A CEO Begs the Questions About Paying Physician "Consultants"

We previously posted about financial ties between Professor David Polly at the University of Minnesota and medical device maker Medtronic. The main issues we discussed were 1) that when the good doctor spoke to a US congressional committee in support of research that might reflect favorably on one of Medtronic's products, he did not reveal that he was paid by Medtronic for "lobbying related costs (according to the Wall Street Journal); and 2) that many of the specific activities for which Dr Polly was paid by the company seemed related to marketing or lobbying, not science or education.

Now the Pioneer Press (Minneapolis - St Paul, MN) and other papers have reported that the payments to Dr Polly have interested not only US Senator Charles Grassley, but at least one active Medtronic shareholder:

Medtronic Chief Executive Bill Hawkins on Thursday defended payments by the Fridley-based manufacturer to doctors who serve as company consultants.

Hawkins told a crowd of about 300 people at the company's annual meeting that such paid relationships are key to the development and improvement of new medical devices.

In his comments Thursday, Hawkins did not specifically mention Polly but noted, 'there is today an active Congressional and media debate about how health care companies work with the clinical community.'

'We must continue our strong support for the physicians and surgeons who provide us with their innovation, passion and unique insights into patient solutions,' Hawkins said at the company's headquarters.

During a question-and-answer period, shareholder John Burbidge, 77, of Edina, said that while he understood the need for input from physician consultants, he was 'taken aback' by the sums of money involved.

'Is it really necessary to pay that kind of money to doctors in order to get good information?' he asked.

'Can you rely on information that you pay that much money for?' added Burbidge, who said he is a longtime Medtronic shareholder. 'Obviously, nobody is going to want to tell you anything you don't want to hear and jeopardize his relationship with the company.'

Hawkins said some doctors collect large sums by virtue of royalty arrangements for their role in developing patented technology.

Others doctors collect fees for providing consultant services. Those service arrangements are important, Hawkins said, because physicians help the company design clinical studies of Medtronic products in development and then teach other doctors how to use the devices once regulators clear them for sale.

Hawkins added: 'Occasionally, we will have physicians come in and work with us and be a part of a team to think about new ideas and new innovations.'

Notice first that the Medtronic CEO never seemed address the reasons the company paid Dr Polly. His comments about payments to physicians were entirely generic. Even those generic comments begged more questions than they answered. In particular,

- "large sums by virtue of royalty arrangements" - In regard to Dr Polly, I do not believe he ever claimed to be paid royalties. The question begged is why specific patents might merit huge sums paid to their holders?
- "physicians help the company design clinical studies" - But most large device, biotechnology, and pharmaceutical companies now employ full-time physicians, statisticians, and biomedical scientists to design studies. Why would they frequently need to hire part-time physician consultants as well? Furthermore, such companies customarily give grants to medical schools, universities, and hospitals to implement clinical studies. In such grants, the investigators are already paid from the grant through the university. So why would companies need to pay other physicians as part-time consultants to design or implement studies?
- "teach other doctors how to use the device" - Again, why not use physicians who are full-time employees of the company to do this?

Finally, Mr Hawkins did not address why it was necessary to pay Dr Polly to "recruit patients for publicity efforts; attend Medtronic national sales meetings;" for " two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room'" and finally "to lobby congress." (Quotes again from the Wall Street Journal.) None of this seems to have anything to do with designing clinical studies or teaching doctors how to use devices.

So it seems that Mr Burbidge's concerns were never addressed, and that there were more questions he ought to have been able to ask.

I think it is telling that Mr Burbidge's concerns only generated vague dismissals from Mr Hawkins. In theory, Mr Hawkins is a company employee who works for stockholders such as Mr Burbidge. (for which Mr Hawkins' total compensation was $ 7,512,626 in 2008, per the company's 2009 proxy statement.) But in the US, public corporations have evolved - perhaps devolved would be a better term - to the point that hired executives really do not seem to answer to those who supposedly are the company owners and their employers.

As we noted earlier, large public health care corporations are now often run by leaders with no apparent training or personal experience in health care. (As we posted earlier, Mr Hawkins does have a bachelors degree partly in biomedical engineering earned in 1976, and did some form of psychology research at that time, but his public biography indicated no further biomedical science or health care experience since 1976.) Freeing such leaders from more than nominal accountability to those who supposedly own the corporations may open the door to mismanagement, personal enrichment by hired executives, and then over-priced drugs and devices whose benefits may be exaggerated and harms hidden, resulting in high costs, poor access, and threatened quality.

To achieve true health care reform, we need to at least make transparent, if not limit or ban health care corporate payments that let medical academics use the prestige of their positions to market drugs and devices. To achieve true health care reform, we need to make sure that leaders of health care organizations have knowledge of, contextual experience in, and sympathy for the values of health care. Maybe leaders with such qualifications would understand how such payments to academics undermines research and teaching, and leads to high costs, poor access, and bad quality.

See also comments by Prof Margaret Soltan in the University Dairies blog, and by Dr Daniel Carlat in the Carlat Psychiatry Blog.

E-Health Hazards: Provider Liability and Electronic Health Record Systems

Sharona Hoffman, Professor of Law and Bioethics and Co-Director of the Law-Medicine Center, Case Western Reserve University School of Law, and Andy Podgurski, Professor of Electrical Engineering and Computer Science at Case Western, had written an important article on HIT that I highlighted in my March 2009 post "Let's Deregulate Pharmaceutical Information Technology."

In that article, entitled "Finding a Cure: The Case for Regulation And Oversight of Electronic Health Records Systems", Harvard Journal of Law & Technology 2008 vol. 22, No. 1, they called for premarketing and postmarketing surveillance of healthcare IT, adverse events reporting, and tight regulation as in the medical device and pharmaceutical industries. They summarized and amplified their views in the short piece "Why Electronic Health Record Systems Require Safety Regulation", Bioethics Forum, March 20, 2009.

In a remarkable new followup article entitled "E-Health Hazards: Provider Liability and Electronic Health Record Systems" available here, they expand their case in a highly organized and extremely well documented piece. The abstract is as follows:

In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements.

They point out that:

EHR systems can facilitate access to patients’ medical records, improve the quality of care and the accuracy of treatment decisions, achieve cost savings, and promote clinical research. Without discounting any of these potential benefits, this article focuses on the risks of EHR systems and on liability concerns associated with their use ...

The liability risks of EHR systems have received little attention in the legal literature. This new technology may bring with it novel responsibilities, burdens, and complexities for medical practices at the same time that it can potentially enhance health outcomes.

The liability risks are not just to hospitals, but to EHR users of all stripes. They find current efforts at HIT "certification" severely lacking in usefulness, and strongly support federal regulation of health IT due to the risks and dangers involved. The authors are opposed to vendor "hold harmless" and "defects nondisclosure" clauses, and have included in their article many well thought out solutions to the double-edged sword that HIT represents.

In summary, though, they believe that:

EHR systems cannot remain unregulated and largely unscrutinized. It is only with appropriate interventions that they will become a much-hoped for blessing rather than a curse for health care professionals and patients.

Download the article at this link. Read the whole thing.

I am in strong agreement with their positions. The unregulated free-for-all that has been the health IT marketplace, with dangerous and even outrageous practices I noted starting a decade ago, must come to an end as the market matures and as diffusion of this technology massively increases per the government mandates now in effect.

The rationalizations for problems, the excuses for defects and the starry eyed utopian exuberance about this technology (not to mention the conflict-of-interest and/or HIT lobby-driven irrational exuberance) must come to an end.

-- SS

Cannot Get Away From Medical Information Errors, Continued

In "This informaticist can't escape clinical IT issues even on personal business", I observed that I encountered HIT informational issues even in my own family matters, when least expecting them. I've had a few incidents since then, generally each time I've taken relatives to the hospital as a medical advocate.

It seems every time I step into a hospital as a medical advocate such issues arise, whether they be complaints from staff about IT, my mother being prescribed an IV antibiotic in the ED that an hour before I'd told the intake nurse she was severely allergic to, that fact being dutifully entered into the EHR - or as in the case below, outright errors regarding surgical procedures.

