Tuesday, April 05, 2005

UK lawmakers slam slack pharmaceutical regulation

The UK is often more outspoken and less "politically correct" in many ways regarding healthcare matters than the US. In this article, I agree with the need for regulatory independence and better reporting and evaluation of adverse drug reactions (in fact, I believe entire domain of AE reporting uses 1950's approaches and needs significant modernization). I also agree with the charges of "disease mongering" by a part of the medical establishment that stands to profit from such line redrawing, damaging the credibility of all clinicians still further beyond what mismanagement, corruption, and managed care have already accomplished.

-- SS

UK lawmakers slam slack pharmaceutical regulation
Tue Apr 5, 2005 03:24 AM ET
By Ben Hirschler

LONDON, April 5 (Reuters) - Regulation of the pharmaceutical industry is inadequate, leaving powerful drug companies free to promote "a pill for every ill", an influential British parliamentary committee said on Tuesday.

Recent scandals, notably the worldwide withdrawal of arthritis drug Vioxx, highlighted significant failings in the system, according to the Health Select Committee.

"Like any industry, drug companies need effective discipline and regulation, and these have been lacking," said committee Chairman David Hinchliffe.

The Medicines and Healthcare products Regulatory Agency (MHRA) -- the body charged with monitoring the industry -- lacked the discipline and leadership needed to protect patients, his committee said.

In future, new drugs should be more tightly controlled, with curbs on their promotion and restrictions on the ability of junior doctors to prescribe them, it recommended. There should also be a public inquiry whenever a drug was withdrawn on health grounds.

Overall, Hinchliffe said far greater transparency was needed in the oversight of medicines and scrutiny of clinical trials to ensure drugs were not over-prescribed before the full consequences of adverse side effects were known.

GLOBAL CAUTION

The strongly worded report is the latest sign of shift to a more cautious approach to medicines around the world in the wake of recent high-profile problems, which have triggered criticism of both drugmakers and regulators.

The global drugs industry was rocked in 2004 by the withdrawal of Merck & Co. Inc.'s Vioxx, after it was linked to increased risk of heart attack and strokes.

A serious safety problem also emerged last year over selective serotonin reuptake inhibitor (SSRI) antidepressants, such as GlaxoSmithKline Plc's Seroxat/Paxil, which have been linked to suicidal behaviour in a minority of patients.

The UK committee said the pharmaceutical industry -- led in Britain by GSK and AstraZeneca Plc -- had produced many life-saving medicines but had become increasingly focused on marketing rather than science.

This was the source of many of the current problems, including a trend towards "disease mongering", whereby increasing numbers of people are defined as abnormal and therefore eligible for drug treatment, it concluded.

Recommendations for change include greater MHRA independence from both government and the pharmaceutical industry, and better reporting and evaluation of adverse drug reactions.

The lawmakers also want to see responsibility for the pharmaceutical industry transferred from the Department of Health to the Department of Trade and Industry, to ensure health priorities are not muddied by trade considerations.

The Association of the British Pharmaceutical Industry said it supported calls for improved information for patients and better reporting of side effects.

But director general Richard Barker said the report contained a number of "fundamental misconceptions" and he challenged the view that drug consumption was excessive, since Britain had one of the slowest uptakes of new drugs in Europe.

Monday, April 04, 2005

One Hospital System Will Stop Aggressive Collection Tactics Targeted at the Uninsured

Meanwhile, from the Minnesota Star Tribune, the state Attorney General's office has secured an agreement fromthe large Fairview Health Services system that it will stop aggressive collection tactics targeted at people without health insurance, and will start offering discounts off its "rack rates" to them. Sounds like a good idea, too. Previously, the Attorney General reported that "Fairview had become so narrowly focused on profits that bill collectors were sent after patients who didn't owe money or could have qualified for its patient-aid programs."
Perhaps these two small stories offer some little bit of hope that we can get away from the sort of culture described by the doctors surveyed by ACPE (see my post below), where "ultimately, the bottom line corrupts absolutely."

A Revival of Physician-Run, Group Model Managed Care?

In Florida, there are now a couple of "provider-sponsored organizations," which seem to be sort of a revival of the old physician-run, group practice model of managed care. The new organizations are nominally for-profit, but "the idea is to create a system in which a large group of physicians can deliver high-quality care under the direct supervision of physicians, not administrators trying to maximize profits." Sounds promising. See the story in the Miami Herald.

Saturday, April 02, 2005

Major ACPE Survey on Unethical Business Practices in US Health Care

The results of a very important survey have just been published by the American College of
Physician Executives (ACPE)
. A summary of survey data is here. The full article, entitled "Unethical Business Practices in US Health Care Alarm Physician Leaders," is here. An American Medical News article summarizing some aspects of the results is here.
Basically the ACPE designed the survey to determine "how have physicians - along with other health care providers - responded to the universal seep of commercial imperatives into the modern practice of medicine." It surveyed about 1500 ACPE members (a 21% response rate). Of those responding, 10.1% were CEOs or the like, 28.8% were at the vice-president, CMO, COO, CIO level or similar, 17.9% were medical directors, 24.5% had academic leadership positions, and 18.6% were practicing physicians, consultants, or house-staff.
The results that were most striking and relevant to the issue of external threats to physicians' professionalism were as follows.
  • A large majority of respondents were quite concerned about "unethical business practices affecting US health care today." (54.6% were very concerned, 35.6% were moderately concerned).
  • Significant proportions of responders were concerned about unethical business practices within their own organization. (33.1% thought that there were one or more physicians in the organization "involved in unethical business practices;" 11% thought there was a board member "involved in unethical business practices;" 14.2% thought there was a non-physician administrator "involved in unethical business practices.")
  • The majority, 53.8%, could identify another health care organization in their community "involved in unethical business practices."
  • Although most, 70.1%, said that their organization had a written code of ethical behavior, only 59.7% of them said the code was actually enforced.
  • A large majority, 80.8% agreed that "professional organizations need to promote tougher ethical standards."
  • Most respondents evinced concern about a variety of unethical practices by physicians. In addition, most were concerned about board members or non-physician executives with conflicts of interest (33% very concerned, 33% moderately concerned about the former, 34% and 32%, the latter.) Most were concerned about board members or non-physician executives accepting gifts from vendors (27% and 29% re the former, 34% and 32% re the latter.)
  • Finally, when asked who was responsible "for sowing the minefield through which today's physicians have to try to pick a righteous path," they named a variety of types of large health care organizations, health care plans and health insurers, pharmaceutical and device manufacturers, hospitals and health system, and malpractice attorneys.
  • Finally, respondents provided some pithy comments."Our health care system is designed to encourage unethical behavior by its misplaced financial priorities." "Current medical practice on a corporate level is schizophrenic." "Ultimately, the bottom line corrupts absolutely!" "'Business ethics'... an oxymoron?"
In summary, although its small response rate is a limitation, this survey begins to quantitate the scope of some of the issues we have discussed on Health Care Renewal. It suggests that our concerns about threats to physicians' professionalism due to concentration and abuse of power are not exaggerated. If physician executives are this worried, it suggests that doctors in the trenches may be even more so.
Now the question is how can we get the folks with these concerns together, and figure out what to do about them?

More Unrest Over the New NIH Ethics Rules

The Washington Post reports yet more unrest among top NIH employees about the new ethics rules.
  • Another prominenet leader is stepping down because he can't comply with the new rules. James F. Battey, the Director of the National Institute on Deafness and Other Communicative Disorders, said "I manage a family trust ... which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. This would cost a lot of money, and I can't do that to my family."
  • A dissenting group of "senior agency scientists," complained that they would have to get permission for practically any outside activity, "whether paid or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization...." from the NIH. "It is intrusive and scary. It suggests the NIH owns our lives away from work."
  • Ashani Weerarartna of the National Institute on Aging was told she could not accept a $200 train ticket from a "physicians' education group" to present a paper. "I felt awful. I had to call and tell them to find someone else."
  • Furthermore, NIH workers complained that they "cannot hold executive postions - even on a volunteer basis - with trade or professional organizations..." Regarding this, Robert L. Nussbaum, Chief, Genetic Disease Research Branch,National Human Genome Research Institute, said "But what I'm really worried about is backlash from the organizations.""We will be cut off, disenfranchised from our academic colleagues."
An interesting theme here, in my humble opinion, is how those who complain about the new regulations seem to exaggerate their impact.
  • Let's start with Dr. Battey, who also does seem to represent a very special case. I would imagine he could continue to manage his family trust himself if he were willing to sell individual stocks of pharmaceutical and biotechnology companies. Why that would be so expensive is unclear, unless he chose some very bad investments. Furthermore, he could re-invest the money in say, mutual funds that specialize in pharma or biotech. On the other hand, he could simply hire a professional money manager.
  • The dissenting NIH employees seem to have exaggerated the effect of the regulations, as summarized here, on outside activities unrelated to their work at the agency.
  • If the meeting were so important, why couldn't Weerarartna ask the NIH to pay her way, or pay her own way? On the other hand, was the "physicians' education group" actually a commercial CME source, or was it funded by pharma or biotech money?
  • Why couldn't Dr Nussbaum participate in some way other than an "executive" role in the organization? If those "executive positions" were the only members not to feel "cut off, disenfranchised" from this organization, why would anyone want to be a member of it?
Again, let me reiterate, NIH leaders have the privilege of working for what many consider to be the world's premier biomedical research institution. In holding such positions, their speech and actions ought to reflect their scientific knowledge and their commitment to the public good. Major personal financial involvements with outside entities, especially for-profit manufacturers of pharmaceuticals and devices, raise questions about whose interests they are really serving. As Director Zerhouni has said, "It is undermining in a profound way — more profound than I personally realized at the beginning of the process — the integrity of our research and our ability to maintain public trust in our research.”
If NIH salaries are too low to attract competent scientists and physicians, they should be raised. But an NIH position should not be license to seek lucrative after-hours employment for industry.

