Separation of Egyptian conjoined twins begins in Dallas today.

Excellent article in this morning's Dallas Morning News by Laura Beil about the ethics of performing surgery to separate two Eqyptian brothers who are joined at the tops of their heads. As co-chair of the ethics committee at Children's Medical Center Dallas, where the separation is being performed, I have given lengthy interviews to a lot of reporters about the ethics of separation and the process that we went through at Children's, and Laura's piece is the only one I've seen (so far) that has attempted to lay out the ethical analysis. The article also quotes Prof. Adrienne Asch of Wellesley College, who makes a valid point about society's culturally determined notions of what is "normal":

The surgeons know there are those who will take exception with the decision to operate. One expert who disagrees is Adrienne Asch, a professor of reproduction and bioethics issues at Wellesley College in Massachusetts.

Dr. Asch is disturbed by the drive to separate conjoined twins because it is usually based on the sense that being conjoined is not a "normal" way to live. But what does normal mean? Does it mean average, or outside statistical boundaries, or desirable? Star athletes and Nobel Prize winners have outstanding qualities that are not considered normal, she pointed out. "We think of some non-normal things as desirable," she said.

People live good lives in a variety of circumstances, and it is not for others to decide whether their circumstances are a burden. To ask whether two conjoined brothers should be separate, she said, is almost akin to asking a black person whether they should be white, or a woman whether she would be better off as a man.

"I don't even like the word normal," she said.

If society considered it acceptable to be conjoined, being attached to your brother or sister would be an unusual but perfectly legitimate way to live, she said. The biggest disability facing these twins, is that society considers it strange. "That's the principal impairment of being conjoined," she said.

I am not so sure that stigmatization is the biggest impairment facing a child with a sibling who is his size and weight attached to the top of his head, or that with these brothers we are dealing with a physical condition that would be considered "normal" in other societies but not here. But I do agree that "normal" is a loaded term that is not particularly helpful in resolving the question whether to separate or leave together conjoined twins.

Withdrawal of "futile" life-sustaining treatment over family objection.

The Baby Miller case discussed here on Sept. 30, involved the resuscitation of a newborn over the objections of parents who wanted no heroic measures. That dispute represents the classic "right to die" scenario. The "reverse right to die" case -- sometimes called the "duty to die" case -- reverses the roles of family and caregiver, with the latter claiming that further aggressive treatment will not benefit the patient. These so-called "futility" disputes can be difficult to resolve. If the patient doesn't die first, and if the family doesn't change its mind about continuing aggressive treatment, the physicians and the hospital staff are in a tough predicament: (a) keep providing therapy they believe to be unethical to continue or (b) unilaterally remove life-support over the objections of family. Texas is one of the few states in the country with a statute that provides legal protection for the health care professionals and institutions that take the latter course. (See Health & Safety Code § 166.046.) A case reported in an article in today's Independent (London) illustrates the problem:

An elderly woman, whose feeding tube was withdrawn by doctors against the wishes of her family, died in hospital yesterday.

Olive Nockels, 91, became the focus of a legal battle about treating the elderly after being admitted to the Norfolk and Norwich Hospital more than two weeks ago. She was unconscious and doctors suspected she had suffered a stroke after an operation to pin a broken hip.

They advised her relatives last week that there was no chance of recovery. They said using drips and tubes to feed and hydrate her would unnecessarily prolong her suffering and the tubes were withdrawn on Friday 3 October.

But Mrs Nockels' family objected and obtained an interim court order on Monday compelling the doctors to restart feeding and hydration until a full hearing could be held. Ivy West, 60, Mrs Nockels' daughter, said: "We think she would still be here now if they had not taken her drip away for three days before they were forced to put it back."

It will, of course, be a very difficult case in which to prove causation. There is no doubt, however, that the peremptory action taken by the hospital exacerbated the family's distrust. The ethics rules that govern these types of disputes appear to be about the same in Great Britain as they are in the States:

The British Medical Association says the "active and intentional" termination of a patient's life is illegal but adds that medical treatment, including artificial feeding and hydration by tube, can be withdrawn when it is "futile, when it would not be in the patient's best interest ... or when the patient has refused further treatment".

