HealthLawProf Blog

Medical Ethics Breached on Guantanamo

According to an article in today's New York Times, "The International Committee of the Red Cross has charged in confidential reports to the United States government that the American military has intentional used psychological and sometimes physical coercion 'tantamount to torture' on detainees at Guantanamo Bay, Cuba."  The Red Cross' inspection team "of humanitarian workers, which included experienced medical personnel, also asserted that some doctors and other medical workers at Guantánamo were participating in planning for interrogations, in what the report called 'a flagrant violation of medical ethics.'"  The charges, which are denied by the Administration, include providing interrogators access to medical files as part of the interrogation process.  It is unclear from the article whether the Red Cross also accused the military doctors of consultating with interrogation teams to calibrate the level of pain to be administered to prisoners.

Yet Even More on Raich and the Oral Arguments

Tony Mauro from The Legal Times weighs in on the oral argument yesterday in Raich v. Ashcroft.  In his opinion, the justices were not receptive to the arguments of those supportive of medicinal marijuana statutes.

The article states,

"The Supreme Court on Monday appeared ready to accept Bush administration arguments that California's medical marijuana law interferes too much with federal efforts to combat illicit drugs.

In spite of the conservative majority's interest in strengthening state powers, most justices seemed skeptical of the argument that California could defy the federal Controlled Substances Act by allowing purely in-state, noncommercial distribution of marijuana for medical use. Ten states have followed the lead of California, whose voters in 1996 passed Proposition 215 to allow marijuana use in cases of medical necessity.

"We face a mess," said Justice Stephen Breyer at one point, lamenting the prospect of states and federal governments having to distinguish between marijuana that was grown and used locally for medical purposes from that which crossed state lines and is subject to federal regulation.

Rather than enacting medical marijuana laws state by state, Breyer said, the Food and Drug Administration should be petitioned to reclassify marijuana in a way that would allow doctors to prescribe it.

"That seems to be the obvious way to get this done," Breyer said. "Medicine by regulation is better than medicine by referendum."

For more information and viewpoints, see the scotusblog.

NJ Posts Med Mal Histories of Doctors

Under  a recently enacted New Jersey law, a state government Web site publishes  doctors' malpractice histories.   The Web site was authorized by the New Jersey Health Care Consumer Information Act, N.J.S.A. 45:9-22.21, and includes malpractice payments in the past five years as well as the medical school, licensing history, hospital privilege restrictions, disciplinary actions and other information about the state's more than 32,500 doctors, osteopaths and podiatrists.

Some lawyers report that the increased publicity may be having a chilling effect on settlements. "Doctors do not want to settle at all now that it has to be reported to the databank for any payment whatsoever," says defense lawyer Richard Amdur, who claims that he used to settle about a third of his cases but estimates that he now that number has declined to between 10 to 15 percent.   Other lawyers claim that the publicity makes no difference.  According to one defense attorney, the issue for doctors becomes the potential for an increase in premiums that follow a malpractice payout.


The Web sites missing information on some doctors appears to be a larger problem, however, for those who may choose to use and rely on it.   According to a report in the New Jersey Law Journal, "The effect of the data gap is compounded by the comparison of each doctor's records with those of other doctors in the same specialty. Each doctor's malpractice experience is rated as average, above average or below average, so without complete data, a doctor might be categorized as above average because of missing data on peers."   

It should be interesting to see how this web site eventually works or does not work.  It may provide the consumer (and plaintiff's attorney) with some helpful information but it may also increase the cost of medical malpractice claims if individual doctors prefer to go to trial rather than have a new addition to their medical malpractice history.

