Saturday, January 10, 2009

A truly troubled organization: FDA scientists allege mismanagement at agency

At "Is Medtronic CEO Abrogating Responsibility Of His Company To Determine Device Safety?" I wrote that the CEO of this medical device company seemed to be punting the responsibility of assuring the safety and efficacy of his products to the FDA.

Others have taken a similar stance, such as in the case of musician Diana Levine, who lost an arm after an improper IV administration of a drug ("The Court Confronts a Grievous Injury", New York Times, Nov. 7, 2008).

Now, nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."

FDA scientists allege mismanagement at agency
Jan. 9, 2009
From Louise Schiavone
CNN

WASHINGTON (CNN) -- Nine scientists at the Food and Drug Administration have written a letter to President-elect Barack Obama and his transition team, alleging gross mismanagement at the agency that has "placed the American public at risk."

FDA scientists wrote a letter to President-elect Barack Obama, saying the agency is "fundamentally broken."

The agency is "fundamentally broken" and "failing to fulfill its mission," according to a copy of the six-page letter obtained by CNN.

The scientists work in the FDA's Center for Devices and Radiological Health, which regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines.

The scientists claim that "the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."

Among the charges:

• Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.

• Devices have not been properly labeled.

• Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.

FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."

• Manufacturers have been allowed to market their products without FDA approval.

An internal investigation of the charges, the scientists said, has resulted "in absolutely nothing: No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted."


I believe this aligns with and perhaps validates a number of observations made about FDA on this blog such as at posts "Staring Idiocy In The Face: The FDA As The Gold Standard, Or Tin Plated Emperor?" and perhaps at "Computer debacle: a Broken down process at the agency - or beyond?" as well.

In effect, the CEO of one of the largest medical device R&D and manufacturing companies, one of the world's largest pharmas, and others may be trying to pass the buck to three famous doctors:



Meet Dr. Moe, Dr. Larry and Dr. Curley.

-- SS

National Research Council: Current Approaches to Health IT Insufficient ... and Other "Master of the Obvious" News

The National Research Council has issued a remarkable press release about a new report on HIT. The press release is at this link:

Current Approaches to U.S. Health Care Information Technology are Insufficient

(Jan 12 addendum: a prepublication pdf of the report itself is here.)

I reproduce the press release below, but please do read my polemic before reviewing it.

My early mentor, cardiothoracic surgery pioneer Victor P. Satinsky, M.D., used to become irritated when people or organizations presented views that qualified them as "Masters of the Obvious." I believe the following release by the highest scientific authorities in the land qualifies for such a categorization.

Sadly, the release by the National Research Council outlines the "what" (what is wrong), but not the "why." Perhaps that will be found in the full report, although many of the "whys" (that is, why these health IT problems exist at all, and why the Joint Commission and NRC reports are even necessary, after 40+ years of Biomedical Informatics, IT-sociology and other research) can be found right here on Healthcare Renewal.

On the positive side for clinicians, life as a typical hospital CIO or other non-medical executive may have just become substantially more aligned towards serving the needs of clinicians, via being compelled by this report and its aftermath to make major changes in the way HIT is pursued. These changes would replace the familiar pursuit of building self-serving IT empires.

In fact, if you're a CIO who is accustomed to doing typical deals with HIT vendors, hires typical business IT staff unknowledgeable and untried in anything medical to work in clinical IT, along with lots of ham-fisted but hats-in-hand consultants who then try to clean up the mess the IT staff make, and who bullies and brands with a scarlet letter anyone who challenges the status quo (such as Medical Informaticists and other cross-disciplinary specialists who actually know what they're doing in HIT) while the latter actually try to protect the "customers" also known as "patients", your life has just become a bit more challenging.

I'd thought the December 2008 Joint Commission Sentinel Event Alert on Health IT, on the risks posed by improperly designed and implemented Health IT had been a one-up. I thought it might have been a fluke, written and released by some young disgruntled employee like Justen Deal who would be fired. I thought the Joint Commission Alert would be ignored by the players in the highly lucrative and often exploitative (of clinician ignorance and learned helplessness, that is) HIT ecosystem.

I may have been mistaken. The NRC report may change that.

Significantly, the NRC report was about a number of the best medical organizations in this country, not about the smaller less experienced hospitals where things are far worse.

Finally, the report is not news to me, others who objectively observe HIT (especially those without financial or other conflicts of interest), or to readers of this blog. In the words of abducted-by-aliens, ignored-by-the-experts pilot Russell Casse after several cities are destroyed by the aliens:


"I've been sayin' it, I've been sayin' it, ain't I been sayin' it?"


Read the whole Press Release below.

Perhaps we as a profession should feel for patients who were denied care due to lack of funds while the IT industry diverted capital out of healthcare for "insufficient" HIT, or were denied good care through malfunctioning HIT or non-functioning HIT, or who suffered outcomes that good HIT could have prevented (i.e., the cost of lost opportunity - my own father died from malpractice as a result of informational confusion a good EHR might have prevented). All while the society's gatekeepers ignored the Distant Early Warning Line of the HIT pioneers that all was not well. (Anyone know of other sectors that crashed this past year where such warnings were ignored?)

