Arguments with Pavlov's Dogs: Health IT Regulation Will "Harm Innovation"? How, exactly?

Health IT hyper-enthusiasts, when faced with the prospect of government regulations, react like Pavlov's dogs with the response "regulation of health IT will harm innovation."

Here's a soliloquy of critical questions that need be asked:

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

Now, Mr. (or Dr.)  Hyper-Enthusiast, you state HIT regulation will harm innovation.

What aspects of regulation, specifically, will harm innovation?

Good manufacturing processes (GMPs)?

Building a safety case for review and inspection?

Pre-market safety/fitness/quality/reliability testing?

Post-marketing surveillance?

What?

Innovations happen before regulatory evaluation, do they not?

What, exactly, are your objections to safety and quality testing of innovations?

Don't innovations need to be tested for safety and quality?

If innovations are not safe, should they not be used on live patients?

How can the industry with its conflicts of interest effectively regulate HIT?

Even if it could, again, how would additional regulatory oversight harm innovation?

----------------------- 

And perhaps this needs to be asked as well:

• Don't you really mean regulation would harm the bottom line?

-- SS

Hospital Retaliation Against Outspoken Physician Reaches New Levels - La Cosa Nostra Levels, That Is

Physicians, take note:

The Advisory Board Company
Feb. 14, 2013  
Hospital Framed Physician; Planted a Gun

A jury has ordered a California hospital chain to pay physician Michael Fitzgibbons $5.7 million after its former CEO allegedly framed him by planting a gun in his car.

In 2006, Fitzgibbons—an infectious disease specialist and former chief of staff at Western Medical Center—was arrested in the hospital parking lot after police found a pair of black gloves and a handgun in his car. Police questioned Fitzgibbons and searched his car after an anonymous 9-1-1 call claimed that the doctor had brandished the gun in traffic.

DNA evidence from the gloves and gun exonerated Fitzgibbons, and he was never charged.

However, the arrest followed a series of disagreements between Fitzgibbons and the leadership of Integrated Healthcare Holdings Incorporated (IHHI), which owned the Santa Ana hospital. Fitzgibbons and his attorney—Ted Mathews—alleged that IHHI's then-CEO, Bruce Mogel, had framed Fitzgibbons in an effort to silence him.

Specifically, Mathews said that the frame was part of Mogel's attempt to "humble" Fitzgibbons after the doctor won a legal victory over IHHI in June 2006.

During the trial, former IHHI President Larry Anderson testified that Mogel had instructed him to create a $10,000 contract for a "scary guy" named Mikey Delgado immediately after Fitzgibbon's legal victory. The contract was for unnecessary work on the health system's website. In his testimony, Anderson said he realized after Fitzgibbons was arrested that the contract was actually for the frame. Mathews told the jury that the $10,000 was used to "[get] Dr. Fitz set up."

IHHI's board learned of the $10,000 contract during Anderson's deposition in 2008. Instead of firing Mogel, the board awarded him an eight-month consultancy worth $43,750 per month, Mathews says. This showed that IHHI board "knew what Mogel did to Dr. Fitzgibbons," Mathews told the jury, adding, "They ratified it, and they gave him a golden handshake goodbye.

The article notes Board acquiescence.

Two questions come to mind:

1.  Have the involved people been permanently removed from positions of authority in healthcaree?

2.  Have the persons involved been charges criminally?

Shocking.  Positively shocking.

-- SS

Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI "Deep Dive" Study of Health IT "Events"

FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   See links to source here and to the FDA Internal Memo on HIT risk - labeled "internal document not intended for public use" and unearthed by investigative reporter Fred Schulte several years ago - here (PDF).

At my Feb. 9, 2013 post "A New ECRI Institute Study On Health Information Technology-Related Events" I opined that a new ECRI study was beginning to peer beneath the waterline of Jeff Shuren's iceberg tip, at what may reside underneath that waterline.  Iceberg tips, needless to say, are usually tiny compared to the iceberg's overall size.

Reporter Kevin O'Reilly at AMNews (amednews.com) has now written about that ECRI report.

The results of the report are concerning:

 Ways EHRs can lead to unintended safety problems

Wrong records and failures in data transfer impede physicians and harm patients, according to an analysis of health technology incidents.

By Kevin B. O'Reilly, amednews staff, posted Feb. 25, 2013.

In spring 2012, a surgeon tried to electronically access a patient’s radiology study in the operating room but the computer would show only a blue screen. The patient’s time under anesthesia was extended while OR staff struggled to get the display to function properly.

That is just one example of 171 health information technology-related problems reported during a nine-week period to the ECRI Institute PSO, a patient safety organization in Plymouth Meeting, Pa., that works with health systems and hospital associations in Kentucky, Michigan, Ohio, Tennessee and elsewhere to analyze and prevent adverse events.

Eight of the incidents reported involved patient harm, and three may have contributed to patient deaths, said the institute’s 48-page report, first made privately available to the PSO’s members and partners in December 2012. The report, shared with American Medical News in February, highlights how the health IT systems meant to make care safer and more efficient can sometimes expose patients to harm.

 Mar. 1, 2013 addendum.  From ECRI, the denominator is this:

Participating facilities submitted health IT related events during the nine-week period starting April 16, 2012, and ending June 19, 2012. ECRI Institute PSO pulled additional health IT events that were submitted by facilities during the same nine-week period as part of their routine process of submitting event reports to ECRI Institute PSO’s reporting program. The PSO Deep Dive analysis consisted of 171 health IT-related events submitted by 36 healthcare facilities, primarily hospitals.   [I note that's 36 of 5,724 hospital in the U.S. per data from the American Hospital Association (link), or appx. 0.6 %.  A very crude correction factor in extrapolation would be about x 159 on the hospital count issue alone, not including the effects of the voluntary nature of the study, of non-hospital EHR users, etc.  Extrapolating from 9 week to a year, the figure becomes about x 1000.  Accounting for the voluntary nature of the reporting (5% of cases per Koppel), the corrective figure approaches x20,000.  Extrapolation of course would be less crude if # total beds, degree of participant EHR implementation/use, and numerous other factors were known, but the present reported numbers are a cause for concern - ed.]

Sept. 2013 addendum: 

Health Leaders Media has more on the ECRI Deep Dive study at http://www.healthleadersmedia.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI:

HIT Errors 'Tip of the Iceberg,' Says ECRI
Cheryl Clark, for HealthLeaders Media , April 5, 2013

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.

Computer programs truncated dosage fields, leading to morphine-caused respiratory arrest; lab test and transplant surgery records didn't talk to each other, leading to organ rejection and patient death; and an electronic systems' misinterpretation of the time "midnight" meant an infant received antibiotics one dangerous day too late.

These are among the 171 health information technology malfunctions and disconnects that caused or could have caused patient harm in a report to the ECRI Institute's Patient Safety Organization.

... The 36 hospitals that participated in the ECRI IT project are among the hospitals around the country for which ECRI serves as a Patient Safety Organization, or PSO.

The 171 events documented, break down like this:

• 53% involved a medication management system.
  • 25% involved a computerized order entry system
  • 15% involved an electronic medication administration record
  • 11% involved pharmacy systems
  • 2% involved automated dispensing systems
• 17% were caused by clinical documentation systems
• 13% were caused by Lab information systems
• 9% were caused by computers not functioning
• 8%. Were caused by radiology or diagnostic imaging systems, including PACS
• 1% were caused by clinical decision support systems

Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

As at the opening of this post, "tip of the iceberg" is a phrase also used by FDA CDRH director Jeffrey Shuren MD JD regarding safety issues with EHRs and other health IT.

Along those lines, at my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" I proposed a "thought experiment" to theoretically extrapolate limited data on health IT risk to a national audience, taking into account factors that limited transparency and thus reduced known injury and fatality counts. The results were undesirable, to say the least - but it was a thought experiment only.

Using the current data, coming from a limited, voluntary set of information over 9 weeks, I opine that the results of an extrapolation to a national (or worldwide) level, in an environment of rapidly increasing adopters (many of whom are new to the technology), on an annual basis, not a mere 9 weeks - would not look pretty.