Either medical information errors follow me around, or they are more common than I realize, because I just spent a few days as a medical advocate for a very long and dear friend.

She had a suspicious thyroid nodule found at the time of exam for excision of a small breast carcinoma. She was set to have a thyroidectomy at a major NYC hospital with relatively advanced HIT capabilities and large endowments from very wealthy contributors, whose paintings hang in the lobbies (and where some high level informatics professionals are involved in clinical IT projects).

When I arrived the evening prior to surgery, my friend showed me her pre-op instructions. They were printed out in a neat and organized fashion, and she'd shown me the calcium supplements she'd purchased as the instructions advised.

"Calcium supplements?", I asked...

The computer form, properly labeled with her name and ID and the name of the nurse practitioner she'd seen for preop evaluation, was quite improperly entitled "Preoperative instructions to patients undergoing parathyroidectomy."

First thing I did in the morning was insist on seeing the surgeon in person. I wanted zero chance for error. Fortunately, the surgeon was familiar with her case and knew this was an error. Suppose, however, the surgeon was not so knowledgeable about the patient, or unavailable, or called away for some emergency and someone else filling in?

I do not know if the error was simple human error by the NP or someone prior who'd performed data entry, a wrong selection due to a mission hostile user interface in the setting of overwork, a computer error due to some cross-link between (to non biomedical personnel) two similar-sounding terms - parathyroid vs. thyroid - or some other cause.

Needless to say, if this error had resulted in an unnecessary and injurious parathyroidectomy and necessity for followup thyroidectomy on a postoperative area, and had been as a result of IT problems either totally or partially , it is likely the vendor would have been "held harmless" and the defect nondisclosed to other organizations.

(Anecdotally, on going to the bathroom, I also noted a group of residents on rounds energetically discussing what "template" was the correct one in which to enter patient data of some type. When I rounded years ago, I remember discussing medical issues...)

While I agree the likelihood of major IT contribution to this error was low, this was a reminder of just how problematic healthcare quality can be, even with advanced IT.

I think the solution is not to see IT as a panacea, and maintain adequate human involvement (with humans not overburdened feeding the bureaucratic machine) in safety issues.

-- SS

On Optimal Expertise for Leadership in Biomedicine

There has recently been debate on these pages regarding optimal expertise for biomedical leadership, precipitated by Roy Poses' posts "Health Care Leaders: Don't Know Much About Health Care" and "NY Times Proclaims Anyone Can Run a Health Care Organization with a Little Studying Up".

I am resurfacing a post I wrote in Jan. 2009 entitled "Pfizer/Wyeth Merger And Sacrificing The Future: Laying Off Scientific Staff All Over The Place" that I believe succinctly states the problems with 'management by amateur.'

Read the entire post, but here are the highlights:

... Those in charge [and who lack domain credentials -ed.] cannot see that which the domain specialist sees.

They cannot see because they lack the training, experience, and what is described as 'meta-competence' (in this brilliant article on competence [the Dunning-Kruger effect - ed.]) essential to seeing that which is obvious. Obvious, that is, to those who do not lack these characteristics. In addition, I've also observed that some lack the fundamental analytical abilities essential to understanding and managing the complexities of biomedical R&D.

Why those without domain expertise are in charge of organizations whose long term viability depends entirely on the most advanced and creative pursuit of biomedical 'miracles' is another matter. I won't address this here, other than saying it reflects the adverse consequences of a bias that has evolved in management "science."

That bias is the belief that all the world consists of faceless labor resources performing easily definable processes upon interchangeable widgets, and that management can therefore be done by generic managers, exclusively. Some of the world is like that [i.e., fast food chains - ed.], but some isn't, such as biomedical R&D. [And clinical medicine as well - ed.]

Management in the absence of domain expertise in this industry is, in fact, mismanagement.

There is nothing here to spin, there is nothing to debate. There is nothing to discuss. This is a first principle.

Failure to accept this reality results in corporate failure.

Those who believe otherwise are engaging in magical thinking.

Further, those without biomedical domain knowledge who disagree should be prepared to discuss how their lack of domain knowledge might affect their insights and opinions on such complex matters, compared to those with both domain knowledge and leadership experience. A question is this: based on the same Western traditions of inquiry and critical thinking that led to modern biomedical science and its accomplishments, whose opinion is likely to be more valid?

-- SS

Cross-occupational invasion of medicine by IT, exemplified

I have written on these pages about a cross-occupational invasion of medicine by IT personnel, wherein the IT personnel seem to forget that they are facilitators of healthcare, not enablers, with a primary purpose of serving the needs of clinicians.

The HISTalk site recently posted an attorney's views on the "hold harmless" and "defects nondisclosure" controversy first reported on by Koppel and Kreda in JAMA, and amplified in my letter to the editor in the same publication. The attorney's views at HISTalk (link below) are quite reasonable regarding such practices.

However, the user comments thread reveals some attitudes exemplifying the "invasion" of which I've written. Both the attorney's post and the responses by a poster under the nom-de-blog "Programmer" to others' concerns can be read at this link.

Read it all. The attitudes of "Programmer" (assuming they are genuine, which is likely) are remarkable.

-- SS

Health Care Leaders: Don't Know Much About Health Care

Our recent post about health care organizations recruiting executives with no experience in or knowledge about giving health care or biomedical science has attracted some attention. Some people suggested that letting some people from the "outside" into health care leadership might lead to fresh thinking and new ideas. My concern was not about that. However, I do believe that to be succesful, the leadership of health care organizations ought to collectively be knowledgeable about health care, and understand its context, culture, science base, and values. My concern was not about a few "fresh thinkers," but that the preponderance of health care leaders today know little about what it's like to actually take care of patients, have little understanding of biomedical science and health care research, and do not understand, much less share the values of clinicians.

To illustrate with some admittedly anecdotal data, I looked up the official biographies of the CEOs of some health care organizations that have recently been mentioned in Health Care Renewal. I selected the most recently mentioned examples of the following types of health care organizations: hospitals and health care systems, managed care organizations/ health care insurers, pharmaceutical companies, device companies, biotechnology companies, and health care information technology companies.

Here are the results.

Hospitals/ Health Care Systems

Example: Sutter Health

CEO: Patrick Fry

Biography:

Mr. Fry joined the Sutter organization in 1982 as an administrative resident at Sutter General Hospital in Sacramento. Over the ensuing years he held increasingly responsible administrative positions both at the local affiliate level and region level, with responsibilities covering the breadth of Sutter Health's services.

After serving as regional president for Sutter Health’s affiliates in the greater Sacramento region, Mr. Fry became president of the organization’s eastern operations. He later assumed leadership of Sutter Health’s Western Division and in 2000 became Sutter Health’s second-in-command, serving as chief operating officer and executive vice president. In 2005 Mr. Fry became President and CEO.

Mr. Fry earned a bachelor’s degree in public health administration from the University of California, Davis in 1979 and earned a master’s degree in health services administration from George Washington University in Washington, D.C.

Managed Care Organizations/ Health Care Insurers

Example: WellCare

CEO: Heath Schiesser

Biography:

Heath Schiesser assumed the role of president and chief executive officer in January 2008. He originally joined WellCare in 2002 as senior vice president of Marketing and Sales and focused most of his effort on the growth of the Company’s Medicaid and Medicare businesses. As president of WellCare Prescription Insurance, he led the Company's successful national entry into Medicare prescription drug plans. Between mid-2006 and the assumption of his current position in January, he served in a part-time role as a senior advisor, focusing on WellCare’s rapidly growing Medicare products.

Mr. Schiesser brings extensive experience in improving operations, developing strategies and growing businesses in several sectors. Prior to joining the Company, he worked at the management consulting firm of McKinsey & Company, co-founded an online pharmacy for pharmacy benefit manager Express Scripts and worked in the development of new ventures.

A cum laude graduate of Trinity University, Mr. Schiesser received his Master of Business Administration from Harvard University.

Pharmaceutical Companies

Example: Johnson and Johnson

CEO: William C. Weldon

Biography:

William C. Weldon is Chairman of the Board and Chief Executive Officer of Johnson & Johnson, the world's most comprehensive and broadly based health care products company.

