How the Fallacy of the "Perfect" Health Care Market Undermined Professionalism and Caused Health Care Dysfunction - in the New York Times

We began this blog way back in 2005 to discuss threats to physicians' values, especially from concentration and abuse of power.  Personal experience, and cases and anecdotes described by colleagues suggested that a dysfunctional health care system was making patients and physicians miserable.  Interviews with more physicians suggested pervasive threats to their values, many stemming from how leaders of health care organizations wielded their power.  

Threats to Professional Values

In a 2007 post, based on an article in JAMA by Dr Arnold Relman, I asserted that the notion that threats to physicians' professional values are a major cause of health care dysfunction was becoming mainstream.  Furthermore, Dr Relman's review of the history of the problem suggested that the rising power of for-profit health care corporations, for whom making money came before the health and safety of patients, was a primary culprit. 

Dr Relman has discussed the issue frequently (e.g., see this post).  However, despite occasional publication in some prestigious medical journals, his views seem to have gotten little traction. 

Arrow's Analysis: Is Health Care a Perfectly Competitive Market?

Amazingly, however, the issue has made it into the New York Times, in the form of two posts in the Economix blog by health economist Prof Uwe Reinhardt.  Prof Reinhardt started by resurrecting the classic article by "Nobel laureate economist Kenneth Arrow," which argued that health care's special context means that the health care market cannot be truly competitive.

First Prof Arrow reviewed the characteristics of a perfectly competitive market:

To lay down a standard to which to compare the health care sector, Professor Arrow explained first on what basis economists consider a perfectly competitive market for some good or service as 'maximizing human welfare,' an outcome economists describe as 'efficient.'

The crucial characteristics of a perfectly competitive market are (1) that all of the quality dimensions of the good or service traded in that market are accurately understood by buyer and seller; (2) that potential buyers have full transparency on the price they will have to pay per unit of that good or service; (3) that it is easy and relatively costless for potential sellers to enter and exit this market; (4) and that there are so many potential buyers and sellers that none individually can affect the market price of the thing being traded.

If those and some other conditions are met, Professor Arrow explained, then for any given initial distribution of income and wealth that market will settle down at a unique equilibrium, that is, a state from which no potential buyer or seller would want to move. This equilibrium has important attributes.

First, in what Professor Arrow calls the First Optimality Theorem of welfare economics, it can be shown that in this equilibrium the traded good or service is allocated among buyers in such a way that it would be impossible through any reallocation to make someone happier without making someone else less happy.

It is an allocation that economists call Pareto efficient, in honor of the Italian industrialist, economist and philosopher Vilfredo Pareto (1848-1923), who first proposed this criterion.

For any given initial distribution of income and wealth, economists declare the associated Pareto-efficient allocation of the thing being produced and traded to be 'welfare-maximizing' — hence the term 'welfare economics' for this type of analysis.

Second, and very importantly, in what Arrow calls the Second Optimality Theorem, he explains that if on ethical grounds society wished to distribute a good or service (for example, education or health care or food or beach houses) among people in a particular way — like egalitarian principles — it need not have government directly involved in producing or distributing that good or service.

In his second blog post, Prof Reinhardt summarized why health care cannot be such a competitive market. The problems are uncertainty and asymmetry of information:

This uncertainty has several aspects.

First, physicians may not agree on the medical condition causing the symptoms the patient presents.

Second, even if physicians agree in their diagnoses, they often do not agree on the efficacy of alternative responses — for example, surgery or medical management for lower-back pain.

Third, information on both the diagnosis of and the likely consequences of treatment are asymmetrically allocated between the sell-side (providers) and the buy-side (patients) of the health care market. The very reason that patients seek advice and treatment from physicians in the first place is that they expect physicians to have vastly superior knowledge about the proper diagnosis and efficacy of treatment. That makes the market for medical care deviate significantly from the benchmark of perfect competition, in which buyers and sellers would be equally well informed.

Uncertainty and asymmetry of information about the quality of goods or services being traded is not, of course, unique to the medical care market. It is ubiquitous in modern economies that trade in highly complex goods and services. We find these characteristics, for example, in financial transactions, including all types of insurance; in automobile repairs, in plumbing and even in the purchase of some consumer electronics.

Wherever asymmetry of information is present, there exists the potential for the better-informed market participants to exploit the ignorance of the less well informed. How society responds to this flaw in markets depends on the severity of its consequences.

In the market for electronic products, for example, the consequences appear to be regarded as trivial. A customer may be seduced into purchasing an excessively complex and expensive product, but society takes no action on this front. In finance, on the other hand, the consequences of asymmetric information can be severe, as we have been reminded once again in the recent financial crisis.

Professional Standards and Mission-Oriented Non-Profit Organizations to Remedy Market Imperfections
Prof Arrow suggested that how health care worked when he wrote his article, in 1963, could be partially explained as attempting to remedy the problems created by uncertainty and asymmetry of information.

Professor Arrow explained many of the nonmarket social institutions and regulations characteristic of medical care [at that time] that he had identified as 'attempts to overcome the lack of optimality resulting from asymmetry of information and the inability of competitive markets to allocate efficiently all of the risks inherent in health care.'

Pointedly, he said, 'It is the general social consensus, clearly, that the laissez-faire solution for medicine is intolerable.'

That was then and this is now.

The Rise of "Greed is Good"

The problem is, of course, that health care has changed a lot since 1963. In an interview with the Atlantic from 2009, Prof Arrow defended his basic analysis:

I think the fundamental questions are the same. I also think there are more problems in the market today than when I wrote the paper. But I think the basic analysis hasn't changed.

He also discussed how failure to heed it have lead to our current dysfunctional health care system:

The market won't work -- it doesn't work well in the health context. But something else supplements the market, and the thing I put stress on in the paper are the elements that put a non-economic influence on the market: professional commitments to provide a service, to engage in services that aren't self-serving. Standards of caring decided by non-economic actors. And one problem we have now is an erosion of professional standards. In a way there is more emphasis on markets and self-aggrandizement in the context of healthcare, and that has led to some of the problems we have today.

Furthermore, he commented on those who sold the idea, which today ought to be totally discredited, in my humble opinion, that health care could be a perfect market, and this market would make everything right:

Sometimes I think it's because of the Chicago School. I think there has been a general drift around the country towards the idea that greed is good. Look at Wall Street. All of these industries involve a professional element in which information is flowing. You're supposed to be constrained to be honest about it. I don't really know why. But there is now more of an emphasis on popularization, which does improve efficiency but can also lead to an erosion of professional standards. There was this idea that professional standards were a mask for monopoly power--a Chicago theory, which I believe came from George Stigler. I don't know if they were that influential, but they seemed to be saying a lot of things that people were taking up in practice. I'm not totally sure why these professional standards changed, but it's more than medical reasons.

So you do not need to take it from me, take it from a Nobel laureate economist.  It now seems clear in retrospect that a major characteristic of modern health care is how the "better-informed market participants ... exploit the ignorance of the less well informed."

Summary: What is to be Done?
We have been sold a real bill of goods that health care could function as an ideal market. That bill of goods has lead to the deprofessionalization and commercialization of physicians, the destruction of the basic values of health care professionals, and the rise of health care organizations that put making money ahead of patients' health, safety, and welfare. And in health care, the dominant slogan has become "greed is good." This is true of course, but only for the greedy.