More on Raich Oral Arugment

Add to yesterday's early reports on the Supreme Court oral argument in Ashcroft v. Raich these excellent accounts:

• Linda Greenhouse in The New York Times
• PBS' News Hour report

VBAC Under Attack

On another obstetrical front, The New York Times on Monday ran a story about hospitals that have prohibited obstetricians from performing vaginal deliveries for women who have previously had Caesarean sections.  Although the recent shift in attitude is explained early in the article by reference to recent studies that have increased the predicted rate of uterine rupture and catastrophic blood loss from 0.5 percent to 1 percent, "[s]ome doctors and hospitals freely acknowledge that fear of being sued has driven their decisions," in addition to "concern for patients' safety":

Hospitals say they cannot comply with guidelines issued in 1999 by the American College of Obstetricians and Gynecologists, which call for a doctor to be available "immediately" throughout active labor during such a birth, to perform an emergency Caesarean if needed. Previous guidelines had called for them to be "readily" available.

I guess they can call this a liability question if they want, but if the leading accrediting college for OBs has had this as a standard of care for the past 5 years, does "risk management" add anything to the debate (unless ACOG's standard was driven by liability concerns and not by science)?  The article does not tar ACOG with that brush:

Dr. Charles Lockwood, chairman of the department of obstetrics, gynecology and reproductive sciences at Yale and an author of VBAC guidelines issued by the American College of Obstetrics and Gynecology, said alarms began to sound in the late 1990's.

"What precipitated this were reports in the literature and reports that came to the college itself about women who had ruptured their uterus, particularly in rural settings, with no doctor and no anesthesiologist around," Dr. Lockwood said. "Babies died, and women lost the uterus in some cases."

That prompted the obstetrics college to change its formal recommendations for vaginal births after Caesareans in 1999, saying a doctor should be immediately available during labor to perform an emergency Caesarean.

And yet the med-mal demon immediately reappears in the article:

"[The ACOG standard] had a chilling effect," Dr. Lockwood said, particularly on hospitals in rural areas that did not have anesthesiologists available around the clock, and on doctors in solo practices who could not stay with a patient throughout her labor.

"I think the real death knell to VBAC's was the malpractice crisis," Dr. Lockwood said.

Med Mal Saga, Political and Personal, in Post

Saturday's Washington Post ran a long front-page article that detailed a 16-year-old obstetrical med mal case and its relationship to the political battle currently brewing in Maryland over tort reform.

Much is being written -- in journals, accreditation standards, and hospital policies -- about admitting errors and the potential power and pitfalls of apologizing for bad outcomes.  The contradictory strands of this debate are well illustrated by this story, which involves a 42-week gestation-age newborn who became stuck in the birth canal and whose delivery resulted in shoulder dystocia and injury to one eye.  Four paragraphs, in particular, summarize the medico-legal problem from the perspectives of the mother, Donnette Dennis, and her physician, Kevin Kearney:

Kearney visited Dennis the next morning. By then, he had seen the lack of tone in Richard's right arm.

"He just told me what had happened in the delivery room, that he was sorry for what he had done," she said. "He was sorry about what happened to Richard's arm."

Kearney said he left the hospital heartbroken. He doesn't remember apologizing to Dennis but said that if he did, it wasn't to convey that he "goofed." In fact, he felt certain he handled the procedure correctly.

It may be the most vexing aspect of shoulder dystocia, he said. If the baby is born with an injury, there is no way to know whether it occurred during delivery or during the baby's descent. The only certainty, Kearney believes, is that the doctor handling the delivery will be sued.

The defense presented evidence that shoulder dystocia occurs because of naturally occuring pressure within the birth canal before an obstetrician ever touches the infant.  Despite this apparently strong evidence attacking the causation element of the plaintiff's case, a jury found that Dr. Kearney's decision against a C-section fell below the standard of care in such cases.  For advocates of apologies to patients, the description of the trial must be somewhat chilling:

Along with medical testimony, attorneys from Schochor's firm presented two other pivotal pieces of evidence. The first, from Kearney's deposition, suggested that he panicked during the birth. He told attorneys he pulled down hard on Richard's head -- harder than during typical deliveries. The second critical detail: Kearney's apology. Why would he seek forgiveness if he had done nothing wrong?

