Stanford authors: Evolutionary Pressures on the Electronic Health Record - "Deimplementing the EHR could actively enhance care in many clinical scenarios"

A brief post.  In this new JAMA article by Stanford authors:

Evolutionary Pressures on the Electronic Health Record
http://jama.jamanetwork.com/article.aspx?articleid=2545405 

Donna M. Zulman, MD, MS^1,2; Nigam H. Shah, MBBS, PhD³; Abraham Verghese, MD⁴

I note the passage:

... Deimplementing the EHR could actively enhance care in many clinical scenarios. Simply listening to the history and carefully examining the patient who presents with a focused concern is an important means of avoiding diagnostic error.7 Many phenotypic observations (the outline of a cigarette packet in a shirt pocket, or spotting neurofibroma, fasciculation, or rash) change the diagnostic algorithm and are easy to miss when work revolves around the computer and not the patient.

I predict pushback against such a bold and contrarian "de-implementation" assertion (contrarian to the hyper-enthusiast and industry narratives, that is).

The authors continue:

There is building resentment against the shackles of the present EHR; every additional click inflicts a nick on physicians’ morale. Current records miss opportunities to harness available data and predictive analytics to individualize treatment. Meanwhile, sophisticated advances in technology are going untapped. Better medical record systems are needed that are dissociated from billing, intuitive and helpful, and allow physicians to be fully present with their patients.

 

I also wrote the primary author with a link to an alternate solution to de-implementation that can "allow physicians to be fully present with their patients", namely, my Aug. 9, 2016 post "More on uncoupling clinicians from EHR clerical oppression" at http://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html

 

-- SS

Ioannidis et al.: What Happens When Underperforming Big Ideas in Research [such as Healthcare IT Exceptionalism] Become Entrenched?

Some years ago, John P. A. Ioannidis, MD wrote this piece:

"Why Most Published Research Findings Are False", John P. A. Ioannidis, PLoS medicine, 2005 August; 2(8): e124

He wrote:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

In other words, in the all-too-common insufficiently powered studies, and even seemingly robust studies in domains with small effect sizes, financial interests, prejudices and other factors more often than not produce false results.

Ioannidis and co-authors recently took their sword to "underperforming Big Ideas in research" (including the "miracles" touted by hyper-enthusiasts such as in genomics and in cybernetics), via a new JAMA viewpoint piece:

What Happens When Underperforming Big Ideas in Research Become Entrenched?
Michael J. Joyner, MD1; Nigel Paneth, MD, MPH2; John P. A. Ioannidis, MD, DSc3
JAMA. Published online July 28, 2016. doi:10.1001/jama.2016.11076
http://jama.jamanetwork.com/article.aspx?articleid=2541515

For several decades now the biomedical research community has pursued a narrative positing that a combination of ever-deeper knowledge of subcellular biology, especially genetics, coupled with information technology will lead to transformative improvements in health care and human health. In this Viewpoint, we provide evidence for the extraordinary dominance of this narrative in biomedical funding and journal publications; discuss several prominent themes embedded in the narrative to show that this approach has largely failed; and propose a wholesale reevaluation of the way forward in biomedical research.

The key word is "narrative."   As per Hayek, those with little real-world operational experience, i.e., intellectuals and academics, often the uncritical cheerleaders for electronic records despite considerable downsides, have only the "narrative" upon which they base their beliefs in healthcare IT exceptionalism:

It is perhaps the most characteristic feature of the intellectual that he judges new ideas not by their specific merits but by the readiness with which they fit into his general conceptions, into the picture of the world which he regards as modern or advanced. . . . As he knows little about particular issues, his criterion must be consistency with his other views and suitability for combining into a coherent picture of the world. . . . It is the intellectuals in this sense who decide what views and opinions are to reach us, which facts are important enough to be told to us, and in what form and from what angle they are to be presented. Whether we shall ever learn of the results of the work of the expert and the original thinker depends mainly on their decision.

(I can add that blogs have to some small degree ameloriated "whether we shall ever learn of the results of the work of the expert and the original thinker", but only to a small degree.)

The "general conception" in cybernetics is that computers are a silver bullet in any domain, and can only result in massive improvements. 

My experience for the past twenty+ years in the Electronic Medical Records/clinical information technology domain, where quality, safety, usability, confidentiality, and other critical real-world issues have been ignored in favor of EHR hyper-enthusiasm, supports Hayek's observations regarding prevalent unfettered beliefs in healthcare IT exceptionalism.

Ioannidis et al. state the factual situation with EHR technology unapologetically, clearly and succinctly:

... The financial and clinical benefits predicted from shifting to EHRs have also largely failed to materialize because of difficulties in interoperability, poor quality, and accuracy of the collected information; cost overruns associated with installation and operation of EHRs at many institutions; and ongoing privacy and security concerns that further increase operational costs.

I would change "interoperability" to "operability."  Otherwise, they're quite correct.  For example, the "Big Data" hyper-enthusiasts quite irrationally believe data from these systems - as they are today -  will somehow "revolutionize" medicine, while at the very same time the IT industry itself and its pundits ignore fundamental precepts of computer science, information science, biomedical informatics, biomedicine and biomedical research itself. 

Some of the hyper-enthusiasts have made predictions that are astonishingly naive, delusionally grandiose and just plain perverse, e.g., see for instance my Jan. 2014 post "Computers + a few docs can manage 'an entire city', and other cybernetic miracles" at http://hcrenewal.blogspot.com/2014/01/computers-few-docs-can-manage-entire.html . 

The new JAMA paper continues:

... These features make the use of EHRs for research into the origins of disease, as proposed in the Precision Medicine Initiative, highly problematic.No clearly specified targets for either improved outcomes or reduced costs have been developed to assess the performance efficiency of EHRs.

Those targets were never specified, but The Market seems to have corrected for that, e.g., via this Jan. 2015 letter from ~40 different medical societies:

 Full letter to HHS available at http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf

The authors continue:

... Although it is difficult to argue for a return to paper records, any claim of future transformation of the medical record should include well-defined accountability and review mechanisms. Otherwise, the health care system may become hostage, wasting increasing resources to continuously upgrade electronic technology without really helping patients.

It is clear to me that the health care system and its clinicians are already hostage to the cybernetic hyper-enthusiasts, as evidenced by letters such as the above and many other sources about the mayhem being caused, e.g., a small sampling on this blog at query links http://hcrenewal.blogspot.com/search/label/glitch, http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20difficulties and http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality.

Finally, I disagree with the authors that "it is difficult to argue for a return to paper records."

Paper has its proper place, and "paperless" is a utopian dream of the hyper-enthusiasts that causes significant damage to the primary role of clinicians - to take care of patients.  I make this argument (with a real-world, highly successful example of my own creation) at my Aug. 9, 2016 post "More on uncoupling clinicians from EHR clerical oppression" at http://hcrenewal.blogspot.com/2016/08/more-on-uncoupling-clinicians-from-ehr_91.html.

