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

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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. summarized and amplified their views in the short piece , Bioethics Forum, March 20, 2009.In a remarkable new followup article entitled E-Health Hazards: Provider Liability and Electronic Health Record Systems, 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. 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: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. 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.

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Cannot Get Away From Medical Information Errors, Continued  

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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 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

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

Addendum:

One physician replied to this message as posted in a private medical informatics listserv with the following statement that I do not identify with:

Regarding the calcium supplement, since unplanned loss of parathyroid tissue is a recognized and fairly common event with thyroid surgery (relative tolerance depends on unilateral or bilateral dissection), you might have been better served by the "error" than its omission.
Medical errors and indolence in correcting the problems can be as much a human attitudinal problem as IT-related.

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On Optimal Expertise for Leadership in Biomedicine  

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There has recently been debate on these pages regarding optimal expertise for biomedical leadership, precipitated by Roy Poses' posts 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 that I believe succinctly states the problems with 'management by amateur.'

Read the entire post, but here are the highlights:

...

Those in charge cannot see that which the domain specialist sees.

They cannot see because they lack the training, experience, and what is described as 'meta-competence' essential to seeing that which is obvious. Obvious, that is, to those who 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. Some of the world is like that , but some isn't, such as biomedical R&D. There is nothing here to spin, there is nothing to debate. There is nothing to discuss. This is a Failure to accept this reality results in 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?

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Cross-occupational invasion of medicine by IT, exemplified  

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

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

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Our recent 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

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

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.
CEO: William C. Weldon

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.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.CEO: Mitchell H Gold, MD

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.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.

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

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A somewhat remarkable new book will be released in Nov. 2009 by the American Health Information Management Association , of which I am an associate editor. It is aimed at the non-medical- informatics IT and healthcare management professional. 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 (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 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).

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

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We just posted about the onrush of people into health care management, including many with little knowledge of or experience in health care. 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 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.

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

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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.

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4 Step Depression Treatment  

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Everywhere you look there is a new medication to help you get you depression under control. While medication is definitely an option that helps many, it should not automatically be the first choice that comes to mind when it comes to overcoming a mood disorder. Not all mood disorders are caused by chemical imbalances, and some of those that are can even be treated with changing other variables in the equation of body, mind, and environment that affect depression symptoms.

The first thing, and the most readily available to management and self control is diet. Vitamin D has been shown to affect mood levels and is very important for alertness and mental health. If you are overweight, underweight, or struggling with eating unhealthy foods, this can have a drastic impact on your ability to control mood. This is the first factor that you need to make sure is optimized for good physical an mental health.

Inactivity can also be a major source of unhappiness, both on a physiological as well as an emotional level. Get out and take a walk, ride bike, or swim. Just getting in 20 minutes of energetic activity a day can help to elevate mood and ward of boredom.

If you low mood is not affected by lifestyle change alone, it is time to seek out professional help. The help of a mental help professional can help you to decide if your depression is mainly an emotional disorder that might be able to be managed through counseling sessions, or if a referral to a physician to see if medication might be needed. There is nothing to be ashamed of, mental health is not different than any other health need, other than the fact that stigma increases the likelihood of lack of treatment due to refusal to acknowledge there is a problem at all.

If medication is needed, then working closely with your doctor and open communication is essential to making sure that the best medication at the appropriate levels helps you to control mood swings as well as allowing you a happy and normal life. There are many people taking depression medication without noticeable difference in behavior or physical ability. Depending on the medication program that is chosen to help you with you depression, regular visits to monitor your progress or regression into depression related symptoms will follow, allowing both you and your doctor to optimize the results of your medication and other treatment.

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Adult ADHD Symptoms & Treatment  

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Though ADHD is predominantly thought of as a childhood disease, there are many adults that also suffer from the condition. If you are an adult, and you experience any of the symptoms of adult ADHD, then it would be best for you to get into contact with your local health care professional and seek diagnosis and treatment if needed.

ADHD is an attention disorder that can usually be controlled by improving the connections between synaptic receptors in the brain that process information. In adult ADHD, the chemical balances that regulate such transmissions is disrupted, and thus the connections, causing loss of the ability to focus, remain committed to activities, or to generally stay motivated. Small doses of prescription medication has shown to improve the connection in the synaptic chain, allowing better processing of information and hormone responses that control these brain-behavioral functions.

