Using Drug Supply Contracts to Censor Negative Drug Utilization Review and Counter-Detailing

The Wall Street Journal reported (see summary here) how at least one drug company places restrictions on negative communications to physicians about its product in contracts that give discounted pricing to insurers and hospitals. In particular, Eli Lilly & Co offers its new anti-depressant Cymbalta ( duloxetine HCl) at a discount but with provisions that bar "negative D.U.R. (drug utilization review) correspondence to physicians," and "negative educational counterdetailing." Thus the hospital or insurer would be contractually prohibited from communicating with doctors in ways that might discourage them from prescribing the drug.
According to the Journal, Tarra Ryker, a Lilly spokeswoman, "says the Cymbalta contract isn't meant to stop communications that are 'backed up by clinical data' and 'presented in a fair and balanced manner.'" Her justification was that "there are a lot of things that are said to physicians and prescribers that in a lot of cases cannot be backed up with scientific evidence."
She also noted that Lilly has similar contract provisions in contracts to sell Symbyax (a combination of fluoxetine and olanzapine) and Zyprexa (olanzapine). Lilly's practices apparently are not unusual. A Pfizer spokesman, Jack Cox, said, that counterdetailing "language is probably in everyone's contracts."
I have previously posted about secrecy in health care (here). It may be that drug utilization review and counterdetailing are sometimes biased. But figuring that out should be up to physicians. And drug companies have plenty of opportunities to get their own messages to physicians. Impeding the free flow of information to physicians about drugs and other aspects of health care does their patients no favor.

Pay For Performance: The Train Has Left the Station, But Will It Stay On the Tracks?

There has been a bit of discussion of the pay for performance issue on several other health care blogs. Retired Doc's Thoughts kicked it off by highlighting discussion of the issue in Internal Medicine World Report by Philip Alper. Both Alper and Retired Doc were concerned about the American College of Physicians (ACP) new partnership with, among others, commercial managed care in the Ambulatory Care Quality Alliance (AQA). Retired Doc asked,

Whose interests will ACP represent as they swim with the sharks of the insurance industry?

Next to take up the topic was Medical Rants,

The ACP leadership has met with insurers and legislators. The quality train has left the station. Too many “experts” have espoused the value of quality measures for the ACP to ignore this movement.
Nonetheless, whether the ACP (or any organization) participates, we will have pay for performance. The ACP has chosen to participate in hopes of controlling the runaway train.

I reluctantly concur that physicians must engage with the proponents of pay-for-performance. But there are a number of important issues they will have to bring up if this movement is to have any net benefit for patients, and at least not heap further misery on physicians.

• How will pay-for-performance guard against perverse incentives? - As someone who has done research in the area, I am very concerned that outcome-based quality measures are likely to lead to perverse incentives. Bad outcomes occur to sicker patients, and we do not yet have reliable methods to control for how sick patients are when measuring outcomes. Thus, outcome-based performance measures are likely to penalize physicians who care for the sickest patients. Although many proposed pay-for-performance measures are "evidence-based" process measures, they too have the potential to create perverse incentives. Putting all the emphasis on a few process measures may distract physicians from doing other things for patients that may have a greater impact on their health. I am not aware of any studies that have tested to see whether stressing such measures has a negative effect on other aspects of health care quality or patient outcomes (but if you do not study it, you will not be able to find an effect.)
• Is pay-for-performance really about quality, or minimizing cost to commercial managed care organizations? - For example, the programs lately pushed by UnitedHealth to rate physicians(like this one, proposed for Kansas City) seem to weight quality of care and "efficiency" equally. "Efficiency" here means saving money for UnitedHealth (presumably so the company will have even more money to pay lavish executive compensation, as documented here and here.) Rewarding "efficiency" in this way tells physicians that they are valued most when they do the least for patients. Having primary care physicians do less could let UnitedHealth cut its costs further without having to address the uncomfortable issue of how well it reimburses for high-tech devices and hospitalizations (e.g. regarding the latter, see this).
• Why is all the emphasis on ambulatory care? - There is ample evidence that primary care physicians have been inordinately stressed by various methods used to control costs by the government and managed care. As we have discussed before, the result is fewer physicians going into primary care. Yet the AQA will deal only with "ambulatory care," and most of the current set of proposed measures would mainly impact primary care. There is no reason to believe that primary care doctors currently are less competent practitioners that specialists, or cause more quality problems than other people involved in health care. Why add to their stress while ignoring quality problems in other parts of the health care system? (For example, isn't producing implantable cardiac defibrillators [ICDs] that are liable to short-circuit and fail, and withholding this information from physicians and the public for years, as Guidant did, not a major quality problem? Why aren't managed care organizations, who may have paid $25,000 for each potentially faulty ICD, concerned about this aspect of quality?)

Finally, let me address the issue that the "train has left the station." Since health care has been dominated more and more by people from the business world, we have heard about a lot of trains that have left the station. Many of them derailed. For example, remember:

• Large, vertically-integrated health care systems - These were all the rage in the mid-1990s. For example, a New England Journal of Medicine Sounding Board article in 1994 proclaimed, "many academic medical centers are developing complex organizations of physicians and large health networks that provide managed care to large groups of people." "The rationale is that a surplus of revenues from clinical care provided by hospitals and professionals is needed to continue support for research and teaching." (1) Furthermore, Sherif Abdelhak, the then-CEO of the Allegheny Health Education and Research Foundation, the then largest health care system in Pennsylvania, proclaimed in Academic Medicine in 1996, "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." (2) Of course, merger mania, as it was later called, produced financial disasters in some of its applications. Abdelhak's AHERF went bankrupt, and Abdelhak went to jail, convicted of misappropriating charitable funds. (3)
• Physicians as gate-keepers - This fad started in the 1980s, (unfortunately, promoted by John M. Eisenberg, among others, [4]), and lasted through the mid-1990s. For example, in 1992, another New England Journal of Medicine Sounding Board proclaimed, "over90 percent of health maintenance organizations (HMOs} use primary care physicians as gate-keepers. (5) Gate-keeping is all but abandoned now.
• Capitation - Again, from the New England Journal, "those who favor capitation seem to regard it as the sine qua non of effective containment of health care costs.... Meanwhile, health care coverage for more and more Americans is paid for in this way. Between 1987 and 1995, for example, the number of Medicare beneficiaries whose health care was paid by capitation (under so-called risk contracts) almost tripled." (6) Capitation is also now rare.

So just because pay-for-performance is now currently fashionable among health care management types does not mean that will remain so for long, or that it will work very well. Physicians have an ethical responsibility to contribute to this debate, but in a highly skeptical manner, informed by real evidence, and with the goal of improving patient outcomes, while not further fraying our already threadbare capacity to provide accessible, high-quality primary care.
References
1. Rogers MC, SNyderman R, Rogers EL. Cultural and organizational implications of academic managed care networks. N Engl J Med 1994; 331: 1374-1377.
2. Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.
3. McKinnon J. Ex-AHERF chief pleads no contest: Abedlhak faces two years in jail. Pittsburgh Post-Gazette, August 30, 2002. P. B-1.
4. Eisenberg JM. The internist as gatekeeper: preparing the general internist for a new role. Ann Intern Med 1985; 102: 537-543.
5. Franks P, Clancy CM, Nutting PA. Gatekeeping revisited - protecting patients from overtreatment. N Engl J Med 1992; 327: 424-429.
6. Berwick DM. Payment by capitation and the quality of care. N Engl J Med 1996; 335: 1227-1231.

