Relman in JAMA on Threats to Physicians' Core Values

The purpose of the Health Care Renewal blog is to address "threats to health care's core values," as noted in our side-bar.

The latest issue of JAMA contains an important article by Arnold Relman on this topic.(1) Much of its content will be very familiar to Health Care Renewal readers.

Relman's first point is that physicians' core values are threatened:

Endangered are the ethical foundations of medicine, including the commitment of physicians to put the needs of patients ahead of personal gain, to deal with patients honestly, competently, and compassionately, and to avoid conflicts of interest that could undermine public trust in the altruism of medicine.

These threats arise from "the growing commercialization of the US health care system." This has been abetted by physicians who accept "the view that medical practice is also in essence a business." Thus, "the vast amount of money in the US medical care system and the manifold opportunities for physicians to earn high incomes have made it almost impossible for many to function as true fiduciaries for patients."

Relman also the growth of specialization, and the "greater economic rewards of procedural specialties," although he did not address why procedures have come to be better rewarded.

I think Relman's most important insights were about how legal changes in the US have undermined professionalism.

The law also has played a major role in the decline of medical professionalism. The 1975 Supreme Court ruling that the professions were not protected from anti-trust law7 undermined the traditional restraint that medical professional societies had always placed on the commercial behavior of physicians, such as advertising and investing in the products they prescribe or facilities they recommend. Having lost some initial legal battles and fearing the financial costs of losing more, organized medicine now hesitates to require physicians to behave differently from business people. It asks only that physicians' business activities should be legal, disclosed to patients, and not inconsistent with patients' interests. Until forced by anti-trust concerns to change its ethical code in 1980, the American Medical Association had held that 'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients' and that 'the practice of medicine should not be commercialized, nor treated as a commodity in trade.' These sentiments reflecting the spirit of professionalism are now gone.

Finally, Relman blames the "growing influence of the pharmaceutical industry," noting that the industry

uses its enormous financial resources to help shape the postgraduate and continuing medical education of physicians in ways that serve its marketing purposes. Physicians and medical educational institutions aid and abet this influence by accepting, sometimes even soliciting, financial help and other favors from the industry, thus relinquishing what should be their professional responsibility for self-education. A medical profession that is being educated by an industry that sells the drugs physicians prescribe and other tools physicians use is abdicating its ethical commitment to serve as the independent fiduciary for its patients.

It is striking that the notion that physicians core values are under external threat is now becoming mainstream.

Hearing from multiple physicians about their central concern "with the abandonment of the core values of medicine,"(2) prompted us to start planning for what eventually became this Health Care Renewal blog. In my European Journal of Internal Medicine article, I summarized these values from some prominent codes of medical ethics: they required "that the physician put the patient's interests first, and then require that the physician practice with honesty and integrity, to uphold the confidentiality of information about individual patients, and to be responsible for the education of the next generation of physicians." The more modern codes also required the physician "to commit to scientific medicine."

However, I wish this essay had considered a broader formulation of the causes of the current crisis.

On one hand, Relman did not discuss how the government runs its part of health care could have some responsibility for the current crisis. In particular, on Health Care Renewal, we have discussed, most recently here, how the US Medicare system allows its physician reimbursement, which heavily favors procedures over primary care, to be determined by a secretive committee, the RBRVS Update Committee, or RUC, dominated by proceduralists and sponsored by the AMA, the same organization that once condemned the commercialization of medicine. It turns out that Relman has just written a book (reviewed here) about how to reform health care, in which he advocated for a government run single-payer system. The notion that Medicare, our current government run single-payer system (albeit only for the disabled and the elderly) may be to blame for much of the current system's problems makes this position harder to defend.

On the other hand, although Relman decried the commercialization of health care, he focused on only one sector, the pharmaceutical industry. Although pharma has had its share of abusive leaders and practices, other sectors, including biotechnology, medical devices, health care insurance and managed care, health care information technology, etc, etc have not done much better (just page through Health Care Renewal for examples.)

On the third hand (oops), Relman came close to excusing the conduct of not-for-profit organizations within health care. He wrote only, "to survive in this new medical market, most nonprofit medical institutions act like their for-profit competitors, and the behavior of nonprofits and for-profits has become less and less distinguishable." Again, Health Care Renewal (and many others) have noted incompetent, conflicted, and even outright criminal leadership of many not-for-profit health care organizations, including some of our most revered. Relman's book, however, advocates that health care delivery be turned over to not-for-profit organizations. Doing so might provide little benefit unless we take drastic steps to improve not-for-profit governance, an issue which I am not sure the book addressed.

In summary, Relman's commentary should help shake awake those who keep thinking that US health care is the best in the world. It should also remind us how different things were only a generation ago. If only physicians still agreed that "'the practice of medicine should not be commercialized, nor treated as a commodity in trade," and that "'in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients." (For more discussion of the history of the AMA's former opposition to commercialization of medicine, see Money-Driven Medicine by Maggie Mahar.)

References

1. Relman AS. Medical professionalism in a commercialized health care market. JAMA 2007; 298: 2668-2670. [link here]
2. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123–130.

The Avandia Case, and a Warning About How Bad Things Can Get

We have posted frequently about the controversy about rosiglitazone (Avandia, by GlaxoSmithKline). Some of the distressing aspects of the case were various efforts made to keep information and opinions unfavorable to Avandia away from physicians, the patients, and the public, including efforts involving obfuscation, deception, and intimidation. (For example, see this post about the "spinning" of Avandia and the ridiculing of Avandia critics, and this post about attempts to silence an early Avandia critic.)

This month, the British Medical Journal printed a news article about the US Senate report that claimed that the critic, Dr John Buse, was intimidated by top GSK executives.

Perhaps with deliberate irony, on the same page was another news article, headlined, "One in 20 East German doctors spied on patients or colleagues." It was based on a study by the Hannah Arendt Institute for Research on Totalitarianism,

About 5% of doctors in the former East Germany spied on their colleagues or patients as unofficial members of the East German secret police (the Staatssicherheit or Stasi), a new report has shown.

The study, by the Hannah Arendt Institute for Research on Totalitarianism, Dresden, and commissioned by the German Medical Association and the German medical journal Deutsches Ärzteblatt, showed that the percentage of unofficial members of the Stasi among doctors was higher than in the East German population as a whole.

'Doctors were one of the main targets of the Stasi because they were thought to belong to a reactionary class and were thought to be especially interested in escaping to West Germany,' said Francesca Weil, author of the study....

Of those doctors who were unofficial spies, about a quarter passed on information not only about colleagues but also about their patients' health and private lives. Psychiatrists and sports medicine experts were the most common specialists among the unofficial spies, and a third of them held a leading position in a hospital. The Stasi also recruited medical students.

Reasons for spying varied. Some doctors were trying to advance their career or were afraid that their careers would suffer if they did not participate; others were committed socialists; and another group liked the economic advantages, which ranged from monthly cash payments to fast tracked delivery of a car or other luxuries.

In my humble opinion, physicians in the West should not view the latter article as affirmation that we do not have things so bad. Rather it is a warning about how bad things can get.

Doctors are not the venture capitalists and R&D arm of Acme EMR Corporation (with apologies to Linda Lovelace)

We have now reached the point where clinicians are being pushed from every side - industry consortia, government, patients, etc. to adopt clinical IT, often at their own cost and risk. Even suggesting that clinical IT may not be all it is cut up to be can result in highly emotional and unhappy feedback from various circles. It seems to be like suggesting God does not exist to the Vatican.

It also seems never to have occurred to the pundits that doctors are not the venture capitalists and R&D/beta testing arm of the Acme Anvil EMR Corporation.

I am a strong proponent of good Electronic Medical Records and related clinical IT (CPOE, CDSS, etc.) as tools to facilitate an improved quality of healthcare. However, several caveats apply:

1. The keyword is "facilitate." It must never be forgotten that the key to good healthcare is smart, well-trained, well-rested, well-compensated experts who treat patients from a framework of peace of mind. Believing you can reliably get good healthcare -- from frazzled clinicians whose practice is a nightmare due to paperwork, frequent battles with payers over minutiae, perplexing EHR's with which they are (apologies to Linda Lovelace) deep-throated by overzealous hospital and IT executives, vendors and governmental agencies, threats of reimbursement cuts and lawsuits, etc. -- is the belief of a fool. Clinical IT does not work cybernetic miracles; and another rule of thumb is that "Computer + Quack ≠ Marcus Welby." (≠ is the symbol for "does not equal.)

