Merck in Two Tubs of Hot Water Over UK Marketing Practices

Merck, Sharpe & Dohme (MSD), the British subsidiary of Merck & Co, seems to have gotten into two separate tubs of hot water over its marketing practices in the last week.

The Times (UK) reported that MSD was suspended from the Association of the British Pharmaceutical Industry (ABPI) for "serious breaches" of its code of conduct. "Merck had offered to provide nurse advisers to help GPs to screen and monitor diabetic patients with high blood pressure. But the company made it clear that only surgeries that regularly used one of its blood pressure drugs, Cozaar, would benefit from the programme." Information about the practice came from "an internal e-mail from a senior manager at MSD and a slide presentation [which] linked the 'Cozaar nurse audit programme' with the drug and referred to sales and prescribing quotas that had to be fulfilled before a surgery could be offered the service...."

Meanwhile, the British Medical Journal reported in its news section that MSD was also "publicly admonished" by the Prescription Medicines Code of Practice Authority for entertaining "doctors and their spouses at a meeting with no clear educational content in an unsuitable venue." The venue was a Chinese restaurant, and the company was unable to come up with any documentation of the educational content of the meeting.

On one hand, it's nice to see a little bit of self-policing going on here. On the other hand, this is probably just the tip of the iceberg of these sorts of pharmaceutical marketing practices that subvert the physician's role as agent in service of the patient's best interests. And we should be thinking about how pharmaceutical companie seem to have so much money on hand to engage in such practices while other parts of the health care system cry poverty

On Intel's and Walmart's "prescription" for Healthcare IT

A medical "prescription" from microprocessor manufacturer Intel's chairman appeared recently. Some who attended this talk have opined that the AP may have not reported his speech entirely accurately, but my feeling is that the gist is likely correct, as I've heard this type of industry prescription for "revolutionizing medicine through computing" (with design and implementation dominated by non-clinical business and IT personnel, of course) numerous times before. I attemped to contact Intel via its public relations office last week and they promised me a call to clarify the AP article, but I have not heard back from them.

With that caveat in mind, paraphrased from the article below, this latest industry view appears to be: "Healthcare is responsible for offshoring, so healthcare better computerize itself, which is easy since other industries like Wal-Mart did it; computers will solve all of healthcare's ills - and therefore save American industry." Wow...

Intel's Barrett blames broken health care system for U.S. job exodus

WASHINGTON (AP) - Intel Corp. chairman Craig Barrett warned Tuesday that U.S. jobs will continue to move offshore at a rapid pace unless corporate America exerts its power to force the health care industry to adopt systems that will cut costs and improve efficiency.

... ``Every job that can be moved out of the United States will be moved out ... because of health care costs,''

Employers should demand that hospitals select standardized record systems to lower costs or take their company's business elsewhere, Barrett told a crowd of 400 at a hotel ballroom.

``The (health care) system is out of control, it's unstable, it's basically bankrupt, it gets worse each year and all we do is tinker around the edges when what we need are major fixes,'' Barrett said, adding that health care costs make it increasingly difficult for U.S. companies to compete with rivals abroad.

The speech came on the same day that health care research group Kaiser Family Foundation reported that health care premiums rose at a 7.7 percent annual rate last year, double the pace of consumer inflation.

Barrett, who chairs the world's largest computer chip maker, said companies should only do business with health care providers who meet certain standards, including fully electronic patient records and published ``best practices'' for patient treatment. Hospital networks could and should be transformed into ``competitive centers for excellence'' that are paid to keep employees healthy.

... Barrett was joined on-stage by Wal-Mart Stores Inc. Executive VP Linda Dillman. He said the health care industry could learn from the efficiency of the retail giant, which tracks every item in inventory using computers.

``Every other industry has adopted this technology and (the health care) industry continues to sit here and debate,'' Barrett said.

The seeming naivete about the complexities of healthcare and the non-sequiturs in this "prescription" are of significant concern.

First, the most troubling issue is an accusatory tone in placing blame for offshoring and deficient US industrial competitiveness on healthcare, not on industry leadership's short-sightedness in maximizing profit and return to investors and speculators at the expense of American workers through socially-disruptive mass layoffs and exploitation of the Third World. This is not to mention other varieties of managerial incompetence, and yes, good old-fashioned corruption, Enron-style.

Also not mentioned regarding healthcare costs is the profit motive of "managed care" and the corruption in the healthcare industry itself as seen on Healthcare Renewal. These are problems computers are unable to solve and will not solve.

(If one is going to fling mud and accusations, I find the somewhat dated site of the Anti-Intel Association and stories such as this one - also see here and here - regarding an aggrieved Intel employee quite interesting.)

Next, Barrett's prescription brings to mind Donald Lindberg's admonition in 1969:

As far back as 1969, EMR and Medical Informatics pioneer Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, made the following observation. He wrote that "computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

Here is Mr. Barrett's bio:

Craig R. Barrett became Chairman of the Board of Intel Corporation on May 18, 2005. He became Intel’s fourth President in May of 1997 and Chief Executive Officer in 1998. He was elected to Intel’s Board of Directors in 1992 and served as Chief Operating Officer from 1993 to 1997. Barrett began his tenure at Intel as a Technology Development manager in 1974. Prior to joining Intel, Dr. Barrett was an Associate Professor at Stanford University in the Department of Materials Science and Engineering.

This will look familiar to Healthcare Renewal readers. Mr. Barrett apparently understands healthcare from the perspective of a lay businessperson, not from a seasoned clinician's perspective.

It also brings to mind the lack of knowledge of such people of the severe difficulties even a state-controlled medical system has encountered trying to "computerize" its GP's:

Sunday, 6th August 2006

Leaked papers reveal NHS computer problems

A multi-million pound national project to upgrade computer systems across the NHS has been so dogged by problems that hospitals would have been better off if it had never been started, according to a confidential document apparently written by one of the scheme's most senior former executives.

The anonymous document, obtained by The Observer, appears to have been sent from the computer of David Kwo, who was in charge of implementing the Connecting for Health system in London until last year.

The analysis warns that "the NHS would most likely have been better off without the national programme, in terms of what is likely to be delivered and when.

Not to mention what all too often happens in this country in our own healthcare IT projects.

Barrett's prescription brings to mind my admonition that "clinical computing and business computing are two different specialties of computing":

... Today the IT personnel and non-medical managers (e.g., non-degreed IT staff, BS or MS in computer science, MBA's, even PhD's) who often hold leadership roles in EMR and clinical data research initiatives via control of critical decisions, budgets and resources, often have inadequate or nonexistent clinical experience and insight. Specifically, personnel of an information technology background, with little or no background in the biomedical sciences, often are empowered as enablers, rather than facilitators, of such initiatives. They retain a major say in what is -- and is not -- done, and in the tools provided to perform clinical care and biomedical R&D.

From a dual perspective as both a clinician and computer professional, it is evident that this arrangement is faulty, and that critical clinical computing projects benefit greatly from an alternate approach to project preparation, development, implementation, customization and evaluation as compared to management information systems (MIS) projects. Clinical computing and business computing are different, highly distinct subspecialties of computing.

IT personnel in hospitals often believe that success in implementing management information systems applications ("business computing") supersedes or actually renders unnecessary the mastery of medicine in leading and controlling implementation of clinical computing tools. Yet, mastery of applied IT towards implementing management information systems is in large part mastery of process (e.g., in acquiring and supporting vendor-written software) and repetition, as opposed to the practice of medicine, which requires mastery of complexity.

In other words, applied IT is a field of a relatively small number of principles, a large number of arbitrary conventions and rules, and a narrow body of knowledge applied repetitively and programmatically, often without scientific rigor. This may be illustrated by the fact that most areas of applied IT can be done well, and often are, by those with little or no formal training. This is not to imply that applied IT is itself easy, which it is not. There is no substitute for talent and real-world experience.

In clinical IT settings, however, there must be the right experience. Experts in clinical computing must provide effective solutions via seasoned application of the concepts, techniques, knowledge, and processes of medicine, and display an expert level of critical thinking in applying principles, theories, and concepts on a wide range of issues that are unique to clinical settings. Business IT experience alone does not provide a sufficient background for such responsibilities to be carried out effectively. Further, medicine is a domain of many difficult, nonintuitive principles, experimentally-derived natural laws, and a large body of knowledge applied in a broad, interconnected manner, ideally with critical scientific rigor. It cannot be practiced successfully without significant mastery of an enormous body of biomedical knowledge and significant hands-on patient care. The IT model of "If it's information, we do it" starts to fall apart and impede progress in such organizationally and sociologically-complex environments.