National, For-Profit Managed Care Organizations Are the Least Trustworthy

I just learned about a recent article in Health Services Research on trustworthiness of managed care organizations that had some fascinating results. (The full citation is Schlesinger M, Quon N, Wynia M, Cummins D, Grey B. Profit-seeking, corporate control, and the trustworthiness of health care organizations: assessments of health plan performance by their affiliated physicians. Health Services Research 2005; 40: 605-646.)
The investigators used data from the American Medical Association's Socioeconomic Monitoring Survey from 1998. They focused on responses from 1274 physicians who had at least one managed care contract to questions asked about the health plan that enrolled the largest number of patients from the physician's practice. The distribution of responses to some of these questions were striking.
How often do the plan's advertisements create an inaccurate impression of its benefits?
Sometimes 30.7%
Often 18.9%
Always 7.2%How often are patients often confused about plan benefits?
Sometimes 36.1%
Often 36.0%
Always 11.9%
How often does the plan forces physicians to compromise their standard of care?
Sometimes 23.6%
Often 6.3%
Always 1.3%
Furthermore, in multivariate analysis, for-profit national plans were rated by the physicians as less trustworthy. For the variables listed above, the odds ratios (approximation of the relative risk) for less favorable responses were:
Ads create inaccurate impression of benefits - 1.69
Patients often confused about benefits - 1.71
Plan forces physicians to compromise standard of care - 1.67

In summary, physicians frequently think that managed care plans run advertising that create false impressions of the plans benefits, confuse patients about their benefits, and force physicians to compromise their standard of care. National, for-profit plans are more likely to behave in such untrustworthy fashions than local and not-for-profit plans. Some points in the authors' discussion, couched in the typically cautious language of scholarly journals, merit repeating:

The managed care industry changed dramatically between the mid 1980's and mid-1990's. The ownership of health plans by large, for-profit corporations expanded markedly
Our findings suggest that the managed care backlash that appeared in the mid-1990's may have been a result of this transformation of the industry....
It is essential to recognize that these segments of managed care are growing rapidly because public policies have encouraged that growth.
Many states have enacted a plethora of regulation applied to managed care practice. As yet, little is known about the efficacy of these interventions, although state resources for enforcement are quite limited. Under these circumstances, public policies that encourage a larger role for more trustworthy forms of managed care may prove a more feasible form of intervention....

However, at the moment, we are instead seeing larger and larger for-profit national managed care organizations being formed by mergers. The most recent example is the merger of UnitedHealthGroup and PacifiCare. The important article by Schlesinger and colleagues suggests such mergers do not bode well for doctors or patients.

The UnitedHealthGroup-PacifiCare Merger: Do Executives Think They Own The Company?

The Los Angeles Times reported on more details of the UnitedHealth Group and PacifiCare merger. To wit,

Top executives of PacifiCare Health Systems Inc. would earn nearly $230 million if it were acqired by industry giant UnitedHealthGroup Inc. by February 1....
Eighteen PacifiCare executives - such as the company's senior vice president for finance and deputy general counsel - would share $14.5 million in 'change of control' payments.
All 39 of the top executives would share in $215 million in PacifiCare stock options previously granted by the company that would vest immediately. An additional $59 million in stock options for 691 other employees also would vest immediately.
[PacifiCare CEO Howard] Phanstiel holds stock options worth $59 million. Last month, he said he would also receive about $131 million in additional retirement payouts and other incentives not included in figures released Monday.
Other top executives also would learn large payouts, with Chief Financial Officer Gregory W. Scott reaping more than $18 million and general counsel Joseph Konowiecki earning more than $22 million....

We had previously posted about how lucrative this deal would be for PacifiCare CEO Phanstiel, and the discrepancy between the generosity of the deal and the UnitedHealthGroup's stated rationale for it of controlling health care costs, not to mention its stated mission to "make health care more affordable." Since the deal is even more lucrative than it appeared before, this discrepancy is only accented.
The deal did not go over well with everyone the Times interviewed, either.

'When you look at someone who is getting millions of dollars, it seems excessive to anyone whose framework isn't Wall Street, [Cindy] Ehnes [director of the California Department of Managed Care] said. 'For all of us who are agonizing about all the people who are going without healthcare, it's very difficult.'
Wall Street analysts and bankers, however, described the compensation as payoff for the gamble Phanstield and other executives took in joining a troubled company and helping it launch a turnaround in 2002.

Here is another discrepancy, and maybe one that is conceptually even more important. The rationale for the huge payments to top executives of PacifiCare was apparently payment for the risks they took. But what risks did they take? They were paid employees. They had none of their own money at risk when they were hired, and would be paid a salaries even if the company did not do well. The financial risks were actually taken by the owners of the company, that is, the stockholders.
Somehow, executives of this company (and I think of other health care organizations as well) seem to see themselves as the owners of the company, and hence entitled to reap whatever gains they can from, and do whatever they want to their company. The attitude may be L'managed care company c'est moi.
I submit that this erroneous sense of ownership of health care organizations by their salaried executives may be an important cause of some of the cases of mismanagement of health care organizations that we have previously documented.

The New York Times Examines Why Implantable Cardiac Defibrillators Are So Expensive

The New York Times ran an analytic article that raised some important points about the pricing of medical devices, and, by extension, the costs of health care. The report focused on the recent controversy about Guidant's multiple recalls of implantable devices, and allegations that the company withheld data about faulty devices from physicians and patients (see our most recent post here).
Here are some key points:

Last year, an estimated 135,000 devices were implanted in patients in the United States alone, a near tripling of the number in 2000. Meanwhile, the three major device manufacturers, Guidant, Medtronic, and St. Jude Medical, have reported a financial bonanza as domestic sales rose during the same period to $3.5 billion....
Defibrillator prices are like those found on a new car, ranging from $20,000 to $35,000 each.

==> The devices are expensive, they cost the health care system a lot of money, but the manufacturers make big profits

Physicians ... and health policy experts say that manufacturers have used a variety of strategies to increase profits by keeping device prices high. For example, rather than offering a low-cost unit that does the basic job of stopping a bad heart rhythm, defibrillator makers are engaged in a sort of medical arms race in which producers turn over models by adding new features.
'These companies don't compete on price, they compete on features,' Dr. Hlatkey (Professor of health research and policy at Stanford)
Doctors and patients also have no reason not to go for a top of the line model, said experts like Dr. Hlatkey. Many physicians acknowledge that they do not consider product prices when deciding on which model defibrillator is best for their patient. And patients have little reason to care about cost because insurers like Medicare cover the cost of an inpatient procedure, which includes the device, regardless of cost.
In just two years, defibrillator-related costs to both Medicare and private insurers are expected to reach $10 billion....
The price of a defibrillator, like other medical devices, follows its own unique economics, experts say. For example, while the prices of other high technology devices like computers and digital cameras have plunged, the price of a standard defibrillator has remained steady or declined slowly....
Many cardiologists ... say they have long lobbied major producers, without success, to make a less-costly defibrillator that performs the device's basic functions of saving a life.
Daniel Schaber, a vice president at Medtronic, said it was unfair to compare defibrillators with consumer products like computers because the market for heart devices was tiny relative to computer sales. And both he and Dr. Eric Fain, an executive at St. Jude Medical, said that the technologies might be costly but were in response to what doctors wanted. 'We have said to our advisers, what would you be willing to back to in terms of functionality?' said Dr. Fain, referring to doctors who serve as St. Jude consultants. And those consultants, he said, have routinely rejected changes that would result in loss of certain features.
Separately, a hospital consulting firm, Aspen Healthcare Metrics of Englewood, Colo., said last year in court papers as part of a lawsuit that the device makers kept doctors loyal to its brand by giving them 'clinical research grants, consulting arrangements, and other gratuities.'

==> The device manufacturers seem to base their argument that physicians only want devices with bells and whistles on the comments of physician "consultants" whom the manufacturers pay for their advice, and hence might be inclined to tell the companies what they want to hear.
The big question again is why Medicare and commercial managed care companies do not challenge the pricing of these devices? The rationale for commercial managed care, of course, was to save money. And clearly Medicare has been aggressive in cutting costs, especially when it comes to paying fees for physicians' cognitive services, and for basic hospital care for acute disease.
It's significant, I think, that the Guidant story has become so big that the New York Times is starting to do both investigative reporting and analytical pieces on it. Let's keep an eye out for what turns up next.