The institute’s report did not rate whether electronic systems were any less safe than the paper records they replaced. The report is intended to alert hospitals and health systems to the unintended consequences of electronic health records.

Ethically, this is really not relevant towards national rollout, especially with penalties beginning to accrue to non-adopters of HHS "Certified" technology in a few years.

As I've written on this blog, medical ethics generally do not condone experimentation without informed consent, especially when the experimental devices are of unknown risk. Not knowing the risks of IT, it really doesn't matter, ethically, what the safety of paper is.  "Hope" is not a valid reason for medical experimentation.  (See below for what a PubMed search reveals about risks of paper records.)

The unspoken truth prevalent in healthcare today seems to be this:  the sacrifice of individual patients to a technology of unknown risk is OK, as long as - we hope -  it advances the greater good.    Perhaps that should be explicitly admitted by the HIT industry's hyper-enthusiast proponents who ignore the downsides, so the spin can be dropped and there can be clarity?

The leading cause of problems was general malfunctions [also known by the benign-sounding euphemism "glitches" - ed.]  responsible for 29% of incidents. For example, following a consultation about a patient’s wounds, a nurse at one hospital tried to enter instructions in the electronic record, but the system would not allow the nurse to type more than five characters in the comment field. Other times, medication label scanning functions failed, or an error message was incorrectly displayed every time a particular drug was ordered. One system failed to issue an alert when a pregnancy test was ordered for a male patient. [These 'general malfunctions' are thus not just computer bugs undetected due to inadequate pre-rollout testing, but also examples of design flaws due to designer-programmer-seller-buyer-implementer lack of due diligence, i.e.,  negligence - ed.]

A quarter of incidents were related to data output problems, such as retrieving the wrong patient record because the system does not ask the user to validate the patient identity before proceeding. This kind of problem led to incorrect medication orders and in one case an unnecessary chest x-ray. Twenty-four percent of incidents were linked to data-input mistakes. For example, one nurse recorded blood glucose results for the wrong patient due to typing the incorrect patient identification number to access the record.  [Many of these are likely due to what NIST has termed "use error" - user interface designs that will engender users to make errors of commission or omission - as opposed to "user error" i.e., carelessness - ed.]

Most of remaining event reports were related to data-transfer failures, such as a case where a physician’s order to stop anticoagulant medication did not properly transfer to the pharmacy system. The patient received eight extra doses of the medication before it was stopped. [Due to outright software, hardware and/or network problems and defects - ed.]

I've been writing about such issues since 1998, not because I imagined them.  As a CMIO I saw them firsthand; as teacher and mentor I heard about them from colleagues; as a writer I heard about them via (usually unsolicited) emails from concerned clinicians; as an independent expert witness on health IT harms I've heard about them from Plaintiff's attorneys, but not from the Defense side of the Bar as yet.  Of course the reasons for that are understandable -  albeit disappointing.

In fact, robust studies of a serious issue - the actual risks of paper towards harm causation - and further, whether any of the issues are remediable without spending hundreds of billions of dollars on IT - seem scarce.  I've asked the PA Patient Safety Authority about the possibility of using data in the Pennsylvania Patient Safety Reporting System (PA-PSRS) database, just as they did for EHR-related medical events, to determine incidence of paper-related medical events.  They are pondering the issue.

As an aside, I note that it would be ironic if the relative risks of both IT and paper were not really robustly known.  (I note that in a PubMed search on "risks of paper medical records", not much jumps out.)  IT hyper-enthusiasts will not even debate the issue of studying whether a good paper system might be safer for patients in some clinical environments than bad health IT.

Considering the tremendous cost and unknown risk of today's health IT (and perhaps the unknown risk of paper, too), would it not make more sense, and be consistent with the medical Oath, to leave paper in place where it is currently used - and perhaps improve its performance - until we "get the IT right" in controlled, sequestered environments, prior to national rollout?

In other words, as I've asked before on these pages, should we not slow down the IT push and adhere to traditional (and hard-learned) cautions on medical research?

Even asking such questions brings forth logical fallacies such as straw arguments (e.g., UCSF's Bob Wachter in a recent discussion I initiated with several investigative reporters: "...where we part ways is your defense of paper and pencil. I understand advocacy, and you have every right to bang this particular drum"), ad hominem attacks, etc.

... It is not enough for physicians and other health care leaders to shop carefully for IT systems, the report said. Ensuring that systems such as computerized physician order entry and electronic health records work safely has to be a continuing concern, said Karen P. Zimmer, MD, MPH, medical director of the ECRI Institute PSO.

“Minimizing the unintended consequences of health IT systems and maximizing the poten­tial of health IT to improve patient safety should be an ongoing focus of every health care organization,” she said.

I recommended that clinicians take matters into their own hands if their leaders do not, as at the bottom of my post here.  This advice bears repeating:

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

(DISCLAIMER:  I am not responsible for any adverse outcomes if any organizational policies or existing laws are broken in doing any of the following.)

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

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

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

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

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

• Inform the appropriate Board of Health for your locale.

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

• Inform a personal attorney.

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

• As clinicians are often forced to use health IT, at their own risk even when "certified" (link), if a healthcare organization or HIT seller is sluggish or resistant in taking corrective actions, consider taking another risk (perhaps this is for the very daring or those near the end of their clinical career). Present your organization's management with a statement for them to sign to the effect of:

"We, the undersigned, do hereby acknowledge the concerns of [Dr. Jones] about care quality issues at [Mount St. Elsewhere Hospital] regarding EHR difficulties that were reported, namely [event A, event B, event C ... etc.]

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

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

CMO __________ (date, time)
CIO ___________ (date, time)
CMIO _________ (date, time)
General Counsel ___________ (date, time)
etc."

• If the hospital or organizational management refuses to sign such a waiver (and they likely will!), note the refusal, with date and time of refusal, and file away with your attorney. It could come in handy if EHR-related med mal does occur.

• As EHRs remain experimental, I note that indemnifications such as the above probably belong in medical staff contracts and bylaws when EHR use is coerced.

These recommendations still stand, although after this recent story, my caution about retaliation should be re-emphasized:

The Advisory Board Company
Feb. 14, 2013
Hospital Framed Physician; Planted a Gun

-- SS

Another Reason for Hope? - Concern about Excessive Executive Pay in Health Care Goes Mainstream

Another recent case suggested that the problem of excess, disproportionate compensation of health care executives is becoming more of a mainstream concern. 

The Case of Eastern Connecticut Health Network

The case appeared in the Manchester (CT) Journal-Inquirer (link requires subscription).  Here are the basics:

ECHN Inc., which owns Mancester Memorial and Rockville General hospitals, reported to the IRS last year that the company paid its president and CEO, Peter J Karl, a total of $1,042,200 in salary and fringe benefits.  That's a 30.7 percent increase over Karl's compensation reported in the previous year,....

ECHN also reported that six other top executives were paid between $254,640 and $591,090, representing increases of as much as 20.6 percent. 

ECHN is yet another relatively small non-profit hospital system with a million dollar plus CEO.

For comment on this, I turn back to the Journal-Inquirer article.  One person the reporter interviewed

says the big salaries and bonuses paid to top officials at Eastern Connecticut Health Network are part of a national scandal over executive compensation propelled by the 'pursuit of talent for short-term gains.'

'The hospital industry is emblematic of what's happened in executive compensation in the United States, where the multiple of the lowest- paid employee to get to the salary of the highest-paid employee has just exploded over the last 30 years,'....

Furthermore, the person interviewed noted that hospital executives were bemoaning decreases in payments to their institutions by state government "while making 10 to 20 times as much money as" the state governor makes.  In this case, the CEO, Mr Karl's "compensation package was 6.9 times [Governor Daniel P] Malloy's salary of $150,000."

A second person interviewed said

Salaries have gotten to the point where they have skyrocketed and are out of control.

