians. Koppel R, Kreda B. JAMA. 2009;301(12):1276-1278. doi:10.1001/jama.2009.398

2011 Closes on a Note of Electronic Medical Record Privacy Breach Shame

2012-01-14T11:20:00.006-05:00

At my Oct. 2011 post "Still More Electronic Medical Data Chaos, Pandemonium, Bedlam, Tumult and Maelstrom: But Don't Worry, Your Data is Secure" and others in this query link on medical record privacy, http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy I wrote:

"Don't worry, your medical data's safe."

Joseph Conn of ModernHealthcare.com apparently disagrees (with my sarcasm, that is) and states the obvious outright. I post his story with few comments and several emphases which are mine:

Year closes on a note of breach shame
Modern Healthcare
Dec. 2012

Three-eighty. Three-eighty. Do I hear four hundred?

With 2011 winding down, there are now 380 major data breaches involving 500 or more patients' records listed on the "wall of shame" website kept by HHS' Office for Civil Rights.

So far, from the first wall postings in September 2009 through the latest on Dec. 8 this year, there have been 18,059,831 "individuals affected," and even that massive number is an undercount of the breach problem.

First, the civil rights office hasn't yet released the records of tens of thousands of breaches it has received under a federal reporting mandate on breaches affecting fewer than 500 patients per incident. I've been asking for electronic copies of those records since June. I hope to hear soon on an appeal of a decision last fall by HHS, claiming that the civil rights office can hide those reports while it "investigates" an estimated 30,000 or more breaches they describe.

Second, even the OCR's posted numbers are low.

A Nov. 4 public notice on a breach reported by the UCLA Health System states that "some personal information on 16,288 patients" was stolen, but the wall of shame lists the "individuals affected" in the UCLA incident as 2,761.

UCLA spokeswoman Dale Tate said in an e-mail that the nearly six-times-larger number in its notice "represents the number of individuals who had some information on the hard drive," while the 2,761 figure sent to the OCR "represents the number of people that met the specific criteria" under the federal breach notification rule.

Under the federal rule, Tate says, "the information for these individuals could possibly cause more than a minimal amount of financial, reputational or other harm." Information on the rest of the individuals, Tate said, did not meet the criteria.

Not to get too harpy, but this breach stuff is long past being ridiculous.

The lawyers are already all over it, and maybe that's what it will take for the industry to finally start addressing the problem. Brian Kabateck, a California lawyer, thinks so.

In the past three months, his Los Angeles law firm has filed a pair class-action breach suits against two of the most highly regarded healthcare systems in the state, University of California, Los Angeles and Stanford, as well as one of the latter's business associates, Multi-Specialty Collection Services.

"I think this is a short blip on the radar," Kabateck said. As the settlement costs pile up, he said, "I think big institutions are going to learn—five years from now, these lawsuits are going to be obsolete."

Class-action lawsuits are needed as much for health IT risk and safety issues causing near-misses, injuries and death as for security breaches, I note.

I think five years is highly overoptimistic as well on the breach issue, considering the degree of "institutional learning" that's occurred on how to do health IT "right" over the past ~ three decades, and considering that the breaches that are increasing, not decreasing, in intensity and severity across all industry sectors. That includes industry sectors far better equipped to manage IT security than hospitals.

Right now, though, Kabateck says, "This is not to the level of being an epidemic, but it's close."

I think it is epidemic.

Rather than being a miracle that will revolutionize medicine, health IT is like any other information and communication technology (ICT): it has unintended consequences (UC's) that can dilute or even negate its advantages. The issue of damaged medical record privacy, confidentiality and security is but one UC of health IT.

-- SS

North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story

2012-01-14T09:56:00.036-05:00

At my Dec. 2011 post "IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised" referencing prior posts, I wrote:

... At 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" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Another "our clinical IT crapped out , BUT ... patient care/safety was never compromised" story just arose:

North Bristol hits appointment problems
E-Health Insider
11 January 2012
Rebecca Todd

Clinicians working at North Bristol NHS Trust have expressed concern about disruption to patient care, which they say is caused by appointment problems following the go-live of a new Cerner Millennium electronic patient record system.

I would have entitled the article "North Bristol hit by IT-created appointment problems."

Reported problems include patients being booked into non-existent clinic appointments or not being told about scheduled operations, resulting in some operations being cancelled.

No patient care compromise possible there. Who, after all, needs a timely operation? It frees up a lot of money for IT golf tournaments to let those of no value to society (i.e., the old, and those who will not admit computers in healthcare with deterministically revolutionize medicine because, well, they're magic) simply die due to delayed or cancelled surgery...

Ehealth Insider understands that some of the problems relate to the way the trust configured the EPR system; including setting up dummy clinics for which appointment letters were subsequently sent out.

It's never the software or computer's fault.

As a matter of fact, I have not seen any official response to the work of Dr. Jon Patrick at U. Sydney on the many software engineering flaws of another product of the same company. His work is entitled "A study of an Enterprise Health information System" and is at this link: http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146. Do they have Class Action lawsuits in Australia?

In a regional BBC news report, aired on Monday evening, anonymous hospital clinicians called the implementation a “complete shambles” and said it represented a “potential danger” to patients.

According to the BBC report, the problems meant patients were being booked for impossible appointment times, such as 12.05 am, and quoted correspondence saying staff and the system were both on the “verge of meltdown."

The clinician comments are anonymous since non-anonymous reporting would get the clinicians declared health IT apostates, and then excommunicated. Non-anonymous 'whistleblowers' could also fear being sued due to possible gag clauses - the kind of clause hospital executives sign in violation of their fiduciary responsibilities to their staff and to patients. (See my 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"at this link and the much-expanded essay on the same themes "Health Care Information Technology Vendors' Hold Harmless and Keep Defects Secret Clauses" at this link.)

Martin Bell, director of IM&T at the trust, confirmed to EHI that North Bristol had experienced some “unexpected problems” in the past few weeks with some of the outpatient appointments and theatre lists.

Bell stressed, however, that patient safety had not been compromised and that this continued to be the top priority.

There's that line again. Perhaps it's part of some hospital administrator JournoList-recommended catchphrase for describing how safety was not compromised during a major workflow disruption?

He said the problems were not down to the software itself, but due to “implementation and data migration difficulties in some clinics."

Right. Quite credible.

“Our information management and technology team, supported by our suppliers BT and Cerner, have been working very hard to sort out any initial issues as quickly as possible and we are already seeing improvements,” he said.

Congratulations are due. They are seeing "improvements" in dangerous clinical IT malfunctions that should never have to have been seen in the first place, if the statement is true.

“Many wards, our two minor injuries units and the Emergency Department, are successfully using the new system." The trust is one of the largest in the South of England, with more than 1,000 beds.

Just give them time.

EHI understands that as part of the Millennium implementation, dummy clinics were set up. Patients were then sent appointment letters for these clinics in error.

EHI also understands that some patients had also not turned up for scheduled operations because they had not been informed about the booking.

Bell apologised to patients who had been “inconvenienced during this transition period” and said staff had shown real dedication to continue to deliver patient care.

What if someone had been inconvenienced into their grave, or ends up there as a result of delays? On what wavelength will the apology be transmitted?

“We firmly believe that the new system, once fully implemented, will improve services for our patients and provide real value,” he said.

That seems to be the mantra, but delivery on such promises are rare. See "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" as here, Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand. The article is a cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.

A £69m contract for BT to deliver Cerner Millennium to three new, or ‘greenfield’ sites in the South of England was agreed in April 2010, under the auspices of the National Programme for IT in the NHS.

That would not be the failed National Programme for IT in the NHS, the NPfIT what went PfffT, would it?

North Bristol was the last of these three sites to go-live with the system in December last year.

It followed Oxford University Hospitals NHS Trust, which went live a week earlier, and Royal United Hospital Bath NHS Trust, which was the first to go-live in July.

Cerner said it was working closely with North Bristol and BT on the recent implementation of Millennium.

“In complex and large deployments, especially when migrating from two different systems, it is always anticipated that it would take time for the new system to bed-in,” it said in a statement.

The patients are given full informed consent on this issue, right? Right?

“Across much of the trust, the deployment has worked well. However, this is a major change management project and there have been some difficulties with outpatient appointments.

“Although this is not a problem with the software, Cerner is working in partnership with BT and trust staff to resolve any issue as quickly as possible.”

Link: BBC News

Right. Perhaps this software and claim needs testing - in a court of law.

The only thing missing is the word "glitch", though I am including that term in this posting's index, since I consider it another story in the ever-growing health IT "glitch" series.

-- SS

Addendum:

A reader sent me this comment:

How can anyone claim the problems at N. Bristol are unexpected. they are EXACTLY the same problems encountered in Taunton five years ago.