2. Another keyword is "good." Health IT can only facilitate improved healthcare if it itself is good. It must be designed via the principles of (at the very least) resilience engineering at the forefront:

The term Resilience Engineering represents a new way of thinking about safety. Whereas conventional risk management approaches are based on hindsight and emphasise error tabulation and calculation of failure probabilities, Resilience Engineering looks for ways to enhance the ability of organisations to create processes that are robust yet flexible, to monitor and revise risk models, and to use resources proactively in the face of disruptions or ongoing production and economic pressures. In Resilience Engineering failures do not stand for a breakdown or malfunctioning of normal system functions, but rather represent the converse of the adaptations necessary to cope with the real world complexity. Individuals and organisations must always adjust their performance to the current conditions; and because resources and time are finite it is inevitable that such adjustments are approximate. Success has been ascribed to the ability of groups, individuals, and organisations to anticipate the changing shape of risk before damage occurs; failure is simply the temporary or permanent absence of that.

In that regard, committees led by unidisciplinary IT personnel, focus on process by "process babes", consensus, systems lifecycle, and other characteristics and methodologies of management information systems and "merchant computing" do not reliably produce good clinical IT. In fact, often the opposite is true.

The rigor that transformed medical education and practice into a more scientific endeavor, initiated by the Flexner Report of 1910, needs to be applied to clinical IT. I personally demand the same rigor of health IT developers and managers that citizens demand of their clinicians. Is that unreasonable, I ask?

3. Clinical IT must be "evidence-based." As in my posts here and here and at my website here, the evidence is not entirely rosey. (I would venture to say the negative indicators are even more concerning than the corresponding indictors for, say, a drug like VIOXX.)

I have noted something peculiar about the changing role of Medical Informaticists as well.

Things are moving backwards.

A decade ago I was sought out to help a large medical organization choose the EMR product(s) best-suited to their various departments, specialties, and culture(s), and then assist in the implementation, customization, and culture changes required for its use.

A decade later (i.e., now), I find myself sought out to help large medical organizations who've pre-selected EMR's, often with the major say residing outside the clinicians and using a "one vendor fits all" approach, to help shove the products down clinicians' throats by pursuasion or coercion if needed. The requirement to continue medical practice and be a part-time CMIO and "Director of Clinician Gag Reflex Suppression" may be, I believe, reflective of this new phenomenon.

I also wonder if the emergence of CCHIT, the Certification Commission for Healthcare Information Technology that "certifies" features of clinical IT products pre-flight-checklist style (good in concept) is having unexpected consequences, as the field of social informatics predicts of any new ICT (information & communications technology) 'revolution.'

Could CCHIT be further facilitating the groundswell in recent years of an "irrational exuberance" and loss of critical, evidence-based decision making by hospitals regarding EMR's? Could CCHIT "certification" be encouraging hospitals to (incorrectly) believe they can skip or skimp on the "selection and evaluation" phase and jump right to purchase, and then hire an informatics expert after the fact to "change the culture?" Although CCHIT does not guarantee overall quality, usability and ultimate success of any product (in a nutshell, CCHIT merely confirms the presence of features), this could explain the "backwards leap" in the CMIO role I've noticed recently.

Finally, I believe the following questions need to be asked, asked again, and asked again.

• Does clinical IT fix the problems it is purported to fix? If not, why not?
• Is it consistently designed and implemented utilizing the best practices known to experts in engineering, medical informatics, HCI, and other areas, and if not, why not? Are the methodologies employed the same as the methodologies used for merchant computing, and if so, why, and what is the evidence this is the best path forward?
• Are its drawbacks, both potential and observed, discussed openly, thoroughly and critically? If not, why not?
• Are those who raise these issues praised, or attacked (e.g., as in Ross Koppel's work on CPOE being called "disingenuous" in print). If they are not praised, why not? If they are attacked, what are the true interests and agendas of those engaged in the attack?

Sometimes it appears the health IT industry reverses the roles of enabler of healthcare and facilitator of healthcare. Ultimately, though, patients do not fall ill, and clinicians do not toil in hospitals, so that the IT industry can have great computers, comfortable careers and watershed profits.

-- SS

What a Tangled Web We Weave - Among Risk Management Education, a Pharmaceutical Manufacturer, a MECC, and an Insurance Program Manager

We have often blogged about the tangled web of conflicts of interest that now spans health care. Here is a story about just how tangled that web may be.

Most of the strands were unearthed by Dr Daniel Carlat on the Carlat Psychiatry Blog. Dr Carlat published a series of posts about how Eli Lilly and Company funded a continuing medical education (CME) program which first seems to have been produced by a medical education and communication company (MECC), PV Updates. The purpose of the program was ostensibly to educate physicians about risk management. But Carlat thought that the idea was to make learners more comfortable about prescribing risky medications.

Perusal of the online slide show to which Carlat referred immediately suggests how knotty this web may be. The program has a copyright notice from "PV Update Publishing," but a Google search revealed no listing for this company, and the URL http://www.pvupdate.com/ yields an error message, albeit with the PVUpdates logo. But the slide show was also noted to be "developed by PRMS, Inc., and under the sponsorship of Eli Lilly and Company." Stay tuned for a moment...

Meanwhile, amazingly, a Lilly spokeswoman answered Carlat almost immediately, arguing he had misunderstood the intent to "to provide helpful, independent, non-product-specific information to psychiatrists to keep the risk of litigation in perspective and to understand what they can appropriately do to reduce that risk." The response begged the question of why Lilly would choose to spend its money on such an educational program, and who actually produced the program.

But here it gets more tangled. An article in the Indianapolis Star noted that Lilly "hired a medical education company, Professional Risk Management Services [PRMS]of Virginia, to help spread the message that psychiatrists can manage risk. The company recently mailed a 14-page brochure to psychiatrists across the U.S. with the message that the best way to avoid malpractice claims is to provide good care and document it carefully." Note that PRMS was listed as the "developer" of the slide show.

But the Indianapolis Star article did not clarify what PRMS does. PRMS is not a MECC. It is an "insurance program manager" which handles "underwriting, claims, and risk management," although in connection with its insurance business, it also provides CME. Thus, a psychiatrist protested to Carlat,

I am outraged that PRMS has accepted money from Lilly and has chosen to offer its authority and reputation toward this Lilly effort. PRMS is the American Psychiatric Association-endorsed entity which directs APA members to a selected malpractice insurance agency. PRMS is thus the agency many or most of us psychiatrists turn to for guidance and direction as to liability exposure and malpractice coverage. For PRMS to work for Eli Lilly is a glaring conflict of interest between their psychiatrist clients and a pharmaceutical corporation whose interests do not necessarily coincide with those of the psychiatrists with whom they have a professional relationship. This is analogous to the same law firm representing two individuals opposing one another in a law suit; in that situation we assume that there cannot be fair representation of either client, and we may imagine that the client with an attorney who has more clout in the law firm may well prevail in the action. How can we trust PRMS, or the APA for that matter, to provide us with the best liability support?

The threads among a pharmaceutical company, apparently a MECC, and an insurance program manager are certainly is hard to follow. So Carlat concluded,

Look, I get as annoyed by conspiracy theorists as the next guy. But the web of money and influence here is so murky and repugnant that it leaves me wondering what's going on.

Sometimes you are paranoid, and sometimes they are really out to get you.

It seems that many trusted medical or health care institutions are now connected to some favored health care corporation(s), and many physicians, academicians, and academic, government, and not-for-profit health care leaders have part time gigs for such companies. The complexity of such relationships sometimes defies understanding. Who can you trust? Who really is for patient care, education, or science?

We may have to expose every such tawdry conflict of interest before we can answer these questions. "Sunlight is the best disinfectant."

The Pots and Kettles Argue About Conflicts of Interest at the Cleveland Clinic

There is yet another twist to the tangled story of conflicts of interest at the renowned Cleveland Clinic.

Two years ago investigative reporting published in the New York Times revealed the complicated relationships among the Clinic, its current CEO Dr Toby Cosgrove, the Clinic's venture capital fund, Foundation Medical Partners, and a small medical device company called Atricure. This coincided with the Clinic's firing of Dr Eric Topol from his leadership positions there. (See posts here and here.) The Cleveland Plain Dealer uncovered more conflicts, involving Dr Cosgrove, the Clinic's board of trustees, Dr Bernadine Healy, and Invacare (see post here.)