True health care reform would help physicians and other health care professionals uphold their traditional values, including, as the AMA once stated, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." True health care reform would put health care "delivery" back in the hands of mission-focused, not-for-profit organizations, which put patients' health, safety and welfare first.

These reforms, however, would certainly threaten the continuing wealth of a lot of people who have profited mightily from the current dysfunctional system. So do not expect them to be happy about even the discussion of them.

"Proprietary Information," Confidentiality Motions, and the Anechoic Effect; the Case of the Contaminated Heparin

The case of the deadly contaminated heparin sold by Baxter International has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Our most recent post, here, noted that an investigation into the contamination of the active pharmaceutical ingredient (API - actually the heparin itself) in China failed to produce any results, apparently because the Chinese government did not see fit to pursue it.  (Note that a brief summary of the whole case is at the end of this post.)
Now a new story in the Wall Street Journal by Alicia Mundy explains even more about why we do not know more about the contaminated heparin:

Baxter International Inc. faces a new challenge in federal court in its bid to block disclosure of documents about the 2008 contaminated-heparin crisis.

Baxter and Scientific Protein Laboratories LLC are fighting a civil mass tort lawsuit alleging deaths and injuries from imported Chinese heparin in 2007 and 2008. A company that isn't party to that lawsuit says some of the information Baxter and SPL want to keep confidential is important to public health and drug safety, and could reveal information about the sources of toxic heparin in the Chinese supply chain.

The two companies want to keep under seal portions of depositions taken in the case, including those related to Momenta Pharmaceuticals Inc., which helped the U.S. government investigate the contamination. Baxter and SPL say they will be hurt if forced to disclose proprietary information.

They have denied that they were negligent in the deaths linked to the blood-thinning drug, widely used in cardiovascular and other conditions.

So,

On Aug. 3, federal Judge James Carr in Toledo, Ohio, ruled in favor of the confidentiality motion by Baxter and SPL.

On the other hand, there are arguments, admittedly by parties with relevant financial interests, for making more information public:

Last Friday, another company entered the fray, contending that the information in the depositions shouldn't be sealed. Amphastar Pharmaceuticals Inc. said public health could benefit if the depositions shed light on circumstances in China.

Amphastar, which has been competing with Momenta for approval to make a newer and more expensive form of heparin, said the information is also important to a congressional investigation into the Food and Drug Administration's handling of the heparin crisis. Republican leaders of a House committee say the FDA failed to trace the contamination in the Chinese heparin supply chain.

On July 23, the FDA granted approval to Momenta to make the special heparin called enoxaparin, while Amphastar's application remains on hold.

Amphastar said in its court filing that the 'serious safety concerns' involving heparin are relevant to enoxaparin because heparin is the starting material of enoxaparin's active ingredient. Most U.S. heparin supplies come from China.

Of course, the companies who want to keep as much about the case secret as they can are not talking about it:

Lawyers for Baxter and SPL declined to comment on their efforts to restrict information related to Momenta. They referred inquiries to Baxter, whose spokeswoman declined to comment.

So here is more about what we do not know about the deadly contaminated heparin from China. One reason that this case has remained so anechoic is that the companies that sold and processed the contaminated heparin, and are now defendants in lawsuits have used that situation as a rationale for keeping "proprietary" information secret.  There clearly may be reasons that Baxter International, the company that sold the heparin under their (formerly?) prestigious US label  wants to keep secret the details about what efforts it did or did not make to assure that the heparin it sold was pure and unadulterated. There clearly also may be reasons that Scientific Protein Laboratories LLC, the US based company that sold the heparin API to Baxter wants to keep secret the details about what efforts it did or did not make to assure that the heparin API was pure and unadulterated. 

The ability of participants in lawsuits to keep "proprietary" information secret clearly adds to the anechoic effect.  Ironically, it may be that civil legal action, which is sometimes the only way to impose negative consequences on health care organizations that have misbehaved, may have the adverse effect of further hiding information about the events in question. 

However, to promote the safety of individual patients and the health of public, and to prevent another deadly case of drug contamination, understanding details about what happened is absolutely vital. The private pecuniary interests of Baxter International and Scientific Protein Laboratories LLC seem to be directly opposite to those of patients, physicians, and the public at large in this case. It is therefore disquieting to learn that the companies' wishes to keep information they declare is "proprietary" seem to have trumped individual patient safety and public health concerns. (Note that these concerns go beyond the commercial concerns of Amphastar Pharmaceutical, although in this case the pecuniary interests of that company do not seem to be opposed to patient safety and the public health.)

If we really want a health care system that improves the health of individuals and the public, we need it to put health and safety concerns ahead of the incomes of health care corporations.  That such a statement seems not a platitude, but revolutionary is a mark of how our health care system has been turned on its head.

Case Summary


In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.


(For a more detailed summary of the case, look here.)

St. Vincent's Goes Bankrupt, Executives Earn Millions

St. Vincent's Hospital in the Greenwich Village section of New York City was a landmark institution which filed for bankruptcy in April, 2010, and then closed its doors. 

Background

A New York Times article written earlier this year described an institution "threatened with extinction" because it stuck to its mission of "compassionate care" in a health care environment that values "fancy equipment and celebrity doctors."  Thus, "officials blamed a high rate of poor and uninsured patients as well as cuts in Medicare and Medicaid and the hospital's inability to negotiate favorable contracts with health insurance companies...." 

Painting Another Picture

However, a story this week in the grittier New York Post painted a different picture:

St. Vincent's Hospital was looted by execs and consultants in the two years before it closed, then grossly exaggerated its debt, according to blockbuster papers set to be filed tomorrow in Manhattan Supreme Court.

The filing, a petition that seeks to force the state Health Department to turn over documents on the closing, says the defunct medical center blew through millions in 'highly questionable' expenses, including $278,000 for a golf outing, while paying its top 10 executives a combined $10 million a year.

It also shelled out $17 million for 'management consultants,' $3.8 million on 'professional fund-raising' and a staggering $104 million on unspecified costs it listed simply as 'other' on its federal tax returns, the petition says.

But even with all that money going out, St. Vincent's wasn't nearly as cash strapped as it claimed, say the court papers, prepared by a law firm working for doctors and nurses formerly employed there and the hospital's West Village neighbors.

Its crushing debt of about $1 billion, which the hospital blamed for having to close its doors in April, was bloated by hundreds of millions of dollars in loans dumped on St. Vincent's from other medical entities run by the Archdiocese of New York, starting in 2001, after the other institutions merged with the hospital, the papers say.

'The debt of the hospital was specifically exaggerated by numerous factors, including the transfer of debt from other Catholic medical centers and mismanagement by the board of directors,' the documents say. 'These transfers . . . remain undisclosed to the public.'

Historical Parallels
These accusations parallel themes that appeared towards the end of the February, 2010, NY Times piece. First, regarding the transfer of debt:

To remain competitive, in 2000 St. Vincent’s merged with several other Catholic hospitals to form St. Vincent Catholic Medical Centers.