The Press Release should be read in its entirety. I will not comment on it here further, other than to say that HC Renewal can be searched on the term "Medical Informatics", "EMR" or similar for much more material on these issues.

Emphases in boldface are mine.

The National Academies

Date: Jan. 9, 2009


FOR IMMEDIATE RELEASE


CURRENT APPROACHES TO U.S. HEALTH CARE INFORMATION TECHNOLOGY ARE INSUFFICIENT


WASHINGTON
-- Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause, says a new report from the National Research Council. The report, based partially on site visits to eight U.S. medical centers considered leaders in the field of health care IT, concludes that greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving.


In 2001, the Institute of Medicine -- which with the Research Council, National Academy of Sciences, and National Academy of Engineering make up the National Academies -- laid out a vision of 21st century health care that involves care which is safe, effective, patient-centered, timely, efficient, and equitable. Many aspects of this vision involve information technology, such as having access to comprehensive data on patients, tools to integrate evidence into practice, and the ability to highlight problems as they arise. To see how leaders in U.S. health care use computing and information management in providing care, the committee that wrote the new report visited eight medical centers -- University of Pittsburgh Medical Center; Veterans Affairs Medical Center in Washington, D.C.; HCA TriStar and the Vanderbilt University Medical Center, both in Nashville, Tenn.; Partners HealthCare System in Boston; Intermountain Healthcare in Salt Lake City; University of California-San Francisco Medical Center; and Palo Alto Medical Foundation in California.


Although the institutions showed a strong commitment to delivering quality health care, the IT systems seen by the committee fall short of what will be needed to realize IOM's vision. The report describes difficulties with data sharing and integration, deployment of new IT capabilities, and large-scale data management. Most importantly, current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) and integrating it with their medical knowledge to form a whole picture of the patient. Many care providers told the committee that data entered into their IT systems was used mainly to comply with regulations or to defend against lawsuits, rather than to improve care. As a result, valuable time and energy is spent managing data as opposed to understanding the patient.


Ideally, IT systems would place raw data into context with current medical knowledge to provide clinicians with computer models, "virtual patients," that depict the health status of the patient, including information on how different organ systems are interacting, epidemiological insight into the local prevalence of disease, and potential patient-specific treatment regimens. Although health care workers could still have access to the raw data if they needed it, clinicians would be able to work with models without drowning in data. This cognitive support would help clinicians more efficiently and effectively determine a course of action through improved understanding of a patient's status, says the report.

The report identifies several principles for improving health care IT. In the short term, government, health care providers, and health care IT vendors should embrace measurable improvements in quality of care as the driving rationale for adopting health care IT, and should avoid programs that focus on adoption of specific clinical applications. In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.


This report was sponsored by the U.S. National Library of Medicine, National Institutes of Health, U.S. National Science Foundation, Partners HealthCare System, Vanderbilt University Medical Center , the Commonwealth Fund, and the Robert Wood Johnson Foundation. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine , and National Research Council are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter. The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering. A committee roster follows.


Copies of COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at
HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).


# # #


[ This news release and report are available at
HTTP://NATIONAL-ACADEMIES.ORG ]



NATIONAL RESEARCH COUNCIL
Division on Engineering and Physical Sciences
Computer Science and Telecommunications Board


COMMITTEE ON ENGAGING THE COMPUTER SCIENCE RESEARCH COMMUNITY IN HEALTH CARE INFORMATICS


WILLIAM W. STEAD 1 (CHAIR)
McKesson Foundation Professor of Medicine and Biomedical
Informatics, and
Associate Vice Chancellor for Strategy and Transformation
Vanderbilt University
Nashville , Tenn.


G. OCTO BARNETT 1
Professor of Medicine
Harvard Medical School
, and
Senior Scientific Director
Laboratory of Computer Science
Massachusetts General Hospital
Boston


SUSAN B. DAVIDSON
Weiss Professor and Chair
Computer and Information Science
University of Pennsylvania
Philadelphia


ERIC DISHMAN
General Manager and Global Director
Intel Corp.
Hillsboro , Ore.


DEBORAH L. ESTRIN
Professor of Computer Science, and
Director
Center for Embedded Networked Sensing
Department of Computer Science
University of California
Los Angeles


ALON HALEVY
Research Scientist
Department of Engineering
Google Inc.
Seattle


DONALD A. NORMAN
Co-Founder
Neilsen Norman Group
Northbrook , Ill.


IDA SIM
Associate Professor of Medicine
Department of Medicine
School of Medicine
University of California
San Francisco


ALFRED Z. SPECTOR 2
Vice President of Research and Special Initiatives
Google Inc.
New York City


PETER SZOLOVITS 1
Head
Clinical Decision-Making Group
Computer Science and Artificial Intelligence Laboratory, and
Professor of Computer Science and Engineering
Massachusetts Institute of Technology
Cambridge


ANDRIES VAN DAM 2
University Professor of Technology and Education and
Professor of Computer Science
Brown University
Providence , R.I.


GIO WIEDERHOLD
Professor Emeritus
Department of Computer Science
Stanford University
Stanford , Calif.