Friday, April 01, 2005

Thoughts on the Merck CEO Getting a "Performance" Bonus

Regarding the post below by Roy Poses: as former Director of Published Information Resources (running Merck Research Labs' science libraries) and Director of The Merck Index of Chemicals, Drugs and Biologicals, an encyclopedia of medicinal chemistry dating to 1889, I was laid off from the company as part of a group of approximately 4,400 in late 2003. While I cannot comment on many of the issues, and have no direct knowledge of events there since my layoff, I can speculate that the CEO performance objectives that led to the noted rewards likely had much to do with "lowering the cost structure" (management jargon for cost cutting).

From Gilmartin's statement at http://www.merck.com/newsroom/press_releases/corporate/2004_0427.html :
Merck is fundamentally lowering its cost structure and improving the efficiency of its operations through numerous actions. For example, Merck is lowering its cost structure by 2005 as much as $300 million annually by reducing 4,400 positions from its worldwide workforce. To date, 3,800 positions have been eliminated. In addition, the company expects to free up as much as $600 million in additional cash flow through 2006 through a series of efficiencies in its operations and capital investment activities.

Recent news reports said that the layoffs have now exceeded 5,100:

Pharmaceutical maker Merck, on the heels of the recall of its flagship drug Vioxx, announced that it will cut about 5,100 jobs by the end of 2004, and will cut its costs by $2.4 billion over the next four years. In October 2003, Merck had said that as part of a restructuring, it would cut approximately 4,400 jobs. The company has thus announced 700 more employee cuts than originally planned. Merck projects savings of $300 million on payroll and benefits in 2005 as a result of the cuts. The company also plans to save $1.2 billion from procurement changes, $300 million from inventory reduction, and $600 million from capital initiatives by 2008
Whether a reward for this is appropriate or not, I can also add that in my opinion, creativity in high-risk, information-intensive biomedical research of any kind, and aggressive cost-cutting measures keyed to pleasing Wall Street and large institutional stockholders , are generally incompatible.

For example, even in the public sector, when the NIH budget is cut, or not raised enough, statements like this follow:

The AAMC estimates that once all factors are taken into account, the new NIH budget will be about 3.1% more than it was last year. With inflation, that is not even really an increase, said Stacie Pabst, PhD, director of science policy for Research America, a public education and advocacy nonprofit organization in Alexandria, Va. "It's a major problem for people doing research," she said.

and this :

... the pending Senate budget resolution could force as much as a $2.5 billion cut in current NIH funding and that level would be frozen until the Year 2002. If the proposed cuts are permitted to take place, it would damage NIH research at a time of unprecedented productivity, drive talented scientists, both young and established, into other careers, and cause the U.S.to lose its hard-won leadership in such fields as biotechnology and pharmaceuticals.
-- SS

After Vioxx Withdrawal, How Did the Merck CEO Get a "Performance" Bonus?

USA Today has an article (with accompanying data table) about the resurgence of stratospheric pay for corporate CEOs. For example, Ray Gilmartin, CEO of Merck, most recently received a salary of US $1.6 million, plus a $1.4 million bonus, and stock options worth $19.2 million. Also, he exercised other stock options, gaining a further $34.8 million. Gilmartin's got the bonus because he met his "personal performance objectives."
However, USA Today noted that Merck's stock price fell 30% last year after it withdrew Vioxx because of its risk of severe cardiovascular adverse events. The withdrawal of Vioxx gained sufficient notoreity to be easily called a debacle. Furthermore, as has been extensively documented (for example, see these "Perspectives" from the New England Journal of Medicine, FitzGerald GA. Coxibs and cardiovascular disease; Topol EJ. Failing the public health - Rofecoxib, Merck and the FDA; and Psaty BM, Furberg CD. Cox-2 inhibitors - lessons in drug safety.), Merck marketed Vioxx extensively as a general purpose pain reliever even though there was no data it was better than conventional non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. (It did have the advantage of causing fewer severe gastro-intestinal adverse effects for at risk patients.) Furthermore, although Merck had data suggesting Vioxx's cardiovascular adverse effects for years, it consistently minimized them to physicians and the public.
Merck's degree of culpability for the over-use and then withdrawal of Vioxx will be argued for a long time. But it is easy to argue, as Psaty and Furberg did, that "physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured."
How these results justified Gilmartin's "personal performance" bonus boggles the mind. Rather, the Merck CEO seems to be yet another example of how health care leaders remain insulated from the consequences of their actions. Per the USA Today article, "directors remain largely beholden to management when it comes to compensation. The era of CEO pay packages befitting royalty still reigns." The article quoted an expert on CEO compensation, "most directors are in the ostrich crowd, sticking their heads in the sand and doing what they've always done."
The accompanying table shows the compensation of the CEOs of some of the largest companies in the US, including some other health care CEOs whose pay only seems to go up, regardless of how they perform. But the Vioxx calamity should warn us what to expect if health care leaders remain unaccountable.

Thursday, March 31, 2005

NIH Update: Resistance Against New Conflict of Interest Rules Continues

The New England Journal of Medicine this week has a good summary by Robert Steinbrook of the latest developments at the NIH. In particular, it has a clear table of the new, more stringent regulations temporarily put in place by Director Zerhouni.
These included:
  • Prohibition of employment with pharmaceutical and biotechnology companies, research institutions that receive NIH grants and contracts, health care providers and insurers, and related trade, professional, or similar associations
  • Prohibition of compensated teaching or writing for these organizations
  • Prohibition of self-employed business activity involving sale or promotion of products or services of a pharmaceutical or biotechnology company or a health care provider or insurer
  • Prohibition of holding stock in biotechnology or pharmaceutical companies for employees who must file financial disclosure reports, a $15,000 limit in holdings in any one company for other employees
  • Prohibition for senior employees only of the receipt of most awards worth more than $200, and a similar prohibition for all employees of such awards from an organization which is involved with the employees work
  • In general, outside teaching, clinical, scientific writing, and scientific editing activities are permitted as long as they comply with other standards.
It also includes a narrative of how Zerhouni changed his mind about the need for such regulations. Much of its contents has already appeared on Health Care Renewal, but it does have some important new items.
One is that the new regulations at the NIH parallel those already in place at regulatory agencies, such as the Food and Drug Administration and the Securities and Exchange Commission. This was in part driven by the realization that NIH decisions can have "increasingly powerful influence ... on financial markets." Moreover, Zerhouni felt the regulations were in response to activities by high NIH officials that "really were purely and imply what you would call product-endorsement activities, speaking for a company on behalf of a product to entice physicians to prescribe that product at greater levels."

The article also mentions the opposition to these new regulations that Zerhouni has encountered. Furthermore, yesterday, the Washington Post reported that apparently a physician recently nominated to head the National Institute of Environmental Health Sciences now has "serious concerns about taking the job under the new rules." "His primary concenr is that he would be unable to recruit or retain top talent."

The NIH is, as Steinbrook stated, is "regarded as the world's premier biomedical research institution." So, it amazes me that some people don't think the could manage to work in full-time leadership positions at the NIH because they no longer could also work for certain outside organizations, or simultaneously pursue self-employed business activity involving the products of such organization. Are NIH salaries really so low that its high level employees need second jobs to get along economically? Or do people now feel so entitled to lucrative side-employment with industry that the notion of loyal service to the public means nothing? But maybe such people are not those who should be working at "the world's premier biomedical research institution."

HCA leads campaign to curb doctor-owned hospitals

An interesting article on the competition between physicians opening specialty hospitals owned by themselves and corporate medicine. Big-business medicine whines that physician-owned specialty centers gives physicians an "unfair advantage." I would classify this story under the heading "The World's Smallest Violin."

Big-business medicine claims physicians "cherry-pick" the best-insured patients for their centers. However, managed care and for-profits tend to try exactly the same thing to minimize care delivery, maximize corporate profit and shareholder value, and minimize physician income in the bargain to add insult to injury.

Businessmen need to realize that in essence, clinicians are the true owners of hospitals. As I've often said, in a somewhat tongue-in-cheek example, even if hospitals all burned to the ground in some hypothetical apocalypse, clinicians could still take care of patients to a good extent in tents using primitive equipment. They are enablers of healthcare; everyone else is a facilitator. (If only clinicians would become more politically astute and use this realization more aggressively.)

