Saturday, February 28, 2004
Bush Ejects Two From Bioethics Council.
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.
Wednesday, February 25, 2004
Mary Ann Glendon on the Federal Marriage Amendment.
- 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.
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.
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.
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
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?
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.
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.
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.
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.
Saturday, February 21, 2004
Anatomy of hope - Jerome Groopman.
Running a hospital by the numbers . . . and quality of care.
Supreme Court to hear 'dirty bomb' suspect's appeal.
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.
Friday, February 20, 2004
San Francisco Judge Rules Gay Marriages Can Continue
Testing Toxics on Humans Is Ethical, Science Panel Says (washingtonpost.com).
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.
[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
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
"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.
- 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
Scalia says "nuts" to recusal for ducks.
Sunday, February 08, 2004
Stark II, Part 2, regs postponed . . . . again.
HHS-CMS RIN: 0938-AK67That 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?
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
NY Times: Whose Problem Is Health Care?
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.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.'''
"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.
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. . . .