He also raised an issue about conflicts of interest affecting the ECHN board

he agreed with state health care advocate, Victoria Veltri, who told the Journal Inquirer last week that nearly $1 million in business deals between ECHN and five members of its board of trustees require further scrutiny

Criticism from the Mainstream

I have been coy about who the commentators were, but bear with me.

So we see in this one somewhat obscure newspaper article about one small regional hospital system points that we have been raising for years about the perverse incentives generated by excess executive compensation in health care.  We have frequently discussed how such compensation is often completely untethered to the organizations' financial results, much less its positive effects on patients' and the public's health.  Compensation often rises faster than inflation, faster than revenue (and sometimes when revenue declines and deficits loom), and even when the organization is facing financial, clinical, or ethical challenges.  Thus it often seems that the primary goal of the organization has become enriching top executives (look here for a recent example).  As the first commentator noted above, this seems to arise out of the business school dogma that puts short-term revenue ahead of all other goals (which we discussed here, and can be termed financialization.)

But our concerns do seem to be getting more mainstream.  The first commentator above was actually the Governor of Connecticut, Dannel P Malloy, himself.  The second commenter was Connecticut state Senator Steve Cassano.  So prominent politicians are beginning to see the perversity of excess executive compensation in health care at a time of still burgeoning health care costs and still threatened health care access and quality. 

So maybe some more people will listen this time when we repeat....  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.

Reason for Hope? - Novartis Rescinds Vasella's Golden Parachute

Enormous compensation of hired health care executives, out of all proportion, if related at all to whether their work had any positive effect on patients' or the public's health, has long been a concern on Health Care Renewal.  For example, back in 2006, we posted repeatedly (look here for links) about the billion dollar plus fortune amassed by the then CEO of UnitedHealthcare which vividly contrasted with the company's avowal to "make health care more affordable."

We have posted many such stories.  Yet maybe there is a whiff of change in the air.  For the first time that I can recall, a gigantic pay package to a top health care executives has been rescinded after public protest.

Novartis' Golden Parachute for Vasella

This is how the New York Times described the huge golden parachute that was initially proposed:

A plan by Novartis, one of Switzerland’s biggest drug makers, to pay its departing chairman $78 million to keep him from sharing his knowledge with competitors has added fuel to an already heated debate about executive pay.

The announcement of the payment to the chairman, Daniel Vasella, was made last Friday, just two weeks before a Swiss referendum to give shareholders more power to determine executive compensation. Mr. Vasella, who had previously said that he would step down as chairman at Novartis’s annual shareholder meeting on Friday, is to receive the sum, 72 million Swiss francs, over six years. 

In a statement, Mr. Vasella said that 'it has been very important to Novartis that I refrain from making my knowledge and know-how available to competitors and to take advantage of my experience with the company.'

Unprecedented Resistance by Shareholders, Politicians and the Public

The plan to provide this "golden parachute" met stunning resistance from Swiss citizens and company shareholders.  As the Times reported,

Swiss lawmakers and shareholder activists criticized the company over the weekend for not making the amount public earlier. They also contended that the planned payment was just the latest of several bad decisions by Novartis on executive pay.

Ethos, a Swiss group of investors, on Monday called on Novartis to immediately cancel the contract with Mr. Vasella and take back any money already paid.

Christophe Darbellay, president of the Christian Democratic People’s Party, told a Swiss newspaper, SonntagsZeitung, that Mr. Vasella’s compensation was 'beyond evil.' Simonetta Sommaruga, the Swiss federal justice minister, told another newspaper, SonntagsBlick, that the payment was an 'enormous blow for the social cohesion of our country' and that such 'help-yourself mentality' was damaging confidence in the economy. 

Even Swiss identified as pro-business or right-wing joined in the criticism.  As reported by the Swiss Broadcasting Company, 

Philipp Müller, president of the centre-right Radical Party which traditionally has close links with the business community, is quoted as saying Vasella was 'taking liberal Switzerland to the henchman'.

Other politicians described the latest figure as 'disgusting' and denounced the recklessness of top managers.

The director of the Swiss Business Federation, which has been leading the fight against the initiative, said he was surprised by the 'dimension of the payment' to Vasella.

A Golden Parachute Despite a Past Record of Misadventures

Maybe there would have been even more outrage if those in Switzerland had known about Novartis' track record of misadventures, at least in the US, while Vasella had been leading it.  In particular,

-  In 2011, as we noted here, a company subsidiary paid $150 million to settle charges by several US states that it had misrepresented pricing information

-  In 2010, as we noted here, the company settled US federal civil and criminal charges in connection with its marketing of multiple drugs for $422.5 million.  The charges included giving kickbacks to physicians disguised as speakers' honorariums and fees for serving on advisory boards.  

-  In 2010, as we noted here, the company settled separate US charges that it made false claims to support off-label marketing of its drug tobramycin for cystic fibrosis for $72.5 million. 

- In 2008, as we noted here, the company settled charges in the US state of Alabama that it defrauded Medicaid for $33.7 million.

However, these legal escapades were not mentioned in the recent media coverage of the proffered and then withdrawn parachute. 

The Company Backs Down.

Nonetheless, what was really surprising was that the outrage made the company back down.  Per the Wall Street Journal, 

Novartis AG on Tuesday abandoned a 72-million-Swiss-franc ($78 million) exit package for its chairman, bowing to pressure from shareholders and Swiss politicians after four days of increasing criticism.

The Swiss drug maker said its board and Chairman Daniel Vasella agreed to cancel a six-year noncompete and related-compensation agreement designed to prevent him from joining or advising rivals and which would have paid him 12 million francs a year.

The agreement was scheduled to take effect on Friday, when Dr. Vasella, 59 years old, is planning to leave the Basel-based company at its annual shareholder meeting

Furthermore,

In the Novartis statement on Tuesday, Dr. Vasella acknowledged that his offer hadn't soothed public opinion: 'I have understood that many people in Switzerland find the amount of the compensation linked to the noncompete agreement unreasonably high,' he said. 

In addition, as Reuters noted, Vasella actually admitted he made "mistakes,"

'The fierce reaction and reproaches that were made as a consequence of the many-sided discussions about my compensation did leave its mark on me,' 59-year-old Vasella said in his opening address to 2,688 shareholders gathered at Novartis's annual general meeting in Basel.

'I made two avoidable mistakes: the first was to even negotiate this contract. And the second to believe that giving up this individual payment to charities would be considered as something positive by society.'

Of course, it is hard to believe that Novartis had previously paid him as lavishly as it did  - the New York Times had reported that his pay just prior to resignation was 12.4 million francs, "about $13.4 million a year" -  without securing an agreement to protect trade secrets.  Many businesses routinely add confidentiality clauses, trade secret protection, and non-compete clauses to contracts of many employees.  Thus adding a $78 million golden parachute ostensibly just to protect trade secrets and defection to the competition seems like impossibly gilding the lily.  Furthermore, if Novartis really thought that Vasella was likely to run to another firm at the drop of a hat, it would have made no sense to entrust someone thought to be at risk of such disloyalty with top leadership positions.

Reason for Hope

At least Chairman Vasella admitted "mistakes," and at least the ridiculous pay package was rescinded. This incident does show that it is possible for public and shareholder outrage over gargantuan payments to executives to have some effect.  That seems like real progress, and a reason to hope. 

Of course, executives of public for-profit corporations are supposed to be working for shareholders.  Thus their general impunity from shareholders' control up to now remains inexplicable.  Furthermore, executives of pharmaceutical companies and other health care corporations seemingly should be responsible for putting patients' and the public's health ahead of their own enrichment.  Thus their ability up to now to ignore public concern about their companies' actions, and to avoid personal responsibility for their companies' bad actions also remains inexplicable.

But progress may now be possible.  In and outside of Switzerland, shareholders of publicly-held for-profit health care corporations should demand accountability from the executives who are supposed to be working for them.  In and outside of Switzerland, health care professionals, policymakers, and the public at large should demand accountability from leaders of health care organizations for the effects of their organizations on patients' and the public's health. 

From another happy EHR user: automatic data "corrections" that alter the past

From another happy EHR user:

One of my patients was married in late 2012.  

Her name changed from XXXX to YYYY.

