The Spoils of a "Scorched-Earth Defense" - Merck CEO Got $13.3 Million in 2011

Last week, Bloomberg reminded us of the legal baggage that pharmaceutical giant Merck is carrying. The company had announced yet another settlement of legal actions pertaining to its ill-starred but very profitable sales of now withdrawn Vioxx (rofecoxib) in 2011 (see post here). Now the settlement, including a guilty plea was accepted by a judge.

A unit of Merck & Co. (MRK), the second- largest U.S. drugmaker, pleaded guilty to a criminal misdemeanor charge as part of a $950 million settlement of a U.S. government probe of its illegal marketing of the painkiller Vioxx.

An official of Merck Sharp & Dohme said today that the company agreed to plead guilty to one count of misbranding Vioxx. U.S. District Judge Patti Saris in Boston accepted the plea as part of the drugmaker’s agreement to pay a $321.6 million criminal fine and $628.3 million to resolve civil claims that it sold Vioxx for unapproved uses and improperly touted its safety.

'I’m certainly going to accept this agreement because I think it’s in the public interest,' Saris said from the bench. 'I hope the size of this settlement and the fact that all these cases are being pressed by the federal and state governments -- the 44 states’ attorneys general -- will be a signal that this isn’t acceptable conduct.'

But unacceptable conduct can lead to a great deal of revenue. As Bloomberg noted,

Approved by the Food and Drug Administration in 1999, Vioxx became Merck’s third-largest-selling drug by 2003, generating $2.5 billion in annual sales. The company pulled Vioxx off the market in 2004 after a study found it posed an increased risk of heart attacks and strokes.

It can also lead to a great deal of personal profit for those at the company tasked with defending such "unacceptable conduct," and what has now been found to be criminal behavior. Writing in Slate, Snigdha Prakash, who wrote All the Justice Money Can Buy about the legal aftermath of Vioxx, identified the current Merck CEO and board chairman as the architect of the defense of Vioxx, as

best known for his phenomenal success in defending a sordid chapter in Merck’s recent past—its years-long silence about the safety problems of the popular painkiller Vioxx.

Furthermore, she wrote,

As he showed with the Vioxx litigation, Frazier is adept at mounting a scorched-earth defense that minimizes payouts to potential plaintiffs.

Tens of thousands of former Vioxx users sued Merck after it withdrew the drug, alleging Vioxx had caused them to suffer heart attacks and strokes. Frazier, then the company’s general counsel, declared Merck had done nothing wrong and refused to settle. 'We’ll fight every case,' he declared, and hired top-flight law firms in several East Coast cities, in the South, in Chicago, and Los Angeles, as well as a prominent New York firm to coordinate the overall strategy. It took three years and $2 billion in legal expenses for Frazier’s hard-nosed tactics to pay off. Merck settled in late 2007 for a relative pittance, resolving some 50,000 Vioxx cases for just under $5 billion. It was a far cry from the $25 billion to $50 billion in liability that analysts had predicted when Merck withdrew the drug.

So it appears that Mr Frazier is now reaping his rewards. The Dow Jones News Service reported earlier in April,

Merck & Co.'s (MRK) leader received compensation valued at $13.3 million for 2011, up 41% from the year before, reflecting his ascension to the drug maker's top post and Merck's ability to exceed certain internal performance targets.

Kenneth Frazier, 57, became Merck's chief executive at the beginning of 2011 and chairman of the board in December. He was previously head of Merck's human health business.

In a proxy statement filed Thursday with the U.S. Securities and Exchange Commission, Merck said certain elements of Frazier's compensation reflected growth in Merck's sales and adjusted earnings for 2011.

In addition, Merck's board considered 'his performance, leadership, planning and oversight during a time of continued economic, regulatory and political challenges for the healthcare industry.'

Earlier this year, Frazier acknowledged that Merck had a tough 2011. The company endured setbacks including negative clinical data for a once-promising heart drug, vorapaxar. Merck's full-year stock price performance lagged behind most of its large-pharmaceutical peers.

But Merck of Whitehouse Station, N.J., continued to cut costs and was able to raise its dividend for the first time in seven years in 2011. Frazier said in January he was optimistic about 2012.

Frazier's total compensation included: $1.5 million in salary, $3.1 million in stock awards, $3 million in option awards, $3.1 million in non-equity incentive plan compensation, and $2.6 million change in pension value and non-qualified deferred compensation earnings.