One of the proposals pending in the Maryland legislature would, in Kearney's view, "make apologies inadmissible in court [and] have kept his words from being twisted."

Catherine Morris has assembled a good on-line bibliography on "Acknowledgement, Apology and Forgiveness."  I particularly recommend Lee Taft's article in The Yale Law Journal, Apology Subverted: The Commodification of Apology, 109 Yale L.J. 1135 (2000) (WestLaw password required).

Oral Argument in Medical Marijuana Case

Early news reports focus on (1) Justice Breyer's comment this morning that patients who want relief from the federal government's stance against the medical use of marijuana should take their pleas to federal drug regulators before coming to the Court, as well as (2) several justices' references to America's large problem with drug addiction.  Souter and Scalia were also described as skeptical of the patients' arguments.

Some of the sources:

• Associated Press (ABC News)
• Reuters
• Bloomberg News
• N.Y. Times

New Article on ADA and Mental Illness

If you find that you have some spare time on your hands (i.e., perhaps the thought of drafting your exam is too much after a lovely Thanksgiving break),  you may want to review  Elizabeth Emen's interesting article, "The Sympathetic Discriminator: Mental Illness and the ADA."  She examines the fact that individuals with mental illness often experience discrimination because others (including fellow co-workers) often feel negative emotions around them.   She contends that an open recognition of that emotional costs will help the courts better understand the tension in the ADA when applied to mentally disabled individuals and promote a less contradictory application of the ADA to those individuals. 

A portion of the abstract follows: 

 
"Discrimination against people with mental illness occurs in part because of how those with mental illness can make other people feel. A psychotic person may make others feel agitated or afraid, for example, or a depressed person may make others feel sad or frustrated. Thus, a central basis for discrimination in this context is what I call hedonic costs. Hedonic costs are affective or emotional costs: an influx of negative emotion or loss of positive emotion. In addition, the phenomenon of emotional contagion, which is one source of hedonic costs, makes discrimination against people with mental illness peculiarly intractable. Emotional contagion is a largely unconscious process by which we absorb the emotions of nearby others. Research on emotional contagion indicates that people with mental illness are likely to prompt others to absorb their negative emotions, and that emotional contagion increases the more we like someone. Contrary to the much-vaunted contact hypothesis that workplace integration increases liking and decreases discriminatory animus, then, integration of people with mental illness may instead give coworkers and employers more reason to want to avoid people with mental illness."

The full article is available on the SSRN website and will be appearing in the Georgetown Law Journal next year.

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Happy National Family History Day!

We hope that you had a terrific Thanksgiving!  If, however, you are feeling guilty about that extra helping of turkey or pumpkin pie, you might want to celebrate next year in the manner of the U.S. Surgeon General. 

The U.S. Surgeon General Richard H. Carmona has launched a national public health campaign, called the U.S. Surgeon General's Family History Initiative to help focus attention on the importance of family health history and to encourage all American families to learn more about their family health history.

The Surgeon General reports on what many health professionals have long known  -- that many common diseases such as heart disease, cancer, and diabetes - and even rare diseases - like hemophilia, cystic fibrosis, and sickle cell anemia, can run in families. He wants Americans to be more aware of the illnesses suffered by their  parents, grandparents, and other blood relatives so that they can help their doctor predict the disorders to which they may be at risk and to take action to keep them  and their family healthy.

To celebrate this new initiative, Surgeon General Carmona declared Thanksgiving 2004 to be the first annual National Family History Day.

So next year you might want to spend time getting to know your family better rather than eating that second helping of stuffing.   Ok, it was only a suggestion . . . .

Complete release at http://www.hhs.gov/familyhistory/

Medical Marijuana Case Argued Today.

