Back to the Future - Another Medical Device Company Accused of Hiding ICD Defects

Suppression of data about defects in and failures of implantable cardiac defibrillators (ICDs) was one of the big issues we featured in the early days of Health Care Renewal (2005-06). 

At that time, Guidant, later acquired by Boston Scientific, was accused of hiding data that certain of its defibrillator models failed, possibly leading to preventable patient deaths (see this post and follow links backward).  Boston Scientific, which acquired Guidant, settled a civil lawsuit and was put on probation in 2011 after it pleaded guilty to misdemeanor charges of failing to file required reports with the US Food and Drug Administration (see post here).   Similarly, in 2010, Medtronic settled multiple patients' lawsuits charging that it knowingly marketed a faulty ICD (see post here).

St Jude and the Obscure Riata Data

Now in 2012, A Wall Street Journal article suggested that St Jude Medical Inc hid problems with its Riata implanted cardiac defibrillator (ICD) for years.   

In December, 2010, St Jude Medical Inc issued a warning letter to doctors: Wires inside Riata defibrillator leads—cables that connect the heart to implantable defibrillators—were sometimes breaking through their insulation from the inside out.


The problem, which ultimately led to a recall last year, could cause defibrillators to send unnecessary jolts to the heart or fail to deliver lifesaving shocks to return chaotic heart rhythms back to normal. The company said it had identified dozens of cases with visible signs of the problem, and pulled Riata from the market.

For many doctors, this was the first notice of a problem with Riata.

But before that 2010 warning, physicians including Alan Cheng, director of Johns Hopkins Medicine's arrhythmia service; Samir Saba, chief of electrophysiology at the University of Pittsburgh Medical Center; and Ernest Lau at the Royal Victoria Hospital in Belfast, Ireland, say they had encountered this so-called "inside-out abrasion" in their own practices between 2006 and 2009. When these doctors brought the incidents to the attention of St. Jude they say they were told by company officials and field representatives that the incidents were isolated. The malfunctions described by the doctors didn't result in deaths.

St. Jude had been tracking the problem for several years, according to company documents collected by the Food and Drug Administration and reviewed by The Wall Street Journal. Cases involving the so-called inside-out abrasion date to at least October 2005, the documents show. Inside-out abrasion became a focus of an internal St. Jude audit, which examined multiple cases of the failure before April 2008.

The Journal article noted that more transparency about device failures might allow physicians to spot problems earlier and prevent harm to patients.

more than a dozen physicians and device-safety experts say that if St. Jude had acknowledged the inside-out failure earlier, physicians might have identified the scope of the problem sooner.


In some cases, doctors concede that they, too, believed the failures were isolated and therefore didn't act quickly to report problems to St. Jude or the FDA, which may have made it harder to spot the growing trend of failures. The leads were implanted in more than 13,000 patients since July 2008.

'Every time you have a failed lead, you assume it's an isolated event, but, you start to string together isolated events, and then you have a recall,' said Dr. Saba.

Summary

So, for Health Care Renewal, this is a straightforward case, at least so far.  Yet another health care organization, this time, a medical device company, failed to reveal data that might have reflected unfavorably on one of its products, and hence lead to decreases in short-term revenue.  However, by suppressing the information, the company may have allowed doctors to keep implanting a potentially faulty device, and exposed patients to risk, possibly of fatality. 

We have discussed many at least somewhat parallel cases of suppression of research (here), and many cases of other kinds of deception by health care organizations (here).  Yet these cases continue to occur, physicians and other health care professionals continue to be fooled by secrecy and data suppression, and patients continue to be harmed by drugs, devices, or other interventions made by people who knew, or ought to have known that they were more dangerous than they appeared to be. 

One problem may be that the people with the most influence on medical practice and health policy continue to cheer lead for the veracity of information about drugs, devices, and other health care interventions supplied by the people who most stand to gain from selling same.  A few weeks ago, the editor of the august New England Journal of Medicine, Dr Jeffrey M Drazen MD, scoffed at physicians' skepticism of pharmaceutical industry funded clinical research, claiming that there were only "a few examples of industry misuse of publications...." [Drazen JM. Believe the data. N Engl J Med 2012;  367:1152-1153.  Link here.]  In doing so, Dr Drazen seemed to ignore all the stories about suppression of medical research (some of which we have discussed here), manipulation of medical research (some discussed here), and deception (some discussed here) and secrecy (some discussed here) practiced by large health care organizations, including but not limited to drug, device, biotechnology, and health care information technology companies.

Instead, the possibility that St Jude kept hidden data about the failings of one of its ICD models reminds us how skeptical we ought to be about the information provided, or not provided by those with vested interests in selling health care goods or services.  Physicians, health care professionals, those interested in health policy, and the public at large need to collectively exert pressure on the leaders of health care organizations to promote greater transparency, especially about data reflecting on benefits and harms of health care goods and services.  . 