So somehow a "tough 2011" for Merck's stockholders (Merck's stock price rose a mere 3.9%, from 36.29 to 37.70 through 2011) resulted in a cornucopia of riches for Mr Frazier. So rather than being rewarded for "maximizing shareholder value," (see post here) maybe Mr Frazier was rewarded for, as Ms Prakash put it, "burying monumental corporate failures at Merck."

Here is the latest version of how top health care organizational insiders manage to make even more money no matter what, in this case, no matter what happens to the fortunes of the nominal owners of the company, no matter what happens to the company's once proud reputation, and particularly no matter what happened to the patients unfortunate enough to suffer adverse effects from its drug.

We will not be able to truly reform health care, to really improve outcomes, improve access, and control costs, until we hold the leaders of health care organizations accountable.

As U.S. Presidential Campaign Ramps Up, Newt Gingrich Plays Down Support for Health IT

Presidential candidate Newt Gingrich, who I recall hearing in person as an an invited speaker at a health IT meeting some years ago (AMIA, I believe), has been pushing health IT rather uncritically in recent years.

However, he seems to have backed off that position at the election cycle heats up:

As Campaign Ramps Up, Gingrich Plays Down Support for Health IT

iHealthbeat.org

Friday, December 16, 2011

Now that he is a frontrunner in the race for the Republican presidential nomination, former House Speaker Newt Gingrich (R-Ga.) is downplaying his previous support for health IT adoption, The Hill's "Healthwatch" reports (Pecquet, "Healthwatch," The Hill, 12/15).

History of Supporting Health IT

During the George W. Bush administration, Gingrich worked with former CMS administrator Mark McClellan and former National Coordinator for Health IT David Brailer on federal efforts to promote health IT, according to the New York Times (Rutenberg/McIntire, New York Times, 12/16).

Gingrich also worked with former Senate Majority Leader Tom Daschle (D-S.D.) to co-author the forward of a book titled, "Paper Kills 2.0," which gives examples of how federal funds for health IT could be used in pilot projects to improve health care (Rowland, Boston Globe, 12/16).

Shortly before the passage of the 2009 federal economic stimulus package, Gingrich criticized the legislation as a "big politician, big bureaucracy, pork-laden bill." However, at the same time, Gingrich praised a provision of the stimulus package that allocated $19 billion to promote the use of health IT. He said, "I am delighted that President Obama has picked this as a key part of the stimulus package."

His views have apparently changed somewhat:

... Campaign Plays Down Health IT Support

On Wednesday, Gingrich unveiled a new brain science initiative that does not include any mention of EHRs, even though the technology was a major component of the brain science proposals he discussed over the summer.

Politics aside (it is probably not too far from the truth to say that all politicians hold out their fingers to see what direction the wind is blowing, although Mr. Gingrich is probably becoming more aware of HIT downsides thanks to lobbying of both sides of the aisle by people such as myself and like-minded experts [1]), I cannot disagree with this:

In August, Gingrich said he aimed to bolster brain science research in part by modernizing FDA through the use of EHRs. Gingrich said EHRs would allow for "much faster [FDA] approval times because you can monitor in real time everyone who uses the drug. And if you start getting inappropriate responses, you can change within weeks" ("Healthwatch," The Hill, 12/15).

In fact, I was championing exactly this idea ca. 2001 when I was employed at Merck Research Labs in the Research Information Systems division. Unfortunately, the answer from more senior personnel was that doing so would be "impossible" due to inability to blind, to control the data quality, etc., responses I considered unreasonable at the time but did not argue with to avoid getting on the Short List early in my employment there.

I also tried to present the idea to Merck as a former employee in Nov. 2006, at an invited presentation to the Clinical Risk Management & Safety Surveillance department of MRL entitled “Medical Informatics Perspectives on Leveraging the EMR in Pharma" (PPT). Also see my 2007 paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" where I address a number of issues related to using EHR's in this fashion (PDF).

Using EHR's (e.g., with special screens and training) for well-defined Phase IV post-marketing surveillance studies would be one of the best uses for the technology [2].

Finally, I note that we need post-marketing surveillance of EHR's, CPOE's and other clinical IT systems themselves, not just drugs. Information technology cannot improve healthcare until it itself is improved significantly regarding its current deficiencies (see "reading list" here for illustrations).