Finally, such industry admonitions bring to mind the fact that effectiveness of clinical IT in reducing costs has not yet been proven - it's still considered an experiment. Such admonitions also bring to mind the fact that the healthcare system has little discretionary capital for IT misadventures, as well as the dirty industry secret that many IT projects across all domains fall severely below their design goals or fail outright:

Journal of Accountancy , Feb, 2001

Research shows high failure rate on IT projects - information technology

A September survey by the Gartner Group, a technology consulting company, revealed that approximately 40% of information technology (IT) projects do not produce their intended results--an indication of how badly some companies need the consulting services of a tech-savvy CPA. Gartner's prediction that global IT spending will reach $3.3 trillion by 2002 highlighted the broader implications of this finding.

(Also see Statistics over IT Failure Rates - ed.)

With these issues in mind, such a prescription from the head of a microprocessor manufacturer and mass-merchandiser would be risible if it weren't so presumptuous and misleading.

This is not to mention that the prescription transfers many of those rare healthcare dollars into the IT industry. That is not simply a small conflict of interest.

Rather than trying to lay blame for U.S. industry's competitive problems and offshoring on the healthcare industry, and bludgeon healthcare and healthcare providers with presumptuous prescriptions, Intel and Wal-Mart should be investing money in improving understanding of how healthcare IT goes wrong, and developing best practices for design and implementation, in concert with medical societies, medical professionals and the informatics and IT vendor community.

Healthcare IT is not so simple. Put in terms Mr. Barrett might understand, just as the semiconductor industry has hit a wall of difficulty in moving CPU clock speeds beyond about 3 GHz due to limitations of engineering, physics, manufacturing, and our imperfect understanding of what goes on in submicron geometries at such high speeds, so there are difficult social and technical issues in healthcare that make computerization extremely challenging and certainly not a panacea as he rather naively suggests.

Semiconductor research is ongoing to overcome these difficulties, as is Medical Informatics research to better understand the difficulties in the healthcare IT world. Bludgeoning healthcare organizations into ill-conceived IT initiatives is not a useful solution.

Finally, as an aside, clinicians generally don't complain about anti-competitive or wasteful practices in the microprocessor industry.

I could complain that tens of millions of person-hours and billions of dollars were wasted dealing with the segmented memory architecture of the Intel 8086/8088 and the resultant fritter, workarounds and bugs, as opposed to other designs such as the Motorola 68000 with linear addressing. This is a design issue that should have disappeared with the likes of the PDP-8. See The Curse of Segments for more on this issue:

... The [Intel] 8086 was an ill-conceived attempt to provide an address space larger 64K bytes [of the older 8 bit microprocessors] without actually incurring the costs of a larger architecture. The 8086 is basically a 16/16 architecture. It has a 16-bit program counter, a 16-bit ALU, four 16-bit general purpose registers, and some 16-bit index registers. It also has four 16-bit segment registers. The 8086 performs all computation and data transfer in 16-bit arithmetic, with one exception. Immediately before gating an address onto the external address bus, the 8086 selects one of the segment registers, shifts it 4 bits to the left, and adds the address to it, using 20 bit arithmetic. The external address is therefore 20 bits, and the processor has an address space of 1M byte.

... Under normal circumstances, a design so twisted and flawed as the 8086 would have simply been ignored by the market and faded away. However, 1980 was Intel's lucky year. IBM chose the 8086 as the processor for the PC. Backed by IBM's marketing might and name recognition, the IBM PC quickly captured the bulk of the market.

Anyone remember extended v. expanded memory? Programs like EMM386 that used extended memory to simulate expanded memory? The crashes and unreliability of Windows 2.0, 3.0, 3.1, 95, 98 and ME that tried to force parts of a large, complex operating system down the throat of segmented-architecture processors, in effect trying to make a silk purse out of a sow's ear? This is something we still haven't fully recovered from, and those who still use Windows ME or earlier may know what I'm referring to.

But I don't complain about this, because clinicians should not be telling the microprocessor industry how to run their businesses. Perhaps that industry could return the favor.

As I have written regarding IT, a person is either part of the solution or part of the problem. In my opinion, this kind of advice from large corporations is part of the problem.

(Note: I use both Intel-based and non-Intel based computers equally.)

Pharma: Not So NICE

The Guardian (UK) just reported that "multinational drug companies have been lobbying ministers in an attempt to subvert the independent appraisal process and get their expensive new medicines approved for large-scale use in the NHS...."

The Guardian documented how "over the eight months from October to May this year, senior executives from 10 drug companies met ministers to press for favorable decisions on their products. The executives were highly critical of the National Institute for Clinical Excellence (NICE), an independent expert body set up to decide which drugs are cost effective for use in the NHS."

For example, "manufacturers, led by Pfizer, have been complaining to ministers about NICE's position on their controversial Alzheimer's drugs." So, "at a meeting in October with the minister, Pfizer executives made it clear that they 'were unhappy with the NICE decision... and thought their processes were flawed." Later, "Pfizer executives warn[ed] the minister, it could always take its business elsewhere. 'Pfizer ... noted that there is a complacency in some quarters of Whitehall regarding their continued investment in the UK. Pfizer asked for more public support from the government for a robust pharmaceutical industry in the UK and more consultation/dialogue with government.'"

The Guardian documented that executives from other companies, including Eli Lilly, Johnson & Johnson, and Bristol-Myers-Squibb [link]. About the latter meeting, which included former BMS CEO Peter Dolan, who was since let go by the company, BMS director of external affairs Richard Marsh said, "companies have a legitimate interest in getting the best for their products and getting a positive appraisal by NICE." On one hand, "I don't think the NICE process is necessarily undermined." On the other hand, "he added that companies want to invest in countries with a 'favourable environment.'"

The actions recounted in this article seem to conflict with public pronouncements made by some pharmaceutical companies. For example, the Pfizer Inc. statement of vision and values includes,

We demand of ourselves and others the highest ethical standards, and our products and processes will be of the highest quality.

We play an active role in making every country and community in which we operate a better place to live and work, knowing that the ongoing vitality of our host nations and local communities has a direct impact on the long-term health of our business.

How did the suggestion to the UK minister not to have too much "complacency" about Pfizer's continued investment in the country, coupled with their criticisms of NICE's processes as "flawed" square with this vision?

The Guardian's account suggests that however much apparent public respect some pharmaceutical companies declare for the scientific method, evidence based medicine, and rational decision making, they will make end runs around them to "get the best for their products." Furthermore, clearly a few companies were willing to pressure the UK government with veiled threats to make their investments elsewhere should they no longer perceive the environment as "favourable."

This is a reminder to be skeptical the next time a pharmaceutical company pledges its faith in clinical science, and to be more skeptical when it is such a company that is controlling the design, implementation, and dissemination of clinical research.

Another Attempt at Suppression of Medical Research: Bayer and Trasylol

The New York Times reported that "Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart surgery medicine might increase the risks of death and stroke, the [US] Food and Drug Administration announced Friday."

Bayer scientists even appeared at a public meeting called by the F.D.A on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.

In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study's existence only on Wednesday.

A top F.D.A. official said the agency learned of the Trasylol study on Wednesday only after getting a tip from a researcher involved in it.

In a written statement, Bayer said 'that it mistakenly did not inform' the F.D.A. of the study and added, 'This data was not shared immediately with the agency because it was preliminary in nature.'

Bayer's study was performed by a contract research organization [whose name was not disclosed]. But Bayer did not inform the F.D.A. that the study was being done, even though that is routine practice.

It examined hospital record of 67,000 patients, 30,000 of whom received Trasylol. The rest got other drugs. It concluded that patients given Trasylol were at greater risk.

Trasylol is the trade name for aprotinin. It is used to reduce the systemic inflammatory response after cardiac surgery.

This case just seems to be just the latest example of a commercial research sponsor attempting to withold the results of a study which turned out not to be favorable to its interests. We have previously posted on other examples of such research suppression, e.g., see this post for discussion of some classic cases from the 1990s, and this post on the attempted suppression of the Famvir vs Valtrex study.

Each new example raises the worry that the entire clinical research base may be distorted by such witholding.

The Times quoted Senator Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, "The remedy is mandatory reporting of all clinical trials and real teeth for the F.D.A to do its job holding drug companies accountable."

The current story, however, is one example of why this would not be complete remedy. The Trasylol study was an observational study, not a clinical trial, and hence would not be included in currently proposed mandatory reporting schemes.

I believe that this is another reason to question whether commercial health care firms should have any role in clinical studies meant to evaluate their products.

Were the "Elephant Men" Given TGN 1412 Infusions Too Fast?