In summary, the authors of this JAMA piece clearly and succinctly break through the "narrative" about hyper-enthusiast dominated fields, including clinical information technology and the belief in 
healthcare IT exceptionalism.
 
Sadly, theirs is almost a single voice in a wilderness dominated by the hyper-enthusiasts - and the profiteers.

-- SS

JAMA LAYS AN EGG

JAMA LAYS AN EGG 

Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.

Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a reply from the original authors. So JAMA didn’t deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.

The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.

The closing sentences of their reply letter illustrate these issues: “Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work.” The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients’ consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.

If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.

UPDATE 05-03-2016
Apparently the link to my earlier post is inoperative. My apologies. Here is a link that should work.
http://hcrenewal.blogspot.com/2016/01/jama-jumps-shark.html 

JAMA JUMPS THE SHARK

JAMA JUMPS THE SHARK

Medical journals are supposed to promote professional values – scientific, social, and ethical. Quality matters, in each of these domains. Lately, however, highly ranked journals are failing in respect of ethics commentaries. Some editors seem happy to publicize or even to co-author commentaries that are dismissive of current ethics initiatives – like transparency of data reporting and disclosure of conflicts of interest (COI). That’s one way for journals to jump the shark in the race for ratings. They surely get attention and applause in some quarters – but those stunts are net negatives for the journals. Here is one example.

Last fall, JAMA went splashy with a sappy Viewpoint article on conflict of interest by Anne R. Cappola and Garret A. FitzGerald. Anne Cappola is also an associate editor of JAMA – what a coincidence! The article was a Pollyanna piece by these two professors at Penn, promoting pushback on perceived pharmascolds, but really just papering over the problem of COI. The sappy formula? They declared conflict of interest to be a pejorative term that should be replaced by confluence of interest. This casuistry was backed up by wishful thinking and hortatory hand waving, weakly argued. Mostly, it gave the impression that the authors, presuming to speak for investigators generally, were offended by the increasing regulations for managing COI. Those developments have occurred at the Federal, institutional, and publication levels. Worse, the authors ignored the reality of recent corruption that led to those new regulations. That uncomfortable fact was airbrushed out of their discussion. In response, one critic of confluence of interest, writing on the COI blog, aptly raised a comparison to Wall Street: “The phrase also reminds me of a statement by then king-of-the-hill securities analyst Jack Grubman: “What used to be a conflict is now a synergy.” (Three years later Grubman was fined $15 million dollars and barred from the industry for life for what were apparently still considered COIs.)”

The Viewpoint article appeared on-line September 24, 2015, and four days later I sent a critical reply to JAMA. The printed version of the Viewpoint article appeared November 3, 2015, and on 4 December, 2015 I was notified that JAMA chose not to publish my letter to the editor. During the following six weeks, now nearly five months since it appeared, JAMA published no replies whatsoever to the Viewpoint article. Could it be that JAMA has deep sixed all the responses? That’s one way to manage bad publicity, but it is inconsistent with the standards we expect of a journal like JAMA. Here is the text of my letter to the editor of JAMA. Keep in mind that there is only so much one can say within a limit of 400 words and 5 references.

LETTER TO EDITOR, JAMA 09-28-2015            Text word count 389

                                                                                5 references

TITLE: CONFLICT OF INTEREST

In their recent Viewpoint (1), Anne Cappola and Garret FitzGerald recommended replacing the term conflict of interest (COI) with confluence of interest, declaring a pejorative connotation of the term conflict. A better suggestion would have been competing interest, which already is in wide use (2) and which does not paper over the problem. The authors did not frankly acknowledge the gravity of recent COI scandals that led to the situation they decry. Sadly, there are real, common, serious, and unacceptable conflicts of interest. Boundaries are needed, and the authors’ effort to weaken the boundaries is misguided.

Their case for re-framing COI more benignly as a confluence of interests is weakly argued. For instance, they warned of concern that current policies on COI “… might restrain innovation and delay translation of basic discoveries to clinical benefit.” (1) They produced no evidence for that speculative assertion, though they said it was a key reason for their endeavor. Moreover, COI policies do not demonize collaboration with industry. We once had an honorable tradition of interacting with industry while retaining our integrity as clinical scientists. That tradition broke down when academic investigators in many specialties were coöpted as key opinion leaders (KOLs) by the marketing departments of corporations. There followed an era of corruption in corporate-funded and KOL-managed continuing medical education and journal supplements; of experimercials disguised as KOL-initiated clinical trials (3); of rampant, biased ghostwriting, commissioned by corporations and often with cynical honorary KOL authorship; and of selective analyses of clinical trials data designed to exaggerate benefits, minimize harms, and maximize markets (4). We can readily agree with the Viewpoint authors that these practices had the effect of “biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator” (1). Inevitably, those practices and individuals were exposed, which led to Congressional action and to staggering legal penalties (over $3 billion in the case of GlaxoSmithKline) (5). In response, COI policies were strengthened at the Federal and institutional levels and, of course, they now inconvenience everybody. Such is the way of bureaucracies. As we survey the aftermath, we should direct our annoyance to the many opportunistic investigators who entered into those compromised relationships with industry. It makes no sense now to shoot the messengers or to use sophistry in an attempt to define the problem away.

ACKNOWLEDGEMENTS

The author declares no competing financial interest or other conflict of interest.

REFERENCES

(1) Cappola AR, FitzGerald GA. Confluence, not conflict of interest: Name change necessary. JAMA. Published online September 24, 2015. doi:10.1001/jama.2015.12020.

(2) James A, Horton R, Collingridge D, McConnell J, Butcher J. The Lancet's policy on conflicts of interest––2004. Lancet. 2004; 363 (9402):2-3.

(3) Carroll BJ. Sertraline and the Cheshire cat in geriatric depression. American Journal of Psychiatry. 2004; 161(6): 1145-1146.

(4) LeNoury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.

(5) U.S. Department of Justice, Office of Public Affairs. GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data. July 2, 2012. http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report Accessed 09-25-2015.

So, yes, Virginia, there is real COI and there is real corruption in medical science. You cannot make them go away by wishing them away. And, JAMA, if you allow your editors to promote divisive, weak, and problematic ethics positions, at least have the decency to allow debate.

Bernard Carroll.

WHEN IS DISCLOSURE NOT DISCLOSURE?

WHEN IS DISCLOSURE NOT DISCLOSURE?

Hint: When it is made by the Chairman of the DSM-5 Task Force.

Here is a case study in conflict of interest (COI). A remarkable confession has just appeared by a group of 5 prominent academics, writing in the journal JAMA Psychiatry. Having been outed to the Editors, they now admit to concealing pertinent financial information. One of the five is David J. Kupfer, MD, chairman of the DSM-5 Task Force and past chairman of the department of psychiatry at The University of Pittsburgh. The others are from Pittsburgh, Minnesota, and Chicago.