Today I incidentally reviewed this patient's chart.

Can you guess what name appears on all progress notes (on the LCD screen and in printed form)…going back to early 2007?

You guessed it…YYYY…even though her name was XXXX until late 2012.

I've also seen this happen with providers.  Example:  an RN received her NP.  When they updated her prof designation in the EHR, ALL of her notes were changed to NP…even though about 10 of those years she was an RN.

That's data integrity if I've ever seen it!

These "features" could create injurious clinical confusion, and credentialing issues in litigation as well.

Thus are the risks of having merchant computing "experts", with little understanding of how clinical and medicolegal issues differ from selling doggie biscuits, shove their bad health IT down clinician's throats.

(Or, perhaps the better metaphor would involve the distal end of the GI tract.)

-- SS

EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

I used to have great respect for the New England Journal of Medicine.

No more.

That respect was reduced significantly in 2010 when I saw the following passage (as I wrote in my July 2010 post "Science or Politics? The New England Journal and The 'Meaningful Use Regulation for Electronic Health Records"):

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].

... So, did the NEJM publish fact, or political platitude?

Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?

The negative if not bitter reader comments to yesterday's New York Times article on the health IT lobby (link) certainly cast some doubt.

My respect has dropped several more notches in 2013.

The NEJM has served as a PR journal for health IT once again.

In a correspondence piece "Early Results of the Meaningful Use Program for Electronic Health Records", N Engl J Med 2013; 368:779-780,  February 21, 2013 by Adam Wright, Ph.D., Stanislav Henkin, B.A., Joshua Feblowitz, M.S., Allison B. McCoy, Ph.D., David W. Bates, M.D. and Dean F. Sittig, Ph.D., the following statement is published (emphases mine):

... The downstream effects of meaningful use on quality, safety, and efficiency are not yet known, and further increases in EHR adoption, functionality for clinical decision support systems, and research are needed to ensure the effectiveness of the meaningful use program

I note that Begging the Question is a fallacy in which the premises include the claim that the conclusion is true or (directly or indirectly) assume that the conclusion is true.

Further, I made the following points in my Jan. 2010 post "Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain":

... there is a major problem with the term "meaningful use" itself:

This [term "meaningful use"] is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."

I go further. Use of a term that a priori assumes some outcome reflects the antithesis of science. The term "meaningful use" in the domain of technology implies that those following the recipe for use of some technology, as well as their subjects, will experience meaningful outcomes. A parallel is in the logical fallacy of begging the question or circular argument, where the conclusion of an argument is among its premises.

In this current NEJM passage, the "question" of MU effectiveness is shamelessly begged like a hungry puppy begging for a Snausage doggie snack.

"Ensure the effectiveness?"  The inherent assumption is that MU (developed by consensus committee without supporting rigorous evidence of effectiveness), whose 'downstream effects' are admittedly unknown, WILL be effective - if only we spend MORE billions of dollars on the technology.

At best, the appropriate statement to have been made is this:

... The downstream effects of meaningful use on quality, safety, and efficiency are not yet known, and further increases in EHR adoption, functionality for clinical decision support systems, and research are needed to determine if meaningful use will have any positive impact on healthcare quality, safety and efficiency."

From a physician commenter overseas who excels in demolishing health IT propaganda: 

Seriously, did they proof read the last paragraph? How did the NEJM editors let that get printed? 

Given the recent food scandal in the UK, it is like the PM saying we are not quite sure that there's horsemeat in the Burgers and Lasagna so we are going to need to import a lot more of this muck from France, Poland & Romania before drawing any conclusions...

Shame on the New England Journal.  My respect for them is even lower than after the 2010 health IT advert as above.  This current letter's conclusion is a high school-level faux pas and, in my opinion, should not have been published in its present form.

-- SS

Addendum:  Let's see if they publish my Letter to the Editor on this matter, submitted today.

Second addendum:  a reader opined that MU could have a negative impact on quality, safety and efficiency (cf. yesterday's NYT article and reader comments, link).  While less likely, we just don't know.

Addendum Mar. 18, 2013. 

I received this today from the NEJM:

Your letter referring to the Wright article of 21-Feb-2013  has been received.  Because of the limited availability of space, we can publish only a fraction of the letters we receive.  Although we will not be able to print yours, we have forwarded a copy to the authors in case they wish to reply directly to you.

 
This is why I blog.

-- SS

It is Harder to Run a Small Public Hospital System than California? - Deep Seated Myths and Logical Fallacies Underpinning Health Care Executive Compensation

Hospital executive compensation, the gift that keeps on giving... 

A Public Hospital CEO's Current Compensation

A recent, somewhat obscure news article shows how deeply rooted is the current practice of paying top hired managers of health care organizations amounts that seem outlandish given the context.

The article, in the Argus - San Jose (CA) Mercury News, discussed the compensation given the CEO of a small public hospital district.  It opened with,

 Amid a budget crunch that has forced sweeping cutbacks at its medical facilities, the Washington Township Health Care District board of directors on Wednesday awarded its CEO $162,783 in incentive pay that raises her total annual compensation and contract perks this year to more than $800,000.

The bonus pushes Farber's total 2012-13 compensation past $813,915, less than the $936,349 she made in 2011 or her $912,519 pay in 2010, when she was among the top five paid government employees statewide in a survey by the state controller's office. 

Note first that Washington Township Health Care District is a public health district.  As an article from January, 2013 in The Argus - San Jose Mercury News explained,

The Washington Township Health Care District is a public agency in southern Alameda County and receives tax money from 320,000 district residents under voter-approved bond measures. 

The District is also under financial stress.  As the earlier Argus - Mercury News article stated,

Physician assistants, nurses and medical directors were among the 200 jobs recently eliminated by the Washington Township Health Care District to cut costs, according to new information released by the district.

In response to a request under the California Public Records Act, the district provided a list this week of the 75 job titles included in the approximately 132 vacant and 68 filled positions eliminated in recent months as part of a 13 percent workforce reduction.

Furthermore, as the newer Argus - Mercury News article noted,

 Farber was overseeing a 13 percent workforce reduction that eliminated 200 mostly vacant jobs. The district had seen operating profits plummet tens of millions of dollars last year from recent years.

So Ms Farber got a large salary plus bonus at a time when hospital "profits" were declining and many employees, including health care professionals with direct patient care responsibilities were being laid off. 

A Long History of Outsize Compensation

Note that this small public hospital system actually has a long history of paying its CEO a lot.


In 2003, the (Fremont-Newark, CA) Argus editorialized (the full article requires payment),

 HOW MUCH is too much?

We don't know the answer to that, but we're pretty sure $479,600 a year qualifies.

That's how much Washington Hospital is paying CEO Nancy Farber.

Farber will make a base salary of $406,000 during the 2003-04 fiscal year, a 10 percent raise from her 2002-03 salary of $368,000, plus she is getting a $73,000 bonus.

That editorial did not seem to prevent Farber from getting raise after raise in the subsequent years.

In 2011, the Los Angeles Times published an article with the headline, "Hospital executives occupy top tier of California's public workers."  It said this about the pay given Nancy Farber, still the CEO of Washington Township Health Care District,

The hospital's chief executive, Nancy Farber, is the second-highest-paid official covered in Chiang's database [of pay to public officials] so far. She was paid about $874,000 in 2009.

So Ms Farber's compensation has about doubled in the last 10 years, during which US cost of living has increased about 24% (look here).  And at least one local editorialist thought she was paid too much in 2003.

Justifying Large Payments with the Usual Talking Points

So why should the pay of the CEO of a relatively small public hospital system keep rising so fast, despite criticism.  To some extent in 2011, and quite clearly in 2013, her supporters trotted out the usual suspect arguments.

We previously have described (most recently here) how whenever anyone bothers to try to justify extravagant executive compensation at hospitals, and for that matter, most other health care organizations throughout the US, they seem to repeat the same set of talking points.    We first listed the talking points here, and then provided additional examples of their use here, here and here.   The talking points are:
-  we pay what everyone else pays
-  CEOs work hard and are brilliant, and so deserve high pay
-  high pay is needed to attract and retain competent, if not brilliant people.

