Case study of medical error in one of the best pediatric hospitals in the US.

This Boston Globe article should be required reading for anyone who is serious about addressing medical error in complex, high-quality, tertiary-care academic medical centers. "Communication and accountability problems" is the generic term for what went wrong at Children's Hospital in Boston, but the devil's in the details. For even more detail, the Massachusetts Department of Health has published a 24-page report on this and three other deaths at the hospital from August 2002 to July 2003. I haven;t found the report on the MDPH web site but I've e-mailed them about any plans they might have to post it and will provide the link as soon as I have one.

End-of-life decision making.

This week's New England Journal of Medicine published a contribution to much-needed research into the way decisions are made about life-supporting treatments. A Canadian group concluded (abstract only; full text requires subscription) on the basis of their study of 851 critically ill patients in 15 ICUs: "Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors." One problem with this approach, as Larry Schneiderman points out in an article on South Africa's Health24.com web site: "Doctors believe they know what patients want in terms of life support, and that family members can fill in blanks. But Schneiderman says his own research suggests that what physicians think critically ill people want is in fact nearer to what they would choose for themselves. Family members, too, aren't especially reliable translators of their loved one's wishes. . . . We're always relying on surrogate decision makers or physicians, Schneiderman says. But there's plenty of evidence that it doesn't correlate too well with what patients truly desire."

Does HIPAA apply to the NFL?

As we all know, HIPAA gives patients a right of access to their own medical records. Right? Right. Unless, that is, you are a professional football player, according to an article in today's Grand Forks Herald (picking up on the story originally run by the Charlotte Observer). Under the collective bargaining agreement between the NFL and the players' association, players can see their medical records twice a year -- and never during the regular season. According to the article, DHHS isn't quite sure whether HIPAA applies to the NFL (neither am I: Is the NFL a "covered entity"? It seems like a stretch). And you would think that players can contract that right away for valuable (very valuable) consideration. But Boston University's George Annas is surely right when he says, "It's so behind the times. The whole country has been moving to open access to your own records, whether they're medical, police, credit or education records. No one would argue with that anymore.

"The problem with secret records is people are making decisions about you, and you don't know why. In this case, when you're talking about professional football players, (teams) could be making decisions about whether they should play or not. Their livelihood and future health could be at stake."

Dubya takes Prop 12 on the road.

Trial lawyers, says the President in today's weekly radio address, are driving up health care costs and taking their fees away from deserving plaintiffs: "I have proposed reasonable limits on the lawsuits that are raising health care costs for everyone. . . . [And] we need to address the broader problems of frivolous litigation. We need effective legal reforms that will make sure that settlement money from class actions and other litigation goes to those harmed, and not to trial lawyers." As pointed out by AP writer Jennifer Loven (see, e.g., the San Francisco Chronicle's version of the AP story), this is a theme that Bush got mileage out of when he was governor and he has to be thinking it has a great populist ring to it for the upcoming election year.

The Safety of Imported Drugs

An editorial in today's New York Times describes the wackiness of the pharmaceutical industry's global pricing strategy. The FDA seems to be playing into that strategy with stern warnings that drug imports might be contaminated or improperly stored or transported. The FDA's position is predictable: given a choice between consumer choice and consumer safety, they will always go with safety, even when the safety concerns are more theoretical than real. (I don't mean to imply there can't be -- or aren't -- real safety concerns. The FDA has sent a warning letter to CanaRx based on that company's shipment of insulin at room temperature when the drug needs to be kept refrigerated. The real question, though, is what is an acceptable safety margin for drugs purchased at an affordable price, as opposed to drugs that are not purchased or administered properly because they are too expensive.) My hometown of Springfield, MA, is leading the way among state and local governments by pursuing an official policy of Canadian drug purchases for city employees, and Illinois is considering the same thing. Many individuals have been importing their drugs from Canada for years, despite a law that says generally only manufacturers are allowed to import drugs. As the Times editorial says, unfair pricing practices are driving this issue, and both the safety and the pricing problems can be worked out if Big Pharm and the FDA can find the desire to do so.

Another North Texas physicians' group charged with price-fixing.

The FTC has filed a complaint against yet another north Texas IPA. (See my earlier post on the last such action, in June of this year.) You can get a copy of the administrative complaint here. This IPA denies the charges of concerted refusal to deal and price-fixing by the 600-member group, which the FTC claims is not a risk-sharing entity and is neither clinically nor financially integrated.

Comfort Foods Switch Off Stress, Scientists Find

No kidding.

Really, did we need a paper in The Proceedings of the National Academy of Sciences on this to know what is now headline news in The New York Times? Here are some of the not-earth-shattering conclusions:

-- "Comfort foods like chocolate cake and ice cream literally blunt the body's response to chronic stress."

-- "This makes sense from an evolutionary viewpoint. . . . Animals that are acutely stressed stop eating, lie low and pull fat and protein from their bodies. But they cannot do that forever. . . . 'After a few days, they need to get out and get a real fix,' [the author] said. 'They need high-energy foods, like a tub of butter, to put money in the bank.' Once energy stores are replenished, a signal, probably from fat, flows back to the brain saying it is all right to calm down [and] the chronic stress cycle is turned off."

-- "'"[I]f you are overly stressed, it's probably a good idea to overeat, at least in the short run,' said [one of the authors]. 'But if you develop a thick tire of fat around your abdomen, you need to figure out a way to reduce your stress or you'll be inviting all sorts of chronic health problems.'"

-- "In an insidious sidelight, stress hormones also activate fat receptors in the abdomen and belly in ways that increase deposits of fat, he said. The more abdominal fat people have, the better they shut down chronic stress but the more vulnerable they are to diabetes, heart disease and stroke."

-- "Chronic stress, perversely, also excites the compulsive pleasure-seeking component of the system, [the author] said. 'If you use sex, drugs or rock 'n' roll instead of high-energy food to get stress-reducing pleasure, you miss out on the metabolic feedback,' he said. 'You don't shut down the chronic stress system. You just seek more cocaine. Things like saccharin won't cut it. You need the real thing or the system won't stay in balance.'"

Anyone for transcendental meditation and a pint of Häagen-Dazs?

Democrats find bright side of loss on Prop. 12

Here, in an article from the Austin American-Statesman, is a somewhat more plausible spin from the losing side of the Prop. 12 battle: Viewed as a Republicans vs. Democrats battle, getting 49% of the 1.46 million votes case was the best showing the Democrats have made in a statewide election in many years. I'm not sure how accurate it is to spin this as GOP vs. Dems, though, with top Republicans like Deborah Hankinson and Jim Baker spearheading the opposition to Prop. 12.

Prop 12 wins in a squeaker

Proposition 12 won by a 51-49 percent margin on Saturday. [See Times article here] Before the election, both sides claimed the Apocalypse was around the corner if they lost. After the election, incredibly (or predictably?) both sides declared victory.

Patients in Florida Lining Up for All That Medicare Covers

The New York Times' Gina Kolata had a great piece (link is to Tampa Tribune's on-line version; the Times link has expired) in Saturday's paper about the Medicare culture in Florida. Here's an excerpt:

Doctor visits have become a social activity in this place of palm trees and gated retirement communities. Many patients have 8, 10 or 12 specialists and visit one or more of them most days of the week. They bring their spouses and plan their days around their appointments, going out to eat or shopping while they are in the area. They know what they want; they choose specialists for every body part. And every visit, every procedure is covered by Medicare, the federal health insurance program for the elderly.


Boca Raton, researchers agree, is a case study of what happens when people are given free rein to have all the medical care they could imagine. It is also a cautionary tale, they say timely as Medicare's fate is debated in Congress for it demonstrates that what the program covers and does not cover, and how much or how little it pays, determines what goes on in a doctor's office and why it is so hard to control costs.

South Florida has all the ingredients for lavish use of medical services, health care researchers say, with its large population of affluent, educated older people and the doctors to accommodate them. As a result, Dr. Elliott Fisher, a health services researcher at Dartmouth Medical School, said, patients have more office visits, see more specialists and have more diagnostic tests than almost anywhere else in the country. Medicare spends more per person in South Florida than almost anywhere else twice as much as in Minneapolis, for example.


But there is no apparent medical benefit, Dr. Fisher said, adding, "In our research, Medicare enrollees in high intensity regions have 2 to 5 percent higher mortality rates than similar patients in the more conservative regions of the country."

Doctors say that Medicare's policies are guiding medical practice, with many making calculated decisions about whom to treat and how to care for them based on what Medicare covers, and how much it pays.