Just a reminder that the Supreme Court hears oral argument today in the case of Ashcroft v. Raich, No. 03-1454, the case that challenged John Ashcroft's attempt to nix the California medical marijuana law by playing the pre-emption trump card of the Controlled Substances Act.  Here's a quick catalog of on-line resources:

• California's "medical marijuana law" (Health & Safety Code § 11362.5);
• Controlled Substances Act;
• complaint (PDF);
• 9th Circuit opinion (PDF);
• cert. petition of U.S. (PDF);
• Supreme Court's docket sheet in No. 03-1454; and
• petitioner's and respondent's principal merits briefs and government's reply brief (PDF)

Commentary:

• Today's Washington Post neatly summarizes the case. 
• See also summary posted by Medill School of Journalism, Northwestern Univ.
• Google News search for "medical marijuana" (includes link to PBS' "Religion & Ethics Newsweekly" story (Nov. 19, 2004) and to good overview in the Nov. 29 issue of the Christian Science Monitor)

Stem Cells - Big News!

Big Breakthrough --  A recent news report states that stem cells have helped a formerly paralyzed Korean woman walk again.   From the news:

SEOUL (AFP) - A South Korean woman paralyzed for 20 years is walking again after scientists say they repaired her damaged spine using stem cells derived from umbilical cord blood.

Hwang Mi-Soon, 37, had been bedridden since damaging her back in an accident two decades ago.

There is also another story from Brazil involving the successful use of stem cells to help an individual regain mobility.  With all these stories, the United States might want to expand the use of umbilical cord stem cells and to re-think its position on stem cell research in general.

Last week her eyes glistened with tears as she walked again with the help of a walking frame at a press conference where South Korea (news - web sites) researchers went public for the first time with the results of their stem-cell therapy.

They said it was the world's first published case in which a patient with spinal cord injuries had been successfully treated with stem cells from umbilical cord blood.

Though they cautioned that more research was needed and verification from international experts was required, the South Korean researchers said Hwang's case could signal a leap forward in the treatment of spinal cord injuries.

The use of stem cells from cord blood could also point to a way to side-step the ethical dispute over the controversial use of embryos in embryonic stem-cell research.

Seattle Hospital Apologizes for Lethal Error on Website

The on-line version of Modern Healthcare (subscription required) reports that Seattle's Virginia Mason Medical Center posted on its web page an apology for a preventable medical error that resulted in patient's death.  The hospital's statement, which may be viewed in its entirety here, begins:

Recently a preventable medical error occurred at Virginia Mason that we believe caused the death of one of our patients. We have offered our heartfelt apologies to the family of the patient and are doing everything we can to help them in this time of grief. But perhaps the only way we can make our apology real is to do everything we can to prevent medical errors in our system. Those efforts start with admitting that we make errors -- as in this case, owning up to errors, learning from them and fixing the systems that allow them to happen.

The MH article cites the Associated Press' report that "a technician mistakenly injected a 69-year-old woman with a toxic skin-cleaning antiseptic, rather than a harmless dye, during an operation two weeks ago. [Medical director of quality Robert] Caplan said both fluids were clear. The hospital has replaced the skin cleanser with an antiseptic-infused swab."

Living Wills: Do They Work?

In the March/April 2004 issue of The Hastings Center Report, Carl Schneider and Angela Fagerlin wrote a piece entitled, "Enough: The Failure of the Living Will."  For reasons best known to the Associated Press (slow news day?), Laura Meckler of the AP ran a story on this topic on Thanksgiving Day. 

The criticisms of the living will are straightforward and well-known:

• "[E]nd-of-life medical questions often involve much more complicated medical and moral questions. Many living wills are so vague as to be useless."
• "People change their minds after they write their living wills but don't update them."
• "Many living wills never make it to the bedside, left in a file cabinet or safety deposit box."
• "And family and doctors often do a poor job of deciphering the patient's wishes even when they have the wills in hand."
• "Since 1990, hospitals have been required in most states to offer all patients the chance to fill out a living will. But despite the law and despite several high-profile end-of-life legal disputes, most people still don't have living wills."

On the other hand, "Naomi Naierman, president of the American Hospice Foundation, acknowledged there can be problems with living wills and other end-of-life plans. But doing nothing is far worse, she said.