Mr. Weldon assumed his current responsibilities in April, 2002. Previously Mr. Weldon served as Worldwide Chairman, Pharmaceuticals Group, and a Vice Chairman of the Board of Directors. He was elected to the Board in February, 2001.

Mr. Weldon joined Johnson & Johnson in 1971 in the sales and marketing department of its McNeil Pharmaceutical subsidiary. In 1982 he was named manager, ICOM Regional Development Center in Southeast Asia. Mr. Weldon was appointed executive vice president and managing director of Korea McNeil, Ltd., in 1984 and managing director of Ortho-Cilag Pharmaceutical, Ltd., in the U.K. in 1986. In 1989, he was named vice president of sales and marketing at Janssen Pharmaceutica in the U.S., and in 1992 he was appointed president of Ethicon Endo-Surgery.

In 1995 Mr. Weldon was named a company group chairman of Johnson & Johnson and Worldwide Franchise Chairman of Ethicon Endo-Surgery, the Johnson & Johnson affiliate that develops new procedures for minimally-invasive surgery and designs related products. In 1998 Mr. Weldon was promoted to the Executive Committee and named Worldwide Chairman, Pharmaceuticals Group.

Among his outside activities, Mr. Weldon is a member of the Board of Directors of JPMorgan Chase & Co. He is also Chairman of the CEO Roundtable on Cancer, Vice Chair of The Business Council and a member of The Sullivan Commission on Diversity in the Health Professions Workforce. Mr. Weldon also serves on the Liberty Science Center Chairman's Advisory Council and as a member of the Board of Trustees for Quinnipiac University. He previously served as Chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Mr. Weldon was born in Brooklyn, NY, and is a graduate of Quinnipiac University in Hamden, Connecticut. He and his wife have two children and one grandson.

Device Companies

Example: Medtronic

CEO: William A. Hawkins

Biography:

Bill Hawkins assumed the role of Chief Executive Officer of Medtronic, Inc. in August 2007 and became Chairman of the Board in August 2008. He was named President and Chief Operating Officer in May 2004 after joining Medtronic as Senior Vice President and President of Medtronic's Vascular business in January 2002.

Bill joined Medtronic from Novoste Corp., where he had been President and Chief Executive Officer since 1998. Previous positions included Corporate Vice President and President of the Sherwood Davis and Geck organization of American Home Products; President of the Ethicon Endo-Surgery organization of Johnson & Johnson; President, Devices for Vascular Intervention and U.S. Operations, for Guidant Corp.; and several increasingly responsible executive positions culminating in the presidency of the Ivac organization for Eli Lilly & Co. He began his medical technology career with Carolina Medical Electronics in 1977.

He received his bachelor’s of science degree in electrical and biomedical engineering from Duke University in 1976 where he also conducted medical research in pathology. Bill also earned a master’s degree in business administration from the Darden School of Business, University of Virginia, in 1982.

Bill is a member of the Board of Visitors of the Engineering School of Duke University and the Guthrie Theatre Board.

Biotechnology Companies

Example: Dendreon

CEO: Mitchell H Gold, MD

Biography:

Dr. Gold joined Dendreon in 2001 as the vice president of business development. He subsequently was appointed a director in 2002 and was named the chief executive officer of the Company in 2003. Dr. Gold has led the Company’s corporate development, acquisition and financing efforts in recent years, completing transactions valued at approximately $225 million, including the acquisition of Corvas International, and raising approximately $350 million in capital. Prior to joining Dendreon, he served as the vice president of business development for Data Critical Corporation, a company engaged in wireless transmission of critical healthcare data, now a division of GE Medical. He also served as the co-founder, president and chief executive officer of Elixis Corporation, a medical information systems company. Dr. Gold is a former urologist at the University of Washington and currently serves on the boards of the University of Washington/Fred Hutchinson Cancer Research Center Prostate Cancer Institute and the Washington Biotechnology and Biomedical Association. Dr. Gold received his B.S. from the University of Wisconsin-Madison and his M.D. from Rush Medical College in Chicago.

Health Care Information Technology Companies

Example: Allscripts

CEO: Glen Tullman

Biography:

Glen E. Tullman joined Allscripts as Chief Executive Officer in August 1997 to lead the Company's transition into the Healthcare Information Sector. He led the Company's Initial Public Offering and Secondary Offerings of the Company, which is now traded on NASDAQ (MDRX) and has driven the Company to becoming the leading provider of clinical software, connectivity and information services to physicians.

Prior to joining Allscripts, Mr. Tullman was Chief Executive Officer of Enterprise Systems, Inc., a leading healthcare information services company providing resource management solutions to large integrated healthcare networks, from October 1994 to July 1997. Mr. Tullman led the company's Initial Public Offering and secondary offerings. HBO and Company of Atlanta acquired Enterprise in 1997 in a stock transaction valued in excess of $250 million. From 1983 to 1994, Mr. Tullman served in a number of management roles including President and Chief Operating Officer of CCC Information Services, Inc., a provider of information systems to the country's largest property and casualty insurers. Under his leadership, the company grew from $17 million to more than $100 million and is publicly traded.

Mr. Tullman graduated from Bucknell University Magna Cum Laude, with a double major in Economics and Psychology. Upon graduation, he joined the Executive Office of the President of the United States in Washington, D.C. and later accepted a fellowship to study social anthropology at St. Antony's College, Oxford University, England. Mr. Tullman serves on the International Board of the Juvenile Diabetes Research Foundation and on the Board of Trustees of the Certification Commission for Healthcare Information Technology (CCHIT). He also is Co-Chair of the National ePrescribing Patient Safety Initiative (NEPSI), a $100 million campaign, led by Allscripts and Dell Computers, to deliver free electronic prescribing to every physician in America. In 2006, he was named CEO of the Year by the Illinois Information Technology Association.

So there we have the leaders of seven important health care oganizations. Only one is health care professional (although he is described as a "former urologist.") Only one of them claims any biomedical science experience, and that was in college. One has bachelors and masters level degrees in health administration, and another has a bachelors degree in electrical and biomedical engineering. That seems to be the sum total of the group's experience, expertise, and formal training in health care and biomedical science. Only one claims any experience directly taking care of patients. Only one has training in any health care profession. Only one is a (?"former"?)doctor, nurse, therapist, or biomedical scientist.

Of course, there are at least thousands of health care organizations in the US alone, each with its own often large (and some might say top-heavy) management teams. But I would wager that if there was a systematic survey of these leaders, the majority would turn out not to be health care professionals, not to be biomedical scientists, and not to have much direct health care experience. I would further wager the larger the organization, the less health care experience, knowledge and training would be found among the leadership.

I repeat, to really reform health care, we need health care leaders who actually understand health care, and support its values. But the bubble may have to burst before many people learn that lesson. For now, there is too much money to be made.

H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations

A somewhat remarkable new book will be released in Nov. 2009 by the American Health Information Management Association (AHIMA), of which I am an associate editor. It is aimed largely at IT and healthcare management personnel who are not knowledgeable in Medical Informatics. I express thanks to AHIMA for their forward thinking in accepting and publishing this material.

Books such as this were difficult to get into print just a few years ago, likely due to resistance to their publication by the powerful trade organizations of the health IT vendors:

H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations

In H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations, the editors—all of whom have led successful electronic health record (EHR) and Health Information Technology (HIT) projects—have collected case studies of HIT implementations that didn't go as planned, offering expert insight into key obstacles that must be overcome to leverage IT and modernize and transform healthcare.

... the adoption of effective HIT—now a national priority with the passing of President Obama's American Recovery and Reinvestment Act of 2009 (ARRA)—remains at a fairly primitive stage compared with IT adoption in every other major industry. In fact, healthcare is the only trillion dollar industry that remains primarily in the paper stage, even though most healthcare data are available electronically.

By studying HIT implementations that failed, the editors are able to document, catalogue, and share key lessons that all project managers of HIT, health system leaders in informatics and technology, hospital executives, policy makers, and service and technology providers must learn in order to succeed with HIT.