RESEARCH COUNCIL STAFF


HERB LIN
Study Director


1 Member, Institute of Medicine
2 Member, National Academy of Engineering

Supplementary points: sometimes saying "I told you so" to those who place the scarlet letters upon those not afflicted with HIT irrational exuberance is appropriate. This is one of those times.

To patients harmed or killed by the clouded vision and/or conflicts of interest of the pundits, I hereby apologize for the learned helplessness of the healthcare community in not taking charge of this situation sooner.

-- SS

Friday, January 9, 2009

Who’s Who and What’s What in Health Information Technology

Prof. Bill Hersh, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University has drafted what I consider an important foundational document related to HIT initiatives by the incoming U.S. administration.

This document defines the "who's who" and "what's what" of personnel involved in Health IT.

His draft is at this link (pdf).

Dr. Hersh writes:

Health information technology (HIT) has become a hot topic! This is mainly because President-elect Obama has decided to include "computerization of health care" in his economic stimulus package. On three occasionals in the last month (Dec. 6th, Jan. 3rd, and Jan. 8th), he has personally stated the value of HIT both in improving health care and creating jobs. The Jan. 8th statement set a goal of all Americans having their medical records in electronic form within five years.

Dr. Hersh has drafted a document meant for policy makers and other that attempts to define all of the terms related to HIT personnel (the "who" and the "what") and put them in context. He believes it is important to get something "out there" before terms and identities of contributors and stakeholders become blurred or mangled.

I believe anyone interested in the improvement of healthcare through IT should be aware of this "ecosystem" of health IT enablers and facilitators.

In my opinion, if policymakers in Washington do not understand these basic fields and roles, let alone more complex and critical issues affecting HIT, we can almost be guaranteed that major difficulties will occur in any national HIT initiative the new administration might undertake.

This would be in part due to misallocation of leadership, management, design, and operational roles, and the resultant WWW Phenomenon (the Wrong people making the Wrong decisions at the Wrong time.)

-- SS

What, The RUC? - A Prominent Health Care Policy Blog Leaves Some Important Things Out

A new US President, health care costs that continue to rise despite declining access and questionable quality, even during an unprecedented global economic crisis all have made health care reform a hot topic once again in the US. This has even lead to discussion of some topics that formerly rarely merited polite discussion, sort of.

Last week, writing in the New York Times Economix blog, Professor Uwe Reinhardt, a noted health care economist at Princeton University, took on the topic of payments to physicians. His main point was:


America’s health care spending issues might have something to do with our fee-for-service payment system.

Studies have shown that physicians are not impervious to the financial incentives inherent in fee-for-service payments. For example, on average, physicians who have a direct financial interest in the use of imaging services, like CAT scans or M.R.I. scans, recommend far more such services for their patients than do physicians without such financial interest....

He noted some possible solutions:


In recognition of the conflict of interest inherent in fee-for-service payment, there is now a worldwide movement to replace the system with so-called 'evidence-based case reimbursement'. Under this approach, one single payment would cover all of the supplies and services that are needed, under best, evidence-based clinical practices, to respond adequately to well-defined medical conditions.

Not all health care, of course, can be categorized into neat, episodic bundles for this purpose. For chronic conditions, for example, payment may shift from fee-for-service to annual or monthly fees per patient, and care for such patients might be organized by clinically integrated health systems or by managed care companies procuring health care from different systems on an integrated basis. And for some patients with very complicated conditions, fee-for-service would still persist. One would think, however, that a move toward these alternative payment systems would not only reduce the geographic variations in per-capita health spending, but help control the annual growth of health spending over all.

What is missing from this picture?

Positive Incentives for Procedures, Negative Incentives for "Cognitive" Services, Especially Primary Care

First, Reinhardt suggested that the major problem with the current way the US pays for physicians is that it gives excess incentives for physicians to order diagnostic tests provided by facilities in which they have financial interests. This is, in my humble opinion, a real problem. But it is hardly the biggest problem with our current system of physician payments.

I submit that the biggest problem with our current system is that it provides big and increasing incentives to do procedures. This may lead to the over-use of some procedures in some instances. Moreover, it promotes high prices for the devices, drugs and support services required by the physicians to do these services. Thus, the current system pays many people well, and makes some people very rich. However, its enormous costs come out of other peoples' wallets, decreasing access and quality. Furthermore, the current system has provided disincentives to provide "cognitive care," especially primary care. Payments to physicians who do primary care do not cover all that they do on behalf of patients. Payments have not even kept up with inflation, nor with the increasing overhead costs of providing primary care, most of which are produced by the demands of government and insurance company bureaucracies. Thus, primary care in the US is dying. It is increasingly difficult for patients to find physicians who will take care them as whole patients, not as a set of different organs.

The Shadowy RUC

These biased incentives that lead to so much mischief are not the product of divine intervention or the laws of physics. They are the result of the actions of people, a few people operating in the shadows.

As we have discussed, the US Medicare system determines what it pays physicians using the Resource Based Relative Value System (RBRVS). This system determines the pay for every kind of medical encounter according to a complex formula that is supposed to account for physicians' time and effort, physicians' practice expense, and the cost of malpractice insurance. The components of physicians' effort assessed are, in turn, technical skill and physical effort; the required mental effort and judgment; and stress due to the potential risk to the patient.

