The Haunting of Hormone Replacement Therapy

US Senator Charles Grassley (R-Iowa) is digging into what appears to be another ghost-writing case. As reported by the New York Times,

Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth’s diet pills, Redux and Pondimin, withdrawn in 1997 after being linked to heart and lung problems.

But the documents Mr. Grassley released Friday provide a detailed look at the practice — from the conception of ideas for journal articles through the distribution of reprints.

The documents released Friday include a 'publication plan tracking report' by Wyeth showing 10 articles in which manuscripts were completed by the company before they were sent to the putative author for review. Any revisions were subject to final approval from the company, according to the tracking report.

A companion article tracked the process of creating a single article. It included the strategy meeting in which the article was conceived by Wyeth staff:

Agenda item II for a Sept. 19, 1997, meeting by company staff members involved the “SHBG Outline.” It is an apparent reference to the working outline of an academic article about the protein SHBG — sex hormone-binding globulin — in breast cancer. The planned steps included initiating contact with Dr. Lila E. Nachtigall, of the New York University Medical School, who would be asked to serve as the article’s author.

Then the ghost-writers were chosen:

A fax from Karen Mittleman, a DesignWrite writer, to Ann Contijoch, a professional medical writer with a Ph.D. in animal science, about developing and improving an outline and reference list for the article. (The document appears to be dated 2005, but that was the date it was obtained in a lawsuit; it was actually dated 1998.)

In the Times interview, Dr. Nachtigall said that Ms. Mittleman had helped her prepare slides for talks but that she had never heard of Ms. Contijoch.

Reached by telephone Friday, Ms. Contijoch said she did not remember whether she had drafted the outline or the manuscript but that she had provided 'editorial assistance,' like copy editing, while Dr. Nachtigall 'drove the content.'

Then the article outline was revised:

DesignWrite prepared a revised outline. Some of the outline’s language appeared verbatim in the final journal article.

Dr. Nachtigall told The Times that the outline might have been based on her previous work and that she must have prepared the references list herself.

Then the draft was sent to the supposed academic first author:

A subsequent letter, written sometime in 1998, to Dr. Nachtigall from Ms. Mittleman of DesignWrite told the doctor that the draft manuscript of the article was on its way to her.

The article finally appeared:

When the article was published in 1999 in the journal Primary Care Update for OB/GYNs, it listed Dr. Nachtigall as the author, but did not mention Wyeth or DesignWrite. The end of the article acknowledges 'editorial assistance' from Ms. Contijoch but does not further identify her.

In the Times interview, Dr. Nachtigall said, 'Ann Contijoch – I’ve never heard of that person.'

The article is Nachtigall LE. Sex hormone-binding globulin and breast cancer risk. Primary Care Update Ob/Gyns 1999; 6: 39-45.

By the way, at the end of the first NY Times article, Dr Nachtigall responded to Senator Grassley's inquiries thus:

It kind of makes me laugh that with what goes on in the Senate, the senator’s worried that something’s ghostwritten. I mean, give me a break.

So as long as people are robbing banks, the police should not care about petty theft? In fact, we should care about this sort of ghost-writing, since it is a difficult to detect deception which disguises marketing as scholarship. This latest case adds to the evidence that ghost-writing is a prevalent problem.

As we and others have said before, ghost-writing is dangerous to health, as it deludes physicians and patients into thinking health care products are more beneficial and less risky than they really are. Ghost-writing also undermines science by shifting the agenda away from interesting and important questions to questions whose answers may mainly benefit vested interests. Finally, on a personal note, ghost-writing demoralizes honest academics who must run their own studies, write their own papers, and manage the logistics of paper submission in competition with fake authors backed by corporate money and corporate staff. So, Dr Nachtigall deserves no break.

A Few Small Steps Towards Better Disclosure of Conflicts of Interest

Various kinds of conflicts of interest affecting medical academics, practicing physicians, and diverse health care decision makers have frequently been topics of discussion on Health Care Renewal.

Recently, on several fronts there have been moves to increase disclosure of financial relationships among health care decision makers and various health care organizations. For example, two weeks ago, the Cleveland Clinic announced it would post some information about the financial relationships of its physicians on its web-site. According to Reed Abelson reporting for the New York Times,

The Cleveland Clinic plans to announce this week it has begun publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers.

In particular,

Under the effort led by Dr. [Guy M] Chisolm, [Chair of the Cleveland Clinic Innovation Management and Conflict of Interest Committee,] every scientist and doctor employed by the clinic must report any industry relationship to the clinic at least once a year. Members of the committee, which meets monthly, typically interview the doctors involved, often requiring documentation like letters to academic journals alerting editors to the industry relationships.

The clinic has been working for more than a year to set up the public listing on its Web site, where consulting payments of more than $5,000 a year, and all royalty and equity interests, will be disclosed.

