Friday, June 27, 2008

An Open Letter to Merck CEO Richard Clark: on Merck's Mission to Rediscover the Wheel

Preliminary notes (as background to better illustrate the context of the Open Letter, below):

I found the recent article "Merck's Informatics Mission" in the journal Bio-IT World enlightening. It resulted in an
Open Letter to Merck CEO Richard Clark, reproduced below these notes.

I believe what I have to say is important to the Company. While I hold no financial stakes in it or in other pharmas whatsoever, I live in a Merck community a stone's throw from the West Point site. The fate of Merck is the fate of my community.

As readers of healthcare blogs know, I have frequently written about the lack of formally-trained Medical Informatics specialists in the pharmaceutical industry.
See "An Open Letter to Senator Grassley", "Why Pharma Fails", "Drug industry officials see room to improve safety - or do they?", "FDA's hefty bonuses seek to retain workers" and "CRO's: we don't need Medical Informatics here" as examples.

I do not believe ignoring an NIH-supported informatics subspecialty (Medical Informatics) -- which Merck and other pharmas seem to do quite effectively, allowing IT and bioinformatics territoriality and ego to run unchecked -- and adhering to the "data processing" paradigms of the past are a good strategy for an "Informatics Mission" in an industry in serious trouble. I do not believe such an approach is fair to stockholders, institutional investors, and patients. I once fought this scenario as an insider; now I describe it as a service to others who might wish the pharma industry to perform better.

As a Medical Informatics specialist, I also observed that it seemed difficult for pharma IT personnel to grasp the difference between information science and information technology, resulting in direct harm to R&D (see "Conflation of Information Science and IT: Sure path to R&D failure"). Expertise in IT does not imply or confer expertise in information science, but the belief that the two are identical is canon in industry.

As a practical result of this 'canon', IT personnel generally lead all information activities in pharma. Such leadership models are based on the historical and, I believe, now obsolete premise generally held by the technology-naive (often senior management)
that "if it's information, the IT people do it."

The priorities in Medical informatics are biomedical information science and use of information by people, not IT. We see IT as a tool, but are not awed by it and do not "worship at its altar." IT is a facilitator in biomedicine, not an enabler.


Knowledge of these differences between technologists and information scientists is growing. For example, my college, the iSchool at Drexel, is one of the growing consortium of iSchools:

The iSchools are interested in the relationship between information, technology, and people. This is characterized by a commitment to learning and understanding the role of information in human endeavors. The iSchools take it as given that expertise in all forms of information is required for progress in science, business, education, and culture. This expertise must include understanding of the uses and users of information, as well as information technologies and their applications [note the order of these issues - ed.]

In this context, I am writing this open letter to Merck CEO Richard Clark:

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The letter:

Dear Mr. Clark,

I found the recent article " Merck's Informatics Mission" in the journal Bio-IT World fascinating - and frightening.

Right at the opening of the article, it is stated:

After five years at the helm of Merck's basic research IT group, Ingrid Akerblom [Ph.D. in biology] calls her move to the clinical side "quite an eye opening experience."

In other words, Mr. Clark, this is a "new experience" for a novice in clinical medicine and clinical IT. It causes me, as a Medical Informatics specialist, to ask why your IT leaders are calling the clinical side "quite an eye opening experience" (a stunning admission). Worse, they are not seeking help from those who have expertise in clinical medicine, EMR's and related clinical IT, Medical Informatics experts.

I suggest Merck's Informatics Mission might better be run with increased attention to state of the art talent management. I wish to make you aware of issues that may prevent that.

Please review my letter published in the same Bio-IT World six years ago, in 2002 when I was Director, Published Information Resources & The Merck Index in MRL:


Medical Informatics MIA

I enjoyed reading the article " Informatics Moves to the Head of the Class " (June Bio·IT World). Thank you for spotlighting the National Library of Medicine (NLM) training programs in medical informatics and bioinformatics, of which I am a graduate (Yale, 1994).