-- SS

Notes:

[1] Health IT risks are a non-partisan issue.

[2] I should note that while I believe EHR's could facilitate postmarketing surveillance of drugs and devices, I take a dim view of more grandiose proposed uses of EMR's such as for comparative effectiveness research (CER). See my essay in the Journal of the American Association of Physicians and Surgeons (AAPS) entitled "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" here (PDF).

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the Health Care Renewal mill since 2005.  For example, see these posts:

- here about ghost-writing of a Vioxx research publication;
- here, and here about allegations that Merck executives tried to intimidate Vioxx critics;
- here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
- here about how an apparently major clinical trial of Vioxx turned out to be a "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
- here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs. 

Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case).

Merck just announced just the latest settlement of Vioxx related legal actions, as reported by Business Week:

Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.

Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well 'honest communication' with doctors.

'In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,' according to the amended code. 'We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.'

Also,

The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.

Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party.

The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories.

Note that this settlement is only of one type of lawsuit, as described in a Wall Street Journal article,

The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx.

Merck had already settled thousands of lawsuits,

Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.

Merck has lots of other legal actions to go through,

The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.

So the parade of legal actions and settlements thereof continues.  We believe that the scope of this parade provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis.

One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research. 

On Health Care Renewal we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of manipulation and suppression of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an organizational ethics policy, which in turn may have the potential to actually improve behavior. 

On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported by the Springfield, MA, Republican:

A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsifying medical research and must pay $420,000 in restitution to pharmaceutical companies, federal court records show.

Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. He signed a plea agreement with prosecutors a week earlier.

Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances.

In one notable instance,

In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients, 100 with Pfizer's product and 100 with a placebo.

'In fact, Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben,' the charge states.

Albert said the fabrications were discovered by medical staff within the hospital during a routine review at the hospital's 'research week,' when clinicians design poster displays of their studies.

A report in the New London, CT, Day indicated the scope of Reuben's fake research:

Anesthesia & Analgesia later had to retract 10 papers authored by Reuben, and medical experts at the time said at least 21 journal articles by the anesthesiologist appeared to have been fabricated.

The agreement calls for Reuben to pay restitution of $296,557 to Pfizer and $16,000 to Wyeth Pharmaceuticals, two companies that merged last fall. Merck & Co. would receive $49,375 from the agreement, according to documents.

In addition to his fabricated Celebrex studies, Reuben had pretended to do research that backed the effectiveness of other pain drugs, including Pfizer's Bextra and Merck's Vioxx, according to prosecutors. Bextra and Vioxx later were pulled from the market because studies showed they increased the risk of death from heart attacks and strokes.

In addition, Reuben published data showing that Pfizer's antidepressant Effexor had exhibited painkilling properties.

Reuben's studies had been considered pioneering at the time they were published. His data had supported the use of two of Pfizer's major products - Celebrex and Lyrica - in combination to treat certain types of post-operative pain.

Reuben 'was a regular on the medical lecturing circuit,' according to court documents, and 'had become a well known figure in the anesthesia and pain management medical communities.'

Pfizer said previously that it had supported five of Reuben's research initiatives. Pfizer, which declined at the time to reveal how much it paid Reuben over the years to be part of its speakers' bureau, said the company played no part in the fraud.

Asked for a comment Friday, Pfizer was not able to provide a timely response.

Note that we usually do not post about stories of individual's clinical research misconduct, not because it is unimportant, but because individual misconduct may be related more to an individual's motives and character than to concentration and abuse of power in health care.

However, in this case it appears that Dr Reubens was enabled, at least in the psychological and logistical senses, by pharmaceutical companies happy to sponsor research which suggested the effectiveness of their products.  Since Dr Reubens apparently fabricated most of his data, notice that he apparently deliberately fabricated data that made Pfizer's Celebrex, Bextra, Lyrica, and Effexor, and Merck's Vioxx look good.  Perhaps there was careerism here.  Positive studies about "innovative" effective drugs are more likely to get published than negative studies or studies of old drugs.  However, we have noted before that pharmaceutical (and biotechnology and device) companies like to sponsor studies with results that make their products look good. 

One bit of good news in this story is that Reuben's colleagues at the hospital apparently were able to uncover the fabrications when they had an opportunity to critically look at data from several of his studies.

Certainly some Pfizer employees had easy access to the same data.  But perhaps they would not have thought to look at it critically as long as it was so unrelentingly positive about their company's products. 