"The bottom line is that the stuff that reimburses well is easier to get done," Dr. Carl Rosenkrantz, a Boca Raton radiologist, said.

"Romer's Law" ("a bed built is a bed filled is a bed billed") predicted that demand for health care services will follow supply in Field of Dreams fashion: If you build it, they will come. This article illustrates the unsurprising corollary: If you pay for it, they will order it.

"Health care pales next to perils of eating kittens"

The only thing more attention-grabbing about an article in Saturday's Toronto Globe & Mail than its headline is its content. Here's a sampling:

Voters say the future of the health-care system is the most important issue facing Ontario. Finally, on the 11th day of the election campaign, the subject was thrust into the spotlight.

Progressive Conservative Leader Ernie Eves and his Liberal counterpart, Dalton McGuinty, yesterday devoted major addresses to the stresses and strains facing Ontario's $28-billion health system. Not that you'll hear much about it. The leaders' noble support of the sanctity of medicare got eclipsed later in the day by the Conservatives' astonishing characterization of Mr. McGuinty as an "evil reptilian kitten-eater from another planet."

And we think our debate over U.S. Medicare is a nasty one . . . .

'Do not resuscitate' instructions often ignored, overlooked

In an article in today's Boston Globe, reporter Alice Dembner relates some surprising stories and statistics about the inefficacy of DNR orders in major hospitals. Here's part of it:

Studies estimate about 20 percent of Americans have some form of "advance directive," including living wills that describe a patient's wishes and health-care proxies that designate another individual to make decisions for the patient. DNRs are written by a doctor, nurse practitioner, or physician's assistant to spell out a dying patient's decision to refuse CPR and mechanical help with breathing. When DNRs are not honored, the problem is that sometimes doctors trained to save lives disagree with the DNR decision.

"There's still a fair number of doctors around who are uncomfortable with patients being DNR," said Dr. David Clive, chairman of the ethics committee at UMass Memorial Medical Center in Worcester. "It may be for personal or religious reasons or it may be their medical opinion that the patient is not sufficiently ill to warrant the DNR order. But it's important to realize that if the patient is competent, they rule the day, not the physician."

Doctors at odds with a patient on a DNR typically try to negotiate a resolution, Clive said. But at UMass, a doctor who decides against following a patient's explicit wishes is required to transfer the patient to another doctor.

More commonly, researchers and advocates said a mistaken resuscitation of a patient happens because of a communication failure.

Many doctors are uncomfortable discussing death and they avoid asking patients what they want. Even if patients and doctors have the conversation and the doctor issues a DNR order, that order isn't automatically shared with a hospital or ambulance service.

Darned good thing the Texas State Board of Medical Examiners requires an hour of ethics instruction each year! Don't you wish your state did, too?

Fewer People on Medicare Are Dropped by H.M.O.'s

Surprising news from the Sept. 9 N.Y. Times: In an article by Robert Pear, it's reported that the "exodus of health maintenance organizations from Medicare, a trend that has alarmed elderly people and members of Congress since 1999, will slow to a trickle next year, the industry said today. . . . Karen M. Ignagni, president of the American Association of Health Plans, the lobby for H.M.O.'s and other private plans, said they would drop 39,000 Medicare beneficiaries next year." Seems the plans are expecting more relief from Congress' parsimonious reimbursement rates in the next year.

Medicare managed care (Medicare+Choice)

Excellent overview of Medicare's managed care program from United Press International: "Medicare+Choice: Failure, success, future."

EMTALA

CMS' final EMTALA rule, mentioned here last week, was published yesterday in the Federal Register.

James Rachels, medical ethicist, dead at 62.

He argued (in 1975, the year before Quinlan was decided) that "passive euthanasia" (i.e., removal of life support to allow for a patient's "natural death") was the moral equivalent of "active euthanasia" (i.e., a lethal injection of a drug with the intention of ending a patient's life). His article, originally published in the New England Journal of Medicine, is undoubtedly one of the most anthologized articles in the history of this field. The clarity of Rachel's thought and expression are a model for us all. What's missing from the obituaries and accolades from colleagues and friends, though, is this: his most famous essary pitches an idea whose time still has not come. Mainstream ethicists, as well as clinicians, judges, and legislators, do not agree that active and passive euthanasia are moral equivalents. Passive euthanasia, under at least some circumstances, is legal everywhere in the United States; active euthanasia is illegal everywhere in the U.S. But his legacy goes beyond one thought-provoking essay, and the impact of his essay goes beyond the realms of statutes and court judgments. For example, at the core of his argument is the insight that whether the conduct is called active or passive euthanasia, and whether the result is called a "natural death" or a "homicide," the removal of life-support from a patient is the cause of that person's death just as surely as a lethal injection would be. And health care professionals, family surrogates, and judges who hide behind the euphemistic notion that "they didn't cause the death, the underlying disease process caused the death," are kidding themselves. I am in favor of removing life-support from competent patients who refuse it and from incompetent patients who either made their wishes sufficiently known or clearly are not benefiting from the treatment. And I am against active euthanasia. But we owe it to the patient, as well as to future patients and to our own ethical understanding of our actions, to have the intestinal fortitude to call a killing a killing -- one justified, the other not. And that was part of James Rachels' legacy, too.

Calif. proposes ban on balance billing for ER services.

According to Modern Healthcare's Daily Dose, "California insurance regulators have filed for an emergency mandate that would prohibit hospitals from directly billing patients for emergency care that won't be fully covered by the patients' health plans. . . . The state Department of Managed Health Care contends that federal laws requiring hospitals to provide basic emergency care to all patients regardless of insurance status, combined with a state law requiring health plans to pay for emergency care regardless of whether they contract with a particular hospital, amount to an 'implied contract' between hospitals and health plans to fully cover patients' emergency-care costs." What are the chances that California, which leads the way in so many cultural trends, including some health-related ones, is establishing a model that will attract other states?

Med mal premiums and access to health care.

The normally sober and responsible GAO, the nonpartisan investigative arm of Congress, issued a report dated August 2003 entitled, "Implications of Rising Premiums on Access to Health Care." Their conclusion:

"Actions taken by health care providers in response to rising malpractice premiums have contributed to localized health care access problems in the five states reviewed [Florida, Nevada, Pennsylvania, Mississippi, and West Virginia] with reported problems. GAO confirmed instances in the five states of reduced access to hospital-based services affecting emergency surgery and newborn deliveries in scattered, often rural, areas where providers identified other long-standing factors that also affect the availability of services. Instances were not identified in the four states [California, Colorado, Minnesota, and Montana] without reported problems. In the five states with reported problems, however, GAO also determined that many of the reported provider actions were not substantiated or did not affect access to health care on a widespread basis. For example, although some physicians reported reducing certain services they consider to be high risk in terms of potential litigation, such as spinal surgeries and mammograms, GAO did not find access to these services widely affected, based on a review of Medicare data and contacts with providers that have reportedly been affected. Continuing to monitor the effect of providers’ responses to rising malpractice premiums on access to care will be essential, given the import and evolving nature of this issue.

"Physicians reportedly practice defensive medicine in certain clinical situations, thereby contributing to health care costs; however, the overall prevalence and costs of such practices have not been reliably measured. Studies designed to measure physicians’ defensive medicine practices examined physician behavior in specific clinical situations, such as treating elderly Medicare patients with certain heart conditions. Given their limited scope, the study results cannot be generalized to estimate the extent and cost of defensive medicine practices across the health care system.

"Limited available data indicate that growth in malpractice premiums and claims payments has been slower in states that enacted tort reform laws that include certain caps on noneconomic damages. For example, between 2001 and 2002, average premiums for three physician specialties—general surgery, internal medicine, and obstetrics/gynecology—grew by about 10 percent in states with caps on noneconomic damages of $250,000, compared to about 29 percent in states with limited reforms. GAO could not determine the extent to which differences in premiums and claims payments across states were caused by tort reform laws or other factors that influence such differences.

"In commenting on a draft of this report, three independent reviewers with expertise on malpractice-related issues generally concurred with the report findings, while the American Medical Association (AMA) commented that the scope of work was not sufficient to support the finding that rising malpractice premiums have not contributed to widespread health care access problems. While GAO disagrees with AMA’s point of view, the report was revised to better clarify the methods and scope of work for this issue."

The beat goes on . . . .

Proposition 12: Does Texas need a constitutional amendment to limit noneconomic damages?

