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.

Post Title → DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

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

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

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

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

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.]

Post Title → JAMA Editors Try Attacking the Messenger

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

Post Title → IT Vulnerabilities Highlighted by Errors, Malfunctions at Veterans Medical Centers

Disclosing Conflicts of Interest: A Story Involving JAMA, Harvard Medical School, Baxter International, Cytyc

We have recently posted about cases in which JAMA (see post here) and the journal Neuropsychopharmacology (see post here) published articles whose authors did not fully disclose conflicts of interests that might have influenced what they wrote. Dr Cathy DeAngelis, the Editor of JAMA, just wrote an editorial calling for fuller disclosure of such conflicts of interest (full citation: DeAngelis CD. The influence of money on medical science. JAMA 2006; )

Some key quotes:

There can be no doubt that editors of peer-reviewed medical journals must always place the interest of patients above all else. Every published article eventually can and should affect patient care. Therefore, all articles that we publish must be ethically sound, valid, reliable, and credible (ie, reflective of work that is performed, written, reviewed, and edited in a manner that is unencumbered by financial pressure). With that in mind, it is important to discern the necessary and honest interests of for-profit companies from the potentially corrupting influence of commercial interests.

In some instances, the marketing goal of a company dominates the scientific aspect of the company-funded research. There have been a number of high-profile examples of such research irregularities involving for-profit companies, such as the refusal to provide all study data to the study team, reporting only 6 months of data in a trial designed to have 12 months of data as the primary outcome; incomplete reporting of serious adverse events; and concealing clinical trial data showing harm.

For-profit companies also can exert inappropriate influence in research via control of study data and statistical analysis, ghostwriting, managing all or most aspects of manuscript preparation, and dictating to investigators the journals to which they should submit their manuscripts.

How do editors preserve the integrity of their journals while ensuring that they serve as vehicles for dissemination of scientific information that could help clinicians provide better care for their patients? First and foremost is to ensure that all published articles are scientifically sound and as objective and unbiased as possible by using rigorous peer review and careful editorial evaluation. Another important aspect is to ensure that readers are aware of the authors' financial relationships and potential conflicts of interest so that these readers can interpret the article in light of that information.

Most remarkable about this editorial was that in it Dr DeAngelis singled out the Harvard Medical School.

Because we are so adamant and open about disclosure of financial interests, it is not surprising that we are being made aware of nondisclosures by authors and by readers. Somewhat surprising was that 3 consecutive cases of nondisclosures, all of which raised the interest of the mainstream press, involved authors from Harvard Medical School. To his credit, the dean of Harvard Medical School has informed me of his plan to send a letter enclosing the disclosure requirements for JAMA (plus our July 12, 2006, editorial) and those for the New England Journal of Medicine to all 8000 Harvard Medical School faculty members. In addition, he indicated that he will work with his faculty to enhance Harvard Medical School's current policies on financial relationships with for-profit companies (Joseph B. Martin, MD, PhD, oral communication, July 18, 2006).

A news article in the Boston Globe actually reported that Dr DeAngelis called Dr Martin and said, "Joe, do something with your kids." "Kids" here refers to the distinguished faculty of the Harvard Medical School.

In my humble opinion, it's good that some of the pervasive conflicts of interest in health care are starting to get more public scrutiny. Although disclosure of conflicts of interest do not negate all the problems they cause, full disclosure would at least make all aware of the scope of the problem

That's where the irony comes into this story. Dr Martin, in addition to his day job at Harvard, is a member of the board of directors of Baxter International, which describes itself as "a global healthcare company that, through its subsidiaries assists healthcare professionals and their patients with treatment of complex medical conditions including hemophilia, immune disorders, kidney disease, cancer, trauma and other conditions." Dr Martin is also a member of the board of directors of Cytyc, which makes a variety of diagnostic and therapeutic devices for use in gynecology. Dr Martin's official Harvard on-line biography does not mention these affiliations. Dr Martin did report these affiliations when writing, for example, an article for the New England Journal of Medicine about academic collaboration with industry (Moses H, Braunwald E, Martin JB, Their SO. Collaborating with industry — choices for the academic medical center. N Engl J Med 2002; 347(17):1371-5.) How Dr Martin simultaneously manages his fiduciary responsibilities to maximize financial results for the stock holders of Baxter International and of Cytyc and his leadership responsibilities at the Harvard Medical School is not clear.

So it would seem that full disclosure about conflicts of interest in health care really should begin at home.

Post Title → Disclosing Conflicts of Interest: A Story Involving JAMA, Harvard Medical School, Baxter International, Cytyc

Won't Get Fooled Again, Again, Again

In mid-July, there were three well-publicized cases in which authors of scholarly articles in prominent medical journals failed to disclose important financial arrangements that may have affected what they wrote. In fact, each case was so well-publicized that I thought it did not need additional comment from Health Care Renewal.

