Friday, September 29, 2006

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.

Thursday, September 28, 2006

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.

Monday, September 25, 2006

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:
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?

Friday, September 22, 2006

"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.

Thursday, September 21, 2006

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.
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:


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

Wednesday, September 20, 2006

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.

Monday, September 18, 2006

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

Sunday, September 17, 2006

Money-Driven Medicine: Mahar Criticizes Market Myths

A few years ago, Harvard Business School professor Regina Herzlinger wrote a breezy and influential book, Market-Driven Health Care, claiming that too little capitalism and consumerism are what ail American medicine. Her cheery book claims that the medical consumer needs to be informed and empowered. Then, a smart, masterful, penny-pinching consumer will demand greater convenience, productivity, and quality from the medical establishment, transforming healthcare for the better. Ideas like hers about the magnificence of market competition and consumer choice now dominate the Washington conservative healthcare agenda: from the Medicare Part D benefit structure to proposed Medicaid changes to “pay-for-performance” to “consumer-directed healthcare" schemes.

In pointed disagreement with Herzlinger’s book, financial journalist Maggie Mahar’s 2006 book, Money-Driven Medicine: The Real Reason Health Care Costs So Much, focuses on the day-to-day reality of what markets can do to American medical care. Herzlinger presents a fairy tale, a charming story of “focused factories” and consumer convenience. Mahar looks at the nitty-gritty reality of corporate medicine and how focus on shareholder returns distorts and worsens medical care and medical practice, to the frustration of worker-bee physicians and other medical professionals. Grimmer, more detailed, and more realistic than Market-Driven Medicine, it is well worth reading.

  • Competition improves medicine? In a cutthroat competitive environment, a Houston hospital declined to share details of its methods for improving pneumonia care, because excellence in that area offered the hospital local competitive advantage. And pharma tests new drugs not against best available therapy but in other ways that showcase their product best.
  • Corporate discipline, structure and targets improve medicine? At the extreme, Mahar recounts the instructions in internal memos of shareholder-pleasing executives at NME to “go out and hire sleazeballs,” executives willing to countenance kidnap and abuse of patients in psychiatric hospitals to amass shareholder dollars. Later, after changing its name to Tenet, the corporation rewarded doctors who performed unneeded cardiac operations in Redding, California, ruining numerous lives. But Mahar also recounts the more-ordinary, subtler, and broadly-destructive ways corporate practices undermine good healthcare and drive up medical costs, forcing even non-profits to act similarly just to stay in existence. Non-profits, for example, typically need to finance expansion through bonds -- and as one section title proclaims: “S&P Doesn’t Give Points for Charity Care.”
Mahar reminds us that financial rewards for excellence indicators can undermine the genuine motivation most workers intrinsically have – when not driven and thwarted – to provide good care. She prefers relying on the “will to excellence” that physicians and others generally bring to their professions and on intrinsic satisfactions of working in a cooperative environment. Mahar cites greater Department of Veterans Affairs achievements in information technology than have been possible in the private sector in this country as resulting from some degree of insulation from capitalistic pressures.

Mahar's book has one major weakness. In reaction to Herzlinger’s focus on consumerism, Mahar chooses to derogate the ability of patients to play an active role in shaping the medical system and their own medical care. Medicine, she claims, is uniquely dependent on trust in one’s physicians and letting them ultimately make the decisions. When she claims that it is psychologically difficult for many people in medical crisis situations – even people who are doctors themselves – not to simply hand over authority to their carers, she is correct; and she is also correct on condemning those few bad doctors who deliberately abuse this situation to provide unneeded care. But I believe her entirely mistaken in making only professionals responsible for the quality of health care. It may be the rare patient who – like a soldier on the battlefield being shot at – can keep his head and make good medical decisions – but that patient does better than the close-my-eyes-and-trust kind. Two fine books – Patienthood: The Art of Being a Responsible Patient by Miriam Siegler and Humphry Osmond (MacMillan, 1979) and Making Miracles Happen by Gregory White Smith and Steven Naifeh (Little Brown, 1997) – argue this point much better than I have room for here.

Siegler and Osmond compare patients to elephant trainers.
“Elephants,” they say, “are like doctors in that the very qualities which make them so useful – their power, strength, and sagacity – also make them dangerous. Patients are like [elephant trainers], in that they need the elephants and can get essential services out of them, but they must learn how to manage them and how to avoid being trampled upon.”
And patients of this kind have changed medicine. Rose Kushner, who under pressure of a breast cancer diagnosis (influenced by a book she found at the public library written by surgeon Barney Crile) sought to avoid Halsted radical mastectomy and consulted 19 surgeons before getting Thomas Dao to perform a less drastic operation, was just as responsible through her writings and activism for much-needed changes in breast cancer management that finally came to pass as Crile or any other doctor.