Prompted by a friend and former student/research assistant, I venture a couple of opinions about the current vote on Proposition 12, which would amend the Texas constitution to authorize the Lege to limit the ability of courts to order judgments based upon large noneconomic damages (such as pain and suffering).

1. As has been reported widely, including last Sunday in the Fort Worth Startlegram, doctors are lobbying patients with posters in their offices, brochures at the sign-in desk, inserts in the mailed bills to their homes, and jawboning during office visits. As the AMA Ethics Code rightly points out (AMA Opinion 9.012), doctors don't lose their first amendment rights when they become licensed. But they have to do so "with the utmost sensitivity to patients' vulnerability and desire for privacy." A careful and discreet physician would at least heed the warning of the Connecticut State Medical Society: "Political conversations are a fundamental part of political freedom. They must be, however, undertaken with great care in order that they do not interfere with the physician-patient relationship, exploit the medical authority of the physician or impose upon vulnerable patients or family members. Physicians should use common sense in deciding on the time and place for the exercise of their political rights." Different people will draw the line in different places, but I favor a more restrictive approach within the existing rule that would avoid political proselytizing within the office (unless the subject is raised by the patient, signalling her comfort level with the discussion), and I'd even extend that to inserts that accompany the bill. For a defense of such an approach, check out the comments of medical ethicist and religious studies professor M. Therese Lysaught.

2. On the merits, Prop. 12 seems both reckless and unnecessary. Unnecessary because HB 4 already limits noneconomic damages in med mal cases, adding Texas to the minority of states to have done so. A recent report from the federal Government Accounting Office (mentioned in this blawg on August 3) has given us plenty of reason to believe that this law won't solve or even particularly address the insurance crisis in Texas, but no one is seriously questioning the constitutionality of HB 4. Doctors who say a vote for Prop. 12 is a vote for your physician are being just a little disingenuous. They got their fix from the 78th Legislature. This isn't about them any more, other than to provide a constitutional "fix" for the inevitable (but, I predict, unsuccessful) constitutional challenge that will be mounted against HB 4. The constitutional arguments are not strong ones, and they've mostly been rehearsed in the courts the last time the Legislature enacted tort reform for health care claims. Reckless because it opens the door to wholesale legislative revision of the tort system and the checks and balances that have worked for a very long time in this state to keep all kinds of businesses and merchants in line. As between the two major groups waging war over this -- Save Texas Courts vs. Yes on 12 -- STC (consisting of a coalition headed by former Supreme Court Justices Deborah Hankinson and James Baker -- neither one known to be partial to the plaintiffs' bar or law-reform groups like the ACLU) seems to have the better arguments, which to one degree or another have been endorsed by every major newspaper editorial board in the state, as well as Texas AARP, MADD, and the ACLU.

Final EMTALA rule due in next Tuesday's Federal Register.

The NY Times reports in a Sept. 3 article that the final EMTALA rule will be published in next Tuesday's Federal Register. Correspondent Robert Pear says the rules lighten the burden on hospitals and physicians. DHHS' fact sheet is here, and the text of the final rule is here.

Rationing Medicare.

Theresa Agovino writes in an Associated Press article that Medicare is prepared to approve a price of $55,000 for an implantable left ventricular assist device (LVAD) that costs hospitals $150-200,000. Most hospitals will be reluctant to cover the shortfall from other operating revenues. But if Medicare paid full price for the device and if there were enough devices to meet the demand, the price tag could top $15-20 billion a year. All this for a device that gives the average patient an average of 8.5 months of life after it is implanted and a 23% chance of surviving 2 years (compared to an 8% chance for those treated medically). All of this foretells a looming problem:

HeartMate's evolution illustrates the nexus of a health care system beset by an aging population, rising costs and limited resources and the longing for lifesaving technology often made by companies seeking to maximize profits. The conflict is expected to become more heated as more expensive technologies and procedures are developed, and at least in their infancy are not overwhelmingly effective. It will be especially difficult for Medicare, facing the baby boomer retirement wave and already searching for a way to finance a prescription drug benefit.

"Technology is being created faster than our ability to put in any kind of a financial, ethical and moral framework," said Dr. Allen Korn, chief medical officer of the Blue Cross and Blue Shield Association, which issued a report saying the device qualified for reimbursement.

"Nobody wants to hear they are going to die. But somewhere there needs to be a bottom line," Korn said.

Adds Art Caplan, chairman of the department of medical ethics at the University of Pennsylvania's medical school, "We are headed for a big political debate about rationing health care - a debate no one wants to have."

Welcome to the tip of the rationing iceberg . . . .

Molly Ivins, amended and expurgated.

If you get your Molly Ivins fix by visiting the Startlegram's website, as I do, you might want to rethink that strategy. They edit out the stuff they don't like, without so much as a howdy-do. Consider her August 26th column, about the impact of real politics on real people and the nice thought that if Arnold wants a life in elective politics, maybe he could learn something about it by running for school board first. Pretty good column, with a good dig at the Texas state legislature for kissing away millions and millions in federal funds for children's health care because they (the Lege) didn't want to come up with the 20% copay (noted in this space the other day). You can read it here.

If you check it out, you will see that it is lacking the original first paragraph, which you can find on the Molly site at Creators Syndicate's web page where the 1st para. is included in all its glory:

"One problem I have with Arnold Schwarzenegger is that he looks like a condom stuffed with walnuts. I realize that is superficial, shallow and unbecoming to a semi-serious-minded liberal like myself, but there it is. The other is that he doesn't know what he's talking about when it comes to public policy."

It's the best part of the whole danged column and those morons in Ft. Worth cut it. Guess they didn't want their readers seeing the word "condom" whilst savoring the morning's first cuppa joe. At least the Dallas Morning News is honest enough to not carry her column at all.

By the way, her Labor Day column is a humdinger. Go Molly!

Court-ordered treatment for patient in persistent vegetative state.

Terry Schiavo has been in a "persistent vegetative state" for 13 years (I think the American Academy of Neurology would call this a "permanent vegetative state"). Her guardian is her husband, who has petitioned the courts in Florida for permission to withdraw her feeding tube and allow his wife to die a natural death. Her parents opposed the petition, as do the approximately 27,000 e-mailers who have allegedly asked the Governor to intervene. Jeb Bush has now done that, at least informally, by sending a letter to the judge who will hold a hearing on the husband's petition on September 11th. Gov. Bush has asked for the appointment of yet another guardian to look into the treatment decisions being made by Terry's husband. Meanwhile, Terry has developed what CNN describes as "a severe total body infection," and the court ruled on Tuesday that the infection must be treated aggressively between now and the Sept. 11th hearing date.

It seems extraordinary that a PVS patient's life-threatening infection has to be treated aggressively over the objection of her husband and guardian, especially if the trial court is only trying to preserve its jurisdiction long enough to have a hearing and rule on the pending petition to establish a date and time for the withdrawal Terry's feeding tube. If so, this ruling surely represents the triumph of form over substance, considering all of the legal proceedings that have previously occurred and the legal status of the case as of Tuesday.

The fact is, this is not the husband's first foray into court to get an order allowing his wife to die a "natural death." The Second District Court of Appeal has already ruled that life-sustaining treatment should be withdrawn pursuant to the guardian's request. The court was then asked by Terry's parents to order a hearing to determine whether "new treatment offers sufficient promise of increased cognitive function in Mrs. Schiavo's cerebral cortex-- significantly improving the quality of Mrs. Schiavo's life--so that she herself would elect to undergo that treatment and would reverse the prior decision to withdraw life-prolonging procedures." The appellate court granted their request on Oct. 17, 2001, and ordered a hearing. The hearing was held between Oct. 11 and Oct. 22, 2002, and on Nov. 22, 2002, the Florida Circuit Court entered the following order:

Accordingly, it is
ORDERED AND AJDUDGED that the Motion for Relief from Judgment filed herein by Robert and Mary Schindler, Respondents, be and the same is hereby denied.
In the event the Motion for Relief from Judgement is denied, the Mandate also requires this court to follow the dictates of the prior Mandate of the Second District Court of Appeal and "enter an order scheduling the withdrawal of life- support". Accordingly, it is
FURTHER ORDERED AND ADJUDGED that Michael Schiavo, as Guardian of the Person of Theresa Marie Schiavo, shall withdraw or cause to be withdrawn the artificial life-support (hydration and nutrition tube) from Theresa Marie Schiavo at 3:00 p.m. on January 3, 2003.