Experience with the Texas law since its enactment 4 years ago suggests that having legal authority for withdrawals of futile treatment actually helps families accept the ethical principle that there are limits to the duty to treat.

Where do disagreements over end-of-life care come from? Michael Wilks, chairman of the BMA ethics committee, said it well:

"If doctors decide a treatment is not providing benefit, it is unethical to continue to provide it. The commonest reason for a breakdown between a health team and relatives is a failure of communication."

Med-mal crisis hits Australia.

Just as in a dozen or more states in the U.S., Australian doctors are claiming that skyrocketing med-mal premiums are forcing them out of the practice, according to a story in the Sydney Morning Herald. The story leads with Michael Kaye's claim:

The amount Michael Kaye is paid by Medicare to see a new patient has not quite doubled to $52 since he started working at Mona Vale Hospital in 1982, while the cost of his medical indemnity insurance has gone up from $100 to $50,000.

Dr Kaye has resigned in protest.

"I can't work without insurance and I can't afford the insurance," he said yesterday.

He is one of three obstetricians at the hospital to tender resignations this week, to become effective in three months unless the Government can find a way to stem rocketing insurance costs.

Dr Kaye says the hospital's eight orthopedic surgeons have resigned and about 12 more specialists plan to join them.

As here, the plaintiffs' bar has a different take on the med-mal crisis, but so far the rhetoric seems to be outpacing the analysis of causes and effects. Dr. Kaye is hoping for a no-fault compensation scheme, but meanwhile the bad blood between doctors and lawyers bodes poorly for a reasoned dialogue: "I got into this to help people, not try and defend myself to some smart-arse years after the event. Lawyers and judges can take a year to make a decision, we have to do it in half an hour or less."

Medicine and the practice of capital punishment.

Two articles in today's New York Times discuss two points of intersection between the practice of medicine and the death penalty:

1. Yesterday, the Supreme Court of the United States denied certiorari in an 8th Circuit case -- Singleton v. Norris (U.S., 02-10605) [requires subscription to WestLaw] -- in which the court of appeals, sittin en banc, ruled that medicating a mentally ill death row inmate in order to make him competent to be executed does not constitute cruel and unusual punishment. According to The Times' article, this is the first case in the country, state or federal, to so hold. That may be why the Supremes denied review; normally they like to let a few more courts chew on a problem before they tackle it (called "percolation"). The AMA, by the way, is against physicians participating directly in capital punishment (Opinion E-2.06: "When a condemned prisoner has been declared incompetent to be executed, physicians should not treat the prisoner for the purpose of restoring competence unless a commutation order is issued before treatment begins.")

2. In a second article, Adam Liptak reports that in more than 30 states that allow execution by lethal injection, a three-drug "cocktail" is used. One of the drugs -- pancuronium bromide -- is a paralytic. Increasingly, corrections officials and medical experts are questioning the practice of paralyzing prisoners as part of the execution process, particularly given the chance that the other drugs used may have inadequately anesthetized the patient. The result in such a case -- where a prisoner could be conscious, starved for oxgyen, and unable to move -- would be akin to turning the inmate's body into a living tomb. It probably goes without saying that the AMA's Opinion E-2.06 also forbids physicians from administering the cocktail, which may paradoxically increase the chance that just such an unintended effect will be produced.

Minority children: over- or underrepresented in medical research?

There's an excellent news release from the University of Chicago today about the participation of minority children in research studies. African-American children are overrepresented (in comparison to their percentage of the total population) in clinical trials, while Hispanic and white children are underrepresented. The last four paragraphs of the release are the most provocative:

Both black and Hispanic children were overrepresented in research on topics that were potentially stigmatizing, such as studies of child abuse, high-risk behaviors or HIV. Fifteen percent of the U.S. population is black but 30 percent of the children in potentially stigmatizing research studies were African American. While 17 percent of the U.S. population is Hispanic, only 10 percent of the children in medical research were Hispanic, and 17 percent of those involved in potentially stigmatizing studies.