Dear HCA, welcome to the true marketplace of competition from those who actually know what they're doing in medicine, its practitioners.

-- SS

HCA leads campaign to curb doctor-owned hospitals (excerpts)
By TODD PACK
Staff Writer, Tennesean.com

Before many of its heart surgeons left to become owners in a nearby specialty hospital, Oklahoma University Medical Center admitted 150 heart patients a month. Soon afterthe doctor's hospital opened, OU's cardiovascular admissions fell to zero.I t was a drop in business that has cost OU nearly $12 million since 2002 and threatened its ability to care for Oklahoma's most critically injured patients, OU's chief medical officer said. ''Simply put, these facilities drain essential resources from full-service community hospitals,'' said Dr. Andy Sullivan, chief medical officer of the OU Medical Center, a teaching hospital that operates under a joint agreement between the school, the state and Nashville-based HCA Inc.

HCA, which runs 190 hospitals in the United States and overseas, has become one of the leaders in the campaign to curb expansion of physician-owned specialty
hospitals across the country. ''This is a hugely important issue,'' HCA Senior Vice President Victor Campbell said.

What makes it important to companies such as HCA is that doctors are allowed to refer patients to facilities the doctors also own.Critics such as the American Hospital Association say this ''self-referral'' gives doctors an unfair advantage because they refer patients to their own hospitals and take the best-insured patients.

... But proponents of the hospitals dismiss such arguments as self-serving.''They bring competition to the community and bring a new way of thinking of health care,'' said Jim Grant, president of the American Surgical Hospital Association and a Nashville resident. ''They should be promoted.''

... Speaking recently before a House subcommittee looking at the issue of specialty hospitals, one AMA trustee said simply, ''Competition works.'' ''In the hospital industry, the addition of specialty hospitals to the mix gives patients more choice, forcing existing hospitals to innovate to keep patients coming to them,'' said the trustee, William Plested, a Santa Monica, Calif., heart surgeon who isn't affiliated with a specialty hospital.


Tuesday, March 29, 2005

Health Care Renewal Bloggers to Speak

Kim Atwood and Tim Gorski will be speaking at a conference entitled "Curing the Ills of Alternative Medicine and Questionable Mental Health Practices." The date is May 21, 2005, and the location is Amherst, NY. Atwood will be talking about “Naturopathic Medicine: Politics Trumps Science” and Gorski, “They Ain’t Measuring What They’re Measuring.”
Wally Smith and I will be giving a Special Symposium entitled "External Threats to Professionalism in a Chaotic Health Care Environment, Thursday, May 12, 2005 at the Society for General Internal Medicine annual meeting in New Orleans. Note that the meeting theme is Out of Chaos: The Critical Role of Generalists. The meeting dates are May 11-14, 2005.

How Academic Health Centers' Advertising Put Their Interests Ahead of Those of Patients

An important article was just published in the Archives of Internal Medicine on the use of advertising by academic health centers (AHCs). [Larson RJ et al. Advertising by academic medical centers. Arch Intern Med 2005; 165: 645-651.] (For a typical media report on it, go here.)
The authors surveyed marketing departments of 17 top rated (by US News and World Report) AHCs to assess the process used to construct advertisements. They then searched for print advertisements placed by the AHCs in local newspapers, and did a structured assessment of each ad.
Let me quote from their results section (with italics added for emphasis). First, the process of development and approval of the ads was almost never supervised by physicians:
  • "About two thirds of the marketing department representatives were familiar with their institutional review board's process for assuring fair, balanced, and straightforward content in advertising to attract research participants. None of the marketing departments had a similar process for reviewing ads to attract patients for health services."
  • "Only 1 center had a mechanism in place for obtaining medical approval from a person outside the department being advertised."
Now, re the ads themselves:
  • The ads promoted dubious services, "Of the 21 ads for single [clinical] services,.... 19 single-service advertisements were for procedures considered cosmetic ..., having limited (or no) efficacy data, ... or lacking consensus."
  • The ads played on patients' emotions, "Most of the institutions' slogans emphasized cutting-edge care and institution status.... The remaining slogans tended to use emotional themes." "Advertising headlines ... commonly mentioned symptoms or diseases or used strategies that might appeal to patients' emotions or fears."
  • The ads exaggerated benefits while avoiding mention of harms, "While more than three quarters of the single-service ads highlighted potential benefits of the services promoted... none quantified their positive claims. Only 1 ad mentioned or implied potential harms of the service...."
And their summary included:
  • "Given the prestige of academic medical centers ... consumers may have great confidence in the quality , accuracy, and underlying altruistic motivations of any information with which the institutions are associated. Because of this trust, consumers may not recognize the different between information intended to inform the public and advertising designed to generate revenue."
  • "Second, many of the ads seemed to foster the perception that more and higher-technology medicine is always better." "As a result, patients may be given false hopes and unrealistic expectations."
Finally, they concluded with this:
  • "If academic medical centers are to continue with advertising to attract patients, we believe they must be more sensitive to the conflict of interest between public health and making money."
Their abstract's conclusion was even more blunt:
  • "Many of the ads seem to place the interests of the medical center before the interests of the patients."
This is a terrific article, providing new awareness of yet another way in which important medical organizations are straying from their mission, with patients as the biggest losers.

From Harvard: Bigotry, the Disabled and Slippery Slopes

The Philadelphia Inquirer has not replied to me nor, as far as I know, retracted its statement published on two consecutive days that in euthanasia, "Even a normal, healthy person would feel little discomfort after the first few days of thirst."

Perhaps they should read this article from the Harvard Crimson by a student with severe cerebral palsy. I agree with its author that judges, politicians and the mainstream media are driving healthcare down some very slippery slopes.

Of note towards lack of discomfort via starvation is this link cited in the Harvard Crimson article.

-- SS

Saturday, March 26, 2005

Pain Management Caught in the Cross-Fire

An op-ed in the NY Times about how doctors (and patients) are caught in the cross-fire when the issue is control of pain. Zealous enforcement of the law means doctors whose patients abuse prescribed narcotics are liable to face criminal charges. Meanwhile, advocacy groups have been pushing for more aggressive treatment of pain, and physicians have certainly faced malpractice suits for perceived undertreatment of pain as well. Certainly, physicians should neither over- nor under-treat pain. But also we certainly need a more rational way to set standards for pain treatment that make medical sense and put patients' welfare first.

Doctors call dehydration a 'peaceful' way for normal people to die?

In the Philadelphia Inquirer article "Doctors call dehydration a 'peaceful' way to die" (Sat, Mar. 26, 2005), staff writers Stacey Burling and Michael Vitez seem to quote Ira Byock, director of palliative medicine at the Dartmouth Hitchcock Medical Center in New Hampshire, John Hansen-Flaschen, chief of pulmonary, allergy and critical care at the University of Pennsylvania Medical Center, and Paul Marik, director of the division of pulmonary and critical care at Thomas Jefferson University Hospital as saying "Even a normal, healthy person would feel little discomfort after the first few days of thirst." From the article:

... Schiavo, who could begin her eighth day without nutrition or water who this afternoon, will die of dehydration, not starvation, the doctors said. It will cause her kidneys to fail. Toxins will build up in her blood, eventually causing her heart to stop beating.

Dehydrated patients gradually weaken, drift into a coma, and appear to die painlessly, Marik said."It's a very painless and very compassionate way of dying," he said. Even a normal, healthy person would feel little discomfort after the first few days of thirst, the doctors [Byock, Hansen-Flaschen and Marik] said.

WHAT?

I am hoping this is a misinterpretation by the Philadelphia Inquirer authors of the physicians' statements. Even a cursory search on google.com, let alone a more comprehensive search of the biomedical literature via specialized tools such as Medline and others, shows that there is a significant amount of controversy on the topic of palliative care and side effects of dehydration and withholding of intravenous fluids. Clicking on the following URL initiates a search via the simplest of strategies [ "palliative care" AND "intravenous fluids" ]: http://www.google.com/search?q=%22palliative+care%22+%22intravenous+fluids%22&hl=en&lr=&start=20&sa=N ).

From just the first few pages of over 8,000 hits from this topic, for example, appears this statement from the official journal of the American Society for Clinical Oncology :
Dehydration can result in serious symptoms in an otherwise healthy person, causing profound fatigue, postural hypotension, renal failure, delirium, and ultimately death. ("To Hydrate or Not to Hydrate: How Should It Be?", Journal of Clinical Oncology, Vol 18, Issue 5, March, 2000: 1156-1158.)
For a more diverse view from another country, Robin L. Fainsinger, M.D., Director, Palliative Care Program, Division of Palliative Medicine, Department of Oncology, University of Alberta, writes in "When to Treat Dehydration in the Terminally Ill Patient?":
Our palliative care group has argued that the viewpoint that dehydration in dying patients is never a cause of symptom distress, overlooks the fact that: - 1) dehydration is well recognized in nonterminal patients to cause confusion and restlessness, problems often reported in terminally ill patients; 2) reduced intravascular volume and glomerular filtration rate caused by dehydration is accepted as a cause for prerenal failure, with opioid metabolite accumulation in the presence of renal failure causing confusion, myoclonus and seizures, having been well documented (1, 2, 3).