'Disclosure is a minimum,' said Dr. Chisolm, who hopes to begin listing the actual dollar amounts involved in a doctor’s consulting arrangements next year. The current disclosure simply lists the companies for whom the consulting takes place. He said the group was planning to improve the clinic’s ability to audit the information it received from doctors, because the clinic must now rely on doctors’ self-reporting to find potential conflicts.

My first comment is that in general, more transparency is better than less. For an elite institution like the Cleveland Clinic to start some sort of systematic reporting of such financial relationships is a step in the right direction.

However, it is, at the moment, a very small step. The sort of disclosures now appearing are extremely telegraphic. For example, here is what is appears about Dr Delos Cosgrove, the CEO of the Clinic, and the Chair of its Board of Governors,

Royalty Payments. Dr. Cosgrove has the right to receive royalty payments for inventions or discoveries related to the companies shown below:

* Allegiance (Cardinal Health)
* AtriCure
* Edwards Lifesciences
* Kapp Surgical
* Terumo

It is interesting to contrast the terseness of this text with the amount of detail about Dr Cosgrove's financial relationships that previously caused controversy (for example, see our posts here and here.)

Review of this and other listings suggest that for the moment, the only information that will be provided will be the broad nature of the relationships (royalty payments, consulting, etc) and the names of the companies or organizations involved. Perhaps in the future, the financial scope of these relationships will be revealed.

But the ostensible goal of this effort, according to Dr Chisolm, is to aid patients' decision making:

Guy M. Chisolm III, the cell biologist who is chairman of the conflict-of-interest committee, says patients should know about such links so they can talk to their doctors or others at the clinic about any financial tie that raises questions.

'Patients are vulnerable,' Dr. Chisolm said.

But how could a patient evaluate the sorts of disclosures that the Clinic is now making? How, for example, would a patient of Dr Cosgrove determine whether a royalty paid to him by one of the listed companies could have any influence on the care that patient would receive? Such a judgment might require some knowledge about whether the company makes any product that could be relevant to the patient's care, and whether the royalty was paid to the doctor for any reason relevant to the patient's care. It might be hard to even begin to make such judgments without some very detailed information along these lines. (Even with that information, it might be hard to judge the importance and influence of the relationship. We have noted findings from cognitive psychology that suggest people have great trouble judging the importance of disclosures about conflicts of interest, and determining the influence of such conflicts on the judgements and behaviors of the people who have the conflicts.)

So although the disclosure to be provided by the Cleveland Clinic is an improvement over what was done before, and an improvement over what most academic medical centers and medical schools currently do, it is only a small improvement.

The Times also reported that

As Dr. Cosgrove sees it, potential conflicts of interest need to be managed, not automatically eliminated, because working with industry encourages innovation by the clinic and its doctors. He has even made 'innovation management' part of the committee’s official title: the Cleveland Clinic Innovation Management and Conflict of Interest Committee.

As I have said before, it is not unreasonable to assert that collaboration between academic medicine and industry could lead to innovation. However, it is not clear to me why such collaboration must always entail payments, often large, by industry directly to individual academics. If such payments occur, it is also not clear to me that tersely disclosing their occurrence will "manage" them sufficiently.

By the way, while this was going on, further details came out about the state of Massachusetts new regulations mandating disclosure of financial relationships among physicians and health care corporations in that state. As discussed by Dr Daniel Carlat on the Carlat Psychiatry Blog, and by Alison Bass on the Alison Bass Blog, it appears that the disclosure initially required by the regulations would also be incomplete. In Massachusetts, no disclosure of any payments related to research would be required. So, once again, a baby step towards full transparency is better than no step at all, but not very much better. Given the pervasive nature of conflicts of interest affecting physicians, medical academics, and health care decision makers, and the questions these raise about in whose interest health care decisions are made, there is a very long journey ahead.

Joint Commission Sentinel Events Alert On Healthcare IT

Finally.

The Joint Commission for accreditation of healthcare organizations in the U.S. has issued a Sentinel Event Alert (link) on the dangers of poorly designed or implemented healthcare information technology (electronic medical records, computerized physician order entry, clinical decision support etc.)

What I and a number of others have been writing about for the past decade - in a contretemps to the prevailing attitude of "irrational exuberance" about healthcare information technology, especially under traditional information systems leadership, as a silver bullet to cure healthcare's ills - has appeared from an organization that might actually be listened to.

Listened to, that is, over the siren calls of the Big Business consortia, the IS guys in hospitals, the Information Technology industry, the former CEO of Intel, Bill Gates, and maybe even Oprah that ignore the downsides of healthcare IT and make it seem easy as 1-2-3 ...

I also believe this Joint Commission alert supports the contention of a number of people in my field that leadership by formally trained and experienced Biomedical Informatics professionals should be, when possible and when available, the "Sine qua non" of healthcare informatics initiatives. (I should also include those without formal biomedical informatics training but with much experience in the research and methods of the field, and a track record of applied success.)

