Tuesday, March 16, 2004

Jerome Groopman profile in NY Times

Jerome Groopman is a top AIDS cancer researcher and clinician, but more to the point, he's a gifted writer of clinical narratives and other essays for The New Yorker. His first two books provided the inspiration for the short-lived TV series, Gideon's Crossing. His latest book, The Anatomy of Hope, is a good read. And he's profiled in today's NY Times.

Medicare-reform shenanigans.

Good editorial in today's NY Times about both elements of the Bush Administration's fraudulent campaign last fall to sell Congress on the Medicare-reform bill:
An Orwellian taint is emerging in the Bush administration's big victory last year in wringing the Medicare prescription drug subsidy from a balky Congress. The plan is being sold to the public through propagandistic ads disguised as TV news reports, and it turns out the government's top Medicare actuary was muzzled by superiors during the debate about the program's price tag.

Richard Foster, one of the government's foremost Medicare experts, says he was ordered not to provide requested information to Congress last fall when doubts were being raised about the drug benefit's cost. The administration denies this, but a ranking former official has confirmed Mr. Foster's story. As the bill was being considered, Mr. Foster privately cautioned that its cost could amount to as much as $600 billion, while the White House publicly stuck to the Congressional Budget Office figure of $400 billion over 10 years. The administration eventually conceded a cost of $534 billion, but only after the bill was safely signed into law.

With program in hand, the administration then attempted to rally support — and take political credit — with government-produced TV ads masquerading as news reports. Actors were hired by the Department of Health and Human Services to pose as television journalists purveying faux upbeat "news" segments about the expanded Medicare coverage. The hope is that TV stations will air them as their own. In one version, anchors are offered a script in which they promise that "reporter Karen Ryan" — an actress — will explain the details of the new drug plan.

This sleight of hand only deepens doubts about White House credibility on a complex issue. The public deserves straightforward information about the changes in Medicare, and federal agencies should not be engaging in political spin. This is no way to run a democracy nourished by information and taxpayers' money.
Meanwhile, the Washington Post reports that Capitol Hill Dems are asking the Bush administration not to take action against CMS' chief actuary, who broke the story that he was pressured to keep the real cost estimates on the program from legislators. They are also, predictably, seeking an investigation into the whole sorry affair. And the LA Times is reporting that "[o]n Monday, less than a week after it concluded that the administration's Medicare commercials and fliers were technically legal but contained 'notable omissions and errors,' the General Accounting Office said it would conduct another investigation to determine whether the video news releases constituted illegal 'covert propaganda.'"

Monday, March 15, 2004

More on same-sex marriage.

Here's a good letter to the editor printed in the Chicago Tribune last week (thanks to Bill Bridge for passing this along):

    VOICE OF THE PEOPLE (LETTER)
    Dangerous unions

    Jackie Bruns
    Published March 8, 2004

    Clarendon Hills -- Here are reasons why same-sex marriages will ruin society:

    - Heterosexual marriages are valid because they produce children. That's why infertile couples and old people can't legally get married.

    - Obviously gay parents will raise gay children, since straight parents only raise straight children.

    - Straight marriage, such as Britney Spears' 55-hour, just-for-fun marriage, will be less meaningful.

    - Heterosexual marriage has been around a long time and hasn't changed at all; for example, women are still property, blacks still can't marry whites and divorce is still illegal.

    - Gay marriage should be decided by people not the courts, because majority-elected legislatures, and not courts, have historically done a swell job of protecting the rights of the minorities.

    - Gay marriage is not supported by religion. In a theocracy like ours, the values of one religion are imposed on the entire country. That's why we have only one religion in America.

    - Gay marriage will encourage people to be gay, in the same way that hanging around tall people will make you tall.

    - Legalizing gay marriage will open the door to all kinds of crazy behavior. People may even wish to marry their pets, because a dog has legal standing to sign a marriage contract.

    - Children can never succeed without a male and a female role model at home. That's why single parents are forbidden to raise children.

    - Gay marriage will change the foundation of society. Heterosexual marriage has been around for a long time, and we could never adapt to new social norms because we haven't adapted to cars or longer life spans.

    - Civil unions, providing most of the same benefits as marriage with a different name, are preferable, because separate-but-equal institutions are constitutional.

Saturday, March 13, 2004

Body Parts Suit Enters Murky Area of the Law

The LA Times provides some legal and ethical analysis of the class action against UCLA in connection with the criminal charges against the managers of its willed-body program.

White House, GOP forced to take a new look at importing drugs from Canada.

The San Francisco Chronicle provides some detail on the movement within the Administration and GOP leaders on the drug-reimportation issue, which was key to getting a vote on the nomination of Mark McClellan to head CMS.

McClellan Is Approved as CMS head.

Ceci Connolly reports that Senate confirmed FDA head Mark McClellan (son of the Texas State Comptroller Carole Keeton Strayhorn and brother of White House press secretary Scott McClellan) to head up the federal Medicare/Medicaid agency. The quid pro quo for the confirmation was an understanding that HHS/CMS/FDA would work toward a loosening up of current restrictions on the reimportation of prescription drugs from countries like Canada, where many drugs sell for a fraction of the US price.

Inquiry Sought for Charge of Threat Over Medicare Data.

Robert Pear will have an article in Sunday's NY Times on the call of House Democrats for an inquiry in reports that the top actuary at the Centers for Medicare and Medicaid Services was ordered by his boss to withhold cost data on the Medicare reform bill passed last fall. Background on the story is here.

Salt Lake County case raises fundamental questions, ethicists, politicians warn.

The bioethicists are starting to weigh in on the murder prosecution for the woman who refused to consent to a C-section.

"Being Human" - humanities reader from the President's Council on Bioethics

Being Human -- published in December by the President's Council and available for free through their web site (1 copy per order) -- is described in Edward Rothstein's review in today's NY Times as possibly "the most unusual document ever produced by any government panel":
Last month the first cloned human embryo was produced by South Korean scientists who said they would continue their research despite the queasiness of critics.

This month a biologist at Harvard announced that he had developed 17 new lines of human stem cells, using private money to bypass a government moratorium on such research.

And as if in demonstration of the roiling passions stirred up by such probings of nascent human life, a renowned biologist at the University of California at San Francisco, Elizabeth H. Blackburn, was dismissed from the President's Council on Bioethics. She then accused the administration of stacking the council with opponents of this research.

In the face of all this, what purpose can possibly be served by a 628-page publication of the bioethics council, an anthology called "Being Human," with its accounts of Peter Pan's short memory, Richard P. Feynman's approach to problem solving and a baseball batter's lightning-fast analysis of a pitch? Do "Silas Marner" and Walt Whitman and Achilles have anything to do with debates over the harvesting of microscopic human cells or the development of antidepressants?

Yes, as it turns out, they do.
As this excerpt demonstrates, Rothstein sees a direct connection between the Council's collection and the controversy swirling around the dismissal of cell biologist Elizabeth Blackburn (see her piece in an upcoming issue of the New England Journal of Medicine and Chairman Leon Kass' reply to her earlier piece in The Washington Post):
One way of understanding that human and moral significance is to examine the written record of humanity's attempts to understand itself.
. . . Mr. Kass wants [these] concerns at the center, not at the margins. The real problem with human cloning or with drugs that might one day extend life and postpone death, he argues, is that they will change fundamental aspects of being human: the way the course of life unfolds, how sufferings are endured, whether children are eagerly sought, whether humanity retains its special status. That is what this anthology implicitly argues.

The human is the terrain over which the battles are being fought. The political problem with the manufacture of human embryos, however early in their development, is not just that it upsets opponents of abortion. It is that it shifts a barrier that might become porous, weakening the sacral quality of the human. And once that takes place, the slippery slope becomes far more slippery. Where are lines to be drawn? Will human life forms ultimately be harvested for the sake of other humans?

This uneasiness may be more widely felt than it seems; the idea of reproductive human cloning is often shunned the way incest is, as a form of primal violation. Therapeutic cloning — the use of these cells in what might become new tissues or organs — is heralded for social benefits: the goal presumably is to alleviate human suffering. But since the slope always slips, the debate must always take place, balancing competing goods and competing risks.