In 2011, per the Los Angeles Times, "officials" of the health district combined all three in a single sentence, :

Officials at the Washington Township Health Care District in Fremont, Calif., also argued that they needed to pay 'market rate' to obtain top-quality staff.

In 2013,  the Argus - Mercury News described how Ms Farber's defenders used them all at length. 


CEOs Work Hard and are Brilliant

Board member Bernard Stewart, a local dentist who has served for more than a decade on Washington's board, said the salary comparison with other public employees was unfair.

'It's a temptation for all of us to compare the CEOs salary with other elected officials or other public officials, but I can't stress in the strongest means possible, that is an absolute error,' Stewart said. 'We in this hospital are a public hospital. We are a publicly elected board, but we are engaged in an incredibly competitive and difficult business and we are different from any other public organization in that regard.'

So one board member explicitly argued that being the CEO of a small public hospital system is much harder than any other kind of state government leadership position.

Since the article also included a comparison of Ms Farber's pay with that of the Governor of California,

By comparison, Gov. Jerry Brown will make just over $165,000 this year.

the board member implied that it is much harder to run a small public hospital district than the whole state.  That is breathtaking.


The board also more generally praised the CEO, 

 Ahead of the vote for the bonus Wednesday, all five board members praised Farber's leadership and said that, because of the difficulties facing the hospital, experienced leadership was needed.

In addition, note that hospital district board members suggested specific aspects of Ms Farber's performance worthy of high remuneration.

Board members credited Farber with implementing a new electronic records system, the construction of the district's new center for joint replacement on time and on budget, and for various accolades the district received last year. Among them, the district was ranked the fourth best hospital in the Bay Area by U.S. News & World Report and among the top 10 in the state for joint replacements by HealthGrades, a designation received for the last seven years.

Board members said Farber's decision to reduce the workforce was evidence of her exemplary leadership.

'Making the decision to downsize, or right-size, when necessary, is as much a part of being a responsible administrator as is building, growing and improving the health care system,' Nicholson said.

Board member Michael Wallace said Farber, 'has made tough and unpopular choices. The easy thing would have been to kick the can down the road, which is what we see happening all the time in Washington, but she didn't do that,'....

So we see here that the CEO is given personal credit for all good things, even good things that obviously required considerable work by other people.  I am certain that the CEO did not personally implement the EHR, did not construct the joint replacement center, and did not directly care for patients.   All the other employees who contributed to these apparent successes implicitly got no credit, and it is likely that some employees who actually contributed were laid off.

Furthermore, note that the board somehow believed that laying off employees in a time of financial stress, a hardly original business strategy in this day and age, and one presumably only undertaken due to a crisis, was somehow a sign of brilliant leadership.  Again, this is breathtaking.  

I would argue that asserting the CEO has a harder job than the state governor, giving the CEO credit for numerous activities that obviously required the work of many others, while denying her responsibility for financial distress amount to a prolonged logical fallacy, a prolonged appeal to authority.  The argument that whatever the CEO does MUST be brilliant, and its assessment should not be the subject of critical thought.


We Pay What Everyone Else Pays
High Pay is Needed for Recruitment and Retention

Admittedly, Ms Farber's defenders did not belabor these points as much, but, board member Michael Wallace said

'I don't want our leadership and management team wooed away by those monolithic systems willing to pay market compensation, which is a risk if we are not willing to do so.'

 He provided no evidence that this supposedly brilliant group of hired managers was in any danger of being recruited elsewhere.  As we have noted before, the evidence suggests that most top executives are recruited from within the organization, and hence this assertion is at best another kind of logical fallacy, an appeal to common practice.  

The Myth of the Divine Right of CEOs

We have seen again and again how top executives of health care organization, particularly CEOs, are given credit for everything good that happens, while avoiding responsibility for everything bad, and have the ability to continually enrich themselves regardless of the evidence about their personal performance, or about the context in which they work.  

Thus they are treated by those around them as some sort of aristocracy,  just short of omnipotent, minor deities.  In fact, as we wrote here, there is reason to think that some trends in economic thinking, combined, as we wrote here, with some trends in religious, or pseudo-religious thinking, have combined to promote something akin to the "divine right" of CEOs.

Yet CEOs and other health care executives are demonstrably human, and hence flawed.  Furthermore, shielding them from all accountability is a tremendous perverse incentive that is likely to lead to ever more incompetent, self-interested, mission-hostile, and even corrupt leadership.  

Somehow we need to start combating the talking points used to justify the lack of accountability and self-interest of top health care organizational leadership, and ultimately the whole notion of hired managers and executives as super human. 
As a society we need to wake up from our dazed acquiescence to ideas that border on crazy.  We need to challenge rote justifications and talking points for that which makes no sense, but serve to make the powerful more powerful.

New York Times: "A Digital Shift on Health Data Swells Profits in an Industry"

The New York Times has published an article today by Julie Creswell entitled "A Digital Shift on Health Data Swells Profits in an Industry."  It is available at this link.

... While proponents say new record-keeping technologies will one day reduce costs and improve care [only when today's bad health IT is abolished - see here - ed.], profits and sales are soaring now across the records industry. At Allscripts, annual sales have more than doubled from $548 million in 2009 to an estimated $1.44 billion last year, partly reflecting daring acquisitions made on the bet that the legislation would be a boon for the industry. At the Cerner Corporation of Kansas City, Mo., sales rose 60 percent during that period. With money pouring in, top executives are enjoying Wall Street-style paydays.

None of that would have happened without the health records legislation that was included in the 2009 economic stimulus bill — and the lobbying that helped produce it. Along the way, the records industry made hundreds of thousands of dollars of political contributions to both Democrats and Republicans. In some cases, the ties went deeper. Glen E. Tullman, until recently the chief executive of Allscripts, was health technology adviser to the 2008 Obama campaign. As C.E.O. of Allscripts, he visited the White House no fewer than seven times after President Obama took office in 2009, according to White House records.

The article does not reveal anything that readers of this blog did not know already.

The push for the financial incentives and profits were also written about at the The Huffington Post Investigative Fund by investigative reporter Fred Schulte, now at the Center for Public Integrity ("Stimulus Fuels Gold Rush For Electronic Health Systems"), and in the Washington Post by Robert O'Harrow Jr. (which I wrote about at this post:  The Machinery Behind Healthcare Reform: How the HIT Lobby is Pushing Experimental and Unsafe Technology on Unconsented Patients and Clinicians).

Rather than re-hash the issues, I wanted to focus on some of the current NYT reader comments:

... After a visit to a Florida hospital for suspicion of heart attack, I asked for a copy of my records to give my home (IL) physician. I was shocked to read that I had had "anal surgery." When I reviewed these records with my doctor, she told me that I had probably told the admitting ER nurse I had recently had a colonoscopy, so the closest coding information their electronic system allowed was anal surgery. So, how can these inaccuracies which will live on forever electronically be helpful toward patient care? The old acronym GIGO certainly applies here--garbage in; garbage out.

... This article highlights only one aspect of the "Failed Promise of Electronic Health Records". Through lobbying but also supported by a study from the RAND organization, the three final 2008 presidential candidates, Hillary Clinton, John McCain, and Barack Obama outbid each other with promises to spend billions to entice doctors to use electronic record systems. Unfortunately, because of unsolved documentation problems, such systems are often disliked and slow the process. Instead of creating interoperability, electronic medical record systems (EMRs) with limited functionality and benefits were created. In particular, true interoperability has been neglected and attempts to create it through networks in the form of CHINs, RHIOs, and HIEs have failed.

... Mr. Tullman's comment is priceless. “I think it’s very common with every administration that when they want to talk about the automotive industry, they convene automotive executives, and when they want to talk about the Internet, they convene Internet executives." Of course, when "they" want to radically alter the way doctors do their jobs, "they" talk to academics, lawyers, publicly traded insurance CEOs and internet executives. Today's diatribe about quality care being more important than quantity care is laugh out loud funny. Unless you're a physician. Only in America does getting paid less and less, with more clerical data entry record-keeping at every step just to get paid and protect against lawsuit, translate into an incentive to provide quality care. Somebody prescribe a dose of common sense. Oops. Too late.