We have posted frequently, here, here, here, and here, about the disastrous trial, now colloquially known as the "elephant men" trial after the bizarre clinical effects it produced, implemented by Parexel International , of a new monoclonal antibody designated TGN 1412, manufactured by TeGenero AG, which is now bankrupt. Last week, the Times (UK) found new information suggesting another hypothesis about what went wrong.

A "reckless” mistake apparently overlooked by government regulators lay behind the drug trial disaster that saw six young volunteers badly injured by an experimental medicine.

Confidential documents obtained by The Sunday Times and Channel 4’s Dispatches programme reveal the drug was administered on average 15 times more quickly to the volunteers than to monkeys in earlier safety studies. The possibility that such a crude error led to the disaster is likely to raise questions over whether the government’s Medicines and Healthcare products Regulatory Agency (MHRA) scrutinises trials adequately and protects the public from the risks of new medicines.

Experts say the drug, TGN1412 — one of a new generation of “magic bullet” treatments targeting the immune system — was infused so quickly into the volunteers that the potential for life-threatening problems was foreseeable.

'When you give an antibody . . . the quicker you put it in, the more likely you are to get an infusion reaction,' said Professor Terry Hamblin of Southampton University, a leading authority on monoclonal antibodies, the family of drugs to which the trial medicine belonged.

The volunteers were given TGN1412 in only three to six minutes. 'To quickly infuse it over three to six minutes in six individuals I think is . . . reckless,' said Hamblin.

Hamblin’s judgment is backed by other experts, including Dr David Glover, formerly chief medical officer of Cambridge Antibody Technology. He concludes: 'The drug was given too quickly.'

The speed at which the monkeys received TGN1412 was set out in the application to the MHRA for permission to carry out the trial. This was submitted by Parexel International, a contract research company, on behalf of TeGenero, a tiny German drug developer. But the paperwork did not explicitly detail how quickly the volunteers would be given the drug, although this could be calculated from the information given.

Parexel declined to comment.

And TeGenero is now bankrupt.

Obviously, whether an excessively rapid infusion of TGN 1412 lead to the terrible results of this trial is unproven. Hopefully, some sort of more detailed official inquiry might come to more definitive conclusions. Yet, as we said in a previous posting, "clearly, this article raises concerns about whether Parexel could have done a better job protecting its research subjects. Minimizing the risks to human research subjects should be the highest priority for those who do clinical research."

Parexel's web-site page on clinical research services states,

Your success depends on your ability to move your product concept from early research through clinical trials and regulatory review to the market in the shortest possible time. The bottlenecks and hurdles in your path, both known and unknown, must be identified and eliminated. Over the past two decades, PAREXEL has helped nearly a thousand clients find success.

Maybe the company's focus on speed hindered its ability to protect its research subjects.

In my humble opinion, it is time to re-think whether clinical trials of drugs and devices should be designed by the companies that make the products, implemented by for-profit contract research organizations, and supervised by for-profit "institutional review boards," as they are called in the US. If we continue these practices, we clearly need to think how to regulate them. Better yet would be to have these trials done by independent organizations who are not beholden to the manufacturers and whose missions include a priority on protecting their human research subjects, and then who are supervised by reviewers with similar independence and similar commitment to patient welfare.

WHAT YOU CAN DO: In the US, write your Representative or Senator, in the UK, contact your MP, and ask for a legislative review of how clinical trials of drugs and devices are designed, implemented, and supervised, with emphasis on scrutinizing the influence of the manufacturer (who want their products t0 look good), and the contract research organizations and for-profit review boards that serve the manufacturers.

King/Drew Continues Downward Spiral

The situation at the King/ Drew Medical Center in Los Angeles continues to spiral downwards. We had previously posted (here and here) about the ongoing troubles at the medical center. Long viewed as a symbol of progress for poor and minority patients in the city, it had fallen on very hard times, attributed to bad management that for a long time hid behind the banner of the hospital's reputation in the community.

Last week, the Los Angeles Times reported that the medical center had failed a key medical inspection, and is threatened with loss of all its Medicare and Medicaid payments at the end of the year. "During the latest inspection, the hospital failed nine of the government's 23 conditions for federal funding, according to a letter from the U.S. Centers for Medicare and Medicaid Services...." One of the problems found during the latest inspection were a lack of "appropriately trained and competent" staff to attend cardiac monitors on one unit. The letter noted "This is especially troublesome, because previously documented cases showed that patients died when nurses at King/Drew failed to heed heart monitor warnings." Another article early this week repeated the entire chronology of King/Drew's problems. Today the Times reported that the most likely strategy to be used to continue to provide medical care to King/Drew's patients is to hand over operation of a down-sized facility to another Los Angeles County hospital, Harbor-UCLA Medical Center.

A few lessons from this sorry story: in health care, it is often the whole institution and its most vulnerable constituencies that suffer for the mistakes made by top managers; and that bad managers can hide for a long time behind institutions that enjoy a favorable reputation.

How Merck and other companies saved billions in taxes

This story appeared in the Wall Street Journal yesterday. It is yet another tale of companies who publically take pride in their "civic commitments to improve society" privately ducking their civic commitments to pay taxes - leaving more of that burden to the ordinary worker (and patient).

The Al Capone quote by the professor who "invented" these tax-avoidance strategies is particularly disturbing ("a good lawyer with a briefcase can steal more than ten men with machine guns"):

Bermuda Triangle: How Merck Saved $1.5 Billion Paying Itself for Drug Patents; Partnership With British Bank Moved Liabilities Offshore; Alarmed U.S. Cracks Down; 'The Art of Tax Avoidance'
Jesse Drucker, Sep 28, 2006.

SOUTHAMPTON, Bermuda -- Merck & Co.'s medications Zocor and Mevacor have been used by millions of people to help lower their cholesterol. But Merck also used the drugs to lower something else: its U.S. tax bill.

Thirteen years ago, Merck set up a subsidiary with an address in tax-friendly Bermuda, in partnership with a British bank. Merck quietly transferred patents underlying the blockbuster drugs to the new subsidiary, according to documents and people familiar with the transaction. Merck then paid the subsidiary for use of the patents.

The arrangement in effect allowed some of the profits to disappear into a kind of Bermuda triangle between different tax jurisdictions. The setup helped Merck slash $1.5 billion off its federal tax bills over roughly the next 10 years.

Now, the complicated transaction -- never publicly disclosed -- has sparked one of the largest tax disputes ever involving a U.S. corporation. The Internal Revenue Service is challenging the tax benefits from the arrangement, which the company code-named "Project Ryland," after a fancy restaurant near the company's New Jersey headquarters. Merck anticipates it will be ordered to hand over a total of $2.3 billion in back taxes, interest and penalties, according to its filings with the Securities and Exchange Commission, which give the amounts in dispute but virtually no other details.

... Many of the strategies like the ones used by Merck, Dow and GE were inspired by one man. In 1988, longtime tax attorney and New York University law school professor R. Donald Turlington published an influential article in the proceedings of a tax conference. Subtitled "The Art of Tax Avoidance," the article began with a 1931 quote from the late Chicago Mafia boss Al Capone: "A good lawyer with a briefcase can steal more than ten men with machine guns."

In the article, Mr. Turlington laid out ways companies could lower their taxes by exploiting a loophole in the way income was allocated within partnerships for tax purposes. He focused on the concept of depreciation, a key tool to lowering taxes.

Mr. Turlington, now retired, says the Merck deal with Abbey was a tax-advantaged way to raise significant capital, and not simply a tax- saving measure. "In my mind the question with a deal like Merck was, and still should be, 'Can a taxpayer who decides to do something for a legitimate business reason, like raising [money], do it in a way that's tax efficient by taking advantage of a rule that the government wrote?'" He added: "Merck's obligation is to do the best it can for its shareholders. If you were going to write that Merck is under some higher social obligation to maximize its taxes, that would probably catch Merck by surprise."

With regard to Mr. Turlington's statement about corporate social obligations, I can add (as the former Director of Scientific Information Resources and The Merck Index of Chemicals, Drugs & Biologicals) that Merck's "higher social obligation" was spelled out in the corporate values it taught its employees.

Employees were advised that their actions should obey not just the letter but also the spirit of the law. As a crucial self-test, employees were admonished to consider how their actions might be perceived if they appeared in print .

Ironically certain tax-related actions, while apparently adhering to the strict letter of the law as written, have now indeed appeared in print and seem to reflect someone perhaps not entirely heeding that admonition. Another unfortunate hit to corporate and industry reputation will likely follow, with negative consequences on an industry essential to improving health.