Along with the flagship hospital in the Village, it ran seven other hospitals: Bayley Seton and St. Vincent’s on Staten Island; Mary Immaculate, St. John’s and St. Joseph’s in Queens; St. Mary’s in Brooklyn; and St. Vincent’s Westchester, in Harrison, N.Y. It was also affiliated with St. Vincent’s Midtown, formerly St. Clare’s, in Midtown Manhattan.

The merger was conceived as a way to streamline management and give the hospitals pricing leverage, but it was troubled from the beginning. After closings and sales, the network was left with just one New York City hospital, the flagship; a psychiatric and substance abuse treatment hospital in Westchester; and several nursing homes and other outpatient facilities. Some of St. Vincent’s debt was inherited from the closed hospitals.

Second, regarding mismanagement:

In 2004, St. Vincent’s turned over management to Speltz & Weis, the first in a series of turnaround consultants. It paid the firms millions of dollars a year to run the hospital and hired their officials as hospital executives. The system filed for Chapter 11 bankruptcy protection in early July 2005, when it appeared, according to court papers filed by hospital creditors, that it would be unable to make its payroll.

In a lawsuit filed in 2007, some of the hospital’s creditors painted a picture of a hospital system trapped between unscrupulous consultants and a passive or gullible board. The lawsuit accused David E. Speltz and Timothy C. Weis, the hospital system’s former chief executive and chief financial officer, of delaying the bankruptcy organization while they and their consulting firm collected millions of dollars in fees.

The lawsuit accused them of hiring high-priced contractors and padding their fees, instead of using hospital employees to do work. And it says they leveraged their positions with the hospital to negotiate the sale of their consulting company to Huron Consulting Group, in Chicago, also a defendant in the case.

The outcome of that earlier lawsuit was unclear.  It does suggest that St. Vincent's may have been chronically bled by greedy managers and consultants.

Contrasting Financial Health and Executive Compensation

Of course, as one of our unofficial legal consultants noted, anyone can file a lawsuit. However, perusal of the latest 990 form filed with the Internal Revenue Service by St Vincent Catholic Medical Centers for calendar year 2008 did reveal a disquieting contrast.

That form stated that the the hospital lost over $65 million in 2008, and over $34 million in 2007. However, in 2008, here were the compensation of its highest paid managers

- Brian Fitzsimmons, Executive Director, $2,135,401
- Bernadette Kingman-Bez, Senvior Vice President, CCO (?), $1,520,841
- Paul Rosenfeld, Executive Director, CC, $1,196,458
- Henry Amoroso, CEO, $1,081,592

In addition, seven current and former executives at the Senior Vice President of Vice President level earned over $500,000 that year, and another 13 earned over $250,000.

Summary

So clearly, while the hospital was hemorrhaging money, and a little more than a year away from bankruptcy, this not-for-profit hospital whose mission emphasized serving the poor served a large corps of  executives very large amounts of money.  So we see again the pattern of top managers rewarding themselves disproportionately (here, grossly so) given the mission and financial status of their organizations.  The picture is of pay entirely independent of performance, and leaders who are ultimately only in it for the money.

How many more examples like this do we need until there is resolve that real health care reform will make top health care leaders accountable for their performance, and provide them incentives that are fair and rational, rather than perverse?

Post-Script

Of course, if we regard the fall of institutions whose mission was to do good as inevitable in our Darwinian world, an explanation that earlier coverage of this story suggested, all we can do is to throw our hands up.  However, the inevitability argument is often made by those who are benefiting from the current way of doing things.  A more skeptical view of this case, and related health policy issues, may suggest a different approach. 

EPIC's outrageous recommendations on healthcare IT project staffing

"Critical thinking always, or your patient's dead" - Victor Satinsky, MD, NSF-funded summer science training program (SSTP) for high school students, Hahnemann Medical College, early 1970's.

Health IT projects are incredibly complex undertakings in equally complex, mission-critical medical environments. They are definitely not an area for novices.

From conception to design to implementation, faulty systems can endanger patients.

Further, one astute author of an article entitled "Faulty Construction" in the journal ForTheRecord.com (link) observes that:

Critics wonder what good it is to invest in EHR technology if it fails to engender itself to users who feel betrayed by its lack of intuitiveness.

Inexperience is a critical factor in creating and implementing HIT that "betrays" users in many ways (see, for example, here on mission hostile HIT).

With these issues in mind, here is how the major HIT vendor, EPIC, recommends hospitals staff their clinical IT projects. It also follows that they staff their own development teams in the same manner.

The recommendations are largely outrageous, especially in the context of medical environments where uninformed, unconsenting patients are subjected to IT experimentation in clinical matters.

From this link at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine:

Epic Staffing Guide

A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project.

Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say.

The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores.

I bet many readers were taught by their HR departments to do behavioral interviewing, i.e. “Tell me about a time when you …” Epic says that’s crap, suggesting instead that candidates be given scenarios and asked how they would respond. They also say that interviews are not predictive of work quality since some people just interview well.

Don’t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid.

Epic likes giving candidates tests, particularly those of the logic variety.

While there's some good here, the part about "not worrying about relevant experience" and about "hiring recent college graduates as HIT project analysts" is downright frightening.

Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be. These practices as described, in my view, represent faulty and dangerous advice on first principles.

The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership."

One wonders if these recommendations are simply the idiosyncratic opinions of EPIC's leadership. They certainly deviate wildly from medicine's culture (e.g., of rigorous domain-specific training, and certification where the test cannot even be taken without prerequisite, very specific experience).

One could also look at these recommendations from an economic perspective. The word "cheap" and a corollary concept, "age discrimination" come to mind regarding a stated preference for recent graduates over experienced personnel.

Finally, from a personal perspective, my grades and test results out of high school and college were very high, e.g., a perfect 800 in math on the SAT, high grades in advanced courses in the 'hard sciences' - not to mention, advanced computer courses such as in IBM mainframe assembly language programming.

Yet the ‘modern me’ (after medical, further IT and informatics education and hard earned applied experience) knows that I would not have wanted the ‘young me’ to have been involved in critical clinical IT functions on that basis.

-- SS

Being a Health Insurance Executive Means Never Being Able to Say You Are Sorry

WellPoint, the largest US for-profit health care insurance company, has provided a steady stream of examples of poor management and bad behavior for the edification of Health Care Renewal readers.  Most recently, a company whose core functions include reliably and confidentially managing electronic data on policy-holders allowed what should have been private data from nearly half a million people to appear on-line (see post here.  For other examples, look here.)

This week, the Los Angeles Times recounted what happened to a highly placed WellPoint executive who tried to improve the company's behavior. 

Leslie Margolin was the public face of Anthem this year when it sought to raise individual insurance rates as much as 39%. The move triggered a backlash in Washington and Sacramento, where lawmakers accused Margolin and her corporate bosses at insurance giant WellPoint Inc. of trying to gouge unknowing policyholders.

Margolin, 55, generated headlines statewide when she was called to testify before angry lawmakers in the state capital. With television cameras rolling, the hearing's chairman stared her down and asked bluntly: 'Have you no shame?'

Now, speaking publicly for the first time since her departure, Margolin says she had been chagrined over the rate hikes for the last year and had worked internally to get Indianapolis-based WellPoint to rescind them or scale them back, and to apologize.