The cases were:

• An article published in JAMA in February found that withdrawing anti-depressants from pregnant women was associated with relapse of depression [Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.]. A letter published in JAMA in July revealed that "all 9 0f the physician coauthors have been paid by antidepressant manufacturers, while only 2 reported disclosures." (See coverage from the Wall Street Journal, available through the Pittsburgh Post-Gazette here.)
• An article was published in Neuropyschopharmacology in July about vagus nerve stimulation as a treatment for depression [Nemeroff CB, Mayberg HS, Krahl SE. VNS therapy in treatment-resistant depression: clinical evidence and neurobiological mechanisms. Neuropsychopharmacology 2006; 31, 1345–1355.] The Wall Street Journal discovered that eight of the article's nine authors had financial ties to Cyberonics Inc, the manufacturer of the device. The ninth author is an employee of the company, which was disclosed." (See previous post on Cyberonics here.)
• An article published in JAMA in July found an association between migraine headaches and the risk of cardiovascular disease and stroke for women [Kurth T, Gaziano JM, Cook NR et al. Migraine and the risk of cardiovascular disease in women. JAMA 2006; 296: 283-291]. The editor of JAMA then discovered that all six authors of the study had financial ties to makers of treatments for migraines or heart-related problems, but did not disclose these relationships, (see the JAMA corrections here, AP here, and PharmaGossip here.)

What has been remarkable is the editorial response to these cases in two of the US most widely-read newspapers.
By Jennifer Washburn in the Los Angeles Times,

Most of us place enormous faith in our universities. We trust that they are autonomous, independent institutions committed to education, scholarship, academic freedom and the production of knowledge free from the influence of special interest groups. Right?

Wrong. In the last 25 years, the United States has given birth to a market-model university, one where professors increasingly work 'for hire.'

Each university is afraid to tighten its rules for fear that this might drive talented faculty (and industry dollars) to other schools with more lax policies. But until the top U.S. research universities collectively adopt one rigorous, uniform policy, their autonomy will continue to erode.

By an anonymous editorial writer in the New York Times, (via the Houston Chronicle),

Leading medical journals seem to be having a difficult time disentangling themselves from the pharmaceutical and medical device industries. If they cannot stop printing articles by scientists with close ties to these businesses, they should at least force the authors to disclose their conflicts of interest publicly so that doctors and patients are forewarned that the interpretations may be biased.
It seems imperative that more muscle be put into forcing disclosure and publication of conflicts of interest. If all leading journals agreed to punish authors who fail to reveal their conflicts by refusing to accept further manuscripts from them, a lot more authors would be inclined to fess up. Better yet, journals should try much harder to find authors free of conflicts. That is the best hope for retaining credibility with doctors and the public.

And by Benedict Carey in the New York Times,

Companies don’t just hire doctors to do research — a practice that in theory ought to help keep businesses scientifically honest — they also trade on the researchers’ names. Like producers shopping a new a movie, they go for star power, an A-list cast with names that themselves sell a product, and pull other doctors along, even when the evidence for a treatment is not strong.

One of the supposed strengths of American science is that it is decentralized and diverse: there are dozens of top researchers who are competitive and critical, enforcing a high standard. But when many or most of the leading figures are playing for the same team — an all-star team — that lineup itself may carry the day, regardless of the science.

With this topic finally getting widespread notice in medical journals and in the main-stream media, I hope it is not hopelessly naive to expect some action. At the very least, we need much more rigorous disclosure requirements for authors of articles in medical journals, and generally for people who bill themselves as academics writing or speaking about medical and health care issues in any venue. In addition, we need broadly based rules about conflict of interest that apply to all people who make decisions in health care.

[For the theme music, go here.]

Post Title → Won't Get Fooled Again, Again, Again

Health Care Renewal Bloggers and Others Expand Discussion of Conflicts of Interest

JAMA just published a set of letters in response to the January article by Brennan et al about conflicts of interest (JAMA 2006; 295: 2845-2849). Basically, Brennan and colleagues focussed on conflicts of interest involving pharmaceutical and device companies that affected practicing and academic physicians. They called for the abolition of certain financial arrangements between doctors and these companies, and for transferring other arrangements to academic medical centers (AMCs). Furthermore, they called for AMCs to be empowered to enforce the new rules. (See: Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.)

The letter by three of us Health Care Renewal bloggers, mirroring my previous blog posting, noted that physicians may be affected by conflicts of interest involving organizations other than pharmaceutical and device manufacturers, particularly managed care organizations. In addition, we noted a variety of conflicts of interest could affect health care decision makers other than physicians, notably, leaders of AMCs. Thus, we called for a broad code of conduct for all health care decisionmakers that would address all kinds of conflicts of interest.

Other letters also pointed out the spectrum of conflicts of interest is larger than that discussed by Brennan et al. They noted other sources of conflicts including: clinical income, NIH grants, advertisements in medical journals, and grants to AMCs and mediacal scientific societies (Meader); pharmaceutical advertising directed at physicians (Gozum) and other pharmaceutical promotional practices so directed (Ting); and pharmaceutical company financing of graduate medical education (Goldblum and Franzblau, and Watson and colleagues). They noted other barriers to implementing the reforms suggested by Brennan et al: a culture of entitlement among faculty physicians; (Watson and colleagues); and AMCs need for funding (Watson and colleagues, and Brody). Finally, Angell noted that Brennan and colleagues' estimates of the amount of money pharmaceutical companies spend on marketing may have actually been very low.

Not to toot our own horn too much, we hope that this set of letters has enlarged the scope of discussion of conflicts of interest affecting not only physicians but also the leaders of health care organizations.

Post Title → Health Care Renewal Bloggers and Others Expand Discussion of Conflicts of Interest