More Multi-Million Dollar Orthopods

Starting last year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

I was surprised how little attention this issue received in the media, given the size of the payments involved, and the extensiveness of the lists of those who received them. Demonstrating the anechoic effect, the issue received almost no attention in any medical or health care publications. Yet every now and then, the story resurfaces.

This week, it resurfaced courtesy the Philadelphia Inquirer, which published two related articles. The most vivid was about a lawsuit filed by a patient who received artificial hip implants that failed. MedInformaticsMD quoted relevant parts of the article and commented on some issues related to the above story here.

The Inquirer also published a companion story with background information on payments made by hip and knee implant manufacturers. Reporter Josh Goldstein took the opportunity to look into payments made to other Philadelphia area surgeons.

Locally, 29 doctors and others received a total of $7.9 million last year. Most of that money went to two of the region's busiest and most prominent orthopedic surgeons.

Richard H. Rothman, founder of the Rothman Institute at Thomas Jefferson University Hospital, received nearly $3 million last year from Stryker. A Rothman spokesman said most of that money came in royalty payments for a hip Rothman helped design.

The other surgeon, Robert E. Booth Jr., who practices at Pennsylvania Hospital, received nearly $2 million from Zimmer Corp., the company that makes the so-called gender knee for women. Booth is one of eight patent holders on it.

Both doctors declined to be interviewed. Through spokeswomen, they said they disclose their company ties to patients. There is no indication that either have engaged in any wrongdoing.

Indeed, many patients seek out surgeons like Booth and Rothman, who help design implants, precisely because they are known as pioneers in the field.

At 72, Rothman, the former chairman of orthopedic surgery at Jefferson, remains busy, replacing more than 600 hips and knees a year. Implants cost as much as $7,500 each.

According to Stryker's disclosures, the company paid Rothman $2.9 million in 2007. In addition, Rothman received $316,885 in "corporate assistance" for research, $52,906 in air travel, $4,705 for ground transportation, and $1,757 in meals.

'The vast majority of payments Dr. Rothman receives from Stryker are royalties for the Accolade hip implant,' said a statement provided by the practice he founded, the Rothman Institute.

At Pennsylvania Hospital, Booth, one of the nation's busiest knee surgeons, routinely replaces a knee in under a half hour - 12 to 14 a day, or about 1,200 a year.

Last year, Zimmer paid Booth $1.9 million, plus $35,729 in air travel, $3,135 for lodging, $1,214 for meals, and a $6 gift.

Susan E. Phillips, a senior executive at the University of Pennsylvania Health System, said Booth's contract with Zimmer prevents him from discussing royalties.

The articles focused on the question of whether these sorts of humongous payments were disclosed to patients, or whether they affected direct patient care by the surgeons who received them.

Since some breathtakingly huge payments were made to apparently very influential surgeons, I wondered if the surgeons disclosed such large payments to other doctors who might be influenced by their words.

In the articles I was able to quickly access published by Rothman during 2007, I found some disclosures of his relationship to Stryker, but none that revealed their magnitude. (These do not constitute a complete sample of his publications, just what I could easily obtain on the web.)

Lettich T, Tierney MG, Parvizi J, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: two- to seven-year results. J Arthoplasty 2007; 22 (Suppl 3): 43-46.

Richard H. Rothman MD, PhD and ... are consultants for Stryker orthopedics.

Pour AE, Parvizi J, Sharkey PF, Hozack WJ, Rothman RH. Minimlly invasive hip arthoplasty: what role does patient preconditioning play? J Bone Joint Surg 2007; 89: 1920-1927.

In support of their research for or preparation of this manuscript, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Stryker.

I was able to access one article written by Booth in 2006, and one in 2004. Again, neither revealed the magnitude of his relationship to Zimmer.

Lonner JH, Jasko JG, Booth RE. Revision of a failed patellofemoral arthroplasty to a total knee arthroplasty. J Bone Joint Surg 2006; 88: 2337-2342.

In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from Zimmer, Inc. In addition, one or more of the authors received payments or other benefits or commitment or agreement to provide such benefits from a commercial entity (Zimmer, Inc.) Also, a commercial entity (Zimmer, Inc.) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or non-profit organization with which the authors are affiliated or associated.

Bezwada HP, Nazarian DG, Booth RE. Acetabular wear in total hip arthroplasty. http://www.emedicine.com/orthoped/TOPIC371.HTM.

Nothing to disclose.

In my humble opinion, a disclosure that a journal article's author received some sort of "grants" or "payments" from a company does not quite have the impact of a disclosure that the author received millions of dollars in royalties. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for joint replacement, or for replacement in specific circumstances or with specific products, might just have been a bit influenced by making millions of dollars a year in royalties from specific joint implants.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from royalty payments enough to make a doctor quite rich? Inquiring minds want to know.