... Every person needs a national health ID with up to date health information. To say that the current EMR systems are problematic would be an understatement. They take away face time with patients, the M.D.'s talents and time are wasted doing data entry and worst of all ,they are potentially dangerously flawed. An example is a recent patient I saw who was treated by a number of physicians. His medications had required significant changes which were done by 2 different M.D.'s from his main doctor. Both gave him computer generated lists from the same system. Both had a mixture of unmatching generic and proprietary names, the patient's actual medicines from the pharmacy had a mixture and different doses from the Dr.'s orders. He was trying to set up his week's supply. But didn't know which proprietary name went with which medicine. These systems should have been tried out on a small scale and approved by M.D.'s before this became law. The VA system which is time tested, physician friendly and free only the VA is using. These other systems are set up to maximize profits for the IT companies, cost the physicians huge amounts to install, cost the hospitals huge amounts esp when they are changing from one system to another due to problems when they were advertised to maximize hospital billing. This another example of our distorted legislative process where profits and politics take precedence over people.

... I am a dermatologist in private practice who teaches at a local medical school part time. Electronic records are problematic. Every doctor I know feels they take time away from being a doctor. I literally don't know a single colleague who feels their benefits are worth the extra time involved. In medical school, we learned how to record notes in medical records so that patient care is improved from visit to visit. In short, we use notes from the previous visits to assist in our decisions in subsequent examinations. In today's digital world, most doctors I know are forced to change their notation style to justify payments from insurance companies. The more detailed the note in the medical record, the lower the chance that an insurance company downgrades the fee charged to the patient. Thus, notes are now longer and more detailed than they were ten years ago. The problem with such notes is that they are filled with detritus geared to prevent payment reduction rather than aimed at improving continuity of patient care from visit to visit. The impact of this adoption of electronic medical records is that insurance company computer systems can easily sift through notes to reduce compensation to doctors who spend more time with patients and who write cleaner, more efficient notes.

... I still use pen and paper.  One requirement would fix this mess: interoperability No, NOT the "industry supported" standard. Thats a joke. Industry wants NO inter-operability because they want to lock us in to a an individual product, The government has a great EMR (the VA system). All commercial ones should be forced to be able to export data in a way that is 100% compatible with that. As such, they would then be 100% compatible with each other. Some of my colleagues are now on their third EMR product in 7 years. Why? Big company buys company B and then stops supporting it. The doctor is forced to switch to Big Company's new product. Of course the data does not transfer over so the doctor has to go through the crude data-entry mess all over.

... The folly of relying only on digital records. Without constant and costly software and hardware upgrades, your digital medical records will be rendered obsolete. Could be a matter of years or decades, but it will happen. Not only that, digital proprietary systems are at huge risk if the private for-profit company goes bankrupt. Paper records can last 1000 years.

... Another scam. Very expensive and involved for end user:ie doctor. Have had to hire an IT company to assist, have to pay annually for service contract, upgrades and what the article didn't mention was the "meaningful use" criteria that all doctors have to comply with in order to pass government inspection for a rebate. The software vendors, labs, and others are charging doctors extra for software upgrades and abilities to comply with each "meaningful use" component . This is already costing more money and aggravation than the worth of the government rebate. Who will subsidize this? Doctors are starting to lose interest. We know this is another corrupt government sponsored ploy and only the tip of the iceberg. If the government were to have spent the 19 billion with a consortium of vendors such as google apple and microsoft, the goal of free software provision capable of interexchangeable data would likely have been completed with all providers on board.

... Common sense can tell you that the real value of these systems is marginal. Much of medical treatment is "incident specific" where history is not necessary. Most PCP's already have a system that works. In larger systems and for complex diseases, perhaps EMR are beneficial but not for routine care. As has been noted, all sorts of problems arise with EMR's: destruction of MD-pt relationship, incorrect data being entered and never removed, cumbersome and expensive requirements of instituting and maintaining the system, etc. It is awful that physicians and patients are "used" in the service of politicians and EMR execs.

... As a practicing physician I have to struggle everyday with the Citrix and Quickbase electronic records. The Electronics Medical Records industry has been getting the gold promised by the government in exchange of a very poor and deficient product. The EMR industry has been selling to the healthcare providers, in need of electronic records, the equivalent of the Formaldehyde-contaminated trailer homes sold to FEMA for the Katrina homeless.

These are just from the first page of comments.  Read the article and the comments at the link above.

My observation is that it seems that as transparency increases, the public "gets it" that these systems are not the panacea the industry wants us to believe, and may impede the clinicians trying to treat them.

Now, when will the government "get it" that they've been had?

-- SS

Addendum:  another "anecdote" just caught my eye because it sings an unfortunate familiar tune to me:

So much data, so little knowledge. My best friend's father just died because none of his who-knows-how-many physicians took the time to actually read and anaylze the reams of info they were dutifully inputting. They killed him with an overdose of one drug and not enough of another.  Useful data collection and analysis is one thing, but what we seem to have now is just institutionalized hoarding. More data doesn't make anyone safer (except the data companies), just like stacks of old magazines or cans of beans makes one safer. More is NOT better; it is just more. More time and more expense wasted on stuff and less spent on actual health care. You've got to USE anything or it is just more useless and potentially dangerous stuff.

-- SS

Are the health IT hyper-enthusiasts inept, or merely insane?

From a psychiatrist, partially in response to the article about me in Kaiser Health News, on the travails of health IT.

They write:

... In psychiatry we screen for certain medication side effects using a tool called "DISCUS."  [Dyskinesia Identification System Condensed User Scale - ed.] In a paper and pen world, we (1) reviewed a single page; (2) circled a score; (3) signed and (4) dated.

In [redacted] EHR, we need to do the following to complete one DISCUS…
    
DISCUS Completion in [redacted] EHR:

• 1.  Log in;
• 2.  Acknowledge to do items by choosing “ok”;
• 3.  Go to “my to do list.”

Then:

• 4.  Double click specific date of to do items to complete (this reveals the specific to do items)
• 5.  Right click specific patient’s name
• 6.  Choose “enter option”
• 7.  Review all 3 pages under “assessment” tab (click through each page)
• 8.  Then choose “evaluation” tab
• 9.  Review “evaluation” (keeping in mind the total score from last page of “assessment”)
• 10.  Choose your “conclusion” in item 5
• 11.  Add “comments” as indicated (item 6)
• 12.  Under “name/ID number” type in the first characters of your last name (or your ID number)
• 13.  Select your name
• 14.  Go to the bottom under “select physician to notify” and UNcheck your name
• 15.  Click “yes” under “is evaluation section complete and ready to be locked?”
• 16.  Confirm above choice by choosing “ok”
• 17.  Press “submit” button across the top
• 18.  Now go back to “my to do list” and you’ll see that the item you just processed above is still there -- double click the same to do item that you just finalized (and processed in item 5 above)
• 19.  Then check “reviewed”
• 20.  Then press “submit”
• 21.  Then press “refresh” and the item will be completed (refresh does not need to be done after each DISCUS)

Finally:

• 22.  For processing of additional DISCUS for a given “sign on," go back to step 3, 4 or 5 (as needed), and repeat.

And this is just the easy stuff.

I'm not a psychiatrist, but I can opine with confidence that anyone who expects human-computer interaction such as this to "revolutionize medicine" is insane.

Perhaps this helps explain city-wide debacles such as this in San Francisco.

-- SS

Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows...

In October, 2010, we noted questions about how Dr Stephen Ondra got to be a Senior Policy Adviser for the US Department of Veterans Affairs. A veteran who was a neurosurgery professor at Northwestern University, Dr Ondra had received millions of dollars in royalties from device manufacturer Medtronic, whose CEO supported his appointment to the government position  (see this post).  As soon as he was appointed, he publicly opposed a nominee for US Surgeon General who had been critical of the medical device industry, and its financial ties to doctors.