The Somerset Trust had sixteen cancelled go live dates and when Cerner 'Millennium" (note: they never defined which Millennium...) was switched on the whole hospital went into slow-motion.

Appointments could not be made at out-patient reception desks while patients waited and therefore had to be posted on. Twenty-four whole time equivalent clerks had to be employed to manage the back-up of appointment requests. So much for enhanced efficiency and cost savings.

The only possible response to this news is again to remind people of Einstein's famous definition of insanity: "repeating the same thing again and again and expecting a different result."

As for other Trusts, why no news of transformed performance by Cerner's systems at other Cerner implemented sites, Berkshire, Newcastle, Kingston, Oxford etc. The only 'good' news we get is that the system has been switched on.

If any of this expensive activity had really produced data, efficiency or cost gains, we would be drowning in Cerner press releases, the silence can only mean one thing, that their system is performing as poorly at other sites as it has in the South West.

Contrast this with the output and data produced openly by Birmingham University Hospital from its in-house created IT system.

Unfortunately one can only draw one serious conclusion about the whole Cerner/ NHS debacle - to paraphrase Mr. Clinton - "It's the (imho substandard) software, stupid!

This story needs serious investigation ... Recently US news items have started to discount the supposed efficiency gains for e-Health implementations and started to emphasize data capture and patient safety as the imperative for switch on. Unfortunately for Cerner supporters (and other vendors) the US Institute of Medicine's recent report stated unequivocally that there was (to everyone's apparent surprise) no quality evidence that e-Health improved patient safety.

I would contend no drug, therapeutic equipment or operation would or could be implemented in secondary care in the absence of critical and peer reviewed evidence of benefit [emphasis mine - ed.] that has characterized the rush to switch-on substandard IT solutions in English NHS hospitals.

I note that critical, peer-reviewed evidence, especially based on prospective randomized clinical trials as opposed to anecdotal, weak retrospective observational studies, have been deemed unnecessary in health IT.

Yet serious case reports of risk and injury from credible sources are deemed the true "anecdotes" and discounted. As I've written before, the science of medicine is nearly entirely lacking in the domain of health IT.

To put it in the words of James Le Fanu (channeling Sherlock Holmes) in his very apropos essay entitled "The Case of the Missing Data: The Dog That Didn't Bark", details on contrary strands of evidence that could reasonably have been expected to appear in evidential text are absent.

-- SS

Three Golden Parachutes and Some Unexpected Sequels

2012-01-12T14:11:00.002-05:00

Golden parachutes are an always fascinating aspect of executive compensation in health care. I have collected three relatively recently revealed stories about golden parachutes given to government and non-profit hospital system CEOs, at least two of which involve unexpected, and also fascinating sequels. They will appear in order of the apparent size of the parachutes.

Santa Clara Valley Health and Hospital System

Santa Clara Health and Hospital System is a county (government) system of moderate size in California. Last week, the compensation given its outgoing CEO in 2010 was revealed by the San Jose Business Journal:

Former Santa Clara Valley Health and Hospital System CEO Kim Roberts walked away with an impressive chunk of change when she abruptly left the job in February 2010.

According to a city and county salary report released from the State Controllers Office, the position earned a little over $1 million that year.

A county spokeswoman confirmed that the total included accrued vacation, sick leave and other payments Roberts was entitled to.

The salary was the highest in the Bay Area for public employees in 2010.

Note that

Roberts was hired as CEO in March 2007 with a five-year contract. The agreement included a starting salary of $285,744 with annual salary adjustments, severance and other benefits.

The issue here is that Ms Roberts was the CEO of a local government run health system. Traditionally, the pay given to people in such positions is closely scrutinized by politicians and tax payers, and hence is usually less than that given out by private, non-profit hospital systems, much less for-profit ones. Nonetheless, while it appears that Ms Roberts got something more than $700,000 worth of compensation beyond her usual salary in her last year, the nature of this compensation, and the justification for it is unclear.

Erlanger Health System

The story that got my attention appeared two days ago in the Chattanooga Times-Free Press:

After more than a month of negotiations, Erlanger trustees reversed a previous vote and approved a controversial $728,000 severance package for outgoing CEO Jim Brexler.

Trustees voted 4-4 against the same severance package in December but voted 5-4 to approve it during a 30-minute meeting Monday morning.

More detail about the package:

The approved agreement provides 15 months of severance for Brexler, worth about $713,000. He also keeps his Erlanger health coverage for 18 months, paying his employee portion, a benefit worth about $15,000.

This story is actually a complex sequel. We discussed CEO compensation at Erlanger Health System, an academic medical center affiliated with the University of Tennesse, a year ago. At that time, we noted that a substantial bonus given to then CEO Jim Brexler was based on favorable financial results in the previous year, but did not apparently take into account the more recent decline in the system's finances. That bonus was justified by the typical paean to the leadership's "real expertise in health care" by one member of its board.

By last month, however, Erlanger's finances had deteriorated dramatically. A Free Press article then stated,

Erlanger hospital employees have been asked to take 12 days off in the next two months, consider voluntary buyouts and face possible layoffs as Chattanooga's only public hospital bleeds money.

The hospital has lost more $6 million in the last five months, half of that in November.

The reason for this accelerating misfortune deterioration remain unexplained. Apparently, CEO Brexler had decided to depart, for also unclear reasons, two months earlier:

In October, the hospital announced CEO Jim Brexler would retire at the end of the year.

At that time, the board had voted to give him the severance package described above, but then suddenly began to reconsider after how bad things were became clear:

The board voted earlier this month not to give Brexler a more than $700,000 severance package, but the issue may be brought back up, board members have said.

It was unclear whether the decline in Erlanger's finances had to do with its relationship with another troubled hospital, Hutcheson Medical Center, as described in another Free Press article:

Despite a new board, new management and the infusion of a $20 million line of credit, a struggling North Georgia public hospital continues to lose money.

Erlanger at Hutcheson, formerly known as Hutcheson Medical Center, lost more than $9 million in the first five months of the 2012 fiscal year, which began in July. It lost the most -- $2.7 million -- in September.

Hutcheson board Chairman Corky Jewell could not be reached for comment last week.

The hospital's administrator, Debbie Reeves, and other management personnel were not in the office the week between Christmas and New Year's, according to spokeswoman Haley Johnson.

The publicly funded hospital in Fort Oglethorpe had been losing about $1 million a month, defaulted on a $35 million bond and laid off 75 employees in fiscal year 2011.

In May, Erlanger Health System took over management of the hospital and extended up to $20 million in credit to it.

Apparently inflated compensation to Hutcheson's CEO was also a subject of one of our posts from about a year ago. At that time, we wrote, "despite a major financial loss, lay-offs and service discontinuations, and a bond default," the CEO got "bonus and incentive compensation" in 2009.

So, to summarize, despite major financial problems, Hutcheson Medical Center's CEO got a bonus and incentive compensation in 2009. As its situation got worse, it was taken over in some sense by Erlanger Health System, whose CEO also got a bonus despite increasing financial problems in 2010. Thereafter, the finances of Erlanger really declined, its CEO announced his retirement, and still will collect a golden parachute.

Thus Erlanger Health System's golden parachute for its outgoing CEO symbolizes the anti-gravitational powers of executive compensation. While lavish executive pay is often justified by short-term financial results, health care executives seem to be able to just keep collecting more and more until they have to flee. Health care seems to more and more be run for the benefit of self-interested insiders.

Also, this case demonstrates how skeptical we ought to be of the breathless praise for health care executives and managers and the uncritical touting of their latest advances and initiatives. (By the way, we posted here, just before it became apparent how badly Erlanger's finances were collapsing, about its breathless advertisement of a "new service excellence program" for Erlanger employees run by the Ritz-Carlton hotel chain. One wonders whether the attention to the peripheral ahead of core responsibilities this denoted could have been one reason for the system's decline.)

And we are just working our way up to our big case....

University of Chicago Medical Center

This story actually dates back to 2009, but was first revealed briefly in late 2011, in Becker's Hospital Review,

The other three highest-paid hospital CEOs in Chicago in 2010 include the following:
• James Madara, MD, and Ken Sharigian, University of Chicago Medical Center: $7.9 million
Note: This includes severance for Dr. Madara, who resigned in Oct. 2009. Mr. Sharigian served as the interim in 2010.

A little more detail came out in a side-bar to a story on executive compensation in higher education by the Chronicle of Higher Education:

James L. Madara, dean of the school of medicine and chief executive of the medical center, U. of Chicago
Total compensation: $7,038,944
Mr. Madara’s base salary was $1.3-million, and he received $2.5-million in severance pay.

There was also a hint of why this was so interesting:

Mr. [sic] Madara stepped down after seven years as dean and three as chief executive to return to the faculty. He resigned amid controversy over his management decisions, such as a plan to redirect medical-center patients to neighboring hospitals, according to local news reports.