ADHD is often diagnosed in adults as they are no longer in the educational system, and the inability to remain on task or keep thoughts in focus is not paid attention to in the same manner. While the child in school might get a referral to the school medical clinic for testing, the adult is usually offered no more than the threat of lost employment or discriminatory behavior as they are seen as lazy or unintelligent.

This same stigma is also a contributing factor in adults not seeking medical treatment for adult ADHD, especially amongst men. The need to seek medical treatment for ADHD is urgent as well as extremely beneficial for the adult who exhibits ADHD symptoms. The difference that proper diagnosis and treatment of ADHD can make in an adults life can be dramatic. Even small imbalances in hormone levels and chemical reactions can have profound effects on the mind and body. Sometimes the mental clarity and ability to focus can be greatly benefitted by better diet and medication without the need for any further medical intervention, though some sort of psychological counseling is usually recommended to deal with the emotional changes that can sometimes come with coping with ADHD or as side effects of medication.

Far from being something to be ashamed of, getting treatment for your adult ADHD can be the best thing that you can do to for your own health and the health of your family. Like other mental and physical health issues, the patient is usually one in a host of people affected, and ADHD is no different.

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Getting Answers On ADHD  

Posted by health and insurance


ADHD is probably one of the most misunderstood, misdiagnosed, and mistreated medical concerns of the 21st century. There are 3 misconceptions about this rather common attention disorder that need serious clarification before an honest and helpful approach to diagnosing and treating ADHD can be undertaken.
Misconception number one. My child has been tested for ADHD.

There are several factors that must be taken into consideration before a person can be said to have problems with ADHD. There is not urine test or other simple sample evaluation process that signifies the existence of ADHD. ADHD is not a known chemical imbalance or a specific disease as in the presence of a specific physical defect in the body, but rather a whole host of symptoms and symptomatic reactions that when taken together, give a consistent picture of what we refer to as ADHD. Behavioral patterns are not enough. Reaction to physical stimulus or chemical makeup alone are not enough. Even when diagnosed with ADHD, it is best to seek out a second opinion as even the definition of ADHD and the severity and extent to which the disease is thought to be able to be controlled by medicine alone can vary from one medical professional to another.
Schools diagnose ADHD.

Teachers and educational professionals play a large part of our children’s lives and our children have a huge impact on theirs. But even with daily close contact and the best intentions at heart, a person who is not a medical expert for one, and a specialist in ADHD in children for two, has no authority to administer a diagnosis of ADHD on a child. Often there are other issues at hand. The most common reason for teacher diagnosis is in fact misbehavior. A child who acts up in class more than the others or has problems focusing does not necessarily have ADHD, but might just be bored. It is my personal opinion that it is sometimes the teacher, unable to maintain the attention of young children, is a problem, and not the child at all. That is not to say that the observations of the educational community are to be ignored, but should be backed up with medical expertise before taking unneeded action.
Misconception number three, ADHD children are intellectually impaired.

ADHD can definitely have a negative impact on academic performance and may even disrupt social skills, but intelligence is not the issue here. There are several incredibly smart people who are affected by ADHD. The inability to concentrate on material at hand or simply being able to stay motivated for any length of time for any single task has nothing to do with how smart a person is. ADHD is a medical condition with accompanying psychological and sometimes behavioral repercussions, but these symptoms usually only act as a barrier to education if they are left unchecked, uncontrolled, and unchanged. Getting over the fear of stigma or guilt, and making sure that ADHD is managed at the first sign of trouble is the best way to ensure that your child continues to learn at a normal pace and does not fall behind the others.

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What is Bipolar Disorder?  

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Bipolar disorder is a psychological condition in which a person finds it hard to control a sudden or continuing swing in mood elevation and depression that can usually be treated through changes in diet and lifestyle, herbal and pharmaceutical medication, or in extreme cases, invasive techniques such as shock therapy.

Not everyone who has bipolar disorder will know it. Sometimes the swings in mood that a person experiences are so gradual that the individual does not notice the wide chasm between the extremes. Often the psychological effects of the moods themselves, or the chemical occurrences in the body can cloud judgment or environmental conditioning allow the person to believe that everything is “normal”.

Some people may experience a light euphoria or may go into full blown mania before going on in the reverse direction resulting in feelings of apathy, or en worst cases, possibly suicidal depression. While changes in mood are normal, rushes towards the extremes, whether chronic and prolonged, or with fast onset and short in duration, should be discussed with your doctor and treated by a trained professional.

While medical attention for bipolar disorder is a must, there are still several things that you can do on your own to make sure your body is best helped in its battle to moderate emotions and physical chemical balances.