H.I.T. or Miss presents a model to discuss HIT failures in a safe and protected manner, providing an opportunity to focus on the lessons offered by a failed initiative as opposed to worrying about potential retribution for exposing a project as having failed.

Authors

The editor and associate editors all served on the 2007 leadership board of the Clinical Information Systems Working Group of the American Medical informatics Association (AMIA).

Editor: Jonathan Leviss, MD

Associate Editors:

Brian Gugerty, DNS, MS, RN
Bonnie Kaplan, PhD
Gail Keenan, PhD, RN
Jonathan Leviss, MD
Larry Ozeran, MD
Eric Rose, MD
Scot Silverstein, MD

This book follows the anonymized case study approach I used in my website on HIT difficulties, started in 1999, itself based loosely on the style of the introduction of the 1994 book "Managing Technological Change: Organizational Issues in Healthcare Informatics" (ed. 1) by sociotechnical issues pioneers informaticists Nancy Lorenzi and Robert Riley.

One can talk about "healthcare transformation" via HIT all one wants, but until the current inadequate approaches to HIT (per the National Research Council, 2009) are themselves transformed, doing so is largely wide-eyed utopianism.

I am quite pleased to see this new book appear. (Note: I will not receive any royalties for sales).

-- SS

NY Mayor: Pharmaceutical Executives "Don't Make a Lot of Money"

We just posted about the onrush of people into health care management, including many with little knowledge of or experience in health care. According to the Associated Press, one prominent politician defended at least pharmaceutical company managers who "don't make a lot of money." [Warning, irony and sarcasm ahead.]

Billionaire Mayor Michael Bloomberg defended multibillion-dollar pharmaceutical companies and their chief executives on Friday, declaring that they 'don't make a lot of money' and shouldn't be scapegoats in the health care debate.

The mayor — and wealthiest person in New York City with a fortune estimated at $16.5 billion — made the comments on his radio show Friday during a discussion about health care.

"You know, last time I checked, pharmaceutical companies don't make a lot of money, their executives don't make a lot of money — not that they couldn't be better," Bloomberg said.

The mayor, a Republican-turned-independent who already has spent more than $36 million on his re-election campaign this year, often battles criticism that he is out of touch with regular people. He built his fortune after founding the financial information company that bears his name.

Earlier this year he declared "we love the rich people" while arguing against raising taxes on the wealthy, and said recently that President Barack Obama, who earns $400,000 a year and has made millions from book sales, "doesn't get paid that much" and is "on a budget" like millions of Americans.

In its article on the Mayor's health care wisdom, the NY Daily News noted,

The highest-paid drug executive last year, Johnson & Johnson CEO Bill Weldon, took home a reported $29.4 million after his company raked in $63.7 billion.

The Associated Press article also commented,

Pharmaceutical CEOs are known to make millions, with generous salaries, stock options and other perks.

Abbott Laboratories Inc. Chairman and Chief Executive Miles White's compensation was $25.3 million in 2008. The North Chicago, Ill.-based company saw profit rising 35 percent to $4.88 billion.

Merck & Co.'s chief executive, Richard T. Clark, received a $17.3 million compensation package for 2008. The company's profit more than doubled to $7.8 billion.

Later,

It was clear that Bloomberg or one of his aides realized his gaffe while he was still on the air Friday.

The mayor, who has sought to cast himself as a financial and business expert, came back from a break and said he had looked up the pay of some pharmaceutical executives.

'Some of them are making a decent amount, more than a decent amount of money,' he said.

Either way, Bloomberg said, it doesn't solve anything to beat up on pharmaceutical companies while trying to come up with health care solutions.

We have previously posted about the notion that the US and the rest of the world is increasingly run by members of the "superclass," whose disconnection from the realities of daily life, including the US dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. Mayor Bloomberg's wealth and political power would qualify him for superclass membership. His notion that multi-million dollar a year pharmaceutical imperial CEOs ought to be pitied for their paltry incomes suggests not only that the very rich are unlike you and me, but that meaningful health care reform is unlikely as long as we allow ourselves to be lead by people so insulated from the vicissitudes of daily life.

NY Times Proclaims Anyone Can Run a Health Care Organization "with a Little Studying Up"

Last week, the NY Times published a somewhat breathless article on the wonderful opportunities available in health care management. Health care management seems to be the one area that is growing during the "great recession."

Health care may be a costly drag on the economy, but it’s still a great place to find a job.

Midcareer managers and other workers have been migrating to health care jobs for years, of course. Now, with the recession, the lure is even stronger.

The article suggested managing health care organizations does not require knowing much about health care.

'The demand for talented leaders in health care is only going to go up,' predicted Jane Groves, a senior vice president at Integrated Healthcare Strategies, an executive search and consulting firm in Kansas City, Mo. 'All that demand can’t and shouldn’t be filled by people already working in health care.'

The article supplied success stories of health care managers who came from unrelated fields, without any actual experience giving care, or knowledge of biomedicine. For example,

Frank Pinkowsky worked as a manager at DuPont for 24 years before taking a position as senior vice president for human resources at the Guthrie Clinic in Sayre, Pa. 'Don’t underestimate the value of what you learned working for someone else,' he advised.

Also,

'We just recently recruited a vice president for human resources from the supermarket industry,' said Mike A. Helm, a senior executive at Sutter Health, a hospital chain with 45,000 employees in Northern California. Sutter hires 20 to 30 executives a year.

At most, becoming a top healthcare executive only requires some course-work on health care management, perhaps on-line rather than in a classroom. Again, no real experience giving care, or knowledge of medicine or biology is required. For example,

Colin Ward, a 37-year-old Baltimore hospital executive, also successfully switched careers, leaving ESPN after eight years of producing sports broadcasts. 'I felt like I wanted to be contributing in some other way,' he said.

After 11 months of graduate classes in the Johns Hopkins Bloomberg School of Public Health and a year as a paid apprentice at a Baltimore hospital, he had a master’s degree in health science and management.

Mr. Ward stayed at the hospital, Lifebridge Health, for three more years and in 2007 moved to his current post at the Greater Baltimore Medical Center in Towson, Md., as director of corporate strategy.

In general,

Many managers with experience in fields like human resources, finance and marketing find a welcome in health care, with a little studying up. Online courses, books, journals and professional magazines provide material.

The article argued that managing health care information technology also does not require any real knowledge of actual health care.

The Obama administration’s $19 billion 10-year campaign to promote electronic medical records opens another huge opportunity, said Dr. Blackford Middleton, a technology research expert at Partners Healthcare in Boston. An estimated 40,000 to 160,000 additional health information professionals could be needed, he said.

The industry trade association, known as Himss [sic] for the Healthcare Information and Management Systems Society, offers an array of online courses that can help technology workers move into health care.

The article did allow

Health care does, of course, have its own jargon and a host of complex challenges. Managers have to know how to deal with doctors, nurses and professional groups, as well as with regulators.

But perish the thought that health care executives who have to deal with lesser species like doctors, nurses and other professionals have to understand much about what these lowly folks actually do.

Somehow, the lessons from the bankrupt automobile companies led by executives with business degrees but no real knowledge of or interest in automobiles and how they are made, and from failed finance companies which sold complex financial derivatives that their executives did not understand do not seem to obtain.

It does all have a certain degenerate, bubble about to burst odor. The notion is the health care boom is so intense that anyone can run a health care organization.

We did find out that anyone can run an automobile company or finance firm too. The results just may not be so pretty.

Is it any wonder that in this climate, people with no understanding of the health care mission are running health care organizations, and soon the organizations are run in conflict with that mission?

As we have said before, to really reform health care, we need health care leaders who actually understand health care, and support its values. But the bubble may have to burst before many people learn that lesson. For now, there is too much money to be made.

WellCare "Did Not Contest" that its Political Contributions Violated State Law

From a report in the St Petersburg (Florida) Times:

WellCare Health Plans on Wednesday admitted to making 129 'questionable' contributions to Florida politicians over four years ending in 2007. In a consent order with the Florida Elections Commission, the Tampa-based managed-care company agreed to pay a $120,000 fine and did not contest the commission's finding of probable cause that the contributions violated state law.