Seeing the Trees But Missing the Forest: On Another Insidious Effect of Payment to Doctors by Medical Device Companies

As a Medical Informaticist with experience in building very specialized information systems for highly specialized medical areas (e.g., population genetics & birth defects; invasive cardiology), certain issues are readily apparent that I believe get missed by others studying the nasty phenomenon of physician payments by medical device makers and merchants.

One issue that emerges is the insidious effect such payments may have on the "nuances" and "creative license" a physician might take on reporting the data.

In fact the entire clinical trials process becomes suspect, perhaps even more so than in pharmaceutical industry. Here is why.

The following story appeared today in my local paper, the Philadelphia Inquirer:

"After hip replacements, a lawsuit: Implant company paid Penn surgeon consulting fees."

Fed up with the constant pain in her hips, Katrina McKenzie took her surgeon's advice and had them replaced with experimental implants. [Civil docket report here - ed.]

The 31-year-old from Galloway, N.J., who agreed to participate in a clinical study, knew there was a risk that her new hips could fail.

But she didn't know that the manufacturer financing the study, Smith & Nephew, was also paying her surgeon tens of thousands of dollars a year as a consultant.

In recent years, such payments to doctors from medical implant manufacturers and drug companies have become increasingly controversial.

Some leading orthopedic surgeons receive six- and seven-figure payments annually, in the form of royalties, consulting deals and speaking fees from the makers of artificial hips and knees.

... Garino and Penn responded, in court filings, that McKenzie received good care and that the payments had no effect on her treatment.

"On the merits of the medicine, we are going to vigorously defend this case," said Susan E. Phillips, spokeswoman for the Penn health system....

In his deposition, Garino said that while Smith & Nephew sponsored the study, he did not receive any direct financial benefit. The company paid Penn for the surgeon's time and expenses.

However, under questioning from one of McKenzie's lawyers, Garino acknowledged that he was being paid for other work by Smith & Nephew - which he did not disclose.

At the time of McKenzie's surgery, Garino estimated, he was making "$20,000 to $50,000 annually" as a Smith & Nephew consultant.

Note the statement made by the treating surgeon that "the payments had no effect on this patient's treatment."

Let me show how such a statement, if it is being reported correctly, is disingenuous at best and downright sleazy at worst.

I shall do this via a series of questions. First, however, read this case study on the difficulties of building specialized information systems to evaluate complex new treatments and technologies: link.

My questions are:

• Who builds the datasets and analytics used in evaluation of new medical devices such as the implants mentioned in the Inquirer article? This is a extremely complex process, filled with nuance and "devil in the details" issues due to the complexity of biomedical science.
  
• Is it the device vendor/merchant?
• Could that be a problem in terms of the dataset elements, definitions, terminologies, data quality, and other factors affecting the transparency of results?
• Are medical informatics professionals - that is, experts formally trained in this activity - or others with comparable expertise involved at the vendor shop or at the healthcare organization then deploying the new devices?
• If not, why not?

In fact, a comprehensive dataset to study invasive cardiology alone ran several hundred data elements. It took months of effort working with a team of committed invasive cardiologists to develop the dataset to match the clinical realities of the field, as well as teach quality recordkeeping (i.e., each clinician needed to have the same understanding of what was meant by each term, down to a fine grained level).

Each case was reviewed by a neutral "data quality" evaluator as well before entered into a robust database with advanced metrics, again developed and refined over several months by the same team.

As the medical informaticist, I steered the development based on my knowledge of biomedical information science, relational database technology, and of medicine. That raises more questions:

• What training do the surgeons who implant orthopedic devices get in recording their data?
• Who does this training? What are their backgrounds?
  
• What motivations might they have to "go easy on the reporting", i.e., blur their findings and and "which box they check on the data collection form" when a potentially bad thing happens? In medical data, this is easy to do, even innocently, let alone when one has motivation - e.g., when one is being paid handsomely by the device maker or seller and consciously or unconsciously seeks not to harm the gravy train.
  
• Do neutral QC person(s) check for this possibility?
• If not, why not?
  

I suggest to malpractice attorneys that they seek answers to these questions. It is negligent for a device manufacturer and medical center not to employ the very best "standard of care" regarding clinical datasets, in my opinion.

There are certainly many, many issues surrounding the quality of pharmaceutical clinical trials data, which to a certain extent are done in a secretive manner. Device trials are likely worse.

Who polices clinical trials data for, say, the new implants that caused the patient in the Phila. Inquirer article her problems?

The answer likely will not be pretty.

In summary, payments to doctors not only may affect their judgment on which devices to use and how often, but also on reporting the issues (using datasets that themselves may be compromised by vendor involvement). "Reportable" issues are often very subtle and amenable to being masked by "spin", "blur" and "invisibility."

I believe this issue is under-represented in considering the effects of payments to doctors, and in litigation when bad things happen.

This needs to change.