A little digging shows there was more to it than that. Recall our recent post that discussed the "Urban Health Initiative," a program ostensibly meant to direct some patients, allegedly mainly poor patients, to more appropriate health care venues, allegedly away from the Emergency Department of the university medical center, and again allegedly to make room for patients who need and whose insurance can pay for more lucrative services.

By February, 2009, the Wall Street Journal reported that

In February, two high-ranking doctors quit their administrative posts to protest the plan, saying it could lengthen already long waiting times for patients who visit the ER.

In particular,

The two doctors who gave up their administrative posts in Chicago were Dr. Vanden Hoek, who stepped down as interim chief of emergency medicine, and pulmonology researcher Joe G.N. Garcia, who had been chairman of medicine. The doctors still can practice medicine at the hospital.

About a dozen other doctors from the emergency room and other departments had signed a letter of protest over the hospital administration's plan to reduce the number of beds available to emergency patients in the ER and other units.

Three months later, as reported by Chicago Business,

Some University of Chicago Medical Center faculty members are accusing CEO James Madara of putting hospital finances ahead of research and teaching.

A letter delivered to Dr. Madaar last month and signed by 76 faculty members asserts that, since adding the hospital CEO title in 2006, Dr. Madara has lost focus on his role as a dean of the Hyde Park medical center's vaunted research and academic enterprise. A preocccupation with hospital profits and an 'insular management style' have 'disenfranchised' the faculty, the letter says.

By that month, according to the Wall Street Journal,

More than 190 doctors at the University of Chicago Medical Center signed a letter to trustees protesting plans to reduce the number of beds available to emergency patients as 'unnecessarily risky' and a threat to patient safety.

The plan was put on hold by the university president a few days later. Dr Madara resigned in August.

So, somewhat like the case above, this involved a hospital system CEO who got a very large golden parachute after leaving under fire, not for declining revenue, but for his role in overseeing a program of questionable ethics, one possibly bad for patients, and having lost the confidence of some important proportion of his medical faculty.

He did not, however, go off quietly into the night. His next stop was Leavitt Partners (as noted in this AMA press release), founded by former President George W Bush administration Secretary for Health and Human Services James Leavitt.

As we noted here, Leavitt Partners advertises that it "advises clients that invest in health care and food safety." It does not publicize its client list, but that list apparently includes Alliance Health Networks, whose press release noted that Leavitt Partners "will help it expand its presence in the US health industry and beyond "(look here); and Connextions, Inc, whose press release noted that it would work with Leavitt Partners to " refine existing health insurance exchange models for federal and state governments, as well as private sector organizations that are navigating health care reform law," (look here.) Mr Leavitt joined the board of Medtronic last year (look here).

Then, however, he got back into the CEO business. While still maintaining a role at Leavitt, in 2011, per the AMA release,

The American Medical Association (AMA) today named James L. Madara, M.D., as its new Executive Vice President and Chief Executive Officer. Dr. Madara will assume leadership of the nation’s oldest and largest physician group on July 1.

That news release noted his past positions,

the Thompson Distinguished Service Professorship and deanship at the University of Chicago Pritzker School of Medicine, where he was the longest serving Pritzker dean in the last 35 years. Subsequently, he added the responsibility of CEO of the University of Chicago Medical Center, bringing together the university’s biomedical research, teaching and clinical activities.

Perhaps not surprisingly, it did not mention the controversies at the medical center that preceded his resignation, nor his sizable golden parachute, nor his ongoing role at Leavitt Partners.

So, the American Medical Association claims to represent all US physicians and their values. It turns out that its current Executive Vice President and CEO is a former hospital system CEO who departed under fire with a golden parachute beyond any severance package a practicing or academic physician would dream about. He also is a former and current consultant with a firm lead by one of our better recent examples of beneficiaries of the revolving door. We have come a long, and the wrong way since the AMA asserted, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." (See this post.)

This story is not just about the ridiculous compensation given to health care executives, and how this provides perverse incentives and suggests that many health care leaders have become insiders who put their self-interest ahead of the health care mission. This story is also about the connectedness of these insiders, and how they appear to control nearly every part of health care.

The Moral of the Stories

Maybe if I write this often enough, it will get some notice.... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

US Presidential Candidates' Financial Relationships with Health Care Organizations

2012-01-09T17:06:00.000-05:00

As the leadership of the large field of Republican candidates for the US Presidency shifts, different candidates come in for increased media scrutiny. Recently, reporting about former Pennsylvania Senator Rick Santorum focused on his financial relationships with a health care organization. Senator Santorum, however, is only the candidate with ties to health care organizations to come into the spotlight most recently. We will review the report on Santorum, and then summarize the publicly known relationships of the other candidates.

Republican Former Pennsylvania Senator Rick Santorum and Universal Health Services

The relationship was first revealed by Bloomberg,

Santorum’s greatest financial gain came from $395,414 in director fees and stock options he listed in a recent financial disclosure.

The fees and options came from King of Prussia-based Universal Health Services Inc., a publicly traded health-care management company....

Senator Santorum started on his board service in 2006. He resigned in June, 2011, when he started his campaign for the presidency.

Note that while Santorum served on the board, the company was accused of ethical missteps:

The Justice Department accused the company in a 2010 lawsuit of submitting fraudulent reimbursement claims under the Medicaid health-care program for the poor. The government said the company falsely claimed to have provided inpatient psychiatric services to children at a detention facility in Marion, Virginia. Pantaleoni said the case has been settled.

The company has also risked losing certification to receive Medicare reimbursement for medical centers that it owns.

According to a release on the UHS website, the Rancho Springs Medical Center and Inland Valley Regional Medical Center in Riverside County regained their certification in November after the Centers for Medicare and Medicaid Services threatened to terminate their provider agreement in June 2010. The state of California had also threatened to revoke the group’s hospital license.

It wasn’t the first time UHS risked losing certification for one of its facilities. In late September 2008, CMS terminated participation in Medicare for the Two Rivers Psychiatric Hospital in Kansas City. It’s a decision that led to a court appeal and settlement requiring Two Rivers to retain an outside monitor for six months.

Thus, Senator Santorum was on the board of a for-profit hospital corporation until just before he became a presidential candidate. While he was on the board, the company allegedly committed unethical actions.

Republican Former Georgia Congressman Newton Leroy "Newt" Gingrich and the Center for Health Transformation and its Numerous Corporate Sponsors

A few weeks ago, we posted about Congressman Gingrich's operation of a health care consulting firm, the Center for Health Transformation. It had relationships with a long list of major health care organizations, including Allscripts, the American Hospital Association, AstraZeneca, Blue Cross Blue Shield, GE Healthcare, Gundersen Lutheran Health System, Johnson and Johnson, Pfizer, Pharmaceutical Research and Manufacturers' of America, Siemens, and WellPoint. At a minimum, the Center helped some of these organizations try to influence health care policy to favor their vested interests in the guise of promoting health policy solutions.

The juxtaposition of the stories about Senator Santorum's and Congressman Gingrich's financial ties to health care organizations suggested we review whether other current candidates also had such ties. Some quick searching revealed that some others did. We will review the other current major candidates below, starting with the other Republicans, in alphabetical order.

Republican Former Utah Governor Jonathan Huntsman Jr

I could not find any publicly reported relevant relationships.

Republican Texas Congressman Dr Ronald E Paul

Dr Paul is a physician, an obstetrics-gynecology specialist. According to Wikipedia, he apparently practiced until his current stint in the Congress began in 1996. I could not find any publicly reported relevant relationships.

Republican Texas Governor James Richard "Rick" Perry and Merck

In September, 2011, Governor Perry's prominence in the campaign caused a reconsideration of his relationship to Merck. As MSNBC reported,

On the campaign trail, Perry had recently apologized for the executive order-which would have made Texas the first state in the country to mandate that all teenage girls, starting with 12-year-old sixth graders, be vaccinated with Gardasil.

Gardisil is made by Merck. Then candidate Representative Michele Bachmann noted that Governor Perry had received campaign contributions from Merck. As the Los Angeles Times reported,

In fact, Merck PAC — the company’s Washington, D.C.-based political action committee — has given Perry $28,500 since 2001, according to Texas Ethics Commission filings.

The bulk of that money came before 2007, when the governor signed an executive order mandating all sixth-grade girls in the state to receive the Gardasil vaccine against HPV.

However, Governor Perry had another tie to Merck, as noted by MSNBC,

Perry's order came after the drug company that manufactured the vaccine hired Mike Toomey, his former chief of staff, as one of the firm's top lobbyists in Austin.

Toomey, who is now running the main 'super pac' backing Perry's candidacy, was retained by pharmaceutical giant Merck & Co., maker of the Gardasil vaccine, which is designed to prevent the human papillomavirus, or HPV, an infection linked to cervical cancer in women.