Bioinformatics appears to receive more media attention and offer more status, career opportunities, and compensation than the less-prestigious medical informatics.
This disparity, however, may impede the development of next-generation medicines. Bioinformatics discoveries may be more likely to result in new medicines, for example via pharmacogenomics, when they are coupled with large-scale, concurrent, ongoing clinical data collection. At the same time, applied medical informatics, as a distinct specialty, is essential to the success of extensive clinical data collection efforts, especially at the point of care.
Hospital and provider MIS personnel are best equipped for implementing business-oriented IT, not clinical IT. Implementing clinical IT in patient-care settings constitutes one of the core competencies of applied medical informaticists.
Informatics specialists with a bioinformatics focus — even those coming from the new joint programs — usually are not proficient in hospital business and management issues that impede adoption of clinical IT in patient care settings. Such organizational and territorial issues are in no small way responsible for the low utilization of clinical IT in patient care settings.
It will be important for medical informaticists focused in the clinical domain and bioinformaticists specializing in the molecular domain to collaborate with other specialists in order to best integrate clinical and genomic data.
Further information on these issues can be found in the book Organizational Aspects of Health Informatics: Managing Technological Change , by Nancy M. Lorenzi and Robert T. Riley (Springer-Verlag, 1995). Various publications from the medical informatics community, such as the American Medical Informatics Association (www.amia.org) and the International Medical Informatics Association (www.imia.org), are also useful.

Also review what the Institute of Medicine of the National Academies had to say:


Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate (The Future of Drug Safety: Promoting and Protecting the Health of the Public, IOM, 2006)

In that same year, Gartner had this to say:


Biopharmas that ignore the opportunity to use analytical tools to proactively review contradictory sources of study information (for example, pre- and post-approval clinical data sets, as well as registries) will miss essential signals regarding product safety. Yet today, only a small percentage of biopharmas routinely utilize personnel with medical informatics backgrounds to search for adverse events in approved drugs (Gartner Predicts, 2006).

The IOM and Gartner are referring to those with formal education and experience in Medical Informatics, not personnel who use the name because they do something with computers in biomedicine (see "What medical informatics is not").

While I know a number of people mentioned in the Bio-IT "Informatics Mission" article and respect their specific skills, I must point out that the "clinical side" is "not an eye opening experience" to those formally trained in Medical Informatics. It is our natural environment.

Mr. Clark, did you know that as far back as 1969, EMR and Medical Informatics pioneer and program funder Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, wrote the following? "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).

Surprisingly, there has been little change in this issue in thirty-five years. Today the IT personnel and non-medical managers (e.g., non-degreed IT staff, BS or MS in computer science, MBA's, even PhD's) who by custom and tradition are assigned leadership roles in EMR and clinical data research initiatives via control of critical decisions, budgets and resources, often lack clinical experience and insight. Yet, as Medical Informatics researchers Nemeth & Cook wrote more recently in 2005,

"The technical work that clinicians perform is hiding in plain sight. Those who know how to do research in this domain can see through the smooth surface and understand its complex and challenging reality. Occasional visitors cannot fathom this demanding work, much less create IT systems to support it" (Hiding in Plain Sight: What Koppel et al. tell us about Healthcare IT” (Nemeth & Cook, Journal of Biomedical Informatics 2005;38:262-263, link to pdf).


Specifically, personnel of an information technology background, with little or no background in the biomedical sciences, often are positioned by senior management as enablers, rather than facilitators, of such initiatives. They retain a major say in what is -- and is not -- done, and in the tools provided to perform clinical care and biomedical R&D.


Also noted in the "Merck's Informatics Mission" article are Bioinformatics specialists. Please read my 2002 article, Mr. Clark, and note that Bioinformatics is not Medical Informatics, and IT is not Medical Informatics. Medical Informatics is its own specialty, funded by NIH for at least the past two decades.


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).