With millions in funding from NIMH, these folks have been developing new approaches to testing for anxiety and depression. The technical details are not important for this story. What matters is that they have clearly set their sights on a large market for diagnostic screening, epidemiological research, and clinical practice. They have recently published promotional reports talking up three products and projecting major applications – but before taking care of the nuts and bolts of scale development.

Their major report in JAMA Psychiatry contained a disclosure to the effect that they might at some time in the future consider commercial development of their depression scale. This disclosure was phony. We now know that, in lieu of frankly disclosing a major COI, they opted for a disingenuous, dissembling statement that was economical with the truth.

I thought the content of their report was sub-par, and the journal published a letter from me to that effect. They responded to my criticism with hand waving, and they tried to impugn me for bias related to my own (disclosed) COI. This foolish, ad hominem tactic aimed to divert attention from the substance of my critique – for which they had no adequate response.

As I am not a person who suffers fools or insults gladly, their evasive response caused me to do some checking. I quickly learned that the gang of five are shareholders in a private corporation. Before their paper was accepted by JAMA Psychiatry, the corporation was incorporated in Delaware and soon after registered to do business in Illinois. Those facts were not disclosed in the original report or in the published letter of Reply to me. These omissions were acknowledged in the notice of Failure to Report that appeared on-line today.

It gets worse. Other things that I learned – and that I communicated to the journal – make it clear that the corporate train had left the station in advance of the letter of Reply. For instance, a professional operations and management executive (Mr. Yehuda Cohen) had joined the corporation. He had established the corporate website, where he was featured as a principal, along with the gang of five. The website also displayed a professionally crafted Privacy Policy, dated ahead of the letter of Reply. This document identified what appears to be a commercial business address for the corporation. The notice of Failure to Disclose is silent on these facts.

So, the published notice of Failure to Disclose still withholds pertinent information, which makes a mockery of the weasel words that they have not released any tests for commercial or professional use. Not yet, they haven’t. But they are under way, make no mistake. This prevarication creates the impression of a habitual lack of transparency. Considering that I gave the journal all this information, one has to be surprised that JAMA Psychiatry went along with this prevarication. Plus, would it have killed them to apologize for their foolish attempt to smear me, as I requested? In correspondence with me, the Editor in Chief of JAMA didn’t want to go there, and he refused to publish my letter that detailed the facts, citing the most specious of grounds. The Editor of JAMA Psychiatry has ducked for cover when I faulted him for publishing the ad hominem material in the first place.

This deplorable episode casts a pall on the repeated assurances by Dr. Kupfer that COI issues were under control in the DSM-5 process. If the chairman of the DSM-5 Task Force doesn’t have his own act together, then what are his assurances worth? The new instruments proposed by this corporation bear an eerie resemblance to cross-cutting dimensional measures that were promoted for DSM-5 but that didn’t make the final cut. As far as I know, Dr. Kupfer didn’t declare his interest in this corporation for scrutiny vis à vis DSM-5.

Another lesson is that even Failure to Report notices can be weasel documents. I fault the Editors of JAMA Psychiatry, Joseph Coyle, MD, and of JAMA, Howard Bauchner, MD, for the non-rigorous standard they applied to the notice of Failure to Disclose. They acquiesced in another dissembling response.

Yet another lesson is that all authors are accountable for the accuracy of disclosure statements. Some of these authors might claim they relied on the lead author and president of the corporation, Robert Gibbons, PhD, a statistician at The University of Chicago, to make sure everything was kosher. Big mistake – just like the infamous case of the Nemeroff-led Cyberonics – vagus nerve stimulation review that failed to disclose that the academic authors (ahem) were paid consultants of the corporation. When your name is on the byline, be sure you cover the bases for your own protection, and don’t squawk when you are called out.

Finally, where is NIMH in all of this? Since when are public NIMH funds to be treated as commercial seed money? Who actually owns the algorithms and data bases on which the Gibbons corporation relies for its commercial aspirations? Why are they not publicly accessible? Is Thomas Insel on top of this?

An Open Letter to the Joint Commission on Their Fiduciary Responsibilities Concerning Health IT

An open letter to the Joint Commission. Emphasis in the original:

From: S Silverstein
Sent: Friday, October 14, 2011 9:21 AM
To: MGiuntoli, Anita; Chassin, Mark; Legaspi, Shirley; McKee, Ana; Schyve, Paul [Joint Commission leaders - ed.]
Cc: [State senator aware of the situation, who was seeking votes at a nursing home/ rehab center while my mother was being treated - ed.]
Subject: "Diary of EHR-Initiated Tragedy"

Dear Joint Commission,

Now that Medicare's [state] QIO has found my mother to have been a victim of care that "did not meet applicable professionally recognized standards of health care" (as at http://hcrenewal.blogspot.com/2011/10/there-are-still-some-medical-watchdog.html), I am making available an overall detailed account of what occurred to her. The account, though anonymous as to hospital, location, clinician ID's etc., is at this link:

http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary

I should let you know that the Drexel URL's readers are tracked (by IP only); in other words, I will be able to tell if JC looked at it or not.

It is my opinion that the JC and its leaders have a primary fiduciary responsibility to prevent such mishaps from occurring, through significantly tighter oversight of hospital's use of IT, which in reality are experiments on human subjects without informed consent.

Please consider yourselves informed of these views.
Sincerely,

Scot Silverstein, MD
Drexel University
Philadelphia, PA

I don't believe any further explanations are necessary.

Oct. 14, 2011 Addendum:

We've corresponded before, the JC and I, after my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in the Journal of the American Medical Association in July 2009, JAMA. 2009; 302(4):382. doi:10.1001/jama.2009.1041, and again after my mother was injured in 2010.

In that 2009 JAMA letter I'd opined:

... When hospital leadership signs agreements specifically excluding the sharing of information about HIT defects and user complaints, it seems they have violated these standards. [That is, Joint Commission Safety Standards such as LD.01.03.01 and LD.03.04.01 that I cited earlier in the letter; see above link to an extract of the letter - ed.] Nondisclosure seems to violate the standards’ spirit and letter.

Signing such HIT contracts may also represent a violation of the legal and fiduciary duties of hospital administrations to protect not just patients but also employees from undue physical and legal jeopardy. Placing the entire burden of liability for HIT malfunctions on clinicians, and not obtaining informed consent from patients for use of these systems, seems a major deviation from the responsibilities of persons with legal and fiduciary obligations to discharge faithfully a responsibility of trust toward others, including safety.

This was nearly a year before my mother became injured.

-- SS

Oct. 16, 2011 addendum:

See what the President of the American College of Physicians (ACP) thinks about today's health IT via my post here.

-- SS

JAMA: "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?" - No, But Utopia Arrives Soon

At a new JAMA piece "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?", former Columbia U. and now NIH medical informaticist James J. Cimino, MD points out issues with the documentation that results from health IT systems.