Human computer interaction, unintended consequences of healthcare information technology, and other sociotechnical matters are areas we study professionally, combined with actual medical experience. These are areas not best left to ad hoc or on-the-job training, or to "amateurs" in business IT or medicine (amateurs in the sense that I am a radio amateur or ham with some technical experience, but not a telecommunications professional).

Several of my comments on the Alert appear below in bracketed [red italic]. Emphases in boldface are mine:

From the Joint Commission, a new Sentinel Events alert on HIT

Safely implementing health information and converging technologies (excerpts)
Dec. 11, 2008

As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate.

Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. These unintended adverse events typically stem from human-machine interfaces or organization/system design [a.k.a. the cognitive academic "soft stuff" that Management Information Systems personnel often scoff at - ed.]

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

... There is a dearth of data on the incidence of adverse events directly caused by HIT overall. [This has been a chronic problem partly due to, I believe, corporate and marketing control of the HIT narrative, and ‘political correctness’ of the healthcare and academic communities, at patient expense - ed.] The United States Pharmacopeia MEDMARX database includes 176,409 medication error records for 2006, of which 1.25 percent resulted in harm. Of those medication error records, 43,372, or approximately 25 percent, involved some aspect of computer technology as at least one cause of the error. Most of the harmful technology-related errors involved mislabeled barcodes on medications (5 percent), information management systems (2 percent), and unclear or confusing computer screen displays (1.5 percent). The remaining harmful errors were related to dispensing devices, computer software, failure to scan barcodes, computer entry (other than CPOE), CPOE, and overrides of barcode warnings. (See the sidebar for a breakdown of these data.)

... Contributing factors

Inadequate technology planning [It would be extremely helpful in the Joint Commission explored how that happens, exactly - ed.] can result in poor product selection [not to mention vendor favoritism and CIO conflicts of interest - ed.], a solution that does not adapt well to the local clinical environment, or insufficient testing or training. Inadequacies include failing to include front-line clinicians in the planning process [unbelievably, this is not uncommon. What manner of IT and executive personnel can make such imprudent decisions, the Joint Commission should ask - ed.], to consider best practices [it is indeed puzzling that including clinicians in HIT is not a "best practice" obvious even to, say, our computer literate children - ed.], to consider the costs and resources needed for ongoing maintenance, or to consult product safety reviews or alerts or the previous experience of others [and the previous and current experience of Biomedical Informatics professionals, I might add - ed.]

... An over-reliance on vendor advice [in direct terms, and in words the Joint Commission will not use, such advice is likely tainted by conflict of interest - ed.], without the oversight of an objective third party (whether internal or external), also can lead to problems. “There’s often an expectation that technology will reduce the need for resources, but that’s not always true,” says Bona Benjamin, BS Pharm, director of Medication-Use Quality Improvement, American Society of Health-System Pharmacists. Instead, technologies often shift staffing allocations, so there is not typically a decrease in staff.

Technology-related adverse events also happen when health care providers and leaders do not carefully consider the impact technology can have on care processes, workflow and safety. “You have to understand what the worker is going through [It is unclear to me why it is assumed that non-biomedical IT personnel can truly do that - ed.] – whether that worker is a nurse, a doctor, a pharmacist or whoever is using the technology. The science of the interplay between technology and humans or ‘human factors’ is important and often gets short shrift,” says Ronald A. Paulus, M.D., chief technology and innovation officer, Geisinger Health System.

If not carefully planned and integrated into workflow processes, new technology systems can create new work, complicate workflow, or slow the speed at which clinicians carry out clinical documentation and ordering processes. Learning to use new technologies takes time and attention, sometimes placing strain on demanding schedules. The resulting change to clinical practices and workflows can trigger uncertainty, resentment or other emotions [and behaviors such as active and passive aggression - ed.] that can affect the worker’s ability to carry out complex physical and cognitive tasks.

For example, through the use of clinical, role-based authorizations, CPOE systems also exert control over who may do what and when. While these constraints may lead to much needed role standardizations that reduce unnecessary clinical practice overlaps, they may also redistribute work in unexpected ways, causing confusion or frustration. Physicians may resent the need to enter orders into a computer. Nurses may insist that the physician enter orders into the CPOE system before an order will be carried out, or nurses may take over the task on behalf of the physician, increasing the potential for communication-related errors.

Physicians have reported a sense of loss of professional autonomy when CPOE systems prevent them from ordering the types of tests or medications they prefer, or force them to comply with clinical guidelines they may not embrace, or limit their narrative flexibility through structured rather than free-text clinical documentation [and business IT and technical personnel often with insufficient human-skills levels may be assigned to "fix" the problems. Talk about being in over your head- ed.] Furthermore, clinicians may suffer “alert fatigue” from poorly implemented CPOE systems that generate excessive numbers of drug safety alerts. This may cause clinicians to ignore even important alerts and to override them, potentially impairing patient safety.

Read the whole thing.