His hiring was part of an aggressive lobbying push in Texas by the drug company, which also donated $16,000 to Perry's gubernatorial campaigns in the two and a half years prior to the executive order. Merck paid Toomey between $260,000 and $535,000 in lobbying fees between 2005 and 2010, according to state lobbying records.

Although Perry's GOP foes never brought up the connection during the debate, Democratic political operatives and a public watchdog group said Thursday his association with Merck is likely to be emerge as a prime example of Perry's 'crony capitalism,' should he win the GOP nomination.

Although there were no reports that Governor Perry personally financially benefited from a relationship with Merck, the company paid substantial amounts to his campaign and to an organization he ran, and to his former chief of staff. There seems to be at least a reason to think that these relationships had something to do with a decision he made that lead to increased sales of a Merck product, and which he now regrets.

Republican Former Massachusetts Governor Willard Mitt Romney and Bain Capital and Numerous Health Care Corporations

Today's Wall Street Journal summarized the investments made by Bain Capital, a venture capital and private equity firm lead by Governor Romney,

The Wall Street Journal, aiming for a comprehensive assessment, examined 77 businesses Bain invested in while Mr. Romney led the firm from its 1984 start until early 1999, to see how they fared during Bain's involvement and shortly afterward.

Among the findings: 22% either filed for bankruptcy reorganization or closed their doors by the end of the eighth year after Bain first invested, sometimes with substantial job losses. An additional 8% ran into so much trouble that all of the money Bain invested was lost.

Of the 10 firms that produced the biggest returns for Bain, four were involved in health care, PhysioControl, Waters, Dade, and Wesley Jessen VisionCare. Dade, a medical diagnostics company, went bankrupt in 2002.

Furthermore, in 2007, the Boston Globe (via the Deseret News) reported on Governor Romney's private equity career, including his involvement with a company that had its ethical challenge,

Bain Capital's 1989 purchase of Damon Corp., a Needham medical testing firm that later pleaded guilty to defrauding the federal government of $25 million and paid a record $119 million fine.

Romney sat on Damon's board. During Romney's tenure, Damon executives submitted bills to the government for millions of unnecessary blood tests. Romney and other board members were never implicated.

More than a decade later, when Romney was in pursuit of the Massachusetts governorship, his Democratic opponent Shannon O'Brien accused him of lax oversight at Damon and failing to report the fraud.

Romney replied that he had helped uncover the illegal activity at Damon, asking the board's lawyers to investigate. As a result, he said, the board took 'corrective action' before selling the company in 1993 to Corning Inc.

But court records suggest that the Damon executives' scheme continued throughout Bain's ownership, and prosecutors credited Corning, not Romney, with cleaning up the situation. Bain, meanwhile, tripled its investment.

Romney personally reaped $473,000.

Thus, Governor Romney was on the board of a device company, albeit many years prior to when he became a presidential candidate. While he was on the board, the company allegedly committed unethical actions.

Democratic President Barack Obama, Michelle Obama, and the University of Chicago Medical Center

The issue of then Democratic Senator Barack Obama's wife's role at the Medical Center was first discussed in 2008, with some follow up in 2009. As the Washington Post reported in 2008,

Shortly after Barack Obama joined the U.S. Senate in 2005, the medical center promoted Michelle Obama to vice president of community and external relations, and more than doubled her salary. She is now on leave from the $317,000-a-year post, in which she sought to bridge the gap between the wealthy institution and its poorer neighbors. The hospital declined to discuss the budget for her program or her input into budgetary decisions.

She was particularly involved in one program that became controversial,

A few years ago, executives at the prestigious University of Chicago Medical Center were concerned that an increasing number of patients were arriving at their emergency room with what the executives considered to be non-urgent complaints. The visits were costly to the hospital, and many of the patients, coming from the surrounding South Side neighborhood, were poor and uninsured.

Michelle Obama, an executive at the medical center, launched an innovative program to steer the patients to existing neighborhood clinics to deal with their health needs.

That effort, in time, inspired a broader program the hospital now calls its Urban Health Initiative.

The Post noted,

The medical center markets its initiative as an effort to improve patient health for the poor and at the same time free its resources for emergencies and complicated procedures. The Urban Health Initiative also could save the hospital substantial amounts of money, by removing the nonpaying poor patients from its emergency room.

However, after Senator Obama became President, his wife became the First Lady and quit her job at the medical center, the program became even more controversial. In March, 2009, the Chicago Weekly reported on the extensions of the Urban Health Initiative

or UHI, which has garnered a lot of criticism recently, such as accusations that it comes 'dangerously close' to the illegal practice of 'patient dumping.' Additionally, the emergency room structure that it will leave in its wake will likely result in a decline in the quality of care provided to Medicaid, Medicare, and uninsured patients.

Ultimately, the Wall Street Journal reported that:

More than 190 doctors at the University of Chicago Medical Center signed a letter to trustees protesting plans to reduce the number of beds available to emergency patients as 'unnecessarily risky' and a threat to patient safety.

At that time, this admission appeared,

Dr. Madara, the hospital's chief executive, said in an interview last week that the hospital is seeking to admit more patients to its 'programs of distinction' such as oncology and advanced surgery, and treat fewer in the ER, and that these moves will mean more privately insured patients at the hospital.

Note that "programs of distinction" may also mean programs that provide the most revenue. Ultimately, the Chicago Tribune reported that the plan was halted by the university president, and a few months later, Dr Madara, the CEO resigned (again per the Tribune).

Thus, while he was a Senator, current President Obama's wife earned a substantial salary from a non-profit academic medical center and hospital system. A program she ran was then and later alleged to have compromised patient safety and perhaps acted unethically.

Summary

We have frequently discussed how large health care organizations seek to influence discussions of health policy to further their vested interests. At times, they have organized stealth health policy advocacy initiatives to comprehensively push their aims. For example, we discussed how commercial health insurance companies have tried, often succesfully, to influence health policy as recounted by former CIGNA public relations leader Wendell Potter in his book Deadly Spin.

It appears that the more one looks, the more one finds evidence of the web of influence of large health care organizations. Pulling together a variety of journalistic efforts over more than three years, it now appears that the majority of the current credible contenders for the presidency of the US have or had financial relationships with health care organizations.

Often these relationships appear significant enough to be called conflicts of interest were the people who had them communicating about health policy in a venue that requires conflict of interest disclosure, like a major medical journal. One candidate until very recently was on the board of directors of a for-profit hospital corporation, and hence had a fiduciary duty to that company and its stock-holders. One candidate until very recently ran a health care consulting company whose clients included major drug, device, and insurance companies. One candidate previously was on the board of a medical device company. One candidate's spouse previously was a top executive of a academic medical center and hospital system.

While the current candidates may now now be writing articles for medical or health care policy journals, by virtue of their candidacies they now receive enormous attention. Anything they say about health care policy is likely to be influential. Yet there is reason to be concerned that many of their views on health policy were influenced by their financial relationships. In particular, would a candidate who at one time got a major part of his or his family's livelihood from a big health care organization be likely to strongly challenge the status quo that allowed that organization to prosper?

In my humble opinion, there needs to be complete reconsideration of how health care policy is made. In particular, we must define how much of the discussion is driven by vested economic interests, and make sure such interests and their relationship to those in the discussion becomes clear. It is just as important for health policy analysts, pundits, and decision-makers to disclose in detail their conflicts of interest as it is for clinical researchers and educators. Maybe the Institute of Medicine would be willing to take up this issue as they took up conflicts of interest affecting research and education.

The Corporate Psychopaths Theory of Health Care Dysfunction

2012-01-04T17:57:00.000-05:00

A new article in the Journal of Business Ethics suggested that the global financial crisis, or great recession, was primarily due to a fundamental flaw in the leadership of financial organizations, one that has important implications for health care organizations.

The article, Boddy CR. The corporate psychopaths theory of the global financial crisis. J Bus Ethics 2011; 102: 255-259 is here. Its premise was:

The Corporate Psychopaths Theory of the Global Financial Crisis is that Corporate Psychopaths, rising to key senior positions within modern financial corporations, where they are able to influence the moral climate of the whole organisation and yield considerable power, have largely caused the crisis.

Note that in 2004 we first posted about the possibility that a proportion of corporate managers, including those in health care, could be psychopaths, raised then by two experts on psychopathy, Paul Babiak and Robert Hare. In 2006, they published Snakes in Suits, about the dangers of psychopaths as executives and managers (see post here). However, the issue got scant attention in those days of letting the good times roll.

Defining Corporate Psychopaths

Boddy described psychopaths as:

the 1% of people who have no conscience or empathy and who do not care for anyone other than themselves. Some psychopaths are violent and end up in jail, others forge careers in corporations. The latter group who forge successful corporate careers is called Corporate Psychopaths.