The Associated Press reported in February that WellCare, its subsidiaries and executives spent $2.4 million in political contributions in the 2004 and 2006 elections. More than 95 percent went to Republicans, who pushed a plan to send more state and federal Medicaid spending through private companies like WellCare.

In May, 2009 we posted about WellCare's submission to a deferred prosecution agreemeent based on charges that it defrauded state programs by inflating its expenses. In 2007, we posted about how the state of Connecticut stopped WellCare from running a plan for poor children after the company refused to reveal what it was paying physicians, and why it was failing to pay for particular services. So WellCare has paid three penalties for three different kinds of unethical behavior in the last two years.

WellCare is one of numerous health care organizations which seem to be serial violators of reasonable ethical norms. Usually, however, the penalties paid for these behaviors are trivial, given the financial capacities of the offending organizations. Furthermore, rarely are the individuals who made the decisions that caused the behaviors identified, much less subjected to negative consequences.

Given our continued permissiveness towards all sorts of deception, dishonesty, cheating, and even outright fraud, bribery, and corruption, is it any wonder that the unethical behavior continues? Such behavior doubtless directly drives up costs. Furthermore, leaders focused on their personal power and enrichment may not lead well, and demoralize employees and professionals who want to do the right thing, leading to further cost increases, access decrements, and threats to health care quality. I submit that to truly reform health care, and have a chance at improving cost, quality, and access, we cannot continue to shrug off these sorts of ethical violations.

A postscript - as we have noted before, one member of the WellCare board of directors is Regina Herzlinger, a well known and prolific health policy expert, and holds the Nancy R. McPherson Professor of Business Administration Chair of the Harvard Business School. As far as I know, Prof Herzlinger is one of the many health policy experts who avoids discussing the sorts of problems with the accountability, integrity, and transparency of health care leadership which is grist for the mill here at Health Care Renewal. Perhaps, Prof Herzlinger, like many other main stream health policy experts, should learn to acknowledge that health care leadership may be unaccountable, opaque, dishonest, and sometimes flagrantly corrupt. Furthermore, Prof Herzlinger, like many other well-paid board members of health care organization, should pay a bit more attention to the mischief being committed by those who answer to her.

Another Haunting Tale

Halloween is more than two months away, but the ghost stories just keep on coming. The latest version was reported by the Associated Press (with a hat tip to Prof Margaret Soltan on the University Diaries blog). To quickly summarize,

Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from 'developing a topic,' to 'submitting the manuscript for publication.'

The actual document is now available from the PharmaGossip blog here. Reviewing that document suggests that the CASPPER program was a bit different from other ghost-writing schemes (for example, see previous posts here.)

A typical ghost-writing scheme would entail ghost-writers employed by a medical education and communications company (MECC) drafting manuscripts of a scholarly-appearing review articles. The articles would be written to support the marketing of a product made by the (usually pharmaceutical) company which hired the MECC. Then, the MECC would recruit well-known medical academics as (guest) authors for the articles. The guest authors might make some minor revisions in the draft manuscripts, which would then be submitted to scholarly journals. The MECCs would handle the submission process, while maintaining the pretense that the articles were the work of the guest academic authors. The ultimate purpose of such schemes apparently would be to market the product in the guise of scholarly publication.

CASSPER, on the other hand, was meant to produce more modest articles, ostensibly written by practicing, rather than purely academic physicians. Review of the CASSPER document leads to some interesting conclusions about the project

- The project was purely a marketing project. "The objectives of CASSPER, from a publication standpoint, are to strengthen the product positioning and overcome competitive issues." The document clearly was written by marketers, and directed to pharmaceutical representatives ("drug reps.") It did not mention any involvement by GSK scientific or medical personnel. The closest it came to making a pretense about any scientific or clinical usefulness of the project was, "publication of such articles will benefit the sales force by expanding the database of published data to support PAXIL."

- It was as much about promoting closer relationships among pharmaceutical representatives ("drug reps") and doctors as about publishing articles. The project was to be implemented by drug reps, and "your participation will establish and/or strengthen your relationships with key physicians and thought leaders in the psychiatric field." The drug reps would handle, and presumably shape all communications between their physicians and the MECC.

- Articles were to arise from instigation by the drug reps, rather than from physicians' initiatives. For example, a scenario for recruiting authors began, "a physician tells you that he or she has had treatment success with PAXIL in certain indications or difficult-to-treat patient populations." Then, "ask the physician if any consideration has been given to publishing a case study based on this clinical experience."

- Although the document is somewhat ambiguous about the role of the putative author in the process, an extensive list of services available from the MECC (Complete Healthcare Communications [CHC] ) would have left little for the author to do. "The full range of editorial assistance that CASSPER can offer contributing physicians includes: developing a topic, coordinating the editorial review process, submitting to the target journal." The company's role would include "coordinating" manuscript preparation, which was defined as "development of an outline and first draft, editorial reviews, and revisions." The company would make available "published literature, available internal support, literature search results, and a database of journal submission criteria." Also, "the numerous details that CHC is prepared to coordinate ... [include] copy editing and proofreading, production of tables and graphics, preparation of the submission package, and follow-up."

So CASSPER seems to be a not really so friendly example of a newly recognized species of ghost-writing, targeted more at promoting relationships among drug reps and physicians than at producing ostensibly scholarly articles. Nonetheless, this example of the haunting of medicine is as fundamentally deceptive as previously described ghost-writing schemes. In the CASSPER project, physicians would be reduced to little more than ectoplasm, goaded by drug reps into token involvement in a writing process exclusively handled by the MECC, and mediated by the friendly appearing drug reps. I wonder whether physicians who participated escaped with any psychological independence from the drug reps who magically turned them into acclaimed "published authors?"

In any case, the disclosure of CASSPER, a ghost who was friendly only in appearance, adds more evidence about how deception and dishonesty now haunts our health care system. To achieve real health care reform, we will have to find a new group of ghost-busters. Who you gonnna call?

ADDENDUM (25 August, 2009) - See also comments by Dr Howard Brody in the Hooked: Ethics, Medicine and Pharma Blog.

Why Siemens Healthcare Fails

I have written numerous times on this blog about the blind-man ignorance displayed by many healthcare IT and biomedical companies regarding Medical Informatics expertise.

As a graduate and postdoctoral-level Medical Informatics educator with considerable applied expertise, as well as talent management experience, I teach students of a variety of healthcare backgrounds that the only way to overcome the sociotechnical complexities (i.e., issues at the intersection of people and their interaction with technology) of HIT is via education and considerable experience.

Once students become aware of the nuances and complexities of HIT in real-world clinical settings (if not already enmeshed in such environments), they find the lessons learned from substantial and rigorous immersion into a wide corpus of literature, overseen by someone with expertise, profoundly important towards advising their own organizations in avoiding pitfalls and achieving success.

I note that I used to admire German engineering rigor, but after seeing ill conceived, misguided position ads like the following from Siemens Healthcare, I am having sincere doubts about that country's current prowess in that domain.

I refer to a recent ad (here at the moment) for a Physician Consultant:

Job Description

Siemens Medical Solutions is the industry leader in Healthcare IT technology and Clinical workflow solutions. We are seeking to hire an experienced Physician for our Professional Consulting Services Organization. In this highly visibly position, you will support the implementation of Siemens products (such as Soarian ) in hospitals nationwide. To be considered for this position, qualified candidates must have the following credentials and experience:

• U.S. based Medical degree with at least five years of post-residency experience in large multi-specialty practice or hospital-based facility in the United States.
• Currently practicing medicine, or must have practiced at least 1 week per month within the last 3 years
• Leadership experience with at least one CPOE implementation in a large, multi-facility health system, Integrated Delivery Network (IDN) setting
• Extensive public-speaking and executive presentation experience
• Medical informatics credentials or advanced degree preferred, but not required [Medical Informatics not required? - ed.]
• Prefer some experience in public-health related projects

Here are the obvious major problems:

One CPOE implementation or even several does not by any means qualify a person to counsel other medical organizations and clinicians as a representative of a company citing itself as "the industry leader in Healthcare IT technology."