-- SS

STANFORD, SCHATZBERG and CORCEPT THERAPEUTICS: RECOGNIZING and MANAGING CONFLICTS

STANFORD, SCHATZBERG and CORCEPT THERAPEUTICS: RECOGNIZING and MANAGING CONFLICTS

The case of Stanford University and Dr. Alan Schatzberg, chairman of Stanford’s department of psychiatry, has been in the news for a week. Senator Grassley raised concerns about conflicts of interest, reporting of same, and Stanford’s policies. In play are a company called Corcept Therapeutics that Dr. Schatzberg founded, and a drug called Mifepristone or RU 486 that is in clinical trials for a severe form of depression. Interest in this case is especially high because Dr. Schatzberg is the president-elect of the American Psychiatric Association. Daniel Carlat, Clin Psych, and University Diaries have had cogent commentaries on the wider implications of this breaking issue.

The University issued a statement in response to Sen. Grassley. This statement asserted that Dr. Schatzberg has fully complied with the University’s rigorous conflict of interest policy and that Dr. Schatzberg “has not been involved in managing or conducting any human subjects research involving Mifepristone, a pharmaceutical that Corcept licenses for the treatment of psychotic major depression.”

Stanford’s account of Dr. Schatzberg’s arm’s-length role in Stanford’s NIH-supported studies of RU 486 (mifepristone) for depression is questionable, if not disingenuous. Dr. Schatzberg’s patent application filing for use of RU 486 in depression occurred in 1997, and he founded the corporation Corcept Therapeutics in 1998. He was a member of the board of directors from 1998 to 2007. He has chaired the corporation’s scientific advisory board since 1998.

There is reason to believe that Dr. Schatzberg had a key role in Stanford’s clinical trials of Corcept’s drug reported in 2001, 2002, and 2006. He was a co-author on all three publications, and there was no disclaimer about his role until 2006. This disclaimer is hardly credible. As Principal Investigator on the NIH grants, Dr. Schatzberg was expected to supervise the junior faculty and research staff at Stanford who recruited, assessed, and treated patients in the studies of RU 486. He was responsible for the choice of outcome measures, about which questions have been raised. He was responsible for the quality of the reported data analyses, which were, frankly, inexpert, when they were provided at all. Above all, he was responsible for the tone of the NIH-supported Stanford publications that claimed Corcept’s drug is effective.

If there were any doubt that Dr. Schatzberg’s hands were all over these Stanford studies, one only has to see the record of his leading role in responding to scientific critiques of their design, execution, analysis, and interpretation. He was clearly the manager.

Moreover, the record is clear that Corcept relied on the NIH-supported Stanford publications for positive claims to enable the corporation to raise capital (well over $100 million by now, with nothing to show for it). Corcept’s own Phase III clinical trials have been uniformly negative. For this strategy to succeed, the Stanford trials had to be portrayed as positive. As Paul Jacobs detailed in the San Jose Mercury News in 2006, using independent statistical experts, Dr. Schatzberg and his Stanford/Corcept colleagues made seriously exaggerated claims for the drug’s efficacy in their 2001 and 2002 publications. These exaggerated claims have been assiduously repeated by Dr. Schatzberg, by Stanford faculty members answerable to him, and by academic members of Corcept’s scientific advisory board in many scientific journals and textbooks. All these testimonials are compromised. The effect of these repeated, unjustified, claims is to raise the profile of the corporation and of the drug. It amounts to public relations and branding through academic outlets. Roy Poses on this site has dissected the scientific credibility of claims for the utility of RU 486 in depression.

Far from being removed from the scientific debate about Corcept’s drug, Dr. Schatzberg has had the leading role in “selling” the story to the scientific community, in “defending the brand” against scientific criticisms, and in providing his corporation a plausible story line to attract new capital. It was Dr. Schatzberg who talked about how the drug “may be the equivalent of shock treatments in a pill” in a 2002 Stanford press release. There is no clear boundary between Dr. Schatzberg’s NIH-supported academic roles and his service to the corporation he founded. As for not being involved in the management of the Stanford projects, Dr. Schatzberg acknowledged to Paul Jacobs of the San Jose Mercury News “that he has considerable influence over the junior faculty members doing the studies. As chairman of psychiatry, he helps set their salaries and can affect their career advancement. And he continues as a co-author of the resulting papers.”

I have already commented on Dr. Schatzberg’s efforts to sell large parcels of Corcept stock during the company’s IPO attempts. Had these efforts been successful, Dr. Schatzberg would have benefited by $7-11 million, while still retaining over 2 million shares of Corcept stock. This aspect of the issue troubles many people. In our capitalist system, considered so necessary for developing innovative drugs, nobody complains when an entrepreneur makes a fortune inventing a useful product. Dr. Schatzberg’s apparent intent, however, was to reach for the reward before contributing any product of redeeming social value. The prospects of RU 486 succeeding as a useful treatment of psychotic depression are close to zero. People view such behavior as gaming the system. Moreover, under Stanford’s existing rules, these projected stock sales might never have been reported.