A Response to the NY Times Article "Ups and Downs of EMRs" So Full Of The Usual Refrains, I Am Using It To Throw A Spotlight On Those Endlessly-Repeated Memes

My Google search alert turned up a response to the Oct. 8, 2012 NY Times article The Ups and Downs of Electronic Medical Records by Milt Freudenheim.

It was posted on the blog of a company Medical-Billing.com and is filled with the usual rhetoric and perverse excuse-making.

It is, in fact, so laden with typical industry refrains and excuse-making that I am using it to throw a spotlight on the misconceptions and canards proffered by that industry in defense of its uncontrolled practices:

A Response to the NY Times on Electronic Medical Records
Posted on October 10, 2012 by Kathy McCoy

A recent article by the New York Times entitled “The Ups and Downs of Electronic Medical Records” has generated a lot of discussion among the HIT community and among healthcare professionals.

It’s an excellent article, looking at concerns that a number of healthcare professionals have about the efficiency, accuracy and reliability of EMRs. One source quoted, Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.

“Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

Seriously? I can’t believe we’re still having this conversation.  [Emphasis in the original - ed.] 

I can believe it -- and quite seriously -- as it's a "conversation" long suppressed by the health IT industry and its pundits.

Seriously, I can't believe the comment about "it's an excellent article"; that comment appears to merely be a distraction for the interjection of attacks upon the substance of selfsame "excellent" article.

In a world where I can go to Lowe’s and they can tell me what color paint I bought a year ago, or I can call Papa John’s and they know what my usual pizza order is, how can we expect less from our healthcare systems?

Because healthcare is not at all like buying paint and ordering a pizza, being several orders of magnitude more demanding and complex and on many different planes (e.g, educational, organizational, social and ethical to name a few).  Only the most avid IT hyper-enthusiast (or those prone to ignoratio elenchi) would make such a risible comparison.

I recently joined a new healthcare system, and I have been impressed and pleased by their use of EMR and technology. I no longer have to worry about whether I told the new specialist everything he or she needed to know about my health history; it’s in my record. I no longer have to remember when I had my last tetanus shot; it’s in my record.

My care is coordinated between doctors, labs, etc., better than it ever has been before. In the past, I felt as though my healthcare was a giant patchwork quilt—and some of the stitches were coming loose, frankly. This new system with a widely used EMR, to me, is a huge improvement.

The problem with this argument is that n=1, and the going's not yet gotten tough, such as it had for people injured or killed as a result of the experimental state of current health IT.

Granted, the problems cited in the article are real and need to be addressed. 

Another dubious statement to be followed with excuses ... here it is:

However, the article itself mentions some redundancies that are in place to insure that a system going down doesn’t throw the entire Mayo Clinic into freefall. And certainly, additional redundancies may be needed to insure that prescriptions aren’t incorrectly sent to a pharmacy for the wrong patient, etc.

Those "redundancies" are not complete, do not cover for all aspects of enterprise health IT when it is down, and necessarily compromise patient care when they have to be called upon.   I, for one, a physician, would not enjoy being a patient nor taking care of patients when the "IT lights" go out.

Do doctors and medical staff need to learn how to code correctly so that they aren’t accused of cloning? Yes—but that’s a relatively easy problem to fix. The problem has already been identified, and training has already begun to address the issue.

Cloning of notes and "coding correctly" are two entirely different issues.  Easy to fix?  The health IT industry has been saying all its problems are easy to fix, i.e., in version 2.0 ... for the past several decades, when few if any problems have been.

I have been through this type of problem before, as have many of you, with new systems. It’s called a learning curve, and it’s relatively easy to work through with patience and determination. I have encountered situations before where the team I was working with threw up their hands when they ran into problems learning a new database system and said “It doesn’t work.” Yet in time, they learned to love the system—and some of the biggest doubters became the experts on it.

I surmise that since they were forced into using it, the Stockholm Syndrome was likely at work.  However, speculation aside, the seemingly banal statement that "it’s called a learning curve" is an ethical abomination.  The subjects of these systems are human beings, not lab rats.

Further, health IT is not a "database system."  It is an enterprise clinical resource and clinician workflow control and regulation device.  This statement illustrates the dangers of having personnel of a technical focus in any kind of authority role in health IT.  Their education and worldview is far too narrow.

Healthcare professionals overcome more difficult challenges than this every day; they bring people back from the dead, for Pete’s sake! I have no doubt that they will adapt and learn to utilize EMRs so that they improve healthcare and take patient care to levels currently unimaginable.

Wrong solution, completely ignoring (or perhaps I should say willfully ignorant of) the fact that there's good health IT and bad health IT (GHIT/BHIT).  The IT industry needs to adapt to healthcare professionals, not the other way around, by producing GHIT and banishing BHIT.  This point needs to be frequently repeated, I surmise, due to tremendous disrespect for healthcare professionals by the industry.

And to say, as was quoted in the article: “The technology is being pushed, with no good scientific basis”? Ridiculous, with all due deference to Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal and made the statement.