As far as an obligation to shareholders, as a biomedical information scientist I had some crazy ideas about actually providing R&D scientists with better access to rationed computer-informatics tools essential for drug discovery, which would increase research cost slightly (i.e., decrease profit slightly) at the great risk of improving the drug pipeline.

As part of a cost-cutting initiative I was laid off in Nov. 2003 perhaps due to my odd NIH/National Library of Medicine-inspired information scientist ideas along with 4,400 others, at a time of perhaps the lowest hiring rates in decades in the U.S., at great disruption to our lives (especially those of us with gray hair on our heads). This cost-cutting was prior to the Vioxx difficulties and was due to the failure of several late-stage drug candidates ... and a weak new-drug pipeline.

That $1.5 billion could at least have been used to keep those 4,400 gainfully employed.

Even Al Capone rewarded loyalty.

Reasoning by (Mis)Analogy Redux: General Motors and Health Care "To Specs"

The Detroit News published an article profiling one Sam Shalaby, who works at General Motors.

Sam Shalaby is a car guy. He used to run a Delphi components plant in Dayton, and his language is still sprinkled with manufacturing terms....

What is the relevance to Health Care Renewal? Sam is now director of community health initiatives for General Motors. Some of his thoughts:

If we ran an auto plant like they run hospitals, we'd be out of business. The medical system is so obsolete, no one understands how to make it work.

We build cars to specs. Hospitals should treat patients to specs.

The article shows that Shalaby's thinking is reflected at even higher levels of General Motors management. It quoted GM CEO Rick Wagoner,

If you want to buy a car, you can go on the Internet, and you can check out the Consumer Reports rating, the J.D. Power rating, the relative stopping distance, the relative resale value, you know all these things.

It amazes me that you could be going into a surgery tomorrow and genuinely want to know about the place you're going, how many times they've done this surgery, how successful they've been, and more than likely, you won't be able to find that information. This is Business 101.

There is considerably more in the article, and some of its criticisms of doctors, hospitals, and the health care system are right on.

But the notion that treating patients in a hospital and making cars on an assembly are closely analogous just amazes me. It is true, as Shalaby says, that automobile makers build cars "to specs." After all, they designed the cars themselves, based on the laws of physics, and engineering principles.

But human beings are not built, much less built "to specs." In fact, our understanding of human biology, physiology, etc is obviously incomplete. Human beings are orders of magnitude more complex than automobiles. Hence our understanding of how to fix their physical problems is also incomplete. Human beings show up in doctors offices or to hospitals with unique sets of circumstances, characteristics, and problems. So the statement, found in the article, "treatment for identical medical conditions varies widely," is close to nonsensical, since different people with sore throats, pneumonia, depression, or whatever may have problems given the same overall name, but are hardly identical.

We have blogged before about how business people with limited understanding of health care seem happy to charge in with simplistic solutions to complex health care problems based on unsupportable analogies. (See post here about a previous leader of Intel who thought hospitals were like computer chip factories, and here about a New York Times op-ed comparing hospitals to companies like Toyota.)

Why they feel so confident in doing so is beyond me. I may be a "car guy," and have an engineering degree, but I would not feel competent to jump in and assume a leadership role in automobile design at GM.

Maybe the car guys now in charge of health care should consider a quote attributed to H L Mencken:

For every complex problem, there is a solution that is simple, neat, and wrong.

The P4P Band-Wagon Rolls, But in Whose Interests?

We have posted skeptically here and here about pay for performance (for physicians) (P4P), one of the most fashionable notions in health care management circles. Briefly, our concerns were that P4P could lead to perverse incentives (by rewarding apparently better rates of good outcomes which could be created by avoiding the sickest patients, or emphasizing a few measured processes and thus distracting physicians from doing anything else, or being based on inaccurate or irrelevant data), could emphasize cost cutting over quality, and could emphasize processes which have been better studied, potentially penalizing the specialties that did the most research about quality.

Nonetheless, the august US Institute of Medicine (IOM), part of the National Academies of Science (NAS), has recently given P4P another push. According to the Hartford Courant,

In a report to Congress released Thursday, the respected Institute of Medicine endorsed the system called "pay for performance," under which doctors who treat Medicare patients would get paid more for doing a better job.

Since it was enacted in 1965, Medicare has paid doctors for how much they do, said Robert Galvin, director of global health care for General Electric in Fairfield and a member of the Institute of Medicine Committee.

"This is based on how well they do," he said. "That's a big conceptual change."

The system for measuring quality of care is still evolving, but essentially would work this way:

Treatment prescribed by a doctor - including tests, drugs and other procedures - would be measured against a list of scientifically proven standards for treating a given condition. A doctor would gain points toward bonus pay for each standard met.

The new system, which could take years to implement, is designed to save federal money by providing better care that prevents expensive complications and hospitalizations.

Thus the authors of the report did not seem overly worried about the concerns we raised above. The report may also have been written before the publication of a systematic review of pay-for-performance (Petersen LA, Woodard LD, Urech T et al. Does pay-for-performance improve the quality of health care? Ann Intern Med 2006; 145: 265-272.) That review concluded that although there was some evidence of improvements in quality, "in all, 4 studies suggested unintended effects of incentives."

Another question is whose interests the IOM report really represents. The Center for Science in the Public Interest (CSPI) recently released a report about conflicts of interest at the NAS, including the IOM, "Ensuring Independence and Objectivity and the National Academies." To quote its executive summary,

This report focuses only on the selection process for and composition of NAS panels.
In 1997, NAS committees funded by the federal government came under the jurisdiction
of the Federal Advisory Committee Act (FACA). Congress required the agency to avoid using scientists with direct conflicts of interest on study panels (unless their expertise is deemed essential and not available elsewhere) and to seek balance on points of view. This report found serious breaches of both of those rules.
Finding: Nearly one out of every five scientists appointed to an NAS panel has
direct financial ties to companies or industry groups with a direct stake in the outcome of that study. This consistent pattern of appointing scientists with conflicts of interest clearly violates the spirit of the Federal Advisory Committee Act amendments that apply to NAS.

Finding: NAS did a poor job of balancing points of view on a majority of the study panels examined. The NAS does not appear to consider information about potential bias or conflicts of interest prior to nominating individuals to a committee. As a result, about half the panels examined had scientists with identifiable biases who were not offset by scientists with alternative points of view.

Finding: The NAS provides brief biographies of nominees to its committees on the agency’s website. Such biographies could assist people who were considering commenting on a committee’s composition. However, those biographies are woefully
inadequate because, in a majority of cases, they fail to provide crucial data
regarding conflicts of interest and points of view.

The 23 authors of the IOM report on P4P, "Rewarding Provider Performance: Aligning Incentives in Medicare," include several from large corporations presumably in their role as employers (e.g., General Motors, General Electric, and JP Morgan Partners.) Based on CSPI's findings, it should come as no surprise that a there were several others with apparent conflicts of interest which were not revealed in the listing of the committee responsible for the IOM report, that on Redesigning Health Insurance Performance Measures, Payment, and Performance Improvemnt Programs.

Most strikingly, the committee included four people who were members of the boards of directors of 13 various health care corporations. Three of these individuals were identified only as academics, and one only as an employee of a corporation not obviously involved in health care:

• Nancy-Ann Min DeParle, identified as a Senior Advisor, JP Morgan Partners LLC. Ms DeParle is a member of the board of directors of Boston Scientific, Triad Hospitals, Cerner, and DaVita Corporation.
• William A Peck, identified as Director, Center for Health Policy, WAshington University School of Medicine. Dr Peck is a member of the board of directors of Angelica Corporation.
• Samuel O Thier, identified as Professor of Medicine and Health Car Policy, Harvard Medical School. Dr Thier is a member of the board of directors of Charles River Laboratories and Merck.
• Gail R Wilensky, identified as Senior Fellow, Project HOPE. Dr Wilensky is a member of the board of directors of Cephalon, Gentiva Health Services, ManorCare, Quest Diagnostics, SRA International, and UnitedHealth Group.

Thus the band-wagon for P4P rolls on, but whose interests it represents remains unclear. Clearly industry may see it as a way to cut costs and make more money. Whether it will be good or bad for patients remains unclear.

Will DMC Run From Wayne State?

No, this isn't about rap music... but this story does typify the clash between physicians' professional and academic values, and the business culture now dominating health care.

The Detroit News recounted the serious rift that has developed between Detroit Medical Center (DMC), a large, up to know academic medical center that also served many poor people in Detroit, and Wayne State University's medical school.

A bitter contract dispute between Wayne State University and the Detroit Medical Center is coming to a head, threatening the survival of medical programs that care for the region's needy and serve as a crucial training ground for Michigan doctors.