Are these significant conflicts of interest? Yes. Have they “influence(d) the conduct of medical research” at Stanford (quoting now from Stanford’s June 24 statement)? Yes. Dr. Schatzberg’s NIH grants dovetail with the efforts of his corporation, and the corporation used data from the NIH-grant-supported projects for commercial promotion. Had the corporation not existed, these particular grants likely would not have been initiated or would have had different scientific emphases. Has Dr. Schatzberg’s research “been compromised by his financial stake”? Yes. His academic publications on depression and RU 486 are compromised by exaggerated and self-serving claims for his corporation’s drug. Senator Grassley is right: it is time for Stanford to get real about corporate-academic boundaries.

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:

----------------------------------------------------------------

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:

http://www.bio-itworld.com/archive/081302/letters.html

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

House Energy & Commerce Calls for Sharing of "Lessons Learned" on Health Care IT

U.S. Rep. Charles W. Boustany, Jr., MD, R-Southwest Louisiana, introduced the Patient-Controlled HealthIT Act (H.R. 6345) to allow patients to control their medical records. Electronic medical records have indeed created much potential for misuse. This is an interesting piece of legislation. Boustany, a former cardiothoracic surgeon, introduced the bill to spur investment in Health IT to help reduce the cost and improve the quality of healthcare for all in Southwest Louisiana, an area seriously affected by Hurricane Katrina.

Of even more interest is H.R. 6357, recently released by Energy & Commerce on Health IT: H.R. 6357 , the “Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology Act of 2008", a.k.a. the "PRO(TECH)T Act of 2008."

I note the E&C HIT bill calls for the National Coordinator (ONC) at HHS to prepare a report:

IMPLEMENTATION REPORT. - "The National Coordinator shall prepare a report that identifies lessons learned from major public and private health care systems in their implementations of HIT systems, including information on whether the systems and practices developed by such systems may be applicable to and usable in whole or in part by other health care providers" (Item 5, page 12).

It is possible that the numerous hits I noted from domain "House.gov" on my website of collected HIT difficulties over the past few months played a role in this proposed language. I track my site's viewers by IP for research purposes (e.g., see this 2006 AMIA poster "Access Patterns to a Website on Healthcare IT Failure": Abstract [pdf], Poster [ppt]. Evidence for this is the language at my site's introductory page to lessons learned:

"Organizational and human factors issues associated with healthcare IT have led to project difficulties and failures. Detailed case accounts might improve knowledge sharing between healthcare organizations on lessons learned and best implementation practices. Web-based, detailed information on healthcare and other IT project difficulty that can be used as “lessons learned” by others in their own projects is uncommon.

With the increasing push for EMR implementation at national levels, knowledge sharing via the Web on project difficulties might be helpful to those involved in design and implementation. In clinical medicine and indeed in any scientific field, you cannot just count the hits and ignore the misses ... We believe filling the information gap on healthcare IT difficulties is an essential goal to which medical informatics specialists can contribute, and that doing so would be helpful to patients and the healthcare community."

The E&C language is a good summary of that wording, which I crafted years ago.

This "lessons learned" item in the proposed legislation suggests Congress is aware that there are lessons to be learned, which implies they are also aware of difficulties, failures etc. that waste precious healthcare resources and time, and transfer money from healthcare to the IT and IT consulting sectors.

As readers here certainly know from my postings, I've been calling for this type of information sharing about HIT problems and solutions for the past decade, to little avail (as an information science "experiment", try a google search on "healthcare IT failure" or similar concepts and see how little comes up).

One might ask where, in fact, the large management consultants have been on this issue. Firms such as Accenture, Deloitte, Booz Allen Hamilton, and many others that have large health care consulting practices but lack experts with formal Medical Informatics expertise have been asleep at this particular switch, it seems.

One can imagine they will try to capitalize on this proposal should it pass into law (which I believe it will). This is both amusing and scary, because in my view (after watching these firms in action in my various healthcare IT leadership roles), they have been more part of the problem in HIT difficulties, closely allied with the Management Information Systems culture and its rigid data processing-card tabulator paradigms and methodologies, much less part of the solution.

In any case, this E&C proposal is a welcome development.
Finally, to those in the HIT vendor sector and in the Medical Informatics community itself who've disparaged writings on HIT difficulties and failures because they were not "academic", not "useful", were "anecdotal", or even "disingenuous" (such comments were actually made about Koppel's paper on CPOE difficulties, see here and here and here and here), I can express this simple observation:

You were wrong.

-- SS

Fearmongering or medical rigor? RFI induces hazards in critical care medical equipment

In "Hacking an ICD", Roy Poses reported on a research study about the susceptibility of implantable defibrillators to possible radio-based tampering.

The posting elicted responses from some quarters that the authors of the research study and of the blog posting itself were anti-industry alarmists carrying out fear-mongering.

I expressed my thoughts on the issue from the perspective of a smart person who actually knows something (i.e., just the attributes that in today's intellectually and ideologically debased world cause advice to be ignored) in "Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective."