After going to Washington, Dr Ondra apparently also served in the Executive Office of the President, in the White House, but returned to Northwestern University in 2012.  However, he did not stay there for long.

This month, a post on Forbes indicated he is moving on again, and back to the corporate side of health care.

the nation’s fourth-largest health insurance company is naming a key former health advisor to President Obama as its top doctor.

Dr. Stephen Ondra, will become senior vice president and chief medical officer at Health Care Service Corp., the Chicago-based parent company of Blue Cross plans in Illinois, Texas, Oklahoma and New Mexico. The plan has more than 13 million health plan members and is looking to grow even more, announcing last year a proposed partnership with the Blue Cross plan in Montana.

Health Care Service Corp is a mutual insurance company, that is, a company owned by its policy-holders rather than stock holders.  However, that does apparently not make it any more ascetic than a typical for-profit insurance company, at least in terms of generosity towards its top hired executives.  As Crain's Chicago Business reported in 2012,

New federal regulations intended to force health insurers to spend less on administration didn't keep the parent of Blue Cross & Blue Shield of Illinois from paying CEO Patricia Hemingway Hall more than $12.9 million in 2011, a 61 percent raise.

The Health Care Service Corp. chief executive's total compensation last year dwarfed the $8 million she received in 2010, according to a filing with the Illinois Department of Insurance. The 2011 increase was fueled by an $11.8 million bonus, which was 69 percent above her 2010 bonus of $7 million.

Ms. Hall wasn't alone in getting a big raise at Health Care Service, whose insurance business booked net income of more than $1 billion in 2011, for the second straight year.

The 10 highest-paid executives at the Chicago-based mutual company — which operates Blue Cross plans in Illinois and three other states — earned a collective $41.7 million, 65 percent more than the $25.3 million they were paid in 2010.

 If Dr Ondra's new position puts him among the latter group of executives, he too stands to make millions a year. 

So to recap Dr Ondra's career so far, in 2010 he was a medical school professor who had earned millions in royalties from Medtronic.  He then went to top leadership positions in the US Veterans Department and Executive Office of the President.  He returned briefly to Northwestern University, only to leave again for a top executive position in for-profit insurance company Health Care Service Corp, where he is likely to make millions more.

Thus Dr Ondra is our latest interesting example of the "revolving door" phenomenon in health care.  He started as an erstwhile academic physician but with a very major financial relationship with a medical device company.  He then went through the door the first time into the US government, and then a second time from the government to a for-profit insurance company, with just a brief stop-over in academia.

By the way, it appears that all of this is quite legal.  It does again raise questions about whether health care leaders in government with previous relationships with industry might still feel undue sympathy to the interests of industry, as might government leaders who can expect future jobs in industry.

Moreover, this case, like previous cases we have discussed,  indicates how leadership in academic health care, corporate health care, and the government tend to blend together.  Leaders of one type of organization have more and more in common with leaders of the other types of organizations than they do with their lesser ranked colleagues, and certainly than with other health care constituencies.  So the more the revolving door revolves, the more we wonder about the corporatism of health care, about how health care seems to be increasingly run by an amorphous group of academic/ corporate/ government leaders whose loyalties may be more to each other than to academic and professional values, patients' and the public's health, and government of, by and for the people.

Kaiser Health News/Philadelphia Inquirer on InformaticsMD: "The flaws of electronic records"

At my Dec. 2012 post "How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's" I mentioned an interview by a reporter from the Kaiser Health Foundation regarding health IT flaws.

His article appeared in both the Philadelphia Inquirer and Kaiser Health News today under the title "The flaws of electronic records":

Philadelphia Inquirer / Kaiser Health News
Feb. 18, 2013

Jay Hancock, KAISER HEALTH NEWS

The flaws of electronic records

Drexel University's Scot Silverstein is a leading critic of the rapid switch to computerized medical charts, saying the notion that they prevent more mistakes than they cause is not proven.

 

Scot Silverstein of Lansdale, one of the most ardent critics of electronic medical records, works on an antique computer. A growing collection of evidence suggests poorly designed medical software can obscure clinical data, generate incorrect treatment orders, and cause other problems.

RON TARVER /Staff Photogapher

Jay Hancock, KAISER HEALTH NEWS
Posted: Monday, February 18, 2013, 3:01 AM

Computer mistakes like the one that produced incorrect prescriptions for thousands of Rhode Island patients are probably far more common and dangerous than proponents of electronic medical records believe, says Drexel University's Scot Silverstein.

Flawed software at Lifespan hospital group printed orders for low-dose, short-acting pills when patients should have been taking stronger, time-release ones, the Providence-based system disclosed in 2011. Lifespan says nobody was harmed.

But Silverstein, a physician and adjunct professor of health-care informatics who is making a name for himself as a strident critic of electronic health records, says the Lifespan breakdown is part of a much larger problem.

"We're in the midst of a mania right now" as traditional patient charts are switched to computers, he said in an interview in his Lansdale home. "We know it causes harm, and we don't even know the level of magnitude. That statement alone should be the basis for the greatest of caution and slowing down."

In an ethical world, it would be.  Medicine, though, is in the throes of a loss of ethics, as many stories at this site and many others attest to.

Use of electronic medical records is speeding up, thanks to $10 billion and counting in bounties the federal government is paying to caregivers who adopt them. The consensus among government officials and researchers is that computers will cut mistakes and promote efficiency. So 4,000 hospitals have installed or are installing digital records, the Department of Health and Human Services said last month. Seventy percent of doctors surveyed in September by research firm CapSite said they had switched to digital data.

But the notion that electronic charts prevent more mistakes than they cause just isn't proven, Silverstein says. Government doesn't require caregivers to report problems, he points out, so many computer-induced mistakes may never surface.

The recent ECRI "deep dive" study of "EHR events" (link) is just the latest to raise red flags on that point.

Even Dr. David Blumenthal, former chair of the Office of the National Health IT Coordinator (ONC) in HHS seems to have changed his message about reporting of medical problems.

From a Feb. 16, 2013 New York Times article "Doctors Who Don’t Speak Out":

....  TRADITIONALLY, doctors have brought problems to the attention of colleagues by conducting research and publishing their findings in a medical journal. The advantage of that system helps ensure the credibility of study data and protects a researcher from random attack, said Dr. David Blumenthal, the president of the Commonwealth Fund, a group that studies health policy issues.

But getting a study published can take a year or two; some Johnson & Johnson consultants did publish studies about the hip’s flaws, but they largely appeared after it had been recalled.

Dr. Blumenthal said there was probably a need for more immediate ways for doctors to share their concerns, like forums supported by professional medical organizations.

Back to the Inquirer article:

He doesn't discount the potential of digital records to eliminate duplicate scans and alert doctors to drug interactions and unsuspected dangers.

But the rush to implementation has produced badly designed products that may be more likely to confound doctors than enlighten them, he says. Electronic health records, Silverstein believes, should be rigorously tested under government supervision before being used in life-and-death situations, much like medical hardware or airplanes.

In fact, arguments otherwise are specious.  "Harm to innovation" is the one I've heard most often.  Yet, those proffering such claims cannot point out what aspect of regulation - adherence to GMP's (good manufacturing processes), pre-market safety and quality testing, post-market surveillance, etc. - will "harm innovation."  Indeed, they opine as if innovation in medicine without objective safety and quality checks is a virtue, rather than a potential vice.

Silverstein "is an essential critic of the field," said physician George Lundberg, editor at large for MedPage Today and former editor of the Journal of the American Medical Association. "It's too easy for those of us in medicine to get excessively enthusiastic about things that look like they're going to work out really well. Sometimes we go too far and don't see the downside of things."

(Dr. Lundberg mentioned me in Nov. 2011 at MedPage today in a piece entitled "Health IT: Garbage In, Garbage Out" as here.)

The patients - including ourselves and our own family members, I might add - are the ones who pay the price of our hyper-enthusiasm.

... The FDA's Jeffrey Shuren, a neurologist, has said such cases "likely reflect a small percentage of the actual events that do occur."