Mr. Kass would prefer to restrict all human cloning research (though as recent news suggests, that would not be easy). But whatever path is taken, the crucial thing, Mr. Kass keeps insisting, is that those risks be clearly recognized. For some reason, this point is often missed. Ms. Blackburn, for example, may or may not be correct in her accusation that the council does not reflect a "full range" of bioethical opinion. But in a polemical article she just wrote with Janet D. Rowley, a council member (and professor of medicine at the University of Chicago), the focus is on scientific realities and "progressive technologies," as if they were sufficient in themselves. The arguments being rejected are not fully grasped. (The article, "Reason as Our Guide," is at: www.plosbiology.org [PDF; text version].)

The problem is that progressive technologies, Mr. Kass might say, could turn out to be regressive. Eliminate all suffering, postpone or weaken a sense of mortality, ease all trauma, and what is left may be something less than human. Even if the revolutionary implications for health care were beyond all doubt, it wouldn't settle the matter. The altered nature of being human would still have to be understood. Which is precisely why Nabokov, Tolstoy and Frederick Douglass are here called to testify.
The full review is worth reading. The long knives are out for Leon Kass these days, because he wears his agenda on his sleeve and the agenda is skeptical of "scientific progress." He, or the president's people, appear to be manipulating the Council by excluding dissenting views. But Kass has made a significant contribution to the debate by firmly situating the bioethics issues in their humane and humanistic context. Kass takes serious ideas seriously (maybe too seriously -- Rothstein: "The anthology abridges a bit too liberally at times, and too completely ignores the importance of humor, but otherwise it is a compelling portrait of what it means to be human"). His efforts to enrich the bioethics vocabulary by drawing from literature should be applauded.

Friday, March 12, 2004

Rx reform bill: Medicare expert says he was told to withhold true cost info.

As reported in a copyrighted story in The Philadelphia Inquirer today, the Medicare program's top actuary -- traditionally a nonpartisan expert whose numbers are freely accessible by legislators on both sides of the aisle -- claims that he was ordered during last fall's debate not to reveal the true cost estimates for the Bush Administration's Medicare reform bill's prescription drug benefit or he would lose his job. Apart from whether Richard Foster will be a candidate for one of Kennedy Library Foundation's Profiles in Courage awards, this story -- if true -- is yet another example of the extent to which this Adminstration will distort the facts to achieve its political goals. Tom Scully, the head of the Medicare agency at the time, denies that he threatened or squelched Foster, but as the article points out, his boss, DHHS Tommy Thompson all but admitted Scully stepped over the line in Congressional testimony last month:
"I may have been derelict in allowing my administrator, Tom Scully, to have more control over it than I should have," Thompson said. "... And maybe he micromanaged the actuary and the actuary services too much... . I can assure you that from now [on], the remaining days that I am secretary you will have as much access as you want to anybody or anything in the department. All you have to do is call me."
Liz Fowler, Ph.D., chief health counsel for Democrats on the Senate Finance Committee, believes Thompson, saying of Tom Scully: "He's a liar."

It's not as if the politicos in past administrations haven't bent the truth and concealed unpleasant facts when they pitched their legislative packages to the Hill. That's what lobbyists do: they spin. But Congress enjoys certain traditions and relationships with sources of information that have to be counted upon for nonpartisan, factual testimony and reports: the Congressional Budget Office, the Government Accounting Office, the intelligence agencies, and CMS' actuarial office. These are human institutions and they sometimes fall short of the ideal of objective, truth-seeking purveyors of the truth-as-we-know-it. But when their message is deliberately distorted, when inconvenient facts are deep-sixed and more convenient fictions are inserted in their place, Congress has a right to be outraged. So do we all, because representative democracy is threatened by lawless demagoguery. In the case of this story, the result is a Medicare bill that is seriously flawed, bloated, and unaffordable. Other policy failures in other realms are heart-breakingly apparent. Mistakes happen, but it's hard to forgive them when it is so abundantly apparent that this administration disrespects and dishonors both the facts and the process.

NEJM -- Bioethics and the Political Distortion of Biomedical Science.

NEJM e-published early a Perspective piece by Elizabeth Blackburn on the President's Council on Bioethics: Bioethics and the Political Distortion of Biomedical Science. Much of it appears to be a recital of facts and arguments presented in her earlier Washington Post piece. The PDF is apparently available to the public, not just subscribers, for free. Early, wide, and full-text dissemination by the editors of the NEJM suggest the importance they place on this story.

Wife-poisoner hired as medical-ethics lecturer.

The University of Manchester has hired a medical-ethics lecturer who served 7 years for trying to poison his wife (and then tried to cover his tracks by poisoning drinks in a Safeway supermarket). Here's the quote I love (from medical ethics lecturer Piers Benn of Imperial College London) in the Reuters report on this story:
"Normally people who get into moral philosophy do so because they care about making the world a better place or putting things right . . . But I can't see any logical contradiction between being able to think about ethical questions and being able to do rather criminal acts."
I hate to be too hard on the fellow, but is it not a bit odd that a criminal conviction for Medicare fraud would almost certainly get you bounced from the bioethics elite, but not the attempted murder of your spouse?

Maternal-fetal conflict results in murder charge against mother.

Perhaps I should reserve judgment until more facts come to light, but it is certainly a shock to see that a Salt Lake County woman has been charged with murdering her stillborn son because of her refusal to follow her doctor's recommendation and have her twins delivered by C-section. See news story and follow-up (The Salt Lake Tribune -- Charge against W. Jordan mother creates legal challenge). This is a very long way from the D.C. Court of Appeals' approach in In re AC: "What a trial court must do in a case such as this is to determine, if possible, whether the patient is capable of making an informed decision about the course of her medical treatment. If she is, and if she makes such a decision, her wishes will control in virtually all cases. If the court finds that the patient is incapable of making an informed consent (and thus incompetent), then the court must make a substituted judgment. This means that the court must ascertain as best it can what the patient would do if faced with the particular treatment question. Again, in virtually all cases the decision of the patient, albeit discerned through the mechanism of substituted judgment, will control. We do not quite foreclose the possibility that a conflicting state interest may be so compelling that the patient's wishes must yield, but we anticipate that such cases will be extremely rare and truly exceptional. This is not such a case."

Same-sex marriages, redux.

As reported this morning in, inter alia, the San Francisco Chronicle, the California Supreme Court (in response to a request by the state's attorney general) has ordered San Francisco officials to stop issuing marriage licenses to same-sex couples. See Lockyer v. City & County of San Francisco, No. S122923 (Mar. 11, 2004): order to show cause; Lewis v. Alfaro, No. S122865 (Mar. 11, 2004): order to show cause.

And in the Commonwealth of Massachusetts, the legislature voted three times yesterday to support a constitutional amendment to ban same-sex marriage. As reported in the Boston Globe:
The Massachusetts Legislature voted three times yesterday to ban gay marriage and establish civil unions, but maneuvers by both opponents and supporters of gay marriage left it unclear whether the constitutional amendment would ever get to the voters. The House and Senate will resume their Constitutional Convention March 29, and other proposals may be considered then.

Meeting in a Constitutional Convention for the second time in a month, lawmakers spent nearly 10 hours debating the proposed compromise that would overturn the Supreme Judicial Court's landmark ruling establishing the right of gay couples to marry. It would also give same-sex couples rights and benefits under state law that would approximate marriage, though under a different legal designation. But the amendment cleared only three of the four votes it needed for final passage before the session recessed at about 11:40 p.m. While the margins were comfortable on all of the votes taken, many of those supporting the measure were doing so for strategic reasons rather than genuine support, in the hopes of winning a different outcome later.
The Journal of the Senate in Joint Session for Thursday, March 11, records the action.

According to the Globe (and as verified by my reading of the Journal, above), here's the text of the amendment:
It being the public policy of this Commonwealth to protect the unique relationship of marriage, only the union of one man and one woman shall be valid or recognized as a marriage in Massachusetts.

Two persons of the same sex shall have the right to form a civil union if they meet the requirements set forth by law for marriage.

Civil unions for same sex couples are established hereunder and shall provide entirely the same benefits, protections, rights, and responsibilities that are afforded to couples married under Massachusetts law. All laws applicable to marriage shall also apply to civil unions.

This Article is self-executing, but the General Court may enact laws not inconsistent with anything herein contained to carry out the purpose of this Article.
Here are some links to the federal marriage amendment debate and the Massachusetts Supreme Judicial Court's advisory opinion (majority, dissents) and original opinion from last July (majority, dissents).