Then compare to what I've been writing at my educational site on HIT difficulties here, founded in 1998.

It's about time.

I can add that the most critical "best practice" for healthcare organizations generally, and healthcare IS departments in particular regarding HIT, is the practice of knowing what you do not know, admitting you do not know it, finding out who does know, and then utilizing those experts maximally.

Addendum: I distributed the Joint Commission alert to a number of officials at my own organization, where I have apparently been deemed a "non team player" for standing against what I see as cavalier attitudes regarding biomedical informatics expertise, which led to a federal lawsuit against the EHR vendor and many other difficulties. (See my post "Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?")

Sadly, here is one response I received from a very high official within the healthcare college. Simply:

"Please remove my name from your list serve."

As I wrote in my essay "Open Letter to President Barack Obama on Healthcare Information Technology", healthcare organizational leaders too often seem to think it's better we "all get along" than patients be protected:

Imagine for a moment my horror [in an ICU, as in the case here] of being unable to intervene due to administration's priorities of "everyone getting along" rather than the absolute protection of patients. Yet this is not an uncommon scenario in the IT backwater of hospitals.

That going through customary, bureaucratic, pathetically slow - and often ineffective - "channels" can trump getting patients protected from defective HIT systems is, in fact, a sign of a seriously debased and corporatized national healthcare culture.

Perhaps thanks to this Joint Commission Alert, we won't have to wait for cybernetic version of a "Libby Zion event", or for the following to occur until healthcare organizations finally "get it" regarding Biomedical Informatics and leadership of healthcare IT:



-- SS

Addendum Dec. 18:

Some have labeled me a "skeptic" of HIT. I'm not a skeptic at all. I've seen the technology work, in various settings. I've made it work in various settings, some rather unusual (e.g., in a Middle Eastern oil producing country where I once would not have been allowed to travel at all, let alone work on HIT for improving care of children).

I'm in fact a skeptic of the way health IT is currently pursued, especially its leadership model and costs based on a management information systems paradigm in design, implementation and lifecycle. HIT is not MIS, and pursuit of HIT as if it is MIS will cause continued difficulties, increased expense, and impaired diffusion.

I'm also a skeptic of the shroud of mystery and in fact a form of censorship that goes on towards its failures, failures largely caused by a 'Bull in a China Shop' approach to HIT. That approach is mediated by false assumptions and underestimations of HIT sociotechnical issues by an inappropriate leadership. That my academic website on HIT difficulties remains nearly unique after ten years,and that there is so little information on HIT difficulties on the web, is in many ways remarkable.

Done right, HIT can succeed. See for example the text "Medical Informatics 20/20" for "best practices" that mean something.

The Joint Commission report should, in fact, be unnecessary. Much of what it states is obvious. That its findings need to be stated as an "alert" at all is perhaps reflective of the above problems.

"Gadfly towards ill informed HIT leadership" might be a more precise term to describe me.

-- SS

No Thanks, Gov. Blagojevich, We Have Enough Corruption In Healthcare Already

In this story, the following appears:

On Nov. 10, in a two-hour conference call with advisers, [Illinois Gov.] Blagojevich appears to feel as though he’s in the driver’s seat, the tapes suggest. In a conversation laced with profanities and bravado, Blagojevich said he wouldn’t fill the seat [vacated Senate seat of the President-elect] without something in return.

He acknowledged that it was unlikely that Obama would tap him for HHS secretary or an ambassadorship because he was under federal investigation.

Thank you for disqualifying yourself from HHS, Mr. Blagojevich.

Healthcare has all the corruption and megalomania it needs already.

-- SS

Drug Company Claims "Disparagement" by Proxy

We have occasionally posted on what has come to be called the "Nancy Olivieri case," one of the most important cases of attempted suppression of clinical research from the 1990s. Briefly, Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri after she revealed preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report) (See this post.) This case has been reprised via several posts by Dr Aubrey Blumsohn on the [Anti-] Scientific Misconduct Blog here, here and here.

This month, the Canadian Association of University Teachers (CAUT) published a news item about a bizarre sequel to this case. Here is the background,

Dr. Olivieri [tried] to enforce an agreement she entered into with Apotex in November of 2004 in settlement of defamation claims by both parties.

On Friday, November 28, 2008, after a lengthy course of litigation, Justice George Strathy of the Ontario Superior Court of Justice ordered that Apotex must perform all the terms of the settlement agreement. Those terms include the payment to Dr. Olivieri by Apotex of $800,000, a figure first made public by Justice Strathy in his order.

The settlement agreement contained a term that Dr. Olivieri would not subsequently 'disparage' Apotex or the drug deferiprone.

Now here is the amazing part,

Most recently, Apotex has made its claims of “disparagement” against Dr. Olivieri in a Superior Court action commenced on November 4, 2008. Justice Strathy’s order does not affect the new Apotex action. In its action Apotex could claim from Dr. Olivieri the full amount of $800,000 required to be paid to her under the settlement agreement.