'I thought the rates were too high,' she said. 'I thought the impact on our membership was too significant.'

Margolin did not object to the rates in her Sacramento testimony this February. But in the months that followed, she repeatedly voiced her objections to WellPoint and in appearances outside the company, remarks that went largely unnoticed by the public.

In a March talk at Pepperdine University's business school, for instance, she told a gathering of students and business leaders that she wasn't responsible for rate increases she believed were ill-timed and ill-advised.

'We have impacted individual consumers in ways that were so significant for those individuals,' she said. 'And for that, I personally feel very, very sorry.'

As she made the Pepperdine appearance and others, Margolin said, she privately pressed WellPoint to abandon the company's get-tough approach to longtime adversaries — doctors and hospitals — and instead collaborate as part of a new 'healthcare transformation strategy' to cut costs and improve patient safety and the quality of care.

So what happened to Ms Margolin? Did she get a big raise and an award for doing the right thing? Is the moon made of green cheese?

In fact, here is what happens to a health insurance executive who says she is sorry for excessively high insurance rates:

Last month, WellPoint replaced her. At the time, Margolin said her departure was a mutual decision. Interviews with company insiders, insurance industry leaders and others familiar with the situation now make clear that she was pushed out.

'Her undoing was that she rocked the boat and wanted to do things a different way,' said one person familiar with the events who declined to be identified for fear of retribution. 'She wasn't a good corporate soldier.'

Margolin herself spoke cautiously about her resignation, but said: 'There is no question I needed to leave.'

In fact, her exit was quite inglorious:

Margolin vividly recalls her last day. Even though her Anthem team was exceeding its financial goals and membership numbers, she said, she was ushered from the doors of Anthem's Woodland Hills headquarters. She didn't have a chance to send a farewell message to her 400 employees.

So it seems that being a top health insurance corporate executive means never admitting a mistake, and never, ever saying you are sorry.

In contrast, in the 2009 WellPoint Annual Report, CEO Angela Braly boasted:

As you can see throughout this report, we’re focused on making health benefits more affordable, improving access to care, and simplifying interactions with the delivery system. We believe that we have to favorably impact the value equation in health care while improving the experience of members, doctors, and employers.

So presumably at WellPoint, "making health benefits more affordable" means raising premiums 39%.  As we mentioned earlier this year, for this and other bits of legerdemain, Angela Braly's 2009 compensation increased 51 percent to $13.1 million. This seems more like pay for propaganda than pay for performance.

In a post in the Dismounting Our Tiger blog, Edwin Lee addressed the origins of the BP oil spill by noting how most big corporations have come to promote leaders distinguished mainly for their careerism, tribal attitude, and disinclination to question received wisdom.  He wrote that the result was promoting "mediocre, short term thinkers with similar work experiences, outlooks, temperaments and personal incentives. Disaster response, creative thinking and fundamental changes are outside their limited range of interests or competencies."  Thus we can expect that at some point, WellPoint, and many similarly lead health care organizations, will create their own disasters.  We can only hope that our health care system survives them.

Meanwhile, kudos to Ms Margolin for trying to put the interests of policy-holders and the public ahead of following the company line.  If only more such people were able to lead health care organizations rather than being unceremoniously fired, we might have a fighting chance to have health care that really is high quality, affordable, and accessible.   

PS - For those old enough to have been forced to watch Love Story, the original quote was "love means never having to say you're sorry."

A Golden Parachute for Making Contaminated Drugs?

In late 2009, we posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year. We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product. In a later post we also why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities.  In May, 2010, we posted about a legal settlement of charges related to its manufacturing problems requiring Genzyme to pay a $175 million fine and function under US government supervision.

Recent news articles suggest that the fix of the company's inabilities to manufacture pure, unadulterated drug remained remote.  Reuters reported that it had to discard "additional inventories of drugs ... for failure to the meet the company's quality control standards."  Bloomberg reported that it "may take three to four years to complete changes requested by U.S regulators after plant contamination."

Meanwhile, however, the company continues to talk to Sanofi-Aventis about being bought out, and the Boston Globe reported just how much Genzyme CEO Henri A Termeer would stand to make if the buyout takes place:

Under the 'hange of control' agreement currently worth $23 million, Termeer would receive several payments. He would receive a lump sum of $11 million, a figure representing three times his base salary plus a bonus. He would also get $356,000 in benefits, including health, life, accident, and disability insurance, outplacement and relocation services, and legal fees. And he could cash out 175,137 shares through accelerated equity awards. Those shares are now worth $11.9 million, but almost certainly would be worth more if the company is acquired at a premium.

Furthermore,

Apart from the golden parachute, Termeer could reap huge stock gains if the company is sold. The 4.1 million Genzyme shares he owns represented about 1.5 percent of its stock as of April 9, the most recent regulatory filing. At the current share price, Termeer’s stake is worth more than $275 million.

So riddle me this: over the last 5 years, Genzyme stock-holders have seen their investment lose 5.7% of its value (according to Google Finance),  while patients have paid outlandish prices for contaminated medicine, or have had to reduce their medication dosages after the defective manufacturing plant was shut down.  So why should the CEO who presided over all this, whose has already become rich as a hired employee of Genzyme, get even richer? 

Once again we demonstrate how massively perverse incentives stupendously reward the top brass of health care organizations for mediocre, or worse leadership and bad results for both patients/ clients/ customers and stock-holders alike.  As long as being a health care CEO is effectively a license to loot the company, is it any wonder that health care organizations continue to be badly lead, and health care costs soar while quality and access suffer? 

Once more with feeling: real health care reform would require us to make health care executives truly accountable for their actions, and penalize them for those that are ill-informed, contemptuous of health care values, self-interested, or corrupt. 

Deceptive Marketing, For-Profit Universities, and Health Care Education

Last week, reports about deceptive marketing and other questionable practices used by the growing for-profit higher education industry in the US appeared in the news.  For example, per Bloomberg:

Recruiters at U.S. for-profit colleges lied to entice students and encouraged them to commit fraud to qualify for aid, a report by the Government Accountability Office found.

Recruiters at all 15 colleges studied by the GAO, Congress’s investigational arm, misled potential students about the costs, duration and quality of their programs, according to a report obtained by Bloomberg News....

Other deceptions include:

“'college representatives exaggerated undercover applicants’ potential salary after graduation and failed to provide clear information about the college’s program duration, costs, or graduation rate,' the report said. 'Admissions staff used other deceptive practices, such as pressuring applicants to sign a contract for enrollment before allowing them to speak to a financial advisor about program cost and financing options.'

Also,

In one case cited by the report, a GAO investigator posing as an applicant was told to lie on an aid application about the number of household members to qualify for grants. When the investigators told college employees that they had $250,000 in savings, officials at three colleges told them to hide their savings in order to qualify for financial aid.

In addition,

For-profit colleges overstated the quality of their programs and the organizations overseeing their accreditation, the report said. One recruiter told an investigator posing as an applicant that his school was accredited by the same one that accredits Harvard University.

'It’s the top accrediting agency,' the recruiter said, according to the report. 'Harvard, University of Florida --they all use that accrediting agency.'