Essentially, your IT and Bioinformatics colleagues will spend the next several years learning and re-learning all the lessons of Medical Informatics that those in the field learned 10-15 years ago (e.g., at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare IT Failure" at this link), at Merck's and shareholder's expense. They will make mistakes, take wrong turns, miss subtle issues, and drive up costs and timelines while missing opportunities, at the expense of the business.

EMR's, clinical IT, 'real-world' (as opposed to controlled clinical trials) clinical data and the often subtle and sociotechnically complex issues around them are neither simple nor easily learned, most especially by non-clinicians. See here for just one recent example of unforeseen complexities (unforseen by those who do not understand the issues, that is) surrounding IT in clinical settings.

At the end of the Bio-IT World article are a series of questions posed, as in the following examples. I comment:


... in the clinical sample area, combining the results data from clinical samples with the associated patient data, what's that platform?

[Mr. Clark, could this be the wrong question, based upon an IT person's technology focus as opposed to, say, a focus that is about facilitating people in interacting with data? Is a "platform" the answer, or is an advanced approach to the problem the answer? We in medical informatics thought about these issues long ago.]

... I know there are new commercially available things coming out like Azyxxi from Microsoft

[
Mr. Clark, do you think there is a possibility this may be the wrong paradigm for this type of activity? Do you think there is a possibility that Medical Informaticists with practical experience in Clinical Data Repository implementation supporting concurrent medical care in large medical centers might actually be knowledgeable, in a very strategic sense, regarding these issues?]

... So we need to be looking at what's out there, what's the gap, and do we put something together ourselves?

[Mr. Clark, why is a 100-plus-year-old pharma company even asking such a question, especially without formal Medical Informatics expertise?]

... We're embarking on an electronic medical records (EMR) strategy looking for signal detection among other uses.

[Mr. Clark, what took so long? Who, exactly, has research and applied EMR experience there? Do your people assume that clinical IT is merely a subspecies of research or management information systems, the intricacies to be learned on-the-job by people unfamiliar with clinical IT? If so, which appears likely, on what do they base this assumption?]

... Those are things that are just starting to be reinvested in, figuring out how do we leverage that information, how do we get that connected?

[Mr, Clark, why is your Company"just starting" on this? Why are your people attempting to re-discover the wheel? ... More generally, do you believe there might be those who are able to, through experience, suggest answers to these and many other questions being asked by non-medical IT and bioinformatics personnel regarding your "Informatics Mission?"]


It seems to me that re-learning from scratch what others have learned from years of experience is not a very cost-effective strategy. It is not the type of research a company that advertises itself as "research-driven" should be performing, in my opinion.

At the same time, formally-trained Medical Informatics professionals are severely under-represented in pharma, including Merck.

In fact as part of the Research Information Systems talent management committee, I asked for the term "Medical Informatics" to be made part of Merck's HR lexicon (it was apparently missing), and made recommendations for the hiring of more Medical Informatics specialists. My advice did not seem to go over well among the non-clinical IT personnel present. No actions were taken on the advice.

From a personal perspective, I advised the VP of Research IT about my underutilized background in clinical IT, to no avail.

One reason is probably basic territoriality, Mr. Clark. This is common in the highly competitive and ego-driven IT fields. Self-serving groups form and act both unconsciously and deliberately to keep out potential competitors. I teach an actual graduate course on just these issues at a major university in your own neighborhood, Mr. Clark:

INFO780: Organizational and Sociological Issues in Health IT syllabus is at this link .
Has anyone at Merck taken this course or one like it, Mr. Clark? The issues taught are relevant not just to clinical settings, but to R&D IT as well. In fact, has anyone at the Company taken any graduate or postdoctoral courses in Medical Informatics such as the graduate healthcare informatics certificate I architected, or had applied Medical Informatics experience in, say, an ICU, clinic or medical office? If not, why not?

While competitive territorial behavior is understandable, I do not believe IT and Bioinformatics personal interests and vanity should outweigh corporate and shareholder obligations to hire the best talent for work at the intersection of clinical medicine and computing.