The only thing "ridiculous" is that Ms. McCoy was clearly too lazy to check the very blog she cites, as conspicuously cited in the NY Times article itself.  (That assumes she has the education and depth to understand its arguments and copious citations.)

Lack of RCT's, supportive studies weak at best with literature conflicting on value, National Research Council indicating current health IT does not support clinician cognitive processes, known harms but IOM/FDA both admitting the magnitude of EHR-related harms is unknown, usability poor and in need of significant remediation, cost savings in doubt - these are just a few examples of where the science (as medicine knows it) does not in 2012 support hundreds of billions of dollars for a national rollout of experimental health IT.

I wish it were not so, but alas, that is the current reality.

Database management of information has been proven to be an improvement on paper records in just about every industry there is; healthcare will not be an exception.

Ignoring the repeated "database" descriptor, I agree, eventually, that electronic information systems will improve upon paper.  That's why I began a postdoctoral fellowship in Medical Informatics two decades ago.  However, the technology in its present form interferes with care and is an impediment to the collection and accuracy of that data, and the well being of its subjects, e.g.:  

• Next-generation phenotyping of electronic health records, George Hripcsak,David J Albers, J Am Med Inform Assoc, doi:10.1136/amiajnl-2012-001145 .  The national adoption of electronic health records (EHR) promises to make an unprecedented amount of data available for clinical research, but the data are complex, inaccurate, and frequently missing, and the record reflects complex processes [economic, social, political etc. that bias the data - ed.] aside from the patient's physiological state.

As I've written before, a good or even average paper system is better for patients than bad health IT, and the latter prevails over good health IT in 2012.

These issues seem chronically to be of little interest to the hyper-enthusiasts as I've written here and here (perhaps the author of the Medical Billing blog post could use her wrist and eyes and navigate there and read).

Is it hard? Yes, it’s hard. To quote the movie A League of Their Own, “If it were easy, everyone would do it.”

It's even harder to do when apologists make excuses shielding a very dysfunctional industry.

Everyone can’t do it. But I have no doubt that healthcare professionals will do it. Remember that part about bringing people back from the dead? This is a lesser miracle.

If qualified healthcare professionals were in charge of the computerization efforts, there would be a smoother path.

However, that is sadly not the case.  It will not happen until enough pressure is brought to bear on the IT industry and its apologists, which I believe will most likely only happen though coercion, not debate.

Finally, the endless stream of excuses and rhetoric that confuse non-healthcare professionals, such as typical patients who are the subjects of today's premature grand health IT experiment and our decision-makers in Washington, needs to be relentlessly challenged.  The stakes are the well being of anyone needing medical care.

-- SS

Note:  my formal reply to the Medical Billing blog post above awaits moderation.  I am reproducing it here:

1. Scot Silverstein, MD on 12 Oct 2012 at 3:59 pm #
   Your comment is awaiting moderation.
   
   Dear Ms. McCoy,
   
   Will all due deference, your own experience with EHR’s is obviously limited.
   
   Your comments demonstrate an apparent lay level of understanding of medicine and healthcare informatics.
   
   “Ridiculous?” “Learning curve?” I.e., experimentation on non-consenting human subjects putting them at risk with an unregulated, unvetted medical technology? That is, as kindly as I can put it, a perverse statement.
   
   Perhaps I am too harsh. You clearly didn’t check the link to the Healthcare Renewal blog conspicuously placed in the NYT article by Milt Freudenheim.
   
   I suggest you should educate yourself on the science and ethics of medicine and healthcare informatics.
   
   I am posting the gist of your comments, and my reply, at that blog.
   
   I do not think most truly informed patients would agree to being guinea pigs as your comments suggest is simply part of the “leaning curve.”
   
   Scot Silverstein, M.D.
   
   

I'll bet the author of the Medical-Billing.com post never heard critique like this coming from today's typical abused-into-submission, learned helplessness-afflicted physicians.

A bit harsh?  Lives are at stake.

-- SS

Health IT Ten Commandments (1970) v. Health IT Truisms (2012)

In 1970, health IT pioneer Dr. Octo Barnett at Harvard/MGH wrote his "Health IT Ten Commandments" (from Collen's "A history of Medical Informatics in the United States, 1950-1990"): 

1. Thou shall know what you want to do

2. Thou shall construct modular systems - given chaotic nature of hospitals

3. Thou shall build a computer system that can evolve in a graceful fashion

4. Thou shall build a system that allows easy and rapid programming development and modification

5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use

6. Thou shall have duplicate hardware systems

7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems

8. Thou shall be concerned with realities of the cost and projected benefit of the computer system

9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization

10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

Four decades later, I write the following 2012 "Health IT Truisms" (perhaps more to follow).  Many of the points summarized here can be found in the past 8 years of my writing on this blog:

1.  Health IT in 2012 remains experimental, not proven effective or safe, with actual results conflicting.

2.  Health IT is costly, not money-saving, diverting scarce healthcare resources away from actual healthcare provision to the IT industry.

3.  "EHR" is an anachronistic term (that disarms the uninformed, who "see" an innocuous file system)  for what is now an enterprise medical resource and workflow control system.