In response, last year the Clinic promised to revise its conflicts of interest policy, and held a big conference on the topic of conflicts of interest, although some were skeptical of these efforts (see post here.)

Now for the latest twist. David Armstrong writing in the Wall Street Journal revealed that last year, the clinic fired Dr Jay Yadav allegedly for violating its conflict of interest disclosure rules. But Yadav sued the Clinic in return, claiming he was a scapegoat whose firing distracted attention from even more conflicts at the clinic:

A former department head at the Cleveland Clinic sued the hospital over alleged defamation and discrimination, saying that the institution is plagued by financial conflicts of interest similar to the kind that were cited as grounds for his dismissal.

Jay Yadav, who headed the clinic's vascular intervention unit until he was fired last year, said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients.

The clinic, in a statement, denied the allegations in the lawsuit and said it planned to file a response as well as a 'counter claim for substantial expenses incurred to review his research.'

Getting rid of doctors over issues related to conflicts of interest is rare. Dr. Yadav says others at the clinic weren't sanctioned -- and his legal action could become an embarrassing public battle for the clinic.

Dr. Yadav had financial stakes in two companies whose experimental products were tested on clinic patients. He says the clinic was well aware of his conflicts and that he properly reported them -- but that he was fired so that the clinic could look tough ahead of a Cleveland Plain Dealer article about his outside activities.

His suit alleges the clinic has been 'indifferent' to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos 'Toby' Cosgrove, according to the complaint.

The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring.

The clinic confirmed Dr. Cosgrove and the hospital share royalties, but declined to answer questions about what patients are told and how much the institution and Dr. Cosgrove earn from sales of the ring. The clinic said the royalty payments were proper.

In another case, the lawsuit says orthopedic surgeon Isador Lieberman, a member of the hospital's conflict-of-interest committee, failed to disclose his significant financial interests in Kyphon Inc. That company manufactures equipment for an orthopedic procedure that Dr. Lieberman advocated and tested at the clinic. The clinic said Dr. Lieberman fully cooperated with a review of his conflict disclosures and that 'all appropriate actions were taken.'

In all of the cases cited in the lawsuit, Dr. Yadav alleges there was no disciplinary action taken against those doctors. The lawsuit alleges that Dr. Yadav, who was born in India, was a victim of discrimination. The clinic, however, said it 'consistently and fairly applied its policies to all of its physicians.'

Dr. Yadav says the clinic accused him of not properly disclosing royalty payments for a device he invented to prevent blockages in patients who receive a neck stent. While he doesn't receive royalty payments, Dr. Yadav says he was compensated with shares by the company that acquired his technology. That company, called Angioguard Inc., was bought by a unit of Johnson & Johnson in 1999 [apparently Cordis].

A copy of that purchase agreement indicates that all shareholders of Angioguard were entitled to deferred payments if certain milestones were met, such as sales targets. Among the other shareholders entitled to the same deferred payments were top officials at the clinic, such as surgeon Kenneth Ouriel, according to the lawsuit.

Dr. Ouriel didn't disclose these payments, according to the lawsuit. The clinic yesterday said: 'Dr. Ouriel received a few hundreds of dollars versus tens of thousands of dollars that Dr. Yadav received. Dr. Ouriel's situation was thoroughly reviewed and he fully cooperated by taking appropriate actions to rectify the situation immediately. After the review, the Clinic officials determined that Dr. Ouriel had not knowingly violated Cleveland Clinic policies.'

A conflict here, and conflict there, soon it starts adding up.

What can one conclude from all this? First, it seems that there are lots of conflicts of interest at the Cleveland Clinic. Of course, perusal of Health Care Renewal suggests that the Clinic is therefore like many other generally revered US medical centers.

Second, it reminds us how confusing and, well conflicted conflicts of interest can become. I will not offer an opinion about the merits of Dr Yadav's lawsuit.

It does suggest that when highly conflicted high powered academics get in disputes over their respective conflicts, the result is lots of smoke and not much light. Will Angioguard, now Cordis guy win, or will the Atricure, Edwards Lifescience, and Kyphon guys win? Will the results benefit anyone other than the parties involved and the companies they represent? But core values like putting individual patients first, teaching the next generation of physicians, and practicing medicine informed by science are likely to be lost in smoke from the battle among vested economic interests.

"Intellectual Bias," the New Bogey-Man

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discussed a new accusation leveled against those who may criticize relationships among academics and researchers and pharmaceutical, biotechnology and device companies. Dr Brody started by noting

Because those of us who are advocating serious reforms in the medicine-Pharma relationship are finally starting to be heard, we now threaten the industry sufficiently to make us worth powder and shot for a counter-attack.

The latest counter-attack seems to be to accuse those advocating reform of the dread "intellectual bias." This charge surfaced in a response to a letter to the editor in Critical Care Medicine.(1) The letter disagreed with recommendations in guidelines written by the Surviving Sepsis Campaign, and discussed commercial ties of the SSC to the pharmaceutical industry. Note that the authors of the letter, Eichacker, Natanson, and Danner, had previously criticized the SSC guidelines in the New England Journal of Medicine,(2), as discussed in this post.

Two members of SSC, Phillip Dellinger and Charles Durbin, then proceed to reply, mainly in the form of accusing the NIH scientists of having no real evidence to back up their claims and yet repeating their attacks on Xigris incessantly despite having no evidence. Here is the key paragraph:

'Drs. Eichacker, Natanson, and Danner accuse the SSC of being biased toward industry, yet fail to acknowledge their own intellectual (academic) bias. This form of bias can be defined as presenting personal, entrenched beliefs as scientific truth in an area where no clear-cut consensus exists. We believe this intellectual bias can be more insidious and damaging than the potential bias arising from affiliations with industry.'

Now, this is quite a piece of work. The NIH scientists believe that the preponderance of the scientific evidence supports their point of view. The SSC guys believe the same for their own point of view. That makes the NIH people guilty of 'intellectual bias' while the SSC remains innocent of that sin.

What is even more breathtaking is that intellectual bias (whatever that turns out to be) is actually much worse than commercial bias. As I have reviewed in HOOKED and on this blog, and as numerous meta-analyses and systematic reviews have shown, commercially sponsored studies are roughly 4 times more likely than neutral studies to favor the company's drug. So commercial bias has been shown to be real and substantial. Against that empirical proof, we are being invited to dismiss commercial bias as no big deal, but to quake in our boots at the possibility of 'intellectual bias.'

The implicit subtext, as best as I can read it, is that people ('academic intellectuals') who work at NIH, or at universities that believe in avoiding conflicts of interest with industry, are some sort of ivory-tower, goody-two-shoes weirdos. They think they are intellectually superior to the rest of us mere mortals, and the best thing to do with these insufferable twits is to ignore them. By contrast, scientists who jump into bed with industry at the first opportunity are regular people just like us, and are hard-headed, pragmatic realists. Their take on the world is much more reliable.

Dr Brody then warns,

I expect to see charges of 'intellectual bias' repeated regularly whenever Pharma feels that it is being placed on the defensive by demands for reform.

The good news here is that those within the cozy academic-medical-industrial complex, and particularly the academic leaders who work part time for health care corporations, and often seem to be promoting their products and services in the guise of disinterested academics, are no longer so comfortable in these roles. Rather than merely ignoring the few people who think that such conflicts of interest may be bad for academia, science, health care and the public, they feel the need to make ad hominem attacks, in this case, charging "intellectual bias. " Let's hope they will soon feel the need to be even more defensive.

References

1. Eichacker PQ, Natanson C, Danner RL. Separating practice guidelines from pharmaceutical marketing [special letter to the editor, with reply]. Crit Care Med 35:2877-80, 2007.
2. Eichacker PQ, Natanson C, Danner RL. Surviving sepsis - practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med 2006; 335: 1640-1642. (see link here.)