"There are possibly benign and not so benign explanations for these findings," Ross said. "Our data could not distinguish. Clearly, black and Hispanic children should be overrepresented in AIDS research as they account for 82 percent of all reported pediatric AIDS cases. On the other hand, there are data to suggest that there is racial and ethnic bias in who is questioned about child abuse."

Why black children were more likely to be involved in clinical research is unclear. One possible explanation may simply be that academic medical centers are disproportionately located in urban centers where minorities live. The authors note that the ongoing shift of clinical research from major medical centers to smaller, suburban, private practices, could reverse this trend.

They conclude on a cautionary note. "Despite the participation of minority children in research, there are data that show that these benefits are not being translated into their clinical care. This should be a top priority." (emphasis added)

A heart transplant program too good to be true.

The Albany (N.Y.) Times-Union has an article in today's paper about Albany Med's three-year-old heart-transplant program. Seems it has outcomes far better than many more established transplant centers at more vaunted institutions. That may be because its recipients were healthier than the transplant surgeons were letting on. By exaggerating the acuity of their patients' illness, the surgeons were leapfrogging sick patients on the transplant list and simultaneously skewing their statistics by putting hearts in healthier patients who could be expected to have better recoveries. What they did is, of course, a violation of the rules established by the United Network for Organ Sharing (UNOS), which administers this country's transplant program under contract with the Department of Health and Human Services (DHHS). The Division of Transplantation of DHHS' Health Resources and Services Administration in turn oversees implementation of the National Organ Transplant Act through its organ-transplantation regulation. UNOS' audit of Albany Med's statistics turned up "discrepancies" that led Albany Med to suspend operation of the transplant center and the two surgeons who run it (see Albany Med's press release). Violations of UNOS protocols are enormously unfair to patients who were in line for a new heart but lost out to patients beneath them on the list. Rank manipulation of the rules of the game also undermines the public's confidence in the whole process. Logically, it's not a stretch to imagine that lessening of confidence in the fairness of the system could have an impact on the willingness of families to designate brain-dead loved ones as organ donors. Bad (and sad) news.

The parents vs. physicians trap

The October 13 issue of U.S. News and World Report continues the Baby Miller theme of parents vs. physicians with this report on the conflict between the parents of Parker Jensen and his physicians. Twelve-year-old Parker was diagnosed earlier this year with Ewing's sarcoma, an aggressive cancer. A tumor was removed from his mouth, and four doctors recommended he receive follow-up chemotherapy to reduce the chance of a recurrence. But Parker's parents refused, despite the fact that "With chemo, the survival rate is approximately 70 percent," while without it, "your chance of living is about 20 percent." His parents whisked him from Utah to Idaho, and local prosecutors charged the parents with kidnapping. Despite the return of cancer, the parents are adamantly against chemo for their son ("The state of Utah needs to leave us alone") and a court hearing is schedule for sometime this month.

Baby Miller case decided by Texas Supreme Court

One year, five months, and twenty-seven days after oral argument, the Texas Supreme Court decided the Baby Miller case today. The court, whose ranks were depleted by retirements, voted 7-0 to affirm the Court of Appeals in an opinion written by retiring Justice Craig Enoch. A few quick thoughts:

1. This is a devastating loss for the family, which has a lifetime of expensive nursing and medical care to pay for. With post-judgment interest, the judgment for the family had to have been worth over $100 million by now. The Court of Appeals reversed and rendered a take-nothing judgment, and today the Supreme Court said, "that's right."

2. The major damage done by the Court of Appeals to the Natural Death Act (now the Advance Directives Act) was technically left alone by the Supreme Court. It affirmed on other state-law grounds and said it didn't need to reach the NDA/ADA issue. But the court offered some dicta that ought to make it clear the court thought the Court of Appeals blew it, which it did (big time). So my major hope for the opinion -- that the NDA/ADA would be restored to its natural meaning -- was half-way realized.

3. The court also side-stepped the Baby Doe issue in the case. It describes the Baby Doe rule as an appropriations/funding rule, which is satisfied by the fact that Texas has CPS policies and procedures in place to respond to reports of failure to provide medically indicated treatment to infants. Period. It does not seem interested in reading Baby Doe as establishing a standard of care, at least unless CPS has been called into a case, which it was not in this case, so as far as the court is concerned: no big deal. But in any event, the court said "this is a state-law, not federal-law, case so we won't technically decide the Baby Doe issue." This is okay with me (even though I think Baby Doe does implicate state law and does establish a standard of care as a matter of state law). Anything the court could have said about Baby Doe (other than what it did say) could only have made a bad rule worse.