4.  The proper framework in which to view "resistance" to health IT is not Luddite clinicians vs. IT modernists.  It's pragmatist clinicians (with ethical and legal obligations and responsibilities), vs. IT hyper-enthusiasts who ignore or are blinded to the ethical considerations and downsides, and whose actions are based not on science, but on faith in technology and self interest.

5.  HIT can be partitioned into good health IT (GHIT) and bad HIT (BHIT) - see definitions at the introduction to  http://www.ischool.drexel.edu/faculty/ssilverstein/cases.

6.  BHIT prevails due to its being far cheaper to produce than GHIT and due to lack of meaningful industry regulation of quality, usability and safety.

7.  The lack of HIT regulation, post-market surveillance, formal validation and accountability is a special accommodation that is unprecedented in modern medicine.

8.  Underlying HITECH and "Meaningful use" is the assumption that all HIT is good HIT.

9.  A good or even average paper system is better for patients than a bad health IT system.

10.  The incentives and coercive aspects of HITECH would not be needed if GHIT prevailed.

11.  The coercive force of government should have been directed not at users, but at sellers, to produce GHIT and to abolish BHIT.

12.  The term "meaningful use" is political rhetoric whose criteria were decided by committee and industry influence; nobody knows if meeting the criteria will prove truly "meaningful" or not.  (That medical informaticists placidly accepted the term is a disgrace to a field that strives for terminological precision; "good faith use" would have been precise).

13.  Human research protections are given the blind eye with respect to commercial health IT.

14.  Health IT being used safely is currently by happenstance and via compensation for flaws by clinicians who improvise (which itself introduces risk and is stressful), not by design.

15.  Business IT a/k/a MIS personnel have far too narrow an education and experience to make pronouncements about health IT "transforming" medicine.

16.  IT personnel should be part of the medical team, including liability for IT-related failure.

17.  The commercial health IT sector is not an evidence-based domain.

18.  A cybernetic "Libby Zion" catastrophe is unavoidable, and probably the only way to "transform" the health IT industry into an evidence-based industry - essential before that industry can even begin to "transform" (i.e., facilitate improvement of) medicine.

Had Dr. Barnett's Ten Commandments not been disobeyed in favor of cybernetic idolatry, the Health IT Truisms in 2012 would appear far different.

-- SS

The Rise of the Corporate Physician, and the "Metastasis of Big Corporations"

Public discussion has raised more questions over the last few months about physicians taking care of patients as corporate employees. 

More Physician Practices Taken over by Large Corporations

This year, more stories have appeared about large corporations taking over physician practices.  In February, there was an account of efforts by competing nominally non-profit health insurance company Highmark and nominally non-profit hospital system UPMC in Pittsburgh in a "race to gobble up private physician practices," per the Pittsburgh Tribune-Review.  In March, the Washington Post featured a first-person account of what it is like for a physician in a private practice to try to hold out against the trend towards corporate practice.  In May, the Los Angeles Times noted how for-profit dialysis provider Da Vita purchased a large, but already for-profit operator of physician groups.  In October, Reuters reported how the recently announced acquisition by giant for-profit insurance company UnitedHealth of the biggest Brazilian for-profit managed care company will result in UnitedHealth owning an operating a Brazilian network of hospitals and clinics.

Concerns about Concentration of Market Power and Prices

In an increasingly financialized country, the media has featured concerns that the trend towards corporate physician practice might result in increasing market power for a few large corporations, and hence increased prices.  For example, in August, Anna Wilde Matthews reporting for the Wall Street Journal, noted

 Hospitals say the acquisitions will make health care more efficient. But the phenomenon, in some cases, also is having another effect: higher prices. 

As physicians are subsumed into hospital systems, they can get paid for services at the systems' rates, which are typically more generous than what insurers pay independent doctors. What's more, some services that physicians previously performed at independent facilities, such as imaging scans, may start to be billed as hospital outpatient procedures, sometimes more than doubling the cost.
 
The result is that the same service, even sometimes provided in the same location, can cost more once a practice signs on with a hospital.

Major health insurers say a growing number of rate increases are tied to physician-practice acquisitions. 

As Ms Matthews also reported for the Wall Street Journal, state regulators are beginning to worry about acquisitions of doctors' practices by hospital systems may drive up prices.

California's attorney general has launched a broad investigation into whether growing consolidation among hospitals and doctor groups is pushing up the price of medical care, reflecting increasing scrutiny by antitrust regulators of medical-provider deals.

Concerns about Care Quality

Concerns about whether physicians who must practice under the command of corporate executives will be able to put patient care ahead of corporate interests are also appearing, but not yet as prominently.

For example, Steve Twedt, writing for the Pittsburg Post-Gazette in September, looked into whether the multiple practice acquisitions by the area's two biggest ostensibly non-profit health care corporations might affect patient care.  He first noted "competition between Highmark and UPMC for doctors, and health care overhaul that is steering doctors into larger systems...."  Then he suggested that this has lead to marked discontinuities in patient care when physicians switch employment,

Out of the blue, people will learn their doctor has left a practice with little or no explanation, and without a forwarding address. When a physician effectively disappears, the cause usually is tied to the physician's employment contract, says a local health care attorney.