Embattled Hospital Advertises for an Arts Curator

Things have been pretty tough for most hospitals in the UK. According to the Daily Telegraph, many hospital trusts have been going heavily into debt. In 2004, they were collectively 366 million pounds sterling in the red, and are projected to be about 800 million pounds in debt this year. As the Telegraph put it, "frantic cost-cutting measures had led to closed wards, cancelled operations, reduced staff numbers and angry creditors." Furthermore, "economists blame higher spending on NHS bureaucrats, increased reliance upon the private sector, higher costs of NHS litigation and higher wage bills." Although in 2000 the government "decided there were too few hospital beds per head of population," "the number of overnight beds in England has fallen steadily, from 186,290 in 2000 to 184,207 last year."
I wonder how those in the US who champion global budgeting in a single-payer health system as a way to nearly painlessly control health care costs would respond?
Meanwhile, a truly picturesque example of questionable management priorities has appeared. Addenbrooke's Hospital in Cambridge has been under fire since a patient committed suicide after asking a physician to "direct her to a tall building so she could jump off" (see the article in the Guardian) and for having one of the worst MRSA (methicillin resistant staphylococcus aureus) rates in the country (see article in the Cambridge Evening News). So the hospital received plenty of unwanted publicity when it advertised a part-time art director's position (at a 37,000 pounds per year rate), described as a "dynamic art curator to manage, lead and develop the hospital's art collection" (see the article in the Times). The hospital claimed that the money came from charitable donations, and that "the therapeutic benefits of art in hospital which embraces visual arts, poetry, music, dance and gardens is well recognised and encouraged by the Department of Health" (see the article in the Daily Mail.) But in the Times, an unnamed hospital nurse said "it's disgusting," and noted that the salary rate for the curator was only slightly less than that of a nurse manager.
The tendency of hospital administrators to focus on their pet projects, even when basic care is under threat, apparently is not limited to the US.

True Lies

In Medical Meetings, Sue Pelletier has written an article, "True Lies," about pitfalls in making continuing medical education evidence-based. She includes not only issues raised by honest mistakes and unavoidable research biases, but also by the intentional manipulation or suppression of the literature. To toot our own horn, the article contains quite a few quotes from Health Care Renewal bloggers. Please take a look.

There are no paradoxes, only false assumptions...

Seen in the eZine 'eCliniqua' entitled "Pharma's Safety Paradox," regarding the pharmaceutical industry's handling of post-marketing clinical data:

ProSanos Talks Safety Tools, Predicts New Controversy

Forget, for a moment, the media hyperbole and legal stakes surrounding drug safety. The related scientific paradox is even more discouraging. Profoundly so.

On the one hand, virtually every seasoned participant in or observer of clinical trials understands that such research will never predict many serious adverse events. These only become apparent once a drug is approved by the FDA and sold in every Walgreens in the country.

On the other hand, sound approaches to analyze a drug's safety profile after its commercial launch remain clinically and mathematically controversial – techniques of art as much as science. When the FDA proposed research to fix this, Congress emitted a bored sigh.

So pharma is stuck with immaculate data from clinical trials – results surprisingly free of noise and confounding factors like other medications. And yet after a decade or more, when a drug emerges from clinical trials and reaches national distribution, the data become filthy, ambiguous, and unsuitable for the same precise analysis that persuaded the FDA to approve the stuff in the first place.

Is there a way forward?

Jonathan Morris thinks so. He's the president, chairman, and CEO of ProSanos, a 30-employee firm out of La Jolla, Calif. He spoke at the Bio-IT World Expo this year, and we chatted with him recently. ProSanos specializes in the analysis of drug safety data. It is helping pharma and biotech companies listen for subtle signals in the data available after a drug has reached the market.

The services, data sources, and software that ProSanos provides are varied. The company may clean your data, design your case report forms, or blend data from your trials and the real world. The math and the IT underlying the company's judgments are cutting-edge, but the company doesn't get mired in arcane theoretical or statistical issues. In some cases, Morris says, ProSanos may have an answer to a drug-safety question in 48 hours.

Morris predicts another Vioxx is on the horizon. "Absolutely," he says. "It's coming." He notes cardiologist Eric Topol of the Cleveland Clinic was not the only person to detect the Vioxx safety signal in 2001, years before the lawyers began circling. "We saw that," Morris says.

His chief concern now? The industry is simply not as sophisticated as it should be in studying the links between drugs and adverse events that arise after a drug has been approved. "We have to be able to understand the associations, the relationships," he says, between drugs and problems allegedly caused by drugs.

... He's blunt about the predictive limits of many clinical trials. "Today, in 2005, the best-designed prospective Phase III studies will not pick up all of the potential safety problems that will occur when the product is being used," says Morris. "Once a product is launched, you have to be able to follow it over time. That's where the unexpected things begin to occur."

Of all the Phase IV studies that sponsors are obliged to conduct, Morris notes, just 27 percent are actually completed. "Many companies do not fulfill their obligations," he notes. "If only a quarter of all the committed studies are done, it's hard to say anyone is holding up the gauntlet for good behavior."

New thinking and new tools are needed. "Conventional statistics and conventional approaches – the way you approach Phase III data – cannot be applied to the association data," Morris argues. "How do you deal with the association between the drug and the event? That we don't have a handle on."

Some customers, he says, want to go deeper. "There is a need, once you integrate the trial data you have, to go to other collections and see if the things you're seeing are there as well." That could mean data from a pharmacy benefit manager. It could mean health insurance claim data, or even reports from emergency rooms.

What's missing here? How about a mention of the electronic medical record that the Office of the National Coordinator for Health Information Technology (ONCHIT) has decreed as a ten-year national imperative?

There are no paradoxes. Only false assumptions and stubborn resistance to new thinking.

Indeed, new thinking and tools are needed. The current thinking in the pharmaceutical industry seems stuck in the "if you don't want to find a fever [and harm sales], don't take a temperature" psychology. Pharma industry progress in understanding, encouraging and exploiting the EMR as a source of adverse drug effects data seems to be close to zero.

-- SS

College (Governance) Follies

One issue that at least some of us here on Health Care Renewal think may be important in the revitalization of academic medicine (see post below) is the revitalization of the governance of academic medical organizations.
In the US, at least, medical schools own or operate most academic medical centers and teaching hospitals. Medical schools, in turn, are usually part of larger universities.
Heather MacDonald, writing in the latest City Journal, has quite a bit to say about the governance of American universities, which should be relevant to the governance of academic medicine.
In particular, she indicts the trustees, who ought to have ultimate authority over how the universities are run, and ought to be insuring that they are run in accord with their missions:

College trustees seem even more determined than alumni to see and hear no evil. Nothing produces more discomfort and denial in your average trustee than being told about the excesses at his college. Federal appellate judge Jose Cabranes has served as a trustee at Yale and Colgate, and is currently on the Columbia board. Have you ever heard your fellow trustees express an interest in the curriculum? I asked him. “Not only never, but such questions make them anxiety-ridden. If the question comes up, most trustees stare vacantly into space.”
A Brown trustee explains: “The culture wars are vicious; most trustees don’t want to be involved. They don’t care about the curriculum. All they want to know is if SATs are up.”
To test this claim, I asked a New York University trustee what she thought about Andrew Ross, a royally paid American studies professor. [Ross is the editor of Social Text, the journal that published Alan Sokal's hoax article about post-modern science.] But though Sokal’s hoax won wide press coverage, including a front-page New York Times story, the NYU trustee had never heard of Andrew Ross. She quickly changed the subject to NYU’s rising place in U.S. News and World Report’s annual college rankings.
[MacDonald inteviewed John Moores, Sr., a "renegade regent" at the University of California, San Diego.] “The regents are furniture,” he says. “They do absolutely nothing. If they were a board of directors of a corporation, they would fire people on the spot for not revealing material information. But the regents don’t want to know about admissions standards. They accept [them] with a sort of biblical inerrancy [as] the revealed truth....
A trustee at one of the most notoriously liberal private universities in the country sounds anguished discussing his service. “Being a trustee is hard to do if you want to live an examined life,” he says. “It’s a very problematic equation. Maybe I should just walk away. It would be completely rational, because so much is so bad.”
Such unruffled acquiescence in whatever folly one’s university has cooked up is not surprising. A board is a creature of the college president, nominated by people close to him or by alumni associations whose members are also chosen for their loyalty. Trustees are usually so grateful for the honor and prestige of the position that they shy away from rigorous oversight. As one big donor observed, the “anxiety for status among what should be self-confident businessmen is remarkable. Once on college boards, they grovel.”