The really disquieting part of the decision is its reliance on the 1920 Moss case (link requires Westlaw subscription).

First of all, it's an opinion by the Texas Commission of Appeals of the Texas Supreme Court, not the Supreme Court itself; this is an oddity of Texas judicial history that makes the precedent potentially not as strong as it might otherwise be.

Second, and following from the first, the Supreme Court (in 1920) "approved the judgment in the case," which is generally regarded as weakening the precedential value of an opinion. If the court adopted the opinion of the commission, the precedential value would be higher.

Third, the holding of Moss is this: A surgeon was liable for performing surgery on a minor without the consent of the patient's parents because although "there was an absolute necessity for a prompt operation, [surgery was] not emergent in the sense that death would likely result immediately upon failure to perform it. In fact, it is not contended that any real danger would have resulted to the child had time been taken to consult the parent with reference to the operation. Therefore the operation was not justified upon the ground that an emergency existed."

Amazingly (in light of the Miller court's use of Moss), the Moss opinion ends with this: "The law wisely reposes in the parent the care and custody of the minor child, and neither a physician nor those in temporary custody of the child will be permitted, in a case of this character, to determine those matters touching its welfare." So the Miller supreme court is "guide[d]" (the court's term) to affirm the court of appeals decision against the parents on the basis of an opinion from 1920 of dubious precedential value containing a ringing endorsement of parents' prerogatives to give or withhold consent and setting a very high standard for an exception (more than "an absolute necessity for a prompt" intervention, there must be an emergency "in the sense that death would likely result immediately upon failure to perform the [intervention]." Curious.

Fourth, in Moss, the surgeon relied in good faith on the apparently valid consent of the child's aunt. He had no reason to suspect there was a lack of consent. In Miller, there was every reason to know there was no valid consent. Moss looks like a case that stands for the simple proposition that we will presume consent in a true emergency as long as there's no reason to believe consent has not or would not be given. But of what relevance is that rule to the Miller case?

Fifth, assume that Moss is good law. Does it really support this result? After all, the hospital seems to have had just about the entire day either to get the parents' consent or to get a court order to override the parents' refusal, and it did neither. I don't think Moss really says this is alright.

Curiouser and curiouser.

Big Increase Seen in People Lacking Health Insurance

Robert Pear of the New York Times has an article on the Census Bureau's report on health coverage and the uninsured. Texas's percentage of uninsured is the highest in the country (24.1%), more than triple the rate for Minnesota, the lowest (8%). Why? Here are two reasons: "Texas, facing fiscal problems and unwilling to raise taxes, cut back Medicaid and its Children's Health Insurance Program this year." Our state CHIP saga is particularly deplorable. The state left over $600 million in federal matching funds on the table because of its unwillingness to allocate money to the program. No state funds = no federal match. Details here.

New form of defensive medicine.

Modern Healthcare's Daily Dose has a short piece today about a new report from the Center for Studying Health System Change. As DD reports, "Some physicians are reacting to higher malpractice premiums by declining elective referrals, sending patients to emergency rooms and refusing on-call duty."

End-of-life care and the battle over medical proxy's right to decide.

The Boston Globe published a lengthy article in Sunday's edition about an elderly woman in a locked-in state and the attempts by Mass. General to provide palliative care only, over the objections of her daughter/surrogate decision maker.

The Times got it wrong.