BLOGSCAN - "AIDS Pundits and Ties to Big Pharma"

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody wrote about his discovery of a web-site entitled, "AIDS Pundits and Ties to Big Pharma," or by its more economic URL, www.shillfactor.net. The site catalogs, with a degree of sarcasm, the multitudinous financial ties to pharmaceutical manufacturers and biotechnology companies of some of the big wigs in the AIDS/ HIV research and academic world. Some of the individuals have truly amazing numbers of consulting jobs, leading the site writers to speculate how they ever have time to see patients or fulfill their academic responsibilities. The site contains pages for people who "control research," "vote on new drugs," "set treatment specs," "educate the field," "write and report," and ironically, "once were activists." The site is sponsored by Project THAMES, which stands for "transparency in HIV authorship, medical education and scientific investigation." Amazing.

EMR's: Take it or Leavitt, HHS secretary says (while putting a gun to doctor's heads) - and should physicians boycott EMR's as a political statement?

I wrote here about an "irrational exuberance" regarding electronic medical records (EMR's). Well, here's an example of the escalating irrational exuberance, Don Corleone-style.

From AHA News:

Leavitt: Medicare should link higher physician payments to health IT

Any legislation to stave off a reduction in Medicare reimbursement rates for physicians in 2008 should require physicians to implement health information technology to be eligible for higher payments, Health and Human Services Secretary Mike Leavitt said yesterday. “Such a requirement would accelerate adoption of this technology considerably, and help to drive improvements in health care quality as well as reductions in medical costs and errors,” Leavitt said. “I’m confident that many members of Congress are of a like mind on this issue and I will actively work with them in the near future.”

Incredible.

From my introductory essay at my web site "Common Examples of Healthcare IT Failure":

...the use of electronic health records, without a major change in health care delivery, would not significantly reduce overall health care costs, the director of the Congressional Budget Office said at the release of the agency's 2007 report on long-term health care spending. Peter Orszag, CBO's director, said that according to data from the report, the return on investment for EHRs "is not going to be as substantial as people think."

... With regard to electronic health records ( EHRs ), a research article in the Archives of Internal Medicine entitled “Electronic Health Record Use and the Quality of Ambulatory Care in the United States” (Arch Intern Med. 2007;167:1400-1405, link to abstract here ) reached what to many was a counterintuitive and paradoxical conclusion. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHR’s were not associated with better quality ambulatory care,” and were bold enough to publish their findings, sure to be unpopular in the health IT industry.

These findings are indeed troubling. An EHR for small-group and solo-practice physicians costs $44,000 per physician, and generates an average ongoing $8,500 per year in annual costs , ACP president Lynne Kirk, MD told the house Subcommittee on Regulations, Healthcare and Trade of the House Committee on Small Business in October 2007. "The business case does not exist to make this kind of capital investment," Kirk told the Subcommittee.

Contrast that with Leavitt's actual words:

The benefits of utilizing health information technology for keeping electronic health records and other purposes are clear. This technology will produce a higher quality of care, while reducing medical costs and errors, which kill more Americans each year than highway accidents, breast cancer or AIDS. Congressional leaders are working on legislation to address Medicare's physician payment system, staving off a reduction in reimbursement rates that is set to take effect in January and is required by law. In my view, any new bill should require physicians to implement health information technology that meets department standards in order to be eligible for higher payments from Medicare.

Regarding EMR exuberance, there's science, then there's fiction -- and then there's science fiction. See additional references below.

I remind that outright coercion further escalates the battle of the technologists vs. those with sociotechnical wisdom regarding health IT, i.e., those who understand that it's not wise to shove semi-proven (or unproven) information technology down people's throats.

Also, one wonders, say, why airline pilots are not forced to purchase, out of their own pockets, computers in their cockpits designed to prevent pilot error or collisions, but that in testing actually often doesn't work, or just makes piloting a plane harder without strongly proven benefits.

Oh, wait ... pilots could just refuse to fly until the systems worked!

Oh, wait ... pilots can just go to their union steward and complain, and then the union can call a strike and shut down the airlines!

Oh, wait ... pilots can just leave and go fly cargo planes in the Caribbean!

But to doctors, the government can make an "offer they can't refuse" with impunity.

This raises a fundamental issue. Physicians can't even associate and share information such as on setting fees or compare their managed-care contracts due to antitrust laws, and have basically lost control of their profession. EMR's are increasingly being shoved at them with the expectation that the costs and increased efforts required to use them will be donated, gratis, and the data from the EMR's will likely be used by payers to increase their own profit further, at physician expense.

Now, the concept of outright "ransom" is being raised -- purchase and use EMR's, or else we will cut your (already not exactly overly generous) Medicare reimbursements!

I am, however, unaware of any laws against physicians, especially those in private practice, boycotting purchase and use of EMR's, as a political statement at the very least. [addendum - see comments section for more discussion of this point - ed.]

Perhaps that's a first step towards regaining control of the profession.

-- SS

Some additional references. EHR as panacea: Science, or science fiction?

- "Sociotechnical Issues in Clinical IT: Common examples Healthcare IT Difficulty" by this author. link

- It Ain’t Necessarily So: The Electronic Health Record And The Unlikely Prospect Of Reducing Health Care Costs. Health Affairs, 25, no. 4 (2006): 1079-1085 (link)

Abstract: Electronic health record (EHR) advocates argue that EHRs lead to reduced errors and reduced costs. Many reports suggest otherwise. The EHR often leads to higher billings and declines in provider productivity with no change in provider-to-patient ratios. Error reduction is inconsistent and has yet to be linked to savings or malpractice premiums. As interest in patient-centeredness, shared decision making, teaming, group visits, open access, and accountability grows, the EHR is better viewed as an insufficient yet necessary ingredient. Absent other fundamental interventions that alter medical practice, it is unlikely that the U.S. health care bill will decline as a result of the EHR alone.

- Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. (link)

- Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure. link to pdf

- Unintended consequences of information technologies in health care--an interactive sociotechnical analysis. J Am Med Inform Assoc. 2007 Sep-Oct;14(5):542-9. (link)

- Expected and unanticipated consequences of the quality and information technology revolutions. JAMA. 2006 Nov 22;296(20):2439; author reply 2439. (link)

- Assessing the anticipated consequences of Computer-based Provider Order Entry at three community hospitals using an open-ended, semi-structured survey instrument. Int J Med Inform. 2007 Oct 9. (link)

- U.S. Court In Illinois Declines To Limit Damages In Hospital's Claim Against Health Record Information System Supplier - ref: Rush Univ. Med. Ctr. v. Minnesota Mining and Manuf. Co., No. 04 C 6878 (N.D. Ill. Nov. 21, 2007).

- Adverse Effects of Information Technology in Healthcare. The Knowledge Center at this link presents a collection of taxonomized information assets on the adverse effects of information technology in its application to healthcare.

- ”Electronic Health Records Raise New Risks of Malpractice Liability” (link to PDF) by attorney Joel B. Korin and Madelyn S. Quattrone, ECRI Senior Risk Management Analyst, the emerging legal issues are summarized.

- Bad Health Informatics Can Kill. This site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI)

Pharma waking up to the potential of the EMR for drug safety surveillance (finally!)

In what might be construed a significant breakthrough for the slow-moving, relatively medical informatics-unaware pharma industy, Pfizer, Lilly and J&J announced collaborations with Medical Informatics experts on exploring how to leverage the EHR for pharmacovigilance. This preliminary work is preparatory for a future time when detailed EHR's might be more widespread, consistent and interoperable.

See article below, or at this link .

I had written an essay on this topic in 2004 entitled "Reflections on the future of drug safety surveillance from the Medical Informatics perspective" (link) shortly after the VIOXX withdrawal occurred. (I had worked for Merck but was laid off as part of the "Equinox" mass layoff of 4,400 people in Nov. 2003).

I had also written a viewpoint paper last year entitled "A Medical Informatics Grand Challenge: The EMR and Post-Marketing Drug Surveillance" pushing on this issue for the Journal of the American Medical Informatics Association (JAMIA), which unfortunately was not accepted for publication. I was unable to work further on the paper due to other obligations, but the paper is here ( http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf) and I am releasing it into the public domain.

Of course, this development enhances the irony in my previous posts here ("Report: Life Science Manufacturers Adapt to Industry Transitions") and here ("FDA's hefty bonuses seek to retain workers"), posts that may help explain why Merck is not on the list of participating pharmas.

-- SS

The above-referenced article announcing the pharma-medical informatics collaboration follows:

eHealth Initiative Leads Effort to Use HIT for Pharmacovigilance (link)
By Neil Versel

December 05, 2007

Health-IT researchers are joining with the pharmaceutical industry and, indirectly, the Food and Drug Administration (FDA) to develop and evaluate new electronic drug-safety tools. Along the way, they hope to prove the financial value of electronic health records and other digital clinical information.