Thursday, March 11, 2004

Cadaveric donation - ethical issues.

The June 1, 2003, issue of the Journal of Medical Ethics was devoted to the topic of cadaveric organ, tissue, and body donations. Most of the articles are focused on organ donation/transplantation, but there are also a couple of pieces on the market for cadaveric tissue.

Donated cadavers . . . the UCLA saga.

The scandal at UCLA Medical School over the unlawful sale of body parts from willed cadavers raises numerous questions. The NY Times hits a few on Friday with these articles:

  • "In Science’s Name, Lucrative Trade in Body Parts," by John Broder:
    About 10,000 Americans will their bodies to science each year, choosing a path that, in the popular imagination at least, leads to the clinical dignity of the medical school or teaching hospital, where the dead help to unveil the wonders of human anatomy or the mysteries of disease.

    Few donors, it is safe to say, imagine the many other ways corpses give their all for science: mangled in automobile crash tests, blown to bits by land mines or cut up with power saws to be shipped in pieces around the country or even abroad. Few see themselves ending up in a row of trunks, limbless and headless, arrayed on gurneys in the ballroom of a resort hotel for a surgical training seminar.

    Nor do many people suspect that corpses are precious raw material in a little-known profit-making industry, and that they are worth far more cut up than whole.

    A scandal at the cadaver laboratory at the University of California, Los Angeles, has thrown back a heavy curtain that has kept this business largely hidden from public view.

    The university suspended its Willed Body Program this week, and university police arrested the program's director and a man the university accuses of trafficking in as many as 800 cadavers in a six-year body-parts-for-profit scheme.

    The accused middleman, Ernest V. Nelson, who has cut up and carted away hundreds of cadavers from the U.C.L.A. medical school since 1998, said the university had been fully aware of what he was doing. He transferred the human parts, for sizable fees, to as many as 100 research institutions and private companies, including major companies like Johnson & Johnson, his lawyer said.
  • "The Logistics of the Cadaver Supply Business," by Andy Newman: big business, large fees, but where's the informed consent?


  • Meanwhile, the news over at UCLA only gets worse:

  • The director of the university's willed-body program and one other employee were arrested over the weekend in connection with allegedly unlawful sales (Washington Post);


  • The director of the program apparently lied about his degrees in philosophy and music, filed for bankruptcy three times in six years, twice before being hired by UCLA (AP/San Jose Mercury News);


  • A class action suit on behalf of families of donors (CNN) will undoubtedly cost the university, and not just in green-backs, but also prestige, reputation, good-will with the community, and -- fairly or not -- the trust and faith of patients who will wonder whether there's something really rotten at this school, which suffered through a scandal involving the willed-body program ten years ago:
    This is not the first time UCLA's cadaver program has been under investigation.

    Ten years ago, it was accused of mixing medical waste and animal remains with the ashes of human donors -- then disposing of them in a garbage dump, according to the suit.

    In 1994, the school entered into a settlement agreement with the California Department of Health Services to restructure the program.
    (CNN)
  • Wednesday, March 10, 2004

    Texas Company Removes Web List of Malpractice Plaintiffs.

    The obnoxious and seriously misguided web site that alerted docs to the names of med mal plaintiffs has been shuttered, according to an article by Ralph Blumenthal, who broke the story in the NY Times last week. Good riddance of bad garbage.

    Government Accounting Office again proves its worth.

    As reported in an article in Thursday's NY Times by Robert Pear, Congress' watchdog agency, the GAO, reported Wednesday that the Bush Administration's ads last year misrepresented the Medicare prescription drug benefit. Nice to seem some recognition of the intellectually corrupt campaign waged by the Bushites on this issue, though I am not at all persuaded the mendacity was different in degree or kind from previous Administrations, Democrat and Republican alike, on Social Security and Medicare issues.

  • Interesting side note, for what it's worth. The headline on Thursday's Washington Post story by Ceci Connolly will read, "Medicare Marketing Within Legal Bounds, GAO Says." On the Pear article, the Times went with this head: "A Watchdog Sees Flaws in Bush's Ads on Medicare." Both accurate, as far as they go . . .
  • HHS Secretary Tommy Thompson jumped on this story fast, issuing a statement that emphasized the positive in the GAO's report: "We are encouraged that the General Accounting Office (GAO) has affirmed our efforts to educate seniors about the new benefits being offered in Medicare, including help paying for prescription drugs. GAO confirmed that the law mandates us to educate seniors and that our ads are not political. The GAO report makes clear our responsibility to inform seniors. We feel a great responsibility to make sure seniors understand the new benefits and how they might help them."

  • The Biloxi Sun Herald probably got it more right than either the Times or the Post: "GAO says Medicare ads not misleading enough to be pulled."


  • As I've written here on more than one -- hell, more than ten -- occasions, the Medicare reform bill was bloated, deeply flawed, insufficiently protective of seniors' interest, and more expensive than we can afford. It figures that even the GAO sees that we were sold a bill of goods by the Administration on this one.

    Starbucks.

    This has nothing to do with health law, con law, or anything else this blawg cares about, but I was struck by this entry on Gregg Easterbrook's blog (Easterblogg):
    AND THERE'S A LONG SLOW-MOVING LINE IN EVERY ONE OF THEM: Starbucks now has 167 outlets within 20 miles of the White House, 219 stores within 20 miles of the Space Needle in Seattle, and 242 locations within 20 miles of the Empire State Building.

    I'm not sure what this means, but I don't like it.
    Sounds ominous . . . .

    Tuesday, March 09, 2004

    Recess appointments: Is the Pryor appointment constitutional?

    Ted Kennedy has written to the sitting judges on the 11th Circuit and suggested they might consider this question sua sponte, before Judge Pryor sits on a panel that decides a case that is then challenged on the ground that Pryor's appointment was an unlawful exercise of the President's recess appointment power under Article II, section 2, para. 3. Here's some reading you can do on the subject:
  • Sen. Kennedy's letter to the court, with attached staff research memo.
  • The Library of Congress' Congressional Research Service (CRS) memo on all known intrasession recess appointments to Article III courts. It's happened 13 times before, but never during an intrasession recess that was nearly this short (10 days).
  • Lou Fisher's CRS memo from 2001 on recess appointments to Article III courts.
  • DOJ's Office of Legal Counsel has relatively few of its opinions on-line, but one of them -- an opinion written in 1992 -- is on this topic.
  • a 1948 opinion of the Comptroller General -- 28 Comp. Gen. 30 (requires WestLaw password) -- covers some of the same ground.
  • Another OLC opinion -- this one from 1979 -- on intrasession appointments. This one has some additional useful citations:
    The question whether an intrasession recess of the Senate constitutes a recess within the meaning of Article II, Section 2, Clause 3, of the Constitution has a checkered background. Attorney General Knox ruled in 1901 that an adjournment of the Senate during the Christmas holidays, lasting from December 19, 1901, to January 6, 1902, was not a recess during which the President could make recess appointments. 23 Op. Att'y. Gen. 599 (1901). That interpretation was overruled in 1921 by Attorney General Daugherty, who held that the President had the power to make appointments during a recess of the Senate lasting from August 24 to September 21, 1921. 33 Op. Att'y. Gen. 20 (1921). The opinion concluded that there was no valid distinction between a recess and an adjournment . . . . The Attorney General, however, closed with the warning that the term 'recess' had to be given a practical construction. Hence, he suggested that no one 'would for a moment contend that the Senate is not in session' in the event of an adjournment lasting only 2 days, and he did not believe that an adjournment for 5 or even 10 days constituted the recess intended by the Constitution. He admitted that by 'the very nature of things the line of demarcation cannot be accurately drawn.' He believed, nevertheless, that:
    the President is necessarily vested with a large, although not unlimited, discretion to determine when there is a real and genuine recess making it impossible for him to receive the advice and consent of the Senate. Every presumption is to be indulged in favor the validity of whatever action he may take. But there is a point, necessarily hard of definition, where palpable abuse of discretion might subject his appointment to review.
    This opinion was cited and quoted with approval by the Comptroller General in 28 Comp. Gen. 30, 34 (1948), and reaffirmed by Acting Attorney General Walsh in 1960 in connection with an intrasession summer recess lasting from July 3, 1960, to August 15, 1960. 41 Op. Att'y Gen. 463 (1960). Presidents frequently have made recess appointments during intrasession recesses lasting for about a month.
  • There does not appeal to be a hard and fast rule that provides concrete guidance in all this. The older authorities seem to agree that a weekend adjournment of a couple of days is not a "recess" for purposes of II-2-3, and some of the functional factors that might decide the question are far from definitive:
    Is the adjournment of such duration that the members of the Senate owe no duty of attendance? Is its chamber empty? Is the Senate absent so that it can not receive communications from the President or participate as a body in making appointments?
    In this connection I think the President is necessarily vested with a large, although not unlimited, discretion to determine when there is a real and genuine recess making it impossible for him to receive the advice and consent of the Senate. Every presumption is to be indulged in favor of the validity of whatever action he may take. But there is a point, necessarily hard of definition, where palpable abuse of discretion might subject his appointment to review.
    This issue isn't going away of its own accord . . . .