Further, the criteria "Medical informatics credentials or advanced degree preferred, but not required" suggests the crafters knows little about Medical Informatics, or hold it at a low level of esteem, considering it an optional "gift" that might add slight extra value to the incumbent's ability to travel the country and give good advice and support in clinical IT implementation. What might substitute for such knowledge and expertise?

This J.D. might better be described as "glorified salesperson." It might be a good exit route for a "techie doc" (usually, someone who knows just enough about HIT to be destructive) who hates the current practice environment. It might also be good for managers who don't want knowledgeable experts pointing out their bad decisions and mismanagement, but I think a global company like Siemens should be setting its sights higher in such a crucial area as electronic medical records and clinical IT consultants.

I would not want such a physician advising or supporting complex HIT projects at my organization.

I spent time at Siemens Healthcare headquarters in Erlangen in 2000, and was offered gracious hospitality and a position overseeing the Soarian cardiology suite. The people I met in Erlangen then seemed extremely competent and informatics-savvy, but I turned the offer down through no fault of Siemens. I'd received a near-simultaneous offer (FAXed to my hotel in Erlangen, in fact) from pharma that involved a much stronger management role.

I understand through conversations over the past few years with current and ex-Siemens personnel that most of the Siemens personnel I'd met in Germany in 2000 are no longer with the company. I was told they'd performed suboptimally after the acquisition/merger with Shared Medical Systems (SMS) in Malvern, PA. (I do not find that credible, and would find it far easier to accept that the problems were on the American side, but that is a personal opinion.)

Questions raised by these observations:

• What manner of ideology about education and expertise does this job description represent?

• Is there nobody left in Germany with a realistic sense of the education and expertise required to advise on and support HIT implementations in a competent manner, I ask?

Allow me to answer question #1. It represents the IT designer-centric, data processing and tabulator punch card culture-based (and antithetical to medicine and science) view that with enough generalists and sufficient "process", any problem can be solved. By this logic, Bach and Beethoven would have had symphonies written for them by low level musicians in the name of "efficiency" and cost savings.

Wanted: consultants to write my Ninth Symphony, according to the Acme Symphony-Writing Process Manual. Musical experience not essential. Must be team players.

Shareholders, take note. I emailed this post to the Siemens Healthcare CEO Hermann Requardt, who I note (almost predictably) lacks a biomedical background other than having been a research assistant for aviation medicine once, and having worked on MRI:

Education

• Secondary school (baccalaureate)
• Studied physics at the Technical University of Darmstadt and University of Frankfurt (Dr. phil. nat., Dipl.-Phys.)

A lack of response is therefore not surprising.

-- SS

On HIT Vendor Nondisclosure of Nondisclosure Agreements

Seen at the HIStalk blog in News of 8/19/09:

A couple of readers wisely suggested that I not consider running nondisclosure language from vendor contracts. Reasons: (a) it might identify the client since terms are often customized; (b) it might violate vendor privacy requirements and get a client or me in trouble; (c) clients might not want to share anyway since they may like the idea of being prohibited from sharing patient safety information. A couple of vendors e-mailed to say they don’t include such terms. I’d be very surprised if Cerner and Epic don’t based on my limited history with them.

My response to the HISTalk blog owner, Tim, and other interested parties:

Sent: Thursday, August 20, 2009 7:32 AM To: mr_histalk@yahoo.com Cc: david.kreda@gmail.com; rkoppel@sas.upenn.edu; Emilia_DiSanto@finance-rep.senate.gov; MChassin@jointcommission.org; pschyve@jointcommission.org Attachments:

To: HISTalk blog Re: nondisclosure of nondisclosure agreements by HIT vendors Tim, Those who've written advising you *not* to post the language of HIT nondisclosure agreements are in fact correct: As per Koppel and Kreda's March 2009 "Hold Harmless" article in JAMA and my July 21 JAMA letter to the editor commenting on it, nondisclosure and hold harmless agreements stifle HIT innovation, put patients at risk, and cause healthcare executives to violate their Joint Commission and fiduciary responsibilities to protect patients and workers from undue physical or legal jeopardy. You and other bloggers should *not* be the ones to clandestinely obtain and post such language. The HIT vendors themselves, in an atmosphere of transparency and in deference to patients safety and to hospital governance, should gladly and transparently do so if such language exists in their contracts. This assumes, of course, that HIT vendors hold patient safety and practitioners' rights as a high priority. S.S.

I think that says what needs to be said.

-- SS

High Costs and Poor Outcomes - A Lesson About the Suppression of Research

Last week, blogger Alison Bass was one of the few to comment on a new article on the risks of antidepressant medications published electronically last week by the British Medical Journal.[1] The article adds to the clinical evidence about these specific drugs. However, it also should remind us about why our health care costs seem to continue to inflate disproportionate to any improvements in health care outcomes.

Background - Why Don't Doctors Diagnose and Treat Depression According to the Evidence?

Here is the background. Since the early 1990s, based on numerous published clinical trials that showed that the newer (mainly SSRI, that is, selective serotonin reuptake inhibitor) antidepressants seemed to be quite safe and effective, authoritative guidelines have urged physicians to screen patients for depression, and have a low threshold for beginning treatment, particularly with these then new drugs. (For example, see the 1993 AHCPR guidelines,[2] and the Ambulatory Care Quality Alliance Recommended Starter Set[3].) Such guidelines targeted primary care physicians as well as psychiatrists. As a primary care physician, I often felt guilty that I didn't screen all patients, including those who did not outwardly appear depressed, for depression, and was reluctant to be the primary prescriber of antidepressants for depressed patients. I was not alone. There was evidence that many primary care physicians failed to follow these apparently evidence-based guidelines.

Suspicions that SSRIs Were Not as Effective or Safe as Thought

However, in 2004, internal documents from one drug company (Glaxo Smith Kline), published by the Canadian Medical Association Journal, suggested that the company had suppressed a study which failed to show its SSRI was effective for adolescent patients.[4] Also, then New York state attorney general Elliot Spitzer sued the company alleging it had suppressed such data.[5] Considerable anecdotal information thereafter came to light suggesting that drug companies may have suppressed data from clinical research (that is, studies done on patients, not in the laboratory) which tended to show the drugs were less effective, or more dangerous than previously thought. Many began to suspect that the drugs increased the risk of suicidal thoughts or behavior, even though one would think that if they were effective in treating depression, they should decrease such risks.

How Does Uncovering Suppressed Trials Change the Evidence About the Benefits and Harms of SSRIs?

Then, an analysis of trials of SSRIs given to adolescent patients, which included unpublished as well as published trials, did show they increased the risk of suicide.[6] But what about adult patients?

In 2008, Erick Turner and colleagues published a meta-analysis that included numerous trials of SSRIs and other antidepressants given to adult patients that had never been published, but whose results had been submitted to the US Food and Drug Administration (FDA).[7] When those trials were included in the analysis, the drugs seemed less effective than was previously believed.

The new meta-analyis by Stone et al[1] suggested how adding evidence from the suppressed trials improves our knowledge about the possible harms of these drugs. Stone et al specifically addressed whether the drugs increased the risk of suicidal thoughts or actions for adult patients. It was based on data from 372 trials that included 99,231 patients. "Most of the studies were unpublished; those that had been published in some form seldom contained information concerning suicidality in the publication." Its main result was that SSRI drugs approximately doubled the risk of suicidal behavior for patients less than 25 years old, but decreased the risk for older patients.

Suppressing Trials Distorted the Evidence-Base

Thus, the combined results of several meta-analyses suggests that SSRIs are neither as safe nor as effective for adult patients as they were previously touted to be. The drugs used to appear to be more safe and effective because the drug companies that sponsored (paid for) clinical trials of their own products suppressed the publication of studies whose results did not show their products in a favorable light. The guidelines once thought to be so authoritative are probably much to enthusiastic about the use of drugs to treat depression. It may be that those physicians who resisted pressure from these guidelines and other efforts by would-be quality improvers to diagnose more depressed patients and treat them with SSRIs weren't so dumb.