Corporate Psychopaths as Leaders

Such people do not make good leaders:

Although they may look smooth, charming, sophisticated, and successful, Corporate Psychopaths should theoretically be almost wholly destructive to the organizations that they work for. The probable mal-effects of the presence of psychopaths in the workplace have been hypothesized about in recent times by a number of leading experts and commentators on psychopathy.

Researchers report that such malevolent leaders are callously disregarding of the needs and wishes of others, prepared to lie, bully and cheat and to disregard or cause harm to the welfare of others. Corporate Psychopaths are also poorly organized managers who adversely affect productivity and have a negative impact on many different areas of organizational effectiveness.

How Corporate Psychopaths Could Have Become Prevalent
Despite the dangers posed by such leadership, corporate psychopaths may rise quickly in management:

Psychologists have argued that Corporate Psychopaths within organizations may be singled out for rapid promotion because of their polish, charm, and cool decisiveness. Expert ccommentators on the rise of Corporate Psychopaths within modern corporations have also hypothesized that they are more likely to be found at the top of current organisations than at the bottom.

The nature of current corporate culture may facilitate the rise of corporate psychopaths:

These Corporate Psychopaths are charming individuals who have been able to enter modern corporations and other organisations and rise quickly and relatively unnoticed within them because of the relatively chaotic nature of the modern corporation. This corporate nature is characterized by rapid change, constant renewal and quite a rapid turnover of key personnel. These changing conditions make Corporate Psychopaths hard to spot because constant movement makes their behaviour invisible and combined with their extroverted personal charisma and charm, this makes them appear normal and even to be ideal leaders.

The destabilization of modern corporations likely lead to the ascendancy of the corporate psychopath:

However, once corporate takeovers and mergers started to become commonplace and the resultant corporate changes started to accelerate, exacerbated by both globalisation and a rapidly changing technological environment, then corporate stability began to disintegrate. Jobs for life disappeared and not surprisingly employees’ commitment to their employers also lessened accordingly. Job switching first became acceptable and then even became common and employees increasingly found themselves working for unfamiliar organisations and with other people that they did not really know very well.

Rapid movements in key personnel between corporations compared to the relatively slower movements in organisational productivity and success made it increasingly difficult to identify corporate success with any particular manager. Failures were not noticed until too late and the offending managers had already moved on to better positions elsewhere. Successes could equally be claimed by those who had nothing to do with them. Success could thus be claimed by those with the loudest voice, the most influence and the best political skills. Corporate Psychopaths have these skills in abundance and use them with ruthless and calculated efficiency. In this way, the whole corporate and employment environment changed from one that would hold the Corporate Psychopath in check to one where they could flourish and advance relatively unopposed.

The Harms Caused by Corporate Psychopaths as Executives

Thus, Boddy hypothesized the rise of management by corporate psychopaths lead directly to the global financial crisis or great recession:

As evidence of this, senior level remuneration and reward started to increase more and more rapidly and beyond all proportion to shop floor incomes and a culture of greed unfettered by conscience developed.

Corporate Psychopaths are ideally situated to prey on such an environment and corporate fraud, financial misrepresentation, greed and misbehaviour went through the roof, bringing down huge companies and culminating in the Global Financial Crisis that we are now in.

Writing in 2005, this author commentating on Corporate Psychopaths predicted that the rise of Corporate Psychopaths was a recipe for corporate and societal disaster. This disaster has now happened and is still happening.

What Could be Next

Worse, if this hypothesis is true, as long as it is not addressed, things will get worse:

The very same Corporate Psychopaths, who probably caused the crisis by their self-seeking greed and avarice, are now advising governments on how to get out of the crisis. That this involves paying themselves vast bonuses in the midst of financial hardship for many millions of others, is symptomatic of the problem. Further, if the Corporate Psychopaths Theory of the Global Financial Crisis is correct then we are now far from the end of the crisis. Indeed, it is only the end of the beginning.

Some Agreement

The plausible theory that corporate psychopaths ascending to top management positions in finance caused the global financial crisis has been noticed by a few prominent financial pundits. Writing in Bloomberg, William D Cohan agreed with Boddy's suggestion that "anyone who makes decisions that affect significant numbers of other people, concerning issues of corporate social responsibility or toxic waste, for example, or concerning mass financial markets or mass employment, should be screened to make sure that they are, at the very least, not psychopaths and at most are actually people who care about others."

Brian Besham, writing in the Independent, suggested that Richard Fuld, former CEO of Lehman Brothers, whose bankruptcy kicked off public awareness of the global financial collapse, saying he wanted to eat the hearts of those selling his company's stock short (see this post), was a "terrifying" example of corporate executive psychopathy. Worse, Besham noted that he had discovered an case of an investment bank which "psychometric testing to recruit social psychopaths because their characteristics exactly suited them to senior corporate finance roles." It may be that corporate psychopaths are actively recruiting their fellows.

Implications for Health Care

This is chilling. It also unfortunately is highly relevant to health care. As we noted, most recently here, leaders of big finance firms, including those whose failures were most spectacular, now often sit on boards of trustees of hospitals, academic medical centers, medical schools, and their parent universities. Thus, the likelihood that a good proportion of the stewardship of our most prominent not-for-profit health care organizations may be in the hands of psychopaths is not negligible.

Furthermore, health care organizations have become as unstable and chaotic, in the way these terms were used by Boddy, as finance firms. This would suggest that their current nature would make it as easy for psychopaths to rise to positions of power in them as they may have in financial firms. In health care we certainly have seen the consequences he suggested were due to psychopathic managers, including

- intimidation (per Boddy, corporate psychopaths are "prepared to lie, bully and cheat and to disregard or cause harm to the welfare of others");
- self-interest ("pursuit of self-enrichment and self-aggrandizement") leading to outrageous executive compensation ("senior level remuneration and reward started to increase more and more rapidly and beyond all proportion to shop floor incomes")
- fraud and other crime ("corporate fraud, financial misrepresentation, greed and misbehaviour went through the roof,... ")

So as we noted in 2006, "a high prevalence of psychopathic managers could explain the prevalence of mismanagement, conflicts of interest, and corruption in the leadership of health care organizations that we have often discussed on Health Care Renewal."

Boddy's first suggestion to deal with the problem in finance was:

Measures exist to identify Corporate Psychopaths. Perhaps it is time to use them.

However, it is as hard to imagine top health care leaders willingly and honestly submitting to the use of instruments designed to identify psychopaths as it is to imagine finance leaders doing so. Furthermore, it is easy to imagine how corporate psychopaths in positions of leadership would ruthlessly deploy their legions of public relations personnel and lawyers to quash any challenge should the notion that they are so dominant gain any credibility.

However, if there is any significant prevalence of corporate psychopaths among the leaders of health care, woe will be unto us until we identify and remove them.

Just Say "No" to the Term "Anecdotes"; and HIT as a Medical Metadevice

2012-01-04T12:26:00.028-05:00

A New Year's thought: there needs to be a push in healthcare for dropping of the word "anecdote" to describe case reports of health IT-related errors.

This word even appears in the late 2011 IOM report on HIT safety (PDF), e.g., the preface:

... We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to balance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available.

The "A" word needs to be dropped from the healthcare IT lexicon, since such reports from reliable sources are in fact incident reports purposed for risk management activities.

Incident reports do not need peer review for consideration for that purpose.

Of note, I do not believe the incident reports filed in hospitals when something awry occurs are labelled "anecdotes", either.

See the Aug. 2011 post "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" for more on this topic.

And on another vein, the issue of HIT being a medical device:

As the good State Rep. Marino of my home state of Pennsylvania and others oddly proffer - that 'certification' of health IT, having nothing to do with safety or usability, relieves HIT from being a device [1] - and as the IOM itself debates exactly what to call HIT and under what guidelines to regulate it, another term/category for HIT devices is needed.

In the spirit of the naming of the UMLS Metathesaurus, and in consideration of HIT's informational governance/orchestration of other medical devices and personnel (including the 'carbon units' known as clinicians and patients) -- I suggest the term "metadevice" for HIT.

Healthcare metadevices need their own specific regulation, apart from traditional medical devices.

-- SS

Note:

[1] As in line 21- 24 on page 6 of the "Safeguarding Access For Every Medicare Patient Act" Bill (PDF) that I wrote about here. The Bill states: "CLARIFICATION OF AUTHORITY. Certified EHR’s shall not be considered a device for purposes of the Federal Food, Drug, and Cosmetic Act."

(This proposal, of course, raises the question of whether Rep. Marino believes non-certified HIT shall be considered a medical device, a topic for another time.)