In its statement of claim Apotex takes a very broad view of what constitutes actionable 'disparagement' by Dr. Olivieri. Apotex claims that actionable 'disparagement' includes situations in which Dr. Olivieri is said to have 'acquiesced or consented' to alleged 'disparagement' by others. Instances of 'disparagement' alleged by Apotex include:

* A Wikipedia internet description of Dr. Olivieri, written by a person other than Dr. Olivieri;
* An opinion column referring to Dr. Olivieri in The Globe and Mail written by a Globe columnist, not Dr. Olivieri, which does not contain any statement about Apotex attributed to Dr. Olivieri;
* A motion picture company’s description of a potential movie about Dr. Olivieri;
* A complaint to a newspaper by Dr. Olivieri that statements made in an article referring to her were incorrect.

In its claim Apotex also makes many allegations of 'disparagement' that appear to be based solely on Dr. Olivieri’s participation or attendance at conferences on the relationship between universities and the pharmaceutical industry at large, academic freedom, scientific research and conflict of interest.

So according to Apotex, physicians and medical academics are liable for what is said or written about them by third parties, even if the physicians and academics had nothing to do with what the third parties wrote or said.

So, by the way, by extension from the arguments made by Apotex, by writing this blog post, I have somehow caused Dr Olivieri to further disparage Apotex.

This is egregious nonsense. The filing of the lawsuit by Apotex, which Dr Olivieri will presumably have to go to considerable expense to defend, is a threat to the academic freedom and free speech of all in academia, but particularly to medical academics, and by extension, also is a threat to the free speech of all physicians. This sort of litigation further chills the atmosphere in free speech in health care, a sphere in which criticism of powerful organizations and their powerful leaders is already scarce and threatened.

This should be a wake up call for those physicians and medical academics who maintain a consistently rosy view who persistently believe that those nice people at the top of pharmaceutical, biotechnology, and medical device companies are always on the side of righteousness and good.

Hat tip to the Center for Science in the Public Interest's Integrity in Science Watch here.

See additional comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

Open Letter to President Barack Obama on Healthcare Information Technology: The "We're Right" Wing vs. The "Left Out" Wing

Mr. President, it is obvious that healthcare requires change. Change is needed in order to assure equal access to all, to end disparities in quality and service, to create sanity in costs, and to accomplish other reforms that will promote healthcare “justice” for all.

You have just called for a significant expansion of use of healthcare information technology (HIT) by hospitals and physicians as part of your economic rescue plan. I strongly applaud such an incentive.

As in other industries using information technology, HIT such as electronic medical records, physician order entry, and clinical decision support systems will play a leading role in healthcare transformation. Without such technology, the healthcare system is far too complex to be managed well.

And managed well it must become. However, there is a major caveat regarding such a national initiative.

Mr. Obama, I offer the following suggestions from the perspective of my medical specialty area, Biomedical Informatics, the formal study of computer applications in biomedicine [1]:

HIT is an experiment. It is, as yet, unproven on a large scale. There have been many warning signs that it is an experiment that could go awry. HIT can be used to assist in healthcare transformation, but not if the HIT itself is defective or mismanaged.

Unfortunately, the problems with HIT are indeed considerable.

Use of HIT after 30-plus years of effort and billions of dollars spent remains limited. As per the 2008 statistics in the New England Journal of Medicine, just four percent of physicians in the U.S. reported having an extensive, fully functional electronic-records system, and just thirteen percent reported having a basic system. Most hospitals are also lacking the technology to any meaningful extent [2].

Clinicians (physicians, nurses and others) are struggling to use awkwardly designed HIT, designed as if for quiet, solitary business offices yet costing millions of dollars per hospital. Hospital boards, executives and department heads are often frustrated by the pushback and resentment they get from their clinicians regarding such HIT.

Too few in the HIT industry, however, ask why this situation exists and what might be done to eradicate these problems.

The healthcare industry and the HIT sector have been reliably tone deaf on these issues, which results in the very low diffusion of HIT. Platitudes, excuses, and blame placed solely on endusers (i.e., the clinicians) are the norm.

Why is this so?

Mr. Obama, I believe that there are two major ideological camps in what I call the “HIT Ecosystem” [3].

On one side are the “HIT industrialists" - the "We're Right" Wing.

The HIT industrialists, including developers, vendors, consultants, and IT personnel in hospitals view HIT simply as another variety of business computing technology, such as finance and accounting systems meant for use in calm, solitary office environments.

They cling to their “religion” of management information systems approaches and methods for design, implementation and evolution of business IT, believing these approaches as valid for the back office as for the pediatric clinic, emergency department or intensive care unit.

Nothing could be further from the truth. This is a leap of logic of absurdist proportions that would be comical if its implications were not so serious.