I am inviting the authors and those quoted in the Philadelphia Inquirer to respond to the seemingly-fantastic statement that "even a normal, healthy person would feel little discomfort after the first few days of thirst."

It seems not only incredibly counterintuitive but also contradicted (or at the very least shown extremely debatable) in even the most cursory, third-grade-level information search. I am hoping this is just a a case of sloppy journalism, not unusual in the world of today's mainstream media.

-- SS

-----------------------------------

Update, Satuday Mar. 26: I received a reponse from Dr. Byock. He writes:

It [the Philadelphia Inquirer quote] is a misstatement. It would be true if the article had said, "Even a normal, healthy person would feel little discomfort after the first few days of hunger." A normal, healthy person would need fluids to avoid feeling persistent thirst.


(Not to mention profound fatigue, postural hypotension, renal failure, delirium, and other not-very-pleasant sensations.) My response to him was:

I'm glad it's a misstatement. However, the article does say: "Schiavo, who could begin her eighth day without nutrition or water who this afternoon, will die of dehydration, not starvation, the doctors said. It will cause her kidneys to fail. Toxins will build up in her blood, eventually causing her heart to stop beating. Dehydrated patients gradually weaken, drift into a coma, and appear to die painlessly, Marik said. "It's a very painless and very compassionate way of dying," he said. Even a normal, healthy person would feel little discomfort after the first few days of thirst, the doctors said", the article seemingly being very precise about the matter of hydration.

I wonder how such a statement got into print. With the Schiavo case being a hotly-contested issue and a cause of hot emotions across the political spectrum internationally, it seems major newspapers need to take significantly more care in what they publish.

Certainly a major correction by the newspaper is in order. Will it happen?

-- SS

-----------------------------------

Update, Sun. March 27: Dr. Marik also responded and said the statement was in error. However, instead of correcting the article, the Philadelphia Inquirer republished it almost verbatim in the Sunday, Mar. 27 edition under the title "Dehydration death seen as peaceful." The bizarre statement that "Even a normal, healthy person would feel little discomfort after the first few days of thirst, the doctors said" is repeated.

I'd sent an email about the error with a link to this blog post directly to the Inquirer reporters just after writing the post yesterday, about 10:30 AM EST. Apparently reporters are delayed in reading their email, don't work on weekends, or perhaps stick by their quotation.

What's amazing is that print newspapers still wonder why people are turning to the Blogosphere for information and away from old media. In the blogosphere, feedback and corrections to errors are rapid.

-- SS

Friday, March 25, 2005

Survival of AHCs: Why Do They?

In a series of interviews conducted last year (2004), Drs. Hamilton Moses and Samuel Thier, along with David Matheson, Esq., asked 23 leaders in 15 academic institutions to address this ingenious and properly-ingenuous question. (Why do they survive? That is, of what use are they, these days?) Essentially, another SWOT analysis. This is one of the best articles in this genre that I've seen in quite a while.

Answers were revealing, beyond the round-up-usual-suspects identification of lesions such as reimbursement issues, problems with community outreach, and perversities in both the internal and external environments.

Of note, unless I missed something staring me in the face, Moses et al. chose to keep their informants--and their institutions--anonymous. OTOH such anonymity no doubt did promote candor. One of the nifty things about blogs is that we don't need to take the classic review-panel high-science approach and take them so much to task in demanding such detail from a JAMA "Special Communication" piece.

The article nicely combines elements of the diagnostic and the prescriptive. What's wrong? What's right? And how to fix what's wrong? It is also a welcome call to arms, when the authors (at least implicitly) revert to their own voices.

The authors say their informants came "from all walks of life," to paraphrase; translate: more than just the ivory tower.

But we may legitimately ask: how many came from institutions that had failed, or were about to fail? I see an interesting defect here, by no means fatal for their arguments and recommendations, but still a potential skew-factor.

Namely, tellingly, included amongst their informants, did they include anyone from AHCs that were, or are, nearing the unlovely status of non-survivorship? There's a thread woven through the piece suggesting that AHCs survive in part because they do a lot of things right, and by contrast other sorts of organizations (industry, CBOs, CROs, etc.) don't always do much any righter!

Thus do the AHCs limp along. ("The Paradox: Survival Against the Odds.")

Yet we might add: not always. The first tier institutions have more money, more lucrative clinical specialty cadres, and bigger research portfolios--they have, that is, a lot of ballast and momentum. But not all of them have been surviving. Witness the recent demise of what was once the Medical College of Pennsylvania (the hospital and most of the faculty are gone, and a vestige lives on on the stationery of Drexel Med). It's not quite cricket for those doing better, for now, to assume that any part of their business-as-usual will guarantee future survival. Seems a bit circular.

With this caveat, I suspect that many of this group of authors' conclusions can be considered to be well taken and useful to ponder. (Though, true, they often verge on bromides.) "Do, don't just preach." "Position yourself as honest information brokers." "Get leaders with experience outside the AHC."

Finally, Moses and his colleagues advocate two "fundamental changes." They are (1) enhance ties with the community and (2) simplify the "organizational labyrinth."

These are interesting, if not wholly new. Below the elite tier, one might point out, such ties, paradoxically and perhaps only because of economic and organizational necessity, are already in place. (That's another minor glitch in the argument, but one that's ultimately unexceptionable.)

The biggest issue, then, is how AHCs are themselves governed--here I think again of Pogo, "we have met the enemy...."

Ultimately, institutions, like families, ultimately fall victim to their own contradictions. The perversities of AHC organization, even in best-of-breed AHCs, are nicely laid out in this article, and paramount among them is probably the huge array of disincentives for true collaboration at all levels.

Ultimately, a question and an opportunity stand out. The opportunity: with outpatient medicine becoming more and more important, as the authors note, AHCs have a great chance, if they find ways to seize it, to take over from the hospital as the traditional framework for improved links with the community. Bingo! Eureka! Touché!

The question: who will give the New Leaders, the cadre of community-, market-, and business-savvy deans and chairs and directors that Moses et al. call for here, the Archimedean lever with which to effect all the changes they call for?

Thursday, March 24, 2005

The Costs of Computer Based Medical Technology

My take on Arnold Kling's article on the "Myth of Massive Health Care Waste" has generated quite a bit of discussion on Kling's EconBlog, here. What generated the most interest was the question of whether the cost of computer based medical technology was too high. (The example used was the CT scanner.)
Some of the main conceptual points raised were:
  • One needs to separate the costs of the equipment and its maintenance from the other costs incurred by hospitals or offices in doing CT scans, and these, in turn, need to be separated from the actual price of CT scans
  • Hardware costs need to be adjusted for inflation, but more important, the increasing capabilities of the hardware need to be taken into account
Some striking opinions were:
  • "I think you'll find that in real dollars, the price of CT equipment and technology as well as the cost per procedure has dropped substantially...."
  • "The PC hardware is a small part of the technology."
  • "GE Medical dominates the market and can charge pretty much what it wants."
  • "as quality/performance rises, 'prices' don't necessarily fall continually...."
  • "If high fixed costs are the problem, more volume (more patients, more procedures) will lower the cost per procedure."
  • "I was part of a design team for a CAT scanner.... I proposed many approaches that would have saved quite a bit in both hardware and software costs without reducing functionality, reliability, and performance. I was frequently met with the answer, 'We want it to be expensive.' The medical technology marketplace is a perverse marketplace. There are too many docs involved in the process and they don't respect anything unless it's expensive."
To make this discussion a bit more data driven, I was able to find some about the economics of CT scans over time. [Stockburger WT. CT imaging, then and now. Radiology Management, November/December, 2004. On the web here.]
From 1974 to 2004, the list price of a CT scanner has gone up faster than inflation (from $385K to $2200K, 471% increase, versus 342% increase in consumer price index). So has the acquisition cost ($385K to $1600K, 416%). However, revenue obtained per CT scan has gone up even faster (the Medicare payment for a CT scan of the head without contrast increased 700%.) Finally, and perhaps most importantly, the amount to be made by CT scanning facilities has risen even faster, because, as noted above, it is now possible to do more CT scans per unit time. In 1974, by my calculations, the typical profit of a single-scanner facility would have been $56700 in 1974 dollars. In 2004, it would have been $577,900 in 2004 dollars! Even adjusted for inflation, that's a big increase (1030% unadjusted, 298% adjusted for inflation)!
So, to summarize, my hypothesis that the costs of CT scanners over the last 30 years have become exaggerated in the face of the vast increase in computer performance/ price, given that the "C" in CT stands for computer, remains unproven. However, there is anecdotal evidence (from the comments above) that suggests that these prices may have been artificially elevated by a less than competitive marketplace plus the industries interest in wanting it to be expensive.
More importantly, the data from the article above suggests the larger problem. Despite the rise of managed care and of government efforts to contain costs, reimbursement for CT has risen faster than costs and inflation, and given that CT scans can be done more and more quickly, which raises volume while it further reduces the fixed costs associated with each scan, the amount of money made by CT scan facilities has risen even faster.
So the big question remains. If managed care was supposed to restrain costs by using a more business-like approach, and more attention to the economic issues, why has it so massively failed to restrain these sorts of costs?