SELF INFLICTED DAMAGE

2012-01-04T11:59:00.000-05:00

SELF INFLICTED DAMAGE

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

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

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

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

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

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

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

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

New York - Presbyterian Hospital Trustee Advocated Novel Cardiac Procedure - "Reach In, Rip Out Their Heart, and Eat It Before They Die"

2012-01-03T14:50:00.000-05:00

The dominant theme of Health Care Renewal has been how problems with the leadership of health care organizations have lead to our current state of health care dysfunction. We have discussed examples of ill-informed, mission-hostile leadership rewarded with excess compensation, exhibiting impunity in the face of alleged misbehavior, and at times descending into corruption. The cause of these problems is doubtless multi factorial. However, one possible cause is that rather than exercise stewardship and hold leadership accountable, those in charge of governance of health care organizations, that is, boards of directors or trustees, have instead infected the organizations with the amoral culture now dominant in much of the business world, especially finance. We have discussed, most recently here and here, how the boards of health care corporations often include heavy representation of leaders of finance, including many of those who seemed responsible for the global financial collapse, great recession, or whatever we will end up calling it.

I recently stumbled upon a particularly graphic example of the sort of predatory culture that now exists on the boards of health care organizations. (More on how I did so later.) Below is an embedded YouTube video of a speech made by a current Trustee of New York - Presbyterian Hospital (who has been on the board since 2007). He is Richard Fuld, the former CEO of Lehman Brothers, whose continuing role on the hospital board, despite his failed leadership of one of the financial firms whose bankruptcy ushered in the global financial collapse, we discussed first here.

Just to underline it once more, Mr Fuld, referring to short sellers of his company's stock, said he "what I really want to do is I want to reach in, rip out their heart, and eat it before they die."

Can there be a more stark reminder of what has gone wrong with the governance of health care? Can anyone watch this video and argue that Mr Fuld ought to be on the board of a hospital system? Why is he still on the board in January, 2012, when this video was released in October, 2011?

While I suspect not many other hospital system board members have been videographed displaying equally brutal sentiments, there are likely others with similarly barbaric tendencies.

So, on a more positive note.... The boards of hospitals, hospital systems, medical schools, and their parent universities ought to be populated with people who take their stewardship roles seriously. They ought to be people who understand, agree with, and support the organizations' mission, and their dedication to patient care and teaching. They ought to understand what good leadership of health care organizations entail. Needless to say, they ought to be of good character and above any ethical reproach. In short, they ought to be the opposite of the sort of person displayed in the video above.

It should now be obvious that grievous problems with the leadership and governance of health care organizations are principle causes of the dysfunction in our health care system. True health care reform will require wholesale changes in health care leadership and governance.

PS - In case the video above seems too short on context, see the one below:

They Think We are "Imbeciles," and They Run Health Care Organizations

2011-12-29T15:32:00.000-05:00

Arrogance seems to fuel many of the problems with health care leadership that we discuss, particularly hostility to the mission, often driven by self-interest; a sense of entitlement to lavish compensation out of proportion to any measure of performance; and a lack of accountability shading into impunity. Some recent stories hint at some of the origins of such arrogance.

The Occupy Wall Street movement drew attention to the plight of the poor and middle class, who had lost income, retirement benefits, jobs, houses, and access to health care while the richest, especially corporate executives, got richer. The less fortunate's anger was not directed indiscriminately at the successful or the rich, but those who got wealthy by gaming the system, or flaunting the rules that lesser mortals had to obey. Perhaps not surprisingly, some of those most vulnerable to such criticism have responded with contempt.

Anonymous or Indirect Defenses of the One Percent

The initial defense of the plutocrats came from some of their political supporters, who denounced their "demonization" (see this opinion piece by Barbara Ehrenreich in September, 2011) or decried the rise of "mob rule" (see this by Paul Krugman in October). Then several articles documented the anonymous complaints of finance insiders about:

a bunch of whiny people who are lazy and incompetent and have nothing to do with their time

from a Reuters article in October.

a ragtag group looking for sex, drugs and rock 'n' roll

from a NY Times article in October.

The Plutocrats Strike Back

However, increasingly those in the one percent are willing to be open. In late December a Bloomberg article documented the sentiments of a number of finance and other corporate leaders.

- Jamie Dimon, CEO of JP Morgan Chase, complained:

Acting like everyone who's been successful is bad and because you're rich you're bad, I don't understand it.

- Bernard Marcus, founder of Home Depot:

Who gives a crap about some imbecile? Are you kidding me?

- John A Allison IV, Chairman of BB&T:

'Instead of an attack on the 1 percent, let’s call it an attack on the very productive,' Allison said. 'This attack is destructive.'

- Stephen Schwarzman, CEO of the Blackstone Group:

'You have to have skin in the game,' said Schwarzman, 64. 'I’m not saying how much people should do. But we should all be part of the system.'

- John Paulson, President of hedge fund Paulson & Co:

has also said the rich benefit society.

'The top 1 percent of New Yorkers pay over 40 percent of all income taxes,...'

- Tom Galisano, founder of Paychex Inc:

If I hear a politician use the term ‘paying your fair share’ one more time, I’m going to vomit

- Ken Langone, founder of Home Depot:

I am a fat cat, I’m not ashamed

Considering how Paul Krugman explained the generation of the global financial collapse by

people who got rich by peddling complex financial schemes that, far from delivering clear benefits to the American people, helped push us into a crisis whose aftereffects continue to blight the lives of tens of millions of their fellow citizens.

Yet they have paid no price. Their institutions were bailed out by taxpayers, with few strings attached. They continue to benefit from explicit and implicit federal guarantees — basically, they’re still in a game of heads they win, tails taxpayers lose. And they benefit from tax loopholes that in many cases have people with multimillion-dollar incomes paying lower rates than middle-class families.

Thus the responses by the very rich above only represent some or more arrogance.

The Plutocrats as Health Care Leaders

One wonders how much this arrogance carried over into health care. We have noted previously how the leadership of finance has increasingly overlapped the leadership of health care, and how top executives increasingly seem to identify more with each other than with their employees, customers, or other stakeholders. Therefore, it should be no surprise that all but one of the group above also had or have leadership roles in health care organizations.

- Jamie Dimon is on the board of trustees of the New York University Langone Medical Center.

- Bernard Marcus formerly served as the chair of the board of the CDC Foundation.

- John A Allison IV is a member of the board of visitors of Wake Forest University Baptist Medical Center, per his BB&T Corp official biography.

- Stephen Schwarzman's Blackstone Group includes the Blackstone Healthcare Group, which invests in various health care corporations (as of 2010, Nycomed, Gerresheimer, Stiefel Laboratories, and Catalant per this press release), and all of whose members serve on one or more boards of directors of health care corporations (per the press release, Arthur Higgins serves on the boards of Zimmer, Eco Labs, and Resverlogix Corp; Lodewijk J R de Vink serves on the board of Roche; Doug Rogers serves on the boards of Codevax, Charles River Laboratories, and Computerized Medical Systems.)

- John Paulson is on the board of trustees of New York University,

- Kenneth G Langone, is vice chair again of the board of trustees of New York University, and chair of the board of trustees of the NYU Langone Medical Center.

I submit that linking their sentiments above to their leadership roles in health care should be highly disconcerting. Do we want people running medical centers who are proud to be "fat cats?" Do we want people running medical centers who do not understand why people who have lost income, retirement funds, jobs or their homes might be upset? Do we want people running health care corporations who do not think the poor and middle-class have any skin in the economic game? Do we want people running health care foundations who think that those who complain about the current economic situation are "imbeciles?"

Summary

The problems of health care increasingly seem to be a part of the larger problems with the global political economy. The problems we have been discussing that affect health care leadership seem to have come out of the culture of what now many are calling the larger plutocracy.

So it now seems that true health care reform will require a larger reform of the political economy. However, we still need leaders who understand the health care context, uphold health care professionals' values, and put patients first. We do not need leaders who are ill-informed, incompetent, self-interested, conflicted, or corrupt. We need governance that is accountable, honest, transparent, ethical, and again puts patients first.

IT Malpractice? Yet Another "Glitch" Affecting Thousands of Patients. Of Course, As Always, Patient Care Was "Not Compromised."

2011-12-28T13:14:00.105-05:00

At 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" I wrote:

There's been yet another health IT "glitch" that, of course, caused no patients to be harmed. See other "glitches" here, here, here and at other posts which can be found by searching this blog on the banal term 'glitch'.

Add another case to the health IT glitch file, under the "do we feel lucky today?" patient risk category.
From the Pittsburgh Post-Gazette (I am quoted):

Computer outage at UPMC called 'rare' Systemwide disruption potentially dangerous, expert warns Saturday, December 24, 2011 By Jonathan D. Silver, Pittsburgh Post-Gazette

UPMC's electronic medical records system for inpatients went offline for more than 14 hours at nearly all its hospitals in the region, marking what the health system called a "rare" outage, but one that it claims did not harm patients.