A preview of the first page of this short Viewpoint piece is available free at this link.  It includes the observation that:

... There is no question that computerization has made patients’ records more available and legible. With respect to completeness, however, there are now complaints that the record is too complete: electronic notes are deemed by many clinicians as being full of extraneous details and obscuring important aspects of a patient’s condition

Dr. Cimino goes on to state that:

Empirical observational studies of clinicians have shown ways to improve EHR functionality ... Similar research on clinical documentation processes is needed to advance this crucial EHR component.

These are excellent observations.

The issue I have with the piece is - and I am finding this true of many articles critical of today's health IT - the ending, which I'm finding to often be PR.  Or, perhaps it would be more accurate to call the endings of late a "salvage operation-style" attempt to save face for the informatics community, who let this domain be overrun by the corporate IT sector and terrible products that violate many of the precepts of design of good health IT learned during five decades of research.

Cimino concludes an otherwise constructive piece with this statement:

... Rather than complain about the challenges [a euphemism if ever I saw one - ed.] they have introduced, clinicians should recognize that current EHRs are illuminating the opportunities for the next generation of systems that will support clinicians as active partners across the spectrum of health care settings and tasks. The resulting improvements in documentation will, in turn, support patients, administrators, and researchers as we move towards a true learning health system.

I note this assertion is at complete odds with the dictum I was taught from my earliest medical mentors, and that no amount of wishful thinking will banish:

"Critical thinking always, or your patient's dead." (Cardiothoracic surgery pioneer Victor P. Satinsly, M.D., Hahnemann Medical College, Philadelphia, early 1970s.)

Translating the statement into plainer English, it seems to me that Cimino is saying this:

"Doctors, shut up, stop complaining about the chaos and patient/professional risk today's bad health IT is causing, take the medicine your betters have prescribed for you, and don't be uncompromising patient advocates as patients are secondary in this quest to reach IT-based Healthcare Utopia - which we will reach come version 2.0."

(This comes, ironically, at a time when physicians are starting to get a voice, e.g., Twitter's #EHRbacklash.)

It appears articles with even a faint tinge of anti-health IT sentiment - in addition to the traditional methods, results, limitations etc. sections - have an "appeasement" section as well.  Perhaps this it what it takes to get past peer review and/or industry ire.

In my view, this salvage mentality sprinkled with euphemisms and Utopian rhetoric spoils an otherwise constructive piece.  This type of language and utopian predictions about HIT have also appeared in other major medical publications by informatics and healthcare leaders (including top governmental office holders), as for example here.

Now, I know Jim Cimino and he is a good scientist.  However, I truly wish the non-scientific, "wait for version 2.0", utopian P.R. would stop.  As a member of the Medical Informatics profession myself, it's actually become embarrassing.

-- SS

JAMA Article Begs Key Questions About Case of Contaminated Heparin

There was a recent reminder of the case of the tainted heparin, which begged more questions than it answered.  (A case summary is appended to the end of this post, and nearly all our posts are here.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.   Three years later, how the heparin was adulterated, and who was responsible are still unknown.
JAMA just published a major news article (Kuehn BM. As production goes global, drug supply faces greater risks to safety, quality.  JAMA 2011; 306: 811-813.  Link here.) This, in turn, was based on a five page case study of the heparin incident in a report by the Pew Health Group entitled "After Heparin: Protecting Consumers from the Risk of Substandard and Counterfeit Drugs" (link here).  Reading between the lines, the Kuehn article raised several questions which it did not seek to answer, but which we have raised previously.

Why Didn't Baxter Look the Gift Horse in the Mouth?

The JAMA article noted that in general, "pharmaceutical companies are shifting the production of drugs and drug ingredients to emerging economies - primarily India and China - to save money."  [italics added for emphasis]  Also, "Many emerging economies do not have robust regulatory systems, and regulators from the United States or other countries may face hurdles in trying to oversee production in these nations."

Why were Baxter International executives not concerned about the quality of a drug offered cheaply from firms in countries with little regulatory oversight? 

Note that we have been asking versions of this question since 2008, e.g., "How hard did Baxter scrutinize the production of the drug? How hard did SPL scrutinize its production? Did Baxter, SPL and/or the FDA realize the drug was being produced in an unlicensed Chinese chemical factory which had never been inspected by the Chinese or US government? If they did, why did they accept its product? If they didn't, why didn't they know?" - from this post on February, 16, 2008.

Who Is Responsible for the Complexity and Opacity of the Out-Sourced Supply Chain?

The article stated, "In addition to becoming more global, the drug supply chain has also become more complex, .... Drug ingredients are now imported from 150 countries, and multiple suppliers, producers, and distributors may be involved in the production and import of a single drug." 

In particular, the article noted that "Baxter relied on the assessment of another company when it began receiving heparin from the plant through which the adulterated drug came."  (The nameless other company was Scientific Protein Laboratories.)  Also, it noted that the supply chain began at "the primitive workshops that extract heparin crude by cooking and drying pig intestines" and proceeded to "the companies that consolidate materials from many such workshops and sell them to the factories that produce heparin."  The article did not discuss how this particular supply chain came into existence.

Did not drug companies in developed countries, like Baxter International in this case, create these convoluted supply chains (mainly to save money, as noted above)?  If not, did they not at least enable the creation and operation of these chains by purchasing their products without asking too may questions?  In any case, the supply chain's complexity and opacity arose out of individual humans' decisions, not an act by a deity. 

Why Have no Individuals Been Held Accountable? 

The article noted that the Pew report suggested, "increasing the financial penalties and allowable prison terms for individuals and companies who violate the rules from their current maximums of $10 000 or 3 years in prison." The implication was that these penalties have proven insufficient.  However, the article failed to note that so far in the case of the tainted heparin, no such penalties have even been sought.  To my knowledge, neither Baxter International, Scientific Protein Laboratories, nor any individual who worked for them has ever been charged with any violation of "the rules" that could result in any penalty as much as "$10 000 or 3 years in prison."    I have asked repeatedly why so far there has been no obvious effort to hold any individual accountable for the contaminated heparin?  (see this post from July 19, 2010, in which I noted legal actions against doctors who implanted IUDs imported from and approved in Canada and asked, "why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients? 

Why Are the Key Issues In This Case Still So Anechoic?

Neither the JAMA article nor the heparin case study in the underlying Pew report directly addressed these questions.  The JAMA article also omitted such details as the name of the company from which Baxter directly purchased the heparin (Scientific Protein Laboratories) and the total number of deaths that may have been related to the heparin.  (It only mentioned 3 deaths related to heparin, while the Pew Report noted the FDA got reports of 68, six more of which it allowed were "possibly caused by the adulterant, 24 were unlikely, and 35 were unassessable.")  As mentioned above, the JAMA article seemed to imply that criminal penalties have been applied to corporate executives whose companies may have profited from cheap but defective out-sourced drugs (but none have been applied in the heparin case).   Ironically, while the JAMA article identified the "culprit" for the adverse events in the heparin case, it used the word to refer to the compound that adulterated the heparin, not those who added it, or who enabled its addition. 