This is all anecdotal, to be sure. But if it is at all representative of how universities are run, the implications for how academic medicine is run are dire. If university trustees are cronies of the administration, and/or unwilling to exercise any oversight over central academic matters such as curriculum and admissions, what sort of oversight should we expect over issues peculiar to academic medicine. And is it then any surprise that American medical schools offer so little instruction on evidence-based medicine, on one hand, and on the business ethics of medicine (for want of a better term), on the other?

Five Future Scenarios for Academic Medicine

Simultaneously published this month in PLOS Medicine in a longer version, and the British Medical Journal in a shorter version is an article by the International Campaign to Revitalise Academic Medicine (ICRAM) presenting five possible scenarios for the future of academic medicine. In the longer version are a list of "current instabilities in academic medicine," which includes some items that many will find familiar, and "drivers of change in academic medicine," most of which are pretty telegraphic.
The five scenarios are fairly extreme, and seem to be products of some fairly severe disagreement among the widely geographically dispersed members of ICRAM (see the BMJ version, "The members of the group often couldn't agree. They disagreed, ofr example, over the importance of business, particularly pharmaceutical companies, in academic medicine. Would business interests destroy or enhance academic medicine?") The scenarios include:

• "Academic Inc" - academic medicine becomes entirely a private, predominantly for-profit enterprise
• "Reformation" - academic medical centers disappear, and all "academic" activities take place in the community
• "In the Public Eye" - academic medicine as celebrity culture
• "Global Academic Partnership" - academic medicine focusses almost completely on the plight of global health
• "Fully Engaged" - academic medicine became fully engaged with stakeholders

The ideas are interesting, and the future may hold some elements of some of them. It wasn't clear whether some of the scenarios were meant as dsytopias or utopias. Surely, this article ought to generate some discussion, but my concern is that this worthwhile movement has not yet clearly defined the problems in academic medicine that it seeks to address.
The lists of "current instabilities" and "drivers of change" contain many poorly defined items. For example, the latter includes "'big hungry buyers' demanding more from health care," "managerialism," and "expanding gap between what could be done and can be afforded in health care." All these touch on issues explored in Health Care Renewal, but don't seem to quite get at the core of the problems. It may be that the problems afflicting academic medicine in countries throughout the world are so varied that it really is hard to define a set of universal issues. On the other hand, international gatherings often end of speaking "international-speak," in which crucial distinctions are blurred in order to avoid offending one party or the other.
Maybe the group will be able to get beyond "international-speak," and engage more directly with the nitty gritty issues that are afflicting academic medicine in individual countries, even if that means coming up with solutions customized to each countries' needs. Let's wish them luck.

Health Care Renewal Blogger in the New England Journal of Medicine

In the New England Journal this week is a skeptical commentary on echinacea by our intrepid Health Care Renewal blogger, Wallace Sampson. [Sampson W. Studying herbal remedies. N Engl J Med 2005; 353:337-339.]

New York City Public Health Proposes Gathering Data on All Diabetic Patients Without Their Consent

From the Associated Press, how the New York City Department of Health proposes to collect data on individual diabetic patients' control (assessed by hemoglobin A1C). "The plan would require medical labs to report to the city the results of a certain type of test that indicates how well individual patients are controlling their diabetes." "By pinpointing problem patients, then intervening in their care, [City Health Commissioner Thomas] Frieden said the city can improve thousands of lives." "The city's program wouldn't initially get patients' consent to collect data, but allow them to opt out later." "Doctors could receive letters, telling them whether their patients have been getting adequate care."
Frieden justified the program thus, "There will be some people who will say, 'what business of the government is to know that my diabetes is not in control?'" "The answer, he said, is that diabetes costs an estimated $5 billion a year to treat in New York and was the fourth leading cause of death in the city in 2003, killing 1,891 people." Frieden concluded, "I don't think we can afford not to do anything."
Dr. Paul Simon of Los Angeles' public health agreed, "Some people are uncomfortable with public-health departments expanding their scope beyond infectious disease, but I would say we have to do it. Chronic disease accounts for the major portion of life lost to illness, these days."
Hold the phone, here. Because diabetes is a severe and costly chronic disease, a local government feels it has the justification to collect individual patient data, without the patients' consent, and then intervene directly in their care? We are on a real slippery slope here, since this justification could be used to intervene on nearly any aspect of medical care, or of private behavior for that matter.
In the past, public health has involved some uncomfortable trade-offs between protecting the population from disease and individual rights. However, most of those diseases were infectious or toxic, and the measures involved protecting people from exposure. But using chronic disease as a justification for the government assuming this degree of control of medicine and of individual's behavior would involve breath-taking trade-offs.
Health Care Renewal quiz time: what nation in the 1930s was known for the unprecedented vigor of its anti-smoking campaign? Hint, an article in the British Medical Journal in 1996 featured a poster with this testimonial, x "drinks no alcohol and does not smoke.... His performance at work is incredible." [For the answer, go here.]
For the tip, thanks to MedPundit.

More Troubles at Provident Hospital

The Chicago Sun-Times reported more troubles at Provident Hospital, a part of the Cook County health care system. In one story, it reported how the hospital has been cited by the Illinois Department of Health for some severe patient safety problems, leading the Department to declare the hospital in "immediate jeopardy." It has until September to correct these deficiencies, or lose its Medicaid funding.
But even more interesting is the choice of Cook County Board President as the new chief operating officer of the hospital. The Sun-Times reported that John Fairman:

• was accused of conspiring to defraud the Houston public health system in the 1980s, and had liens filed against him by the Internal Revenue Service (IRS);
• was accused of excess spending personal spending using public money from the Denver public health system in the 1990s, and was fired from his job there; and
• was under criminal investigation in the District of Columbia for how he ran the Public Benefit Corp, which folded after Fairman was fired as its head.

Fairman's brother is Cook County's public safety director.
Provident Hospital got attention from Health Care Renewal late last year, after allegations were made that its security contract with Digby Security Services was politically motivated.
Another troubled health care organization with questionable leadership for our collection....

Quality Improvement Organizations: Organized to Address Their Mission?

The Washington Post continued its series on Medicare with a story on Quality Improvement Organizations (QIOs). The story points out some legitimate policy questions about these organizations, particularly related to how their roles have changed as they evolved from "peer review organizations."
Specifically,

• QIOs are apparently still tasked with collecting and addressing patient complaints. However, their current role is mainly to work collaboratively with physicians and hospitals on quality improvement projects. They have been accused of being slow and unresponsive in the face of such complaints, and the number of complaints seems inconsistent state to state. Although they have the power to sanction doctors and hospitals, they rarely do so. The boards of QIOs are made up almost entirely of physicians, but rarely include more than one consumer advocate per state.
• Given that QIOs are tasked to do quality improvement projects, old rules that mandate a high level of secrecy about their work no longer clearly make sense. "These rules even prohibit them from publicly naming the hospitals they work with unless the facilities agree." Why "few do" is unclear. Specific QIOs said "the names and outcomes of their projects are private under their contract with Medicare."