It is as if the industrialists believe one should be able to travel to the moon in a hot air balloon. The moon is "up" and balloons go "up", therefore, why not? All that's required are the right "processes" -- with which the Acme Hot Air Balloon Co. executives can accomplish anything -- and ignoring those pessimistic scientists, engineers and other experts who speak of vacuum of space and radiation and all those esoteric "gotchas" that are bad for business! (See my Powerpoint presentation to the IEEE Medical Technology Policy Committee on this issue at this link.)

To the Moon in a Hot Air Balloon!

The industrialists forget -- or never knew -- that a thousand generic workers following the finest of process will always be outperformed by a few people who actually know what they're doing.

The HIT industrialists usually refuse to accept more progressive, “activist” approaches to these issues that recognize that clinical computing and business computing are not different sides of the same coin, but are in fact distinct subspecialty areas of computing requiring distinct and specialized approaches.

The industrialists would also have us believe that the HIT “economy” is fundamentally sound and that we should proceed with business as usual.

I shall refer to the industrialists as the “We’re Right” Wing of the HIT Ecosystem.

I use this title based on their often reactionary and procrustean views towards HIT. The adjective “procrustean”, derived from certain practices of Procrustes, a figure from Greek mythology, is defined as “designed to produce strict conformity by ruthless or arbitrary means” [4]. These views, that the “old” ways of designing and implementing IT are the “right” and in fact the only way to proceed, are strongly held. I believe they are, however, being made obsolete in an age of unparalleled IT innovation.

Largely as a result of the “We’re Right” wing’s views, costly, morale damaging (especially to clinicians) HIT difficulties and failures are commonplace, and the benefits of which this technology is capable are not being realized.

Clinicians must toil with ill conceived or badly designed IT in their already harried ten to fifteen minute patient visits, and the industry is largely deaf to their misery. It’s bad for the IT business.

On the other hand, knowledgeable clinician-informaticists in the aforementioned field of Biomedical Informatics, true computer scientists (as distinguished from management information systems or MIS personnel), sociologists studying IT, and other related specialists, some working for more than thirty years, have found better ways to develop and manage HIT than has the traditional IT industry, which itself has a dismal record of project cost overruns, failures, and system abandonment in fields far less complex than clinical medicine.

Sadly, the specialists are often pushed to the margins of the HIT Ecosystem. I will call this “we actually know what we’re doing” group of specialists the “Left Out” Wing.

It is particularly ironic that the Biomedical Informatics group is marginalized, in that it was that group of pioneers who experimented in the early days of computing and essentially invented the foundational elements for today's health IT. Even then, the pioneers noted issues in HIT that are unchanged many decades later. For example, as I note at my academic website on HIT difficulties:

As far back as 1969, EMR and Medical Informatics pioneer Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, made the following observation.

He wrote that "computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

With regard to Biomedical Informatics specifically, the U.S. National Institutes of Health (NIH) has spent hundreds of millions of dollars over the past twenty years to expand Biomedical Informatics through funding of rigorous training at many of this nation’s major universities, as have many other educational organizations on their own funds.

Yet, the lessons of Biomedical Informatics and the other specialist areas have yet to diffuse into the HIT industry and effect needed “change” in that sector. When informatics experts bring their activism into the equation, they are often not taken seriously or placed into “advisory roles” (that is, away from true leadership roles) in most healthcare organizations.

Experts in the Left Out wing offer sage advice. “It is unwise spending millions on Electronic Medical Records without investing thousands in Biomedical Informatics expertise”, these specialized personnel say [5].

Yet there are many “unwise” organizations within healthcare. Examples abound of healthcare organizations not just passively but actively and almost absurdly rejecting the presence or counsel of the specialists as if the organizations are run by intellectually challenged leadership (does this sound familiar regarding other industries in the news recently? See example here), and I believe there is great value in studying the results of this lack of insight [6]. However, others do not.

The following is meant not to be humorous but to reflect a dangerous reality:

The Industrialist "We're Right" Wing's Simplistic and Overoptimistic View of Healthcare Environments

The Informaticist "Left Out" Wing's Reality-Based View of Healthcare Environments

If you think the above is exaggerated, Mr. Obama, read my account "Serious Clinical Computing Problems in the Worst of Places: An ICU" at this link regarding an actual situation some years ago in an ICU at the largest healthcare provider in Mr. Biden's home state, and the cavalier attitudes taken by its executive administration over endangerment of ICU patients via computer.

Imagine for a moment the horror of being unable to intervene due to administration's priorities of "everyone getting along" rather than the absolute protection of patients. Yet this is not an uncommon scenario in the IT backwater of hospitals.

This state of affairs has significant real world implications.

Even now I hear of ill conceived and poorly implemented ICU systems that endanger premature infants, EMR's that interfere with adult patient care and clinician mental focus in offices and clinics, order entry systems that encourage rather than prevent medication errors, and systems that impair hospital operations to the point of putting seriouly ill patients at risk of being misdiagnosed and intermittently losing patient information.