Yes, Herzlinger’s money-and-convenience-driven super-consumer-patient is a destructive fantasy. But I wish Mahar had not seen fit to counter that by an emphasis on a supposedly-inevitable patient ignorance and ineptness at making medical judgments and decisions. A skepticism about a role for shareholder-held corporations in medicine is not intrinsically allied to a distrust of patient intelligence and ability. If we frame it like that, we just contribute to the myth that popular, conservative voices advocating allegedly-desirable healthcare system changes actually do promulgate people power – as they claim to while they blather on about “consumers” and “choices.”

All the same, read Mahar’s book. Grit your teeth – I did!– when she explains how blind trust in physicians is desirable and inevitable. But read it for the detailed, real-life stories about money and medicine, which provide a superb antidote to a near-religious faith in the invariable virtues of markets and financial incentives.

Thursday, September 14, 2006

The NIH: "An Ethical Potemkin Village"

We have posted quite a bit about the ongoing story of conflicts of interests affecting some of the top leaders and researchers at the US National Institutes of Health (NIH). Most recently, we commented on the generally lenient treatment the NIH gave to researchers with such conflicts of interest.

The Los Angeles Times reported on a congressional hearing about the issue, which produced some notable quotes:

This is the largest scandal in all of the NIH's existence - Rep. Edward Whitfield (R-Kentucky) to NIH Deputy Director Raynard S Kington

We certainly hope it will be the last - Kington's reply

This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave - Rep. Joe L Barton (R- Texas)

You're sittin' on your bottom, and you're not doing anything about it. It's a farce - Rep Barton to John O Agwunobi, Assistant Secretary for Health

I believe that the tentacles of the drug companies influence the research at NIH, much to the consternation of the American people - Rep. Bart Stupak (D- Michigan)

It does seem there really is some outrage here. There should be. One of the world's foremost, and formerly most respected research institutions has been badly tarnished. Those entrusted with its management need to do some rigorous polishing.

Until the situation is cleaned up, what lessons do researchers in the trenches learn from this: that you are a success when you get fat consulting fees from the drug, device, or bio-tech company whose products you are investigating? What lessons do practicing doctors learn from this: that when even the august NIH researchers really work for such companies, whose research can you trust as independent?

Wednesday, September 13, 2006

Stanford's New Conflict of Interest Policy: No Coffee Mugs and Pens, But Consulting Contracts, Directorships, and Stock Options are Fine

With much fanfare, as reported by the New York Times, Stanford University announced it will "prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education." Also prohibited will be "accepting free drug samples and from publishing articles in medical journals that are ghost-written by industry contractors. The policy would also apply to sales representatives from makers of medical devices and other companies, not just pharmaceutical companies. Company representatives would be barred from areas where patient treatment and doctor education occur...."

Dr Philip A Pizzo, the medical school dean, proclaimed, “We want to secure the public trust to value what happens in academic medicine.” Interviewed by the Los Angeles Times, he said, "we were really seeking to do the right thing. We want to set a standard."

On the other hand, " The new policy does not cover consulting agreements between faculty members and companies aimed at developing drugs or medical devices. Those are governed by an existing conflict-of-interest policy. Such interactions are especially important at Stanford, where many professors have been involved in starting or advising companies in nearby Silicon Valley." However, "a Stanford spokeswoman said having a financial interest is not necessarily a conflict if the faculty member is not providing patient care. "

That seems like a curious point of view, because a faculty member could have great influence on patient care without providing it directly. Stanford faculty, of course, teach students and residents. And they write articles in respected medical journals and given talks at national and international venue.

In fact, only two months ago, Paul Jacobs authored an expose of conflicts of interest at the Stanford medical school and teaching hospitals in the San Jose Mercury News. Some of the anecdotes reported in the series (see posts here, here, and here) were:
  • "The school's 700-plus faculty members last year disclosed 299 potential conflicts of interest related to their research, according to figures provided by Stanford."
  • "Potential conflicts occur throughout the school's ranks. More than a third of the school's administrators, department heads and other leaders -- at least 26 out of 67 reviewed by the Mercury News -- have reported outside financial interests related to their research within the last four years. "
  • "One researcher has founded six companies, most based on research that came out of his own lab. He is a managing partner of a venture capital firm focused on medical research and sits on the boards of several other companies. "
  • "And the physician who until January chaired the department of gynecology and obstetrics is a longtime director of Wyeth, which manufactures controversial hormone replacement therapy for women -- therapy she defended in 2002 when potentially serious health risks were emerging."
  • The Associate Dean for Research "holds stock options in and is a consultant to MedImmune, which makes an influenza vaccine he is studying under a federal grant." He also "a paid member of MedImmune's scientific advisory board and holds stock options...."
  • The Chair of Psychiatry is currently running a federal grant on mifepristone as a treatment of depression, and has previously been the senior author of two related articles. Although he acknowledged that he helped found and still has a "financial interest" in Corcept Therapeutics, he did not fully disclose that he "took a seat on the board of directors and a part-time post as chairman of the company's scientific advisory board, a job that now pays him $60,000 a year. He and his family were granted 3 million Corcept shares for $1,000 -- today worth nearly $12 million." He had been accused of making exaggerated claims about Corcept's products in scholarly articles which did not reveal the extent of his involvement with the company.
  • Dr Pizzo defended the continuing involvement of Stanford and its faculty with commercial firms "to bring the fruits of university research to the public. This process has resulted in many medical innovations and advances that have improved the lives of millions of Americans."
So at Stanford, a junior faculty member will not be able to accept a coffee mug with the Wyeth logo, while a senior faculty member can serve on the board of directors of Wyeth.
Is it "doing the right thing" to prohibit minor conflicts of interest affecting mainly trainees and junior faculty, while letting senior faculty and administrators preserve their large conflicts of interest? What sort of hypocritical "standard" does it set to prohibit junior faculty from being influenced by pens and coffee mugs when making clinical decisions, but allowing senior faculty to be influenced by five-figure consulting income, and seven-figure stock option holding when writing papers, speaking to national audiences, and teaching trainees?