The collaboration, dubbed Connecting Communities for Drug Safety, will employ health-IT to find new ways of measuring risks and benefits of drug therapies as part of a national effort to create an “active” national drug-safety surveillance system for post-market drugs and prevent a repeat of the embarrassing, expensive Vioxx withdrawal in 2004. (See “Safety Last?” )

Anecdotes suggest that health care providers with EHRs had an easy time pinpointing which of their patients were on Vioxx when the FDA ordered the Cox-2 inhibitor off the market, but participants in Connecting Communities for Drug Safety hope to turn up scientific evidence. “It holds promise for the post-marketing side,” Michael Ibara, head of pharmacovigilance information management for the Pfizer Safety and Risk Management Department, says of electronic clinical data. New York City-based Pfizer is one of three pharmaceutical companies participating in the collaborative, along with Eli Lilly & Co. and Johnson & Johnson . (Pfizer had to pull its own Cox-2 inhibitor, Bextra, in the wake of the Vioxx recall.) Ibara says that the drug companies are providing funding and some subject-matter experts for the work, including epidemiologists to advise the primary researchers.

“We need to express in real terms the value of electronic clinical information … and create a business case,” says Janet Marchibroda, executive director of the eHealth Initiative (eHI) and its related eHealth Initiative Foundation , which are leading the effort.

“Drug safety is one of many business cases.”

The collaboration expects to inform and build off the research of the Reagan-Udall Foundation, a private, independent, nonprofit organization authorized by the recently signed Food and Drug Administration Amendments Act of 2007. The Reagan-Udall Foundation is charged with improving much-maligned FDA safety procedures and with modernizing development and innovation of products under the agency’s purview.

“Collaborative partnerships like these will provide critical insights to identify and advance new, innovative approaches to improving the quality and safety of medical products,” foundation chair Mark McClellan, the former FDA and Centers for Medicare and Medicaid Services chief, said in a written statement.

Last week, McClellan, who now directs the Engelberg Center for Health Care Reform at the Brookings Institution , a Washington , D.C. , think tank, gave a speech to biotechnology executives, in which he reportedly heaped praise on the drug-safety monitoring aspects of the FDA Amendments Act.

The Connecting Communities for Drug Safety Collaboration has designated Partners HealthCare System in Boston and Regenstrief Institute in Indianapolis as “learning laboratories” for the program, and two well-known figures in health-IT are leading those efforts, namely Partners CIO John Glaser and Regenstrief director of medical informatics J. Marc Overhage, M.D.

Both were traveling Tuesday and unavailable for comment, but Overhage offered a statement in an eHI press release: “New, innovative approaches are needed to increase the timeliness and effectiveness with which we can identify drug safety issues. This collaboration gives us an opportunity to assess the feasibility of using clinical data for these issues, and develop methodologies that can be replicated by others,” he said.

Over the next 12 months, Partners and Regenstrief will mine clinical and administrative data for “safety signals,” in hopes of developing technical guides for drug safety programs, according to eHI.

They will focus on three use cases: cholesterol-lowering drugs and laboratory results associated with liver failure; bleeding from anti-clotting drug warfarin; and a specific list of adverse drug reactions called “designated medical events.”

Separate studies will use data from EHRs, clinical information gleaned from claims data, and a combination of both. “In terms of us using clinical data, we’re breaking new ground,” Marchibroda says. “Electronic data is better than today’s system, which basically is a review of individual cases.” Adds Ibara, “We’re taking a very focused look at how EHR data can supplement and expand what we learn from claims data.”

Marchibroda calls the drug-safety research the first step in a program to be announced early next year in which health-IT interests study the efficacy of consumer access to clinical information. For that, the eHealth Initiative likely will tap into existing care management and disease management programs, Marchibroda says, though details have not been finalized.

For Connecting Communities for Drug Safety, eHI has set up a Web page at http://www.ehealthinitiative.org/drugsafety/ , but to date, it only contains the press release announcing the new collaboration.

Some Payback by a Former Managed Care CEO

We had posted often (see these posts here, here, and here from 2006 with links backward) about the hugely lavish compensation afforded to the Dr William McGuire, former CEO of UnitedHealth Group, one of the largest US insurers/ managed care organizations, and how this remuneration stood in stark contrast to the stated mission of UnitedHealth Group:

UnitedHealth Group is a diversified health and well-being company dedicated to making the health care system work better. The company directs its resources into designing products, providing services and applying technologies that:
- Improve access to health and well-being services;
- Simplify the health care experience;
- Promote quality; and,
- Make health care more affordable.

Most recently, controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here).

Today, per Bloomberg News,

UnitedHealth Group Inc.'s former Chief Executive Officer William W. McGuire agreed to give back more than $600 million in benefits, mostly stock options that investors claimed in a lawsuit were illegally backdated.

Other past and present officers have relinquished about $300 million, UnitedHealth said today in a statement announcing settlement of the lawsuit. Attorneys for pension funds in Ohio and other states that filed the suit said current CEO Stephen J. Hemsley is paying $240 million, although the company said he isn't doing so as part of the settlement.

UnitedHealth's former general counsel David Lubben will pay about $30 million, including $20.6 million gained through the March 2007 exercise of stock options, the company said.

William Spears, former head of the company board's compensation committee, has also agreed to settle. The amount will be determined by binding arbitration, the company said.

McGuire also agreed to pay a $7 million fine in an agreement today with the U.S. Securities and Exchange Commission, the largest levied by the regulatory agency so far for options backdating. McGuire didn't admit or deny wrongdoing under the SEC settlement.

McGuire said that the settlements of the derivative suit and the SEC action end major legal actions against him.

'The last 18 months have been extraordinarily challenging period for my family and me,' he said in an e-mailed statement. 'I am very pleased to have reached a resolution that puts these matters to rest.'

It would just be too much to ask the CEO of a huge health care corporation to ever admit even to making a mistake. Of course, others saw things differently,

'The recovery of more than $920 million is an extraordinary event,' said plaintiffs' attorney Chad Johnson in an e-mailed statement. 'This result sends a clear message to corporate executives everywhere -- that if you abuse your position for personal gain at the expense of the shareholders, you will be held accountable by institutional investors.'

'Whenever a corporate officer misleads investors about a company's performance by secretly backdating stock options, the integrity of our markets is undermined,' SEC Chairman Christopher Cox said in a statement.

It is remarkable that McGuire had to return so much money. How much of a fortune he still holds due to his tenure as leader of UnitedHealth is unclear. At one time, his stock option holdings were valued at a stratospheric $1.78 billion. [ADDENDUM 8 December, 2007 - In fact, the Wall Street Journal reported that McGuire still will have stock options worth approximately $800 million left, and received $530 million in pay from 1991 to 2006.] Having to pay back some ill-gotten gains may serve as a minor deterrent to abuse by corporate health care leaders, although the prospect of still walking away with many millions may lessen this deterrent effect. Given that many miasmanagers of health care organizations walked away with no negative consequences whatsoever in the past, this settlement may mark some slight degree of progress.

Once again, it seems that in retrospect, Dr McGuire's conduct stood in sharp contrast to the lofty sentiments expressed in UnitedHealth's mission statement. It also stood in stark contrast to the lavish praise once heaped upon him. A 2006 Pulitzer Prize winning article in the Wall Street Journal quoted UnitedHealth director and Dean of the Columbia University School of Nursing Mary Mundinger,

We're so lucky to have Bill. He's brilliant.

This case is a poster child for much of what is wrong with health care in the US today. Health care is dominated by large organizations who profess to be acting for lofty ideals, and are often lead by autocratic executives who are hugely compensated and hailed as "brilliant" and more. Yet it is clear that too many of these leaders are in it mainly for themselves. When they fall, their sycophantic supporters move on, and no one seems to admit that there were lessons to be learned. Any penalties the leaders pay are not sufficient to make up for the damage done, and the companies write the whole thing off as the cost of doing business.

When health care leaders are paid fabulously no matter how badly they perform, why does anyone wonder why costs keep going up, access keeps shrinking, and quality keeps eroding?