First, as my aforementioned Nov. 2011 post and its contained links point out, these events are not as "rare" as they should be. (The asteroid colliding with Earth that caused the extinction of the dinosaurs - now that's a "rare" event.)

Second, as multiple posts on this blog have pointed out, the claims that "no patients were harmed" is both misleading and irrelevant:

Such claims of 'massive EHR outage benevolence' are misleading, in that medical errors due to electronic outages might not appear for days or weeks after the outage, depending on what information was corrupted/lost/misindentified/or otherwise mishandled after it is 'backloaded' once the system is up. All it takes is one med lost to cause misery and death. (I can speak about that from unfortunate personal experience.)

Claims of 'massive EHR outage benevolence' are also irrelevant in that, even if there was no catastrophe directly coincident with the outage, their was greatly elevated risk. Sooner or later, such outages will maim and kill.

The outage affected a system designed by Cerner Corp., a global electronic records company, and customized by UPMC that doctors and nurses rely on for communication about patient records, medical orders and prescriptions.

It was unavailable from about 8:45 p.m. Thursday to 11 a.m. Friday at almost all of UPMC's hospitals except for Children's and UPMC Hamot in Erie, spokeswoman Wendy Zellner said.

"This is rare. This kind of widespread, extensive downtime would be rare," Ms. Zellner said.

Doctors and nurses continued to have access to patients' electronic records through backup systems, she said. They also had to resort to using old-fashioned paper records for documentation and orders.

"These things happen. They have really well spelled-out procedures for what to do when something goes down," Ms. Zellner said.

She acknowledged that doctors and nurses faced some challenges.

Faced 'some challenges?' In other words, care was compromised by the outage and the 'challenges' were to avoid medical error (and, of course, to make sure billing was unaffected):

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

Thousands of patients were affected, again reinforcing my point about how IT can and does greatly amplify the risks of paper -- as in my Rhode Island post -- such as errors and confidentiality breaches.

I cannot, for example, think of a single instance where thousands of paper records went unavailable simultaneously (unless, that is, someone lost the key to the Medical Records department), were made available to identity thieves en masse, or where thousands of medical orders were scrambled or truncated in a relatively short period of time as in Rhode Island.

These amplified risks could wipe out any advantages of EHR's over paper in a microsecond.

A partial list of facilities apparently affected in this latest episode of EHR mayhem, from this list:

Magee-Womens Hospital of UPMC
UPMC Bedford Memorial
UPMC East
UPMC Horizon
UPMC McKeesport
UPMC Mercy
UPMC Montefiore
UPMC Northwest
UPMC Passavant
UPMC Presbyterian
UPMC Shadyside
UPMC St. Margaret
Western Psychiatric Institute and Clinic of UPMC

That accounts for several thousand active patients, I am sure.

(12/28 Addendum: Bed counts of PA hospitals are here. Searching on "University of Pittsburgh Medical Center", it can be seen that thousands of beds were indeed involved.)

"Whenever people aren't working in their native system and workflow I have to believe that is more cumbersome for the clinicians, but these folks are well-trained in what to do when these things happen."

This seems at best an insensitive and perhaps even inhumane bit of P.R. More "cumbersome" for the clinicians? What about the poor patients? How would Ms. Zellner feel, I wonder, if it were her mother, child or significant other on the Operating Room table or having an acute MI when the EHR/CPOE systems went down?

Ms. Zellner said UPMC's public relations staff was unaware of the outage until contacted by a reporter.

It appears P.R. is not very high on the list for receiving information when a crisis arises. I may have known of the outage before they did.

The outage was caused by a "bug" or glitch in software designed by a vendor affiliated with Cerner, Ms. Zellner said. She refused to identify the company.

"We're not trying to point fingers at different vendors. It's a database bug, that's all I can tell you."

(That is, it's not our fault, it's the fault of the database vendor. Hospitals, I regret to inform you - you are responsible for unapproved medical devices used in your facilities, no matter what the source.)

And there's that word "glitch" again, accompanied by the equally banal "bug."

It's just a "bug." Cute little critter!

Me again in the Post-Gazette:

Scot M. Silverstein, a doctor and assistant professor Healthcare Informatics at Drexel University in Philadelphia, disagreed with the use of the terms "bug" and "glitch."

"What occurred here was a disruptive, potentially dangerous major malfunction of a life-critical enterprise medical device," he said.

Somehow, when a clinician makes a mistake, the terms "bug" and "glitch" are never used. In fact, when clinicians fail to meet accepted professional standards of healthcare practice, it is called "malpractice."

I think we can all agree that a major near-full-day outage of an enterprise EHR affecting multiple hospitals and thousands of patients does not meet accepted professionals standard of life-critical computing practice. Yet, all this merits is the word "glitch." It seems to me that if patients are harmed by, in reality, what is (on its face) IT malpractice during such events, not only the clinicians affected should be held liable.

Ms. Zellner said the problem was not a "crash" of the system because there were alternate methods used to cope that prevented patient care from being compromised.

The usual refrain. Let me repeat my definition of "compromised:"

Compromised -

a. To expose or make liable to danger, suspicion, or disrepute

b. To reduce in quality, value, or degree; weaken or lower.

A simple question - if extended EHR outages like this never seem to "compromise" care, then why not eliminate health IT entirely and spend the hundreds of millions saved on patient care?

"This is not a crash of Cerner either," Ms. Zellner said. "I think a crash is, 'Oh my God, the sky is falling,' nobody can get anything."

I leave it to the readers to ascertain the computer expertise levels and reasonableness of what Ms. Zellner thinks a "crash" is.

Technicians from UPMC, Cerner and the third company [the 'mystery' database company? - ed.] worked together on-site to identify and fix the problem. Ms. Zellner said she did not know why it took 14 hours to fix and the underlying cause was still unclear.

"They know what the problem is and I believe it's been fixed, but we really don't know what triggered it," Ms. Zellner said. "I think the next step would be some actual software upgrades."

They "don't know what triggered the 'problem'" - is a proper translation that they have no idea what went wrong?

In fact, regarding another Cerner EHR system which was extensively studied (see "A Study of an Enterprise Information System" at this link), Dr. Jon Patrick came to the conclusion that one of the sources of catastrophic failures is poor software engineering that has made the behavior of the studied system "non-deterministic." Further, software upgrades are not protected from incremental changes made by maintenance and customization staff, and may introduce even more instability.

A software upgrade without clearly understanding "what triggered the problem" is simply asking for more trouble. (My bet, however, is that they attempt it anyway.)

A Cerner representative could not be reached for comment.

What's to say?

How about this:

Dr. Silverstein said based on what he was told about the computer outage, it means that hospital medical staff would have been unable to update patient charts and probably would not have been able to issue any orders through the system during the time it was off line.

He also questioned how up-to-date the hospital's redundant records were.

Repeating UMPC's statement from the article that appeared after I gave my quotes to the reporters: "Doctors and nurses continued to have access to patients' electronic records through backup systems, [the UPMC spokesperson] said. They also had to resort to using old-fashioned paper records for documentation and orders."

My stated fears of disruption and increased risk due to compromised care seem well-grounded.

In May, Allegheny General Hospital had to shut its electronic medical records computer system down because of problems with the vendor's hardware.

The hospital used backup procedures to continue care for patients, including using paper orders and record-keeping.

Wait ... I thought I'd heard these events were "rare." Two in the same city within six months?

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

Truth be told:

The primary rule in computing is:

Either you are in control of your information systems, or they are in control of you.

Clearly the latter was the case here.

The following questions arise:

Was the software containing the "bug" properly vetted before being used on live patients? This is not just the vendor's obligation.
If it was not vetted properly, why not?
Was it an "upgrade" or patch? (If so, the same vetting rules apply.)

Further, the soft-selling of these incidents must end. The use of terms such as "bug" and "glitch" must also end. What occurred here, echoing my newspaper quote, was a disruptive, potentially catastrophic major malfunction of a life-critical enterprise medical device.

System-wide EHR crashes are not merely ‘glitches’ or ‘bugs.’ They need to be considered, as in medicine itself, as 'never events.' From AHRQ:

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable.

Further, re: "patient care was never compromised." How do they know that? In fact, this is 'spin' and word games on its face. By definition, if CPOE and chart updating was unavailable, patient care was compromised, where "compromised" means "increased levels of risk for error were created, requiring workarounds."

Further, as mentioned earlier, harms might not show up for some time. Lost orders, corrupted data, errors of omission or commission transcribing backup paper records into the computer ("backloading"), etc. can take their toll later. Post-outage vigilance is essential, putting even more stress on clinicians that increases likelihood of further error and that they certainly do not need. Clinicians are stressed enough already.