On June 6 of this year, the Second District Court of Appeal affirmed the trial court's ruling, ending its opinion with this language:

At the conclusion of our first opinion, we stated:

In the final analysis, the difficult question that faced the trial court was whether Theresa Marie Schindler Schiavo, not after a few weeks in a coma, but after ten years in a persistent vegetative state that has robbed her of most of her cerebrum and all but the most instinctive of neurological functions, with no hope of a medical cure but with sufficient money and strength of body to live indefinitely, would choose to continue the constant nursing care and the supporting tubes in hopes that a miracle would somehow recreate her missing brain tissue, or whether she would wish to permit a natural death process to take its course and for her family members and loved ones to be free to continue their lives. After due consideration, we conclude that the trial judge had clear and convincing evidence to answer this question as he did.

Schiavo I, 780 So.2d at 180. Nothing in these proceedings has changed this conclusion. The extensive additional medical testimony in this record only confirms once again the guardianship court's initial decision.
On remand, following the issuance of our mandate, the guardianship court should schedule another hearing solely for the purpose of entering a new order scheduling the removal of the nutrition and hydration tube.

According to CNN, the Florida Supreme Court declined to review this decision in an order handed down last week.

So: what's left for the trial court to do? The Court of Appeal has twice affirmed trial court rulings that the guardian's decision is amply supported by the record and that Terry Schiavo should be allowed to die. The parents have fought a desperate battle to alter the outcome based upon their mistaken belief that their daughter's PVS can be treated and they will get her back. The guardianship court has no discretion, as I read the June 6 order of the appellate court, to do anything other than enter its own order to set a date for the withdrawal of Terry's feeding tube. No legal question remains concerning the appropriateness of this husband to serve as guardian or the appropriateness of his decision to withdraw life support from his wife. Meanwhile, physicians are under a court order to stave off the inevitable with aggressive therapy so that Terry Schiavo can be allowed to die of malnutrition or dehydration, instead of dying from the infection that is ravaging her body, while an opportunistic governor succumbs to the temptation to turn that body into a political football. This is nuts.

Comparing prescription drugs.

The New York Times editorializes today that pharmaceutical manufacturers should not be allowed to bring a new drug to market unless it can show that the drug is superior to those already on the market. Without comparative data, "patients and doctors . . . rely mostly on intuition, trial and error, or the salesmanship of the drug makers." Medical superiority is often not the point of a new drug, the editorial continues. "In many cases, a manufacturer introduces a new patented product that is little different from an existing drug that is losing patent protection and whose price will thus be plummeting. The manufacturer typically implies that the new drug is better, a tactic that causes many doctors to prescribe it. . . . Congress is making moves toward reform with legislation that would provide modest sums for federal health agencies to sponsor research on the comparative effectiveness of top-selling prescription drugs. The drug industry opposes the bills. But at a time when prescription drug costs are escalating and consumers are deluged with commercials touting one drug or another, it is vital to provide objective, reliable information on what works best." PhRMA's site is down this morning, but I'll be back with their comment on the pending legislation later.

Texas and uninsured children.

In yesterday's Fort-Worth Star-Telegram writer Mitch Mitchell provided excellent coverage of the SCHIP scandal in Texas. We are second only to California in the amount of federal health-insurance assistance for children that we've lost. By refusing to allocate $$ for the health needs of uninsured kids, the state loses matching funds from Washington, to the tune of $618 million. Granted, we've had budget deficit to deal with recently, but (A) that doesn't explain our failure to take advantage of the availability of these funds when the state was flush, and (B) even in the current budgetary crisis mode, we are spending billions and billions on other things, just not on the health needs of poor children. Quotes from two legislators pretty well sums up the mindset in Austin:

State Sen. Jane Nelson, R-Lewisville, said legislators fought hard to minimize the budget crisis's negative effect.

"If money were available to match the federal dollars in the health care arena, I believe we would draw down those available federal dollars," said Nelson, chairwoman of the Senate Health and Human Services Committee. "But we have other services, like education, that we had to fund."

But state Rep. Garnet Coleman, D-Houston, said that if lawmakers wanted the state to get more federal CHIP funding, they wouldn't have cut the program.

"This is a philosophical difference," said Coleman, a member of the House Public Health Committee. "These folks have chosen to cut children rather than cut other things, and it's not a priority for them. The reason it's not a priority is because poor children don't make campaign contributions and poor children don't vote. This is not rocket science. You either want to cover kids or you don't."

Thanks to the Kaiser Family Foundation for this lead. Following health policy developments has never been easier than it is by subscribing (for free) for the KFF updates. Click here to find out how.

Medicare reform bill.

The Kaiser Family Foundation picked up a report (requires paid subscription) from today's Wall Street Journal that Sen. Grassley (Republican chair of the Senate Finance Committee) has pulled his staff out of the conference committee negotiations over the House and Senate Medicare reform bills. His complaint: not enough time is being devoted to rural health issues. Earlier reports on the process indicated that this promises to be the largest package of Medicare amendments since its inception in 1965, but Grassley's on-again-off-again relationship with Ways and Means Committee chair Bill Thomas highlights one of many schisms on the Republican side.

Dallas Morning News blogatorial page.

Congrats and a high-five to the editorial board of the Dallas Morning News for letting it all hang out on their new DMN daily, a blog-like page on their web site. Now, if only there were an RSS feed . . . .

Conjoined twins.

Two brothers from Egypt who are joined at the tops of the their heads (a condition known as "craniopagus") are scheduled to be separated in a 2-day procedure at Children's Medical Center of Dallas later this fall. The medical, human, and ethical issues are explored sensitively and well in a special-section insert written by medical reporter Laura Beil in today's Dallas Morning News.

Health care industry's federal fines at record pace.

According to a Wall Street Journal article reprinted in today's St. Lous Post-Dispatch, "[i]n the last three fiscal years, the government has amassed $4.21 billion in fines, settlements and restitution payments from its health-care probes, well more than the $3.29 billion it collected in the previous 10 years combined":

This year, the federal government is poised to collect more than $2 billion in payments from HCA Inc., Abbott Laboratories, AstraZeneca PLC, Bayer AG, Guidant Corp., GlaxoSmithKline PLC, Tenet Healthcare Corp. and Pfizer Inc.

More settlements are expected. Schering-Plough Corp. anticipates more than $150 million in liability from investigations by U.S. attorneys in Boston and Philadelphia into alleged marketing violations. Fred Hassan, who took over as Schering-Plough's chief executive in April, has said that he's holding "constructive dialogue" with the prosecutors and that he's ready to settle the issue.

This would be a good time to invest in a law firm with a good white-collar and complex civil practice . . . .

Medicare HMOs under the spotlight in South Florida.

South Florida, one of the last places where managed care organizations can make a pretty healthy profit in the Medicare+Choice program, and where competition for enrollees is intense, is also where CMS is watching marketing campaigns and the beahvior of HMO execs very closely. In an article in today's Miami Herald, it's reported that Medicare -- which dinged CarePlus for its marketing practices -- has now sent a letter of reprimand to CarePlus' CEO for incomplete and potentially misleading comments made last month to the Miami Herald in connection with a story about the Medicare fine. The marketing abuses included a claim that CarePlus offered unlimited pharmacy benefits (they should have said "unlimited generic pharmacy benefits") and their failure to state "that disabled Medicare beneficiaries, not just seniors could enroll in the Medicare+Choice HMOs."

Non-heartbeating [organ] donors.

Canada is now engaged in a very healthy debate over whether to initiate protocols to harvest organs from non-heartbeating donors (NHBD), according to a story in Thursday's Ottawa Citizen. The concept involves a return to the days before "brain death" criteria had been developed, at least in those cases in which waiting for brain death may result in the degradation of the viability of the transplantable organs. The protocol, some version of which is in place in many transplant centers around the U.S., involves disconnecting a patient from life support, waiting for a nominal period of pulseness and apnea, declaring death according to traditional cardiopulmonary criteria, and then harvesting the organs. The ethical questions have to do with two features of the protocol: (1) A drug (phentolamine, e.g.) is administered to dilate blood vessels and maximize blood flow and oxygenation, but dilation may lower blood pressure, perhaps catastrophically, raising the question whether death is being induced by the regitine. If the regitine is causing death, is the procedure homicide? (2) How long should surgeons wait after the termination of life support before declaring (to borrow a widely adopted state-law standard for declaring death) that circulatory and pulmonary functions have irreversibly stopped? The longer the surgeons wait, the more damage is done to the organs. An article in the current issue of the Canadian Medical Association Journal argues that the protocol could increase the supply of transplantable organs dramatically. But, as the redoubtable Margaret Sommerville stated in the news article, "I know the pressure to get organs for donation. . . . But we must be very careful that we're not fudging the criteria of death for the purposes of organ transplantation. . . . If they're suggesting nearly dead is as good as dead then there's a big problem in it. . . . The Criminal Code says any shortening of life, no matter how small, is murder." In this day and age of passive euthanasia, terminal sedation, and physician-assisted suicide, the lines are getting blurrier all the time. This is one opportunity for some needed clarity.