BLOGSCAN - Running Afoul of E&M Coding Rules

On the Covert Rationing Blog, DrRich continued his discussion of the irrationality of Medicare's E&M coding, that is, the bizarre and complex rules the US Medicare system uses to control its reimbursement for "evaluation and management services" that physicians provide patients. In turn, "evalation and management" means everything physicians do for patients: interviewing, examining, orderding tests for, diagnosing, counseling, prescribing treatments, etc for them. The regulations are so complex that it is virtually impossible to fulfill them. This, per DrRich, is a perfect example of a "regulatory speed trap." Again, while Medicare makes it so difficult, if not impossible, to bill correctly for office visits, it pays lavishly for procedures. Is it any wonder primary care is going out of business, and all physicians who mainly provide cognitive services (e.g., services as listed above, but not procedures or surgery) are seriously threatened?

Is the Sustainable Growth Rate the Main Problem with Medicare Physician Reimbursement?

I applaud the current US Secretary of Health and Human Services, Mike Leavitt, for being a member in good standing of the blogsphere. His Secretary Mike Leavitt's Blog is here.

Getting into the blogging kitchen, however, requires taking some heat. So I strongly beg to differ with what his latest post says about what is wrong with how Medicare reimburses physicians.

This week, the Congress will begin working on the Medicare Sustainable Growth Rate (SGR) or what people call the 'doc fix.' The doc fix is a ritual crisis brought on annually by a terrible system Congress put into place in 1997 to manage the amount Medicare pays doctors for various procedures.

Here’s how it works: Each year, the Secretary of Health and Human Services is required by law to establish a target for the rate of overall spending on Medicare Part B.

If, collectively, doctors bill Medicare for more than the target, the Secretary of HHS is then required by law to make it up on future updates.

However, the doctors just keep billing more and more procedures to Medicare and spend far more than the target.

This has gone on now for more than 10 years and Medicare has now paid so much more than the target that the formula in the law dictates that doctors receive negative updates, cutting the amount they get paid for each procedure. This year, the SGR hole is so deep the law requires HHS to reduce the future rates we pay doctors by 10%.

So, each year Congress steps in and overrides the system by instructing Medicare not to cut the reimbursement rates. Consequently, the amount that doctors get paid at least stays the same or is a little more.

Here’s an important point. When Congress overrides the law, it doesn’t fix the system or pay off the deficit which is now so large it would require nearly $200 billion to pay off the backlog.

This is a lousy system and it hasn’t reduced Medicare costs. The total expenditures just keep going up. Why? When rates per procedure don’t go up, doctors have simply done more procedures.

Secretary Leavitt correctly identified how Medicare pays for procedures as a major problem, but ignored how Medicare sets the rates it pays for procedures. Contrast his description with how Bodenheimer et al's article in the Annals of Internal Medicine explained how the disparity in reimbursement between primary care (and other "cognitive") physicians and procedural specialists came to be, and why it is important. [Bodenheimer T, Berenson RA, Rudolf P. The primary care-specialty income gap: why it matters. Ann Intern Med 2007; 146: 301-306.]

Its main points (quoting this previous post) were:

• The widening income gap between primary care and other physicians correlates with declining interest in primary care.
• Medicare's Resource-Based Relative Value Scale (RBRVS) system was advertised as a way to make reimbursement more equitable, and particularly fairer for primary-care, but it has had the opposite effect, for three main reasons
• Proceduralists are often able to learn how to do their procedures more quickly, and thus increase the volume of procedures done, while office and hospital visits can only be sped up so much.
• The process used to update the RBRVS system is biased towards procedures for three main reasons: 1. "specialty society influence in proposing RVU [relative value unit] increases," 2. the specialist-heavy RUC [Relative Value Scale Update Committee] membership," and 3. "the desire of RUC specialists to avoid increases in evaluation and management [that is, cognitive, or non-procedural] RVUs."
• Medicare now uses a formula to limit increases in overall spending. The use of this formula leads to across the board cuts in all reimbursements. Since cognitive services reimbursements were never high to begin with, and have rarely been individually increased, these cuts tend to have disproportionate decreases.

Adding insult to injury, Medicare seems to rely only the RUC for input into the RBRVS updating process, yet the RUC, which claims to be just an advocacy group sponsored by the AMA, operates in secret and even its membership is not public. Let me quote again a brilliant rant (from DBs Medical Rants) on the subject.

The story of the RUC often reminds me of conspiracy theories. They (we never really know who they are) determine the fate of the world (or at least the economy). The RUC has disproportionate power and has apparently taken a reasonable idea (RBRVS) and corrupted it. If you want to know who to really blame, it is the RUC. I blame the AMA for developing a committee which does not represent the interest of overall health care, but rather the interests of subspecialties.

I do believe that the RUC has done more to negatively impact outpatient continuity, chronic care than any single entity.

This issue deserves more attention. We must expose this problem and make it reach the national conscious. I fear that it is important but a bit obtuse. I cannot imagine a sound bite approach to the evil the RUC has wrought.

Thus, although the sustainable growth rate system contributes to excess reimbursement for procedures and the worsening squeeze on primary care and cognitive services, how Medicare relies on the RUC, and how the RUC updates the RBRVS system are far more to blame.

The rest of Secretary Leavitt's post sings the praises of electronic medical records (EMRs) for fixing Medicare's problems. Anyone who has read MedInformaticsMD's post on Health Care Renewal (see this one most recently) would realize that current health care IT is far too often badly designed, unsuitable for the health care context, hard to use, expensive, and often the cause of unintended adverse effects. It will take a great deal of clever research and design to get health care IT into a position where it can actually benefit health.

Meanwhile, replacing the RUC with a better transparent, rational, accountable alternative seems almost simple.

On ACP's Endorsement Of "Single Payer", And A Call For An End To Irrational Exuberance over EMR's

A letter to the Philadelphia Inquirer that likely will never make it into print due to its iconoclastic, "reality that nobody wants to hear" content. Also cc'd to the leaders of the American College of Physicians, on the ACP's endorsement of "single payer" and the oft-stated panacea of the EMR as the tool "to reduce medical administrative costs."

I believe it's time to put the brakes on the "irrational exuberance" that characterizes today's EMR efforts. Healthcare IT is a field that unless brought back to sanity will transfer countless dollars to the IT sector that healthcare and patients cannot afford, and will develop tools that make patient care even more unbearable for clinicians than it is today through inept design and inept or disingenuous "performance metrics." For much more on these issues, see my web site "Common Examples of Healthcare IT Failures" at this link.

In fact, EMR's are still an experimental technology and should be thought of as such. They were invented by researchers and experimenters in medical informatics and were slowly and deliberately being perfected, until massive reductions in costs of computing hardware and increases in speed and ubiquity gave many in the IT, government and payer sectors (via a leap of logic of supernova proportions) the technologically deterministic idea that every aspect of medicine could and should be easily automated. And that it would be hysterically profitable to do so: profitable for everyone except, of course, practitioners and patients.

To: sburling@phillynews.com
From: MedInformaticsMD
Date: 12/04/2007 01:29PM
Subject: Re: American College of Physicians endorse single-payer

Re: American College of Physicians endorse single-payer (Phila. Inquirer, Dec. 4, 2007, http://www.philly.com/philly/business/12109247.html)

Dear Ms. Burling,

While one can argue the merits and demerits of creeping socialism, and while I find it ironic that the ACP endorsed "single payer medicine" at the same time that the people of Venezuela rejected socialism, there is one item in your story reflecting another "irrational exuberance" that should not be taken at face value.

That item is the oft-repeated statement that electronic medical records work miracles, in this case that the "greater use of electronic medical records (EMR) reduces medical administrative costs."

In fact, I increasingly believe the opposite is true, even when the electronic medical record project is successful, which most are not.

The majority of information systems developments in most sectors are unsuccessful, and the larger and more complex, the harder they fall ("Pessimism, Computer Failure, and Information Systems Development in the Public Sector." Public Administration Review 67;5:917-929, Sept/Oct. 2007). Healthcare is no exception.

A number of organizations have spent billions on EMR systems, such as Kaiser Permanente, have had massive delays and cost overruns, and are still years away from anything resembling "reduction of administrative costs." See my post at http://hcrenewal.blogspot.com/2006/11/kaiser-healthcare-it-meltdown.html.