Yet, I've been told directly by a Merck official that "we don't need Medical Informatics here" in attempting to be rehired after the Equinox layoffs of Nov. 2003. Ironically, this was a senior person in the area of drug safety and adverse events surveillance, and said this not long before Vioxx's tumultuous withdrawal from the market. I was seeking to provide help in improving the adverse events database and analytical tools.

He told me "we don't need Medical Informatics" as I was showing him my work in building from the ground up a highly specialized EMR for invasive cardiology (link) to detect, among other issues, device adverse events and complications in a cardiac cath lab performing 6,000 procedures/year.

This sounds like an aversion to clinical IT expertise to me. Can you provide a better explanation for this apparent boycott, Mr. Clark?

Remember the failed CRISP clinical trials IT initiative, Mr. Clark? Where people and $100 million got turned into "crispy critters?" Medical Informatics professionals such as myself were trying to get into pharma then, to no avail; same responses then as now, including your company. We could have prevented this debacle from ever occurring:

In the 1990s, Merck struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco.

"This project ran into a lot of problems," says one former manager who was involved near the beginning of the CRISP project ... Merck significantly underestimated the challenge, according to a former Merck executive who was involved in the early phases ... The task of creating this software led the programmers into unfamiliar territory.[Not unfamiliar to Medical Informaticists - ed.]

Not only did they [IT personnel leading the project] have to learn new programming techniques, but they were continually frustrated in their effort to build a single system that would work for all trials. The real problem was that the data to be collected varies significantly with the nature of the medicine being tested and the malady it addresses.

[Remarkable of them to discover that basic principle all on their own, taught in Medical Informatics intro courses, at a mere cost of $100 million - ed.]

The cause of this debacle was not mysterious to those in Medical Informatics. Oh, wait ... you didn't have any of those specialists working at the Company.

Will another CRISP occur, Mr. Clark? Why or why not? Are you certain?

Perhaps another reason for what effectively appears to be a boycott of an entire discipline is found in your eRecruiting system. My own CV which is strongly focused on Medical Informatics is on file in Merck's e-Recruiting system.

Yet that system seems to only send frivolous alerts, implying it is badly mistuned (and also implying informatics experts are invisible to your internal recruiters). I get alerts like this one:

A job opening consistent with the job interests you expressed in your profile for a SAP Security Analyst--Merck & Co.,Inc.-INF003774 has just been posted in our Career Section.

I know little of SAP and SAP security, and SAP is mentioned nowhere in my CV. In fact, "Medical informatics", "clinical IT" and common words such as "Director" (Merck management, level 4) and "MD" appear. Why are alerts regarding "analyst" (low level) positions even being sent under such conditions, when Merck's own management-grade title is prominent in the CV? How many other people and specialties does this phenomenon affect?

Also see here wherein I describe other frivolous alerts I've received and how I've let my former HR colleagues at Merck know about this problem, to no avail.

In effect, the Bio-IT World article speaks more loudly not of state of the art informatics but of suboptimal talent management , which in the taxonomy of business falls under the subject heading of "mismanagement."

While I somewhat admire Merck's readily apparent belief in technological self-sufficiency and the strong self-assurance of its IT leadership, I do believe it falls under the general heading of "arrogant ignorance." I believe that mindset has gotten Merck and other pharmas in trouble before.

I do not believe your "Informatics Mission" strategy best serves patients, shareholders, institutional investors, and others. I believe those stakeholders need to look into these issues.

-- SS

2 comments:

Anonymous said...

Merck seems to be attempting to reacquire thier image, that may have been suffering over the past decade in particular. As a former employee of Merck, it is in fact saddening that they lost thier uniqueness as being one of the few remaining ethical pharmaceutical companies before thier acceptance of profit over patients, as viewed presently by the public for which historically they served with great admiration.

MedInformaticsMD said...

The issues I raise are not about ethics. They have to do with the difference between "me-too" science and true excellence in science.

The surest way to "align IT to the business" is to have leaders who understand the business.

When that business is medicine, that does not mean IT leaders from Boston Chicken or International Paper.