An article in today's New York Times follows up on research first published last year in the medical journals Brain (abstract only; full text requires subscription) and Neurology (abstract). The gist of the research is that many "permanently unconscious" patients are in neither a coma nor a permanent vegetative state; instead, they may be experiencing some degree of consciousness:

The implications of this research, both for medical ethics and practical policy, are potentially huge. Traumatic brain injuries are a significant health problem in the United States, but the study and treatment of them are clouded with a sense of hopelessness, a feeling that consciousness is too mysterious to be understood. When faced with patients in a vegetative state, doctors can do little more than wait to see if they wake up. No treatment has ever been definitively shown to help patients recover consciousness, and doctors can't predict which patients will emerge from a vegetative state and which won't. If patients don't show signs of recovery in a few weeks, they usually wind up at home with their families or in nursing homes, and they rarely see a neurologist again. In 1976, in a famous court case, the parents of Karen Ann Quinlan, a woman who had been in a vegetative state for about a year, won the right to take her off a ventilator (after which she lived until 1985). ''There's a point where people give up'' and discontinue aggressive treatment, says Joseph J. Fins, chief of the division of medical ethics at Weill Medical College. ''The question is, Are we giving up too soon on the ones who might become more functional?'' Schiff and his colleagues say that the answer, in too many cases, may be yes.

Indeed, some of the patients may be able to recover, however fleetingly, quite remarkable levels of conscious interaction with others, through deep massage:

Giacino works hard to tease out hints of awareness in a patient. Sometimes he can actually coax patients into consciousness by working his fingers deep into their muscles. Neurologists have found that the stimulation of the nerve endings in the muscles can be powerful enough to arouse activity in networks of neurons in the brain. Giacino has a particular knack for the technique, and after a few seconds of muscle work, he can get some minimally conscious patients to speak. Some tell him their names, others tell him to leave them alone. As soon as he removes his hands, they slip away again.

Marie Conniff has seen Giacino work this transformation many times. On New Year's Day in 1998, her son Scott was on duty as a New York policeman when a drunken driver rammed his car. Today, Scott sits in a wheelchair, his gaze often drifting across the room. Sometimes he laughs, sometimes he growls like a bear. He gives hard kicks to a big orange beach ball hanging from the ceiling. When Giacino begins to work her son's muscles, Conniff finds herself startled at how well Giacino can bring Scott back, in the look on his face, the clarity of his movements. ''I see a lot of what I had before he got hurt,'' she told me.

Until now, I have been very skeptical of claims that patients in a persistent or permanent vegetative state were "disabled" patients in need of protection against discriminatory policies that give up on the disabled as if they were already dead. The accepted paradigm for PVS is that the neocortical hemisphere is, for all intents and purposes, dead. This article -- quite misleadingly -- suggest that it is quite plausible that some number of such patients, diagnosed as PVS in accordance with protocols published by the American Academy of Neurology, experience relatively high levels of functioning, some of which might be recovered through appropriate therapies. Some of researchers whose work is discussed in this article have written to The Times to dispute any such implication. (I'll provide a link when and if The Times publishes their letter.) They want to clarify that PVS is and continues to be a valid diagnosis from which there is no return to sentience.

Medicare reform.

Saul Friedman argues in today's Newsday ("GRAY MATTERS: Ideology and Meanness in Medicare Debate") that "as it now stands, any legislation that is likely to emerge based on the bills passed in June by the House and Senate would be hopelessly inadequate, too costly and too complicated for most Medicare beneficiaries. I doubt that the members of Congress who are writing it could explain it to their aging parents. More important, the legislation is a kind of pact with the devil, for the price of a paltry drug benefit is the eventual privatization and death of Medicare. In addition, the legislation would not only encourage private insurance companies to sell prescription drug coverage, the House version would help beneficiaries pay the premiums to lure them to sign up for a better deal with private insurance and desert Medicare. The intended result is the demise of Medicare, which leaves health care for the nation's elderly in the hands of dozens of private insurance and drug companies." Friedman continues:

While Medicare's opponents may take cover in ideology in the debate over these larger issues, ideology can't explain the myriad outrages buried in the 800 pages of the legislation that would cost the taxpayers unnecessary billions and pick the pockets of the sickest and oldest among us.

One extraordinary example is a provision prohibiting the government from saving money by using its buying power to negotiate volume discounts with drug companies to get the best prices on drugs for beneficiaries. Indeed, the legislation would exempt drug companies from the cost controls that govern every other Medicare provider - doctors, hospitals and laboratories.