It's time for a bit more "fear mongering." [explanatory note: the preceding sentence is satirical! -ed.]

In today's papers and newswires there's a report on the June 25 JAMA article "Electromagnetic Interference From Radio Frequency Identification Inducing Potentially Hazardous Incidents in Critical Care Medical Equipment ." Notably:

In 123 EMI tests (3 per medical device), RFID induced 34 EMI incidents: 22 were classified as hazardous, 2 as significant, and 10 as light. The passive 868-MHz RFID signal induced a higher number of incidents (26 incidents in 41 EMI tests; 63%) compared with the active 125-kHz RFID signal (8 incidents in 41 EMI tests; 20%) ...

As a ham radio enthusiast Extra class, and someone who did a clerkship in biomedical engineering in medical school, I find the outcomes of the research on the effects of RFID and other wireless systems on critical medical equipment simpy appalling.

It is reminiscent of the problems with HIT: a huge gap in resilience engineering, a rigor that would ensure the devices function well in context (i.e, in actual medical environments).

In my local paper the following is reported via AP ("Microchips may be hazards in hospitals"):

Nearly 20 percent of the cases involved hazardous malfunctions that would probably harm patients. These included breathing machines that switched off ; mechanical syringe pumps that stopped delivering medications; and external pacemakers that malfunctioned .

The frequencies that caused interference were not "special" Star Trek subspace faster-than-light communication frequencies, they are in the very conventional longwave and UHF spectrums.

The susceptibility to RFI (radio frequency interference) of any piece of electronic equipment is not a random matter. Equipment needs to be deliberately and purposefully engineered to be resistant to RF. Such RF resistance should not be a hit-or-miss proposition.

If the manufacturers had been doing their jobs properly, the results of the experiments would have been negative. However, I believe they are not doing their jobs in terms of RF susceptibility engineering, and the failure is a failure of both imagination and of dedicated concern for the "customer" (ultimately, patients) free of economic concerns (i.e., profits).

The malfunctioning of external pacemakers is particularly alarming. Internal pacemakers and ICD's came under scrutiny some months ago. In " Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective " I wrote:

The bottom line is: manufacturers need to work a little harder when they deploy wireless devices ... In biomedicine, the most meticulous resilience engineering is never a bad idea.

I believe the same issues will prove relevant regarding the devices found susceptible to common RF in the current JAMA study.

Finally, in my local paper, again via the AP, Harvard Medical School CIO John Halamka, MD was quoted as saying:

"It is absolutely an issue, but you have to manage around it," said John Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston.

While I agree with John that hospitals must out of practicality "manage around" the weaknesses of their equipment, that is a very partial solution. Just as in HIT, workarounds should be temporary and a source of very strong feedback to vendors.

The long term solution is for physicians and others who are genuinely dedicated to patient care to take the lead in demanding the tools critical to patient care be properly engineered.

-- SS

The Clinical Trials "Torture Economy"

Two recent commentaries in major medical journals on the same topic failed to get the recognition they deserved. Both were about exploitation of the poor in clinical research, usually in Phase I drug trials conducted by contract research organizations (CROs), supervised by for-profit institutional review boards (IRBs), and both paid by pharmaceutical, biotechnology or device companies.

The first article was by Carl Elliott and Roberto Abadie. [ Elliott C, Abadie R. Exploiting a research underclass in phase I clinical trials. N Engl J Med 2008; 358: 2316-7. Link here.] Per Elliott and Abadie, the context is:

Over the past decade, clinical trials have moved from universities to private testing sites, the pressure to recruit subjects quickly has intensified, and ethical oversight has been outsourced to for-profit institutional review boards (IRBs). Payment to subjects has escalated, creating 'shadow economies' in cities throughout North America and elsewhere.

The authors then cited several misadventures that we have discussed on Health Care Renewal: the trials by SFBC International (now PharmaNet Development Group) in Miami that enrolled immigrants, often undocumented, under questionable circumstances and in Montreal that resulted in the transmission of active tuberculosis (see post here and links backward); and the trial by Parexel International in London that put most of the subjects in intensive care (see post here, with links backward).

Elliott and Abadie concluded "there are good reasons to believe that poor subjects are being exploited," and cited several justifications for this belief:

• "Poor people are less likely than wealthier ones to get access to the drugs in question." This "appears to contravene article 19 of the Declaration of Helsinki, which states that medical research is ethically justified only if there is a reasonable chance that the population in which it is conducted will benefit from the results."
• "The U.S. oversight system is not well equipped to monitor a highly competitive, market-based, multinational research industry." The Office for Human Research Protection "has no jurisdiction over privately sponsored studies," the US Food and Drug Administration (FDA) has insufficient funds to monitor all but a tiny minority of trials. The institutional review boards (IRBs) that are supposed to supervise trials are ill-equipped to protect against the sort of abuses that are likely. Furthermore, for-profit IRBs that are dependent on research sponsors for repeat business may be loathe to upset the apple-cart.
• "Most sponsors apparently do not provide free care or treatment when subjects are injured."