To keep the system, which was started in 1990, current, requires addition of new kinds of encounters, which means encounters involving new kinds of procedures, and updating of the estimates of various components, including physicians' time and effort. To do so, the Center for Medicare and Medicaid Services (CMS) relies almost exclusively on the advice of the RBRVS Update Committee (RUC). The RUC is a private committee of the AMA, touted as an "expert panel" that takes advantage of the organization's First Amendment rights to petition the government. Membership on the RUC is allotted to represent specialty societies, so that the vast majority of the members represent specialties that do procedures and focus on expensive, high-technology tests and treatments. However, the identities of RUC members are secret, as are the proceedings of the group.

This opaque and unaccountable process has resulted in increases outstripping inflation in fees paid for procedures, while fees paid for "cognitive"medicine, i.e., for primary care, and for services that involve diagnosis, management of acute and chronic disease, counseling, coordination of care, etc, but not procedures, have lagged inflation. The effects of the RUC have been amplified by the unexplained tendency of commercial managed care and health insurance to track the RBRVS system when making their own payments to physicians.For further details about the RUC, see these posts on Health Care Renewal (here, here, here, here, and here) and important articles by Bodenheimer et al,(1) and Goodson.(2)

By the way, why the US Center for Medicare and Medicaid Services (CMS) relies de facto exclusively on the RUC to control the RBRVS system, and why the AMA made the RUC into a secret organization apparently beholden only to the organization's proceduralist members are unanswered questions.

What Reinhardt Left Out, and Why?

Professor Reinhardt, one of our most distinguished health care economists, barely touched on the biggest problems with how the US fee-for-service payment system works, and why these problems occurred. Thus, it is not surprising that the few solutions he recommended seem irrelevant to these problems.

As an aside, his discussion is not atypical of what is seen in most writings about health care policy that have to do with costs. It appears that it is politically incorrect to say that incentives are skewed, that this skewing appears to have resulted from the acts of a few individuals, and that these acts occurred with little outside attention or accountability. Why do health care policy experts follow these dictates of political correctness?

I don't know, but one possible explanation is that they are themselves biased by their own incentives. So let us further consider the case of Professor Reinhardt.

Professor Reinhardt's Conflicts of Interest

Not listed in the NY Times official bio of Professor Reinhardt are the following relationships:

- Professor Reinhardt is a member of the board of directors of Amerigroup, a health insurance company specializing in providing Medicaid and Medicare managed care. The company's 2008 proxy statement said that Professor Reinhardt owns the equivalent of 134,482 shares of stock, current value, $3,859,633 (at its current price, $28.70 per Google Financial), and got $221,422 total compensation in 2007.

- Professor Reinhardt is a member of the board of directors of Boston Scientific, a medical device company. The company's 2008 proxy statement said that Professor Reinhardt owns the equivalent of 51, 533 shares of stock, current value, $396,288 (at its current price, $7.69 per Google Financial) and got $118,885 total compensation in 2007.

In addition, per the above proxy statements, Professor Reinhardt is on the board of two funds from H&Q Healthcare Investors, and is a Trustee of Duke University and the Duke University Health System.

Boston Scientific, a device manufacturer, benefits from increased demand for its products due to physicians' pay incentives that favor the procedures for which they are used. As a director of the company, Professor Reinhardt has a duty to advance the financial interests of the company and its shareholders. Amerigroup may benefit from the current status quo in how physicians are paid. As a director the company, again Professor Reinhardt has a duty to advance the financial interests of the company and its shareholders. Thus, it seems that Professor Reinhardt's legal responsibilities to these companies might tend to bias him against actively questioning how physicians are currently paid, or proposing solutions that might upset the status quo.

Professor Reinhardt's leadership roles in US publicly traded corporations are public, but not easily found unless one knows where to look. (A previous post on Health Care Renewal did discuss Professor Reinhardt's previous failure to review relationships relevant at the time to a riposte Reinhardt wrote in response to an op-ed in the New York Times by a physician who decried the increasing commercialization of health care.)

However, the New York Times did not choose to make public these conflicts of interest. I should note that biographies of Professor Reinhardt on the Princeton web-site, and furnished by the Princeton Bioethics Forum, the Commonwealth Fund, and the Henry J Kaiser Foundation did not note these relationships. A transcript of an interview on the Public Broadcasting System Frontline show also did not reveal these relationships.

Without the knowledge of these financial relationships, one might suppose Professor Reinhardt's opinions are only based on his disinterested expertise as a well-known economic scholar. Without knowledge of these financial relationships, one might think that a secretive, opaque process skewing physicians' payments toward procedures is not an important problem for our health care system.

We have come to a critical time in the history of attempts to reform the US health care system. Whether reform occurs, and whether it does any good will depend on the quality of the debate that precedes it. Such a debate should be robust, but those involved ought to make clear where their biases and interests may lie.

Unfortunately, it may be that some of the most prominent voices in the debate are those of people with strong personal financial interests in having health care reform go in certain directions, not others. Furthermore, people with particular interests may not want certain issues to be even brought up. If these interests are not revealed, the debate becomes deceptive.