There's more to read -- and to fume over -- in Friedman's excellent review of all that's wrong with what's going on in the Conference Committee that is trying to harmonize the House and Senate bills. I agree with Friedman: If the price tag for a prescription drug benefit we can't afford includes the ruination of the Medicare program, let's hope the conferees come up empty-handed.

When an untested drug is a patient's last chance.

An article in the Boston Globe this week explored the problems faced vby patients with terminal illnesses who have run out of drugs to help them fight their disease. In the view of some, "the current ways to get experimental drugs -- through clinical trials, 'compassionate-use' or 'expanded-access' programs -- are tragically inadequate." In response, some patients' groups are suing the FDA "to create a new level of review called Tier 1 Initial Approval. Under this plan, patients would be able to get an experimental drug if it has passed Phase I trials, if the patient has been rejected from clinical trials of the drug, and if nothing else has worked. Perhaps most controversially, they also want to allow patients to pay manufacturers for the drugs, an issue that opens a Pandora's box of ethical and liability questions." Opposition to the proposed new classification is mounting. "Nancy Roach, a director of the Marti Nelson Cancer Foundation based in Vacaville, Calif., . . . opposes the Tier 1 idea, saying, 'It would rip the heart out of clinical research.' . . . At the end of a Phase I (safety trial), a drug may have been tested in only a few dozen people. (It is not until Phase II and Phase III trials that a drug is tested in more people and researchers study dosages and efficacy.) 'You don't give drugs to people unless there's a good reason to, you know how to give them, and the person has some chance of benefiting,' she said." The widely respected physician-ethicist, Marcia Angell is also against the idea: "'New drugs are far more likely to fail than to succeed,' she said, 'so the chances are that a patient will be hurt by a drug rather than helped.' . . . She said she also is appalled that patients might end up paying manufacturers for experimental drugs. Drug companies already 'are profitable beyond any industry,' she said. 'They are protected by the government. They have monopoly rights, patents, tremendous tax breaks.' And the opposition doesn't stop there. Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said it would be "potentially reckless" for manufacturers to release drugs after only Phase I trials because at that point there is "no proof of efficacy at all."

Boston Children's Hospital.

More cases, going back three years, not just one (the main focus of the Mass. Department of Public Health's scathing report last week), are starting to emerge. (See story in today's Pembroke Mariner.)

Children's Hospital in Boston.

With The Boston Globe's archive policy, it's hard to find the links to all of its articles about the investigations into deaths there over the past year. Here's everything I can find (with no guarantees that these links will continue to work forever):
September 18 | September 19 | September 20 | September 22 | September 23

There's a bit of a media frenzy going on, but it's a compelling story with the additional lesson that if it could happen at one of the country's best hospitals, it could happen in yours, too.

214th birthday of the Judiciary Act of 1789.

Please allow a former teacher of Civil Procedure and Federal Courts to note the anniversary of the passage of the Judiciary Act of 1789. Building on the sketchiest of language in Article III of the Constitution (which provides for "one supreme Court, and . . . such inferior Courts as the Congress may from time to time ordain and establish"), the Act gave us the District Court/Court of Appeals/Supreme Court structure we have today, though with very different functions for the lower courts. The Act also filled in the details of diversity jurisdiction; created removal jurisdiction, the predecessor of the All Writs Act, and a rule that compels discovery in actions at law to the same extent as proceedings in chancery; codified the "no adequate remedy at law" rule for equitable actions; created rules of procedure for trials and appeals; defined the (nondiscretionary) appellate jurisdiction (as opposed to the discretionary jurisdiction over writs of review) of the Supreme Court; and created the office the the United States Attorney in each federal judicial district. All of this and more can be tracked from 1787 to 1982 through the "Landmark Judicial Legislation" page of the Federal Judicial Center.

Medical error at a children's hospital

The Boston Globe has printed another good article on the recent deaths at the local children's hospital, this time focusing on the systemic, root causes (still a matter of conjecture) and considering whether there's something in the culture of teaching hospitals -- or at least some of them -- that stands in the way of effective communication, accountability, appropriate decision making, and safe system design. Important questions all.

Proposition 12: the dawning of a new day . . . .

Here's a good one from the unbeatable Ben Sargent . . . http://www.ucomics.com/bensargent/2003/09/16/

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.