These cases of apparently vanishing physicians may be due to the contracting practices of physician employers, particularly large health care corporations.  The lawyer Mr Twedt interviewed explained,

most physician contracts now contain clauses that prohibit doctors from soliciting patients if they leave a practice.

While it's not always clear what constitutes 'solicitation,' it generally means departing physicians cannot contact their patients to invite or entice patients to follow them to their new location. They also cannot take their patient list with them, since that is property of the practice.

'I would imagine the doctor wouldn't contact them because he can't, or he doesn't have their address,' said Mr. Cassidy.

Contracts also often require that doctors cannot practice medicine within 10 miles of the previous practice office, and sometimes the required distance is even greater. Nor can they give out information about the practice they're leaving. Violating these contract terms could mean a financial penalty, such as loss of severance pay.

Finally, and most troubling, cardiologist blogger Dr Melissa Walton-Shirley recounted in some much more colorful language some consequences of cardiology practices which were acquired by large hospital systems.  She noted...

 

Referral Decisions Influenced by Management Edicts, but Maybe Not Patients' Needs

 

Physicians may be

sweating bullets over whether they are going to hit their benchmarks to retain their salaries. My anxious friends are now calling me for more referrals and more practice support.  They take any transfer I give them....

They may

 morph from human flesh into a Rubik's cube of relative value units (RVUs), the formula through which all future salaries and bonuses are calculated.

Resulting Loss of Continuity

Independent cardiologists opened office doors to find their patients who were anticipating decisions on timing of defibrillators, caths, or medical therapy had undergone testing at other facilities. Those tests were interpreted by cardiologists who were in no way connected to their care, their referrals to unfamiliar testing venues now incentivized by hidden contractual microformulas. They were evaluated far away from the familiar eye of their long-time cardiologists.

Summary

Back in the day, most physicians who took direct care of patients did so out of practices they or other physicians ran and owned.  The majority of physicians who took care of physicians as employees worked for the military or the Veterans Administration, or took care of patients only part-time as faculty of medical schools.  In a country increasingly prodded by market fundamentalism, the last few years has seen a major change in health care:  more and more physicians are taking care of patients as employees of large corporations, more often for-profit.

 I should add, though, that the recent push towards corporate practice was not just due to market fundamentalism, but also seems to in part be due to provisions of the recent attempt at US health care reform, the Affordable Care Act, which called for care by large organizations called accountable care organizations (ACOs).   However, like some other major changes in health care in the US over the last few years pushed by the increasing dominance of large corporations, this one happened without any rigorous assessments of whether the benefits for individual patients or public health would outweigh the harms, and justify the costs. 

Justified by the realization, now mostly forgotten, that health care is nothing like an ideal free market (look here), direct health care used to be almost entirely provided by health care professionals, often working in small, non-profit community hospital settings.  In fact, the American Medical Association used to condemn the corporate practice of medicine.  In addition, the corporate practice of medicine used to be illegal in many US states (look here).

We have changed all that, without too much thought, and without any rigorous assessment.  Now it seems increasingly likely that these changes are just increasing health care costs, and probably will cause worsening patient care and will worsen patients' and the public's health. 

As Dr Melissa Walton-Shirley wrote more vividly,

Monopolies never meant to be planted in gardens so small grew like bull thistles, literally overtaking all the good things that small community medicine had to offer. They are now barely recognizable small towns with the crabgrasslike metastasis of big corporations....

Will there be time to rethink this headlong rush before our health care options are restricted to that provided by one of a few huge corporations?  

True health care reform would reverse the trend to organize health care within ever larger, more bureaucratic, more monolithic, more dominant organizations.  Such reform is unlikely to happen until we see the nadir produced by the current bandwagon. 

New York Times: "The Ups and Downs of Electronic Medical Records"

The "downs" of health IT have rarely been presented in a prominent public forum.

After a recent Center for Public Integrity series and New York Times story on EHR-related upcoding, the New York times does so again.  This blog is cited:

October 8, 2012
The Ups and Downs of Electronic Medical Records
New York Times
By MILT FREUDENHEIM

The case for electronic medical records is compelling: They can make health care more efficient and less expensive, and improve the quality of care by making patients’ medical history easily accessible to all who treat them.

Small wonder that the idea has been promoted by the Obama administration, with strong bipartisan and industry support. The government has given $6.5 billion in incentives, and hospitals and doctors have spent billions more.

But as health care providers adopt electronic records, the challenges have proved daunting, with a potential for mix-ups and confusion that can be frustrating, costly and even dangerous. 

"Dangerous" is the concept that has been most lacking in public debate.  Through my many years of writing on health IT difficulties and more recently my legal work, I know of injuries and deaths caused or contributed to by bad health IT (e.g., see here and here).  I experienced a tragedy in my own family as well.