"'You're only leaving a mess behind if you don't have directives for when you cannot speak on your own behalf,' said Naierman, whose organization promotes living wills. 'It's a terrible burden to leave with the family.'"

The article provides a lengthy vignette that is supposed to illustrate the limitations of living wills:

Jeanne and James Hanchett thought they were prepared. Both physicians, they had filled out living wills saying they did not want extraordinary treatments. Each had given the other legal power to make medical decisions.

While watching his beloved Pittsburgh Steelers play at Three Rivers Stadium, James Hanchett's head fell onto his wife shoulder. Mrs. Hanchett and bystanders tried to revive him. "There was no response at all," she said.

Paramedics arrived about 25 minutes after he suffered the heart attack and put a tube into his lungs to get them moving again. But Mrs. Hanchett, a semiretired pediatrician, knew it was too late.

At the emergency room, she told the doctor to stop resuscitation attempts. He refused, saying, "'If it were my mother or wife, I would want this to continue,'" Mrs. Hanchett recalled.

She said the doctor dismissed her when she told him that her husband had a living will and that she had power of attorney.

"So I turned on my heel and walked out. I didn't want to start screaming and yelling. I had to call our children," she said.

It was 29 hours before she succeeded in persuading doctors to remove the equipment.

"I'm a bit angry, mostly frustrated," she said, a year later. "We had done everything we thought we should do and it was ignored."

What this illustrates, however, is that if you call 911, you can expect the paramedics to do what they are trained and required by law to do: attempt to resuscitate.  Living wills aren't designed to overcome this problem.  That's what nonhospital DNR's are for.

As Schneiderman and Fagerlin suggest, the better answer may be the medical power of attorney.  Personally, I usually recommend both the MPA and the living will, for a variety of reasons.  There is no question that the living will hasn't, and often won't, solve subtle treatment problems.  But is it better than nothing?  I tend to agree with Naomi Naierman.  And in tandem with an MPA, the living will can be better yet.

On a bioethics listserv today, a colleague posted the following message:

>I would welcome the List's comments on the following scenario:
>
>A psychiatric patient is treated and released from a psych unit of a
>hospital. Nothing comes up during this stay that would lead treating
>staff to suspect that the patient has committed a crime or poses a
>danger to others. However, following the patient's discharge, several
>members of the health care staff read in the local paper a police
>profile of a person suspected in an armed robbery. These staff members
>believe the profile (which includes a police sketch) is of the psych
>patient released from the hospital. Aside from the legal issues raised
>by this case (which are governed by state law and HIPAA), the staff
>members want to know whether it is ethically permissible to notify the
>authorities of the identity of the suspect. For example, would it be
>permissible for the staff member to notify the authorities anonymously?
>The staff member is not certain that the psych patient is the suspect,
>though the patient fits the fairly detailed profile to a tee.
>
>Anyone faced this sort of situation before? Thanks in advance for your
>thoughts.

The first three responses, from bioethicists on the listserve with real name-recognition in the field, were that notifying the officials would be (1) permissible, (2) impermissible, and (3) mandatory. 

Now, I don't offer this mini-colloquy as proof of anything, certainly not as proof that the field of bioethics lacks coherence.  But these responses made me take a bit more seriously than I might have an editorial from Michael Cook in The Age (Melbourne), in which he takes on "Julian Savulescu, the Uehiro professor of applied ethics at Oxford, who recently returned home to tell Australian parents that they have a moral obligation to genetically modify their children. An obligation, mind you, not just a nice idea":

Savulescu insists that this isn't Nazi eugenics, because Nazi eugenics was "a state-imposed vision".

He's wrong, of course. Eugenics is eugenics is eugenics. Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating. He simply wants to achieve it through free-market, libertarian eugenics rather than through old-fashioned command economy eugenics. And as everyone in a globalised world realises, the libertarian approach has been far more effective at changing public preferences than Nazism or communism.