Now, doctors DO things with computers

In my writing I've long called for substantive leadership roles and titles for medical informaticists in healthcare, where the attitudes are slowly evolving from the "doctors don't DO things with computers" attitudes (meaning they should be advisors or internal consultants, not leaders) I observed in entering medical informatics. At long ago as 1998 I wrote in a piece called "Ten critical rules about job structure and reporting for applied informatics positions" that:
"Informaticists should aim for positions at the Assistant V.P. level or higher. Director-level (or worse, manager-level) positions often lack real authority and executive presence. Such characteristics are often essential for success in a cross-disciplinary, cross-territorial area such as applied medical informatics. If a position being considered is at the director or manager level, an inquiry as to why it is rated at such a low level may be helpful in understanding the true feelings of the senior executive team about medical informatics leadership."

Today, March 24, 2005, for the first time (in my personal experience) I've seen a free-standing hospital actually offer an informaticist an advanced title: VPMIO.

Position Title: Vice President, Medical Information Officer (M.D.)
Organization Name: (witheld)
Location: (the South)

Job Description: Multi-specialty medical center located on the Gulf of Mexico, in one of the fastest growing areas in the South, seeks an experienced Vice President – Medical Information Officer. This modern facility, with over 400 beds, is in the forefront of modern healthcare delivery with a medical staff comprised of nearly 300 physicians representing more than 40 medical specialties. This hospital offers some of the most advanced information technology and medical services available in the country. The Vice President – Medical Information Officer (VPMIO) is a member of senior management and is responsible for IT strategic planning, medical informatics, and clinical implementation of data, information and knowledge.

This position reports directly to the Chief Executive Officer and frequently works in coordination with the Director of Information Systems. The VPMIO serves as a liaison between the administrative and information technology planning groups. This position is responsible for leading the IT initiatives of the hospital while optimizing use of operating resources and capital financial resources to ensure efficient operation and proper support of clinical and administrative functions. The VPMIO facilitates the overall information management processes of the hospital, as well as the promotion and implementation of these processes, as they relate to the medical staff. The VPMIO must be a visionary and maintain a “hands on” understanding of information technologies.

Required Education: Medical Degree. Board certification in chosen medical field. Preferred Education: Master’s Degree in Medical Informatics, Management and Information Systems, Information Technology, or related field. Required Experience: Five years healthcare experience in an executive leadership role. Preferred Experience: Previous experience in executive IT role—CIO, Director of Medical Informatics, etc.


Now here is an organization that knows what it's doing in clinical IT.

-- SS

Now, doctors DO things with computers

In my writing I've long called for substantive leadership roles and titles for medical informaticists in healthcare, where the attitudes are slowly evolving from the "doctors don't DO things with computers" attitudes (meaning they should be advisors or internal consultants, not leaders) I observed in entering medical informatics. At long ago as 1998 I wrote in a piece called "Ten critical rules about job structure and reporting for applied informatics positions" that:
"Informaticists should aim for positions at the Assistant V.P. level or higher. Director-level (or worse, manager-level) positions often lack real authority and executive presence. Such characteristics are often essential for success in a cross-disciplinary, cross-territorial area such as applied medical informatics. If a position being considered is at the director or manager level, an inquiry as to why it is rated at such a low level may be helpful in understanding the true feelings of the senior executive team about medical informatics leadership."

Today, March 24, 2005, for the very first time (in my personal experience) I've seen a healthcare organization actually offer an informaticist an advanced title: VPMIO.

Position Title: Vice President, Medical Information Officer (M.D.)
Organization Name: (witheld)
Location: (the South)

Job Description: Multi-specialty medical center located on the Gulf of Mexico, in one of the fastest growing areas in the South, seeks an experienced Vice President – Medical Information Officer. This modern facility, with over 400 beds, is in the forefront of modern healthcare delivery with a medical staff comprised of nearly 300 physicians representing more than 40 medical specialties. This hospital offers some of the most advanced information technology and medical services available in the country. The Vice President – Medical Information Officer (VPMIO) is a member of senior management and is responsible for IT strategic planning, medical informatics, and clinical implementation of data, information and knowledge.

This position reports directly to the Chief Executive Officer and frequently works in coordination with the Director of Information Systems. The VPMIO serves as a liaison between the administrative and information technology planning groups. This position is responsible for leading the IT initiatives of the hospital while optimizing use of operating resources and capital financial resources to ensure efficient operation and proper support of clinical and administrative functions. The VPMIO facilitates the overall information management processes of the hospital, as well as the promotion and implementation of these processes, as they relate to the medical staff. The VPMIO must be a visionary and maintain a “hands on” understanding of information technologies.

Required Education: Medical Degree. Board certification in chosen medical field. Preferred Education: Master’s Degree in Medical Informatics, Management and Information Systems, Information Technology, or related field. Required Experience: Five years healthcare experience in an executive leadership role. Preferred Experience: Previous experience in executive IT role—CIO, Director
of Medical Informatics
, etc.


Now here is an organization that knows what it's doing in clinical IT.

-- SS

Wednesday, March 23, 2005

Wash. Post on Cedars-Sinai CPOE failure

For anyone who doubts clinical IT is an area where angels fear to tread, there's this story in the Washington Post:

Cedars-Sinai Doctors Cling to Pen and Paper
By Ceci Connolly, Washington Post Staff Writer
Monday, March 21, 2005


Excerpts, with notable passages in bold and my interspersed comments in italics:


... For every doctor, nurse and executive here, there is a different explanation of what went wrong. The technology, created in-house, was clunky and slow. Only a fraction of the 2,000 doctors with privileges at the hospital were involved in developing the system, even though they faced a dramatic change in the way they practiced medicine, from jotting notes on a clipboard to logging onto a computer to type in their treatment and medication orders. Training was insufficient, and administrators opted for what Hackmeyer called a "big bang" implementation rather than switching one ward at a time.

Now, two years later, the hospital often viewed as an industry leader is being held up as a cautionary tale in the drive toward bringing medicine into the computer age, and officials here say they have no intention of trying again for at least a year.
(note: my opinion on their initial remediation plans were published in Health-IT World in Sept. 2004 -- SS)
The marriage of information technology and medicine is all the rage in health policy circles. Five years after the Institute of Medicine issued a landmark report cataloguing the life-and-death consequences of medical errors, corporate leaders, politicians and physicians are embracing computer-assisted health care.

Yet the spectacular failure at Cedars-Sinai -- described by Bush's technology guru as "the worst case" he has seen -- demonstrates how difficult it can be to make the transition. Even well-financed, sophisticated hospitals face enormous hurdles moving from the Marcus Welby era of pen and paper to one in which doctors spend precious minutes entering data into a machine that never went to medical school and does not have the flexibility to make nuanced judgment calls.
(Neither did most of the IT people developing and leading implementation of such machines, but that seems a problem that is rarely addressed -- SS.)
... "The important lesson of the Cedars-Sinai case is that electronic health record implementation is risky," David J. Brailer, national coordinator for health information technology, said in an interview. "Up to 30 percent fail."
(We're talking billions of dollars of capital and expense dollars that hospitals simply do not have an abundance of -- SS)

... Each time a patient arrived, pulmonary specialist Andrew S. Wachtel would have to find a computer (preferably one of the newer, faster ones), log in and begin checking boxes in at least a half-dozen categories to indicate the patient's symptoms, allergies, diagnosis, tests and medications. A task that once took three minutes to scribble shorthand at the patient's bedside suddenly devoured 30 to 40 minutes, he said.
(Reminds me of the passage in the book "House of God" about finding a medical student who only triples an intern's work - SS)
... even techies found flaws. The system refused to recognize even slight misspellings, so Hackmeyer's efforts to order the laxative Dulcolax -- easily understood by nurses even if he was off by a letter or two -- were thwarted by the computer. It was also impossible to use it to order "clear liquids and advance diet as tolerated," another routine instruction when easing a patient back to solid foods, he said.
(Even Microsoft Word does a better job on typos than that -- SS)
... But the biggest complaint -- with potentially dangerous implications -- involved the automatic alerts that flashed on the screen every time a doctor made an out-of-the-ordinary request. Designed to catch errors before they occur, the alerts became an unending series of questions, reminders and requests on fairly basic decisions.
Infectious disease specialist Stephen Uman said he went around in circles trying to give patients the antibiotic Vancomycin. Although the recommended dosage is 928 milligrams, Uman knows to round up to 1 gram because pharmacies dispense the medication in multiples of 250 milligrams. But when he typed 1 gram into the computer, the machine rejected the request.