The New York Times has done a significant public service in mentioning this critical issue, long hushed by the hyper-enthusiasts to whom computers seem to hold more rights than people, and to whom plans for a "cybernetic healthcare utopia" override long held principles and standards for human subject research protections.

Some doctors complain that the electronic systems are clunky and time-consuming, designed more for bureaucrats than physicians. Last month, for example, the public health system in Contra Costa County in California slowed to a crawl under a new information-technology system. 

Doctors told county supervisors they were able to see only half as many patients as usual as they struggled with the unfamiliar screens and clicks. Nurses had similar concerns. At the county jail, they said, a mistaken order for a high dose of a dangerous heart medicine was caught just in time. 

That scenario, not at all unique (e.g., see New York Times, "Designed for Efficiency, New Computer Software at Health Dept. Misfires", Nov. 2010 and my comments here), is a warning that the technology needs significant work and cannot just be rammed into place.

The first national coordinator for health information technology, Dr. David J. Brailer, was appointed in 2004, by President George W. Bush. Dr. Brailer encouraged the beginnings of the switch from paper charts to computers. But in an interview last month, he said: “The current information tools are still difficult to set up. They are hard to use. They fit only parts of what doctors do, and not the rest.”

Refreshing candor that should be coming from the present ONC leader, not the two-generations-ago former incumbent.

Like all computerized systems, electronic records are vulnerable to crashes. Parts of the system at the University of Pittsburgh Medical Center were down recently for six hours over two days; the hospital had an alternate database that kept patients’ histories available until the problem was fixed. 

Those crashes are also not uncommon.  See for instance my posts on the common refrain when that happens that "patient care has not been compromised" (query link).

Even the internationally respected Mayo Clinic, which treats more than a million patients a year, has serious unresolved problems after working for years to get its three major electronic records systems to talk to one another. Dr. Dawn S. Milliner, the chief medical informatics officer at Mayo, said her people were “working actively on a number of fronts” to make the systems “interoperable” but acknowledged, “We have not solved that yet.”

Perhaps the worst example of that phenomenon is the DoD-VA interface debacle.  See my apparently popular (based on "hits") March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?"

Still, Dr. Milliner added that even though there a lot of challenges, the benefits of information technology are “enormous” — improved safety and quality of care, convenience for patients and better outcomes in general.

Enormous?  It is quite clear that this has not been proven in the real world with large scale health IT, especially in its present form.  It may be the case that the improvements will be modest at best.  Many if not most healthcare problems may not be related to documentation at all (see my Dec. 2010 post "Is Healthcare IT a Solution to the Wrong Problem?" for instance).  Also, as I've written, a good or even fair paper record system is better for patients than BHIT (bad health IT).

In the rare event that a large-scale system goes down at Mayo, backup measures are ready, teams are called in to make rapid repairs, and if necessary “everyone is ready to go on paper,” Dr. Milliner said. 

Paper records do not unexpectedly "go down" en masse.

Reliable data about problems in the electronic systems is hard to come by, hidden by a virtual code of silence enforced by fears of lawsuits and bad publicity. A recent study commissioned by the government sketches the magnitude of the problem, calling for tools to report problems and to prevent them. 

"Omertà" is perhaps the best term of art for this form of silence...

Based on error rates in other industries, the report estimates that if and when electronic health records are fully adopted, they could be linked to at least 60,000 adverse events a year.

My own estimates are much higher if the technology and its industry are not first drastically reformed, as in my April 2010 post "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers."

The Obama administration will issue a report on patient safety issues in early November, the current national coordinator, Dr. Farzad Mostashari, said in an interview. That report was requested last year by a panel on health I.T. safety at the Institute of Medicine, a unit of the National Academies of Science.

Considering the available data is limited, as per the FDA and IOM itself (see addendum here), the report should be immediately suspect for underestimation/cheerleading if not whitewashing.

... Elisabeth Belmont, a lawyer for the MaineHealth system, based in Portland, advises hospitals to reject contract language that could leave them responsible for settling claims for patient injuries caused by software problems.

The IT industry is quite mature and no longer merits such special accommodation.  As in other industries, liability should be covered by the industry itself, not by customers (and patient victims).  See "No More Soft Landings for Software: Liability for Defects in an Industry That Has Come of Age", Frances E. Zollers, Andrew McMullin, Sandra N. Hurd, and Peter Shears, Santa Clara Computer & High Technology Law Journal, May 2005.

The institute also recommended that software manufacturers be required to report deaths, serious injuries or unsafe conditions related to information technology. So far, however, neither a new safety agency nor such a reporting system has been adopted.  Some of the largest software companies have opposed any mandatory reporting requirement.

Post market surveillance is standard for other medical device sectors and the pharma industry, as well as other mission critical IT sectors.  The continuing, remarkable special accommodation for health IT is unearned, unjustified and ethically inexplicable.

Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.” 