The nation's largest medical school and the eight-hospital system are entrenched in a years-long battle over terms of contracts that bind the institutions as a medical school and teaching hospital.

The national body that accredits graduate medical programs, effectively deciding whether they can operate, has caught wind of the troubles in Detroit and is giving the two sides until Oct. 1 to report on where they stand.

Without approval from the Accreditation Council for Graduate Medical Education, Wayne State and the DMC face losing nearly 1,000 medical residents and hundreds of faculty physicians who make up the core of programs that treat the city's poor and uninsured and train hundreds of doctors a year.

Why are these two partners at odds?

Wayne State says the DMC's increasing focus on the bottom line conflicts with the medical school's focus on research and community care. The DMC says the medical school is abandoning Detroit by looking to set up operations in the suburbs and forming alliances with hospitals that compete with the DMC.

Already, the fight has cost the region an orthopedic residency program, forcing 24 DMC residents to find new hospitals in which to finish their education. The accreditation council has asked for the voluntary withdrawal of the cardiothoracic surgery residency, because of similar squabbling. WSU wanted to team with Oakwood Health System because it performs more surgeries in that field; the DMC objected.

[Wayne State School of Medicine Dean Robert] Mentzer said the DMC, in its efforts to remain profitable, is moving away from programs that cater to community and research needs.

The medical school, for example, wants an emphasis on family medicine, urology and dermatology. The DMC, meanwhile, is looking to carve out a niche as a heart hospital, of which there are several in the area, he said.
'When a hospital system develops a business strategy that is no longer consistent with our mission, we have to re-evaluate,' Mentzer said.

He said WSU has looked to partner with other hospitals to help meet the medical school's needs.

That has irritated Duggan and the DMC and resulted in disputes over contracts. Mentzer said he has submitted a proposal to Duggan that would include no pay increase to Wayne State despite higher operating costs at the medical school.

[Detroit Medical Center CEO Mike] Duggan has said Wayne State's efforts to pair with other hospitals threaten to create competition with the DMC for business, compromising the health system's ability to stay in the black. The DMC has just begun to make money under Duggan after years of multimillion-dollar losses and a $50 million bailout by the state.

There is other evidence that underlying this dispute the discordance between the medical school's professional and academic mission and the business orientation of the hospital's new leadership.

The dispute over the orthopedics residency program, which seemed to touch off the larger conflict, ensued when DMC canceled the program (see this article in Crain's Detroit Business) after (see this April 1, 2006 Detroit Free Press article) the medical school would not accede to DMC CEO Duggan's wish to redirect the clinical focus of the program.

Duggan wanted to build a stronger sports medicine component within the program, but some doctors feared it would be at the expense of care for poor people.

And what made Mike Duggan an expert on the need for specific kinds of orthopedic services? That's a good question.

It turns out that Duggan came to his job as CEO of DMC with no direct health care experience, and no experience managing a health care organization. He is the former Prosecutor for Wayne County (Michigan). In a profile in Modern Health Care we see the thinking that lead to his appointment.

In December 2003, as Duggan was preparing to run for re-election as county prosecutor, DMC Board Chairman Chuck O'Brien asked him to interview with the board's search committee....

O'Brien, president and owner of Emerald Steel Processing, says Duggan has proved he's able to lead large, complex organizations.

'He has excellent skills and a superb understanding of where the bottom line is.'

Duggan conceded that just because he's never operated a hospital before or studied healthcare administration, it doesn't mean he doesn't know healthcare.

'I helped start Wayne County's HealthChoice program, an award-winning health plan that we built from scratch. So it wasn't like the terminology was a great mystery to me. And I've dealt extensively in my other jobs with all of the major local (healthcare) players.'

Roger Quick, a partner in the executive search firm Quick Leonard Kieffer, who led the search for Porter's replacement, characterizes Duggan as an unconventional candidate. 'I won't pretend that Mike's lack of hospital administrative experience didn't come up. People thought and talked about it. But ultimately the board saw it as a plus that he came from outside of the industry. If you're smart, creative and hard-working, you can learn the industry.'

I guess I should no longer be amazed that business people and lawyers think that they can pick up all they need to know about health care by developing a quick understanding of "the terminology" and by being "smart, creative, and hard-working." To think of all those years I wasted in medical school, internship, residency, and fellowship.

How much a lawyer learning about health care on the job really understands about health care is one question. How much such a person internalizes health care's values is another.

The incipient split between two once-proud health care institutions, to the apparent detriment of both, is more evidence that health care is too important not to be put back into the hands of health care professionals.
If the split occurs, the lawyers and businesspeople will quickly find new pursuits. But who will take care of the patients if the medical center suddenly loses most of its doctors?

"While Rome Burns"

The latest issue of the British Medical Journal featured a number of remarkable articles on the perilous state of the UK health care system. The main points were well summarized in a lead editorial by Editor Fiona Godlee, ominously titled, "While Rome Burns."

Something strange is happening in the NHS [National Health Service].

Something important is quietly dying. I don't think it is too fanciful to call it the spirit of medical professionalism. And we, the medical profession, are watching it die.

Far from being privatised, medicine in England has become ever more a creature of the state.

All that has really changed ... is who does the kicking and who is kicked. Increasingly centralised decision making, driven by a political imperative for constant reform, has left us victim to 'a patchwork of mutually contradictory ideas struggling for dominance.'

And although medicine has embraced the need for evidence based medicine, policy making remains largely an evidence-free zone. [Richard Lehman wrote,] "the personal responsibility of our professional leadership to mark out where the evidence lies, what it says, and what it is lacking.'

But where is our leadership? And where, asks Ian Greener, are the voices raised in protest against the breakdown of Aneuran Bevan's founding concordat: that the government would fund the health service but leave its operational running to the doctors. 'The government has found ways to interfere in medical practice on a remarkable scale,' he writes. In the absence of coherent protest we might conclude that doctors have once more had their mouths stuffed with gold or that the medical profession wholeheartedly approves of the government's reforms. However, the most likely reason is more worrying still, as Greener agrees: that most doctors no longer have the will or power to stop the reforms.

I remember sitting in one committee meeting (I will not say where or when or about what) in which we were contemplating some new abuse of power by some administrator. The committee seemed unable to come up with a response. Finally, one member, a clinical psychologist, decried the learned helplessness that seemed to have infected us.

Fiona Godlee has taken on the role of Cassandra to warn us that a similar learned helplessness may have also infected British doctors.

Unless we heed her warning and conquer our learned helplessness, whether in the US, in the UK, or in other countries, we all will surely watch professionalism die at the hands of the managers, bureaucrats, and executives.

More Conflicts of Interest - Health Insurance Consultants Paid Both By Employers and Health Insurance Companies

The Wall Street Journal reported (available here free from the Stamford Times) on how some employee-benefits consultants may charge employers for their advice about picking the best health insurance for their employees without disclosing that they also are paid bonuses or commissions by health insurance companies.

The article included this anecdote,

When Kevin Grady took over as an employee-benefits consultant for the Columbus Public Schools District in 2001, he signed a contract promising to act "in the best interest" of the schools. The Ohio district agreed to pay him $35,000 a year to help it choose a health insurer. Officials thought that was all Mr. Grady was getting out of the deal.

It wasn't. After the district switched its health insurance to UnitedHealth Group Inc. on what it says was Mr. Grady's recommendation, he started getting payments and other compensation from the big Minnetonka, Minn., insurer. Thank you and United for the steaks,' Mr. Grady wrote....

All told, UnitedHealth paid Mr. Grady $517,138 for helping it get the district's business.

Last month, the Ohio Department of Insurance suspended Mr. Grady's license for three years, accusing him of 'deception.' He was ordered to pay $137,000 in restitution to the Columbus district and a $25,000 civil penalty. Earlier this year, UnitedHealth agreed to pay a $125,000 penalty to settle the matter without admitting wrongdoing.

The article included other cases, involving other insurance companies and pharmacy benefit managers, and summarized the practice thus,

The episode spotlights a widespread and largely invisible practice that critics say boosts the cost of health care. Many consultants and brokers who are hired to help employers get the best deal on health insurance or prescription-drug coverage have significant financial ties with the health vendors they are supposed to be scrutinizing. The ties may take the form of bonuses for bringing in business, commissions or consulting fees. Often they are disclosed only partly or not at all.

So,

Consultants and other middlemen are prospering even as employers struggle with spiraling health-care costs.

The complexity of the US health care system encourages the flourishing of various middlemen, as J D Kleinke might put it, the fourth, fifth, sixth, seventh, etc parties in health. Furthermore, as system complexity and assymetry of information increases, the opportunities to make more money by deception increase.