Elliott and Abadie observed that most subjects in such trials see their participation as a job, rather than as a voluntary activity to promote science and human welfare. As the authors point out, if so, it is a poorly paid, risky job with few benefits and protections. Their conclusion is troubling,

The result is what one Philadelphia trial subject describes as 'a mild torture economy.' 'You are not being paid to do something,' he explains. 'You are being paid to endure.'

The only addition I can make is not only does the treatment of some patients in such trials appear inhumane, it amounts to bad science. Results from "professional trial subjects," who are likely to conceal characteristics which might have excluded them from this line of work, who may undergo one trial while still recovering from the effects of a previous, undisclosed trial, and who may be prone not to follow study protocols likely will not generalize to the patients who might actually be candidates for the drugs and devices assessed.

An editorial in the American Journal of Medicine was based on an article by Carl Elliott on the same topic published in the New Yorker. [Alpert JS. Dealing with ethical conflicts in clinical research. Am J Med 2008; 121: 457. Link here.]

His main conclusions were:

The ethical failure of such activities is obvious. The Nuremburg and Helsinki codes, developed following the human experimental atrocities of World War II, strongly advocate for voluntary participation on the part of research subjects. The substantial sums of money paid to the human 'guinea pigs' described by Elliott clearly obfuscate any volunteerism on the part of the individuals involved in these clinical experiments.

Lives saved and disease suffering lessened at the expense of individuals who are lured and perhaps even coerced into clinical trial participation cannot be allowed to continue in an open and equitable democracy. Clearly, the article by Elliott should be widely disseminated among academic and community physicians and governmental authorities. The topic should be openly discussed leading to corrective actions. Steps must be taken in the near future to protect the lives and the civil rights of individuals participating in clinical research studies.

Despite this call, I found no news coverage, and so far, no public discussion of any kind of the issues raised by these articles.

I hope that the charges that many current trials violate international ethical standards might get some peoples' attention, and maybe even inspire some action. I am not optimistic that anything will be done too hastily. After all, a lot of people are benefiting financially by the current scandalous status quo. They will not give up their ill-gotten gains gracefully. But this "mild torture economy" signals the approaching moral bankruptcy of our current health care system.

CMS Attempting To Put Out A Forest Fire With a Water Pistol?

The well-intentioned CMS EHR Demonstration Project will introduce EHR's to perhaps a few hundred primary care practices over the next few years.

CMS is developing a new demonstration initiative that aims to reward delivery of high-quality care supported by the adoption and use of electronic health records in physician practices. This initiative expands upon the foundation created by the Medicare Care Management Performance (MCMP) Demonstration. The goal of this 5-year demonstration is to foster the implementation and adoption of EHRs and health information technology (HIT) more broadly as effective vehicles not only to improve the quality of care provided, but also to transform the way medicine is practiced and delivered ...

On June 10, 2008 CMS announced the selection of 12 community partners to help CMS implement this demonstration. The approved community partners in each site represent diverse collaborations of organizations including, but not limited to, varied HIT stakeholder collaborations, medical societies, primary care professional organizations and health departments. Recruitment of physician practices in the first four Phase I sites will begin in the fall of 2008. Recruitment for Phase II sites will begin in the fall of 2009.

I believe, however, that the CMS demonstration project is unlikely to cause the "tipping point" in EHR diffusion to be reached.

In the NEJM's June 2008 article " Electronic Health Records in Ambulatory Care — A National Survey of Physicians " the following figures were cited:

Just 4 percent of doctors use software that includes electronic prescriptions and drug-interaction warnings. A larger group, 13 percent, opted for more basic software that only allowed them to enter notes and medical histories. Those who use the computer systems said they helped improve patient care.

After 30+ years of effort, that's simply amazing. The causes of the low diffusion go very far beyond the article summary's conclusion that

... Financial barriers were viewed as having the greatest effect on decisions about the adoption of electronic health records.

Of course, as readers here know, I have different views about the barriers. And, the barriers are not mysterious forces, just forces whose acknowledgement seems to encounter much resistance as they are "politically incorrect" (health IT is a silver bullet to solve healthcare's ills, after all) and potentially damaging to the profits of the "HIT-industrial complex."

Until (as one commenter to my writings said) the "skeletons in the closet of the HIT ecosystem" - that is, the sociotechnical issues - are acknowledged and dealt with, I believe HIT will continue with suboptimal diffusion rates.