But more in the Health Care Renewal bailiwick, the article revealed that QIOs now provide their leaders very generous remuneration. Forty-one of the state-wide QIOs provided their CEOs with more than $200,000 in total compensation, while eleven provided more than $300,000. The highest compensation, $519,084 pluse use of a BMW, went to Martin Margolies, CEO of PRONJ of New Jersey. Many of their boards are paid, even though in the larger not-for-profit world, board members are rarely paid. At best, such generous compensation may distract leaders from their primary mission.
Although the issues here don't seem as severe as many discussed on Health Care Renewal, many QIOs no longer seem organized to optimally address their mission.

Reasoning By (Mis)Analogy: Should Hospitals be Compared to Microchip Factories?

Rant alert: I have become increasingly distressed by changes in health care prompted by poor analogies between it and various businesses. One of my pet peeves has been hospital quality improvement schemes based on what purportedly works to improve quality on production lines.
Hospitals couldn't resemble mass production in a factory less. Yes, of course, most products used in hospitals are mass-produced in a factory, and physicians and other health care professionals depend on products manufactured with great uniformity and predictability. Each patient presenting to a hospital, however, has a unique set of problems and issues. Attempts to manage these issues are based on our currently far from complete understanding of human biology, and how psychosocial factors impinge on it. Patients present at any time, with varying degrees of severity, at various stages in their life. The goal is to provide the best approach to each patient customized to that patient's situation and problems. Doing so is likely to require using drugs, devices, and equipment that will perform predictably and reliably. But the choice of what tests to do, what treatments to employ, how to discuss and inform the patient of what is going on, etc are unique to each patient.
In contrast, the goal of production lines is to produce identical products, designed by humans, based on good understanding of physics, chemistry etc., and the principles of engineering. So how would practices designed to improve the design and manufacture of goods and equipment on a production line likely apply to how hospitals take care of unique patients?
In this week's JAMA there appears a good example of the genre of applying industrial production techniques to health care, an article by Andrew S. Grove PhD, the "former chairman of the board of Intel Corporation." [Grove AS. Efficiency in the health care industries: a view from the outside. JAMA 2005; 294: 490.]
Grove starts off with this comparison: "the health science/health care industry and the microchip industry are similar in some important ways: both are populated by extremely dedicated and well-trained individuals, both are based on science, and both are striving to put to use the result of this science." These criteria are extremely broad. One could use them to compare health care with the airline industry, major league baseball, or the Communist Party in the Soviety Union under Vladimir Lenin. All these organizations could have claimed to be populated by well-trained, dedicated people, who based their work to some extent on scientific principles.
Then blithely dismissing that "one industry deals with the well-defined world of silicon, the other with living human beings," Grove goes on to tell us how to do health care better.
Particularly galling, I think, is his criticism of the slow pace of the "war on cancer" compared to the increase in the number of transistors included on microchips.
Maybe he really got to the point nearer the end, when he pushed for more and quicker implementation of the electronic medical record. "When it comes to operational efficiency, nothing illustrates the chasm between the 2 industries better than a comparison of the rate of implementation of electronic medical records with the rate of growth of e-commerce." This comparison is hard to fathom. EMRs, to be useful, need to digitally categorize data that is very hard to organize. No one yet knows how to store, for example, the contents of the medical history in anything other than a text file. Yet an electronic medical record that consists mostly of text and image files may be no easier to manipulate than a paper chart. E-commerce, on the other hand, must simply keep track of stereotyped transactions. (Readers of Health Care Renewal have seen why the EMR may not be as much of a panacea as its promoters proclaim.) But selling more EMR systems may increase the demand for Intel's chips.
I have no objection to inter-disciplinary work. And health care can obviously benefit from insights from other fields. But why are we in health care constantly berated by people based on bearing such bad analogies as those proposed by Grove?

Allegations of Conflicts of Interest at JCAHO

The Washington Post has been running a series on Medicare. One particularly significant article was on how Medicare has farmed out most evaluation of health care quality to the Joint Commission on the Accreditation of Health Care Organizations (JCAHO), pursuant to language in the original 1965 legislation that set up Medicare. Also, many states have closed down their inspections of health care facilities, and rely on JCAHO accreditation. For example, "Maryland regulators used to conduct their own hospital inspections until a wave of deregulation swept the state in the 1980s and state legislators agreed to accept joint commission accreditation for licensing purposes. According to Carol Benner, director of the state Office of Health Care Quality, Maryland 'had no authority' over the joint commission: 'We couldn't tell them what to look for in their surveys, and they didn't consult us.'"
Yet the article stated, "the joint commission's practices raise questions about potential conflicts of interest and the rigor of its hospital surveys." The article charged:

• There have been "glaring examples" of JCAHO missing important quality problems, notably at Redding Medical Center (California), Maryland General Hospital, Norwalk Hospital (Connecticut), and Palm Beach Gardens Medical Center (Florida).
• "The board of directors of the joint commission is dominated by representatives of the American Hospital Association and the American Medical Association." [The listing of the current Board of Commissioners is here. The listing does not appear to have many people with overt associations with the AHA and AMA. The web-site describes the Board as having "diverse experience in health care, business and public policy. The board consists of 29 individuals, including physicians, administrators, nurses, employers, a labor representative, health plan leaders, quality experts, ethicists, a former health insurance executive, a consumer advocate and educators."]
• "About 99 percent of the hospitals reviewed by the joint commission win accreditation...." "Some critics point to the approval rate as evidence that the joint commission is captive to hospitals."
• JCAHO sells hospitals "We Are Accredited" products, e.g. "banners, coffee mugs and enamel pins."
• JCAHO has a "subsidiary, Joint Commission Resources, [which] was established in the 1990s to consult with hospitals on how to gain accrediation and improve their performance." "Directly or indirectly, most of JCR's nearly $33 million in revenue comes from helping hospitals win the joint commission's seal of approval." JCR CEO Karen H. Timmons "said that there is a firewall between the subsidiary and the joint commission...." However, there are substantial money flows between the groups. "In the past three years, JCR has paid its parent about $10.5 million in management fees and $867,000 in royalties. And according to its 2003 tax return, JCR owes the joint commission nearly $8.4 million."

In my humble opinion, if the main function of JCAHO is for hospitals and other health care facilities as a group to improve their own health care quality, that would be admirable, and the practices above would not constitute problems, for the most part. However, if the federal and state governments have out-sourced quality control to JCAHO, the questions about conflict of interest raised by the Post become very serious.

"Buffeted Biovail"

I noticed this one on my trip to Canada last week.... From the Globe and Mail, a story about the ongoing travails of Biovail, a large Canadian drug-maker best known as the manufacturer of Wellbutrin. The article described how the company's largest shareholder, Eugene Melnyk, is promoting a buy-out to take the company private, prompted in part after the company "became a pariah when regulatory probes, governance issues and operating profits drove the stock price down." But, "Mr. Melnyk has attracted controversy at Bioval because of his compensation and governance practices." "In 2001, he earned $122-million, making him the most handsomely paid CEO in the country, and in one three-year stretch he pocketed $226-million by cashing in stock options." In addition, "the U.S. Securities and Exchange Commission announced recently that it was expanding its 18-month investigation into the company's accounting practices.... The Ontario Securities Commission is probing four instances of probable insider trading involving Biovail, along with whether a company press release about a trucking accident in the fall of 2003 contained 'misleading statements.'" The press release apparently arose after the company issued a profit warning due to an accident in which a single tractor-trailer truck whose load included Wellbutrin XL got in an accident outside Chicago. The company valued its cargo between $10 and $20 million.
This is just a reminder that management and leadership issues are hardly limited to US health care organizations.