Cedars-Sinai was unable to strike a balance between useful computer warnings and a machine that seemed to constantly cry wolf, acknowledged Harold, the former chief of staff. "Buried in those annoying alerts is probably one life-saving alert," he said.
("Unable" to strike a balance? That sounds like an interesting story in itself. -- SS)
... Even with that data, Cedars-Sinai is in no rush to try again. The hospital is waiting for the technology to improve and perhaps for more young, tech-savvy doctors to arrive. In the meantime, Neil Romanoff, the physician who oversees safety procedures here, said the hospital relies on extra layers of staff to double- and triple-check its procedures.
The technology will improve when those behind it have a better grasp of the complexities of medicine. Pioneers in EMR such as Morris Collen, Donald Lindberg, Octo Barnett, and others published guidelines on how to best implement clinical IT that warned against the cornucopia of problems mentioned in this article. Sadly, they did so starting in -- and perhaps even before -- the 1960's.
A good source on references to the wisdom of the pioneers is "A History of Medical Informatics in the United States 1950-1990, by Morris Collen MD, section 3.4. For example, Octo Barnett's clinical IT "10 Commandments" (written in 1970) as reproduced in Collen's book on page 169, as well as 1960's and 70's material by Lindberg, Lamson, Collen, Davis, Baker, and numerous others address many of the substantial problems encountered by Cedars-Sinai in 2003 as documented above.

Medical informaticists are specifically educated in the necessity of minimizing the problems mentioned above, I should add, yet often are not sufficiently empowered to effect change. In my case, efforts to avoid such issues in clinical IT projects were often resisted by IT personnel who "knew better" than the "informatics guy" whose ideas were "way out there" (the actual words of an executive in charge of IT, as reported to me by people who disliked his micromanagerial and bullying style. Of note, that executive is now a CEO at a major healthcare facility).

-- SS

Clarification on VA Hospital System IT initiatives

In response to my postings on the Penn CPOE controversy such as here, where I included a reference to the Bay Pines VA Hospital IT system failure, a VA official involved in IT pointed out that this system, known as CoreFLS, was a financial IT system, not a CPOE or clinical IT system.

I should clarify that the VA’s VistA system and its EMR module (CPRS) are exceptionally well-regarded in the healthcare IT community and are actively promoted by the open-source community especially, and are distinct from the CoreFLS initiative.

I should also point out that my critiques are not of CPOE or EMR or clinical IT in general, but of the leadership model of healthcare IT.

(Note: I define clinical IT as IT utilized in actual clinical interactions between a provider and patient such as EMR, CPOE, decision support, enduser clinical data repository, concurrent-care knowledge management apps, etc. Healthcare IT is a broader domain that subsumes clinical IT but also includes Management Information Systems or MIS applications in hospitals, such as financial, registration, master patient index and other administrative systems. Others' precise definitions may vary.)

My opinion on healthcare IT leadership is summarized by a major point I raise in my web site on Healthcare IT failure :

"The belief that mastery of IT process and repetition for management information systems implementation entitles IT personnel to lead and control implementation and operationalization of essential tools in complex domains such as medicine (for example, electronic medical records systems) is presumptuous and creates an environment strongly misaligned with the business of healthcare delivery."

I consider an enterprise hospital financial system to be an essential tool for healthcare delivery. In my website on Healthcare IT Failure, I presented another example of a situation where mismanagment of a healthcare financial system by those without clinical knowledge led to dire consequences: "Insufficient IT management depth results in Justice Department investigation."

I included the CoreFLS failure in my critiques of healthcare IT leadership based partly on the fact that the failure of that financial system had a major impact on clinical operations at Bay Pines due to resulting inventory ordering problems (preventing surgery from being performed, for example), and partly on an article in The Tampa Tribune, "VA Faults Training At Bay Pines" (Richard Lardner, Mar 24, 2004) that states, among other factors:
… the VA inspector general released an interim report of an investigation into Bay Pines and CoreFLS. The report criticized weak hospital leadership, poor staff training and ``serious deficiencies'' in the sterile surgical supply process. Before joining the department, Campbell [VA assistant secretary for management] was chief financial officer for the Coast Guard, where he oversaw the implementation of a system similar to CoreFLS. ``It is a failure on my part, having done this [implemented a financial IT system] at another agency [Coast Guard]. I did not anticipate the complexity [of the system] and the difficulty of training,'' he said.
My point is that one might not anticipate the complexity of healthcare environments when one is not a healthcare professional. The admission of a project leader of a major IT initiative not understanding the complexity of a healthcare environment is an illustration of what I've been teaching in medical informatics for a number of years, that multidisciplinary training that includes a healthcare background helps a person better understand the complexities of healthcare.

Hence my view is that high-level leadership roles in healthcare IT initiatives (and especially clinical IT initiatives) should be very carefully defined with regards to experience and skill sets.

Organizations that ignore this do so at their peril, in my opinion, and sooner or later I predict provider-side and R&D sector (e.g., pharma) litigation that will be based on patient harm and/or financial losses that result from inadequacies in healthcare IT leadership.

-- SS

Massive Health Care Waste? - Follow-Up

For Kling's response on the EconLog blog to the post below about waste in health care, go here. (For some comments on his Tech Central Station article, go here.) He raises some interesting issues on the cost of old technology versus "high technology." It will be interesting to see whether this generates any comments from those more expert in the economics end of this.

Is Massive Health Care Waste a Myth?

There is an interesting contrarian piece on the costs of health care by Arnold Kling on Tech Central Station, which was also picked up by Tyler Cowen on Marginal Revolution.

Like some other comments by libertarian economists on health care, I found it intersting and provocative. I also found myself agreeing with some, and strongly disagreeing with other points he made.

To summarize, he contends that the US spends more than other countries on health care, but also provides significantly better health care. He thinks that the "usual subjects" rounded up in arguments to support the massive inefficiency of US health care are not guilty as charged. These suspects include spending on the last year of life, drug company profits and overhead, and administrative overhead. Finally, he thinks we spend too much on physician compensation and high-technology procedures.

My comments, point by point, are

  • Paying More to Get More - I think this idea is defensible, and I would like to see it discussed better and more often in the medical and health care literature. Surely, we can now cure illnesses that we couldn't cure before, and we can substantially improve the lots of patients with many other illnesses whom we couldn't effectively treat in the past.
  • Spending in the Final Year of Life - His arguments are reasonable, and again, I would like to see this issue discussed more clearly and rationally in the literature, with a bit more attention to the clinical context and the clinical epidemiological issues.
  • Drug Company Profits - This industry is often made into the bogey-man. In our criticisms of it, we should not ignore the fact that the industry provides us with many of the means to treat illness and alleviate suffering that we use to such good effect. On the other hand, their have been numerous abuses perpetrated by drug companies, some of which we have discussed on this blog. Furthermore, this is a bit of a straw man argument. I do think that if one considers the total profits and overhead not only of drug companies, but also of device manufacturers, information technology providers, managed care and health insurance companies, hospitals and hospital systems, and all the other miscellaneous players in our horribly complex US system, they would clearly in toto be excessive. Then, if you consider the various ways some of these organizations have acted in conflict with physicians' core values, the problem is even greater.
  • Administrative Overhead - Admittedly, the data about this issue is not very good. But I suspect the reason it is not very good is that researchers have been timid about addressing the issue, not because there is not a lot of administrative waste and inefficiency. My personal observation is that physicians, especially primary care physicians are drowning in paperwork and bureacracy, and so are hospitals. I did find one study of interest. MGMA compiled detailed data on the administrative and bureaucratic tasks that physician group practices must perform. They found that group practices were spending about $24,750 per physician on some specific "unnecessarily complex or redundant administrative tasks." I suspect that the more researchers look for administrative and bureaucratic tasks that physicians, other health professionals, and hospitals must undertake, the more they will find. Adminstrative and bureacratic methods to control costs may cost more than they are worth. Yet the administrative and bureaucratic load on physicians seems to continue to climb.
  • Physicians' Compensation - I am not sure where Kling got his numbers. My sense, and a brief web search suggests that the compensation primary care and "cognitive" physicians receive is comparable to that of physicians in other developed countries. For example, here is data on the compensation of UK physicians in 2002. Note that consultants, i.e., physicians who have finished their hospital training, get from 52,000 to 133,000 pounds sterling. On the other hand, here is data on average levels of physician compensation in the US in 2002 by specialty. Note that internists, family practitioners, and pediatricians average about $150,000 to $160,000. Correcting for the exchange rate in 2002, this would have been quite comparable to what UK physicians got. Of course, "procedural" specialists like anesthesiologists got much more. Kling suggested reducing physician compensation to levels comparable to those in other developed countries. My best guess is this would have little effect on "primary care" and "cognitive" as opposed to "procedural" physicians, perhaps even raising some of their pay. It would have major effects on "procedural" physicians. Its effect on total health care costs would be considerably less than Kling expects.
  • High-Technology - Here I suspect Kling is very much on target. The question is why such interventions are so expensive. It's interesting that the examples he used, CT scans, MRI scans, and open-heart surgery, were of technologies developed 30+ years ago. CT scans, for example, were developed in the 1960's by Sir Godfrey Hounsfield. So his examples are actually of mature, not "high-" technologies. Outside of medicine, the price of technologies drop as they age. Admittedly, there have been many incremental improvements in CT scans, but there have been no revolutionary changes. In particular, the "C" in "CT" stands for computer. CT scans use computers to process multiple x-ray images into the images of body slices which we are familiar. The original CT scanners used main-frame computers to do the image processing. Main-frames were very expensive in the 1960's. Yet now one can get a personal computer that is just as powerful for a many orders of magnitude lower price. Since a large part of the expense of CT scanning used to be computer hardware and software, why hasn't the price dropped like the prices of other computer hardware and software? The biggest failure of managed care and government efforts to control costs seems to be their failure to address the huge costs of "high-" or old technology. One possible explanation is that the people charged with controlling costs in managed care organizations and the government don't really understand the technologies for which they pay. Thus, they don't realize it when specific ones are drastically over-priced.
I hope we can engage folks like Kling in some creative thinking about ussues like this related to health care dysfunction.