    Sunday, March 07, 2004

    Blackmun redux.

  • NPR has collected all of its reports (by Nina Totenberg) on the release of Harry Blackmun's papers in one place, and packaged them with previous interviews and other materials.
  • PBS' NewsHour ran excerpts from Harold Koh's 38-hour oral-history interviews with Harry Blackmun.
  • Linda Greenhouse's two articles ran in the NY Times ran on Wednesday and Thursday last week.


  • Norval Morris dead at 80.

    Norval Morris, an author whose Brothel Boy stories have played an important part in my Law, Literature and Medicine course for many years, has died at the age of 80. The best obituary on him so far was in The New York Times, but the difficulty of finding a stable link to that article has sent me to The Seattle Times, which ran the Times' obit in full. Morris was an extraordinarily gifted writer whose explorations of criminal responsibility and justice were original and entertaining.

    Saturday, March 06, 2004

    A 'Full Range' of Bioethical Views Just Got Narrower (washingtonpost.com)

    Tomorrow's Outlook section of the Washington Post has the following article by Elizabeth Blackburn, the recently fired member of the President's Council on Bioethics. (The link will only work for 14 days.) Other material on this story can be found here, here, and here.

    Friday, March 05, 2004

    NY Times' second installment on the Blackmun papers.

    Discussed at SCOTUSblog. I will have a complete set of links this weekend.

    Just when you thought you'd heard it all.

    Ralph Blumenthal's article in today's NY Times is certainly making the e-mail rounds today. It's about a website that lists medical malpractice plaintiffs and can be accessed by physicians who might decide they don't want to provide medical care to someone who has sued a doctor or hospital in the past. The website, most of which is off-limits to nonmembers is here. I have to admit, when I read this article and saw the website, I was stunned at the venality of the thing.

    Drug testing in third-world countries.

    In an article in today's NY Times, Gina Kolata explores the ethical issues confronting pharmaceutical manufacturers who test drugs in second- and third-world countries.

    Thursday, March 04, 2004

    Justice Blackmun's papers released.

    Fascinating pieces at SCOTUSblog on the NY Times and NPR stories based on the about-to-be-released papers of Justice Harry Blackmun. Check out:

    Most excellent: U.S. Department of Faith's proposed Federal Marriage Amendment(s)

    This is one great site. Have to see it to believe it.

    More on the Bioethics Council firings.

    Ordinarily Leon Kass could expect to find some support for his actions from the journal Reason (subtitled "Free Minds, Free Markets"), but not when it comes to his op-ed piece in the Washington Post this week: "Leon Kass Learns to Spin". Does the President's Council on Bioethics have a shred of credibility after this sorry affair? I don't think so, and that's a shame.

    Federal Marriage Amendment (FMA): Outlook Cloudy.

    Today's Washington Post has some encouraging tidbits if you share my lack of enthusiasm for the Bush-endorsed FMA. In a story about the politics of gay marriage, Alan Cooperman and Dana Milbank report:
    In Washington, the Senate held a contentious hearing on whether to amend the Constitution to restrict marriage to the union of one man and one woman. Sen. John Cornyn (R-Tex.), who presided over the hearing, argued that defending 'society's bedrock institution' should be 'a bipartisan issue.' But Democrats were having none of it.

    'This is a divisive political exercise in an election year, plain and simple,' said Sen. Russell Feingold (D-Wis.), the ranking minority member of the Judiciary subcommittee on the Constitution.

    In a sign that the constitutional amendment endorsed by President Bush may be running into trouble on Capitol Hill, the Judiciary Committee's chairman, Orrin G. Hatch (R-Utah), is preparing to introduce wording that would leave the definition of marriage up to the states.

    Congressional aides said that Hatch, while vowing to support the version of the amendment favored by Bush, has drafted language to appeal to conservatives concerned that Bush's version would intrude on states' responsibilities.

    Bush last week announced his support for an amendment banning gay marriage, such as the text introduced by Rep. Marilyn Musgrave (R-Colo.) and Sen. Wayne Allard (R-Colo), which would define marriage as the union of man and woman. Hatch's proposal would allow each state legislature to define marriage as it chooses and to decide whether to recognize the standards of marriage allowed in other states.
    If Orrin Hatch thinks the current version of the FMA will be a loser in the Senate, the administration would do well to sit up and listen. But don't expect much action on any version of the FMA until after the election. The real question for members of Congress from both major parties is how to tee up the issue so that they have an issue to run on while avoiding a vote that will commit them to a position before November. After the election, who knows? One thing is for sure: the biggest backer of the FMA in Washington (Bush) won't need the issue for his reelection, no matter what the outcome is in the presidential race.

    Wednesday, March 03, 2004

    Chairman Kass responds to charge that Bioethics Council deck is being stacked.

    Leon Kass wrote a strong denial of the charge in a Washington Post op-ed today: "We Don't Play Politics With Science". Among other things, Dr. Kass spins the personnel shakeup as one that is based on neutral principles, but the spin doctor may have gotten out ahead of the facts on this one. For example, he writes that Bill May wasn't pushed off the Council: he had expressed a desire to leave. But the Baltimore Sun reported today "that it wasn't his choice to leave the council. Although he and the chairman often disagreed, May said, the two had a good relationship." Reading between the lines, it sure sounds like the White House got its panties in a knot and axed two members in order to put some avowedly pro-life members on in their place.

    Tuesday, March 02, 2004

    Rationing in America.

    For those few Americans who still believe that rationing is what the health care systems in Canada and the UK do, but not us, a subscription to the Wall Street Journal would be a real eye-opener. The Journal's been running stories about health-care rationing in the US for the past 6 months and has them collected on the home page of its special health care edition. The titles include:

    • Six Prescriptions to Ease Rationing
    12/22/03

    • Universal Care Has a Big Price: Patients Wait
    11/12/03

    • Longer Dialysis Raises Hopes, but Poses Dilemma
    10/02/03

    • Stark Choices at a Texas Hospital
    09/23/03

    • Lilly Fuels Debate Over Rationing
    09/18/03

    • An Invisible Web of Gatekeepers
    09/16/03

    • Health Care's Big Secret: Rationing Is Here
    09/12/03

    Saturday, February 28, 2004

    Bush Ejects Two From Bioethics Council.

    The President's Council on Bioethics lost two members yesterday and gained three, but in the process it lost *any* credibility it had as a source of public policy formulation. As reported in the Washington Post this morning, Bill May (my colleague here at SMU for the better part of 20 years, before his semi-retirement to Virginia last year) and Elizabeth Blackburn got their walking papers from the White House personnel office yesterday, presumably because of their outspokenness on the issue of stem-cell research, though the Post article mentions "[May's] views on . . . other topics had also run counter to those of conservative council members." You have to wonder whether his public comments lambasting the administration's Medicare prescription drug reform sealed his fate.

    There are still a handful of excellent people on the Council, including Dan Foster from UT-Southwestern Medical Center here in Dallas. Like Bill May, Dan is someone whose learning and judgment I hold in the highest regard. But, frankly, a pink slip from this White House should be regarded as a badge of honor. It's all about politics all the time, isn't it, Karl?

    Thursday, February 26, 2004

    U.S. to launch year-long study of prescription drug imports from Canada.