Finally:

IT personnel have not only deliberately inserted themselves into clinical affairs (e.g, via the HITECH Act of 2009), they have also done so with a stunning arrogance and unproven braggadocio about their systems "revolutionizing" medicine (whatever that means).

Indeed, they need to accept the medical responsibility and obligations this territorial intrusion entails.

On its face, this massive outage was the result of issues that did not meet accepted professional standards of IT practice for life-critical environments. Res ipsa loquitur.

Something was not vetted properly, there was a lack of redundancy, the IT personnel were NOT in control of their systems.

Just as when physicians don't provide care that meets accepted professional standards of healthcare, this incident and others like it are, by definition, a result of IT malpractice.

If patients are harmed, IT personnel and their management (often non-IT C-level officers) involved in this system need to be held accountable.

If they can't take the clinical heat (as clinicians do daily since the time they enter medical or nursing school), then they need to get out of the clinical kitchen.

-- SS

Note: see this take on these matters at the HIStalk blog:

UPMC’s Cerner systems go down for 14 hours at most campuses last Thursday and Friday, forcing them to go back to paper. The PR person blamed “a database bug,” which makes the above Oracle press release from this past summer a particularly fun read. Cerner and UPMC have an atypical vendor-customer relationship since they’ve invested big money together in innovation projects and UPMC runs a Cerner implementation business overseas.

Now we know who the unnamed "mystery database vendor" is...

-- SS

Dec. 29, 2011 Addendum:

Was UPMC acting as a "proving ground" for some Oracle-Cerner-UPMC experimental health IT technology that resulted in the crash? The claim of being an IT "proving ground" has been made in the past:

Pittsburgh Tribune
May 2, 2006
UPMC partners with technology provider

The University of Pittsburgh Medical Center is taking another step in a quest to commercialize new medical technology.

UPMC on Monday signed a three-year deal with health care information technology provider Cerner Corp. to develop and market medicine-related technological advances. Both parties will contribute $10 million in cash, services and intellectual property to the effort.

The deal is a smaller version of an April 2005 deal between UPMC and information technology behemoth IBM.

As is the case in the IBM deal, UPMC will serve as a built-in proving ground for jointly developed technologies and products, with Cerner marketing the products and UPMC awarded a share of profits.

As I wrote at "Proving Ground for IT Tests On Children: Pioneers in Health IT, or Pioneers in Ignoring the Past?":

"A hospital and patients are not a learning lab for HIT vendors. The appropriate "proving ground" for new medical technology is the controlled clinical trial where participants (in this case, patients and healthcare professionals alike) have freedom of choice whether or not to participate, and a chance to give (or deny) consent after being fully informed of potential risk."

This is a fundamental human rights issue.

-- SS

Legal Settlements Have Become So Common that They are Barely News

2011-12-28T12:06:00.000-05:00

Legal settlements by big health care organizations have become so common that those of less than blockbuster size barely seem to qualify as news. They have become "dog bites man" stories. For example, the following stories barely got noticed in the media (presented chronologically).

Novartis Settles Price Misrepresentation Suit for $150 Million

This story was mentioned as an aside in a a news story covering a settlement by Watson Pharmaceuticals in September. In slightly more detail, it has only appeared in PharmaLot in November. In a very small nutshell,

the Sandoz unit of Novartis earlier this week agreed to pay $150 million to settle lawsuits filed by the states of Florida and California, as well as a whistleblower, to settle charges that it deliberately misreported pricing information in order to hike reimbursements from Medicaid.

By the way, per the settlement document, the allegations were that Novartis' subsidiary knowingly maintained, set or reported "false, fraudulent, and/or inflated Reported Prices," yet, as is typical of nearly all settlements, the settlement "shall not constitute or be construed as an admission of fault, liability, or unlawful conduct."

Roche Settles Off-Label Promotion, Physician Kickback Suit for $20 Million

This story was reported briefly in some blogs, including again PharmaLot, and in the most detail in the San Francisco Business Times. The basics of it were:

Genentech Inc. will pay $20 million to settle a whistleblower lawsuit around off-label marketing of the cancer-fighting drug Rituxan.

It only took eight years since a whistle-blower raised the issue:

John Underwood, ... was a senior manager of sales development from the start of Genentech’s oncology franchise in 1997.

When Underwood filed the suit in July 2003 in U.S. District Court for the Eastern District of Pennsylvania, he was a senior hospital systems specialist for Genentech.

This suit is actually of particular interest because it was not just about off-label promotion,

Genentech, the suit claimed, retained doctors to act as independent speakers on behalf of Rituxan and its off-label uses, paid kickbacks to doctors that were disguised as consulting payments, 'exerted significant pressure' on sales reps to increase off-label uses of Rituxan, and devised and conducted 'selling skills workshops' for sales reps devoted to non-label uses,

What’s more, the suit claimed, Genentech invited doctors to attend “medical education seminars” at 'luxurious locations' and gave financial incentives to sales reps to get doctors who sold the most Rituxan to attend the events.

These were serious allegations, involving allegedly direct efforts by the company to subvert physicians' ethics by tying their decisions for individual patients to payments for prescribing specific products whatever the benefits and risks of those products for those patients. The allegations suggested that "consulting payments" to physicians may be nothing more than disguised bribes, and that the companies making these payments may be quite conscious of this.

Nonetheless, as usual,

Genentech, the South San Francisco-based U.S. subsidiary of Swiss drug giant Roche, did not admit wrongdoing....

So, as in the famous recent Citigroup case (see this post), the settlement obfuscates the crucial question, did the corporation involved commit illegal acts? It seems likely that what they did was in some sense unethical, since they were willing to pay millions not make the matter go away.

By the way, one member of the Executive Committee of Genentech at the time these events were allegedly occurring is now the Chancellor of the University of California - San Francisco (See our post here). Maybe concerned students or faculty might ask her what really went on.

CVS Caremark Settles Fraud Suit for about $20 Million

As reported briefly in the Los Angeles Times,

Pharmacy and prescription drug management company CVS Caremark Corp. has agreed to pay nearly $20 million to settle three lawsuits involving allegations that the company defrauded pension systems in three states, including California’s giant pension fund, attorneys said.

The whistleblower lawsuits, filed by two former CVS Caremark pharmacists, accused the company of reselling returned drugs, changing prescription orders to make them more expensive and submitting false reports about how long it took to fill prescriptions.

Not the least bit surprisingly, the company did not admit liability in the settlement, and had no comment for the Times. Ho, hum, another big company paying millions to make allegations of fraud go away... nothing to see here, so we will just move on.

Merck Settles Fraud Suit for $24 Million

This story was picked up by AP, so a very brief version of it did appear in a variety of locations. A longer version was published by the Boston Globe,

At this point, it should be no surprise that it took a long time to get to this settlement, eight years in fact, just as in the case above,

Merck & Co. has agreed to pay $24 million to the state Medicaid program to settle long-running civil charges that it charged too much for some drugs, in the largest single-case Medicaid fraud settlement in Massachusetts history.

The agreement, unveiled yesterday by Attorney General Martha Coakley’s office, closes out a 2003 lawsuit....

Again, the allegations were of fraud,

Coakley said her office’s Medicaid fraud division wanted to hold accountable drug companies that defraud taxpayers.

Again, "hold accountable" did not translate into establish the allegations as true,

Ron Rogers, a spokesman at Merck corporate headquarters, said the drug company did not admit liability or wrongdoing in the settlement. He said Merck agreed to resolve the claims to put the matter behind it.

Nothing more to see here, so we will move on again.
Summary

Every month, it seems that more settlements are announced of cases alleging all sorts of wrongdoing by major health care organizations. Very often, the allegations are of wrongdoing that appears serious to the uninitiated. For example, most of the above cases involved allegations of fraud, and one involved allegations of kickbacks, that is, bribes to doctors.

Yet, in every one of these cases -
- The monetary penalties were barely more than pocket change for the corporations involved.
- The payments were made by the organization as a whole, and hence would disadvantage many people who were not involved in and did not benefit from the specific actions alleged. Such de facto victims of the settlement included company shareholders, employees, and probably patients (who may have paid prices raised to pay for settlements), and the public (who may have indirectly paid these higher prices through insurance premiums or taxes.)
- The organization did not have to admit any facts, leaving the record foggy, and clouding the chances for any people who might have been hurt by the actions to take legal action.
- No people who actually authorized, directed, or implemented the apparent bad behavior suffered any negative consequences.

Thus, these settlements, like many others we have discussed, did not appear to be any major deterrent of future bad behavior.

These settlements do provide a public, if largely ignored, record that suggests how a miasma of sleazy behavior, if not outright corruption has settled over health care. These settlements do provide the context for many pithy questions that could be asked of health care organizational leaders, if anyone dared to do so. The settlements do suggest a need for wholesale, real health care reform that would make health care leaders accountable for what their organizations do, particularly when these organizations misbehave.