It seems to me for a consultant to accept bonuses or commissions from health insurance companies while being paid for disinterested advice by employers constitutes yet another important, but heretofore unrevealed kind of conflict of interest in health care. Like other conflicts of interest, it has the potential of driving up costs and leading to bad choices about health care insurance.

The holes in the quest to enable the electronic clinical trial ...

... may be in the heads of the pharmaceutical industry's information technology leadership.

Readers of Healthcare Renewal are familiar with stories about industry mismanagement, conflicts of interest, corrupt practices, and other ills. I try to add the angle of technologic backwardness and blindness to state-of-the-art thinking about clinical information technology.

Recently posted to a number of medical informatics-related membership lists was the announcement of this Drug Information Association-sponsored conference:

"The Quest to Enable the Electronic Clinical Trial: Finding Clarity in a Confusing World" (300kb pdf)

I find the conference brochure quite interesting. There are numerous talks on medical informatics-related subjects, including "Medical Informatics Opportunities to Improve the Benefit-Risk Assessment of Drugs", "EMR's, PHR's and Electronic Clinical Trials: Pathways to Convergence", and even a tutorial "Introduction to Biomedical and Health Informatics" by reputable industry and academic speakers.

It is good to see more publicity about Medical Informatics in a pharmaceutical domain. As I've dicsussed in previous posts including here and here, the field has been nearly invisible to pharma, and it has been pharma's loss.

However, also of interest regarding this conference is a critical area studied in medical informatics that is entirely omitted. Once again, it's that "messy" area of organizational and sociological issues that impede clinical IT progress and cause healthcare IT difficulties and failure , including the current chaos in the Connecting for Health national programme for Health IT in the United Kingdom:

Leaked papers reveal NHS computer problems

A multi-million pound national project to upgrade computer systems across the NHS has been so dogged by problems that hospitals would have been better off if it had never been started, according to a confidential document apparently written by one of the scheme's most senior former executives.

The anonymous document, obtained by The Observer, appears to have been sent from the computer of David Kwo, who was in charge of implementing the Connecting for Health system in London until last year.

The analysis warns that "the NHS would most likely have been better off without the national programme, in terms of what is likely to be delivered and when.

In my experience (I was formerly a group director in the Research Information Systems division of a large pharma), pharma is blind to these issues. Worse, they don't know what they don't know. I can envision similar chaos in the race for the eClinical trial, chaos compounded by the simulataneous challenge for healthcare providers in implementing EMR's and other clinical IT for ordinary day-to-day patient care.

It's also an area that in my experience IT leaders in the pharmaceutical industry won't touch and seem to believe doesn't exist, or is of no importance to the "process-driven" world of pharma. Such debacles as the failed $100 million CRISP system at Merck were the result:

... Merck saw the potential to use information technology to compress the clinical trials process a long time ago, and has had supporting information systems in place for 30 years or more, although it hasn't always been a smooth process.

In the 1990s, Merck struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco.

"This project ran into a lot of problems," says one former manager who was involved near the beginning of the CRISP project. He asked that his name not be used ... The problems started when Merck decided to create a graphical user interface to CRISP, allowing clinical researchers to do their own data entry rather than having Merck personnel transcribe the results from paper forms.

Merck significantly underestimated the challenge, according to a former Merck executive who was involved in the early phases. Merck's scientists were impressed by the ease of use of the Apple Macintosh computers they were using at the time. They thought creating a graphical data collection tool ought to be an easy task for Merck's programmers.

The task of creating this software led the programmers into unfamiliar territory. Not only did they have to learn new programming techniques, but they were continually frustrated in their effort to build a single system that would work for all trials. The real problem was that the data to be collected varies significantly with the nature of the medicine being tested and the malady it addresses.

The "territory" was unfamiliar only to those in IT management who are not engaged in its study. It is not hard to foresee similar debacles for many companies in the future.

The pharmaceutical eClinical trials conference discusses pharma/provider interaction and implies that pharma will become "an embedded part of healthcare's transformation through health IT." The conference concludes with a panel discussion on the somewhat ironic question "Where are the holes in the quest to enable the electronic clinical trial?"

The organizational and sociological issues that impede healthcare IT progress have strong analogs in the pharma industry. I observed them with interest as a member of a research IT division at Merck, after a period as Director of Informatics implementing EMR at a large healthcare system. I believe that collaborations between pharma and provider organizations that don't take these issues into account in any joint work in eClinical trials may find these sociotechnical issues worse than simply additive.

However, pharma is at this point blind to these particular "holes." I predict there will be hundreds of millions of dollars wasted per pharma (money that drug purchasers provide and shareholders will lose) in efforts to automate clinical trials that do not take the sociotechnical factors into account.

I also think some answers to the question "Where are the holes in the quest to enable the electronic clinical trial?" will be found in an upcoming Nov. 2006 American Medical Informatics Association Annual Conference workshop on healthcare IT failure entitled "Avoiding The F-Word: IT Project Morbidity, Mortality, and Immortality", the first of its kind:

SESSION DESCRIPTION

Recent studies of health care computer applications and the reported failures of well-known systems surprised the medical informatics community, leading to questions of how to increase the chances of IT systems success and the reduction of errors.

Similar problems plague a variety of different systems, whether for institutions as a whole, for ancillary services, or for consumer health, and have done so for many years. Despite an accumulation of best practices research that has identified a series of success factors, some 40% of information technology developments in a variety of sectors are either abandoned or fail, while fewer than 40% of large systems purchased from vendors meet their goals. According to the recent CHAOS Report by The Standish Group, which surveyed failures of IT in general (not just in health care), only 34% of IT projects were considered truly successful. Similar numbers have been estimated for health care, and the number has unfortunately remained approximately the same for at least the last 25 years. While there have been some published reports of failures, removals, sabotage of systems, or how failures became successes or were otherwise redefined, there has been too little opportunity to learn from studies in which technology interventions resulted in null, negative, or disappointing results.

The purpose of this session is to examine why this happens and what might be done to improve the situation, and to collaboratively develop a series of frameworks for various types of systems and healthcare settings to aid in implementation and evaluation. The session builds on a lively exchange by numerous members of a number of AMIA Working Groups concerning success and failure in medical informatics.

The session will be devoted to better defining or characterizing "success" and "failure." From there, participants will break out into smaller groups to continue the discussion, develop a set of important issues, action items, and recommendations.

I will be representing the AMIA Clinical Information Systems Working Group at this workshop. The workshop idea was largely the result of an energetic reponse and flurry of emails in the Medical Informatics clinical information systems mailing list that resulted from my research assistant's message seeking additional cases of healthcare IT difficulty for the web site on the subject I created in 1998. This website "Sociotechnologic issues in clinical computing: Common examples of healthcare IT failure" remains nearly unique to this day. In past years, similar requests produced little interest. I hypothesize that in the intervening years, more medical informatics personnel have become familiar with the issue of health IT discord and failure, or have experienced the issues personally. I will be presenting a poster on the website at the AMIA annual conference as well:

Access Patterns to a Website on Healthcare IT Failure
Organizational and human factors issues associated with healthcare IT have led to project difficulties and failures. Detailed case accounts might improve knowledge sharing between healthcare organizations on lessons learned and best implementation practices. We conducted a study of access patterns to a website created by our first author that explicitly addresses the issue of health IT failure via highly detailed case accounts in an ‘anonymized’ format. We found that our website is one of few relevant sites that is retrieved via major search engine queries on “healthcare IT failure” or related concepts, and we hypothesize that “hits” on our website may reflect a significant portion of the demand for information on this issue. We then studied the demographics and queries used by viewers of our website via a public website-tracking utility (no personally-identifiable information was obtained). We found that demand for information on healthcare IT difficulty and failure via the Web is ongoing by searchers of a variety of demographics, and we believe the demand is largely unmet. The medical informatics community can contribute to filling this gap.

A talk "Medical Informatics Perspectives on Pharma eClinical: Leveraging EMR Expertise" presented by me at a CBI-sponsored eClinical meeting was an attempt to start to bridge this knowledge gap in pharma. It seemed of interest to the pharma audience. The "Gartner Predicts" in that presentation should also be of interest.

As an end note, it was ironic that expertise in Medical Informatics and healthcare IT was seen as unneeded by the former VP of Research Information Systems at Merck Research Labs, who had me laid off as part of a 2003 restructuring and later eliminated one of the two science research libraries I ran at MRL. I had been the only formally-trained Medical Informatics specialist at this company. In 2005, that VP's contract was not renewed. That person, of an IT background but lacking a biomedical and scientific background, now works for a company "dedicated to delivering dynamic interactive realism to the ever demanding complexity of next generation computer games."