Health Policy Implications

The recently published meta-analysis of the risk of suicidal ideation or behavior due to SSRIs for adult patients[1] adds not just to the clinical evidence about the treatment of depression, but to the evidence that suppression of research by those with vested interests in its results may not be rare. There is no reason to think that suppression of research about other medical interventions used for other clinical problems does not occur just as often.

This underscores why we as a society should not have handed over control of how new drugs and devices are evaluated to the companies that stand to profit by selling them. The apparent benefits and safety of most drugs and devices brought to the market in recent years may have been exaggerated by the ability of the corporations who sponsored the research to suppress those studies that were least favorable to their products. Thus, it is very likely that doctors have over prescribed newer (and more expensive) drugs and devices based on erroneous beliefs about their safety and effectiveness, beliefs supported by an evidence base which was distorted by suppression of studies whose results did not show the results their commercial sponsors wanted to see. Furthermore, we have likely collectively paid too much for these drugs and devices based on these same erroneous beliefs. Thus, the distortion of the clinical evidence base caused by putting the makers of medical products in charge of their evaluation has likely led to increased costs and worse outcomes for patients.

Health care reformers serious about wanting to improve patient outcomes and reduce costs ought to be at the forefront of a movement to make clinical research more honest. All clinical trials completed and submitted to government regulators ought to be published in some form, so that the data they contain is available to guide clinical decisions. Going forward, all studies should be published in some form in a timely manner to prevent future research suppression. There ought to be better regulation of research sponsored, and de facto run by companies who have vested interests in the results being favorable to their products. It would not be unreasonable to prevent companies with such vested interests from running or otherwise directly influencing clinical research meant to evaluate their own products.

But here in the States, we are probably too diverted by yelling at each other about whether a "public option" is vital or nefarious to worry about such issues.. Meanwhile, expect our health care to continue to get more expensive, less accessible, and less good for patients.

ADDENDUM (25 August, 2009) - Also, see the comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma Blog

References

1. Stone M, Laughren T, Jones ML et al. Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration. Brit Med J 2009; 339: b2880. Link here.
2. Depression Guideline Panel. Depression in Primary Care: Volume 2 - Treatment of Major Depression. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research, 1993. Link here.
3. Ambulatory Care Quality Alliance. Recommended Starter Set: Clinical Performance Measures for Ambulatory Care. http://www.ahrq.gov/qual/aqastart.htm
4. Kondro W. Drug company experts advised staff to withhold data about SSRI use in children. Can Med Assoc J 2004; 170: 783. Link here.
5. Wadman M. Sptizer sues drug giant for deceiving doctors. Nature 2004; 429: 589. Link here.
6. Hammad T, Laughren T, Racoosin JA. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006;63:332-9. Link here.
7. Turner EH, Matthews AM, Linardatos E et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358: 252-260. Link here.

CCHIT Has Company

It appears CCHIT, an offspring of the large HIT trade association HIMSS, won't get its wish for Health IT Certification hegemony. I think the outcome of a multidisciplinary HIT policy workgroup's deliberations on this issue reasonable:

Aug. 17, 2009

iHealthBeat.org

Policy Committee OKs Plan To Establish Multiple EHR Certifiers

On Friday, the [HHS] Health IT Policy Committee adopted recommendations that called for multiple entities to certify electronic health record systems, Health Data Management reports.

The committee's certification and adoption work group issued the recommendations (Goedert [1], Health Data Management , 8/14).

To receive official certification, EHR systems must meet a minimum set of criteria and achieve the "meaningful use" objectives of the federal economic stimulus package. Under the stimulus law, health care providers who demonstrate meaningful use of EHRs will receive Medicare and Medicaid incentive payments (O'Harrow, Washington Post , 8/15).

Recommendations

The work group recommended that:

* Certification criteria allow for open-source software;
* Certification processes should let health care organizations qualify for EHR subsidies under Stark Law exceptions that allow organizations to subsidize the cost of EHRs for physicians;
* Certification should last for four years;
* Multiple groups perform HHS certification under a single set of criteria;
* The National Institute for Standards and Technology should participate in accreditation and certification decisions;
* The Office of the National Coordinator for Health IT should define certification criteria;
* ONC should create an accreditation process for certification groups;
* Officials develop alternative certification processes for self-developed software; and
* Vendors are required to receive certification from only one group ( Health Data Management , 8/14).

The work group said it envisions the establishment of 10 to 12 different EHR certification groups, in addition to the Certification Commission for Health IT (Manos, Healthcare IT News , 8/14).

The recommendations now go to HHS for consideration ( Health Data Management, 8/14).

The workgroup said CCHIT is too closely aligned with the health IT industry, noted that the industry trade group HIMSS helped found CCHIT, and noted that CCHIT's members includes several people with ties to HIMSS and health IT companies. They were clearly uncomfortable with the potential conflicts of interest, especially if CCHIT gained sole responsibility for HIT "certification." [A term I put in quotes since it really is "features qualification" at this point, not certification such as a physician receives after passing Specialty Boards - ed.]

Having been on the receiving end of CCHIT bullying myself ("Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-Certified HIT"), it's clear most Americans don't like bullies, especially bullying from powerful lobbying organizations such as HIMSS and its progeny. (It's also become clear they don't like 1000+ page healthcare reform plans shoved, unread, down their throats by political bullies.)

By the way, since the July 21, 2009 publication of my JAMA letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" and Koppel and Kreda's reply, pointing out the terrible situation that HIT "defects nondisclosure" and "hold harmless" clauses create for hospital executives, physicians and patients, I have heard from the Joint Commission, but not from HIMSS.

Perhaps HIMSS leadership believes I have nothing worthy to add to the discussion. (Perhaps another 'Open Letter' is called for.)

-- SS

Philips Medical: A Followup

In a Nov. 2008 post entitled "Who Leads in Intellectually Challenged Responses to Medical Informatics Backgrounds, The U.S. or Europe?", I chastised Philips Medical for their ossified and uninspired approach to biomedical informatics talent management (by nonmedical "experts", in fact), and that ossification's deleterious effect on innovation.

I forwarded the post to Philips management. Needless to say, I never received a response.

This appeared on Aug. 5, 2009 at layofftracker.blogspot.com:

Wednesday, August 5, 2009

Philips Healthcare announces layoffs

Got via a Tip.

Philips Healthcare announces layoffs. Memo below.

Message from Steve Rusckowski

Dear Colleague,

In our Q2 and Semi-Annual 2009 Report released on July 13, Philips reported a year-on-year decline in Healthcare sales. While we are substantially lower in our profitability as compared to Q2 2008, material improvements were made in our profitability from Q1 2009 to now, due to our sustained efforts on cost-containment. However, we still fell short of our targets and there is risk for further deterioration in several of our markets.

To build a stronger organization for our future, we need to be a simpler, leaner, more flexible organization, while continuing to bring costs and capacity in line with current demand levels. Our long-term success will be measured by our ability to pro-actively and purposefully navigate through the lingering economic slowdown.

The Healthcare Executive Team, in collaboration with our extended management across the sector, will adapt our organization to the needs of the markets. Where we see opportunities we will seize them, where markets change we will take the necessary steps to enable profitable growth.

To safeguard and strengthen our business, our sector will expand, and where possible, accelerate our efforts to cut further operating costs, including an additional reduction in our workforce. After careful analysis and consideration, this action will impact nearly all of our businesses and functions within North America beginning this month.

The necessity of this workforce reduction is driven by increasing double-digit declines in equipment orders across all of our businesses in North America. The combination of tightening credit markets, persistent delays in capital equipment purchases, reimbursement pressures and the uncertainty of health care reform, are contributing to a weak overall U.S. health care market. [He forgot to mention innovation failure - ed.] Responding to these dynamics is crucial to secure our immediate business performance and preparation for our future.

In North America, the vast majority of employees affected by the workforce reduction will be notified next week. Some employees will be notified as early as this week, with others notified later, as business needs dictate. Impacted employees will be notified by management and/or representatives from Human Resources.

As always, Philips is fully committed to supporting all employees through this process and will treat everyone fairly, professionally and with respect. In accordance with local legislation and procedures, affected employees will be offered severance packages and other appropriate assistance and support. [Being treated with "respect" at a time of massive unemployment, of course, means being handed a few months' salary -- unless you are an executive -- and then being booted out the door - ed.].