Recruiters exaggerated their colleges’ benefits and graduation rates, the report said. A beauty college recruiter said barbers earn as much as $250,000 a year, while the Bureau of Labor Statistics said 90 percent of barbers make less than $43,000 annually, according to the report.

A later report by the Dow Jones news service named some of the corporate players whose educational "institutions" were involved in dubious schemes.

Colleges operated by Apollo Group Inc. (APOL), Corinthian Colleges Inc. (COCO) and Washington Post Co.'s (WPO) Kaplan Higher Education unit were among the schools the U.S. Government Accountability Office found provided 'deceptive and otherwise questionable information' to agents who posed as prospective students in an undercover investigation of for-profit student recruitment tactics.

It is tempting to look for parallels with health care, once a calling like higher education, but now increasingly an "industry," often run, as we have documented endlessly, by people with little experience or knowledge about how health care is actually done on the ground, with little sympathy for the values of health care professionals, and given strong incentives to maximize the money coming in, whatever it takes.

However, the issue goes beyond these parallels. In fact, many of the bigger for-profit education corporations provide considerable health care education, including the three named above. The University of Phoenix, a subsidiary of the Apollo Group Inc, offers a Masters of Science in Nursing degree. Several of the "brands" of Corinthian Colleges Inc offer offer "diploma and/or degree programs in health care." Kaplan University, a subsidiary of Kaplan Higher Education Corporation, has a School of Health Sciences.  So it seems likely that many health care professionals, or would-be health care professionals, have been enticed by the sorts of sales practices documented in the report. 

There are no known for-profit US medical schools.  However, as we have discussed, many US students go to for-profit "off-shore" medical schools, often in the Caribbean, who mainly "educate" US citizens who want to practice here (as opposed to all the schools in countries other than the US whose main goal is to educate doctors for their own countries.)  Some of these off-shore schools are owned by big US corporations.  One can only wonder whether their recruitment tactics are similar to those of the for-profit "universities" located in the US. 

We have discussed deceptive marketing of hospitals, drugs and devices, but now it seems that deceptive marketing is even more widespread in health care than we originally thought, along with the take the money and run ethos that has infected so much of the business world.

If we truly want to reform health care to improve quality and access, and control costs, we need to restore the focus to care, the care of the patient, and away of the false pursuit of economic efficiency that only seems to benefit the quick buck artists. 

UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports here and here, for example.

However, they have appeared to have learned from their mistakes and in fact are on the way to being far ahead of the U.S. in terms of understanding what it truly takes for HIT to be efficacious - and perhaps even more importantly, as safe as possible.

From an informatics colleague who informed me of these developments:

The UK has recently adopted the ISO draft standards for the development and deployment of HIT. They don't go as far as premarket approval, but do require vendors to develop and deliver to healthcare organizations a formal hazard assessment for their products, require both to continually update their risk assessments, and require care delivery organizations to have an explicit process for identifying & mitigating risks, and formally accepting (or not) the residual risks that remain. The thinking is these standards will be adopted across the EU once the ISO approval process is completed.

These two remarkable documents are available from the UK's NHS:

http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009

"Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software"
Formerly ISO/TR 29322:2008(E)
DSCN18/2009

and

http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009

"Health Informatics — Application of clinical risk management to the manufacture of health software"
Formerly ISO/TS 29321:2008(E)
DSCN14/2009

From the first of these, the overall intro:

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

Then on to matters at hand:

Introduction

The threat to patient safety

There is mounting concern around the world about the substantial number of avoidable clinical incidents which have an adverse effect on patients, of which a significant proportion result in avoidable death or serious disability, see references [1], [2], [3], [4], [5] and [6]. A number of such avoidable incidents involved poor or "wrong" diagnoses or other decisions. A contributing factor is often missing or incomplete information, or simply ignorance, e.g. of clinical options in difficult circumstances or of the cross-reaction of treatments (a substantial percentage of clinical incidents are related to missing or incomplete information).

It is increasingly claimed that information systems such as decision support, protocols, guidelines and pathways could markedly reduce such adverse effects.

[As I have written in many places such as here and here, this may or may not be true regarding today's commercial healthcare IT as it is currently designed and deployed. Evidence supporting the assertion, especially robust studies such as randomized controlled clinical trials, is scarce, and evidence contradicting it is growing. The technology remains experimental - ed.]

If for no other reason – and there are others – this is leading to increasing deployment and use of increasingly complex health software systems, such as for decision support and disease management. It can also be anticipated that, due to pressures on time and to medico-legal aspects, clinicians will increasingly rely on such systems, with less questioning of their "output", as a "foreground" part of care delivery rather than as a "background" adjunct to it. Indeed, as such systems become integrated with medical care, any failure by clinicians to use standard support facilities may be criticised on legal grounds.

Increased use of such systems is not only in clinical treatment but also in areas just as important to patient safety, such as referral decision-making. Failure to make a "correct" referral, or to make one "in time", can have serious consequences.

Economic pressures are also leading to more decision support systems. The area of generic and/or economic prescribing is the most obvious, but achieving economy in the number and costs of clinical investigative tests is another.

Thus the use of health software and medical devices in increasingly integrated systems, e.g. networks, can bring substantial benefit to patients. However unless they are proven to be safe and fit for purpose they may also present potential for harm or at least deter clinical and other health delivery staff from making use of them, to the ultimate detriment of patients. Annex A provides some examples of the potential for harm.

Harm can of course result from unquestioning and/or non-professional use, although the manufacturers of health software products, and those in health organizations deploying and using such products within systems, can mitigate such circumstances through, for example, instructions for use, training and on-screen presentation techniques, guidance, warnings or instructions.

Some of these system deficiencies are insidious, may be invisible to the end user [an obviously perilous situation - ed.] and are typically out of the sole control of either the manufacturer or the deploying health organization.

The reports note the obvious, something that the health IT vendors' contractual gag clauses and secrecy in the health IT industry make difficult to rigorously evaluate:

A necessary pre-cursor for determining and implementing controls to minimize risks to patients, from a health software systems that is manufactured and then deployed and used within a health organization, is a clear understanding of the risks which the deployed system might present to patients if malfunction or an unintended event were to occur, and the likelihood of such a malfunction or event causing harm to the patient.

These risks cannot be properly evaluated in an industry where the flows of information are dominated by the vendors.

Some examples of potential for harm, from annex (appendix) A, will likely sound quite familiar to readers of Healthcare Renewal:

• Patient (mis)identification
• Inadvertent accidental prescribing of dangerous drugs (such as methotrexate)
• Incorrect patient details retrieved from radiology information system
• CT and MRI images could not be seen after being moved to PACS
• Drug mapping error
• Pre-natal screening risk computation errors
• Radiotherapy errors
• Slack security

I especially note the following in the first document (on deployment):

5.3 Competencies of personnel

Persons performing risk management tasks will need to have the knowledge, experience and competencies appropriate to the tasks assigned to them. This will need to include, where appropriate, knowledge and experience of the particular health software systems (or similar health software products) and applications, the technologies involved and risk management techniques. This should include appropriate registered clinical input throughout the process. Appropriate competency and experience records will need to be maintained.