-- SS

No More "Political Juice" for UMDNJ

After yet another brief hiatus, UMDNJ is back in the news once again. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.)

The indefatigable Newark Star-Ledger recounted a report by the federal monitor now overseeing the university about the relationship of the university and New Jersey State Senator Wayne Bryant, chairman of the Budget and Appropriations Committee. The report alleged that Bryant was hired by the University for a "no-show" job.

Our conclusion is that UMDNJ created a no-work job for Senator Bryant so that he could use his political power in the state Senate to benefit his employer -- UMDNJ's School of Osteopathic Medicine. In short, Senator Bryant was paid $35,000 per year by UMDNJ to lobby himself in his capacity as a state senator.

The Star-Ledger also noted,

After Bryant took the job in March 2003, state funding for the university's School of Osteopathic Medicine, near Camden, increased substantially -- from $2.7 million in 2003 to $5.83 million in 2004. However, no one could document any real work Bryant did on campus.

No reports, memorandums, e-mail communication, correspondence or evidence of any work by the senator could be found or produced by the administration at the medical school in Stratford. No UMDNJ administrator could recall supervising what the senator was doing or what he was supposed to be doing.

Most people interviewed by Stern's office said Bryant spent only three hours a week on campus, from 9 a.m. to noon on Tuesdays -- and, even then, inconsistently.

While Bryant was in his university office, the only thing anyone observed him doing was reading newspapers.

The dean of the osteopathic school, R. Michael Gallagher, indicated he wanted to hire Bryant and instructed his staff to create a position for Bryant to take advantage of his political clout, the report states.

Gallagher was removed as dean in June, after one of Stern's reports found Gallagher had charged thousands of dollars in dining and entertainment bills to university accounts....

According to the report, Gallagher ordered staffers to develop a job description for Bryant because there was no existing position in the medical school's table of organization that matched the senator's qualifications. Officials at the osteopathic school told the monitor's office it was clear Bryant was offered the post for his 'political juice.'

Bryant's response to the report was terse, according again to the Star-Ledger,

Under mounting political pressure, the influential chairman of the state Senate Budget and Appropriations Committee said yesterday a report that the state's medical university created a no-show job for him was 'not accurate in many respects.'

In a written statement, Sen. Wayne Bryant (D-Camden) said that during the entire time he was employed by the University of Medicine and Dentistry of New Jersey, he 'regularly performed the various duties and services that were consistent with my job description.'

The statement offered no elaboration, and Bryant, who has kept a long silence about the matter, did not return calls to his office for comment.

We can only hope that the leadership of UMDNJ, now operating under a deferred prosecution agreement, has ended its craving for "political juice." Instead, this parent university of multiple medical schools, academic medical centers, and other academic health care programs, deserves competent, transparent, ethical governance.

As a post-script, the story of UMDNJ remains one of the great examples of the "anechoic effect." This story has been reported essentially only by regional news media, lead by the Star-Ledger, and discussed only there and in blogs. No mention of it has appeared in any medical or health care journal. Failure of such stories to be discussed widely means that concentration and abuse of power in health care may still be going unrecognized as a national, even global problem.

More on Blue Cross of California's Retroactive Cancellations

The Los Angeles Times has followed up on the story of Wellpoint Blue Cross health plans allegedly retroactively denying insurance after patients run up big medical bills. (See previous post here.)

In a prototypic case, a person (or family) applies for and gets an individual insurance policy (i.e., not an insurance policy obtained through employment.) After the policy is obtained, the policy-holder develops a new, and very expensive medical condition. Once major bills are incurred, the insurance company cancels the policy, claiming that there were errors or omissions on the application.

For example, the Times reported this case, involving Blue Cross of California, which is owned by WellPoint Inc.,

When Steve and Leslie Shaeffer's daughter, Selah, was diagnosed at age 4 with a potentially fatal tumor in her jaw, they figured their health insurance would cover the bulk of her treatment costs.

Instead, almost two years later, the Murrieta, Calif., couple face more than $60,000 in medical bills and fear the loss of their dream home.

Shortly after Selah's medical bills hit $20,000, Blue Cross stopped covering them and eventually canceled her coverage retroactively, refusing to pay for treatment, including surgery the insurer had authorized in advance.

The company accused the Shaeffers of failing to disclose in their coverage application an undiagnosed bump on Selah's chin and physician visits for croup. Had that been disclosed, the company said in a letter, it would not have insured Selah.

The Shaeffers say they weren't trying to hide anything. When they applied for coverage, Selah did not have a tumor, at least as far as they — or any physician — knew. The doctor visits occurred after Leslie filled out the paperwork, and they seemed routine, the Shaeffers say.

The company is facing a number of lawsuits from policy-holders whose policies it retroactively canceled. "The suits accuse health plans of dumping sick policyholders without evidence that the consumers intentionally omitted information about their medical condition or history. They also accuse insurers of using applications that are vague and confusing by design, trapping consumers into making mistakes that can be used to cancel their coverage later."

The article noted that a Blue Cross "employee said in a deposition last year that a special department considers as many as 1,500 cases for cancellation each week in California alone. A consumer lawyer who saw Blue Cross' cancellation tally sheets described the department as a rescission factory."

According to other depositions,

The health plans routinely scrutinize medical records, back 10 years or more, when subscribers submit claims for certain conditions within two years of signing up for coverage.

If the health plans find information in the records that was absent from the application, they cancel, often without finding out whether the discrepancy was an intentional lie or an honest mistake, according to the depositions.

Furthermore, Blue Cross is now in trouble with regulators. "Late Friday, a spokeswoman for the Department of Managed Health Care said the agency could take action against Blue Cross as early as this week. The agency has concluded that the company systematically violated the law by improperly canceling policies and failing to verify medical information on applications before issuing coverage."

Furthermore, "Amy Dobberteen, enforcement chief for the Department of Managed Health Care, said the law was clear. Health plans 'are not supposed to be waiting until they get a huge claim and then trying to find a way out of it,' she said. After a claim comes in, they may cancel only for 'willful misrepresentation. Those words are plucked right out of the statute.'"

Insurance that is liable to be canceled any time a policy-holder makes a big claim is hardly deserving of the name. So what should one call what Blue Cross of California is selling to individuals?

ADDENDUM (20 September, 2006) - The Los Angeles Times reported today that Blue Cross responded to the issues above,

Blue Cross of California said Tuesday that it would change some of its procedures for canceling individual health insurance policies, after allegations that it illegally dumped sick policyholders to avoid expensive claims.

The state's largest health insurer said it would make the changes — including creating an ombudsman and revising its appeal process — but maintained that it had done nothing wrong.

'The vast majority of rescissions to date are unquestionably proper under any criteria,' said Blue Cross Chief Executive Dave Helwig. 'But we are taking these major steps to minimize the possibility of errors.'

Critics were only partially mollified.

'I'm underwhelmed,' said Bryan Liang, executive director of the Health Law Institute at California Western School of Law in San Diego. 'The fundamental issue still is that they are not addressing these policies according to California law. Once they issue the policy, unless there is actual fraud, they cannot rescind. So despite whatever window dressing they put in place, they are still violating the law.'

On the other hand, William Shernoff, a lawyer representing several plaintiffs in a suit against Blue Cross, said

The major breakthrough is when you get a large corporation like this that says they are going to change their ways. But we'll see if these changes are going to be significant and real. The devil's in the details.

Top Managers Get Big Share of CDC Bonuses

The Atlanta Journal-Constitution and the New York Times both just reported on how the US Centers for Disease Control (CDC) awards bonuses. To summarize the story in quotes from the Times,

Top officials at the Centers for Disease Control and Prevention received premium bonuses in recent years at the expense of scientists and others who perform much of the agency's scientific work, agency records show.

Those inside the office of the centers' director, Dr. Julie L. Gerberding, have benefited the most, the records show.

From 2002 through mid-2006, William H. Gimson III, the agency's chief operating officer, received bonuses totaling $147,863, which included seven cash awards of more than $2,500. Mr. Gimson's bonuses were about twice the amount granted to any other C.D.C. employee, the agency's records show.

Mr. Gimson's deputy, Barbara W. Harris, received six premium bonuses of $2,500 or more from 2002 through mid-2006 for a total of $84,894, agency records show.

Mr. Gimson and Ms. Harris are part of the federal government's Senior Executive Service, a cadre of top civil servants whose salaries are generally among the highest in government.