    Ordinarily this would be good news. The FDA has been implacable in its opposition to such imports, so a study ought to provide a basis for reevaluation of their position, perhaps leading to the development of safety-related guidelines, or with more permissive rules for certain classes of drugs. But the headlines in today's papers tell a slightly different story, because the head of the study is Mark McClellan, the president's nominee to head CMS, current FDA Administrator, and the point man in the administration's very public drive to squelch imports. In the N.Y. Times, both aspects of the story appear in their headline: "U.S. to Study Importing Canada Drugs but Choice of Leader Prompts Criticism". The San Diego Union-Tribune's headline over the A.P. story wasn't nearly as balanced: "Foe of drug imports to lead study of the issue". In a presidential election year, every move by the administration is subject to scrutiny and evaluation for its political content. This decision, however, defies ready explanation. As obviously talented as Mark McClellan is, he is not the right person for this job. Putting him in charge of the study makes it look like this will be a worthless effort to shore up our existing anti-importation policy. And who gets hurt by this policy? In large numbers, retirees whose votes the administration was cultivating with their disastrous Medicare reform law.

    Wednesday, February 25, 2004

    Mary Ann Glendon on the Federal Marriage Amendment.

    In today's Wall Street Journal there's an op-ed piece (requires paid subscription) by Harvard Law professor Mary Ann Glendon in support of the federal marriage amendment. It begins, "President Bush's endorsement of a constitutional amendment to protect the institution of marriage should be welcomed by all Americans who are concerned about equality and preserving democratic decision-making." She argues that same-sex marriage:
    • constitutes "a bid for special preferences of the type our society gives to married couples for the very good reason that most of them are raising or have raised children";
    • will be enormously expensive (in terms of retirement and health benefits);
    • creates "a real problem of distributive justice";
    • will impair the rights of children;
    • means that "[i]n marriage-preparation and sex-education classes, children will have to be taught about homosexual sex";
    • is a threat to religious freedom;
    • and contributes to a "flagrant disregard shown by judges and local officials for the rights of citizens to have a say in setting the conditions under which we live, work and raise our children."
    These are bare conclusions, and she has her reasons for each one. Her reasoning is worth considering, even if you find it unpersuasive.

    Tuesday, February 24, 2004

    McCain threatens to stall CMS head.

    The Hill is reporting that Mark McClellan's nomination, which would move him from his current position as FDA Administrator to head of the Centers for Medicare and Medicaid Services, may be held up by Sen. John McCain unless McClellan starts answering McCain's questions about the FDA's intransigence on the issue of prescription drug imports from Canada. McCain, whose relationship with the Bush administration is strained at best, says he wouldn't necessarily put a hold on the nomination. Part of the problem may be Senatorial pique: McClellan was a no-show on two occasions when invited to the Hill to defend the FDA's anti-importation stance.

    But Robert Pear is reporting in Wednesday's N.Y. Times that Sens. Byron Dorgan (D.-N.D.) and Debbie Stabenow (D.-Mich.) are considering holds of their own until they get some satisfaction from McClellan on the FDA's position.

    Constitutional conundrum.

    President Bush today threw his support behind a constitutional amendment that would make it clear that "marriage" can only be between one man and one woman. Here are his remarks:
    Thank you. Please be seated. Good morning. Eight years ago, Congress passed, and President Clinton signed, the Defense of Marriage Act, which defined marriage for purposes of federal law as the legal union between one man and one woman as husband and wife. The act passed the House of Representatives by a vote of 342-67 and the Senate by a vote of 85-14.

    Those congressional votes, and the passage of similar defense of marriage laws in 38 states, express an overwhelming consensus in our country for protecting the institution of marriage. In recent months, however, some activist judges and local officials have made an aggressive attempt to redefine marriage. In Massachusetts, four judges on the highest court have indicated they will order the issuance of marriage licenses to applicants of the same gender in May of this year.

    In San Francisco, city officials have issued thousands of marriage licenses to people of the same gender, contrary to the California Family Code. That code, which clearly defines marriage as the union of a man and a woman, was approved overwhelmingly by the voters of California. A county in New Mexico has also issued marriage licenses to applicants of the same gender. And unless action is taken, we can expect more arbitrary court decisions, more litigation, more defiance of the law by local officials, all of which adds to uncertainty.

    After more than two centuries of American jurisprudence and millennia of human experience, a few judges and local authorities are presuming to change the most fundamental institution of civilization. Their actions have created confusion on an issue that requires clarity. On a matter of such importance, the voice of the people must be heard.

    Activist courts have left the people with one recourse. If we're to prevent the meaning of marriage from being changed forever, our nation must enact a constitutional amendment to protect marriage in America.

    Decisive and democratic action is needed because attempts to redefine marriage in a single state or city could have serious consequences throughout the country. The Constitution says that full faith and credit shall be given in each state to the public acts and records and judicial proceedings of every other state.

    Those who want to change the meaning of marriage will claim that this provision requires all states and cities to recognize same-sex marriages performed anywhere in America. Congress attempted to address this problem in the Defense of Marriage Act by declaring that no state must accept another state's definition of marriage. My administration will vigorously defend this act of Congress. Yet there is no assurance that the Defense of Marriage Act will not itself be struck down by activist courts.

    In that event, every state would be forced to recognize any relationship that judges in Boston or officials in San Francisco choose to call a marriage. Furthermore, even if the Defense of Marriage Act is upheld, the law does not protect marriage within any state or city.

    For all these reasons, the defense of marriage requires a constitutional amendment. An amendment to the Constitution is never to be undertaken lightly. The amendment process has addressed many serious matters of national concern, and the preservation of marriage rises to this level of national importance. The union of a man and woman is the most enduring human institution, honored and encouraged in all cultures and by every religious faith. Ages of experience have taught humanity that the commitment of a husband and wife to love and to serve one another promotes the welfare of children and the stability of society.

    Marriage cannot be severed from its cultural, religious and natural roots without weakening the good influence of society. Government, by recognizing and protecting marriage, serves the interests of all.

    Today, I call upon the Congress to promptly pass and to send to the states for ratification an amendment to our Constitution defining and protecting marriage as a union of a man and woman as husband and wife.

    The amendment should fully protect marriage, while leaving the state legislatures free to make their own choices in defining legal arrangements other than marriage. America's a free society which limits the role of government in the lives of our citizens. This commitment of freedom, however, does not require the redefinition of one of our most basic social institutions.

    Our government should respect every person and protect the institution of marriage. There is no contradiction between these responsibilities. We should also conduct this difficult debate in a matter worthy of our country, without bitterness or anger. In all that lies ahead, let us match strong convictions with kindness and good will and decency
    First, has the president thrown his support behind the constitutional amendment currently pending before before both houses of Congress (S.J. Res. 26; H.J. Res. 56)? I don't believe so. It provides:
    SJ 26 IS

    108th CONGRESS

    1st Session

    S. J. RES. 26

    Proposing an amendment to the Constitution of the United States relating to marriage .

    IN THE SENATE OF THE UNITED STATES

    November 25, 2003


    Mr. ALLARD (for himself, Mr. BROWNBACK, Mr. SESSIONS, Mr. BUNNING, and Mr. INHOFE) introduced the following joint resolution; which was read twice and referred to the Committee on the Judiciary

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


    JOINT RESOLUTION

    Proposing an amendment to the Constitution of the United States relating to marriage .
    Resolved by the Senate and House of Representatives of the United States of America in Congress assembled (two-thirds of each House concurring therein), That the following article is proposed as an amendment to the Constitution of the United States, which shall be valid to all intents and purposes as part of the Constitution when ratified by the legislatures of three-fourths of the several States within seven years after the date of its submission by the Congress:
    `Article--

    `Marriage in the United States shall consist only of the union of a man and a woman. Neither this Constitution, nor the Constitution of any State, nor State or Federal law, shall be construed to require that marital status or the legal incidents thereof be conferred upon unmarried couples or groups.'.
    As I read it, the amendment would ban same-sex marriage and civil union statutes such as Vermont's, and Bush said the amendment should "leav[e] the state legislatures free to make their own choices in defining legal arrangements other than marriage." But who knows? Maybe the president's call for an amendment will end up prohibiting civil unions, as well, whether he intends that result or not.