Medicare prescription drug benefit.

As noted repeatedly in this space, Congress is currently fighting over the details of a projected $400-billion-Medicare-prescription-drug-benefit-that-we-can't-really-afford. In an editorial today, the Christian Science Monitor appears to say they wouldn't mind seeing the benefit enacted if only Congress would get around to trimming the budget in some eminently trimmable ways (as recently reported by the Government Accounting Office). It's a thought, ain't it?

Medicare to Pay for Major Lung Operation.

The Medicare program has approved a controversial procedure (discussed here earlier this week) that offers significant relief from symptoms for many emphysema sufferers, though at a very high price (~ $60,000 per procedure). The CMS press release on their coverage decision for lung volume reduction surgery is here.

International notes from all over.

France. In addition to Germany, whose health care reform plans were mentioned here last month, France's Jacques Chirac has acknowledged that his country's death toll from Europe's current heat wave -- which France's government minister for the elderly estimates will reach 10,000 -- will prompt a government review of the health system's "insufficiencies."

Canada. As reported in the Toronto Globe and Mail this morning, Steffi Woolhandler et al. have an article in today's New England Journal of Medicine that says the U.S. health system's overhead expenses $450 billion per year, triple that of Canada, and the gap appears to be growing. They attribute our overhead to the costs of maintaining a fractured private system of health care finance and delivery. After calculating each country's expenditures to a common currency and recalculating the difference based upon per capita expenditures, the real difference is said to be $209 billion. (See abstract here; full text requires subscription) Even if Henry Aaron of Brookings is correct (extract) that Woolhandler's group has overestimated our overhead expenses by $50 billion, the difference is striking. More fundamentally, however, he questions whether the exercise is a significant one for purposes of developing health care policy. A comparison of dollars spent on administrative expenses, or any other category of health care spending, ignores something fundamental about the health care system of any country, including ours:

"More fundamentally, the administrative structure of any nation’s health care system, and certainly those of Canada and the United States, evolves out of its political history and institutions. The U.S. health care administration, weird though it may be, exists for fundamental reasons, including a pervasive popular distrust of centralized authority, a federalist governmental structure, insistence on individual choice (even when, as it appears to me, choice sometimes yields no demonstrable benefit), the continuing and unabated power of large economic interests, and the virtual impossibility (during normal times in a democracy whose Constitution potentiates the power of dissenting minorities) of radically restructuring the nation’s largest industry — an industry as big as the entire economy of France. For these reasons, careful scrutiny of how the United States administers its health care system, with an eye to how it can be improved within the limits imposed by history, politics, and economics, is useful. But analytically flawed comparisons with other nations, whose systems differ greatly from our own and that we are most unlikely to emulate, may titillate policymakers and others but provide them with little useful guidance."

The same issue of NEJM has a piece by Detsky & Naylor entitled, "Canada's Health Care System -- Reform Delayed" (extract). It is a useful political and social history of Canada's national Medicare system, often held up by health-reform advocates as a model worth emulating by the U.S. Taking a page from Henry Aaron, a reader would be wise not to try to draw explicit policy conclusions for the United States from Canada's experience. For example, the constitutional structure of Canada's system

"puts the authority for taxation largely in the federal sphere but the management of health care systems under provincial jurisdiction. The inevitable byproduct of this division of powers is recurrent squabbling among levels of government about health care. Because the federal government has very limited powers to promulgate legislation or regulations that control provincial health services, it can lead only by persuading the provinces to accept conditions on funds that it transfers to them. If the provinces fail to comply with the conditions set by the federal government, the only recourse is to impose financial penalties by withholding portions of the transfer payments. Most provinces, in turn, have resisted the imposition of conditions on federal transfers, and the resulting negotiations among provinces and with the federal government are usually intense. As a result, Canada’s health care system is best described as a collection of plans administered by the 10 provinces and 3 territories, each differing from the others in some respects but similarly structured to meet the federal conditions for funding. The simplicity of the five federal conditions is arguably one of the beauties of the Canadian system. They are the provision of all medically necessary services (defined as most physician and hospital services), the public administration of the system, the portability of coverage throughout Canada, the universal coverage of all citizens and residents, and the absence of user charges at the point of care for core medical and hospital services."

Detsky & Naylor also point out that

"[t]he system is unique in the world in that it bans coverage of these core services by private insurance companies, allowing supplemental insurance only for perquisites such as private hospital rooms. This ban constrains the emergence of a parallel private medical or hospital sector and puts pressure on the provinces to meet the expectations of middle-class
Canadians."

Interestingly, CanadaEast.com reports today that the Canadian Medical Association has joined a case before the Canadian Supreme Court challenging Medicare's government monopoly. CMA says it isn't advocating the creation of a private-care option, which is being advocated by others in the suit, but instead wants stirct guidelines to limit the long waits Canadian patients sometimes have to endure before getting care covered by Medicare. The alternative that CMA wants is a right to go outside the province or even outside the country (guess where?) at home-province expense once the maximum waiting period has been exceeded. Stay tuned . . . .

Pediatric drug testing.

This is a good Associated Press article that reports the unsurprising news that the FDA believes pediatric drug testing has made drugs safer for children (according to an article published in today's JAMA) (abstract only; full text requires subscription). What makes this newsworthy is the checkered history of such testing, from being almost nonexistent to being required by the FDA for many drugs to being declared beyond the FDA's statutory authority to being authorized by Congress last year.

Organ transplant shortage.

This is the public-health version of the saying "no good deed goes unpunished." Fewer young people's organs are available for transplant over the past decade or so, a trend that is fueled in part by a salutary trend: a decrease in the number of young people who die from trauma, according to a story in today's New York Times (no permanent link available at this time). In a related story, Randi Hutter Epstein reports on the diplomacy required to persuade parents to donate their child's organs for transplant.

JCAHO.

It's a rare day when JCAHO revokes a fully accredited hospital's accreditation. I have found only one so far, but I've only checked the larger states on the JCAHO "Quality Check" page, where you can find the accreditation status and accreditation history of various health care organizations. Modern Healthcare's "Daily Dose" reports that Greater Southeast Community Hospital in Washington, D.C., has lost its appeal of JCAHO's June revocation decision, but GSCH was never more than conditionally accredited.

Patient Privacy Rules Bring Wide Confusion.

HIPAAmen.

Antitrust claims of medical residents.

I've always thought that the medical residents' antitrust challenge to the National Resident Matching Program -- in which hospitals and graduates alike agree not to compete for positions but to accept the computer-generated pairings -- had considerable merit. Here's one analyst's take on the plaintiffs' theory:

"The antitrust lawsuit against the ACGME claims that the Match is anticompetitive because it eliminates the influence of free markets on salaries. Although the Match does not technically fix prices, it prohibits residency programs from making offers outside of the Match. This rule wipes out the market for medical residents and undermines price competition, because it prevents students from negotiating with the different hospitals. Without an offer in hand, students have no power to negotiate with the programs, and programs do not need to compete for residents through salary or other monetary benefits. Programs are also deterred from increasing salaries to compete for students, because they cannot be guaranteed that the students whom they really want (and whom they believe are worth a higher price) will be matched with them. Therefore, programs have, in effect, set a flat salary of roughly $40,000 for all members of house staff throughout the country, irrespective of the specific demand for their labor." (Sanders Chae, "Is the Match Legal?", 348 N. Eng. J. Med. 352 (2003) (extract; full text requires subscription))

At the same time, it is difficult to imagine the staffing chaos -- and the impact on the availability of much needed health care services -- that would be produced by a market-driven, frankly competitive system in which no one knows where all the residents will be working until June 30. Apparently the defendants think there might be some merit in those claims, as well. Of course, inconvenience and higher costs are not defenses to an antitrust suit, but they find support in various courts' analyses of the "procompetitive effects" of otherwise anticompetitive behaviors and can provide reasons to take the defenses very seriously. Here's the same analyst's view of the "procompetitive" defense:

"Specifically, the Match appears to increase the choice of residency programs for medical students by allowing them to interview at multiple programs. It also prevents insiderism and thus might enhance diversity."