I fear that much of the debate up to now has been deceptive, and will not lead to good outcomes.

References

1. Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306. Link here.
2. Goodson JD. Unintended consequences of Resource-Based Relative Value Scale reimbursement. JAMA 2007; 298(19):2308-2310. Link
here.

Wednesday, January 7, 2009

To Whom Did the "Scorpions in a Bottle" Owe Their Allegiance?

In 2000, an important meeting took place between two men.

The first was a member of the board of directors of Merck Inc, the global pharmaceutical company, and of the board of Charles River Laboratories, which helps "our global partners accelerate drug discovery and development by providing them with tailored research models and preclinical, clinical, support services." The second was a member of the board of IMH Health, which advertises that it provides "global information, analytics and consulting" to support "the life cycle of medicines," from "the earliest stages of research and development through product launch, product maturation and patent expiration," and on the board of BankBoston Corporation, a national and international bank holding company. What might they have talked about?

It does not seem unreasonable to guess that they talked about pharmaceutical development. But that was not their topic.

In fact, the two men were Dr Samuel O Thier, who was then also the CEO of Partners Healthcare, and Mr William C Van Faasen, then CEO of Blue Cross and Blue Shield (BCBS) of Massachusetts. Their subject, as we discussed recently, was a secret increase in the reimbursement BCBS would give to Partners, far beyond the reimbursement given to other Boston teaching hospitals. Why BCBS was so willing to pay so much money to one hospital system is unclear. This revelation of this secret agreement showed how an important precept of the supposedly "market-based" US health care broke down. We had previously discussed that in a deregulated system, organizations like hospitals and health insurers/ managed care organizations were supposed to have negotiated vigorously for their interests. The former would try to maximize their reimbursement. The latter would try to minimize their costs. In the secret agreement between Thier and van Faasen, this did not happen.

I cannot explain why this secret agreement was made. I can point out some factors that may have been influential, but have not often been discussed.

The first factor is that the people leading health care organizations often have divided loyalties, and hence their actions on behalf of particular organizations may not be completely explained by their roles with these organizations, and consequent responsibilities and duties. For example, as noted above, the CEO of Partners also was a director of a pharmaceutical corporation, and a contract research/ drug development corporation. His responsibilities to advance the mission of Partners may have conflicted with his fiduciary duties to the stock-holders of Merck and Charles River Laboratories. Similarly, the CEO of Blue Cross Blue Shield was also a director of a drug development corporation and an international finance corporation. His responsibilities to advance the mission of Blue Cross Blue Shield may have conflicted with his fiduciary duties to the stock-holders of IMH Health and BankBoston Corporation.

The second factor may be revealed by considering the current leadership of the two organizations, leadership which has maintained the secret agreement (at least until it was made public).

The current Board of Trustees of Partners Healthcare, which has 16 members, includes:
- Jack Connors, the chair of the board, who is also the Chairman Emeritus of marketing communications company Hill, Holliday, Connors, Cosmopoulos Inc, whose clients include pharmaceutical and pharmacy benefits manager CVS / Caremark, and is also a member of the board of directors of Covidien, a medical device company.
- Anne M Finacane, who is chief marketing officer for Bank of America, an international financial corporation
- Steven S Fischman, who is President and Chief Operating Officer of New England Development, and real estate development and investment company.
- Edward P Lawrence, a member of the board of directors of Invesco, a global investment management corporation, and of AMVESCAP PLC, another global investment management corporation.
- Jay O Light, an "advisor/trustee to several corporate and institutional pools of capital," a member of the board of directors of Blackstone Group Management, the general partner of the Blackstone Group, a global investment and advisory firm, and a member of the board of directors of ESurg.com, an online source of health care supplies and information.
- Terrence Murray, who is on the board of directors of CVS/Caremark, and is former chair of FleetBoston Financial Corporation and its predecessor FleetBoston, into which BankBoston merged, and which subsequently merged into Bank of America.
- Gary A Spiess, former vice-president of FleetBoston Financial.
- Dorothy A Terrell, a venture partner of First Light Capital, a venture capital firm.
- David A Thomas, a member of the board of directors of Cambridge Trust Company.

The current Board of Directors of Blue Cross Blue Shield of Massachusetts, which has 18 members, includes:
- Mara Aspinall, senior advisor to Genzyme Corporation, a biotechnology firm, member of the board of directors of Predictive Biosciences, also a biotechnology company, and member of the board of trustees of the Dana-Farber Cancer Institute, a component of Partners Healthcare.
- Brian Barefoot, a former executive vice president and director of investment banking for PaineWebber Inc, an investment firm that was merged into UBS.
- Samuel Cabot III, a member of the board of directors of Fiduciary Trust Company, an investment management firm.
- Richard C Garrison, senior vice president and "catalyst" of Vertex Pharmaceuticals, a biotechnology company.
- Paul Guzzi, member of the Partners Healthcare corporation.
- Marian L Heard, is a member of the board of directors of CVS/ Caremark.
- Philip W Johnston is president and CEO of Johnston Associates, a consulting firm whose clients include Partners Healthcare, numerous medical device companies, including Covidien, and numerous other health care corporations.
- Cleve L Killingsworth, a member of the board of overseers of TIAA/CREF, an investment company.
- Karen Kruck, a senior managing director and head of strategy for State Street Global Advisors, an investment management company.