The New England Journal of Medicine on Guidant

In this week's New England Journal of Medicine, the indefatigable Robert Steinbrook has provided a nice summary of the Guidant case to date, complemented by some notable original reporting. (The link is here, but getting the full article requires a subscription. The full citation is: Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med 2005; 353:221-224.)
Steinbrook summarized the events in the case, including how in 2002 Guidant discovered a fault in its implantable cardiac defibrillators (ICDs) that could cause them to short-circuit and fail; how Guidant re-designed the devices in 2003, but continued to ship devices prone to the fault; and only notified physicians and the public of the problem in 2005. (We have posted frequently on the Guidant case, most recently here.)
The problems with Guidant's ICDs first became evident to physicians after a young man with an ICD implanted for hypertrophic cardiomyopathy (pathologic excessive growth of the heart muscle) died in 2005 of a rapid heart rhythm that his ICD failed to stop. Steinbrook reported how his physicians at the Minneapolis Heart Institute investigated, searching the Manufacturer and User Facility Device Experience (MAUDE) data-based held by the US Food and Drug Administration (FDA). They found other reports of short-circuit induced failures of Guidant ICDs. Steinbrook quoted Dr. Barry Maron, director of the Hypertrophic Cardiomyopathy Center:

"We became very concerned. We were keeping a secret not just from our patients and their physicians, but also from all the patients with the device and their physicians. On May 12, four Guidant officials came to my office and gave a very educational presentation. I asked, 'What are we going to do about this? We are in an untenable situation ethically and morally with our patients. How are we going to get the word out?' They said, 'Well, we are not. We don't think we need to. And we don't think it's advisable.' The officials expressed doubt that the patients would be able to understand the medical issues involved in determining whether or not to replace the devices. I said, 'I think this is the biggest mistake you will ever make.' They said they didn't agree."

This appears to be a chillingly direct example of external threats to physicians' core values arising when the leaders of a large health care organization put the organization's short-term financial interests ahead of their ethical obligation to provide the information needed by doctors and patients to make good clinical decisions.
Steinbrook concluded, "For more than three years, Guidant kept quiet about the serious malfunctions of some of its ICDs and continued to sell defective devices after it made manufacturing changes to fix the defects. The company will have to regain the trust of patients and physicians."
The New England Journal and Robert Steinbrook deserve commendation for treating this story as one of broad significance. This article stands in sharp contrast to the kid-glove treatment given the Guidant's Chief Executive Officer Robert W. Dollens during his interview by a senior editor of Health Affairs (see our post here). The interviewer never acknowledged either that Guidant had manufactured ICDs that were prone to fail, that they had knowingly shipped such ICDs from stock after beginning re-designed models that corrected the fault, or that Guidant had concealed these facts from physicians and the public for three years. The Health Affairs interview seemed to be an example of the "anechoic effect," how stories about threats to physicians' core values arising from concentration and abuse of power produce no echoes outside of the local news media. The New England Journal and Dr. Robert Steinbrook have dealt the anechoic effect a mighty blow.
[In other news about Guidant's troubles, also note that the New York Times has just reported that Senator Charles E. Grassley, Chair of the Senate Finance Committee, may have his committee review the recent Guidant recalls; and the Times also reported that Guidant's recommendations for correcting problems with some of its ICDs by reprogramming them might not prevent the devices from failing, and that Guidant has yet to come up with an alternative solution, other than removing and replacing these devices.]

EMR's are coming...perhaps not so fast

I agree with Egan that EMR's have the potential to be abused. The disquieting metaphor of clinicians becoming "glorified data entry personnel for third parties (to a greater extent than we already are)" is a distinct possibility unless clinicians take charge of the tools of their own profession.

On the other hand, to throw a monkeywrench into the beliefs of the optimists, there's this:

J. Am Med Inform Assoc. 2005 May 19; [Epub ahead of print]

The Impact of Electronic Health Records on Time Efficiency of Physicians and Nurses: A Systematic Review.
Poissant L, Pereira J, Tamblyn R, Kawasumi Y.
Clinical and Health Informatics, McGill University, Montreal, Canada.

A systematic review of the literature was performed to examine the impact of electronic health records (EHR) on documentation time of physicians and nurses and to identify factors that may explain efficiency differences across studies. In total, 23 papers met our inclusion criteria; five were RCTs, six were posttest-control studies and twelve were one group pretest-posttest designs.

... Studies that conducted their evaluation process relatively soon after implementation of the EHR tended to demonstrate a reduction in documentation time in comparison to the increases observed with those that had a longer time period between implementation and the evaluation process.

This review highlighted that a goal of decreased documentation time in an EHR project is not likely to be realized. It also identified how the selection of bedside or central station desktop EHRs may influence documentation time for the two main user groups, physicians and nurses.

PMID: 15905487

Ten year timeline to national EMR's in the U.S.? I recall that same timeline being championed - when I attended the AMIA conference (then known as SCAMC) for the first time in 1991.

-- SS

EMRs are coming, EMRs are coming

Here is my response to an article by Ken Karpay in the periodical, Physicians Practice (July/August): http://www.physicianspractice.com. The article's thrust is fairly obvious from the title: that electronic medical records are on the way, in a big way, whether physicians resist or not, but with potentially great benefits to us, blah, blah, blah...

-----------

EHRs are coming – Like it or Not

Dear Ken,

I recently read your ‘Politics and Your Practice’ column for July/August of Physicians Practice. I too believe we have reached a ‘tipping point’ in the migration toward EMR in medical practice; politics surely has proved to be the critical force in the impending turning point. In general, I agree with the main thrust of your article. As a physician and medical informatician in Rochester, New York who has both developed and used EMR technology in an Internal Medicine practice I can attest to both the pitfalls and benefits in this space.

I would expound on one point you made in the article: “…you will have something you’ve never had before: hard data about your practice.” Control of one’s data is the critical point here. Many central entities around the nation (Regional Health Information Organizations, or RHIOs, for example) are forming in an effort to entice/push (depending on your perspective) physicians toward EMR adoption. These efforts often entail centralizing data (e.g. lab data) in a community; in some areas of the nation the efforts are quit evolved—e.g. offering an ASP (application service provider) model to deliver EMR technology from a central source. The central stores of data in these initiatives will have the potential to NOT be in the control of individual practitioners. This potentially could serve as yet another means to micro-manage physicians’ practices. And if you think current “report cards” often produced by IPAs today are detailed just wait until the highly granular data from an EMR makes it to a centralized data repository. Third parties will have unprecedented access to very detailed information regarding practice operations.

I implore physicians and other providers to educate themselves about health information technologies. We all must ensure that we have first access to the data we collect; that we retain a high degree of control over these data. The risk is that we become glorified data entry personnel for third parties (to a greater extent than we already are) and hence, actually diminish our already slipping grip on practicing medicine. I am a big advocate of information technology. However, if physicians approach EMR adoption passively (or passively aggressively) they risk getting run over by this horse that is clearly out of the barn.

Egan F. Allen, MD

Internist and Health Information Technology consultant

Pittsford, New York

Suddenly Sick

At this site, the blog's readers will find a fascinating series by some truly intrepid Seattle Times reporters, on a topic near and dear. Namely, big business manipulating doctors. But there's a subtle twist here which, to whatever extent it holds water, gives a real frisson. How does marketing impact the way we actually make diagnoses? Download this, while it's free (as a PDF, about 6 MB), and decide for yourself.

Neutralizing doctors

In my avocation ham radio, the term "neutralize" refers to applying capacitive or inductive feedback in an amplifier, often a high-power radio transmitting amplifier. The purpose of the neutralization is to prevent unwanted, out-of-control waverings and oscillations that can cause interference with the business of radio operation, or damage the critical and potentially saleable assets of the ham radio operator, i.e., the amplifier itself.

In pharmaceutical marketing to clinicians, however, "neutralization" means providing education, according to the press report below.

Next time your drug rep appears in your office, ask them if you are being neutralized, and if being neutralized carries CME credit.

Merck executive testifies in nation's first Vioxx trial
07/19/2005

By KRISTEN HAYS / Associated Press

Merck & Co.'s marketing team targeted doctors viewed as unfriendly toward Vioxx to bring them into the fold, neutralize or discredit them, the plaintiff's lawyer in the nation's first Vioxx-related lawsuit to go to trial alleged Tuesday.