Clinical risk management tasks can, and should, be performed by a project team that contains representatives of each of the functions that are involved in deploying and subsequently using the health software systems or system, with each contributing their specialist knowledge to build both awareness and consensus. Of particular importance will be clinical input from clinicians who are familiar with the practical realities of the environments within which the software system will be used and the clinical processes to which the software system is directed.

Emphasis on the last sentence is mine. At a time when U.S. CIOs and health IT "talking heads" still find the need to write touchy-feely "Master of the Obvious" articles extolling the virtues of permitting clinicians 'input' into health IT projects, usually under the aegis of unempowered "Directors of Informatics" or "Chief Medical Information Officers" (a.k.a. Directors of Nothing and Chiefs of Nothing, with no true executive presence or authority), the latter direct, definitive sentence is refreshing.

Miracle of miracles, even postmarketing surveillance is covered (the pharma and medical device industries have been mandated by regulators to conduct such studies on their products for decades):

11 Post-deployment monitoring

Both manufacturers and organizations deploying and using health software and other products within systems, have a business need to establish, document and maintain a process to collect and review information about the clinical safety performance of the products and system in the post-deployment phase, at least to help manage their liabilities but also to enable them to optimize their products and systems.

There is much more in these documents.

Download and read the PDF's. I will have more to say in future posts, but thank god someone is considering the risks to patients of this technology, touted as universally beneficent by health IT exceptionalists, in a serious manner.

Now if only we can import this thinking into the United States.

-- SS

2 Legal Settlements + 1 Corporate Integrity Agreement = $130 Million Retirement Package?

Omnicare's Trail of Legal Settlements

Last year, we discussed a $98 million settlement made by Omnicare, US based corporation that manages pharmacy-benefits, of allegations that it received kickbacks from generic drug manufacturers for buying and recommending their drugs.  Omnicare had previously submitted to a corporate integrity agreement in 2006, and paid $102 million to settle allegations it defrauded Medicaid.  At the time, we noted that this was yet another of the many cases in which the organization alleged to be involved in wrong-doing paid a fine, but no one who authorized, directed, or implemented the bad behavior was subject to any negative consequences.

So last week, Cincinnati.com ran a story on the retirement of the CEO who presided over Omnicare during the time of the alleged misconduct. 

Before reading further, would anyone care to guess whether the company's previous bad behavior would negatively impact his fortunes?

Contrasted with the Size of the CEO's Retirement Package

No exactamente:

As Omnicare Inc.'s new leadership begins to reshape its corporate culture - one that had included generous pay for senior executives - the Fortune 500 firm's exiting CEO stands to collect one of the largest payouts landed by a U.S. corporate executive in recent history.

Former president and CEO Joel Gemunder, who surprised analysts and investors when he retired on July 31, is in line to receive more than $130 million in severance, pension and departing payouts.

At 71, Gemunder had led Omnicare Inc., the nation's largest provider of pharmaceuticals for the elderly, for nearly 30 years.

On his retirement, Gemunder was up for a lump sum pension payment of more than $91 million. That's in addition to a monthly pension payment of $1,719 and roughly $5.38 million from a deferred compensation plan.

Gemunder also will receive $16.2 million in cash severance payable through next July. His 2.7 million in stock options and more than 705,100 shares of restricted common stock also became fully vested on his retirement. Collectively, the shares were worth more than $21.7 million, according to the company's most recent proxy.

To recapitulate so far: the company had to make two settlements of charges of kickbacks and fraud, totalling about $200 million, and accept a corporate integrity agreement. The CEO on whose watch this occurred left the company with a $130 million retirement package.

Can we spell "impunity?"

Protest from the Main-Stream Media

But this case was different from many of the legal settlements that we have chronicled in the past. In those previous cases, we noted how corporate bad behavior cost the organization as a whole, and hence collectively cost the stock-owners, the employees, and the customers/ clients/ patients involved, but not the leaders who authorized and directed the bad behavior, nor the particular people who implemented it. Hardly anyone else, however, took notice.

However, after Mr Gemunder's obese retirement package was made public, there was actually outrage in the opinion section of the Wall Street Journal:

Health-care costs, the national debt and taxes are all going up, and Joel Gemunder is one reason why.

Until Mr. Gemunder's abrupt retirement was announced on Monday, he was CEO of Covington, Ky.-based Omnicare, the nation's largest dispenser of pharmaceuticals to nursing homes.

Omnicare gets most of its revenue from Medicare, Medicaid and other companies sucking on these same government feeding tubes. Omnicare also lives up to its name, serving 1.4 million beds in 47 states.

Mr. Gemunder, 71, had been in charge since 1981, but now he's split with one of the largest lump-sum pension payouts in history, The Wall Street Journal reported. He's getting a $91 million pension payout, plus severance, vesting of restricted stock and other goodies that bring his final payday to at least $130 million. And that's on top of the $14 million he bagged last year.

As CEO, Mr. Gemunder touted 'cost reduction initiatives,' including salary cuts for employees, but these initiatives didn't apply to himself.

And what did the shareholders get for their money? Omnicare shares took a tumble last week after the company reported a shocking drop in the number of prescriptions it fills.

Omnicare stock peaked in March 2006 at more than $61, but now trades under $23. That's a drop of more than 60% -- versus a roughly 11% decline in the S&P 500 during the same period.

And what did the taxpayers and customers get? Omnicare has long been plagued by huge litigation costs amid allegations of kickback and billing schemes.

It's nice to have company. And it's very nice that the issue of the impunity enjoyed by leaders of top health care organizations has made it into the main-stream media. Now it is time to do something about it.

Summary

Let me say it again:  The Omnicare settlement coupled with its CEO's outlandish retirement package fit right into the parade of legal settlements we have discussed. As we have said again and again, the usual sorts of legal settlements we have described do not seem to be an effective way to deter future unethical behavior by health care organizations. Even large fines can be regarded just as a cost of doing business. Furthermore, the fine's impact may be diffused over the whole company, and ultimately comes out of the pockets of stockholders, employees, and customers alike. It provides no negative incentives for those who authorized, directed, or implemented the behavior in question. My refrain has been: we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Postscript: A Conflicted Board Member?

The Cincinati.com story described the bizarre process used to set the size of the Omnicare CEO's retirement package.

Just ahead of Gemunder on the big pension list is Thomas M. Ryan, president and CEO of CVS Caremark Corp. with $94.4 million at the end of 2009.

CVS posts annual sales in excess of $98 billion compared to Omnicare's $6.17 billion. Annual profit at CVS is $3.6 billion compared to $ 211 million at Omnicare.

Despite the sizable differences, CVS is among 40 companies whose CEOs pay is considered when Omnicare's executive compensation committee determines pay for its top executives, according to the firm's April proxy. The company's compensation committee, which declined comment for this story, is made up of three long-time directors Andrea R. Lindell, board chair John T. Crotty and Steven J. Heyer.

Other companies considered include New York-based Bristol-Myers Squibb Co. with $17.8 billion in sales; Dublin, Ohio-based Cardinal Health, Inc. with $99 billion in sales and New Jersey-based Medco Health Solutions, Inc. with $72 billion in sales.