Savulescu is becoming a celebrity, but more for his brazen cheek in mentioning the unmentionable and trampling ancient taboos underfoot than for the depth of his arguments. His reasoning can accommodate any behaviour you want, as long as you make a freely chosen rational decision and accept the consequences. Stay tuned for further instalments.

Eugenics means that people are bred like cattle to get the best genetic traits. And this is what Savulescu is advocating.But rather than bat the shuttlecock of human genetic engineering back and forth across an ethical net, I'd simply like to ask what credentials Savulescu possesses to give him such prominence in the Melbourne media. Isn't it a bit unfair to the rest of Australia's fruitcakes to invite him to give public lectures? They have loopy ideas too. Why isn't anyone interviewing them?

The answer, of course, is that Julian Savulescu works at Oxford and is a bioethicist. But do these two qualifications really guarantee his credibility as a minor guru when he pays us a visit?

Only if you still suffer from cultural cringe. Oxford, ancient Oxford, the Oxford of postcards and poetry, radiates 800 years of scholarship. Savulescu, however, works in a new Oxford, a competitive, funding-hungry Oxford. A Japanese benefactor offered the new Oxford a generous endowment to create the Uehiro chair in "applied ethics" - a code word for the philosophy of Peter Singer. Oxford took the Japanese shilling and hired one of Singer's most distinguished disciples, despite the fact that even among bioethicists Singer is regarded as weird and narrow.

So wipe the Oxford glaze off Savulescu's outrageous proposals. Pretend that he teaches at the University of Lincolnshire and Humberside. How sensible do they sound now?

Nor does working as a bioethicist make you a font of wisdom. In fact, it is becoming increasingly clear that calling yourself a bioethicist is not necessarily an advance on qualifications in astrology.

The word "bioethics" was invented by American academics as recently as 1970. The new field metastasised quickly, invading medicine, ecology and sociology as well as traditional philosophy. But unlike sharp-edged disciplines such as physics or mathematics, the goals, methods and boundaries of bioethics are as murky as the bottom of the Yarra.

A couple of weeks ago, for instance, an article in the world's leading medical journal, The Lancet, called bioethics a "bankrupt" discipline. Professor Roger Cooter, of University College London, wrote that "hardly wet behind the ears, bioethics seems destined for a short lifespan". He argues that some US bioethics centres have been funded by pharmaceutical companies; that it has a narrow and old-fashioned notion of ethics; and that bioethicists themselves can't even agree how it started or what it means. And Cooter is by no means alone in his assessment.

Not meaning to offer a comment on Savelscu's work, which I haven't read, I am struck by the responses on the bioethics listserve today.  Evidence of bioethics' incoherence? Evidence of its rich and diverse underpinnings? Or . . . . ?

Med-Mal Reform Developments in 8 States (Redux)

The Nov. 23 Kaiser Daily Health Policy Report reviewed med-mal-related developments in 8 states.  Here are the leads:

• Arkansas: A 2003 state tort reform law (Act 649) has not led to reduced malpractice insurance premiums, according to a report by the Arkansas Insurance Department, the Arkansas Democrat-Gazette reports.
• Florida: Circuit Judge Janet Ferris on Nov. 15 temporarily barred the implementation of Amendment 8, which would allow the revocation of the medical licenses of physicians who lose three malpractice lawsuits, until the last day of the state legislative session, the AP/South Florida Sun-Sentinel reports (Royse, AP/South Florida Sun-Sentinel, 11/16). (Previously noted on this blawg.)
• Maryland: Gov. Robert Ehrlich (R) on Thursday said that he will present a revised malpractice insurance reform bill to Democratic legislative leaders this week that would not rely on the state general fund, the Washington Times reports.
• Georgia: Senate Republicans last week announced that in the 2005 legislative session they will press for an agenda that includes tort reform legislation, the Atlanta Journal-Constitution reports.
• Massachusetts: The state Board of Registration in Medicine last week released a report that found total malpractice jury awards and settlements in the state have fallen 8% over the past three years, from a peak of $129 million in 2001 to $119 million in 2003, the Boston Globe reports (Allen, Boston Globe, 11/16).
• Michigan: American Physicians Assurance, the state's largest medical malpractice insurer, has begun a contest for enrollees of the plan in an effort to reduce the number of malpractice lawsuits filed by patients, the Detroit News reports.
• Ohio: State representatives over the last two weeks have begun considering a measure that would limit noneconomic and punitive damage awards in medical malpractice lawsuits, CongressDaily reports.
• Oregon: The Oregon Medical Association is drafting a package of proposals to lower medical malpractice insurance rates that it plans to submit to the state Legislature, the Associated Press reports.