In other words, while I am an advocate for good health IT, the technology is not yet ready to be pushed nationally.  Bad health IT prevails.  From my Medical Informatics teaching site:

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. 

(I would replace the term "critic" with "realist" and/or "patient rights advocate.")

Another critic, Dr. Scott A. Monteith [who has guest-posted at this blog - ed.], a psychiatrist and health I.T. consultant in Michigan, notes that Medicare and insurance companies generally do not pay for experimental treatments that have not proved their effectiveness ... Dr. Monteith said the electronic systems were “disrupting traditional medical records and, beyond that, how we think” — the process of arriving at a diagnosis. For example, the diagnosing process can include “looking at six pieces of paper,” he said. “We cannot do that on a monitor. It really affects how we think.”

The systems are disruptive due to the paradigm changes, made far worse by their also often being mission hostile in design.

“The problem is each patient is an individual,” said Ms. Burger, who is president of the California Nurses Association. “We need the ability to change that care plan, based on age and sex and other factors.” She acknowledged that the system had one advantage: overcoming the ancient problem of bad handwriting. “It makes it easier for me to read progress notes that physicians have written, and vice versa,” she said.

While this is true, it is also true that the loss of context and structure produces legible gibberish that does not relate the patient narrative well.  Also, the same legibility improvement could be obtained via word processors - or typewriters - that cost far less than the tens of millions of dollars or more per organization that clinical IT commonly costs.

Some experts said they were hopeful that the initial problems with electronic records would be settled over time.

I'm one of them.  Without major health IT industry reforms, however, including strict adherence to evidence-based practices (as that selfsame industry sector demands of medicine and ironically and hypocritically claims its products will enable), I don't expect to see the problems settled in my lifetime.

Dr. Brailer, who now heads Health Evolution Partners, a venture capital firm in San Francisco, said that “most of the clunky first-generation tools” would be replaced in 10 years. “As the industry continues to grind forward, costs will go down,” he said. 

One should ask - why are 'first generation' tools still in abundance, decades into the healthcare information technology industry?  Further, as the industry "grinds forward" without oversight and patient protections, people will be injured.

Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money.  “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.”

That is an understatement.

(Not covered in this article perhaps due to limited space are the issues of information security, privacy and confidentiality that are compromised by current clinical IT.)

In conclusion, it is good that the New York Times has brought the downsides into the public eye.  While the technology's not "ready for prime time", a story like this is ready for prime time, and is in fact long overdue:

-- SS

Healthcare IT Transparency Could Stand Some Improvement

Transparency in the health IT sector is akin to the transparency of Pb (lead).

The following report comes from the FDA Maude (Manufacturer and User Facility Device Experience) voluntary-reporting database, reported by a (likely unhappy) biomedical engineer a month after the "incident" - the nature of which is deliberately kept hidden.  This is regarding the PICIS "Pulsecheck" EHR for emergency departments:

Report Date     05/14/2010

PICIS INC. CARESUITE ED PULSECHECK S/W, TRANSMISSION & STORAGE PATIENT DATA
Event Type:  Other
Patient Outcome:  Required Intervention

Event Description

The customer has reported a patient incident that has prompted a review of their internal process and possible issues surrounding the incident. The customer report alleges the involvement of picis' ed (emergency dept. ) electronic health record application, whereby, duplicate results were received by the picis ehr application from an enterprise info system, which, when displayed in their entirety may have contributed to some degree of confusion for the treating physician - the context of which the customer has declined to clarify any further.  [What in the world? -ed.] At this time, we have been informed by the customer that they are restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support picis' investigation.

"Restricted by senior leadership from disclosing any specific details regarding the patient's status, the specific type of result or evidence of application performance to support Picis' investigation?"

That is perverse on its face, and probably in violation of Joint Commission safety standards on reporting of incidents that could affect other organizations.

Manufacturer Narrative

Picis' investigation into the reported incident is based on a limited exchange of info with the customer, as well as our internal review of the application design and current configuration in use at the reporting site. Review of configuration files, existing system build at the client site, interface specification documents and previous customer communications demonstrate that the customer implemented and accepted the picis edis in 2008. During this process, the picis edis system was configured to display all results sent from the customer's enterprise system rather than configuring the results display in 'overwrite' mode. Prior to acceptance, an investigation by picis and the client revealed that it was the sending system, sending multiple duplicate results messages [great quality - ed.] and a request was made by the customer of that enterprise vendor [I can only wonder who that was - ed.] to investigate. However, due to the enterprise system's protocol for 'add on' tests, it was not possible to utilize the 'overwrite' configuration due to the risk of filtering out unique results and subsequently not presenting the clinicians with important info. Therefore, the customer elected to have all results displayed.

A workaround that apparently, from the limited information provided, led to physician confusion..."the context of which the customer had", not very helpfully, "declined to clarify any further."

Hospitals also are required to have add'l safeguards in place for the handling of critical results including expedited reporting of critical results with a licensed responsible caregiver rather than relying solely on standard results reporting processes (joint commission national patient safety goal 02. 03. 01).