The increase in bonuses to these officials was part of a decision by the Bush administration to make transformation of the management of the centers a top priority, said Glen Nowak, chief of media relations at the centers. 'If we want to retain people, we need to recognize them,' Mr. Nowak said Friday in an interview. 'We are operating in a highly competitive environment.'

Before Dr. Gerberding's appointment, members of the C.D.C. director's inner circle rarely received premium bonuses of $2,500 or more. After her arrival, in July 2002, such cash awards increased....

In 2005, the records show that officials in Dr. Gerberding's office received 60 premium bonuses totaling $515,075, or about 4 percent of all bonuses granted within the centers.

Because bonus money is limited — about 1.5 percent of the total personnel budget, Mr. Skinner said — the growing share of premium bonuses for Dr. Gerberding's closest advisers has meant less money is available for some scientists and other workers.

The administration also made security a priority, Mr. Nowak said. He said that helped to explain $41,485 in premium bonuses given since 2002 to William T. Porter, the agency's head of security.

Among the other recipients of large cash awards since 2002 were James D. Seligman, the agency's chief information officer, who received $62,455 in premium bonuses; John C. Tibbs, director of the agency's financial management office, who received $52,880; and Kimberly S. Lane, a senior adviser to the Coordinating Center for Infectious Diseases, who received $50,565.

It seems to be the same old health care song - even in organizations where highly trained clinical or scientific staff do the vital work, the hired managers, bureaucrats, and executives always seem to have the financial edge.

Like in stories about how top executives of for-profit health care companies are paid so well, we hear the rationale that the organization must pay managers well to keep top people.

Yet there are reasons to think that the management of the CDC may be troubled. The Times noted,

Soon after arriving at the centers, Dr. Gerberding began a comprehensive reorganization of the agency. In its wake, many of the agency's senior scientists and leaders either left or have announced that they are planning to leave.

The Washington Post and The Atlanta Journal-Constitution have reported on the turmoil at the centers in articles quoting disgruntled former senior scientists who said the changes had undermined the agency.

Five of the six former directors who led the agency in the past 40 years recently wrote a letter to Dr. Gerberding expressing concerns over the exodus of crucial administrative and scientific leaders and scientists, The Journal-Constitution reported.

Furthermore, the Journal-Constitution noted,

Low morale and an exodus of key leaders and scientists from CDC since 2004 has caused significant concern among several of the agency's former directors and drawn the attention of a congressional committee.

The fear is that turmoil within the agency may be harming its ability to handle public health emergencies — from bioterrorism attacks, to an influenza pandemic to the toll of obesity, the Journal-Constitution reported last Sunday.

By the end of this year, all but two of the directors of the CDC's eight primary scientific centers will have left the agency. Other high-profile departures include world experts in several diseases.
The agency's cash awards program is one tool in its arsenal that can be used to improve morale and stem departures. Yet the distribution of frequent large cash awards mainly to budget and administrative staff and managers is an example of how the agency has become increasingly enamored of its non-scientific staff, said three current CDC employees, who declined to speak publicly for this article.

Last year, a CDC poll of its employees, called Pulse Check, found that one of their top concerns was the 'loss of public health focus/mission in exchange for inappropriate business focus.'

Paying larger bonuses to top managers has not clearly correlated with obviously better organizational performance. And why is it so important to pay bonuses to top managers to retain the best employees, while it is not so important to pay bonuses to the scientists, physicians, and other professionals who actually fulfill the organization's mission?

Instead, we hear another familiar song - a once mission-oriented organization has now has "an inappropriate business focus."

If we want health care organizations to provide health care well, if we want academic medicine to do academic medicine well, if we want public health organizations to do public health well, then the organizations must focus on their mission, not on high pay for their hired managers.

Study: Nurses (and Doctors) Not Trained for IT

Interesting article below, pointing out a need for more education about IT and involvement of clinical personnel in EMR etc. initiatives. Money quote in the article:

Nurses say that they or their nurse managers are unlikely to be involved in the IT selection process . Only a little more than one-third indicate that nurses at their organization participate in choosing IT systems. Still, they may fare better than physicians. Nurses report that only 14 percent believe that physicians at their institution are consulted about the use of IT.

Study: Nurses Not Trained for IT
By Stacy Lawrence , Ziff Davis Internet
September 6, 2006

With health care organizations investing millions into IT, it may seem a little strange to find that most nurses receive little or no IT training. But that's exactly the result of one of the most comprehensive surveys to date about nurses and their IT work environment, conducted by health IT provider CDW Healthcare.

One of the most surprising findings was that one-quarter indicated they had received no IT training on the job over the last year, while another 56 percent said they had gotten only between one and eight hours of IT training.

It's not surprising to those in the Medical Informatics field. Health IT is somewhat a backwater. What is strange is that healthcare is one area of IT that should be a shining star; an environment where the highest of rigor is exercised.

... When asked what would have the greatest impact on improving their use of IT in their job, 55 percent responded that more training would help. This survey consulted nurses in a variety of care settings, but those in organizations with nursing informatics positions are the most likely to have adequate training. Only about four out of ten organizations had such a position, but if they did they were twice as likely to offer more than 16 hours of IT training per year.

Such positions are often deemed a frill, cost-ineffective, or even a territorial intrusion by the IT departments.

... Nurses say that they or their nurse managers are unlikely to be involved in the IT selection process. Only a little more than one-third indicate that nurses at their organization participate in choosing IT systems. Still, they may fare better than physicians. Nurses report that only 14 percent believe that physicians at their institution are consulted about the use of IT.

If this is true, it rises to the level of healthcare mismanagement on a national scale.

"If a decision is coming down from a C-level executive and there's been little involvement from the nursing and physician constituencies, it's pretty tough to force doctors and nurses to use the IT systems that are being put in place," said Bob Rossi, general manager for CDW Healthcare.

My money quote: Why do statement like this still need to appear in print in 2006? It's as if the New England Journal of Medicine still published articles on the value of sterile technique in the surgical suite.

Despite this potential disconnect, nurses spend a significant amount of time each day working with IT. Of the respondents, 44 percent said they spend three or more hours daily using some IT device. The most common device, by far, is still the desktop computer, which 89 percent of them use, while 21 percent employ a laptop, 16 percent use computerized diagnostic equipment, 9 percent use a handheld device and only 3 percent use PC tablets.

Imagine as little training in the use of more "standard" medical equipment and devices. It is simply inconceivable.

Beyond lack of training, other chronic frustrations are nagging nurses in their IT use. Chief among these issues are incompatible systems, unreliable systems and limited access to necessary systems.

Interesting how such statements are often presented impersonally, as if these systems sprout and grow randomly from seeds. In fact, someone is behind the development, engineering and (mis)integration of these systems, and it isn't medical personnel.

More than one-third of nurses surveyed complained that each of these issues were a major barrier to their IT use. Lack of nurse training and the need to spend too much time helping doctors on the systems were among the most frustrating problems for about one-quarter of nurses.

This only adds to an already bludgeoning workload.

Still, nurses are relatively optimistic about IT in their workplace. Eighty-six percent indicated that it has the potential to improve the quality of patient care. And most are happy with their IT group; nearly six out of 10 gave their IT team a high mark.

Which means four out of ten didn't. In any case, I often am amazed about how often IT manages to get such a pass. I have seen it with my own eyes and it is a truly remarkable phenomenon. If clinical personnel had such failure rates, they'd be removed. IT seems steeped in mysticism, even in the age of commodity computing where most IT concepts can be understood (and often are, to the consternation of IT directors) by teenagers.

It has been said by IT personnel that clinicians are unreasonable, "a pain in the ass", "impossible to please" and so forth.

This is an irresponsible critique. From an end-results perspective, there is a great asymmetry regarding IT/clinical relations. When clinicians give IT people a "hard time", it is often for good reason, and can inconvenience the IT department (at worst) with regard to their budget and timelines. The clinicians may be overruled on such a basis. When IT people marginalize clinicians, on the other hand, it can and does decrease quality of patient care, or even cause outright errors through deficient applications (e.g., as in Ross Koppel's provocative JAMA article Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors.)

These results were based on an online survey of 559 nurses working in a wide range of settings, including large hospitals and medical centers, clinics and physician offices, long-term care facilities, home care, visiting nursing associations, public health organizations, insurance companies and corporations.

We need many more such surveys to be adminsitered and acted upon if a U.S. national initiative in EMR is not to go the same route of its British counterpart, now in considerable turmoil.

While such turmoil might represent a windfall and job security for insiders and consultantcy companies who have to clean up the mess, it represents a terrible economic calculus for healthcare. One sometimes wonders if a strong disincentive to get IT "right the first time" is built into the information technology culture.

-- SS