I also consider the "HIT ecosystem" itself unhealthy, consisting of:

• the optimists or idealists (who believe HIT will "revolutionize" medicine without seeming to care much about potential political or societal downsides or potential unwelcome effects on the medical professions and their practitioners, and relentlessly promote only HIT virtues, real and imagined -- "Pollyannas cheerleading for health care information technology", as put by one of my colleagues),
• the opportunists (who come in two flavors - the industrialists, who will leverage the enthusiasm generated by the optimists to make money, e.g., payers, vendors, without caring about other issues; and the ideologues, who will use the enthusiasm to advance their ideological goals such as increasing control over clinicians and/or ushering in nationalized healthcare - think Hillary);
• the technicians - the IT people who design and implement HIT, who probably act as a negative feedback or inhibitory force through not understanding medical culture and the "hiding in plain sight" complexities of healthcare and HIT; and
• the realists (a minority) who see HIT as a facilitative tool to clinicians if done right, done well, with consideration to downsides and unexpected consequences, and not overdone and oversold.

Many in Medical Informatics fit into the latter category.

-- SS

Just A Language Change, Or A Step In Slouching Towards Gomorrah?

I am not sure of the ultimate meaning and outcome of this CMS update to the OPPS, but my fear is that it may represent yet another step in "slouching towards medical Gomorrah" - that is, physician oversight of patient care by a wide variety of ancillaries being deemed entirely unnecessary and redundant.

Of course, health IT will turn even the lowliest LPN into Marcus Welby...

American Health Lawyers Association (AHLA) alert

CMS Modifies "Incident To" Restrictions at Provider-Based Sites

By Kelly R. Anderson*

On June 19, 2008, the Centers for Medicare and Medicaid Services (CMS) posted the July 2008 Update of the Hospital Outpatient Prospective Payment System (OPPS).

Notably, in the update, CMS announced revisions to the Medicare Benefit Policy Manual "to remove language stating that services furnished in provider-based departments of hospitals must be rendered under the direct supervision of a physician 'who is treating the patient.'" This is a much-anticipated modification for hospitals and their lawyers since the release of Medicare Transmittal 82, in February 2007. Transmittal 82 required provider-based clinics to furnish therapeutic services under the direct supervision of a physician who is treating the patient.

According to CMS, the language of Transmittal 82 has caused confusion in relation to the requirements of the Code of Federal Regulations. Prior to the release of Transmittal 82, the Code of Regulations provided that services furnished incident-to in a provider based hospital outpatient department required the oversight of a supervising physician who is immediately available in the event of an emergency, but not necessarily the treating physician. 42 C.F.R. § 410.27(f). It appears that for services furnished incident-to in a provider based hospital outpatient department, hospitals may again rely on the supervision of a physician who generally does not have a treatment relationship with the patient.

View the July update (Transmittal 1536).

*We would like to thank Kelly R. Anderson, Esquire (Baptist Healthcare System, Central Baptist Hospital, Lexington, KY), for providing this email alert.

One wonders how the explicit removal of language on care "rendered under the direct supervision of a physician who is treating the patient" to care that can "rely on the supervision of a physician who generally does not have a treatment relationship with the patient" will play out in the real world of medicine.

A world where the almighty dollar rules.

-- SS

An Open Letter to Sen. Grassley Re: Withholding of Paxil Adverse Events Information

June 21, 2008

Sen. Chuck Grassley
135 Hart Senate Bldg.
Washington, DC
20510-1501
via email

Dear Senator Grassley:

Regarding the June 21, 2008 article in my local newspaper, the Philadelphia Inquirer, entitled “Glaxo’s Paxil faces scrutiny on the Hill” (http://www.philly.com/philly/business/20624784.html), I note your concerns that Glaxo/GSK may have withheld Paxil adverse events information on suicidal behavior from regulators.

As a physician and medical information science specialist, I feel obligated to express an even broader concern based on my personal experiences and that of my colleagues.

One way for a pharmaceutical company to “withhold” or suppress adverse information is to not have the information to begin with.

One way to not have such information, or to have less information, is via capricously denying hiring of specialists who could help better identify, uncover, and produce this information. In effect, one can hide information by evading or avoiding ever discovering the information through talent management (or mismanagement, as the case may be).

The Institute of Medicine of the National Academies of Science, after careful consideration, formally recommended that pharmaceutical companies engage Medical Infomatics experts in drug adverse event surveillance:

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.

(From "The Future of Drug Safety: Promoting and Protecting the Health of the Public”, Committee on the Assessment of the US Drug Safety System, Alina Baciu, Kathleen Stratton, Sheila P. Burke, Editors, Board on Population Health and Public Health Practice (BPH), Institute of Medicine, 2006)

I am such a specialist, and yet just a few short years ago, after my role as chief of scientific information at Merck Research Labs, I was turned down flat -- even for an interview – by GSK for an Informatics Director position, on what I believed was indeed capricious and unusual grounds.

With my expertise and experience in information technology for collection, analyis and management of biomedical information, including identification of adverse events, and coming with strong recommendation from GSK’s own retained recruiters in the UK who had identified me as a candidate for this very role, I was stunned when GSK refused even to talk to me.

My credentials were summarily dismissed. Attached below are the details of this event ("Case Example On Pharma Hiring Practices"), a case study I use in my graduate teaching of medical informatics.

I have experienced similar responses towards similar roles from numerous other pharmas as well, as have a number of my colleagues.