    Second, is such an amendment a good thing or a bad thing for federalism? Is this an example of the federal government taking control of a state-law issue and shoving a single, one-size-fits-all answer down the throats of all 50 states? Or is this an example of appropriate federal protection for a social norm that has broad majority support at the state level? On the federalism point, it's been argued that there will be a federal answer sooner or later, either from the Supreme Court (interpreting the due process clause (Vth and XIVth Amendments) or the equal protection clause (XIVth Amendment) or from an amended constitution, so what's really wrong with the president jumping in there with a constitutional amendment before the issue gets to SCOTUS? But that argument gives away too much. Certainly one federalist response to the Massachusetts Supreme Judicial Court and to San Francisco's mayor would be to say that the federal constitution doesn't speak to these issues at all, so it's up to each state to figure out what its marriage rules should be. Another federalist response, if Bush cared at all about state's rights, would be a call for an amendment that put the Defense of Marriage Act (i.e., "no state is required to recognize a same-sex marriage that is legal in another state") into the constitution and leave it at that. But Bush's call is much broader than that.

    Third, wouldn't Bush's amendment be a Romer-like statement of political animus against a group of citizens without parallel in our federal constitution since the repeal of Article I, sec. 2, cl. 3 by the XIVth Amendment? Put otherwise, I never thought I'd live to see a President of the United States propose a constitutional amendment that was so blatantly bigoted and discriminatory.

    Do physicians have a duty to treat during epidemics?

    I recently wrote (in an editorial for the Pediatric Infectious Disease Journal) that they do, but not beyond the point where heroism turns into martyrdom. There's a nice piece on the web site of the American Journal of Bioethics by Samuel Huber and Matthew Wynia that reaches about the same conclusion but develops the historical, social, and ethical themes at greater length than I did in my short piece. Here's the abstract:
    The threat of bioterrorism, the emergence of the SARS epidemic, and a recent focus on professionalism among physicians, present a timely opportunity for a review of, and renewed commitment to, physician obligations to care for patients during epidemics. The professional obligation to care for contagious patients is part of a larger "duty to treat," which historically became accepted when 1) a risk of nosocomial infection was perceived, 2) an organized professional body existed to promote the duty, and 3) the public came to rely on the duty. Physicians' responses to epidemics from the Hippocratic era to the present suggests an evolving acceptance of the professional duty to treat contagious patients, reaching a long-held peak between 1847 and the1950's. There has been some professional retrenchment against this duty to treat in the last 40 years but, we argue, conditions favoring acceptance of the duty are met today. A renewed embrace of physicians' duty to treat patients during epidemics, despite conditions of personal risk, might strengthen medicine's relationship with society, improve society's capacity to prepare for threats such as bioterrorism and new epidemics, and contribute to the development of a more robust and meaningful medical professionalism.
    The full piece is well worth reading . . .

    Monday, February 23, 2004

    Sierra Club files motion with full Court to have Scalia recused from Cheney's case.

    The Sierra Club has taken the unusual, and usually futile, step of filing a motion with the full Court to get Justice Scalia recused from the Cheney case based upon his January duck-hunting trip with the Vice President, according to an Associated Press article filed by Gina Holland. It's unusual because the Supreme Court's Rule 21 -- which Sierra presumably invoked -- governs motions to the Court, while recusal motions are traditionally handled with a motion to the individual justice pursuant to Rule 22. The existence and rationale for this tradition are covered well today in Goldstein Howe's SCOTUSblog, and as recently as January 26th, CNN reported that Chief Justice Rehnquist dismissed senators' calls for recusal as "ill considered": "'It has long been settled that each justice must decide such a question for himself,' he said, although he added that justices often consult among themselves when such issues are raised."

    Sierra Club hires savvy lawyers who know the odds. They have to know that the Court is not going to grant their motion and is likely not even to consider it on its merits. And despite the public comments of Scalia himself (at Amherst College on Feb 10: "It's acceptable practice to socialize with executive branch officials when there are not personal claims against them. That's all I'm going to say for now. Quack, quack."), SC must be thinking that Scalia will surely bow to the rising tide of calls for him to recuse himself (unlikely), and failing that, that the full Court will "consult among themselves" -- including Justice Scalia -- on the subject. (And never let it be said that the Sierra Club's motives are pure. They desperately want Scalia out of the case because they predict his will be a vote against their likely position on the merits, which has less to do with the National Energy Policy Cheney produced than it does the process by which the policy was developed and the authority of the federal district court to compel the Vice President to comply with discovery requests concerning that process.) As much as Scalia would not want to appear to be bowing to public pressure to bow out, he could change his mind for the good of the Court, and no one would think any less of him.

    Concierge medicine now supported by trade association.

    As reported in today's "Daily Dose" from Modern Healthcare,
    A new national organization has been formed to serve as an advocate and information clearinghouse for practitioners of concierge medicine -- a controversial model of patient care that usually requires patients to pay an annual membership fee for such perquisites as customized-care plans and round-the-clock access to doctors. Officials with the not-for-profit American Society of Concierge Physicians said doctors in about two dozen states now offer some form of concierge service but remain a small fraction of all practicing physicians. An ASCP spokeswoman said the group has 26 members, representing "10% to 20%" of doctors involved in concierge services. John Blanchard, president and co-founder of the group and founder of Premier Private Physicians in Detroit, said he expects the number of physicians involved in concierge services to grow dramatically in the next several years because the model "allows (doctors) to practice medicine the way it was intended to be practiced -- with the patient as the focus." The organization has scheduled its first annual conference for May 27 and 28 in Denver, where about 20 practitioners from across the country will discuss ethical, legal, regulatory and social issues surrounding retainer-based practices.
    Membership in the ASCP requires payment of a $500 fee; the application form doesn't say whether this is an annual or one-time fee.

    For the time being, CMS is taking no position as to whether retainers paid to physicians to secure preferential treatment constitute "balance billing" or "private contracts" under Medicare law. A plausible argument could be made either way, but if CMS were to take the position that the retainers were either one, that would be a serious blow to the concierge-medicine movement. "Balance billing" is limited to 109.25% of the Medicare approved amount for covered services; presumably concierge retainers are significantly in excess of that amount. "Private contracting" is permitted under the Medicare law, but it requires that the physician agree not to bill Medicare for any covered services for any Medicare beneficiaries (not just the one with whom the private contracted is entered into) for a period of three years. There are some specialties that can afford to take the hit (i.e., those with relatively few Medicare beneficiaries and those with a high percentage of services that are not covered by Medicare), but many can not. A Feb. 2004 publication (Physician's News Digest) does a nice job of reviewing the developments from the AMA (so far, the practice is deemed to be not inconsistent with their ethics opinions, which are supportive of diversity and innovation in the delivery of physicians' services, as long as certain guidelines (adopted by the Council on Ethical and Judicial Affairs at its June 2003 meeting) are adhered to).

    The most sustained criticism of concierge medicine is from Troy Brennan (faculty member at Harvard's Medical School, School of Public Health, and Law School ("Luxury Primary Care -- Market Innovation or Threat to Access?" N. Eng. J. Med. 2002;346:1165-1168) (requires subscription), who identifies a number of ethical concerns with concierge medicine: (1) transitioning from a standard to a concierge practice may result in the abandonment of existing patients or in a diminished quality of care; (2) concierge medicine undermines the cross-subsidization of care for patients with lousy insurance or no health insurance at all; and (3) by allowing physicians to focus on the needs of a relatively small patient population defined by their ability to pay fairly steep retainers, the practice could exacerbate inequities in access to care that already exist. Of course, the flip side, as Brennan concedes, is that the development of concierge medicine may be the crystallizing event that leads organized medicine to examine more seriously than it has to date the myriad ways in which financial inequities limit access to care and to start addressing them in a concerted fashion.

    Sunday, February 22, 2004

    Appellate advocacy at its finest.

    For all the 1L's in my Constitutional Law class, preparing their briefs for moot court and anticipating the day they will get up and argue their first (moot) case, here's a keeper from Howard Bashman's "How Appealing" blog:
    The perils of an advocate's trying to replicate an allegedly hostile work environment from the lectern at the start of an appellate oral argument: Today in the U.S. Court of Appeals for the Seventh Circuit, a three-judge panel consisting of Circuit Judges Richard D. Cudahy, Richard A. Posner, and Ilana Diamond Rovner [by the way, none of these links appears to be working, but I'm including them from the original post, just in case the problem is only temporary] heard oral argument in the case of Leslie D. McPherson v. City of Waukegan. The attorney for plaintiff-appellant McPherson began his oral argument as follows:
    My name is Jed Stone, and I represent the appellant Leslie McPherson.