BC/BS employs non-credentialable person to do their credentials

I couldn't invent a better story.

BC/BS of Mass,( and many other health plans across the country) use a credentialing service for radiologists called: Radiology Management Sciences, LLC. Finding them is difficult as they operate in stealth mode, but the are apparently located in Menlo Park, Calif.

They are ? owned by, and certainly run by, one Stephen Bloch, MD.

Bloch has his bio on the net on the website of his venture capital firm, www.canaan.com/team_bloch.html . Bloch is listed as someone who "was a practicing radiologist".

Going to the website of the Mass Medical Board, one finds from his profile that Dr. Bloch is NOT board certified in radiology. It is odd that someone would complete the Mass General program in radiology and not get boarded, isn't it? Maybe he didn't finish? I don't know.

I phoned Dr. Bloch, after he signed a letter of denial for credentials for radiology for my office (we employ boarded radiologists to read our films, but BC/BS wants me to apply for credentials, which they won't grant since I'm an internist). I caught him in his Connecticut VC office, busily doing VC work. Guess what, Bloch never read my letter of appeal from their rigid rules. We have quality films, done in a state-licensed facility, done by licensed techs, and read by boarded radiologists. The issue was how to bill for this service without making the patients jump through hoops. Bloch didn't even see my letter, yet he sent a letter to me denying my appeal.

Another gem I gleaned from Bloch's bio is that the he founded TeleRad, a teleradiology services company.

I guess that means he might compete with those he credentials (or doesn't).

I suppose one might conclude that he might have a bit of a conflict of interest.

Bloch and Co. wrote a paper in Radiology in 1999 where they indicated that they save 2% of total radiology costs by denying credentials to some people. They claim this is all for quality, but don't show how quality was affected by their denial. Thus, the health plans must like Dr. Bloch, and Dr. Bloch noted in his paper that the cost of his program is only 20% or so of the savings. Thus, the health plans save 1.8% on radiology costs by employing him. Measured across all the radiology expenses this is a large number.

I'm all for quality measures and ensuring quality. But should it be on the backs of doctors like me who are trying to do the right thing, but just don't fit the box BC/BS wants to keep us in.

Last time I checked we still had free speech in this country. If anything I've written is not factual I will be happy to correct it upon presentation of evidence that I am incorrect.

These are the opinions of:

Robert S. Baratz, MD, PhD, DDS

Tuesday, March 22, 2005

On the Terri Schiavo case

On the Terri Schiavo case, I post a question above and beyond its being taken over from clinicians (as seems to occur in healthcare more often in the past few decades) by politicians and lawyers:

In my medical training and experience, while feeding tubes may have been removed from terminal patients (e.g., with cancer or post-stroke), an IV with basic fluids was not.

To my knowledge, Ms. Schiavo is not receiving IV fluid hydration such as normal saline solution. If anyone knows differently, please correct me.

The body loses significant fluid each day from respiratory losses, perspiration, etc. Without replacement, death will occur via dehydration long before it occurs from starvation.

Dying of dehydration was considered inhumane, at least in the medical world I trained in. I ask, somewhat rhetorically, if this has changed in the past decade since I left clinical practice for Medical Informatics.

-- SS

My opinions on Penn CPOE controvery published in Health-IT World

My opinion piece on the JAMA article on the Hospital of the University of Pennsylvania's CPOE system problems has been published in Health-IT World. My piece is at "HITW Readers' Take on JAMA's CPOE Article" (second item).

They published almost verbatim my hcrenewal blog posting that I submitted for Health-IT World's consideration. They have published opinion pieces from me in the past.

I have yet to hear from JAMA on publication of a similar letter to the editor I submitted.

-- SS

Monday, March 21, 2005

What Mercy Will the Uninsured Patients of Mercy Health Systems Get?

A story from Arkansas about hospitals billing uninsured patients at higher "rack rates" than they bill insured patients contains some important insights about this increasingly recognized problem.
Lawyers for St. Mary's Hospital, one of the hospitals under fire for its billing practices, defended its actions thusly, "Just as a company that buys 100 widgets from a seller will get a better price than a company that buys just one widget from the seller, a managed care plan that 'buys' St. Mary's services for hundreds of patients can legitmately expect to pay less for St. Mary's services than patients such as plaintiffs who buy St. Mary's services only for themselves."
The analogy is not a good one because one can produce a lot of widgets at a cheaper unit cost than one can produce one widget. But health care must be customized for each patient, so how would knowing that a group of patients are insured by a particular company lower the costs of caring for them enough to justify a volume discount?
Furthermore, the communications director for Mercy Health System, of which St. Mary's is a part, said the system agrees with "the American Hospital Association's stance on the issue of uninsured billing." That stance is apparently that the federal government should keep its hands off the issue. On the other hand, former Secretary of Health and Human Services Tommy Thompson wrote to the AHA that "hospitals charging the uninsured the highest rates is a serious issue that demands all of our attention." He called the AHA's position "not correct and [it] certainly does not reflect [Health and Human Services] policy.... I strongly encourage you to work with the AHA member hospitals to take action to [end the situation] where ... uninsured Americans and others of limited means are often billed and required to pay higher charges."
But the real issue here is not the pricing of widgets, or even whether the federal government or the states should have roles regulating the prices hospitals charge uninsured patients.
Mercy Health System's mission statement says that it "is committed to the ministry of health and healing for all God's people, with particular concern for the economically poor." By charging the uninsured the full rack rate, and then vigorously defending this pricing scheme as documented above, the hospital and system leadership appears to be in fundamental conflict with their own stated worthy mission.
This is another striking example of a fundamental problem in the US health care system (and perhaps in other countries as well.) Health care organizations' actions are more and more in conflict with their stated values.
So what mercy will the uninsured patients of Mercy Health Systems get?
(Thanks to the Health Business Blog for the reference to this article.)

Saturday, March 19, 2005

Generous CEO Compensation and Corporate Governance

Re some previous posts in which we noted that managed care CEOs who publicly champion cutting health care costs often seem to command disproportionately high personal compensation (e.g., see the posts here on United Healthcare and here on Harvard Pilgrim)....
The NY Times just ran a commentary by Nicholas Kristof about how exceedingly generous levels of CEO compensation seem to better correlate with corporate governance problems than with corporate financial performance. (Some of the scholarly articles he mentioned can be found here, by Grinstein and Hribar, and here, by Bebchuk and Fried.) One striking figure he mentioned was that public corporations now devote 10% of their total profits to the compensation of their top five managers, up from 6% in the 1990's. Also, "another study found that of the 1,000 largest companies, two-thirds claimed to have outperformed their peers. That's the 'Lake Wobegon effect': all CEOs in America are paid as if they were above average."
In that context, managed care CEOs with million dollar plus compensation packages berating physicians and patients for excess health care costs just adds insult to injury.

Friday, March 18, 2005

AMIA on the JAMA CPOE article controversy

A reasonable assessment of the recent CPOE controversy by Don Detmer, MD, the President and CEO of the American Medical Informatics Association, is below. He writes that healthcare IT is of great value, is moving forward, and that those in clinical IT need to rigorously assess issues and problems and correct them iteratively, as in any evolving field. He is confident that AMIA and its researchers, clinicians, and educators are committed to these objectives and will continue to raise the performance bar for clinical IT. I heartily agree, as does Ross Koppel, the author of the AMIA article that caused the controvery on CPOE (see the end of this blog entry).

A Statement from the AMIA President and CEO
March 15, 2005

In politics and marketing it is often said, “all headlines are good headlines.” There certainly have been a lot of headlines lately about health care IT. The March 9 issue of the Journal of the American Medical Association included two articles on the state of computerized clinical decision support and computerized physician order entry systems and an editorial on the state of computer technology in clinical work more generally (Garg et al., 2005; Koppel et al., 2005; Wears and Berg, 2005). And this week, the British Medical Journal published the results of an extensive review of clinical decision support systems while AMIA announced the availability of a white paper on clinical decision support in electronic prescribing (Kawamoto et al., 2005; Joint Clinical Decision Support Workgroup, 2005).