These incidents raise the following question: could such hiring practices be part of a systematic pattern designed to impair the comprehensive uncovering of adverse events information?

My suggestion is that you should investigate not only possible withholding of data from regulators, but also pharmaceutical hiring patterns that could in effect obstruct or suppress the detection and production of drug adverse events information.

Sincerely,

S. Silversteien
MedInformaticsMD
Healthcare Renewal Blog

-----------------------------------------

Case example on pharma's hiring practices:

In July 2004 I received an unsolicited email about a new job opening from a prestigious British recruiting firm (“headhunter”) retained by GSK, Armstrong Craven Ltd. It referred to a cheminformatics position I'd once applied to (and never heard back about), and sought me out for a converstation about a new role: Director of Medical Informatics (text of letter here).

I set up a phone interview with the recruiter, who called me from the UK a short while later. We spoke for over an hour about the Director of Medical Informatics role. As a result of our detailed conversation, the recruiter felt I was highly qualified for the position. As a further check, he emailed me a GSK document that described the position in great detail.

With extensive medical informatics training and experience in both hospitals and pharma, having been Director of Scientific Information Resources and of The Merck Index at Merck Research Labs, I must have seemed to him well qualified for the job description. That JD included items such as identifying, prioritizing and partnering on projects where Medical Informatics can deliver business impact, and developing both strategic (long term) collaborations that will have a sustained impact as well as short term efforts that will impact high-priority R&D projects. The full job description can be seen here.

Finally, the job was described as reporting at a high level but not to an M.D. It reported to the Vice President of Informatics & Knowledge Management who apparently authored the description, a Ph.D. The recruiter told me he would speak with the hiring team and present my credentials to them ASAP. He fully expected at least a follow up interview.

Unfortunately, this was not to occur.

I received a call back from the recruiting firm several days later to tell me that GSK had no interest in my background, and the Ph.D. hiring manager did not wish to speak to me at all. When I inquired why, I was told he was looking for someone with “an extensive computer science background to write algorithms to solve business problems.”

Needless to say, I was rather disappointed by this response. The Armstrong Craven response raises a number of important questions:

• Was it typical at GSK for a hiring manager to read a resume that came from its own retained recruiter and, on the basis of secondhand knowledge from the recruiter and line items on a piece of paper, make a decision not to even talk to the recommended candidate – or even meet in person, since that candidate lived perhaps fifteen miles from one of the sites the hiring manager frequented? Is this above-board, state-of-the-art talent management in an industry as critical and under such societal mistrust as pharma?
• Was there anything in my resume with regard to my training and experience in biomedical computing science and in healthcare suggesting I could not write such algorithms to solve biomedical business problems?
• How was the prejudicial decision that algorithms needed to be written by a Medical Informatics specialist made? Who set this as a strategic objective? Why was it done by someone with no apparent Medical Informatics credentials?
• Is the best use of a medical informatics specialist to write algorithms (i.e., do programming), or is it to create and direct the writing of algorithms, separating the high-level biomedical cognitive tasks form the lower ones (i.e., programming)? See example of this issue here.
• Why do we have computer-oriented VP's lacking medical credentials evaluating resumes of those who do?
• Did the lack of medical credentials and experience prevent proper understanding of critical line items on my resume?
• Were other potentially valuable Medical Informatics candidates turned away on similar reasoning?

This was not my first encounter with GSK / SKB. I had also had fruitless discussions with SKB in the 1996-8 timeframe, while I was Director of Clinical Informatics at Christiana Care. In February 2000 as well, a senior recruiter had contacted me, interviewed me in person after a phone discussion and then enthusiastically tried to sell my background to GSK discovery scientists. He was quite puzzled that they expressed no interest.

In conclusion, I wonder if pharma really "gets it" regarding Medical Informatics. Many of my observations indicate the industry does not. That the IOM needs to call pharma's attention to a specialty field whose professional education is largely NIH-sponsored is quite revealing.

One also wonders if such hiring practices impair companies’ abilities to monitor the safety of their drugs, and if Avandia’s, Paxil’s and other drug’s safety issues would have been detected earlier if, as the Institute of Medicine (IOM) suggests, more Medical Informatics professionals were involved in drug adverse events surveillance, and in roles beyond "writing computer algorithms to solve business problems.

I do not know if this letter will be read or taken seriously. It does express highly personal views and anecdotal evidence regarding a possible blindness in pharma to modern information science thinking, perhaps willful, towards formally trained Medical Informatics specialists. However, I believe one should not attempt to fix symptoms of problem(s) without doing a thorough diagnostic of the problem(s).

It is not hard to conjecture that pharma management might fear critical thinking professionals in a field whose major purpose might be described as enhancing transparency in medicine through dual, formal expertise in medicine and biomedical information science.

To illustrate that this talent mismanagement phenomenon is not limited to one company, see here and here. Finally, even when such talent is brought in, it can be misutilized.

-- SS