According to an article by Neil Lewis in today's New York Times, they are trolling the halls of Congress looking for legislative protection from potentially devastating monetary damages. (A spokesman for the Association of American Medical Colleges, one of the defendants, denies any such implication and insists that the legislation is being sought precisely because they believe the suit has no merit.) In addition to generating fees for lobbyists and defense attorneys, the antitrust suit appears to have had another impact as well. The governing board of the Match voted at their May meeting to delay implementation of a new policy that would require all participating institutions to register all of their positions with the Match ("only" about 80% are currently listed), a policy that could have the effect of compounding the antitrust injury -- if any -- currently produced by the Match. There is a nonfrivolous argument that the Match does not produce antitrust injury, as explained by the same NEJM analyst:

"Antitrust claims under Section 1 must show that the restrictive practice has anticompetitive consequences, such as an inefficient transfer of wealth due to higher prices, a reduction in output, or a diminished quality of goods or services.4,5 It is not obvious that teaching hospitals are underpaying residents in order to transfer wealth from resident to hospital as excess revenue or profit. However, there may be a transfer of wealth when residents care for the private patients of attending physicians who do not participate substantially in resident training. It is also hard to believe that the Match reduces output by decreasing the amount of health care that teaching hospitals provide. Indeed, low salaries might increase output by enabling teaching hospitals to hire more residents, leading to more health care. A final difficulty is that Medicare pays salaries through a fixed sum paid to the hospitals. If Medicare would not provide higher salaries in a freemarket system, the Match might not be responsible for low salaries."

If you're interested in Dr. Chae's full analysis, address reprint requests to Dr. Chae at the Department of Medicine, Columbia University College of Physicians and Surgeons, 622 W. 168th St., New York, NY 10032, or at sanderschae@post.harvard.edu.

Rationing health care.

Two articles in today's New York Times raise provocative questions of health-care rationing and justice. One story is about Zell Kravinsky, a multimillionaire (well, he was a multimillionaire before he gave away $45 million to various foundations) who more recently donated one of his kidneys to a complete stranger. His wife has threatened to divorce him if Zell doesn't tone down his altruistic tendencies, and even his mother disapproves: "You can give money, you can give service. Body parts are quite another thing." Zell's explanation is strictly a utilitarian one: "No one should have a vacation home until everyone has a place to live . . . . No one should have a second car until everyone has one. And no one should have two kidneys until everyone has one."

In the second article, "New Therapies Pose Quandary for Medicare," Gina Kolata discusses medical therapies that could benefit tens of thousands of Medicare beneficiaries but at a cost of (as the late Carl Sagan would have said, in a different context) "billions and billions," indeed at a price that would dwarf the projected price tag for the prescription drug benefit currently being debated in conference by Congress. As Kolata puts it: "The federal Medicare program is expected to decide this week whether to pay for an aggressive and expensive lung operation that could offer a lifeline to tens of thousands of elderly patients. But health economists and medical experts say the treatment, however alluring, is part of an unsettling trend: new and ever pricier treatments for common medical conditions that are part and parcel of aging — procedures that could potentially benefit tens of thousands of patients, at a total cost that would far exceed the kind of prescription drug benefit now being considered by Congress. The questions, these experts say, are how much Medicare can or should pay, and whether cost-effectiveness should enter into the decisions." The chief medical officer for the Centers for Medicare and Medicaid Services, which administers the Medicare program, is quoted as saying "he understood that the costs of new technologies can be staggering. But he adds that cost has traditionally not been a consideration in deciding what to cover. 'If the technology was effective, we would find a way to pay for it,' he said. 'There is no dollar value per life per year at which Medicare would decline to pay.' But," adds Kolata, "costs are mounting."

Cryonics.

So: Alcor, the cryonics firm that has Ted Williams' body frozen in Scottsdale, now admits that they mistakenly decapitate the Splendid Splinter despite his family's expressed wishes to keep him in one piece. (See story) And Alcor's ex-COO posted pictures of Williams' head on the Web. And this COO is ready to testify as to all sorts of shoddy practices concerning the handling of DNA (including Williams'), human remains, and body parts. Meanwhile, a Boca Raton firm, Suspended Animation, has applied for the necessary permits to become Florida's first cryonics facility for humans. (See story) As reported by Popular Mechanics, the technical problems of freezing and thawing something the size and density of a human body are mind-boggling. This raises the question whether it is unethical to sell this service at this time, even with appropriate informed-consent disclosures, or should the regulators just let the suckers continue to be gyped.

Single-payer national health insurance redux.

As noted here on Tuesday, the Physicians' Working Group for Single-Payer National Health Insurance published their recommendations for such a plan in this week's JAMA (abstract only; full text requires subscription). Yesterday's Seattle Post-Intelligencer thoughtfully recommended that the debate should begin on the key questions posed by the doctors' group's recommendations ("Doctors diagnose health care woes":

"[JAMA editorialized that] 'American health care system and the American society face a real problem and are compelled to search for an answer.' . . . In the way of such an answer lie many questions. If we were to tax ourselves to provide a certain level of health care for everyone, what would that level be? How would that be decided and by whom? Who pays for what's not covered and how? Much disease is preventable through proper nutrition and behavior, while a huge portion of health care costs are incurred in the last months of life. Would public funding of health care necessitate a public policy debate on how the funding is allocated? Could an American national health plan be designed to offer the benefits of other nations' programs without the shortcomings? . . . The physicians have opened what should be a healthy -- and long overdue -- debate on an issue that literally touches everyone's life."

How much better a response to the doctors than the knee-jerk opposition of the AMA itself (as opposed to its mostly and almost always editorially independent journal, JAMA) and editorialists such as Jerry Heaster of the Kansas City Star. Heaster writes in today's paper that the announced decrease in physician reimbursements from the Medicare program next year, against the backdrop of Congressional debate over a $400-billion-Medicare-drug-benefit-we-really-can't-afford, highlights the ineptitude of the government when it comes to running really big, complex programs. He ends on a sourly populist note: "There are three ways to do things: the right way, the wrong way and the government way. This is a good example of the government way."

Okay, fine, Congress is blowing it big-time with this budget-busting drug benefit, and they have shown contempt, if not bad faith, in their dealings with physicians in recent years (and even going back some years before that, truth be told). But how much can we know about the operation of a national single-payer system from the history of a government program that is engrafted upon a market-based system? How, in other words, can Medicare possibly get out of the budgetary hole and regulatory morass it is in when it has to coordinate the functioning and financing of its benefits with an otherwise investment-driven and employer-dominated system? Maybe it will turn out that in the long run a single-payer system is a pig in poke and shouldn't be attempted. But we won't know unless there is honest debate on the kinds of important questions identified by the Seattle PI's editorial board, rather than chest-beating and snidely anti-government sloganeering.

More on stem cell research and cloning.

In addition to the three-fer in the Mayo Clinic Proceedings mentioned here yesterday, the New England Journal of Medicine had its own three-fer on this topic in its July 17 issue. The NEJM offers full text articles, with rare exceptions, for subscribers only, so all I can give you here are links to the abstracts, which are available to the public for free.

Prometheus's Vulture and the Stem-Cell Promise, by Nadia Rosenthal, Ph.D.

Review Article: Nuclear Transplantation, Embryonic Stem Cells, and the Potential for Cell Therapy, by Konrad Hochedlinger, Ph.D., and Rudolf Jaenisch, M.D.

Edtorial: Legislative Myopia on Stem Cells, by Jeffrey M. Drazen, M.D.

Boutique medicine.

According to a story in the Aug. 11 Boston Globe, Tufts-New England Medical Center will open a "concierge" or "boutique" primary care practice for patients who have the $1,800 to pay annually for access to longer appointments and quieter waiting rooms. The hospital system says the extra income will help subsidize the primary care it offers to all patients regardless of ability to pay and help stem operational losses that totaled over $12 million last year. As noted here on August 5, Washington's Commissioner of Insurance recently ruled such arrangements illegal. The Globe reports: "Blue Cross & Blue Shield of Massachusetts, Tufts Health Plan, and Medicare, the federal insurance program for the elderly, currently contract with concierge practices, but they are wary."

Not-for-profit conversion gone wild.