Electronic medical records require a huge investment and significant "upkeep.' This "cost of ownership" puts a big doubt upon EMR projects as a cost-reducing endeavor. Rather, EMR's should better be thought of as a cost center.

An EMR for small-group and solo-practice physicians costs $44,000 per physician, and generates an average ongoing $8,500 per year in annual costs, the past ACP president herself, Lynne Kirk, MD told the house Subcommittee on Regulations, Healthcare and Trade of the House Committee on Small Business in October 2007. "The business case does not exist to make this kind of capital investment," Kirk told the Subcommittee.

In fact the use of EMR's will not significantly reduce overall health care costs, the director of the Congressional Budget Office said at the release of the agency's 2007 report on long-term health care spending. Peter Orszag , CBO's director, said that according to data from the report, the return on investment for EMRs "is not going to be as substantial as people think."

My own university's faculty practice plan at Drexel attempted to implement electronic medical records. Due to failure of the billing component, the exact component that was supposed to help "reduce administrative costs" but instead raised it by a few million dollars to manually correct the errors, the result was a multimillion dollar lawsuit (link to online court records here) by Drexel against the EHR vendor AllScripts and Allscript's partner Medicomp System s , a "corporation specializing in the development of point-of-care tools for Electronic Medical Records ... to help overcome physician resistance to adoption. " Temple University Health System delayed electronic medical records rollout due in part to unaffordability and a likely, justified fear of costly problems, which came to my attention due to the decision's delaying the doctoral thesis work of a graduate student here.

I also believe the EMR is rapidly becoming a tool for payors to minimize their costs and maximize their profits, while inconveniencing physicians trying to take care of patients under increasingly pressured timelines due to poor design. EMR's are largely designed under processes led by technologists, not clinicians.

Finally, with regard to effectiveness of EMR's in actually improving healthcare quality, even that is doubtful. A research article in the Archives of Internal Medicine entitled “Electronic Health Record Use and the Quality of Ambulatory Care in the United States” (Arch Intern Med. 2007;167:1400-1405, link to abstract here ) reached what to many was a counterintuitive conclusion. The authors, EMR experts, examined EMR use throughout the U.S. and the association of EMR use with 17 basic quality indicators. They concluded that “ as implemented, EMR’s were not associated with better quality ambulatory care ,” and were bold enough to publish their findings, sure to be unpopular in the health IT industry.

It appears the clinical case may not exist, either, for EMR's as they are designed and implemented today.

These issues are international in scope. Richard Granger, former head of the UK's “Connecting for Health” national EMR program, had this to say about a program described by some UK members of Parliament as “the largest government IT debacle ever” (see here for more):

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that [our large American clinical IT vendor] has put in recently is appalling ... [vendor] and [prime contractor] had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."

So, next time you hear that single payor systems enhanced by EMR's to "reduce administrative costs" are a panacea, think of Hugo Chavez' wondrous plans for a socialist utopia as President for Life of Venezuela.

You can read much more and see examples of EMR failure and mishaps at my web site "Common Examples of Healthcare IT Difficulties" at http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm

-- SS

Addendum: an editorial from a health IT publication whose editor understands reality, FierceHealthIT - Weekly News for Health IT Leaders:

The EMR rollout dilemma: The necessary evil
December 3, 2007

When it comes to EMRs, big healthcare organizations have a big, nasty problem on their hands. The problem? While they pretty much have to invest in an EMR system to stay competitive, by most IT industry standards this is a lousy time to jump in and do it. At the same time, however, they seem determined to move ahead.

Compared with other types of enterprise IT spending, EMR investments are a major crapshoot at this point, given the lack of support from some clinical staffers and the questions still floating around as to what features they should have. But in this case, providers are facing huge pressure from the federal government, some payers and hanks to ongoing PR efforts, even consumers to bring up an EMR system.

Sure, if they're going to spend the money, now's probably the time, rather than waiting five or ten years for the EMR product category to mature [I actually disagree with that - ed.] After all, organizations the size of Kaiser Permanente and Sutter Health--both rolling out the Epic EMR--will spend years integrating such systems into their already formidable infrastructure. So they have to begin getting their hands dirty with the technology now.

But there's still something odd [I would say "monstrously odd" - ed.] in how many formidable organizations are choosing to invest in a product whose feature set is still in question and whose popularity among key users is in doubt. In most industries, billion-dollar enterprises don't get pressured into buying a product this early in its lifecycle and cramming it into their operation. (The closest I can think of is the wave of ERP platform adoptions over the past decade or so--another very expensive boondoggle which only seems to be creating real value after years of heartache and expense.)

If nothing else, let's admit that the talk about avoidance of medical errors and efficiency improvements is a bit of a smokescreen--because if Kaiser was spending a few billion for that, it'd certainly be losing its shirt for quite some time into the future. While quality is a factor, I'd argue that most execs want to see EMRs in place so they can gather data needed for pay-for-performance incentives and shunt quality and outcomes stats to regulators.

As I see it, if health system leaders, health plans and government officials want EMRs in place so badly, they might want to start by being honest about their motives. Once they do that, they might get clinicians to see EMRs as more than just a necessary evil. - Anne

To which all I can add is "indeed."

-- SS

Why Dont' Physicians Do What They Say They Ethically Ought to Do?

The Annals of Internal Medicine just published a major study that contrasted physicians' attitudes toward professional norms with their self reports of whether they acted in conformity with these norms. [Campbell EG, Regan S, Gruen RL et al. Professionalism in medicine: results of a national survey of physicians. Ann Intern Med 2007; 147: 795-802. Link here.]

In brief, the authors developed a survey which asked physicians whether they agreed with various professional norms organized according to the 2002 ABIM/ ACP/ ESIM Physician Charter. They also asked them about whether they acted in conformity with these principles in terms of their recent actions, or in responses to scenarios. Physicians surveyed were primary care practitioners (family medicine, general internal medicine, and pediatrics), cardiologists, anesthesiologists, and general surgeons. The overall response rate was 52%.

In general, large majorities of physicians agreed with the ethical norms. How often they reported acting in agreement with these norms varied. In particular, nearly all physicians reported treating patients honestly (less than 1% reported telling a patient's family member something untrue in the last 3 years, 3% reported withholding information from a patient or a family member.) However, although 96% agreed that "physicians should put the patient's welfare above the physician's financial interests," 24% would refer a patient to an imaging facility in which the physician was an investor, without revealing this conflict of interest.

Some commentators suggested that external pressures may prevent physicians living up to the standards they themselves have endorsed. For example, physicians interviewed in a Washington Post article suggested that the current emphasis on patient satisfaction may conflict with the physician's ethical obligation to avoid wasting resources when a patient demands an unnecessary but not clearly harmful test. The Congressional Quarterly reported quoted the CEO of the Federation of State Medical Boards saying that physicians "were penned in by the American the health care system, fighting giant bureaucracies while fearing legal action if they make a mistake."

However, there was not much more discussion of the sorts of external pressures that might push physicians to forsake their values. Yet readers of Health Care Renewal might be able to come up with more examples.

For example, consider the pressures on young medical school faculty, who are under tremendous pressure from their academic leaders to become "taxpayers," i.e., people who bring in more money from external funding sources than they consume (See this post, in which the Dean of a prominent medical school ranked such "taxpayers" above all other faculty.)

Since government and foundation research support is tight, this leads many faculty to seek research support from pharmaceutical, biotechnology, and device companies. Once they get such support, they may find it hard to turn down offers of consulting positions, speakers' honoraria, advisory board positions and the like from such companies. Spurning such positions may cost them their research support. And their academic superiors often set the example that it is fine to accept such payments. (See this post about the prevalence of such financial arrangements among medical school department chairs.) Under these circumstances, preaching to young faculty about conflicts of interest seems to be just adding insult to injury.

I am most reminded of an article about business ethics we discussed back in July. The theme was that business students understand ethical principles, and know what they ethically ought to do. The problem is that they have trouble actually doing it.

The new article by Campbell et al also suggests that physicians know what they ethically ought to do. They thus don't need new statements of ethical principles, or more instruction about what they ought to do.

Instead, physicians need to focus on the discrepancy between what they know they ought to do and what they actually do.

Some of these discrepancies no doubt arise from their own human failings.

But absent in most of the current discussion is the enormous pressures physicians feel, often from leaders of powerful organizations with strong (usually economic, sometimes political or ideological) vested interests that may conflict with the admirable values embodied in the Physician's Charter.