Summary

Thus, the public discussion in the main-stream medical media of the case of the adulterated heparin is still remarkably squeamish even three plus years after it first became public.  While the heparin case has made it into major medical journals, it still simply is not done to even publicly discuss whether the leaders of health care organizations who become rich partly as a result of decisions such as the unsupervised, uninspected, apparently barely considered out-sourcing of heparin to be accountable when these decisions turn out to have adverse effects on patients.

If we cannot even discuss the accountability of leaders of health care organizations, how can we hope to actually hold them accountable?  

To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.


To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

Case Summary

- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.


- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)

- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."


- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post here).

- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

-  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)

-  In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post here.)

-  In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.

Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look here and here for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.

Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?

In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes?

Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

Inquiry to Joint Commission on points I raised in my July 22, 2009 JAMA letter on HIT

As I posted here, my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA on July 22, 2009. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

This JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing HIT "Hold Harmless" and "Defects Nondisclosure" contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability.

I've sent the following inquiry to Paul M. Schyve, M.D., Senior Vice President, The Joint Commission:

July 24, 2009

Paul M. Schyve, M.D.
Senior Vice President
The Joint Commission
schyve@jointcommission.org

Cc: MChassin@jointcommission.org, otrippi@jointcommission.org

Dear Dr. Schyve,

In testimony to the House Committee on Veterans' Affairs on July 22, 2009 at this link , you state:

... The Joint Commission has established standards that require the hospital to:

• Create a culture in which adverse events are reported and evaluated for underlying ("root") causes, and preventative actions are taken.
• Identify high-risk processes and prospectively determine their possible modes of failure, the effects of those failures, and the actions that will prevent the failures or mitigate their effects.
• Establish a culture of safety throughout the hospital. This accreditation standard became effective January 1, 2009, although its purpose and expectations were publicized for over a year in advance.

In my JAMA letter to the editor of July 22, 2009 entitled " Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" ( link ), I point out that the Hold Harmless and Defects Nondisclosure clauses signed by hospital executives in contracting for healthcare information technology (such as CPOE and EHR systems) are in violation of Joint Commission safety standards, as well as hospital executive fiduciary responsibilities to patients and clinicians. These clinical IT systems can and do cause medical errors and patient harm.

My letter was in response to Koppel and Kreda's March 25, 2009 article " Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians ", JAMA. 2009;301(12):1276-1278.

I am interested in the Joint Commission's response to the issues I raise.

I await a response.

-- SS

JAMA letter: "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"

My letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA yesterday. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

The letter was in response to Koppel and Kreda's groundbreaking March 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians."

The JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing such contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability. In the Drexel website essay I also noted that:

... these stipulations [hold harmless and gag clauses in contracts] further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel.

Koppel and Kreda note in their JAMA reply to my JAMA letter that:

Dr Silverstein's letter adds context to our Commentary on HIT vendors' self-protective "hold harmless" clauses while introducing an important discussion about hospitals' and vendors' possible violations of Joint Commission standards. We agree with Silverstein about the misapplication of the standard business software contracting model.

Of interest, the American Medical Informatics Association (AMIA) had authored a reply to Koppel and Kreda quite different than mine, which for a time appeared on their national website (www.jamia.org) but was later withdrawn apparently due to concerns that such a letter might be viewed as an official organizational position. It was entitled "Response to Commentary in JAMA -- Ross Koppel, David Kreda" and can be read in its entirety here.

The AMIA response piece concluded:

"While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals. At a minimum equal attention needs to be given to the role that provider organizations bring to configuration, management and oversight of the software and related processes."

In fact, Koppel and Kreda addressed the provider side issues extensively in their article.

Of interest, JAMA did not publish the AMIA response but instead published mine. Perhaps it's because JAMA felt I had something important to say, as opposed to simply making excuses for HIT vendors and valuing prevention of "stifling of innovation" over hospital leadership's safety and fiduciary obligations to patients and staff.

"The belief that the best approach to improving HIT safety is via regulation is misplaced?" (Misplaced how, exactly?) Tell that to the airline or public transit or pharma or the medical device industries. Or to the public whose care is increasingly dependent upon these HIT systems.

It is my firm opinion that "innovation" done recklessly, in secrecy, without accountability, and via exploitation is not innovation at all.

-- SS

July 23 addendum:

Dr. Koppel has forwarded to me a letter he and Mr. Kreda submitted to AMIA in response to AMIA's aforementioned critique of his March 2009 JAMA "Hold Harmless Clause" article. Koppel and Kreda's letter, "On the AMIA Response to Commentary in JAMA by Ross Koppel and David Kreda" can be read here (MS Word .doc format).

Highlights:

... Where the AMIA authors disagree with us is the emphasis placed on errors produced in the coupling. [The coupling of healthcare organization and software, i.e., alterations and customizations beyond the control of the software vendor - ed.] We say a vast number or errors are generated in the marriage. But they say we have essentially ignored how many errors are created by doctors and hospitals seeking to consummate their relationship with HIT systems in situ ...

... A brief recap of our JAMA commentary seems in order. We wrote about: (1) the HIT vendor “non-disclosure” clauses that prevent clinicians from sharing information about errors generated from faulty software; (2) the clauses that remove all vendor responsibility for errors in their systems – and place all responsibility on clinicians and hospitals (the “hold harmless/learned intermediary” clauses); (3) the need to protect vendors from responsibilities for errors introduced when hospitals implement HIT or when untrained or incompetent clinicians use the HIT; and (4) the need for more balanced contracts that are fair to clinicians and hospitals ...

... Given that we addressed the non-software issues we are said to have ignored, we are not sure why our JAMA commentary earned the response it received on official AMIA letterhead. We hope, therefore that this letter can further a longer conversation about the many ways to make clinical IT software and its implementation better. Nonetheless, we stand by our statement that the imbalance in incentives we described in our JAMA Commentary is a structural obstacle that on balance hurts improving the clinical part of clinical IT.

Read the whole thing at the link above. (I placed Koppel and Kreda's response to AMIA on my faculty server. The response, to the best of my knowledge, was not published by AMIA itself.)

-- SS

JAMA Editors Try Attacking the Messenger

Early this month, yet another story surfaced about allegations of undisclosed conflicts of interest affecting the author of a highly publicized clinical trial. This story has now taken such an odd twist that it seems worth discussing in some detail. Let me first try to present some relevant facts, derived from published articles, mainly peer-reviewed, which do not seem to be in dispute, in chronological order.