I recognize the impact of these decisions is difficult and distracting on a personal and business level. [Getting laid off is indeed somewhat "personally distracting" - ed.] On behalf of the Executive Team, I want to thank you for pulling together and giving your best effort to stay focused during these challenging times.

It is important to recognize, we are battling a global recession, with impact extending across all sectors and geographies. While we are taking these measures within the North American region, we will continue to assess economic conditions and business challenges across our sector and will implement further cost measures whenever needed.

I will continue to keep our lines of communication open [to survivors - ed.], as we proceed ahead. As we do, let’s continue to focus on our customers, as we commit to supporting one another.

I remain confident in our business strategy and our collective passion to make a positive difference in health care.

Best regards,

Steve Rusckowski

CEO

Philips Healthcare

I suggest that to "build a stronger organization for our future" ("our" referring to those who actually retain their positions for now), Philips management start reforms at the top. One reform would be to re-evaluate just how "expert" their experts are.

Philips shareholders, take note.

-- SS

Lessons Unlearned: Health IT Failure, Act 2

The following appeared on the HISTalk site on 8/14/2009 from a writer with the screen name UCSFWatch:

From UCSFWatch: “Re: UCSF CIO’s e-mail. The GE Centricity Enterprise project is in full stop mode.” The attached and unverified e-mail from CIO Larry Lotenero says this: “The medical center’s Senior Management Group has engaged Kurt Salmon Associates (KSA) to assist us with a review of our IT clinical strategy. We are doing the review because we are dissatisfied with our progress to implement clinical applications to support the care of our patients. KSA will arrange interviews with many of you to capture your insights for the strategy planning. They will be on-site to begin their interviews on August 18. If KSA contacts you, I ask that you be as flexible as possible with your schedule to accommodate this process. We expect to receive a final report before November. For now, all activities associated with developing the GE clinical system should immediately be put on hold. Despite this action, we remain fully focused on our goal to complement our excellent clinical care providers with equally excellent clinical applications as soon as possible.”

If true (as it likely is), I find this remarkable.

I would have to refer to it as "UCSF Healthcare IT Failure, Act 2" for reasons just below.

I find it remarkable that this resource- and money-wasting scenario (with possible adverse patient care repercussions) can occur:

• In a state that's in a severe economic crisis,

• At an organization that failed severely in a HIT and administrative IT merger just ten years ago (in the failed, late 1990's attempted merger between UCSF and Stanford's medical centers, see the 2000 stories "UCSF/Stanford: Marriage was rough; divorce is expensive" here and "A thousand MIS personnel cannot merge two healthcare systems" here),

• With an EHR product, Centricity, that is the descendant of Logician that others have implemented successfully (including myself, speaking from experience),

• With GE, a major global high technology vendor, presiding over this new failure at a major academic medical center,
  

• With ample preventive material available in books, journals on the web about such failures (e.g., at the many pages and links here and here, as just a few examples).
  

This last point raises additional questions:

• Do IT managers at UCSF and GE actually read the HIT literature and the web, I wonder? Have they ever done a Google search on "healthcare IT difficulties" or "healthcare IT failure", or related concepts?
  

• Do they think the materials found via such searches frivolous, useless, or not credible?
  

Finally, it is quite remarkable that the best UCSF can do is hire yet another expensive management consulting firm to try to remediate this failure. What are UCSF IT personnel paid to do, exactly?

Perhaps AMIA, AHRQ, HHS and others in the administration need to focus less on new research on figuring why these situations occur, and devote resources to ensuring modern knowledge of HIT failure scenarios already extant is leveraged.

If not, we're likely (as I fear) to have a lot of UCSF Act 2's in the next few years, as organizations attempt to implement HIT by 2014 so as to not be penalized by HIT provisions in the ARRA act.

Perhaps (again, if the HISTalk note is true), we need to bring back the likes of "Neutron Jack" (Jack Welch, well known for laying off less than stellar divisions at GE), and perhaps the Governator needs to "terminate" the roles of the leadership of this project.

Gov. Schwarzenegger had a way with those
who fiddled around destructively with computers...

See other disappointing stories about events at UCSF on this blog at this link.

-- SS

A University Leader's Goal: "Taking New Biotechnology ... to Market?"

An article from the San Francisco Chronicle noted how the new Chancellor of the University of California - Davis (UC-Davis), Linda Katehi, is already contending with controversy. One brief section about her goals for the campus caught my eye. The article noted that Dr Katehi (who has a doctorate in engineering) holds 16 patents, then:

Now Katehi wants to transfer that entrepreneurship to the campus she'll lead.

'The campus is in a wonderful position to become a major force in improving and strengthening the economy of the state,' Katehi told The Chronicle, adding that she'll help UC Davis to become more aggressive in taking new biotechnology and agriculture products to market.

So it would seem that Dr Katehi's goals are making UC-Davis more entrepreneurial, strengthening the California economy, and marketing selling biotechnology products. All of that would make some sense if UC-Davis were a biotechnology company.

However, it is not. UC-Davis, of course, is a major academic campus of the University of California system, with multiple graduate and professional schools, including a medical school. Its mission is:

Through a distinctive tradition of core-discipline excellence, interdisciplinary collaborations and productive partnerships, UC Davis teaches students to think critically, objectively and creatively and to be lifelong learners, engaged leaders and productive citizens; pursues research to advance knowledge and to address state, national and global challenges; and serves the public through the generation, broad dissemination and application of knowledge.

The statement does mention "application" as well as dissemination of knowledge. It seems quite a stretch, though, for that one word to justify putting a priority on entrepreneurship, economic development, and marketing biotechnology products. In fact, Dr Katehi's goals seem to be far removed from, if not in conflict with the university's mission. This is just a recent example of how the leaders of academic institutions seem to be forgetting or radically deconstructing their academic missions, and in particular, how leaders of academic medicine seem to think that their job is to sell drugs and devices.

Consider how Dr David Korn, then Senior Vice President, Division of Biomedical and Health Sciences Research of the of the Association of American Medical Colleges (AAMC), wrote that medical schools and their parent universities must confront "societal demands that they become engines of economic development," so that they must "create a precarious equipoise between the world and values of commerce and those of traditional public service." Furthermore, the government and the public, " impatient for new medicinal products, disease preventions, and cures," "fail to understand or too easily forget that in our capitalistic economy the pathway by which research invention becomes beneficial application is often totally dependent on venture capital, the availability of which commonly demands the active participation of the academic inventors in the commercial venture; put simply, no participation, no money. It is this demand, more than any other cause, that has driven the dramatic increase in medical faculty entrepreneurship." [Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-7. Link here.] Thus, nine years ago, Dr Korn, and the AAMC seemed to have acquiesced to a radical restructuring of the academic medical mission to put entrepreneurship, and the development and marketing of commercial products ahead of teaching, research and patient care.

This fundamental change of the focus on academic medicine seems to have been accepted, if not embraced by other academic leaders, like Dr Katehi. It does seem to correlate with some notable changes in how academic medical leaders think and act: devaluing the education mission and demanding that faculty put a priority on bringing in money (see post here); , forming their own, often highly lucrative financial relationships with health care corporations (see post here); acquiescing to faculty becoming "key opinion leaders" and thus supporting marketing of drugs and devices (see post here and this link); allowing continuing medical education to serve marketing purposes (see link here); allowing drug and device company sponsors of clinical research to suppress and manipulate the research (see link here and here); etc, etc. Thus it seems to underlie many of the most dysfunctional aspects of our current health care system.

I find it hard to believe that the public really would want existing respected academic institutions to be turned into biotechnology companies, without any plans to replace their academic roles, and that it wanted faculty members to turn into product developers and salespeople. (Yes, there may be good reason for faculty who do basic science, but not clinical research to consult for health care corporations, in certain instances. But that is a relatively minor, and somewhat separate point.)

In my humble opinion, one goal of meaningful health care reform would be to refocus academic medicine on its academic mission, and let drug and device companies alone develop and market their products.