'These companies are enormously bigger than you would expect for a comparative group' for Omnicare, Crystal said. 'It's the equivalent of the local ball team that's not in the major leagues using their comparative group as the New York Yankees.'

Note that one member of the compensation committee that used this absurd standard to set the CEO's compensation was one Andrea R Lindell. The above story did not identify her further, but as we noted last year, she "is also Dean of the College of Nursing at the University of Cincinnati. One would think that someone who thus boasts 'the success of our students, faculty, staff and alumni who work together to promote excellence in education, research, service and practice' needs to keep a closer eye on the ethical aspects of her company's management. But as the New York Times just noted on the front-page of last Sunday's business section, as another blow to the anechoic effect, "Academics may be trained to ask tough questions in their own fields, but when confronted with tricky business issues far above their level of expertise they 'often become as meek as church mice'...." and hence are just the sort of directors that self-interested CEOs intent on lining their own pockets love. 

So this case becomes another reason to take seriously the increasingly frequent conflicts of interest generated when top leaders of non-profit health care organizations sit on boards of for-profit health care corporations.  These conflicts may not only distract the leaders from the mission of the non-profit organizations, but also distract them from their fiduciary duties to the stock-holders of the for-profit corporations. 

Despite Scandal, Former UnitedHealth CEO was Ninth Best Paid CEO of the Decade

A little while ago, the Wall Street Journal reported on the highest paid US corporate CEOs of the past decade.  One name stood out for those interested in  health care: Dr William W McGuire, the former CEO of giant health care insurance company/ managed care organization UnitedHealth Group.  Dr McGuire was number 9 on the list, with a total realized compensation of $469,300,000. 

We started discussing the disconnect between Dr McGuire's corpulent pay and his company's failure to uphold its stated ideals back in 2005, when he was reported to have received more than $124 million to lead a company which championed "affordable" health care.  Later, it turned out that much of Dr McGuire's compensation came in the form of back-dated stock-options, and the resulting scandal was followed by his resignation.  Later, Dr McGuire was forced to give back some the options.  The final settlement of the fiasco cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options.

Meanwhile, UnitedHealth was compiling an unenviable record of ethical lapses:

• as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
• UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
• UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
• UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
• UnitedHealth frequently violated Nebraska insurance laws (see post here);
• UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).

At the same time, UnitedHealth continues to boast that:

Our mission is to help people live healthier lives.

* We seek to enhance the performance of the health system and improve the overall health and well-being of the people we serve and their communities.
* We work with health care professionals and other key partners to expand access to quality health care so people get the care they need at an affordable price.
* We support the physician/patient relationship and empower people with the information, guidance and tools they need to make personal health choices and decisions.

Dr McGuire certainly expanded his access to money, which doubtless empowered him.   

And as we noted here, his successor, Mr Stephen J Helmsley, seems to be going down the same path.  In 2009 his total compensation was $8.9 million, and he sold stock options obtained from previous compensation packages for $98.6 million.  Mr Helmsley was a top leader (President and Chief Operating Officer [COO]) of UnitedHealth during Dr McGuire's reign as CEO, so should be viewed as having some responsibility for the excesses of the McGuire years.

Despite recent attempts to reform health care, or at least health insurance, it seems that the health insurance industry still leads the way in providing its leaders perverse incentives while failing to hold them accountable for their organizations' unethical behavior and subversion of their stated missions.  Is it any wonder that these organizations continue to act unethically, and that the costs of the goods and services they provide rise continuously?


If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the aforementioned Huffington Post Investigative Fund article "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" and timeline of industry resistance to government oversight of health IT (link), one document stands out in my mind.

The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted at this link (PDF) is quite fascinating.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  Download the full PDF by clicking here.

The memo begins:

This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information.

 
(I've mentioned MAUDE here and here, including a report of an HIT-related patient death at the latter link.)

To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "Markopolists"):

When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:

In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

 
This is especially true considering the FDA's own noted limitations of their information sources:

Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

 
If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already.

(Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at this Scribd link. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS)

One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices.

When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

and the HuffPo Investigative Fund quotes him as follows:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

 
... a statement easily demonstrable to be without merit, in fact, then one has to wonder where science has gone.

One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia?

Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply.

As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":

"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives."

-- SS

More on Huffington Post Investigative Fund: "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight"

Re: today's Huffington Post Investigative Fund article "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight."

(I'd written some preliminary comments at an earlier post entitled "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight.")

First, some relatively obvious questions about the Cerner health IT crashes at the Trinity Health System chain of hospitals featured in the story:

• How many patients were affected? Is the number actually known?
• Were affected patient charts corrected?
  
• What restrictions, if any, have been placed on physicians, other clinicians, employees, contractors, staff, etc. about speaking to the press on the Trinity Health HIT malfunctions?
• If any restrictions were placed, are they in violation of Joint Commission Safety Standards as in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" at this link?
• Did this healthcare system sign "hold harmless" clauses with Cerner, as per Koppel and Kreda's 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians, JAMA 2009;301(12):1276-1278, at this link?
  
• Did this healthcare system sign a gag clause with Cerner, the vendor of their affected systems according to the Huffington Post article?
• Medical adverse events from medical record errors can occur quickly, or be more delayed. If patient harm comes of the IT errors that occurred, will the healthcare system file a public report?

Now, on to some specific comments and observations on the Huffington Post Investigative Fund article.

The Huffington Post article begins:

Computers at a major Midwest hospital chain went awry on June 29, posting some doctors’ orders to the wrong medical charts in a few cases and possibly putting patients in harm’s way.

The digital records system “would switch to another patient record without the user directing it to do so,” said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.

The bolded passage sounds like obfuscatory PR language, as if the EMR system changed the window focus to another patient's window (people do this all the time when they have multiple windows open in a GUI). If so, that would not be a major problem - the user would just switch back via clicking on the desired window.

Let's state what it sounds like the problem really was with crystal clarity:

Data a clinician entered into the window of primary focus (say, on Mary Jones) would end up in the electronic record of a window that was not the window of primary focus and in the background (say, that of Tom Smith).

The clinician would be unaware this had occurred, and two errors would then occur. The first error was that appropriate data would be missing for Mary. The second is that inappropriate data would be present for Tom. These events put both patients at risk of medical error.

Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren’t being delivered to nurses for dispensing to patients, he said.

Was this 'glitch' [a code word for "we are not in control of our system, it is in control of us" - ed.] related to the problem above? If so, that would suggest major system problems deep within its code. If not, it suggests lax overall quality control of this IT.

“As soon as it was brought to our attention, we moved to fix the problem,” Shivinsky said of Trinity’s system

This statement says nothing. One would not expect them to wait to fix a potentially dangerous problem.

He said nobody was injured in either event, ...

As in my prior post, the correct statement would be:

Nobody was injured, yet, due to the errors.

... the Cerner Corp. system now works properly,

Does that mean all the problems are fixed? The article implies not via its ending where Shivinsky is quoted that:

... Meanwhile technicians are still trying to figure out the root cause. “We’ll get to the bottom of it and fix it,” he said.

By the way, I note the following employee reporting site on Cerner's environment: link. Could this be a factor in Richard Granger, the former head of the UK's NHS national IT programme saying that:

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu 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."