As we have said before, health care professionals, policy makers and patients ought to be extremely skeptical of clinical studies sponsored (and often deeply influenced) by those with vested interests in the studies' turning out in certain ways.  We ought to reconsider national research policies that have turned over sponsorship of the majority of clinical research to those with such vested interests.

Hat tip to Prof Margaret Soltan on the University Diaries blog.

ADDENDUM (19 January, 2010) - see also comments on the Alison Bass Blog.

Does the CEO of Google Use Google? - And: Platform, Platform, Who's Got The Platform?

Over at the WSJ health blog, reporter Jacob Goldstein's Jan. 8, 2010 post "Google CEO & Harvard Surgeon Talk Health IT" quotes Google's CEO:

"Google’s CEO Eric Schmidt doesn’t know why docs haven’t embraced databases to help them sort through medical information."

[Schmidt said] ... So when you show up at the doctor with some set of symptoms, in my ideal world what would happen is that the doctor would type in the symptoms he or she also observes, and it would be matched against the data in this repository

[such as DXplain? -- which we learn from a - er, um, Google search - was developed starting in the mid 1980's by medical informatics researchers who actually know this domain, and which offers this explanation and warning: "DXplain uses an interactive format to collect clinical information and makes use of a modified form of Bayesian logic to derive clinical interpretations ... DXplain does not offer definitive medical consultation and should not be used as a substitute for physician diagnostic decision making"? - ed.]

... Then this knowledge engine would use best practices, and all the knowledge in the world to give physicians some sort of standardized guidance. This is a generalized form of the checklists that you’re talking about …

As computer scientists, this is a platform database problem, and we do these very, very well, as a general rule. And it befuddles me why medicine hasn’t organized itself around these platform opportunities. [No - the successful practice of medicine is not a 'platform database' or any other reductionistic information retrieval problem - ed.]

I note that IT personnel like to refer to "platforms", "solutions" - a rather presumptuous term, "paradigms", and other buzzwords to mask the fact that what they're referring to are more commonly known as "hardware" and "software" and arrangements thereof.

Does this "platform opportunity" view reflect naïveté about the complexities of medicine and medical decision making, or does it reflect something else? Could this "befuddlement" be construed as calling physicians obtuse? Is this yet another example of what I referred to in my post "Healthcare IT Failure and The Arrogance of the IT Industry" and other writings as a cross-occupational invasion of medicine by IT?

IT personnel seem to have a propensity to offer healthcare-related opinions far outside their own areas of expertise -- or if in healthcare organizations, edicts - based upon the narrow view of their own relatively linear and deterministic fields. The risk is, especially when coming from high perches, that such opinions and edicts can result in deleterious actions (e.g., government initiatives).

In an absurdist reductio ad absurdum, deliberately made absurdist due to many years of exposure to equally absurd (to those with actual domain experience) "who needs medical school/residency/patient care experience to profess on medical matters?" attitudes:

Why don't physicians offer the advice that Google could improve its search algorithms, or Intel and AMD their microprocessors, by utilizing intelligent psittacine platforms as in this British Broadcasting Company (BBC) video narrated by a true technology expert, Captain James T. Kirk?

Kirk did have a (computerized) physician son: Nomad!

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

Quite seriously, physician reluctance to "embracing databases" and health IT in general is not about database platforms. I only wish it were so simple.

The WSJ seems to understand this. In a Jan. 12, 2009 article by reporter Bret Stephens entitled "Can Intelligence be Intelligent?", the observation is made that technology is a mere facilitator, and intelligent, well trained, experienced, critical-thinking people are the enablers of any complex field that requires human judgment. They must be unfettered by machine and bureaucrat:

... Terrifying as the thought may be to many of its current practitioners, the true art of intelligence requires, well, intelligence. That is a function neither of technology nor of "systems" [a.k.a. "platforms" - ed.], which begin as efforts to supplement and enhance the work of intelligence and typically wind up as substitutes for it. It is, instead, a matter of experience, intellect, initiative and judgment, nurtured within institutions that welcome gadflies in their midst.

I've left the following comment at the WSJ health blog:

Mr Schmidt,

If you’d like to learn more about why many physicians are reluctant to embrace clinical IT, you might also do a Google search on “healthcare IT failure” and similar terms.

Need I say anything more about the irony of that advice?