Houston litigator Mark Lanier questioned Nancy Santanello, head of Merck's epidemiology department, about an internal list of 36 doctors identified as "physicians to neutralize" in an e-mail circulated two months after the popular painkiller went on the market in 1999.

"Attached is the complete list of 36 physicians to neutralize with background information and recommended tactics. You will notice that some have already been 'neutralized,'" the e-mail said. It also said a previous e-mail had a subset of the 36 physicians "we would like to get involved in Merck clinical research" and that the e-mail's recipient should "be aware of our most challenging (and also most vocal) national and regional physicians."

Santanello said the term "neutralize" was a marketing strategy to educate doctors about Vioxx.

On another note, some press releases such as this one review issues in FDA warning letters that had been received. For example:

... among those [warning letters] was a letter Merck received in September 2001 — two years after Vioxx was introduced to the market with much fanfare — about Vioxx marketing in the aftermath of a 2000 study dubbed VIGOR. The study found some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen, sold under the brand name Aleve.

"The [FDA] letter said Merck was engaged in a promotional campaign for Vioxx "that minimizes the potentially serious cardiovascular findings" observed in the 2000 study, and "misrepresents the safety profile for Vioxx."

The letter also said that Merck's campaign discounted the fact that patients on Vioxx "were observed to have a four to five fold increase in myocardial infarctions (MIs)," or heart attacks, compared to patients taking naproxen.

The FDA also challenged Merck's attribution of the disparity to naproxen's cardioprotective qualities, not a defect in Vioxx.

"That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence and there is another reasonable explanation, that Vioxx may have pro-thrombotic properties," or the ability to cause blood clots, the letter said. "

Company representatives have repeatedly opined that non-clinical trial data such as from retrospective review is invalid, since it is not based on the gold standard of randomized clinical trials. For example:

... an FDA analysis of a Kaiser Permanente database reportedly showing that 27,785 heart attacks and sudden cardiac deaths might have occurred, and might have been avoided if Celebrex were used instead of VIOXX, was reported by the Wall Street Journal. This conclusion is controversial, however. In an interview in the Boston Globe, Merck CEO Raymond Gilmartin refutes the study's findings because it was based on a review of medical records, not a clinical trial. "You can't take a study like this and take a patient population and extrapolate those kinds of numbers," he said. "It's just not valid to do that."

Yet, the explanation proposed for cardiovascular observations about VIOXX compared to Naproxen - that Naproxen protects the heart - "has not been demonstrated by substantial evidence" and is hypothetical, according to the FDA.

Contradiction alert. It seems it's not quite valid to make hypothetical, unsubstantiated assumptions about pharmacology and drug effects. To do so seems a significantly greater leap of faith compared to making inferences from retrospective review of actual medical data -- such as non-clinical trial data from HMO claims or from an EMR. But what do I know. I'm just a physician-Medical Informatics specialist (who pushed hard to improve provision of scientific information to Merck's research lab scientists), who then got "neutralized" by the non-medical former computer executive who presided over biomedical information provision to the labs. This occurred as part of the non-VIOXX related 4,400 layoffs in Nov. 2003.

-- SS

Now It's Guidant's Pacemakers that Spring Leaks

From the New York Times, another story about faulty products from Guidant. The company just announced that the "hermetic sealing component" in a variety of its older pacemaker models "may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case," leading to failure. 28,000 pacemakers still implanted out of 78,000 manufactured in the Pulsar, Pulsar Max, Discovery, Meridian, Virtus Plus II, Intellis II and Contak model lines are affected.
Guidant's CEO Robert W. Dollens stated "the health and safety of our patients is paramount. Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients."
Guidant has previously reported several problems with its implantable cardiac defibrillators (see our posts here and here.) In addition, as detailed in the links in the latter post, Guidant withheld information about some of these problems from physicians and the public, and continued to sell older versions of the devices from inventory that included a known design flaw even after it had started manufacturing improved versions that were not flawed. Guidant's CEO and other executives have been sued for securities fraud for concealing these problems while the company was in merger negoations (see this post).
Guidant seems to represent the many troubled organizations which collectively are an important cause of health care dysfunction, but one rarely discussed outside of Health Care Renewal. (We had noted how a recent long interview with Guidant's CEO Dollens in Health Affairs barely touched on any of these issues.)

Where Does the Money Go? - From New York State Medicaid, Nearly Everywhere

The New York Times just published the results of a massive investigative reporting effort documenting amazing levels of Medicaid mis-spending in the state, amounting to billions of dollars.
New York's state Medicaid program, started in 1966 under Governor Nelson Rockefeller, has become the most expensive in the US, spending $44.5 billion annually. Yet the Times reported that it is "so lightly policed that it is easily exploited." The retired chief state investigator of Medicaid fraud estimated that 10% of that amount goes to fraud, and another 20-30% to abusive, if not frankly illegal spending.
Examples the Times noted spanned a large spectrum. They did include a Russian-trained physician who prescribed $11.5 million worth of the drug Serostim in one year, much of which may have been diverted to the black market for body-builders. However, some of the less usual suspects included:

• A dentist who once billed for 991 procedures in a single day, and who, with an associate, billed Medicaid for more than $5 million a year. After the Times told the Medicaid Fraud Control Unit about this case, the two dentists were indicted for grand larceny.
• Ambulette services that often billed for more than 100 rides a year for a single individual, or billed for rides for fully mobile patients. Very few of these services have even been audited by Medicaid.
• Multiple public school systems which can bill Medicaid for services such as speech therapy for their students. Medicaid paid $1.2 billion to public schools for speech therapy over eight years. The Times reported how school officials literally rubber-stamped documents stating that thousands of students needed such therapy, without evaluating more than a fraction of them. 86% of claims from New York City schools were unsupported by any explanation of the need for services. However, the US Justice Department suspended its inquiry into this matter after complaints from politicians like Senator Charles Schumer (Democrat - New York).
• Executives and owners of nursing homes. Nursing homes in NY get more than two-thirds of their revenue from Medicaid. 70 nursing home executives made more than $500,000 in 2002, and 25 made more than $1 million. New York nursing homes have at times been known for their poor care, according to the Times, and have lower than average staffing levels.

This story is a telling illustration of how health care dollars can be siphoned off in multiple directions. Health care practitioners, unfortunately, must share a good chunk of the responsibility, but a variety of other people and organizations clearly account for a major part of the problem. What is most striking is how this particular government "single payer" system seemed so oblivious to where its money was going.

Celebrities More Often Pitching "Disease Awareness"

The Associated Press reported on the increasing frequency of "disease awareness" advertising featuring celebrities. Examples included Cheryl Ladd talking about menopausal symptoms (for Wyeth, makers of Prempro and Premarin), and Lance Armstrong talking about cancer (for Bristol-Myers-Squibb, makers of various chemotherapeutic agents). Important older examples include Dorothy Hamill and Bruce Jenner talking about arthritis (for Merck, maker of Vioxx, now off the market) and, of course, Bob Dole talking about erectile dysfunction (for Pfizer, maker of Viagra). The article suggests that pharmaceutical companies will be increasingly turning to disease awareness campaigns, since such advertisements do not necessarily mention specific drugs, and hence do not have to discuss adverse effects.
The article noted that celebrities may make from $200,000 to $1 million for such advertisements, and that their work is facilitated by several agencies that specialize in connecting them to health care companies.
I was surprised that Thomas Abrams, head of the US Food and Drug Administration (FDA) division of marketing, advertising, and communication, endorsed such advertisements, "we think disease awareness commercials are very beneficial. There's a number of diseases in the United States ... which can have devastating effects of they go untreated." Based on the examples above, it appears his definition of "devastating effects" may be a bit broad.
Again, it appears that some pharmaceutical companies are eager to entice patients with emotional appeals made by popular public figures skilled in communicating, but hardly expert in medicine. There won't be any extra support, however, for physicians who will have to balance their patients' new "disease awareness" with the risks and costs of the drug manufacturers' latest products.