First and foremost among the “We’re Right” wing is an aversion to detailed investigation of IT failure, as should be performed, NTSB style. However, doing so might be bad for business. In the industrialist culture of IT, it’s bad to air the dirty laundry.

As a result, our government has been seduced by the promise, the potential, the Siren Song if you will of HIT, and shielded from information on its true challenges, difficulties, downsides and failures. An "irrational exuberance", a Syndrome of Inappropriate and Uninformed Overconfidence in Computers prevails in healthcare (my webcast on irrational exuberance in HIT can be heard at online journal "Government Health IT" here).

As a result of this seduction and censorship of the unpleasant realities, seasoned legislators such as Sen. Max Baucus are led to make claims such as:

“Everybody talks about health IT. We all know we need it. It hasn't happened. Why? Partly because we're America. We're not a single-payer system like the UK, which can say, you hospitals, you have to put this in because we're paying your bills” [7].

This implies that Sen. Baucus believes the UK should have an easy time of it in their multi-billion dollar national HIT program, NHS Connecting for Health.

Yet this has proven to be profoundly untrue:

The future of the NHS's £12.7bn computer programme was in doubt last night after its managers acknowledged further delays in introducing a system for the electronic storage and transmission of patients' records.

Connecting for Health, the NHS agency responsible for the world's biggest civil IT project, said it was no longer possible to give a date when hospitals in England will start using the sophisticated software that is required to keep track of patients' medical files.

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care [8].

I should add that the “appointed head of informatics” has no apparent formal Biomedical Informatics background, but had been CIO of candy/beverage company Cadbury Schweppes, a puzzling background to lead a national HIT initiative.

If health IT is easier in the UK due to their single payer system, then God help us here in the United States.

Lessons from HIT difficulties and failures are rarely spoken of and often hidden. Detailed investigations down to fine grained causes that are routinely performed in other areas of technology failure – airlines, trains, etc. – are not done when health IT fails. This is due to the industrialist biases.

Yet, as per the European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems, you should be aware that bad HIT can kill [9].

Further, the repeated advice of the “We’re Right” wing of the HIT Ecosystem is that the cause of failure, besides those darn clinicians, is neglecting to adhere to obvious and simplistic “best practices” typical for business IT. These practices largely involve common sense, such as involving end users at all stages of development, focusing on the value added rather than the technology, and other “sterile technique is needed in surgery” advice.

Unfortunately, even in non-healthcare IT, technology projects have a bad reputation for going over budget and schedule, not realizing expectations, for providing poor return on investment, or in failing outright and being de-installed. Surveys and reports on the acceptability of new IT systems seem to highlight constantly the same problems and probable causes of failure yet businesses, large and small, continue to make mistakes when attempting to improve information systems and often invest in inappropriate or unworkable changes without proper consideration of the likely risks [10].

In HIT, these problems are perhaps worse, with the added complexity of the unpredictable, poorly bounded environment of healthcare.

Enter Biomedical Informatics, computer science, social science and the other true experts. Advice often heard from this “Left Out” wing, but largely dismissed by the industrialists, include:

• Simplistic “best practices” of business IT are often inadequate for the complexities of IT in clinical settings, and even these are often not followed in healthcare IT.

• CIO’s are not unaware of, nor do they go out of their way to pass up, best practices. The reasons that commonsense best practices, e.g., strong clinician involvement and empowerment in health IT projects are not universally employed is a sociological issue, and requires investigation.

• The most important "best practice" of all is often not followed: the practice of knowing what you do not know, identifying those who do know, becoming familiar with their work, and utilizing them and their knowledge maximally. Most hospital CIO's are unaware or have a very narrow and faulty view of Biomedical Informatics. Considering the impact of the CIO role in healthcare, and the ease of obtaining such information via the web, this amounts to fundamental negligence.

• There are highly specialized and nuanced “best practices” arising from decades of Biomedical Informatics, IT-sociology and other research of which traditional IT personnel are generally unaware, and therefore do not use. This is harmful to the healthcare enterprise.
  

• The reasons for “worst practices” seen of many stakeholders – such as active and passive aggressive behaviors that occurs for many reasons and negate any “best practices” - need to also become deeply understood, not treated in a cavalier manner or ignored. These behaviors reflect hidden, critical human issues of which nobody speaks, and it is these unspoken issues that can cause HIT to fail.

• Continued inattention to HIT ease of use to maximize vendor profits, and issues such as pay for performance formulas based on electronic medical records data, but prepared in a typical corporatized manner unfair to clinicians and harmful to medicine’s core values, will be recognized as such by clinicians. This will lead to increased active and passive aggression against HIT that will cause HIT (even otherwise well designed HIT) to fail.

There are many other points of wisdom contained in a huge body of literature that, in fact, could have helped avoid the major problems within the UK’s national HIT initiative, and that can prevent the same from happening here.