So another factor seems to be that the leadership of organizations which are supposed to negotiate at arms' length may have more in common with each other than with their organizations' constituencies. Note that these two boards have a lot in common. Both have disproportionate numbers of members who work or retired from one sector of the economy, financial services, and are or were top leaders within that sector. (Half, 8/16 of Partners board members are from this sector. 22%, 4/18 of the Blue Cross Blue Shield board are from this sector.) Keep in mind that of the employed US population, less than 6% work in this sector. This sector is also that which has brought us the global financial crisis.

There are also a variety of interlocks and overlaps among the two boards. These include:
- A major client of a firm run by a member of the BCBS board (Johnston) is Covidien, whose own board includes a member of the Partners board (Connors).
- Another major client of Johnston's firm is Partners itself.
- A member of the Partners board (Murray) and a member of the BCBS board (Heard) both sit on the CVS/ Caremark board.
- A major client of the former firm of a member of the Partners board (Connors) is CVS/ Caremark, a firm on whom a member of the BCBS board and a member of the Partners board sit.
- a member of the BCBS board (Aspinall) also sits on the board of a the Dana-Farber, a component of Partners.
- a member of the BCBS board (Guzzi) is also on the Partners corporation.

Finally, a number of the members of both boards have leadership roles in other health care corporations whose goals could conflict with Partners of BCBS respectively. Two members of the Partners board and three members of the BCBS board sit on the board of such health care corporations.

In summary, the current "market-based" approach to the organization of our health care system is based on the assumption that health care organizations will compete vigorously with each other, and different kinds of health care organizations will negotiate vigorously and at arms' length for their own interests.

However, it appears that the leaders of large health care organizations may have more in common with each other than with other members of their organizations' constituencies. For example, the leaders of a hospital system and of a health insurance/ managed care corporation may be more like each other than like their own employees, patients, trainees, etc. This may make it less likely that they will negotiate vigorously and at arms' length.

It also appears that conflicts of interest affecting these leaders may be widespread, and that conflicts can be of a variety of types.

Finally, it appears that leaders of the finance sector may have a disproportionate overlap with the leadership of health care organizations. The current global economic collapse have lead many to characterize the culture of the financial sector as marked by arrogance, greed, and corruption. Having this culture disproportionately influence the leadership of health care organizations may be responsible for some aspects of the ongoing health care crisis.

This case, and many others reported on Health Care Renewal, suggests that we need leaders of health care organizations to be dedicated to the principles and mission of their organizations, and not to have divided loyalties and conflicts of interest.

Has Bioinformatics Hit A Hard Wall of Stagnation?

Is the field of bioinformatics in trouble?

I ask this due to two disturbing trends. The first is the misuse of bioinformatics for "dubious" purposes. The second is, has bioinformatics itself reached a wall of stagnation due in part to disciplinary insularity and resultant inadequate collaboration with its medical counterpart?

Terminology note: Bio-informatics is the application of IT to the field of molecular biology, as opposed to the broader Bio-medical Informatics. Biomedical informatics includes both bioinformatics and my field, Medical informatics, which deals with application of IT to patients, along with fields at different granularities such as public health informatics. See a diagram of these relationships in the PDF article here.

On the first issue, consider the following:

In "A Professor and an Anti-Aging Tonic", Roy Poses commented on an academic who may have violated the trust of patients by getting entangled with commercial interests, in this case with what seems a magic potions operation. He wrote:

Academics have long been trusted to seek and disseminate the truth in a spirit of free enquiry. Academics who use their reputations to sell products, and take advantage of their reputation thus to enrich themselves, violate this trust. When the academics who do so are medical academics (even if they are not physicians), they also violate the trust of patients.

I will make observations about this story from different angles than Poses', that of misuse of a scientific discipline itself, and that of stagnation and insularity within that discipline, namely, bioinformatics.

In the WSJ story, it is noted that the protagonist, Harvard Medical School professor Dr. David Sinclair has a PH.D. in biochemistry and molecular genetics but isn't a medical doctor.

Also noted in the article:

In obtaining the backing of Dr. Sinclair this summer, Shaklee scored a coup. Dr. Sinclair knows resveratrol; in 2006, he led a study showing the molecule could counteract the ill effects of overfeeding laboratory mice. One notable benefit: resveratrol let overweight mice live about 114 weeks on average, compared with 102 weeks without the chemical.


Ph.D. in biochemistry and molecular genetics, and tests in mice.

If it works in mice, it's only a sign that human testing is then merited, of course. Well known from drug trials is that what works in animals often does not work, or can even be harmful to human subjects. Yet here we went from mice to people directly. A misuse of a scientific discipline, by either the company or the scientist, or both. Abracadabra!


Abracadabra!