I can only wonder.

... and the hospital chain determined that “technician error” led to the system shutdown and that the mixing up of patients was the result of a “Cerner coding issue” involving software that occurred after an upgrade.

What was the "technician" doing that led to the shutdown, what was the technician's background and qualifications to be doing it to a mission critical medical device?

Further, what, exactly, was the "Cerner coding issue?" Was it Cerner's fault? Trinity's? Both?

Were other organizations using the same software similarly affected?

How will other healthcare organizations learn if the cause of the problems is not revealed?

Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 – at an anticipated tab to taxpayers of up to $27 billion – technology’s boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.

That's not been my observation. Look at the UK for instance:

The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are here (released under the UK’s Freedom of Information Act), and a summary of 16 key points is here.

I wish there were strong documentary evidence on the latter point about major savings, and that there wasn't evidence to the contrary. The healthcare system doesn't have enough spare capital to throw away on the hopes some touted technology (from which an industry stands to make billions) is a panacea.

Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.

That is no excuse for decades of toleration of the flaws. It is an amoral position. As at my July 28 post "An Open Question on Moral Authority and Healthcare IT", it is playing God.

The HuffPo article continues:

“There’s an assumption that just because you have an electronic system, it’s going to be safer, so people let down their guards,” said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.

It's not an "assumption." This meme has been pushed so long by the HIT industry and its irrationally exuberant, uncritical supporters, it's become an accepted statement of fact - as per my July 14 post "Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records" where the Chairman of ONC states it as fact in the New England Journal of Medicine, with nary a footnote to back it up:

Blumenthal - The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

That's pretty definitive. If there's a trace of doubt, I don't see it.

Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn’t sure if federal officials had been notified of the difficulties at Trinity — or would be. No rule requires it.

Why is there no rule? What if this were a medical device such as a CT scanner, or heart defibrillator? Why does health IT get special accommodation when it is now a regulator and governor of clinician communications and actions, placed in between clinician and patient?

Almost a month after the first event at Trinity, David Blumenthal, the government’s top medical health information technology official, didn’t know about it. “First I’ve heard about it,” Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing. Since then, Blumenthal has declined to discuss the incident or its implications.

That's perhaps because it conflicts with his other assertions on health IT technological determinism, noted above. How many other "events" is he aware of?

Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.

What are they hiding? Perhaps other affected healthcare systems?

... Many industry groups contend that FDA regulation would “stifle innovation” and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal’s office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.

In an industry with contractual gag clauses and clinician fear of speaking about HIT problems (e.g., of retaliation by hospital officials), how can anyone be sure of this? Is this a scientific statement, or a marketing position?

See may paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" for more on this issue.

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

This statement is without merit, as per my prior post "Huffington Post Investigative Fund: FDA, Obama Digital Medical Records Team at Odds over Safety Oversight."


Further: note to Dr. Blumenthal: Consensus is not science:

[Chrichton, Caltech Michelin Lecture, 2003] ... I want to pause here and talk about this notion of consensus, and the rise of what has been called consensus science. I regard consensus science as an extremely pernicious development that ought to be stopped cold in its tracks. Historically, the claim of consensus has been the first refuge of scoundrels; it is a way to avoid debate by claiming that the matter is already settled. Whenever you hear the consensus of scientists agrees on something or other, reach for your wallet, because you're being had.

Let's be clear: the work of science has nothing whatever to do with consensus. Consensus is the business of politics. Science, on the contrary, requires only one investigator who happens to be right, which means that he or she has results that are verifiable by reference to the real world.

In science consensus is irrelevant. What is relevant is reproducible results. The greatest scientists in history are great precisely because they broke with the consensus. There is no such thing as consensus science. If it's consensus, it isn't science. If it's science, it isn't consensus. Period

Blumenthal goes on:

In public remarks that day, Blumenthal said he “expects” an eventual certification process for the digital systems to “collect information about the problems that occur with the implementation of electronic health records, if any.” He did not say when that would happen.

Eventual? Why not NOW, considering that the HIT industry has been in business for decades? The infrastructure for such reporting already exists, such as the FDA MedWatch system and Manufacturer and User Facility Device Experience (MAUDE) database - where, by the way, an HIT-related death was reported (link).

Imagine the aviation, nuclear energy industry or pharma making such outrageous statements about getting around to collecting information on potentially hazardous flaws "eventually."

In a later interview, Blumenthal said “safety concerns are not being ignored,” but wouldn’t comment further.

Yes, they are being ignored. Worse, they're being suppressed as in this case example, "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare."

... Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.

Just anecdotal, according to ONC and others.

“People just assume that computers will make things safer,” said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. “While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards.”

This is a principle direct from the discipline of Social Informatics. Social Informatics (SI) refers to the body of research and study (e.g,, as collected here) that examines social aspects of computerization, including the roles of information technology in social and organizational change, the uses of information technologies in social contexts, and the ways that the social organization of information technologies is influenced by social forces and social practices.

Some experts are calling for closer government monitoring of the systems to protect the public. “We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they’re deployed,” said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.

I am one of those experts, and I agree.

... In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach “without substantial regulation.”

“The time wasn’t right at that time to move forward or the support wasn’t there (for safety regulations),” said Robert Kolodner, who ran the national coordinator’s office during some of the Bush years.

Again, I ask - why the hell not? When is a good time to discuss healthcare and HIT safety? Would such attitudes be tolerated in other industries? I dare say, hell no.

Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren’t a “primary concern” as tech companies began to expand their offerings.

That is a startling revelation - it could be the basis for medical malpractice plaintiff lawsuits on the basis of negligence, all the way to criminally negligent homicide if a patient dies of an HIT-related event.

Criminal negligence: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner.

The HuffPo article further observes:

Earlier this year, the [health IT] trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn’t think the organization would take a stand on government regulation of the industry, but said: “We recognize that there are significant challenges that the field as a whole is facing.”

The "first time" in an industry messing with people's medical care for decades? How is this possible?

... ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.”

Just how many "anecdotes" do we need in an industry that places gag clauses on health IT users?

[March 2011 addendum - see thoughts on health IT "anecdotes" at this posting: Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost, Supreme Court-Style - ed.]

He told the Investigative Fund that he believed nothing in the report indicated a need for regulation [i.e., absence of evidence in a tight-lipped industry as evidence of absence - ed.] Yet others see anecdotes as a starting point for a more methodical look at problems that arise.

Who is more attuned to risk mitigation when they see red flags? Who are the clinician scientists, and who are the "see no evil, hear no evil, speak no evil" politicians?

The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls.

Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a “broad consensus” among experts that electronic medical records need to function better and safer. “The truth is that we do not at this time know what would make an EHR (electronic health record) safe,” he said.

Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren’t designed in ways that prevent and limit new errors—and that nobody is holding the industry accountable.

Again I ask: how is this possible after decades of this industry's selling of products to hospitals for use on actual patients?

Also, the simple question arises: is this technology truly ready for the ambitious national roll out plans of the past two administrations?

I've touched on many of these issues in past years on this blog and at my academic website on HIT problems.

I see a clear runaway train and train wreck headed down the tracks.

The next few years in health IT should prove interesting indeed.

-- SS