Interpreters Lower Risk in Hospitals

The Associated Press reports that a program currently underway at Temple University, and nine other universities, aims to increase the number of highly trained interpreters in America’s hospitals.  A recent study found that, although hospitals receiving federal funding are required to provide interpretation services, fewer than ¼ of all hospitals had professional interpreters on staff.

In another small study, interpretation errors occurred on an average of 31 times during each of the 13 recorded doctor visits.  About 22 percent of patients using untrained interpreters, such as family members or friends, had interpretation errors of potentially serious medical consequence, compared with 12 percent for those with a staff interpreter. 

Medical Data Network Would Improve Care, Create Privacy Issues

An interesting New York Times article (free registration required) reports on advances in medical data networks.  The issue was addressed last week by a panel of experts, during a conference hosted by Rockefeller University. 

According to the article, approximately 31 percent of the nation’s annual health care bill is attributable to administrative expenses.  The implementation of a sophisticated data network would reduce both costs and the number of patient deaths caused by medical errors (it is estimated that 45,000 to 98,000 people die each year from medical errors attributed to misunderstood handwritten prescriptions and hospital charts or lost laboratory test results). 

In addition to administrative and patient-safety benefits, a comprehensive database could provide the ability to assemble and distribute up-to-the-minute epidemiological studies.  Of course, a network packed with so much patient information is sure to raise plenty of privacy concerns. The proposed data network is part of a 10-year plan being promoted by the National Institutes of Heath. 

Brain Dead, Medically Dead, Legally Dead, or Really Dead?

That's the title of a talk I frequently give around town.  It's intended to be a humorous reminder that "brain death" isn't some sort of watered-down version of death; it's the real thing.  All 50 states are more or less clear on this, except for New York and New Jersey, where it is possible for families to opt out of the neurological criteria for death and wait for cardiorespiratory death to occur.

It's also apparently not a clear concept in Utah, where physicians last month pronounced death on a 6-year-old cancer patient, Jesse Koochin.  Even though their son's body had begun to decompose, his parents disagreed and obtained a preliminary injunction that required "life support" (a misnomer in these circumstances) to be continued until a court hearing could be held a few weeks later.  The parents and hospital (Primary Children's Medical Center in Salt Lake City) reached an agreement under which the parents were allowed to take him home on a ventilator, where home hospice care would be provided, and the hospital would refrain from filing a death certificate.

Jesse's heart stopped last Friday and resuscitative attempts were unsuccessful.  News articles and broadcasts routinely stated that November 19th is the date Jesse "succumbed" to cancer or is the date he died (see the Salt Lake Tribune article and the KSL-TV news broadcast that evening).

The Tribune article repeats an assertion that appears in a number of news stories about Jesse: "The murky question of what should be done when parents disagree with a doctor's determination of death remains. There are no laws saying doctors have to keep patients they believe   are dead on life support."  The AP story by Debbie Hummel ends on a similar note:

In Utah, there is no case law regarding whether doctors have to keep patients they believe are dead on life support. The law says a person is dead if physicians have determined "irreversible cessation of all functions of the entire brain, including the brain stem."

Statutes provide guidance in cases where a patient has an advance medical directive or family members want to remove their loved one from life support. But they do not state what should happen when a family disagrees with a doctor's determination of death.

