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.

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).

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)

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 . . . .

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 . . . .

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.

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.