Eating right and getting plenty of exercise can often elevate mood without resorting to crashes later on. Cutting out empty calories and processed foods high in simple carbohydrate and sugars can not only keep you feeling your best, but can also help moderate levels of insulin and hormone creation in the body.

Lowering stress by discovering and enjoying a relaxing hobby, or even getting a small pet for companionship are all things that can help to keep us in good spirits.

While the physical symptoms of bipolar disorder can be treated in various ways by your physical doctor, the help of a mental health specialist can help you to develop the skills to better deal with the emotional response that comes with chemical changes in the body, as well as the complications and frustrations that can be placed on a persons lifestyle as a result of their bipolar disorder. Following the advice of both your physical doctor, as well as your therapist of counselor, while doing all you can on your own by changing personal behavior patterns, can help you to manage bipolar disorder a lot better than dealing with it on your own.

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Nutritional Value of The Acai Berry  

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The Acai Berry is a bi-annual fruit from South America that has been hailed as the best super food alive on the planet today, and a “miracle fruit”, correctly pronounced as “ah-sa-ee” and is in actuality a simple palm fruit of amazing nutritional benefit.

The actual fruit of the Acai palm is similar in size and shape as the blueberry with a purple hue. It is rich in antioxidants and is often used in juices and other drink forms as a health shake. The berries are also great in cooking and can be added to breads, or added as topping on desserts. The Acai berry is extremely tasty and has been even been said to have a hint of chocolate in its flavor.

One of the major benefits of the Acai berry is that it is so rich in anti-oxidants. Anti-oxidants are known for their free radical fighting properties are known to damage cells and reduce the body’s ability to fight off infections and disease. Free radicals are also connected with skin disease, so their elimination is excellent for dermal health.

Acai berry not only helps the body cleanse itself of unwanted toxins and promote healthy immunity, but the wide range of nutrients and vitamins it contains adds to the nutritional value of this wonder food.
Nutrients in Acai berry.


The Acai berry is bursting with amino acids known to regulate efficient metabolic levels and promote weight control, as well as a host of beneficial vitamins such as C, A, and Iron. Fiber, calcium, and potassium, as well as ample amounts of protein is also packed into this button sized berry. The nutritional impact of Acai berry alone can help a person stave off the effects of aging, skin problems, eye and bone deterioration prevention, and help in the fight against anemia.

A heart healthy food with a powerful nutritional and anti toxin punch, the Acai berry has recently been entered into research to determine its effectiveness in the fight against cancer. Now that a lot of good from one little palm berry.

Acai berry is available in some health food stores and from reputable online vendors. It can be found in whole fruit, juice, and even powdered supplement form. Convenient, good tasting, natural, and good for you, Acai berry has no negative side effects and does not carry either the inconvenience or the risks associated with other dietary supplements, being simply a super healthy fruit.

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Soda: The Worst Food Imposter On The Planet  

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Want to know the solid facts?

1/2 of us will die from heart disease; about a 1/3 from cancer;2/3 of us will die obese; and 1/4 of us will get diabetes. All of this is because of our love of behaviors and products that eventually killed us. I will not argue that genetics plays a part in medical propensities for certain diseases, but nothing in my family history could prepare use for a three Big Mac, 2 milkshakes and a diet soda consumer demand driven society. Many people do not even know that the amount of food, and especially the types of food they eat, could be directly increasing their chances for ailment and actually robbing them of the very nutrients they were thought to be providing. One huge, pseudo food market is the soda pop industry. This liquid is manufactured, canned and bottled for distribution worldwide at a rate of 150mg of high power fructose for every person on Earth daily.

Soda pop is liquid high fructose corn syrup and/or artificial sweetener mixed with water and carbonated soda, allowing for an immediate flood of simple, processed carbohydrates and sugars to overwhelm the bloodstream and insulin processing systems in crashing waves. This can serious erode health and contribute to an imbalance in the body’s ability to handle energy usage and storage management efficiency, leading to diabetic problems or the excess storage of fat. Fat storage of the sugars contained in sodas is quite common as the body cannot possible utilize the amount of sugar rushing into its system during consumption, and thus is instead turned into fat and sent to all of your “unsightly” places. A soda usually contains in excess of 150 empty calories each. People who consume 2 sodas a week will gain ten pounds a year throughout their lifetime if these calories are not burned off. Also exacerbating weight is the fact that the main sugar in soda, fructose, when processed by the liver, is often turned into fat and stored instead of burned off as energy calories. Combined with the fact that fructose also has a tendency to create craving but leave little satisfaction for hunger makes for an equation for weight gain disaster.