Minimal Disincentives for Conflicts of Interest at the NIH

We have posted a lot about the story of wide-spread conflicts of interest affecting top leaders at the US National Institutes of Health (NIH). After the NIH conflict of interest rules were relaxed in the mid-1990's, some top NIH managers received five- and six-figure consulting payments from pharmaceutical and biotechnology companies. Some failed to disclose these payments, even when writing journal articles favoring the products of the companies for which they worked. Since then, NIH Director Zerhouni made the organization's conflict of interest policies much more stringent, although not without opposition from some of his staff (see post here).

Most recently interest has focused on two cases. Dr Trey Sunderland, a leader within in the National Institute of Mental Health (NIMH), part of the US National Institutes of Health (NIH), provided tissue samples to Pfizer Inc while receiving consulting fees from the drug company. (See posts here and here.) We also posted about Dr Thomas J Walsh, Head, Immunocompromised Host Section, Pediatric Oncology Branch, Center for Cancer Research and the National Cancer Institute (NCI). A Los Angeles Times investigation had suggested that Dr Walsh, while working full-time for the NIH, had received money from several pharmaceutical companies, and also had had spoken for these companies' products at several US Food and Drug Administration (FDA) meetings. An internal NIH investigation just accused Walsh of "serious misconduct." (See post here.)

However, yesterday a report by the Associated Press suggested that while the NIH now may have more stringent regulations, government enforcement of existing regulations on conflicts of interest has been anything but rigorous. To wit,

Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll, the National Institutes of Health told The Associated Press this week in the most detailed accounting it has released.

Of the 44 alleged offenders, six left NIH before they could be punished and two had offenses so minor they merited no sanction....

The majority received reprimands or warnings for failing to properly obtain approvals for their outside consulting work, he said. Suspensions ranging from a week to 45 days were meted out to a few who did not get prior approval or did not report their drug company ties....

NIH spokesman John Burklow said his agency wanted eight others reviewed for possible crimes, but those cases were rejected by the investigating office at the U.S. Health and Human Services Department.

The two still outstanding -Drs. Trey Sunderland and Thomas Walsh -both committed "serious misconduct," so grave that they would be fired if they were civilians, NIH internal ethics reports contend.

NIH says it has been unable to act against the two because they are part of the Public Health Service Commissioned Corps, which provides medical help during disasters.

Some scientists whose consultancies were negatively highlighted in 2004 congressional hearings and press accounts left NIH voluntarily. They suffered no repercussions.

Cancer researcher Lance Liotta said he retired in May 2005 with pension and benefits, accepting 'a great opportunity' in research at George Mason University. His consulting activities, though questioned after the fact by Congress, were approved at the time, and he never was sanctioned.

Another former researcher, 33-year NIH veteran Michael Brownstein, had held nearly $2 million in stock with four companies whose boards he served on while he worked at NIH. The agency approved the consulting and never accused him of wrongdoing, said Brownstein, who continues his genetic research at the J. Craig Venter Institute in Rockville, Md.
Some in Congress are not happy,
Rep. Bart Stupak, D-Mich., said he wants to know why it is taking so long to resolve the case of Sunderland, a leading Alzheimer's disease researcher whose request to leave government service has been denied for two years.

'Where's the accountability? Where's the response?' Stupak said. 'This person should be dealt with severely.'

He referred to allegations that Sunderland improperly transferred human tissue samples from NIH patients to the drug company Pfizer.

'These people thought they were helping other people, not some scientist profiting,' he said. Sunderland, through his attorney, denies that his consulting payments from Pfizer were tied to samples he provided in his government capacity.

Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee, said the case points out deeper problems at NIH.

"In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited. It's really, really disappointing," he said.
Regulating conflicts of interest will not have much effect if violating regulations does not produce much in the way of negative incentives, and if there is no change in the underlying organizational climate. Reprimands or brief suspensions will likely not discourage people from seeking six-figure consulting contracts.

A particularly distressing aspect of this story is the possible violations of the trust of human research subjects. The Nuremberg Code states that in order for a research participant to give truly informed consent
[he or she] should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.
Barton's words, however ungrammatical, have a resonance here: "These people thought they were helping other people, not some scientist profiting." Was their consent obtained without "fraud, deceit, ... [or] over-reaching?" If not, was it really informed?