    "What color is your bra? Does it match your panties?"
    Immediately thereafter, Judge Rovner interjected:
    Are you speaking to Judge Posner?
    The courtroom erupted in laughter. You can download the audio of the oral argument via this link (right-click to save MPG audio file to your computer's hard drive before playing audio). Thanks so very much to the reader who emailed to bring this oral argument from earlier today to my attention.
    If you listen to the sound clip, check out Mr. Stone's seamless recovery . . .

    Other blawgers.

    Life being nasty, brutish, and - most importantly for present purposes - short, I rarely get to visit the blawgs listed to the left of this post. But a few minutes at Jack Balkin's blawg yielded two nice pieces that relate to what we are doing in Con Law these days. First, a critique (or, a link to a critique) of the Federal Marriage Amendment's sloppy drafting. Second, a quick hit on the questionable and opportunistic originalism of Justice Scalia.

    Saturday, February 21, 2004

    Anatomy of hope - Jerome Groopman.

    I'm working on my own review of Jerome Groopman's new book, The Anatomy of Hope, but meanwhile the N.Y. Times has beaten me to the punch with a review in today's Books section. Groopman, an oncologist at Harvard and the model for ABC's short-lived series, "Gideon's Crossing" (based on his first two books: The Measure of Our Days and Second Opinions), also writes for The New Yorker. His clinical narratives are gems that should be required reading for all medical students and residents. Happily, his New Yorker essays -- which are a nice blend of clinical writing and policy musings -- are collected on his web site.

    Running a hospital by the numbers . . . and quality of care.

    The Sunday N.Y. Times has an article by Andrea Gabor that describes the turnaround at St. Joseph Health Center in suburban St. Louis. The bottom line is looking better (from losses a few years ago to a modest net revenue of $17 million on $1.8 billion in gross revenues), quality measures are up, and nurse turnover is down. And the key appears to be the dreaded "cookie-cutter" management controls so hated by clinicians. The key seems to be to create a systems approach that focuses on quality and safety, even when it increases costs, because the savings to the hospital are even greater, at least when the investment is focused on achievable advances.

    Supreme Court to hear 'dirty bomb' suspect's appeal.

    SCOTUS agreed yesterday to review Jose Padilla's case (see CNN's report). The Court's order contains an expedited briefing schedule, presumably to allow it to be argued the same day as the detention case brought by Yaser Hamdi (U.S. No. 03-6696). Other good reviews of the case and the issues it raises are in today's Boston Globe, N.Y. Times, and Washington Post.

    This brings to three the number of cases on SCOTUS' docket involving the detention of "enemy combatants" in connection with the prosecution of the war in Afghanistan or pursuant to President Bush's Nov. 13, 2001, Military Order. (Read the order at 66 Fed. Reg. 57833 (Nov. 16, 2001); text version loads faster). Here's the dope on all three cases (docket no., caption, link to ruling below, documents in case (where available)):
    • 03-1027 - Rumsfeld v. Padilla [American citizen's challenge to military detention] - 2nd Cir. opinions (majority)(concurring & dissenting)
    • 03-0334 / 03-0343 - Rasul v. Bush / Al Odah v. U.S. [foreign nationals' challenge to Guantanamo Bay detentions] - D.C. Circuit opinion; case documents

    • 03-6696 - Hamdi v. Rumsfeld [military detention in Virginia of presumed American citizen captured in Afghanistan] - 4th Cir. opinion

    States looking into screening Canadian pharm imports.

    As reported in today's N.Y. Times, Minnesota and Wisconsin will soon ask other states to join them in screening Canadian drug imports. The effort is an attempt to counter safety warnings from the FDA, which has been an implacable foe of importing the lower-cost drugs from our neighbors from the north. Just yesterday, the FDA sent a warning letter to yet another pharmacy (this one is in West Virginia) that allegedly helps its customers obtain drugs from Canadian sources. The FDA's web page re: imported foreign prescription drugs is here. It collects all the agency's regulatory policy statements on the issue, consumer alerts, news summaries, etc.

    Friday, February 20, 2004

    San Francisco Judge Rules Gay Marriages Can Continue

    The NY Times will report on Saturday that "[o]pponents of gay marriage suffered another setback here [San Francisco] on Friday when a judge refused to block the issuance of same-sex marriage licenses, saying the opponents had not shown that the weddings were causing immediate harm." Moreover: "Some judicial experts said that the moves in San Francisco and New Mexico indicated the debate over the licenses was becoming more rooted in legal, not political, ground." For more legal analysis, with an emphasis on the con law aspects of the debate, you could do worse than to start with Larry Lessig's blog on this.

    Schiavo update.

    After many months and many posts (see here and here, among many others), the Terri Schiavo case is resurfacing. Here's a good editorial from today's Palm Beach Post.

    Testing Toxics on Humans Is Ethical, Science Panel Says (washingtonpost.com).

    As reported in the Washington Post, a panel of scientists from the National Academy of Sciences issued a report yesterday that says it is ethical to test pesticides and other toxic substances on human subjects to determine whether environmental safety standards can be lowered: "Many scientists and ethicists have argued that such research is never justified, and yesterday's unprecedented verdict by the National Academy of Sciences took environmentalists by surprise."

    The ethical analysis is summarized thusly: "While volunteers would derive no benefit and some might incur transient harm, the panel of experts said this would be outweighed by societal benefits. Besides helping regulators set accurate benchmarks for environmental dangers, such trials might also address, for example, how much insecticide can safely be used to fight a malaria outbreak." As politicized and polarized as the debate has been over this kind of testing, the esteemed co-chair of the panel, Jim Childress of the University of Virginia, observed: "While there was no 'foolproof mechanism' to eliminate all risk of patient harm, [the risk for volunteers would generally be] exceedingly low."

    What's next? --
    Yesterday's decision by a panel of the National Research Council will allow the Environmental Protection Agency to devise a final rule over the next several months, an EPA spokesman said. Both the pesticide industry and environmental groups said they expect the agency will accept the recommendation of the panel, which would also allow the EPA to evaluate human studies of pesticides that had previously been conducted, and give the industry an incentive to conduct new trials.

    The panelists called for a rigorous safety and ethics system to evaluate and approve such trials, much like the system used by the Food and Drug Administration to evaluate drug trials conducted by the pharmaceutical industry.

    The report allowed for the possibility of trials involving children, but panelists said they could not imagine such tests would ever be conducted. But Erik Olson, senior attorney at the Natural Resources Defense Council, an environmental group, said such tests have already been performed: As recently as 2000, he said, a manufacturer petitioned the EPA to consider data from an Italian study of infants that deliberately exposed them to dichlorvos, an insecticide sold under the brand name Vapona."
    The prepublication version of the report can be found on the NAS website. The news release is here.

    Thursday, February 19, 2004

    HHS to AHA: discounting care for the uninsured doesn't violate federal law.

    Today HHS Secretary Tommy Thompson released a letter to the president of the American Hospital Association, Richard Davidson, in which Thompson wrote:
    [H]ospitals can provide discounts to uninsured and underinsured patients who cannot afford their hospital bills and to Medicare beneficiaries who cannot afford their Medicare cost-sharing obligations. Nothing in the Medicare program rules or regulations prohibit such discounts. In addition, the Office of Inspector General informs me that hospitals have the ability to offer discounts to uninsured and underinsured individuals and cost-sharing waivers to financially needy Medicare beneficiaries.
    Thompson went on to write: "To be sure that there will be no further confusion on this matter, at my direction, the Centers for Medicare & Medicaid Services and the Office of Inspector General have prepared summaries of our policy that hospitals can use to assist the uninsured and underinsured." I'm looking for those summaries and will provide a link as soon as they show up on the HHS web site.

    Tuesday, February 17, 2004

    Paul Krugman: The Health of Nations

    Paul Krugman's op-ed piece in today's N.Y. Times is the first in what I can only hope will be many articles on the Bush administration's political vulnerabilities in the health care arena. Don't get me wrong: the mess we are in is not exactly the Bush administration's doing, not all of it anyway. We've been on a collision course with reality since 1965, some would argue since Teddy Roosevelt's Bull Moose plank in favor of a national, single-payer system was rejected at the beginning of the 20th century. But Bush's economic report has nothing useful to say to the 40 million uninsured or to the many millions of others who are periodically uninsured or chronically underinsured. Speaking of the nature of the problem and the vacuousness of the administration's response, Krugman concludes:
    The result is that American health care, which at its best is the best in the world, offers much of the population a worst-of-all-worlds combination of insecurity and high costs. And that combination is getting worse: insurance premiums are rising, and companies are becoming increasingly unwilling to offer insurance to their employees.