Not only does soda’s extra calories and lack of nutrients contribute to higher risk of obesity, these products have also been known to strip the body of much needed calcium, weakening or even causing the wasting away of bone mass. The kamikaze style of entry and processing by the body can further complicate the risk of diabetes or other maladies associated with the body’s resistance to insulin.

Some researchers have even contended that soft drink beverage consumption might even contribute to a person’s risk of contracting certain types of cancers. While the sugars in soft drinks can be avoided with the use of artificial sweeteners, studies have shown them to carry and even higher incident of cancer and other serious ailments that fructose. My suggestion would be to avoid the soda altogether, and make all natural, calorie free, water your main beverage and favorite drink. Your body will thank you for it.

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Water: The Building Block of Life  

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Without water there would be no life on planet Earth. There is probably no substance on the face of the planet that is more valuable, contributes more to health, and sadly, is the most under-utilized natural preventive remedy for many of today’s health problems.

With two thirds of the earth’s surface covered by water and the human body consisting of 75 percent of it, it is evidently clear that water is one of the prime elements responsible for life on earth. Water circulates through the land just as it does through the human body, transporting, dissolving, and replenishing nutrients and organic matter, while carrying away waste material. Further in the body, it regulates the activities of fluids, tissues, cells, lymph, blood and glandular secretions.

While it is possible to live without food for a little over a month, a few weeks without water and you would be a drying corpse. While we constantly talk about how important good diet and exercise is to our overall health, correctly so, we should be spending more time talking about the benefits of getting adequate amounts of the very building block of life itself, good old H2O.

The average person should be drinking about 8-10 glasses of drinking water a day. Coffee and tea, though they contain water, are actually counterproductive to hydration, as the caffeine content of these drinks can actually be a source of dehydration. Similarly, high sugar drinks such as sodas and Kool-Aid are little help either, as the detrimental effects of high fructose corn sweetener and other simple sugars far outweigh any benefit you get from the actual water content.

Water is a great source of weight control power also. Studies have shown that some people simply over eat because they do not know the difference between being thirsty and hungry, and so they continue to eat when they are in fact simply dehydrated. People who drink high amounts of sweetened drinks and even certain fruit juices are often dehydrated and do not even know it due to the fact that they feel that if they are taking in liquid that this is impossible. Also sweetened drinks that contain fructose do little to curb thirst while dehydrating the body at the same time, creating a vicious circle of continued consumption and dissatisfaction. A few glasses of water and some fruit instead of a six pack and a burger is often much more satisfying, will give you more energy, and healthier for you in the long run.

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Wipe Out Bad Sugar In Order To Wipe Out Bad Health  

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A regular can of soda contains the same amount of sugar that you would find in 10 teaspoons of table sugar. While sugar is a carbohydrate, and the body needs carbohydrates to function, other types of carbohydrates are available, such as whole grains and many fruits and vegetables. The amount of sugar, especially in the form of glucose, as is found in soft drinks and candy is an extremely unhealthy and high percentage intake compared to what is actually needed on a daily basis for good health. Glucose enters the bloodstream at a very fast rate, and is especially hard for the body to utilize in any efficient fashion. Processed foods, especially bleached or otherwise ‘enriched” breads and pastas produce high amounts of glucose when digested and present the same problem.

Simple carbs are sugars that are formed previous to digestion, and can be found in fruits and vegetables and milk products. While both naturally occurring sugars and processed carbohydrates and sugars are considered simple carbohydrates, the two are not the same. The naturally occurring sugars are accompanied with all of the other nutrients, vitamins, and fiber that the sugar host provides, while processed foods are usually deprived of any nutritional value upon taking their processed form. This state of nutrition-less processing labels these as “bad carbs” and contribute to obesity and other health problem while offering little or no benefits.

Eating processed foods and sugars are not only an easy way to flood the body with an excess supply of simple sugars with no real nutritional benefit, there are also other negative factors that need to be considered when considering the effects of processed foods on the average person’s health.

* The chances of becoming obese is increased literally exponential to the amount of sugars consumed and the amount of nutrition value absent due to processing.
* In pastas and processed breads, the carbohydrates and sugars added significantly increase the chances of tooth decay as they tend to advance damage and change to sugar more rapidly that have complex carbohydrates.
* Flooding the system with simple sugars at regular intervals can actually result in sugar addiction, making the risk of developing serious health related issues and the inability to control intake often lost without the help of an physician or mental health professional.