2005 - In a multi-author review article on mood disorders in the medically ill, Dr Robert G Robinson, of the University of Iowa, disclosed that he served on the speakers bureau of Forest Laboratories.(1) In an article in Stroke: Clinical Updates, he made a similar disclosure.(2)

28 May, 2008 - Dr Robinson was the first author of an article published in JAMA that described a randomized controlled trial comparing placebo, problem-solving (cognitive talking) therapy, and escitalopram (Lexapro, Forest Laboratories) in the prevention of depression in patients who have had strokes.(3) Patients who received placebo had a higher rate of depression (11 major, 2 minor cases, 22.4%) than patients who received escitalopram (3, 2, 8.5%) or who received problem-solving therapy (5,2, 11.9%). At the end of the article, Dr Robinson disclosed, "over the past 5 years, Dr Robinson reports serving as a consultant to the former Hamilton Pharmaceutical Company and Avanir Pharmaceutical Company," but made no disclosure about any financial relationship with Forest. In a news article published the day before, Dr Robinson was quoted as saying, "I think every stroke patient who can tolerate an antidepressant should be given one to prevent depression," but did not advocate the use of problem solving therapy.(4)

15 October, 2008 - In a letter to JAMA, Lacasse and Leo asked whether Robinson et al had done an analysis directly comparing problem-solving therapy and escitalopram, and noted that the reported incidence data for stroke in the two treatment groups suggest that the difference in treatment results "does not appear to be either clinically or statistically significant."(5) Robinson et al responded that there was no statistically significant differences between the groups.(6)

5 March, 2009 - In a rapid response section in the British Medical Journal, Leo and Lacasse raised their concerns about the interpretation of the results of the 2008 trial, and also stated that "during a subsequent internet search we were surprised to learn that four years previously the lead author had been listed on the speaker's bureau for Forest. The omission, however innocent or mistaken, is disturbing; neither the JAMA article nor subsequent media accounts noted that the lead author had served on the speaker's bureau for the manufacturer of Lexapro."(7) Their citation was to our reference 2.

11 March, 2009 - In a letter to JAMA, Robinson and Arndt reported that the financial disclosure for their 2008 article was incomplete, "resulting from erroneous recollection of the appropriate dates for speaking presentations sponsored by pharmaceutical companies...."(8) Dr Robinson disclosed receiving honoraria for two presentations in 2004, and serving on the Forest Laboratories speakers bureau "in 2004 and perhaps 2005." No editorial comment accompanied this letter.

So far, this seems to be a familiar story about an author who seemed to be excessively enthusiastic about a product of the company with whom he had had a financial relationship, but reluctant to disclose this relationship. But wait,

20 March, 2009 - A rather extraordinary editorial was published electronically in JAMA on 20 March, 2009.(9) Let me review its main points, section by section.

After acknowledging the attention conflicts of interest now receive, and briefly describing the 2008 study and the subsequent letter by Lacasse and Leo, the editorial stated that JAMA editors had received a communication from Leo on or after 16 October, 2008 which "indicated he had evidence that Robinson had not reported in his article that he had served on the speakers bureaus for pharmaceutical companies."

The editorial then devoted several paragraphs explaining the "due diligence" JAMA editors used to investigate this "allegation." They noted the "sensitive nature of these investigations," which required them to conduct them "confidentially," and again insisted "these investigations into undisclosed conflicts of interest are time-intensive and require careful attention." Thus, from the time Leo sent his "allegations," (apparently 16 October, 2008), it took until 31 January, 2009 to get a letter from Robinson et al acknowledging his undisclosed conflicts, and until 11 March, 2009 to publish it, a total of five months.

However, the concerns with confidentiality, and the repeated emphasis on the need for unusually painstaking investigation seemed disconnected to the particular case. It is clear that it may take quite a bit of time and effort to investigate some allegations of undisclosed conflicts of interest, especially when the allegations are vague, but the alleged conflicts are severe. However, in this case, it should have taken trivial effort to find Dr Robinson's previous, published disclosures. (It took me about 5 minutes of internet searching to find the two 2005 articles.) Once (easily) discovered, the disclosures in the 2005 articles starkly contrast with the disclosures, or lack thereof in the 2008 article. Furthermore, since these disclosures were already in the public domain, there should have been no concerns with confidentiality.

Nonetheless, the editors then asserted:

While the confidential investigation of unreported conflicts of interest is under way, we consider involvement of third parties— such as Leo had done by his posting on the BMJ site and by contacting the media—to be a serious ethical breach of confidentiality that not only potentially damages our ability to complete a fair and thorough investigation (of the specific issue that Leo had brought to our attention), but also potentially damages JAMA’s reputation by the insinuation that we would fail to do so.

This makes no sense. There was no need for confidentiality, because the allegations were not based on whistle-blowing or confidential information. They were based on published articles, articles which clearly disclosed Dr Robinson's financial ties to Forest Laboratories. Anyone who bothered to do a simple Google search could have found that Dr Robinson's disclosure in his 2008 JAMA article did not agree with his disclosure in several 2005 articles. Lacasse and Leo used no confidential information whatsoever in making their allegations. Actually, they were not making "allegations," but simply pointing out that an author had published statements which were inconsistent. Since Lacasse and Leo were simply pointing discrepancies among published articles, how could they have breached "confidentiality," ethically or not?

Second, there was no need for a complex or prolonged investigation. The discrepancies were apparent as soon as one viewed the published articles side by side.

The third point was a non sequitur, and a classic example of blaming the messenger for the message. JAMA had published an article. Other journals published other articles. Publishing these articles put them in the public domain. If comparison of these articles in the public domain were to reflect badly on on of their publishers, it would not be the fault of making the comparison.

Regardless of the illogical nature of their concerns with non-existent confidentiality, assertions that it takes a long, complex investigation to demonstrate the obvious, and their aspersions on the messenger for the message, the JAMA editors then revealed that:

A telephone conversation intended to inform Leo that his actions were inappropriate transformed into an argumentative discussion, as Leo continued to refuse to acknowledge any problems with his actions, even after he was informed that the investigation was completed and was advised to read the upcoming March 11 issue of JAMA (where the letter of explanation and apology from Robinson and the formal correction were in press).

Furthermore, the editors proposed punishing Leo, first by effectively banning him from publishing in the pages of JAMA,

Leo also was informed that, if his actions represented his apparent lack of confidence in and regard for JAMA, he certainly should not plan to submit future
manuscripts or letters for publication.

Then, by complaining to his supervisor

However, since Leo apparently did not appreciate the serious implications of his actions, despite our attempts to explain, we felt an obligation to notify the dean of his institution about our concerns of how Leo’s actions were potentially damaging to JAMA’s reputation. We sought the dean’s assistance in resolving this issue involving a member of the faculty of his institution, to assure there would be no need to publicly identify that faculty member. No dean wants his or her institution implicated in a publication reflecting improper behavior by a faculty member.

Finally, they seemed bitterly offended that the British Medical Journal would publish anything that disagreed with anything printed in JAMA:

In addition, we were dismayed that BMJ would post the article by Leo with the allegations against Robinson and the negative insinuations about JAMA, without at least contacting JAMA to verify the veracity of the report.