A report in today's Baltimore Sun says that federal investigators have subpoenaed records of CareFirst BlueCross/BlueShield in connection with the aborted attempt by Maryland's largest health insurer and its officers to convert the company to a for-profit corporation and sell itself to WellPointHealth Networks in California. The 15-page subpoena is directed at CareFirst, the Maryland Insurance Administration, and the law firm that represented CareFirst and its CEO. The federal probe follows upon the heels of a 352-page report by Maryland Insurance Administration Commissioner Steven B. Larsen in March, which accused the CEO and others officers of CareFirst of deception, conflicts of interest, mismanagement and flagrant attempts to profit personally from the proposed sale.

Stem cell research.

If you're not a microbiologist, or if you've just been out of touch with stem-cell issues for the past 6 months, getting back up to speed on the science of stem-cell research and the regulatory issues and ethical debate can be a daunting matter. The August issue of the Mayo Clinic (no relation) Proceedings can get you on top of the issue in an hour.

First, there is "An Overview of Stem Cell Research and Regulatory Issues" by Christopher R. Cogle, MD; Steven M. Guthrie, BS; Ronald C. Sanders, MD; William L. Allen, JD; Edward W. Scott, PhD; and Bryon E. Petersen, PhD. -- a good overview of the science and the public-policy debate.

Second, there's a commentary by Neil D. Teise, MD on "Stem Cell Research: Elephants in the Room," described as an "exceedingly personal" commentary on "issues of scientific methods and sociopolitical situation that impact the science."

Finally -- and likely to generate the most interest in political circles because of the prominence of some of the authors -- there's another commentary by William P. Cheshire, Jr; Edmund D. Pellegrino; Linda K. Bevington; C. Ben Mitchell; Nancy L. Jones; Kevin T. FitzGerald; C. Everett Koop; and John F. Kilner entitled "Stem Cell Research: Why Medicine Should Reject Human Cloning." Although the authors "enthusiastically affirm the importance of medical research and ardently support the goal of healing people," they conclude:

"To rewrite medical ethics to permit human cloning would ensnare physicians in a perilous compromise of professional standards. To acquiesce to human embryonic cloning would be to disregard, to an unprecedented degree, the value of new human life. Human cloning would also represent a decided step toward the devaluing of humanity universally because justifications of human cloning research disturbingly imagine a category of dismissable human
life. Such a designation is utterly foreign to the Hippocratic ethic, which respects human beings at all stages of life."

Arguing for a total and permanent ban on both reproductive and research cloning, the authors go beyond the majority position of the President's Council on Bioethics, whose report last July called for a permanent ban on "cloning-to-produce-children" and offered a split decision on "cloning-for-biomedical-research," with 10 members calling for a 4-year moratorium and 7 members supporting "cloning-for-biomedical-research now, while governing it through a prudent and sensible regulatory regime."

Single-payer national health insurance.

This week's JAMA has published a "Proposal of the Physicians' Working Group for Single-Payer National Health Insurance" (abstract; full article requires paid subscription). The challenge, as they see it, is to get the richest country on earth to finance basic health care for all Americans, including the 41 million without health insurance. Here's how: "We endorse a fundamental change in US health care—the creation of an NHI program. Such a program, which in essence would be an expanded and improved version of traditional Medicare, would cover every American for all necessary medical care. An NHI program would save at least $200 billion annually (more than enough to cover all of the uninsured) by eliminating the high overhead and profits of the private, investor-owned insurance industry and reducing spending for marketing and other satellite services." As reported by Modern Healthcare's "Daily Dose, the AMA itself remains opposed to a single-payer national plan.

"Promotion" of off-label drug use?

Good story from the Associated Press on a whistleblower suit in Boston that accuses Parke-Davis and its parent, Warner Lambert (all part of Pfizer now) of various nefarious and underhanded activities to encourage physicians to prescribe Neurontin "for unapproved uses such as relieving pain, headaches, and psychiatric illnesses." (Additional details about the alleged marketing abuses are described in an article in the Indianapolis Star.) Prescribing for an off-label use is perfectly legal, but manufacturers may not "promote" approved drugs for off-label uses. "Promotion," as the article makes clear, is a vague term, which allows for some leeway. Up to a point, we should welcome off-label uses, which are a cornerstone of medical progress, and who better than the manufacturer to know how the drug might be used in addition to its approved uses? But the law clearly expresses a preference for manufacturers to develop their theories about approved drugs through formal clinical trials and resubmission of data to the FDA to expand the claims for which the drug may be marketed. It will be interesting to see where the district court draws the line between innovation and patient safety.

Medical error and poor penmanship.

Medical error in general -- medication error in particular -- is undoubtedly a complex systemic problem, but one of the more obvious sources of the problem is the bad handwriting of many physicians. They are not alone, of course, with their poor penmanship, but few of us can kill someone with an undecipherable scrawl. The solution? Tens of millions of dollars of computer wiring and hardware installations per hospital to support a Palm-Pilot-based system of medical data entry, starting with the physicians and medical students who write the progress notes and medication orders, according to a story in today's Los Angeles Times (free subscription required). It's too soon for this to be the standard of care, but that time is coming, so hospitals can pay now or they can pay later, but they are going to have to pay.

Medicare reform.

Finally, someone is starting to focus on the inability of private health plans to provide Medicare benefits -- including the drug benefit under consideration by a conference committee in Congress -- at anything remotely resembling lower costs (to beneficiaries or to the Medicare program itself). According to an article in today's New York Times, out-of-pocket expenses for Medicare enrollees in existing private health plans have doubled since 1999. Anyone who thinks privatizing the Medicare program will be a panacea for projected budget increases, especially in light of the-pharmacy-benefit-we-really-can't-afford, needs to take a look at the report that the Times' article was based upon, which was issued today by the Commonwealth Fund.

Doctor listings on the Web.

An article in today's Washington Post makes the point that if health plans (and I assume some hospitals, as well) can't keep their on-line list of physicians cleansed of doctors who are deceased or who have been disciplined for sex-related felonies, what does this tell us about their on-going peer-review?

Living organ donors.

An Associated Press story today (published in The Cleveland Plain Dealer and probably a thousand other places as well) makes the point that (a) more donors come from living donors than from cadavers and (b) the transplant "system" is not doing a very good job of collecting and tracking data or providing meaningful and accurate informed-consent disclosures concerning risk.

Health reform and Harry Truman.

As students in my health law class know, the current health care woes of the U.S. are part of a familiar pattern, dating back to the beginning of the 20th century. By the time Harry Truman became president, he was sufficiently concerned that he included universal health care coverage in his first message to Congress. A story in today's Lawrence (Kan.) Journal-World is a nice reminder of Truman's worries for our system and the similarities between then and now.

Health care coverage for the college-bound.

Excellent discussion in the New York Times today about the ins and outs of health care plans for college students. Even though most college-aged students are fairly young and pretty healthy, it pays to pay attention to the fine print, especially if you plan to rely on one of the parents' employer-provided family coverage, and most especially if that's a managed care plan, which can have some severe limits on non-emergency out-of-network care.

Health care reform.

Scott Burns' nationally syndicated column ran a particularly good story August 7th on health care as a "bet-the-country-sized problem." Here are the numbers:

The unfunded liabilities of Medicare, according to the latest generational accounting figures from economists Jagadeesh Gokhale and Kent Smetters, now amount to $35.5 trillion. That's about five times the $7.2 trillion unfunded liability of Social Security. It's also about 10 times the Treasury debt held by the public.

Worse, the Medicare liability is growing with the speed of a nasty cancer. It will increase by $1 trillion more by next year's presidential election, dwarfing the recognized federal deficit. Then it will grow $5 trillion more by the presidential election of 2008.

There's also so good stuff here from John Wennberg's "Dartmough Atlas of Health Care," showing that "geography is destiny" when it comes to what sorts of health care services you get.

Medical staff issues.

Modern Healthcare's Daily Dose reported last week on a decision that holds that "[t]he medical staff of 222-bed Community Memorial Hospital of San Buenaventura, Ventura, Calif., is a legal entity and may sue the hospital's board over a new code of conduct and control of a $250,000 bank account. . . . The physicians contend the code of conduct and a new conflict-of-interest policy threaten the medical staff's independence and ability to police quality. . . . Hospital attorney Lowell Brown of the Los Angeles office of Foley & Lardner said, 'The question remains: Who gets to run the hospital -- the medical staff or the board?'"

Medical retainer fee (a/k/a "boutique medicine") nixed in Washington.