In order to protect yourself from the harmful effects of processed carbohydrates and sugars, knowing the other terms and names that these added ingredients go by can be quite helpful. Look for all forms of the word sweetener, as in corn or the words glucose, fructose, and syrups such as malt or maple, any honey, molasses, and even white grape juice (which is almost pure fructose).

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Carbohydrates: The Body’s Edible Food Factories  

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Carbohydrates are needed for proper body function. They are the main source of fuel used foe energy in a person’s diet. As carbohydrates are introduced into the body, the body breaks them down into sugars that are then used as food for cells in the body such as the muscles and other organs, including the heart. While the emphasis in diet trends over the last few years has focused on a low carbohydrate intake, how the body processes carbohydrates in relation to blood sugar levels and weight gain would be better approached by looking at the type of carbohydrates in the diet as well as their amounts.

There are two types of carbohydrates, simple and complex. Simple carbohydrates process into sugars very quickly as well as having very little nutritional benefits. One example is fructose. Fructose, usually eaten in the form of processed grains or sweetener, rapidly floods the blood with sugars that are above and beyond the processing ability of insulin in the system. Excess sugars are instead stored in the body as fat, and the binge leaves the body with too much too fast, with complete absence nutrition in its wake.

Complex carbohydrates on the other hand go through a more gradual and balanced processing, are usually part of foods with the added vitamins and minerals that provide the body with much needed nutritional support, and provide the body with needed energy at a more reasonable level over a longer period of time. Whole grains and fresh fruits and vegetables often are great sources of complex carbohydrates, though some fruits do contain sucrose and fructose in higher levels than vegetables and whole grains.

This is the very reason that it is easier for a person with diabetes to control their blood sugar levels with complex carbohydrates than with simple carbs. With society pushing for faster and faster food on the go, and the emphasis on cheap production in large quantity the norm in commercial food production, the amount of processed foods and simple carbohydrates consumed by the general population, and intake of complex carbs and other nutritional food on the decrease. Many diseases that top the charts for fatality every year could be significantly decreased if this trend could be reversed, even if the amount of food consumed did not change. The absence of nutrients in our diet, combined with forcing our bodies to respond to the rollercoaster of chemical reactions involved in digesting the unhealthy food we do eat has created an environment prone to imbalance and extremes. Carbohydrates are our friends, and we have turned them into our enemy.

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Protein  

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Protein, along with carbohydrates and fats, make up the major building blocks in a healthy diet that allow for proper body function. Without any one of these compounds, called macronutrients because the high amounts needed as compared to other nutrient, the body would quickly run into problems and show signs of malnutrition. Carbohydrates supply the blood with much needed sugar fuel, fats provide the body with the ability to gain weight as well as save energy for later use, and proteins help with muscle production as well as energy production. Proteins are readily found in meats, cheeses and other dairy products as well as certain vegetables. Protein is also an important source of the Amino Acid Phenylalanine which is important to alertness and other brain function. Without an adequate source of protein in your diet, muscle production would be impossible, and muscle breakdown and atrophy would begin. This is the reason that protein is so important to bodybuilders and those with muscular dystrophy, as atrophy of the muscles is exacerbated by a lack of protein, and additional protein can be utilized for increased muscle mass production.

Most people get enough protein in a balanced diet for good muscular health, and many get much more protein than they actually need. In Western culture meat is often considered the main, and largest course in a meal, and while providing the body with much needed protein, too much meat, especially red meats, can also bring along massive amounts of fat and if prepared in a restaurant, usually plenty of salt to go along with that. The extra fat and salt are retained by the body, and the excess protein is either stored as fat or exits the body as waste.

The more active a person is the more protein the body can utilize, and the more muscle can be built. Inactivity causes even the smallest amount of protein to go to waste or go to the waist. It is either converted to fat and will later be used as energy, or passed from the body. Smaller cuts of meat and the introduction of vegetable, fish, and soybean sources of protein can be a great way to maintain proper protein levels without overindulging. The other option is to increase exercise that also brings with it increased benefits in both the present and for the future. Protein rich fish is also high in Omega 3 fatty acids that promote heart health, which can give it a healthy edge over beef or poultry.

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Another Haunting Tale  

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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.

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Why Siemens Healthcare Fails  

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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.

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On HIT Vendor Nondisclosure of Nondisclosure Agreements  

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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:
Cc:

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.

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

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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.

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Philips Medical: A Followup  

Posted by health and insurance in , ,

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.

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