Again, rather than raising unsubstantiated allegations, Leo and Lacasse's letter to the BMJ simply showed the discrepancy between the disclosures in Robinson and colleagues' 2008 JAMA article and those in one of his 2005 articles. Both articles are publicly available. What useful information about the letter above and beyond that provided by viewing the discrepant articles could the JAMA editors have provided?

While the JAMA editors castigated Leo for unethical behavior, and sought to punish him for it, they said nothing negative about Robinson. Yet it was Dr Robinson who was supposed to disclose his conflicts to JAMA, but who managed to forget conflicts that he had disclosed before. Why would would it be more unethical to point out publicly available evidence about failure to disclose conflicts of interest than to conceal these conflicts in the first place?

This story is saddening. JAMA has published many important and useful articles on conflicts of interest, and other matters relevant to Health Care Renewal. We have probably favorably cited more editorials by JAMA on these topics than those in any other journal. Yet now the journal's leadership seems to have somehow lost their way. Instead of trying to constructively respond to criticism, they now seem intent on punishing the critics. I hope they find their compass soon, before an important medical institution really is irreparably damaged.


Note: another detailed analysis of this case is here in the Hooked: Ethics, Medicine and Pharma blog. Here is Professor Leo's response to the JAMA ediorial.

ADDENDUM (24 March, 2009) - see also the extensive analysis of this case on the Respectful Insolence blog, and the comments here on the Effect Measure blog, here on Gooznews, and here on KevinMD.

References

1. Evans DL, Charney DS, Lewis L et al. Mood disorders in the medically ill: scientific review and recommendations. Biol Psychiatry 2005; 58: 175-189. [Link here.]
2. Robinson RG, Zorowitz RD. Pseudobulbar affect and stroke. Stroke: Clinical Updates 2005; XV (Jan-Feb). [Link here.]
3. Robinson RG, Jorge RE, Moser DJ et al. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA 2008; 299: 2391-2400. [Link here.]
4. Elias M. Study: antidpressants help stroke victims. USA Today, May 27, 2008.
5. Lacasse J, Leo J. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1757-1758.
6. Robinson RG, Jorge RE, Arndt S. Escitalopram, problem-solving therapy, and poststroke depression. JAMA 2008; 300: 1758-1759.
7. Leo J, Lacasse J. Clinical trials of therapy versus medication: even in a tie, medication wins. Brit Med J, 2009: 338: b464. [Link here.]
8. Robinson RG, Arnd S. Incomplete financial disclosure in a study of escitalopram and problem-solving therapy for prevention of poststroke depression. JAMA 2009; 301: 1023-1024. [Link here.]
9. DeAngelis CD, Fontanarosa PB. Conflicts over conflicts of interest. JAMA 2009; 301: [Link here.]

IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans Medical Centers

Bill Gates's company, Microsoft, touts the User Experience as the Sine Qua Non of computing. Billions of dollars have been spent tweaking every little nuance of Windows, with version 7.0 soon to appear. Apple has done likewise with Mac OS X. (The various X-windows managers for Linux, less so). I respect these efforts and use both mainstream OS's in my daily work.

In HIT, however, the "user experience" as I outlined in my eight part series starting here is deemed an issue to solve once the sale is made and physicians are scrambling to avoid harming or killing patients. After all, the HIT industry is unregulated, shielded from liability based on the "learned intermediary" doctrine (a.k.a., clinicians are the bank and insurance company for IT vendors, in that they are the creative implementors of workarounds to IT mismanagement and misdesign), and contractual gag clauses against public disclosure of product defects.

This arrangement makes the pharmaceutical industry look like kids in a sandbox.

In the article "IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans' Medical Centers", Journal of the American Medical Association 2009;301(9):919-920, author Bridget M. Kuehn illustrates the risk of improperly implemented or managed HIT, even in the VA.

The VA is probably the finest environment in the world for HIT, its development of clinical IT over the past few decades being largely driven by experts from within, and being dedicated to patients and not profits. Yet its HIT is subject to the same issues as HIT in the for-profit HIT sector.

Kuehn writes in JAMA:

Medical errors and software malfunctions that were linked to changes in the electronic medical records system used at Veterans Affairs (VA) medical centers across the country are drawing attention to the potential vulnerabilities of such systems.

Although many advocates of electronic medical records systems promote them as a means to reduce mistakes affecting patient care, the recent problems in the VA system and other evidence suggest that malfunctions of these systems or problems with the way they are implemented have the potential to lead to medical errors.

Drawing attention after how many years of physicians observing such problems in the commercial HIT sector and being muted by HIT companies on such issues, I ask?

How many times will we need to see such articles in print before physicians and patient advocates wake up? How many times would we need to see in print "chiropractors performing neurosurgery is harming patients" before we put a stop to that practice?

How many medical centers have lists and databases of known HIT defects, waiting to be fixed, that their patients and the public do not know of? How many physicians have been threatened with litigation for airing the dirty laundry?

Understanding how such problems occur as well as how they might be prevented is particularly critical as the Obama administration considers health care reforms that include more widespread adoption of electronic records systems in health care.

Indeed, although I would add "... as the Obama administration also moves from a suggested timeline of 2014 to a coercive 'do this or else' timeline."

As I've written, such a change is cavalier and suffers from the misinformation fed the administration by both the HIT ecosystem industrialists and opportunists, and those suffering from the utopian Syndrome of Inappropriate Overconfidence in Computing.

After a software update of the electronic medical records system at VA hospitals in August, health care workers at these facilities began to report that as they moved from the records of one patient to those of a second patient, they would sometimes see the first patient's information displayed under the second patient's name.

If not for the diligence of the users, that type of error could lead to dead patients.

This records-scrambling problem was reported at 41 of the 153 VA medical centers, said Gail Graham, deputy chief officer of Health Information Management at Veterans Health Administration Headquarters in Washington, DC. Graham explained that the jumbling of records was an uncommon occurrence that only occurred after a particular sequence of events.

As I mentioned above, the VA is an example of the finest environment, probably in the world, for HIT, being dedicated to patients and not profits (see the book "Medical Informatics 20/20" by Goldstein et al., and my linked quote, on that culture).

Imagine what goes on in commercial products where vendors' first priority is to profit margin.

Health care workers at the VA medical centers were notified about this potential problem in October, and on December 20, the centers received a software "patch" to fix the problem.

Nine VA medical centers reported another type of problem related to their electronic records system: physician orders to stop medication were missed, causing some patients to receive intravenous medications longer than necessary. The problem occurred because after the software upgrade, physician orders to discontinue such medications, which had previously appeared at the top of the screen, were not displayed.

In 3 cases, patients received infusions of drugs such as heparin for up to 11 hours after their physician had ordered the drug to be discontinued. Graham said the affected patients were not notified because they had not been harmed by the oversights. This software problem was corrected on December 8.

Again, this type of error occurs once too often, your patient's dead.