This is indeed an unusual example. However, it seems many bioinformatics findings touted in the press and in biotech prospectuses are of associations that probably merit far more skepticism than received. When I see reports in the news that certain genetic markers are "associated with disease X", for example, especially in animal models, my wishful thinking radar (and/or fraud radar) lights up. See, for example, "Why Most Published Research Findings Are False" by John P. A. Ioannidis, PLoS Medicine, 2005 August; 2(8): e124 (full text and PDF available free here). Ioannidis writes:

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

The article is worth reading in its entirety.

On the second issue, that of stagnation and insularity of bioinformatics:

Molecular genetics and bioinformatics are fields I am familiar with, having been a co-PI of IT in a genetics and birth defects collaboration with a desert kingdom where consanguinity rates are high, some years ago.

As a result of this background and obervations I made in collaborating with molecular and clinical geneticists, in 2002 I wrote the following, published in the journal Bio-IT World:

Bio-IT World
Aug. 13, 2002
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. ...

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


The key phrase is "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." In fact, the "with other specialists" was added to my original to appease others within the company who reviewed this letter for publication.

The Sinclair anti-aging matter reminded me of this issue. Here, we have a nonclinical molecular scientist experimenting on cells from animals, and apparently either he and/or the company extended these observations to possibilities in people, without involvement of clinician and/or Medical Informatics expertise. This is the issue I raised in my Merck letter.

There was no such collaboration at Merck. There is none at many universities, including my current one (the Ivies may be an exception; I enjoyed such collaboration a number of years ago as a Medical Informatics postdoc and then faculty at Yale School of Medicine). Colleagues report there was no such collaboration at GSK, or Wyeth, or several other pharmas.

I've also noted such organizations paradoxically don't even recognize Medical Informatics as an essential specialty e.g., "Why Pharma Fails", "CRO's: We don't need medical informatics here", "We don't need medical informatics here Part 2" and "GSK, Avandia and Medical Informatics: More on Why Pharma Fails."

I fear in the field of Bioinformatics, the lack of collaboration with Medical Informatics occurs frequently, and in fact billions of investor dollars might be going down the drain in the pursuit of cybernetic in-silico miracles as a result.

An observer and commentator with relevant industry and academic experience, Felix Fulmer, observed in addition to the misuse of bioinformatics, this second and even more critical issue. He surmises that perhaps bioinformatics itself has reached a point of stagnation, even when used with the best of intentions but without medical input:

People in specialized disciplines ignore closely related fields, often out of arrogance. They may suffer of professional disciplinary "blinders", and bioinformatics is a prime example.

Doesn't it seem that Bioinformatics has hit a hard wall of stagnation? There have been tens if not hundreds of billions of dollars invested in this area, and yet lately there have been few truly revolutionary, tangible products on the medical shelf as a result. Pharmas are re-evaluating their approaches to bioinformatics, in fact, and numerous restructurings (example) have occurred in what seems an increasingly desperate attempt to leverage this discipline beyond the 'interesting journal article.'

The bioinformatics field may need intentional, massive, deliberate involvement of medical informatics personnel in order to continue achieving the benefits it promises, rather than casual and semi-serious involvement as we see so far.

We can observe that in computer science there is not much to be learned from medical informatics. In fact, it would be somewhat strange if computer scientists became interested in medical informatics for anything other than an application of their research.

On the other hand, that "management science" shows no interest in medical informatics is not surprising since management science has taken the arrogant stance that it alone is a fundamental discipline requiring no input from others; that everything is a widget and everyone is a resource to be dealt with in exactly the same way with minimal input from specific domains. Management has a "domain agnostic approach" to practice. So if computer and management science don't collaborate with medical informatics, it is understandible.

But bioinformatics should certainly be aware of the vital necessity for the strongest of collaborations with medical informatics professionals.

I issue a challenge to any bioinformatics professional who reads this blog to tell me why medical informatics is not an essential discipline to work alongside in discovery of new cures. As a sign of disciplinary insularity, however, I will unfortunately bet that few if any bioinformatics professionals actually read this clinically related blog or blogs on related topics such as medical informatics.

(A corollary of the same phenomena of misuse of experimental fields such as bioinformatics, disciplinary insularity and overconfidence in computing is the use of informatics as a substitute for biological testing altogether. I wrote recently about that issue in "A 21st Century Plague? The Syndrome of Inappropriate Over-Confidence in Computing." I observed via "New Drugs, Virtual Tests", Wall Street Journal, Dec. 17, 2008, that the U.S. Food and Drug Administration plans to use "new computer technology" to simulate how some drugs in development are supposed to work, helping researchers and regulators spot safety and effectiveness issues before late-stage tests on humans are completed.)

As a final aside, perhaps VC's (venture capitalists) ought to take far more care when investing in bioinformatics. They should become better informed (e.g., by reading my site on difficulties in health IT due to failures of collaboration between technologists and clinicians), and invest in cross-disciplinary - not monodisciplinary - endeavors, because monodisiplinary approaches to medicine have probably been plowed dry.

There is likely little to be reaped, nor anything of truly major significance done by lab scientists alone. The low hanging fruit is all gone.

Once an oil field is dried up, it does not matter how many more wells one drills nor how deep one goes. One must accept that a field is dried up, and go elsewhere. Bioinformatics may be in denial and not willing to admit this understandable but unfortunate reality.