Connecticut Medicaid HMOs Keep Their Physician Payments Secret

The Hartford Courant reported how Connecticut Medicaid HMOs have tried to keep what they pay doctors secret. The story started when a group of clinics in New Haven found their patients were having trouble getting appointments with cardiologists and gastroenterologists. They wondered if low rates of reimbursement of these services by the patients Medicaid HMOs were deterring doctors from seeing them. But when the clinic doctors asked the state's Department of Social Services (DSS), which administers the state Medicaid progam, what its HMO contractors paid for sub-specialty services, the Department refused. The clinics' attempt to force the state to reveal these rates using the state Freedom of Information Act is pending. The state attorney general said, "as a matter of policy, I disagree with the DSS position." The article noted that "lawyers for the HMOS - Community Health Network of Connecticut, Health Net of Connecticut, FirstChoice Health Plans of Connecticut and WellCare of Connecticut, decline to comment for this story, but referred a reporter to legal papers filed with the Freedom of Information Commission. In the papers, the HMOs claim that disclosing the amount they pay doctors would reveal commercial secrets."
There they go again. The biggest secrets in health care these days, it seems, are what some organizations charge or pay for specific services. (See our post here about how hospitals keep their "list prices" secret.)
This secrecy seems to contradict claims made by some of the HMOs, for example, that "our members are very important to us, (by Community Health Networks of Connecticut), or to "be responsible for the commitments we make and the results we deliver," by (WellCare, in its statement of values.)
Prices paid for physicians services hardly seem like trade secrets like Coca-Cola's secret syrup formula. So inquiring minds want to know what it is about these prices that the HMOs so strongly want to keep secret.

Rhode Island Blue Cross Settles Class-Action Lawsuit

Our own Rhode Island Blue Cross just settled a class-action lawsuit, according to the Providence Journal. The plaintiffs had claimed that Blue Cross collected inflated inflated co-payments for drugs by charging patients a percentage of the list price, while the company actually was only charged a discounted price. The example given in the article was someone "might, for example, get $100 in perscriptions ... and end up paying $20, based on a 20-percent copayment, while Blue Cross would secure discounts and pay just $40 for that medication." Although Blue Cross did not admit wrongdoing, the settlement would prevent it from basing co-payments on inflated list prices in the future.
Blue Cross was not exactly forthcoming in this matter. The plaintiff's lawyer described its defense of this lawsuit up to the time it was settled as "trench warfare."
This is, of course, yet another example of a insurance company/ managed care organization "bilking subscribers," to use the article's words. More importantly, it also appears to be an example of how mismanaged health care organizations end up hurting the patients they are supposed to serve. At the time Blue Cross was inflating patients' copayments, it was lead by a CEO who turned out to have an equally inflated salary, received an interest free loan from Blue Cross to help finance a lavish new house, and be getting free treatments from a local acupuncturist who hoped to get the company to start paying for his services (see our post here). In addition, Blue Cross is currently being investigated after a state legislative leader revealed they he accepted money from the company to promote its legislative agenda (see our post here).

NIH Report Revealed "Ethical Problems Are More Systemic and Severe Than Previously Known"

The Los Angeles Times reported that an internal review conducted by the National Institutes of Health showed that 44 of 81 scientists investigated violated the then current NIH policies on conflicts of interest. NIH Director Elias Zerhouni wrote to senior members of the House Energy and Commerce Committee that "we discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of the NIH as an affiliation."
Rep. Joe Barton (R-Texas) said that the "ethical problems [at the NIH] are more systemic and severe than previously known."
The 44 people found in this effort may be but a fraction of NIH employees and officials who had conflicts of interest. The LA Times referred to "industry consulting deals that involved hundreds of agency scientists." However, the NIH would not provide Congress with documentation of the extent of this problem. The 81 identified for the current review were derived from responses from 20 companies to letters sent by the Congressional committee inquiring about NIH employees who had consulted for them. Many other companies were not contacted.
Also keep in mind that the policies the individuals mentioned above violated had already been substantially relaxed in the 1990's from the previously stringent rules. Furthermore, individuals previously identified by LA Times investigative reporters as having major conflicts of interests included not just rank-and-file scientists, but leaders of NIH laboratories and divisions. (See the LA Times summary article from December, 2004 here, and this Health Care Renewal post, which recounts how Director Zerhouni concluded that the NIH had a systemic problem, and refers to many previous posts on the subject.)
One can only hope that Director Zerhouni stands firm against those who are still protesting his new, more rigorous conflict of interest rules (See relevant posts here, here, and here). Too much damage already has been done to this once proud institution.

A "Tune-Up" from Nesiritide?

Here is another story about a pharmaceutical company appearing to go well beyond the evidence in its promotion of a new, expensive drug.
This week's New England Journal of Medicine features a Perspectives article on the marketing of nesiritide, sold as Natrecor by the Scios division of Johnson & Johnson. (Topol EJ. Nesritide - not verified. N Engl J Med 2005; 352: 113). Also, an article about the marketing of the drug appeared in the Boston Globe.
The main points made by Topol were:

• Two randomized controlled trials of nesiritide showed that it lead to short-term improvement in the pulmonary capillary wedge pressure (PCWP) of patients with acute decompensation of congestive heart failure (CHF). PCWP assesses the degree of lung congestion. One trial also showed some short-term symptom improvement.
• Both trials showed increases in 30-day mortality of patients treated with nesiritide, although these increases did not achieve statistical significance, i.e., could have been due to chance alone. However, the trials were to small to prove that nesritide did not lead to a higher risk of death.
• Patients who received nesiritide also had a higher rate of kidney problems, but again, this could have been due to chance.
• No trial demonstrated any long-term improvement in any clinically important outcome due to nesiritide.
• There have been no controlled trials of nesiritide used for prolonged periods of time, or in out-patient settings.
• Nonetheless, previous news reports, and the new Boston Globe article showed that Scios has been encouraging physicians to open "infusion centers" to administer nesiritide to outpatients over weeks or months, as a "tune-up." Each dose of nesiritide in this setting costs about $500. The company set up a telephone hotline to help physicians get reimbursement for this service, and published a "Natrecor Reimbursement and Billing Guide," that shows how physicians can collect professional fees for outpatient nesiritide administration. The Globe quoted Dr. Steve Nissen from the Cleveland Clinic, "my moral compass went off when I saw this. It felt like the company was promoting the use of a drug to profit physicians, rather than to benefit patients." However, Mark Wolfe, a Johnson & Johnson spokesman, said "Scios does not promote Natrecor for regular, scheduled outpatient infusions."

Topol concluded, "in my view, nesiritide has not yet met the minimal criteria for safety and efficacy." So, "we need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety."

Medicare Overpaid for Chiropractic

The Washington Post reported that the Inspector General of the US Department of Health and Human Services concluded that Medicare overpaid chiropractors about $285 million in 2001, about two-thirds of the total paid that year for chiropractic services. Most of the excess payments went for "maintenance treatments," periodic manipulation of the spine in absence of specific symptoms, which Medicare currently considers ineffective. The American Chiropractic Association claimed, however, that the issue was really "a universal problem in physician documentation."
This apparently will not discourage the Center for Medicare and Medicaid Services (CMS) from starting a pilot program to increase coverage of chiropractic care. According to the Mark McClellan, CMS administrator, the program is meant "to evaluate whether expanding coverage of chiropractic services reduces overall Medicare expenditures for neuromusculoskeletal conditions." The article did not mention whether it was also meant to improve patients' health outcomes.
Of course, I haven't heard about any CMS pilot programs to pay more for physicians' services for primary care, yet, as we have documented, their reimbursement has failed to keep up with rising overhead expenses.
Again, this is a reminder that most cost-cutting efforts by federal payers and managed care organizations seem to have been directed to across-the-board cuts of reimbursement for general primary care and acute care services, while the prices of some "complementary and alternative medicine" (like chiropractic), on one hand, and some "high technology," like BilDil and Thalidomid, go unchallenged.