I'd also noted a fixation on "platforms" as solutions to biomedical problems (best when they come in shrinkwrapped, off the shelf, "on the IT roadmap" packages!) in my June 2008 post "An Open Letter to Merck CEO Richard Clark on Merck's Mission to Rediscover the Wheel."

A nonmedical research IT leader, who'd found a move from basic research to clinical IT "quite an eye opening experience" (i.e., a domain in which she had little or no experience but was paradoxically appointed to lead) talked all about "platforms" in Bio-IT World:

... We've invested a lot in some core platforms; we need to start translating that into results in the clinic at some point. And so having people who have an understanding of what does that really take to help inform the earlier research directions, the platform directions [i.e., research direction = platform direction - ed.], is a key theme...We already have siloed platforms to show that data, we need to integrate it more than it is... combining the results data from clinical samples with the associated patient data, what's that platform?

Platform, platform, platform. Who's got the platform?

My comments to that CEO in my Open Letter were that this was the wrong mindset and question, based upon an IT person's focus on information technology. This is as opposed to a focus on information science and on facilitating people in interacting with data and information in order to gain actionable knowledge, i.e., an information science and human-computer interaction-based approach that those in medical informatics thought about long ago.

In line with the conclusions of Greenhalgh et al. [1] who called for "eschewing sanitized accounts of successful projects" and instead recommending studies of clinical IT in organizations that “tell it like it is” using the de-identified critical fiction technique, I'd written on how conflation of information technology and information science impaired R&D in pharma at my essay "Sure path to R&D failure: Conflation of IT with information science in the pharmaceutical industry."

That piece and the aforementioned Open Letter were written before Merck sold itself to Schering-Plough in a "reverse merger" due to the unsustainability of doing business from an empty wagon of new products, a sign of just how well this IT-centric "platformania" has been working out for R&D.

In the information science-centered view and approach, the "platform," a.k.a. computer technology, is merely a canvas and facilitator, the artist (clinician or scientist) and the brush wielded by them being the primary enabler of and contributor to the masterpiece.

Unfortunately, I don't think anyone is "home" in pharma or in the HIT sector anymore to parse these ideas; in fact I've only recently learned that the people I did work with who could parse these ideas into creative reality were laid off by the very IT people making such statements and asking such questions.

IT personnel perhaps need to move away from their reductionist platformania. (Perhaps they are confusing "platforms" with "pixie dust.") Rather, they need to start thinking in terms of facilitating clinicians and scientists through domain specific and individualized-to-need information science and HCI innovation that arises of true cross-disciplinary expertise.

They need to leave creation of cybernetic miracles to people such as Irwin Allen and George Lucas. And platforms to carpenters.

-- SS

[1] Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method. Greenhalgh, Potts, Wong, Bark, Swinglehurst, University College London. Milbank Quarterly, Dec. 2009. Available at: http://eprints.ucl.ac.uk/18821/

The Door Revolves: Tufts Medical School Dean Goes Back to Merck

A little news item in the Newark Star-Ledger:

Merck announced the appointment of Michael Rosenblatt as executive vice president and chief medical officer.

The appointment, which was announced this morning by the company, is effective immediately.

Rosenblatt will be responsible for bringing greater focus to Merck’s global medical activities as well as shaping innovative medical strategies. He will report directly to CEO Richard Clark.

Rosenblatt has served as dean of Tufts University Medical School since 2003.

Earlier, he was senior vice president for research at Merck Sharp & Dohme Research Laboratories, where he co-led the worldwide development team for Fosamax, Merck’s treatment for osteoporosis.

A quick Google tour revealed that while he was Dean, Dr Rosenblatt also served as a Scientific Advisor to Boston Millenia Partners, a venture capital firm; a Founder and then Scientific Advisor to Nuvios, which now is known as Radius Pharmaceuticals;  an Advisor to Puretech Ventures, which specializes"in company creation and early-stage investment in novel therapeutics, medical devices, diagnostics, and research technologies"; and a Director of Shire, "one of the world’s leading specialty biopharmaceutical companies."

This is a reminder how fuzzy the line has become between medical academics and health care corporations.  Here is an example of someone who alternated his main employment between leadership posts in academic medicine and in the pharmaceutical industry, but while in academia maintained a string of part time commitments to a further variety of biotechnology and pharmaceutical companies, and related venture capital firms.  Given all these positions and financial relationships, who knows where his main allegiance was? 