It's easy to say that individual physicians always ought to do the right thing, regardless of external pressure. Maybe the individual physicians who feel uncomfortable being pressured into doing the wrong thing might get better organized to resist this pressure.

It would be even more helpful if medical and health care leaders could actually support physicians who want to do the right thing. Given that many medical and health care leaders have vested interests that push them in opposite directions, they may not jump at this opportunity.

For the Price of a Cane

We have posted a bit recently about how the US Medicare system, our single-payer federal insurance system for the elderly and disabled, uses an opaque and complex system for physician reimbursement that favors procedures and is helping to wreck primary care (see posts here and here).

The New York Times just published an investigation about how Medicare's reimbursement for simple medical supplies and devices is also irrational.

Millions of people with respiratory diseases have relied on oxygen equipment, delivered to their homes, to help them breathe. A basic setup, including three years of deliveries of small oxygen tanks, can be bought from pharmacies and other retailers for as little as $3,500, or about $100 a month.

Unless, that is, the buyer is Medicare, the government health care program for older Americans.

Despite enormous buying power, Medicare pays far more. Rather than buy oxygen equipment outright, Medicare rents it for 36 months before patients take ownership, and pays for a variety of services that critics say are often unnecessary.

The total cost to taxpayers and patients is as much as $8,280, or more than double what somebody might spend at a drugstore.

The high expense of oxygen equipment — which cost Medicare over $1.8 billion last year — is hardly an anomaly.

Medicare spends billions of dollars each year on products and services that are available at far lower prices from retail pharmacies and online stores, according to an analysis of federal data by The New York Times. The government agency has paid above-market costs for dozens of items, a comparison of Medicare figures with retail catalogs finds.

For example, last year Medicare spent more than $21 million on pumps to help older and disabled men attain erections, paying about $450 for the same device that is available online for as little as $108. Even for a simple walking cane, which can be purchased online for about $11, the government pays $20, according to government data.

These widespread price discrepancies, including those for oxygen services, have been noted in dozens of regulatory reports.

It is not surprising that the companies that supply these simple devices want as much reimbursement as they can get. Maybe it should not be surprising that they have cloaked their push for generous reimbursement in the mantle of needs of the elderly.

But when officials and politicians have tried to cut these costs, they have often encountered a powerful foe: the companies that sell these devices, who ask their elderly customers to serve, in effect, as unpaid lobbyists, calling and writing to their representatives in Congress, protesting at rallies, and even participating in political attacks against individual lawmakers who take on the issue.

As the nation’s elderly population grows, dozens of industries have tried to harness the political might of older Americans for corporate goals. Physician groups, medical device manufacturers, insurance companies and other businesses have rallied aging voters to protest even minor legislative changes.

'These industries rely on a basic threat: If you mess with us, we can turn the seniors against you,' said former Senator Alan K. Simpson, Republican of Wyoming, who tried cutting Medicare payments while he was in Congress. 'Angering seniors is the quickest route to political suicide.'

While any industry can hire lobbyists, few can marshal tens of thousands of older citizens to accuse politicians of trying to take away their lifelines. That ability, say lawmakers and their staff members, is the real clout of home medical equipment companies and other industries that sell to the elderly.

When Congress proposed cutting oxygen payments last year, for instance, trade groups and companies began warning patients that if the law changed, there might be no one to repair their equipment or provide emergency services.

'I’m scared to death that they are going to cut us off,' said Beverly Karagin of Morning Sun, Iowa, whose husband has used oxygen equipment for about 11 years. Mrs. Karagin wrote her senators and congressman after her oxygen delivery company told her about proposed payment cuts, she said.

'If something goes wrong with the machine and Medicare won’t pay to repair it, my husband could die,' Mrs. Karagin said in an interview. 'I told them that this is a matter of life and death.'

Lawmakers say such fears are unfounded. After patients take ownership of the equipment, Medicare pays for repairing machines and backup systems.

Even so, last year 'our office received over a thousand phone calls from oxygen patients in two days, and all of them said they were going to die if we passed this law,' said a high-ranking Congressional staff member who requested anonymity because he was not authorized to speak to the media.

Stealth lobbying, it's as American as apple pie.


Of course, seniors will not be well served in the long run if the Medicare program wastes huge amounts of money overpaying for oxygen and canes, and thus does not have the money to pay for other health care services that might also be of value. As we have noted before, Medicare payments to primary care and cognitive physicians started off low, and have failed to keep up with inflation (see post here). Meanwhile, they shadowy RBRVS Update Committee (RUC) manages to continually boost what Medicare pays for procedures (see posts here and here). Medicare requires physicians to follow arcane and impenetrable rules, and fulfill burdensome bureaucratic requirements (see post here). The result is that primary care is dying off. All for overpriced canes and oxygen tanks.

We clearly need to push Medicare into a rational, transparent reimbursement system that does not penalize primary care and other cognitive physicians.

This is also a reminder that those who put their faith in establishing a single payer health care system to cover all US citizens may be sorely disappointed. If a single payer system continues the irrationality, opacity, and susceptibility to political influence of our current single payer system, having such a system cover everyone might just make things worse.

Medical Academics Consulting for Industry: Riding the Tiger

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody dissected the complex relationships among GlaxoSmithKline (GSK), and its physician consultants regarding the drug rosiglitazone (Avandia).

We had previously posted about the report of a US Senate committee implicating top GSK executives in an attempt to silence a physician who was one of the early critics of Avandia. Dr Brody went through the report in depth, and found that things were more complicated. The physician involved was simultaneously a consultant to GSK, and to the company that made a competing drug. Brody wrote,

I agree that it is bad when companies try to intimidate scientists to keep quiet about potential drug risks. But what about the academic physician-scientists, who think that they can ride the tiger and still stay in control? Dr. Buse, it appears, thought that on the one hand he could pocket his consulting fees (and perhaps speaker fees as well; we are not told) from these drug companies; and on the other hand could freely speak his mind as an academic scientist. His new owners told him in no uncertain terms that once the business deal had gone through, he had better remember who was calling the shots. Buse himself seems to have gotten the message as to who owns his opinion--when the press approached him recently to say something nasty about GSK, he refused, saying that the matter was over years ago, that they had apologized to him, and he was eager to let bygones be bygones.

My central message in HOOKED is: when we physicians are lacking in our own professional integrity, pointing fingers at the bad drug companies is hardly an adequate ethical response.

It's clearly an important point, and a reminder to us physicians that too often in health care, the old quote from Pogo applies: "we have met the enemy, and he is us."

These days, a lot of academic physicians and other medical school faculty are trying to ride the tiger. They may end up doing this because what counts most to their academic bosses is how much external funding they bring in (or, as one medical school dean said, whether they are "taxpayers.") Since health care corporations (pharmaceutical manufacturers, biotechnology companies, device manufacturers, etc) now are the largest collective source of medical research money, they are thus under great pressure to collaborate with these companies. An academic trying to raise research money from one such company might find it hard to resist offers of consulting fees, speakers honoraria, advisory board positions, etc from that company. But once the academic thus starts to work part time for the company, who knows where his or her interests lie? And how the academic has to try to stay on the tiger.

BLOGSCAN - Easily Finding Unconflicted Experts

Responses to criticism of the US Food and Drug Administration's (FDA) for allowing people with conflicts of interest to serve on its advisory panels often include protests about how difficult it is to find qualified experts who do not have conflicts. (This is often further justified by assertions that pharmaceutical, biotechnology, and device companies only get the "best and the brightest" as consultants.) But on GoozNews, Merrill Goozner posted to the contrary. It really is not that hard to find unconflicted experts, if one bothers to look.

BLOGSCAN - Irrational Reimbursement

On DB's Medical Rants, this post continues on the theme of the irrational, complex, opaque system that the US Medicare program uses to determine physician reimbursement. This system is a major driver of the increasing cost of health care, and the priority the US puts on procedures, devices, and high-tech care versus primary care and physicians' cognition. Yet the mind-bending complexity of the system has seemingly diverted attention elsewhere, so that the conventional wisdom about increasing health care costs rarely directly implicates it. Furthermore, until recently, almost no one noticed how the system is influenced, if not controlled, by the shadowy RBRVS Update Committee (RUC), privately run (by the AMA), and dominated by sub-specialists whose names are not public. (See our most recent posts on the RUC here and here.)