This doesn't strike me as an advance-directive problem, because there are simply no treatment options for a patient declared dead according to neurological criteria (unless a state legislatively abandons "brain death" or carves a hole in their statute to provide for conscientious objectors).  In ordinary practice, if a family's disagreement with the diagnosis of death has to do with the competence of the neurologists, the accuracy of their exam, or the criteria they applied, a second opinion would be appropriate.  Beyond that, however, the law is silent because once death occurs, the patient no longer presents a medical case.  Correction: the law isn't entirely silent.  Once death occurs, the state's laws on the handling and disposition of dead bodies, as well as the criminal laws against the abuse of a corpse, apply.  Hospital policies, as well as the word choices and practices of health care providers, should reflect these realities.  And local judges should be reluctant to sow confusion and prolong the suffering of families with decisions that are uninformed about the law.

Bioethics and Public Health

Ronald Bayer and Amy Fairchild, both at Columbia, have published an article in Bioethics: "The Genesis of Public Health Ethics," 2004. 18(6):473-492.  Their abstract has been posted on the SSRN website:

As bioethics emerged in the 1960s and 1970s and began to have enormous impacts on the practice of medicine and research - fuelled, by broad socio-political changes that gave rise to the struggle of women, African Americans, gay men and lesbians, and the antiauthoritarian impulse that characterised the New Left in democratic capitalist societies - little attention was given to the question of the ethics of public health. This was all the more striking since the core values and practices of public health, often entailing the subordination of the individual for the common good, seemed opposed to the ideological impulses of bioethics. Of what relevance is autonomy-focused bioethics for public health, with its mix of justifications including those that are either implicitly or explicitly paternalistic or that seek to impose strictures on individuals and communities in the name of collective welfare? To examine the deep divide between the central commitments of bioethics and the values that animate the practice of public health, we focus on a series of controversies implicating the concepts of privacy, liberty, and paternalism. Recognising the role of moral values in decision-making was a signal contribution of bioethics in its formative period. Over the past three decades a broad array of perspectives emerged under the rubric of bioethics but individualism remains central. As we commence the process of shaping an ethics of public health, it is clear that bioethics is the wrong place to start when thinking about the balances required in defence of the public's health.

Big Pharma and Patents.

As reported in today's Wall Street Journal (subscription required), later this month Pfizer Inc. will face its first courtroom patent challenge against Lipitor, the cholesterol pill that is the biggest-selling drug in the world. Ranbaxy Laboratories Ltd., an Indian generic-drug company seeking to expand in the U.S. market, is trying to crack two patents that Pfizer says protect Lipitor through 2009 and 2011. If Ranbaxy shows that the patent protection shouldn't apply or that its copy of Lipitor doesn't infringe on Pfizer's patents, then it would be allowed to market a cheaper copycat version.

The battle over the Lipitor patents is emblematic of a much larger pattern:

After years of strong profits, generic-drug companies have hit a rough patch this year. Big buyers like wholesalers and national drugstore chains are driving harder bargains. And big pharmaceutical giants have found ways to put pressure on generics with their own generic products.

In the next five years, however, branded drugs with annual sales of $72.9 billion are expected to lose patent protection, according to analyst Gregory Gilbert of Merrill Lynch. Mounting concerns about prescription-drug costs will also fuel use of generics.

Industry critic Marcia Angell has assailed the use of patents by pharmaceutical companies to reap profits that far outstrip any reasonable return on their investment in drugs. An early version of her critique appeared as an editorial in the New England Journal of Medicine ("The Pharmaceutical Industry — To Whom is It Accountable?", NEJM. 2000;342:1902-1904 - requires subscription; letters to the editor are here). She expanded her critique in this year's The Truth About the Drug Companies: How They Deceive Us and What To Do About It; an abridged version appeared this summer as "The Truth About the Drug Companies," New York Review of Books, July 15, 2004.

The industry trade association, PhRMA, hasn't taken all of this lying down.  In anticipation of the publication of Angell's book, it issued a 28-page refutation of her points.