I would hope that the Dean of  a medical school would be the primary steward of the academic and clinical missions.  But what kind of stewardship can one expect from someone who came from one lucrative position in the pharmaceutical industry, and was to go back to an even higher level position, and who worked for several biotechnology/ pharmaceutical firms, and venture capital firms on the side?

Hat-tip to Shearlings Got Plowed blog.

Medical Informatics, Pharma, Health IT, and Golden Advice That Sits Sadly Unused

In recent correspondences with colleagues I was reminded of a letter I wrote seven years ago that was published in Bio-IT World, a journal about biomedicine focusing mainly on pharma, bioinformatics and related fields.

As the sole formally-trained Medical Informatics specialist at Merck, I wrote:

Medical Informatics MIA [Missing in Action - ed.]
Bio-IT World
August 13, 2002

Dear Bio-IT World:

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.

Scot Silverstein, MD
Director, Published Information Resources & The Merck Index
Merck Research Laboratories

I was also responsible for the entry of the term "Medical Informatics" into the controlled vocabulary pool used for various purposes at Merck.

As far as I can tell, the Medical Informatics talent gap still exists in all major pharmas despite writings on the topic from colleagues as well as myself. With the present turmoil including declining pipelines, mergers and mass layoffs pending in many large pharmas, and even despite Medical Informatics on a fast path to being declared a full medical subspecialty, it is likely this gap will persist for years longer. This is a shame. The field offers insights that can help R&D substantially, and I speak from direct experience from my time in that domain.

I am reminded via all this of another industry that seems to hurt itself via ignoring the advice of Medical Informatics professionals, the health IT industry. Healthcare IT is actually the core competence of Medical Informatics professionals, but those people are under-represented in the higher ranks of the health IT industry as well. Many job postings seek such people, but for lower level roles (as I've posted here in the past), and/or conflate formal training with informal experience and with those who qualify for the title of Medical Informaticist like I qualify (being an amateur radio licensee, extra class) as a professional RF engineer.

The irony is this: the wisdom of the Medical Informatics field on health IT goes back not years, but decades. It is advice that could have made the vendors much higher margins, allowed them to produce better products, avoid the government regulation that is now nearly inevitable (in some EU countries, clinical IT has already been determined to be a medical device requiring regulation), and in many cases, enabled corporate longevity.

Yet the teachings and accumulated wisdom of the field were, and largely still are, ignored, making books such as the new "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" necessary even in 2009.

Here is just a small sampling of that wisdom:

Dr. Donald A. B. Lindberg (now Director of the U.S. National Library of Medicine at NIH), 1969:
"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."


Dr. Octo Barnett's [Harvard] health IT Ten Commandments, 1970:
1. Thou shall know what you want to do
2. Thou shall construct modular systems - given chaotic nature of hospitals
3. Thou shall build a computer system that can evolve in a graceful fashion
4. Thou shall build a system that allows easy and rapid programming development and modification
5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use
6. Thou shall have duplicate hardware systems
7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems
8. Thou shall be concerned with realities of the cost and projected benefit of the computer system
9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization
10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.

[Dr. Barnett played a key role in the 2009 National Research Council report about current approaches to health IT being inadequate, Press Release at http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572, and full report "COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS. - ed.]


Dr. Morris Collen's Five Rules, 1972
Most common causes of health IT failure:

• Suboptimal mix of medical and computer specialists … resulting in communications difficulties and in the computer staff underestimating the vast medical needs
• Gross underestimation of the large amounts of money needed
• Suboptimal systems approach with serious incompatibilities between modules
• Unacceptable terminals
• Inadequate management organization and poor judgment
  

Dr. R. Friedman, Reasons for slow spread of EMR, 1977:

• Poor engineering and unreliability
• Physicians not provided with computer-based applications that exceeded their own capability!
• Inability to prove a positive effect on patient care
• Difficulty transferring one application from one institution to another
  

(All taken from Collen's "A history of Medical Informatics in the United States, 1950-1990".)

I might add that the PC did not even exist in 1977, unless you consider the Altair and Heathkit H8 "personal computers."

Four-decades-old wisdom like this, and much more, sits out there in the ether and in the Medical Informatics field's professionals like a pot of gold, but is apparently considered as valuable as lead by the HIT - and pharma - industries. I find this amazing - and a pity.

-- SS