    What would an answer to the growing health care crisis look like? It would surely involve extending coverage to those now uninsured. To keep costs down, it would crack down both on drug prices and on administrative costs. And it might well cut private insurance companies out of the loop for some, if not all, coverage.

    But the administration can't offer such an answer, both because of its ideological blinders and because of its special interest ties. The Economic Report of the President has only negative things to say about efforts to hold down drug prices. It talks at length about insurance reform, but it mainly complains that we rely too much on insurance; it says nothing about either expanding coverage or reducing insurance-company overhead. Its main concrete policy suggestion is a plan for tax-deductible health savings accounts, which would be worth little or nothing to a vast majority of the uninsured.

    I'll talk more about alternatives for health care in future columns. But for now, let's just note that this is an issue the public cares about — an issue the administration can't address, but a bold Democrat can.

    Saturday, February 14, 2004

    Placebos - ethical and effective ways of giving them

    Accprding to Medical News Today, Howard Brody is lecturing about ethical and effective ways of giving placebos:
    "This new way of thinking defines the placebo effect as a special kind of mind-body interaction that occurs in a health-care setting," Brody said.

    "Doctors may never prescribe placebos – dummy pills – but can make use of the placebo effect every time they see a patient. Seeing that the 'placebo effect' does not depend on the 'placebo' is key to making use of its healing potential in an ethical way.

    "Features of the healing environment usually include a physician or healer that listens carefully to what you say and gives you a realistic and sound explanation of what is happening to you," he said.

    "People express care and compassion for your fears and suffering, and you leave feeling more in control of your life and your illness."

    In addition, Brody said evidence exists that creating positive feelings in the health care environment goes a long way in treating a patient.

    South Korean cloning breakthrough and the Times.

    It's pretty obvious the New York Times doesn't want to see any angle on the most recent human-cloning story appear first in a rival paper. In the last couple of days there has been a raft of stories occasioned by the story of South Korean scientists who have cloned a human embryo:
    • Denise Grady filed first with a story on early reactions to the Korean story: "Debate Over Cloning in U.S. Remains Intense" (Feb. 12);


    • Samuel Len's story profiled the Korean researchers who broke through: "South Korea, With Renowned Scientists, Revives Debate" (Feb. 13);


    • Laurie Goodstein and Denise Grady did a story on the debate in this country over cloning-for-reproduction vs. cloning-for-therapy: "Split on Clones: Research vs. Reproduction" (Feb. 13);


    • Andrew Pollack has a good story on what remains to be learned before cloning for stem cells will produce therapeutically useful interventions: "Medical and Ethical Issues Cloud Plans to Clone for Therapy" (Feb. 13);


    • Gina Kolata does her usual excellent job in today's N.Y. Times on the cloning story: "Despite Advance in Cloning, Scientists Are Tempering Hope With Reality" (Feb. 15);


    • Nicholas Wade did a story about the double default cause by the Bush administration's current policy against cloning for therapeutic research (the possibility of a science gap as researchers in other countries leap-frog over hog-tied researchers in this country, combined with our inability -- as a non-player -- to participate in the ethics and policy discussion): "Human Cloning Marches On, Without U.S. Help" (Feb. 15); and


    • from Dale Fuchs a story about a stem-cell bank in Spain: "Bank for Human Stem Cells Starts Ethics Debate in Spain" (Feb. 15).

    Wednesday, February 11, 2004

    Interns' diary.

    Two interns at a Harvard-affiliated teaching hospital are publishing a 5-day journal this week in Slate: http://slate.msn.com/id/2094977/entry/2095201/. Ingrid Katz (Amherst '93) and her partner, Alexi Wright, are the authors. They are also occasional bloggers (a link to their blog is over there in the left-hand column of this page).

    Scalia says "nuts" to recusal for ducks.

    Speaking at my alma mater last night, Antonin Scalia provided his most direct answer to date concerning calls for him to recuse himself from a hotly contested APA case involving Dick Cheney, with whom he went duck hunting last month. According to an article in the Boston Globe, Scalia said he saw no conflict of interest. As reported in Slate.com, he added that Cheney hasn't been sued in his personal capacity, only in his official capacity as Veep, and neither the law nor Court tradition prohibits socializing with executive branch officials who are not parties before the Court in their personal capacity.

    Sunday, February 08, 2004

    Stark II, Part 2, regs postponed . . . . again.

    The OMB's OIRA Executive Order Submissions Under Review document has been recently revised to show a new "Received" date of 12/7/2003 for the Stark II rule (Part 2):
    HHS-CMS RIN: 0938-AK67
    Medicare Program; Physicians' Referrals to Health Care Entities
    with which they have Financial Relationships -- Phase II
    STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
    RECEIVED: 12/17/2003 LEGAL DEADLINE: None
    That means the rule probably won't be out before March 16. Care to make a little wager that it won't be published before summer?

    NY Times: Whose Problem Is Health Care?

    Nice piece in today's business section of the New York Times by Daniel Gross on the problems of employer-based health care. The story is about a December 2003 report from the Manufacturers Alliance and the National Association of Manufacturers that details the factors that make it difficult for American manufacturers to compete with foreign firms -- not just those in developing countries with low labor costs, but in developed countries as well. One of the culprits that cancels out gains in productivity and cost controls is the structural costs of operating in the US: corporate income taxes, employee benefits, and rule compliance. The article looks particularly at health care costs:
    After corporate income taxes, employee benefits are the second-largest structural cost for American manufacturers, adding 5.8 percent to costs, according to the study. In all major economies, paying for health care means a combination of public and private money. But in the United States, businesses pay a larger chunk than do their European and Asian counterparts.

    "In Canada, for example, a lot of the expenditures for health are funded out of general revenues," said Jeremy Leonard, an economic consultant for the Manufacturers Alliance, and the report's main author.

    In Canada, the private sector spends 2.8 percent of gross domestic product on health care; in the United States, the private-sector figure is 7.7 percent. And American private-sector spending falls disproportionately on big employers like manufacturers. Some 97 percent of members of the National Association of Manufacturers provide health care coverage for employees. In 2002 alone, General Motors, which covers 1.2 million Americans, spent $4.5 billion on health care.
    Best quote, predictably, comes from the eminently quotable Uwe Reinhardt, "an economist at Princeton, has referred to General Motors, Ford and Daimler-Chrysler as 'a social insurance system that sells cars to finance itself.'''

    The debate is between a governmental program for retiree health care (and can employee health care then be far behind?) and the current, privately financed employer-based approach. The article concludes, "Whatever way, we all pay." Increasingly, though, large employers are looking for ways to shift their health-care costs to a larger denominator (say, all taxpayers). The tradeoff in terms of slight increases in corporate taxes will be more that offset by the many-times-larger reduction in health-care costs. It will be interesting to see if and when the captains of industry start throwing themselves behind a national, single-payer system. . . .

    How Appealing's 20 questions site.

    I am continually impressed by Howard Bashman's How Appealing's 20 questions site. Students looking for a diverse collection of opinions by sitting appellate judges on the nature of their work -- and, necessarily, their view of the Constitution, Congress, their relationship with the Supreme Court, etc. -- will have a field day on this site. There doesn't appear to be any ideological bias here - the judges represent all points along the two-party political spectrum (apparently no Greens need apply for judicial appointments in this country), and the questions are probing but respectful. Some of my favorite judges are here (e.g., Tacha, Tjoflat, Posner, Richard Arnold, Reinhardt) with, I hope, many more to come.

    Thursday, February 05, 2004

    Scalia and Cheney: Ex parte, or just a party?

    The NY Times' Michael Janofsky has a good article in Friday's paper on the ethics fallout from the duck-hunting expedition shared by Associate Justice Antonin Scalia and Vice President Dick Cheney, who is a named party in a major administrative procedure case in which SCOTUS granted review just three weeks before. Senator Patrick Leahy (D.-Vt.) had the best line: "Frankly, I'm puzzled by it. I know Justice Scalia well; he's a very intelligent person. He has to know that with similar tactics, in any state in the country, a State Supreme Court justice would have to recuse himself. It's Law School 101."