The JAMA articles as well as those in the BMJ have generated a lot of interest and debate within the medical informatics community. A careful reading of these articles provides us -- the developers, purchasers, users, and advocates for these system -- with a fresh perspective on how to evaluate our past efforts and frame our future work. Some readers can miss what may be the deeper message of the recent JAMA articles and editorial. As a result, they may reach the conclusion that once again the information technology in health care has been oversold and that there is no reason to attend to or invest in the current generation of information technology. I would in particular like to take issue with Wears and Berg’s suggestion that computer technology and clinical work are like Estragon and Vladimir of Beckett’s Waiting for Godot. Although we are by no means where we want to be with respect to the development and implementation of electronic health records, clinical decision support, computer physician order entry systems or a national health information infrastructure, we are also by no means still in the same place as where we started.

Progress in any complex environment comes in steps, but progress has been achieved over the past two decades. The progress in computer-based health records is now sufficiently successful that newer versions of older legacy systems such as those reviewed in JAMA have left the centers of these early adopters and innovators – the enthusiasts – and are entering mainstream care. Meanwhile, some of the innovating institutions are just now upgrading from their legacy systems. Like the older systems, these newer ones also involve substantial transformations in practice behavior. And, like the older systems, the newer ones also come with human adaptation risks that sometimes create new problems as well as new solutions. Further, there is always pushback from those clinicians who simply don’t wish to change. Historically, most substantial changes to clinical practices that are resisted by clinicians appeal to a concern that the quality of patient care is being compromised. This was noted as long ago as the origins of the use of the stethoscope.

Not all change is progress, but some of it actually is. The informatics community does need to keep its focus not upon simply putting heretofore paper processes into a computer format but to redouble its resolve to create evidence-based applications that do indeed transform care by involving patients themselves in utilizing personal health records, by enhancing safety, by increasing the timeliness of care through use of the Internet, and by enhancing efficiency. Further we need to continue to reinforce the message so aptly stated by Wears and Berg, “any IT acquisition or implementation trajectory should, first and foremost, be an organizational change trajectory. This is true at the organizational level and the national level …” Thus, we must continue to advocate for other system changes that are needed for health care transformation – including the creation of appropriate incentives through reimbursement mechanisms and a workforce trained to use developing information technologies effectively.

While there is much work yet to be done, the optimism remains that the use of communications and information technology will greatly improve both care and human health. Emerson noted that in nature, nothing is free. While there are real prices to be paid as a result of experimentation, at time things actually do get better. What we need to do is to continue to assess rigorously the balance between the sunny and shady sides of IT innovation and ‘stick to our knitting’. I am confident that AMIA and its researchers, clinicians, and educators will remain committed to these objectives and will continue to raise the bar for our performance.

Don E. Detmer, MD, MA, FACMI
AMIA President and CEO


The only addition I'd make to Dr. Detmer's assessment would be to the statement "any IT acquisition or implementation trajectory should, first and foremost, be an organizational change trajectory. This is true at the organizational level and the national level." I would add that "organizational change" should include investigation into change in the leadership and management of clinical IT projects towards leadership by cross-disciplinary experts, in recognition that those solely of a Management Information Systems (MIS, or business computing) background often do not have adequate knowledge and expertise to effectively lead major change trajectories in scientific computing, of which clinical computing is a subset.

It has often seemed unreasonable to me that the leadership and process models of business computing could be deemed adequate for the needs of major change trajectories in clinical medicine. Via an internet collaboration several years ago, I and other medical informaticists documented our own examples where the unidisciplinary MIS leadership model has not only been inadequate, but actually harmful.

I think the Koppel JAMA article does reflect what happens in real life in today's medical centers. The UPenn authors advise appropriate caution in implementing any clinical IT. They state that "with any new technology, initial assessments may insufficiently consider risks and organizational accomodations." I agree. It then goes on to suggest how organizational and risk issues should be handled, including the "need for continuous revisions and quality improvement."

It's not simply a question of obsolete software versioning either, as some have stated. As Joan Ash, Ph.D. noted at Oregon Health & Science University in a 2003 study “Most hospitals don't use latest ordering technology” (http://www.eurekalert.org/pub_releases/2003-11/ohs-mhd112403.php ), "patient care information systems like CPOE also can create unintended or "silent" errors, according to a separate study conducted by Ash and colleagues in The Netherlands and Australia. This study also was published in the online version of JAMIA.

The study's authors divide these silent errors into two main types: errors during data entry and retrieval, and errors in the communication and coordination process. Both types of errors occur because the systems simply don't take into account the work atmosphere most health care professionals experience, according to Ash, also lead author of this study ... "many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments … some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician."

Attempts to develop a CPOE system internally, such as at Cedars-Sinai Medical Center in Los Angeles, have also not been entirely successful (AMA News, Feb. 2003, "Doctor Pull Plug on Paperless System"), subtitled "California's Cedars-Sinai turns off its computerized physician order entry system after physicians revolt, demonstrating that implementing new technology is easier said than done." I was not sanguine about the planned remediation attempts, either ("How to Avoid CPOE Failure a Second Time"), which seemed more focused on the traditional MIS "process analysis" than on the organizational and sociotechnical issues that likely led to unusability and revolt in the first place. As Berg noted, "The depictions of the formal workflow of medical work are often not realistic; for example, the task boundaries between doctors and nurses are not always tightly drawn. Translating professional knowledge and workflow processes into some automated record is not impossible, but much care and evaluation must be taken for it to not be hazardous to a healthcare environment." ("Considerations for sociotechnical design: experiences with an electronic patient record in a clinical context", Berg M. et al, International Journal of Medical Informatics, 1998;52:243-251)

An interesting collection of related articles on sociotechnical aspects of clinical IT can be seen via a PubMed search initiated by clicking on this link .

I think any controversy about the UPenn article is coming from emotions, not logic, as a result of the Penn authors having critiqued "established wisdom" (i.e., dogma) on CPOE, and from vendors who see it as putting even more doubt in the minds of capital-strapped hospital executives.

In other words, it is a political controversy, not a rational, scientific one.

The article "Experts Expect CPOE Adoption To Continue Despite Study on Errors" by Fanen Chiahemen, iHealthBeat staff writer, is also worthwhile. Of note are the following excerpts:

Ross Koppel, a sociologist at the University of Pennsylvania School Medicine and the study's lead author, conceded that there initially was some fear that the health care industry would now "go slow" on CPOE adoption, but he said "that would be like throwing the baby out with the bathwater." Koppel said that the study was not intended to discourage the adoption of CPOE and that the authors are in favor of the technology. "We're very much pro-CPOE, but we're against arrogant CPOE," Koppel said. "Do I want to go back to a system where somebody scribbles on a piece of paper? No," he added.

... Paul Tang, the chief medical information officer at the
Palo Alto Medical Foundation, said he hopes the study will increase awareness about what is required to implement IT in health care. "Successful implementation of CPOE and realization of the safety benefits from using the technology requires good software design, a clinically led implementation effort and good training," he said. "It would be a shame if we lost sight of the lifesaving potential of CPOE because of a report of one experience in which many of the critical success factors -- good product design, good implementation strategy and good training -- were not in place," he said.

Wears said training plays a role in enhancing the effectiveness of such systems, but he believes the real issue is better system design. "If you need a lot of training to take young, computer-savvy, highly motivated people to get them to use this thing to do their work, that should tell you something," he said. "These are not the kind of people that should normally take a lot of training if the tool actually helps them," he said.

Building on that notion, Suzanne Delbanco, CEO of the
Leapfrog Group, said the study could put a little bit more pressure on vendors to develop systems that have all the capabilities that benefit patients as much as possible.

However, [Upenn author] Koppel stressed that even new systems have to be thoroughly investigated and constantly evaluated because "every change has cascading changes." He said he has been looking at some new systems that have "tons of foolish programming and poor integration issues." Therefore, health care practices that choose to adopt CPOE not only have to closely monitor how physicians and nurses use the systems, but they also have to "be a lot more humble and a lot more vigilant," Koppel said.

I strongly agree with that assessment. I also believe Medical Informatics specialists (MD's, PhD's, nursing informaticists, etc.) need to take genuine leadership roles in clinical IT initiatives if these initiatives are to succeed in a time frame and at a cost acceptable to those who provide the capital and expense dollars. By leadership I mean substantive control of vendor product evaluations, project hiring (including personnel evaluations), major decisions affecting clinical care, and other factors that distinguish leaders from what I once termed "Directors of Nothing."

The MIS mantra "doctors don't do things with computers" may or may not have been appropriate in the days when the MIS department was referred to as "Data Processing", but as I pointed out in a 1998 webpage on stereotypes of medical informaticists, is entirely inappropriate today [note: I have not maintained that old site; some links will not work]. This is especially true now that the U.S. and other countries such as the UK are embarking on national EMR initiatives.

-- SS