"Tip of the iceberg" were his exact words (link).

... At conferences and working from home on the "Health Care Renewal" blog, Silverstein chronicles digital failures and criticizes hospitals in the same dogged way he applied himself to building the 1970s-era Heathkit computers [and amateur radio equipment - ed.] he still keeps in his home, say people who know him.

"His message has been consistent": Health IT "provides far less benefit than is claimed by its proponents and opens new, sometimes potent, routes to failure," said Richard I. Cook, a medical error expert at the University of Chicago who sat on a panel examining electronic record safety at the authoritative Institute of Medicine. "No one wants him to be visible. But his message and tone have not wavered."

Dr. Cook wrote the lone dissent to milquetoast IOM recommendations on health IT risk - the magnitude of which IOM itself admitted is unknown - in their 2012 report "Health IT and Patient Safety: Building Safer Systems for Better Care" available here.  See Appendix E.

The last scientific conference at which I chronicled these failures was at the Health Informatics Society of Australia's HIC2012, as a keynote speaker on health IT trust (link).  I would have been at HIC2011, to which I had been originally invited, but was helping care for a relative injured by bad health IT at that time.  Her death freed me to travel Down Under in 2012.

I have presented at a number of plaintiff attorney's meetings since then, however, such as the American Association for Justice Winter Convention (AAJ, formerly the Trial Lawyer's Association) just last week (link).  Trial lawyers don't seem to mind a very direct approach to the issues, unlike many so-called scientists who, as author Michael Crichton once warned (link), seem to believe in "consensus" rather than science.

The HIMSS Electronic Health Record Association, an industry group, declined to comment on Silverstein. A spokesman for the Office of the National Coordinator for Health Information Technology, the administration's proponent of digital records, said: "It's important to listen to all the voices" in the discussion of the subject. 

Some voices, unfortunately, are louder than others and backed by lobbyists and big money.  See, for instance, the May 2009 Washington Post article by Robert O'Harrow Jr. "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" (link to the article and my essay about it is here).

I do point out, however, for the benefit of those at HIMSS and ONC, that knowing of risks, while doing nothing substantive while "listening to all voices in the discussion" can be seen as gross negligence.

Trained as an internist and in medical information technology [Medical Informatics- ed.] as a Yale University postdoc, Silverstein, 55, served as Merck & Co.'s director of scientific information in the early 2000s and then as a full-time Drexel professor, shifting in recent years to part-time teaching and working on medical liability cases for plaintiff attorneys. His insistent warnings about digital health risks over more than a decade have effectively barred him from a lucrative career at a hospital or software vendor.

Perverse as that reality may be, it's also the reverse:  I would not want to work for a hospital or software vendor in 2013, where effecting change to protect patients from bad health IT is hard if not impossible, e.g., as at link, link, and link, and at the other case examples at that site.  I find it a far more effective use of my time to help enact change from the outside - and avoiding the pathological individuals who make such scenarios possible.

"I'm sure Scot would be better off by keeping his mouth shut and getting a job with a hospital that's just put in a big . . . system," said Matthew Holt, a Silverstein critic and cochairman of Health 2.0, which organizes health technology conferences.

I note that the raison d'être for this blog is the impact of many people doing just that sort of thing - "keeping their mouth shut" and making money, no matter what the ethical implications.  (The patients killed by such behaviors are, unfortunately, unavailable for comment.)

Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused a hospital to overlook a key medication. Personalizing his campaign, some thought, made him seem less objective.

I'm at a loss here.  "Too strong" - on matters of life and death that affect everyone?  A proficient writer, who had been writing about health IT problems since 1998, should have kept silent about a first hand story of HIT harm in 2010 of potential great relevance towards public safety?  Writing about the incident 'lessens objectivity'?  That makes little sense, and is perverse.  Those who opined as such have their priorities in serious disarray.

Such personalized accounts are common and have caused great change.  Libby Zion's death due to hospital neglect, and her father's making the issues quite public, comes to mind, as do the many laws enacted that are named after people who've gone public after personal tragedy:

... Grieving the loss of their child, Zion's parents became convinced that their daughter's death was due to inadequate staffing at the teaching hospital.  Sidney Zion questioned the staff's competence for two reasons. The first was the administration of meperidine, known to cause fatal interactions with phenelzine, the antidepressant that Libby Zion was taking. The second issue was the use of restraints and emergency psychiatric medication. Sidney's aggrieved words were: "They gave her a drug that was destined to kill her, then ignored her except to tie her down like a dog." To the distress of the doctors, Zion began to refer to his daughter's death as a "murder." Sidney also questioned the long hours that residents worked at the time. In a New York Times op-ed piece he wrote: "You don't need kindergarten to know that a resident working a 36-hour shift is in no condition to make any kind of judgment call—forget about life-and-death." The case eventually became a protracted high-profile legal battle, with multiple abrupt reversals; case reports about it appeared in major medical journals.

An alternate explanation is that, lacking other credible means, this is an ad hominem reaction (of those "some") seeking an angle to attack the message ... and the messenger ... or is simply a reaction of, to put it bluntly, castrati who are more at home in a country club than in the world of ideas.

For a bona fide example of "coming on too strong", there's this:

In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals. 

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

Another bona fide example of "coming on too strong":

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit 

We shall transform health (into what, exactly, is not specified) one thunderous mouse click after another!

It doesn't get any stronger than that, unless, perhaps, the thunderous wrath of God is invoked.

Back to the Inquirer once again:

"His refusal to temper his message makes it sometimes difficult to hear," said Ross Koppel, a University of Pennsylvania sociologist and digital health record skeptic.

As per a recent article by Joe Conn in Modern Healthcare entitled "Health IT Iconoclasts" (link), which wrote of Dr. Koppel, Deborah Peel, Lawrence Weed and me, Dr. Koppel has firsthand experience at his message being found "difficult to hear" by the hyper-enthusiasts:

... Researcher Ross Koppel started an uproar in 2005 when he and a colleague coauthored an article in the Journal of the American Medical Association that found a first-generation computerized physician order entry system (CPOE) at the Hospital of the University of Pennsylvania was simultaneously creating new errors even as it reduced others.

Koppel’s bombshell—he’s now an adjunct professor of sociology at the University of Pennsylvania— brought down the wrath of information technology boosters. The Healthcare Information and Management Systems Society, a health IT trade group, challenged the study’s “methodology and its subsequent outcomes,” and criticized its authors for their “limited view” and not “looking at the big picture.”  [Others wrote that his work was 'disingenuous', although it had similar findings to my own observation of the very same CPOE system at Yale-New Haven Hospital ... in 1992 - ed.]

... In 2009, he revealed in another JAMA article that health IT vendors’ contracts included “hold harmless” clauses that shielded software developers from legal liability for medical errors their systems caused, even if the developers had been warned about the defects. “That got me major upheaval,” the worst of his career, Koppel recalls.

Koppel, a sociologist, has probably done more for health IT transparency and safety than the physicians of the entire academic medical and medical informatics community combined.

... But Silverstein says his position today is the same as it has always been. He believes in the potential power of electronic records for good, he says. But any doctor who feels bound by the Hippocratic oath's injunction to "first, do no harm," he adds, should balk at what's going on.

"Patients are being harmed and killed as a result of disruptions to care caused by bad health IT," he said. "I'm skeptical of the manner and pace" of implementation, "not of the technology itself. . . . My only bias is against bad medicine. And my bias is against people with complacent attitudes about bad medicine."

The issues are actually relatively simple, using terminology coined by Dr. Jon Patrick of U. Sydney at the aforementioned HIC2012 meeting in Australia during our discussions.  Bad health IT must be removed from the market, and good health IT must replace it.

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

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

  
It is this author's opinion that this change will not happen by "going along to get along" or "listening to all the voices in the discussion of the subject" (especially those with Big Money and Big Lobbyists behind them) while doing nothing.

I also note that "complacent attitudes about bad medicine" are not the sole province of IT personnel or healthcare management.  Physicians and nurses who acquiesce to bad health IT are part of the problem.

-- SS