There are hundreds of types of problems that can occur as a result of such technology, and those experienced by the VA medical centers are not uncommon, according to Ross Koppel, PhD, professor of sociology at the School of Medicine at the University of Pennsylvania in Philadelphia.

For example, the scrambling of two different electronic records is a common problem that is not limited to systems used in health care settings, he said. Additionally, research indicates that poor layout of information in electronic medical records and related health information technology systems is the most common type of flaw (Koppel R et al. JAMA. 2005;293[10]:1197-1203). He explained that when health care workers have to look at several different screens or scroll through pages to access the information needed to make medical decisions, mistakes can occur.

My eight part series came to the same conclusions. In fact, I reached those conclusions and started writing publicly about them, in 1998. Was anyone listening? How many patients have been harmed, or died, in those past ten years due to industry inattention to these issues and leadership of HIT projects by unqualified personnel?

Additionally, medical errors also may arise from poor communication between electronic medical records and related technologies (such as computerized physician order entry systems) or between software applications created by different companies.

Other types of errors are caused not by flawed software but by how workers use that software in real medical settings. For example, an electronic medical record system may require a physician to enter a weight for a patient before prescribing a drug, even if a precise weight is not needed for that particular drug. A physician in a rush may enter an estimate of the patient's weight, but another physician who subsequently views the record might use that estimated weight to prescribe a medication that does require an accurate weight, potentially causing a dosage error. Detecting such problems requires careful observation of how systems are being used in real clinical settings and interviewing clinical staff about their experience, noted Koppel.

I claim these types of errors are due to flawed software. The flaw is in the ill-conceived, management information systems (MIS) inventory-system-mentality, mission hostile user experience the software presents to clinicians.

Although makers of electronic medical records software test it to detect problems that may lead to errors, federal oversight of such testing is lacking. The Certification Commission for Healthcare Information Technology, which is composed of health information technology industry organizations, has a certification program, but critics argue that such oversight is not sufficient and that the US Food and Drug Administration, the Centers for Medicare & Medicaid Services, or a new governmental agency should be given the authority to oversee these systems (Hoffman S and Podgurski A. Harv J Law Tech. 2008;22[1]:104-165).

"The bar on certification has to be raised to a level that ensures real safety, not just minimal compliance," Koppel said.

The CCHIT process is merely a specifications check or qualification of features, and is nearly useless by their own admission regarding most of the issues discussed in these articles. Worse, CCHIT has significant conflicts of interest with the HIT industry, having senior people who also hold senior industry positions and thus have fiduciary responsibilities to their employers (whether that is acceptable for a "certifying" organizations is open to debate, but the conflicts exist as fact). On a more minor point, this organization can't even manage its books properly, failing to file its required reports and temporarily being dissolved, involuntarily.

In fact, let me state that the lack of oversight of this industry amounts to, at best, governmental negligence, and at worst a complete dereliction of obligation to protect the public.

Imagine this type of arrangement in pharma or the (physical) medical device industry. Almost ten years ago I wrote HIT is a clinical tool for unforgiving medical environments that happens to involve computers, not a management information system that happens to involve doctors.

In other words, HIT systems are virtual medical devices that affect every aspect of care, and can cause the "learned intermediaries" to commit error as the JAMA article illustrates.

Koppel also urged caution as electronic records are rolled out. Although these technologies offer great promise in providing data for research and quality-improvement initiatives, he said more work is needed to make these systems work effectively in the context of health care.

"We should encourage [the technologies' development, but we should not force doctors to use them until they are shown to be more responsive to the needs of physicians and other clinicians," he said.

As to the "they", I believe Ross Koppel was referring to the computer artifacts themselves.

I would extend the "they" to mean the healthcare IT vendor industry itself, to most of whose leaders I've probably give an "F" regarding these issues and knowledge of Biomedical Informatics.

Excluding NextGen, whose AVP for Government Relations holds the vaunted and much coveted "American Medical Informatics Certification for Health Information Technology."

Finally, the VA is going to embark on upgrades to its laboratory components not by relying on its internal expertise, but by engaging the services of a private HIT company, Cerner, a company with a troubled record regarding the national IT initiatives in the UK (see here, here).

Considering that company's issues, and the internal complexities, dependencies, intra-component messaging, and other idiosyncracies of a system as complex as VistA, I opine that this is a major error.

Based upon my decades of knowledge about IT, biomedical informatics training, my analytical abilities and my own informed judgment, it is my deep fear that the VA will not "luck out" as in the above JAMA article. Patients will be harmed as a result somewhere down the line, I fear.

-- SS


Addendum 3/5/08:

I am promoting a user comment and my response to the body of this post itself, as I think they exemplify a central issue regarding HIT:

Paul Trossel on March 5, 2009 5:05:00 AM EST said...

Computer software in the Health industry are tools to use. Often the user thinks they are the ‘law’ in what they have to do. As long as people don’t understand the way they have to use their tools (eg surgical scalpel, machines, software etc.) mistakes will be made. Always check the outcome of the computer with your own judgement. As long as supervisors, bosses etc. help their people to understand that the use of the mind of a qualified professional is the outmost important and that the outcomes of the tools are the next, mistakes that lead to the death of a patient, will keep occurring!

My reply:

Mr. Trossel,

Forgive me for saying so, but you sound like an apologist for the Health IT medical device industry, which rightly fears increased scrutiny of its design, development, QC and lifecycle practices.

HIT is a medical device that happens to involve computer automation.

My apologies if I am incorrect, but it appears you're not taken care of a patient in the "fog of war" known as the ED, ICU or busy hospital floor.

Tools that distract, tools that mislead, tools causing cognitive overload are simply dangerous in such an environment. That is a clinical reality.

It is also clear you've not read my post [as above] in its entirety, nor my multi part series on the mission hostile user experience presented by HIT.

It appears even the most highly trained experts, especially when distracted, can be misled by faulty devices.

The recent crash of the Turkish airliner seems a case of just that. See "Altimeter, Crew Cited in Dutch Crash" in the Wall Street Journal.

It is the primary responsibility of the manufacturer of a medical device such as HIT to assure it is the best device possible, accounting for the very well known realities of the clinical workplace.

It is not the responsibility of the end user to be the bank and insurance policy for cavalier software design through tiring improvisation and workarounds to software device mismanagement and design decisions made by incompetents and HIT amateurs.

There is no excuse for ill conceived, designed and implemented HIT devices. None whatsoever, most especially depending on busy human users to compensate for the flaws on a 100% reliability basis.

Resilience engineering, a term I learned when presenting these HIT issues to the IEEE Medical Technology Policy Committee in Dec, 2007 (PPT here), is not about depending on busy people to cover for your device's defects.

Regarding a meta-issue:

It's absolutely a sign of our culture being in great distress when physicians have to answer to IT personnel about why the physicians best not be the "workarounds" and safety valves to ill conceived IT.

-- SS