As reported in the Puget Sound Business Journal (Seattle), the Commissioner of Insurance in the state of Washington has determined that the growing practice of physicians charging patients a retainer for premium access (responses on nights and weekends, office appointments on short notice, etc.) violates the state's insurance laws. In two draft technical assistance advisories, the deputy commissioner of insurance ruled that such arrangements are, in effect, insurance, because "[t]he fee is paid by the patient regardless of the amount of services provided [and] even if no services are provided. These arrangements result in a transfer of risk and, in essence, are insurance agreements." Actually, the transfer-of-risk/insurance element of the analysis seems weird to me. In what sense do the doctors take on risk? The care isn't pre-paid with the retainer; only access is pre-paid. The patient's health insurer is going to be tapped for the care, and no part of the insurer's risk is being shifted downstream to the physician. Granted, there is some risk that the demand for services at any given time might outstrip the physician's ability to schedule, but that's not a financial risk, is it? The higher the utilization, the higher the fees for the physician. I'm not sure I see any insurance element in this arrangement at all. On the other hand, I think Troy Brennan's ethical analysis of these arrangements in the New England Journal of Medicine (Volume 346:1165-1168 -- April 11, 2002) (subscription required for full text) is spot on: "[T]he development of luxury primary care might be seen as a crystallizing event. The medical community must be prepared to step forward with ideas and programs that ensure an equitable distribution of health care services. No matter how innovative and attractive luxury primary care is to some patients and physicians, it poses questions about equity. We should identify ways in which luxury primary care can be regulated by the medical profession (perhaps by mandatory cross-subsidies and careful monitoring of the prevalence of such care), while also addressing other threats to access. The questions that luxury primary care poses should remind us that as physicians we have a commitment to the equitable distribution of health care and therefore a duty to address market innovations that could leave some patients without access to care." Thanks to health lawyer Jeff Sconyers for bringing this decision to my attention.

Abortion funding.

According to the San Antonio Express-News, "[s]ix Planned Parenthood affiliates can continue to perform abortions with privately raised funds in Texas without jeopardizing $13 million in annual state funds, under a temporary injunction granted by a federal judge Monday." The court's injunction effectively stays a recent state law that would otherwise have gone into effect on Sept. 1. See also article in Austin American-Statesman. Hate to admit it, but I am coming up dry in my search for a bill number on this budget item . . . .

Stem cell research.

Celgene Cellular Therapeutics broke ground yesterday on a facility that will harvest stem cells from placentas and umbilical cords, thus sidestepping the moral morass produced by harvesting stem cells from embryos or fetal tissue, according to an article in today's Monroe (La.) News Star. NIH has the next move: where do these stem cell lines fit within the President's research-funding policies announced two years ago this month?

Brain surgery.

And while I'm on the subject of technological challenges to "human nature," consider the article in today's L.A. Times entitled "New surgery to control behavior". There are examples -- and this might be one of them -- of technology that makes us more human, not less.

Gene therapy.

A thought-provoking piece on germ-line therapy appeared in today's issue of The (Melbourne) Age. Bill McKibben's article is based upon his forthcoming book, the apocalyptically entitled, Enough: Genetic Engineering and the end of Human Nature, and ends with this paragraph: "Right now our technology is advanced enough to make us comfortable, but not so advanced that it has become us. We have enough insight from Darwin and Freud and Watson and Crick to allow us to understand some of what drives us, but we’re not yet completely reduced to hardware. We have Prozac for the incapacitated and pain-ridden, but it’s not encoded in our genes. We have enough medicine to give most of us a good shot at a long life, but not so much as to turn us into robots. We are suspended somewhere between the prehistoric and the Promethean. Closer to the Promethean. Close enough." McKibben's argument, which relies to a considerable degree on assumptions about our shared understanding of the notion of "human nature," reminds me of the position of Dr. Leon Kass, chairman of the President's Council on Bioethics, whose most recent book, The Beginning of Wisdom: Reading Genesis, was reviewed quite respectfully in yesterday's New York Times (subscription required).

Med mal insurance crisis.

The GAO's new report on the med mal insurance crisis should be required reading for anyone (including me) who has said med mal recoveries aren't the real culprit behind rising premiums - it's the business cycle combined with myopic and greedy insurance companies' business plans. Turns out it is both and a lot more, too.

Medicare drug benefit.

The conference committee proceeding to hammer out a prescription drug benefit for Medicare keeps getting messier and messier. Forget for a moment that the price tag -- conservatively estimated at $400 billion a year -- is a budget buster. And put aside the notion that the drug benefit will go to the 90% of seniors above the federal poverty line as well as the 10% below. (I don't know where it makes sense to draw the line on this entitlement -- 10% above the poverty line? 25% above? -- but at this price, and in these economic times, you'd think Congress would show a little more interest in targeting this benefit to help those who most need it, not to senior whose incomes can cover drug costs, or whose retirement health plans already include a drug benefit.) Now the plot thickens as conferees deal with the impasse over prescription-drug reimportation. As reported in The Washington Post, the House bill would allow reimportation from Canada and two dozen other countries, while the Senate version would allow reimportation only from Canada. The Boston Globe and others report that 53 senators have signed a letter that says the House version is a deal-breaker for them, and the drug industry trade organization PhRMA supports the senators' position. PhRMA says it's a safety issue: we don't know how those drugs have been stored and transported, and substandard handling practices can reduce the potency of the drugs. The FDA and its parent agency, DHHS, also have historically opposed reimportation on safety grounds. (A nice review of reimportation is in the Sept./Oct. 2002 issue of FDA Consumer magazine.) In addition to the safety issues, PhRMA has another concern that the senators aren't talking about: the impact of "importing foreign government's price controls" on the pharmaceutical industry's bottom line and ultimately on its R&D budgets. Thus, PhRMA "urge[s] Congress and the Administration to . . . overturn foreign governments' price controls on prescription medicines. Foreign governments' policies . . . lead to free-riding on American consumers and reduce the pace of development of new medicines." Using Rep. Bernie Sanders' analysis of drug company profitability (as reported by Forbes), the concern about slashing R&D budgets does seem a bit overdrawn. Reliance on Forbes' numbers has been challenged by the conservative Buckeye Institute, but even by their reckoning, industry profits were at 18.3%. Buckeye was taking aim at a Public Citizen report that pegged industry profitability at a rollicking 33%; Sanders' numbers reflected a more conservative calculation of 18.6%. Even at 18%, industry profits are robust. The policy question for Congress is how much of a hit the industry can take and still produce new drugs that benefit us all.

Duke's transplant woes.

The Raleigh News & Observer reports in an article today that Duke's transplant program was given a clean bill of health by the regional CMS office in Atlanta. At issue were a lack of coordination between the transplant center and the regional organ procurement organization, as well as problems with dialysis equipment that were discovered after the death of Jesica Santillan last summer. The story is an interesting representation of today's health care system in a microcosm: Duke states that its goal "is to maintain the highest safety standards for the benefit of our patients and staff," while the paper notes that "[a]t risk were the hospital's Medicare and Medicaid reimbursements, which make up 40 percent of its revenues." Duke's chances of losing Medicare/Medicaid certification are about equal to my chances of setting the Major League Baseball home run record, but the publicity alone, let alone the theoretical possibility, tends to focus the institution wonderfully.

Dumb and DOMA.

President Bush, in his news conference on Wednesday, July 30, put his "compassionate conservative" principles out in full view by stating that we should be tolerant of gays and lesbians (despite his reference to them as "sinners" -- that must be the compassionate side of Dubya), while at the same time stating that administration lawyers are looking into the legal steps necessary to make sure that "marriage" is a status that will be reserved to opposite-sex couples as a matter of federal law. Putting aside the most likely explanation for this comment -- that he was appealing (or pandering, as you like it) to his conservative base -- and taking his words at face value, exactly what the lawyers are looking into is a bit of a mystery. Maybe a constitutional amendment, though clean-up hitter and press secretary Scott McClellan did not take the bait on that one at his daily press briefing on Thursday. (By the way, kudos to the White House press office for a fully functional search engine and an indexed press briefing feature on their web page. In terms of functionality, the Bush crew got off to a slow start, but the availability and functionality of retrievable White House comments is now excellent.) As many have noted, the 1996 Defense of Marriage Act ("DOMA") already establishes (i) that "marriage" means opposite-sex unions for purposes of federal statutes, rules, benefits, and programs and (ii) that states do not have to give full faith and credit to any other state's legal decrees to the contrary. It's hard to see how all this would have come up, at least at this time, if it weren't for the Supreme Court's decision in Lawrence v. Texas, which not only struck down Texas' Penal Code provision on homosexual sodomy but also ruled that the states' police powers need more than a purely moral basis to pass even rational-basis review by the federal courts.