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?
Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Saturday, February 28, 2004
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."
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.
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:
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.
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.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:
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
SJ 26 ISAs 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.
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.'.
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.
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,
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.
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:If you listen to the sound clip, check out Mr. Stone's seamless recovery . . .My name is Jed Stone, and I represent the appellant Leslie McPherson.Immediately thereafter, Judge Rovner interjected:
"What color is your bra? Does it match your panties?"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.
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)):
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? --
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 prepublication version of the report can be found on the NAS website. The news release is here.
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."
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.
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