Final note: an excellent powerpoint presentation entitled "Seven Deadly Sins of Bioinformatics" by Prof. Carole Goble at the Univ. of Manchester, UK can be seen at this link.

Addendum: I've noted some comments at Reddit.com on this posting. Examples:

  • Uh, yeah. Some professor (who isn't even a bioinformaticist) may or may not have endorsed a sketchy nutritional supplement with exaggeration of his own results, so clearly the entire field is "in trouble".
  • Has Bioinformatics Hit a Hard Wall of Stagnation? No.
And these at The Life Scientists:

  • That blog post is all over the place - a lot of incoherent ranting, I don't see the main message.
  • Main messages - bioinformatics is stagnant (nor argument for it) and isolated from medical informatics (again no argument).

It is unclear whether the posters were bioinformaticists. However, it seems they do not fully understand how to proffer logical argumentation, nor respond to the challenge I plainly posted above.

Jan 8 - an interesting and useful discussion is now seen at the above Reddit site.

-- SS

Why The Joint Commission Sentinel Event Alert On Healthcare IT Will Likely Be Ignored By Hospitals And Health IT Vendors

In "Joint Commission Sentinel Event Alert On Healthcare IT" I applauded the Joint Commission (the organization that accredits U.S. healthcare organizations such as hospitals) for releasing a Sentinel Event Alert in December 2008 on the risks of improperly implemented health IT. At "A 21st Century Plague? The Syndrome of Inappropriate Over-Confidence in Computing" I pointed out that prior to this Alert, those who have written on the issue of HIT risk when improperly designed and implemented have taken reputational hits as alarmists.

Finally, at "The Health IT Clueless, Or, Mr. Obama Gets Wrong Cautions on HIT" I wrote that resistance to, or lack of acknowledgement of the findings in this Alert were leading to bad advice on Health IT challenges to the incoming administration. The administration is being advised that all would be well in HIT if we just invest more in the technology.

I also observed that:

The focus of that [Joint Commission Sentinel Event] alert was minimally on technology per se, and maximally on sociotechnical issues: inadequate planning, insufficient testing or training, failing to include front-line clinicians in the planning process, failure to consider best practices for HIT operationalization, failure to consider the costs and resources needed for ongoing maintenance, failure to consult product safety reviews or alerts or the previous experience of others, over-reliance on vendor advice, failure to carefully consider the impact technology can have on care processes, workflow and safety ... need I go on?

I now am hearing anecdotal stories of the Joint Commission Health IT Alert being glossed over by hospital IT planning meetings and by vendors. It seems the Alert will likely be treated as nearly invisible in these circles, like the rest of the literature on Health IT failure and difficulty. Unless, that is, after inspection the Joint Commission starts seriously "dinging" hospitals on the basis of their health IT problems. I doubt that will occur.

This raises the question: why would hospital leadership and its IT departments, as well as health IT vendors, not put this alert as a top priority regarding their businesses? Why would they not see it as an opportunity to have their eyes opened to an entire dimension of wisdom that they have largely ignored in the past?

An answer occurred to me as follows:

The Alert's findings seriously challenge the business models of the health IT industry.

Specifically, it challenges the leadership models of healthcare IT projects and of healthcare IT vendors. Not explicitly, but through just a little introspection the challenge is apparent. It is likely terribly threatening to hospital IT leadership, the health IT industry, and pundits of these cybernetic miracles which they believe will "revolutionize medicine" (or at least make industry insiders a lot of money).

The Alert's basic message is that "it's not the technology, stupid", it's the manner in which the technology is designed and implemented and used by actual humans, clinicians for the most part, in the care of patients.

The leadership model of health IT (and all IT) seems to be based on the assumption that "technologists know best" and should lead all IT initiatives.

The Joint Commission Alert alludes to the problem that technologists have fallen down on issues that in fact are critical to IT success: the issues involving people, their work, their emotions, their cognitive capabilities, social issues, and the like. The implication is that such personnel are perhaps inappropriate for ultimate leadership of healthcare IT initiatives (as I have long argued here).

These very human sociotechnical issues, in fact, are largely outside the purview of technologists; outside their education, outside their core competencies, perhaps outside of their worldview and cognitive capabilities altogether (a bold statement, indeed, but backed by my observations of many such personnel and of some of my students who've yet to take courses that inform them of these issues).

In the biomedical world, these issues are also largely outside the purview and comprehension of the non-IT, not technical bureaucrats very often placed in leadership roles in health IT initiatives.

If this is the case, the Joint Commission Alert and others like it that follow will be ignored and people promoting its findings will likely be marginalized, just as have been the people in the fields of biomedical informatics, sociology, true computer science (as opposed to management information systems), and others who have been writing on these issues for years.

If this is the case, the Joint Commission Alert's intent will fail and the wasteful, harmful mismanagement and other nonsense that goes on in healthcare IT will continue.

I suggest any clinician or interested party reading this posting familiarize themselves with the Alert, found at

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm.

Spread it around among your associates and professional societies, and bring it to the forefront of any meeting with hospital administration and vendors when discussing health IT difficulties (which are most often reflective of the issues in the Alert).

The question should be, "what are you doing about the findings in this Alert, and what part of it don't you understand?"

-- SS