Mr. President, I implore you and your advisers and staff to become personally familiar with these issues. Seek out the advice of Biomedical Informatics experts, computer scientists, those who study social issues in computing, and others. Have your advisers read books such as “Medical Informatics 20/20: Quality and Electronic Health Records through Collaboration, Open Solutions, and Innovation” by the VHA pioneers [11], “Managing Technological Change: Organizational Aspects of Health Informatics” by informatics researchers Lorenzi and Riley [12], and “Understanding And Communicating Social Informatics” by IT social issues innovators Kling, Rosenbaum and Sawyer [13].

Push as strongly for HIT reform as for healthcare reform itself, lest our HIT initiatives suffer the same delays – and the same costly failures – as the UK’s national electronic medical records program.

If this is not done, Mr. President, billions of precious healthcare dollars that might be spent on “IT misadventure” in a time of unprecedented national financial challenges and hardships might simply be better spent on delivery of needed medical services, health insurance and other "safety net" interventions.

HIT in 2009 and beyond, as healthcare itself, is at a crossroads. If we do HIT right, we get rewarded. If we do HIT wrong, then the results shall be deserved.

My takeaway lesson is simply stated: healthcare’s defects cannot be effectively changed or reformed via healthcare IT, if that healthcare IT itself is defective.

Both require change.

Sincerely,

Scot Silverstein, M.D.

References:

[1] “Training the Next Generation of Informaticians - A Report from the American College of Medical Informatics.” J Am Med Inform Assoc. 2004 May–Jun; 11(3):167–172. PDF at this link.

[2] “Electronic Health Records in Ambulatory Care - A National Survey of Physicians.” NEJM 359:50-60.

[3] “Introduction to the Complex Ecosystem of Healthcare IT.” Essay at website “Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties.” Scot Silverstein MD, Drexel University, Philadelphia, PA, http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=ecosystem (accessed Nov. 26, 2008).

[4] The American Heritage® Dictionary of the English Language: Fourth Edition, 2000. http://www.bartleby.com/61/85/P0578500.html

[5] Paraphrasing William Hersh, M.D., Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, http://www.billhersh.info

[6] “Medical Informatics, Information Technology Leadership, and Clinical IT Success”, Scot Silverstein MD, Drexel University, Philadelphia, PA, http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm (accessed Nov. 26, 2008).

[7] “Health” supplement, Wall Street Journal, Nov. 24, 2008, p. R10

[8] “Bank bailout puts £12.7bn NHS computer project in jeopardy”, John Carvel, The Guardian, Oct. 29, 2008, http://www.guardian.co.uk/society/2008/oct/29/nhs-health (accessed Nov. 26, 2008).

[9] “Bad Health Informatics Can Kill.” European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems, http://iig.umit.at/efmi/badinformatics.htm (accessed Nov. 26, 2008).

[10] “Developing a risk estimation model from IT project failure research.” M Bronte-Stewart, Computing and Information Systems, University of Paisley, 2005, 9(3): 8-31. http://cis.paisley.ac.uk/research/journal/V9/V9N3/failure.doc (accessed Nov. 26, 2008).

[11] Medical Informatics 20/20: Quality and Electronic Health Records through Collaboration, Open Solutions, and Innovation. First edition. Goldstein, Groen, Ponkshe & Wine, Jones & Bartlett Publishers, 2007, ISBN-13: 9780763739256

[12] Managing Technological Change: Organizational Aspects of Health Informatics. Second edition. Lorenzi & Riley, Springer-Verlag Publishers, 2004, ISBN: 0387985484

[13] Understanding And Communicating Social Informatics: A Framework For Studying And Teaching The Human Contexts Of Information And Communication Technologies. Information Today Publishers, 2005, ISBN 1573872288.

BLOGSCAN - Car Allowances and Country Club Membership for University Executives

On the University Diaries blog, Margaret Soltan posted on the perks afforded to top leaders, including the medical school dean, at the University of South Florida(USF). These included country club memberships, and car allowances at $650/ month. The rationale seemed to be that the administrators need to appear to be rich in order to hob-nob with the sort of rich folk needed as donors. The perks have continued even though the state-supported university is facing budget cuts.

I would comment that these perks might also be based on university executives' sense of entitlement to being at least on the fringe of the power elite, or superclass. This sense might truly be fed by their contact with even more wealthy people who might be prospective donors, and the sorts of masters of the universe who seem to have gravitated to university boards (see our posts about the Dartmouth board here and the Harvard Corporation here). But I would suggest that the perks handed out at USF might be bush-league compared to those found at the more supposedly elite universities.

I am afraid the main effect of such perks is to further isolate academic leaders from the people they are supposed to serve. After all, academic institutions are supposed to serve truth-seekers and learners. (Academic health care is also supposed to serve patients.) Country club memberships, or having a fully-staffed house and a car and driver might tend to make one feel apart from the common folk in the student body, or the patient population.