This is not a resounding statement of confidence in health IT...

The customer is currently working with a 3rd party integration consultant to improve the handling of results sent to picis' electronic health record application. We are providing support as it is requested. At this time, no corrective action is needed. 

The "senior leadership" that withheld details was protecting what, exactly?  Money and contracts, perhaps; conflicts of interest, possibly ... but not patients.

All I can say is:

Imagine if this was a report on a new drug suspected of harming people. 

What in heaven's name was going on here?

As I've written many times, and as illustrated by this MAUDE report, the health IT industry must first be transformed into one of evidence-driven IT practices and transparency before anyone touting its products has any business even speaking about the technology "transforming medicine."

-- SS

Good HIT, Bad HIT, HIMSS And Reckless Technology Advocacy: Will This Hurt President Obama?

HIMSS, the Health Information Systems Management Society, is the large vendor trade group representing healthcare IT sellers.

At the HIMSS blog entitled "Health IT is an essential element to transform the Nation’s healthcare system" (link), Carla M Smith, MA, CNM, FHIMSS writes this with regard to the House  letter to HHS Secretary Sebelius asking her to suspend payments for the EHR Incentive Payments authorized in the American Recovery & Reinvestment Act of 2009:

HIMSS opposes halting the Meaningful Use EHR Incentive Program. Health IT is an essential, foundational element of any meaningful transformation of the Nation’s healthcare delivery system. 

(Of course, not mentioned is "transformed" into what, exactly; this utopian ideation is a topic for another time.)

A chart is then presented as to "how US civilian hospitals have, since the first incentive payments were made in second quarter, 2011, matured in their use of health IT."  Then this statement is made:

Healthcare providers are adopting certified EHRs and using them for meaningful purposes; thus, achieving Congressional intent to improve the quality, safety, and cost-effectiveness of care in U.S.

Really?  (See my Feb. 2012 post "Hospitals and Doctors Use Health IT at Their Own Risk - Even if Certified.")

This non-evidence based, amoral advocacy by HIMSS for health IT may cost the President the November election.  HIMSS has beguiled the president into similar unquestioning advocacy for the technology in its present form, which his opponents are now (rightfully) seizing upon as in the House letter.

The reckless mistakes made by HIMSS and their advocates include these two:

1.   The unquestioned belief that this expensive technology would save billions of dollars in healthcare costs, instead of depleting precious healthcare resources better spent on, say, improvement of healthcare services for the poor.

2.  More importantly, the appallingly naïve belief that any health IT is good health IT, and that any health IT is only capable of good, not bad.

HIMSS has thus failed to recognize - or perhaps worse, recognized but recklessly ignored - the profound difference between good health IT (GHIT) and bad health IT (BHIT).

As I defined at my teaching site on Medical Informatics:

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.  

I am an advocate of the former, and an opponent of the latter.

Bad health IT is prevalent in 2012 due to lack of meaningful quality control, software validation, usability standards and testing, and regulation of any type - a situation HIMSS long favored.   (The failed National Programme for HIT [NPfIT] in the NHS learned this the hard way, as will Australians needing emergency care, I predict.)

Put bluntly, in the end BHIT maims and kills patients, squanders precious healthcare resources, and drains the treasury into IT industry pockets (see my Oct. 3, 2012 post "Honesty and Good Sense on Electronic Medical Records From Down Under" and this query link on health IT risks). 

Further, the failure to recognize that the technology's downsides need to be understood and remediated before national deployment occurs and under controlled conditions, not after (which uses patients as non-consenting experimental subjects for software debugging), speaks to gross corporate negligence on the part of HIMSS.  It's not as if they did not have advance warning of all of healthcare IT's deficiencies. 

BHIT also permits record alterations after the fact that may be to conceal medical error.  I am aware of numerous instances of such alterations, fortunately caught by critical-thinking, detail-minded attorneys.  However, like health IT harms, the incidences of known alteration attempts likely reflect the "tip of the iceberg."

HIMSS and its fellow travelers have thus led this administration down the Garden Path of health IT perdition.

I warned of this in a Feb. 18, 2009 Wall Street Journal letter to the editor:

Dear Wall Street Journal:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. [That project, the NPfIT in the NHS, has now been abandoned - ed.]

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, MD

Mr. President, again, quite bluntly, the health IT industry took you for a ride, and the damage is done and is continuing due to lack of any meaningful health IT post market surveillance.   (As I wrote here, the untoward results have already been used against the current administration, with more perhaps to follow.)

In the U.S. we have the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) in place:

The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form.  See Elixir Sulfanilamide disaster. It replaced the earlier Pure Food and Drug Act of 1906.

It should be honored, not ignored via special accommodation to the health IT industry and its trade group.

HITECH also needs to be put in dormancy until the problems with these unregulated medical devices get worked out in relatively small, controlled settings to minimize risk, with patient informed consent.  This is in accord with human rights documents dating at least to the Nuremberg Code, as in any new, experimental or partly-experimental medical device, pharmaceutical, or therapy.

-- SS