Placebos - ethical and effective ways of giving them

Accprding to Medical News Today, Howard Brody is lecturing about ethical and effective ways of giving placebos:

"This new way of thinking defines the placebo effect as a special kind of mind-body interaction that occurs in a health-care setting," Brody said.

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

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

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

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

South Korean cloning breakthrough and the Times.

It's pretty obvious the New York Times doesn't want to see any angle on the most recent human-cloning story appear first in a rival paper. In the last couple of days there has been a raft of stories occasioned by the story of South Korean scientists who have cloned a human embryo:

• Denise Grady filed first with a story on early reactions to the Korean story: "Debate Over Cloning in U.S. Remains Intense" (Feb. 12);



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



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



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



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



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



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

Interns' diary.

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

Scalia says "nuts" to recusal for ducks.

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

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

The OMB's OIRA Executive Order Submissions Under Review document has been recently revised to show a new "Received" date of 12/7/2003 for the Stark II rule (Part 2):

HHS-CMS RIN: 0938-AK67
Medicare Program; Physicians' Referrals to Health Care Entities
with which they have Financial Relationships -- Phase II
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED: 12/17/2003 LEGAL DEADLINE: None

That means the rule probably won't be out before March 16. Care to make a little wager that it won't be published before summer?

NY Times: Whose Problem Is Health Care?

Nice piece in today's business section of the New York Times by Daniel Gross on the problems of employer-based health care. The story is about a December 2003 report from the Manufacturers Alliance and the National Association of Manufacturers that details the factors that make it difficult for American manufacturers to compete with foreign firms -- not just those in developing countries with low labor costs, but in developed countries as well. One of the culprits that cancels out gains in productivity and cost controls is the structural costs of operating in the US: corporate income taxes, employee benefits, and rule compliance. The article looks particularly at health care costs:

After corporate income taxes, employee benefits are the second-largest structural cost for American manufacturers, adding 5.8 percent to costs, according to the study. In all major economies, paying for health care means a combination of public and private money. But in the United States, businesses pay a larger chunk than do their European and Asian counterparts.

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

In Canada, the private sector spends 2.8 percent of gross domestic product on health care; in the United States, the private-sector figure is 7.7 percent. And American private-sector spending falls disproportionately on big employers like manufacturers. Some 97 percent of members of the National Association of Manufacturers provide health care coverage for employees. In 2002 alone, General Motors, which covers 1.2 million Americans, spent $4.5 billion on health care.

Best quote, predictably, comes from the eminently quotable Uwe Reinhardt, "an economist at Princeton, has referred to General Motors, Ford and Daimler-Chrysler as 'a social insurance system that sells cars to finance itself.'''

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

How Appealing's 20 questions site.

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

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

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

New poetry column.

Number 30.

Bush reportedly knew of higher Medicare costs

According to a syndicated article from the Washington Post, GW knew the true price-tag on Medicare reform months ago. So all the time I was writing in this blawg that we can't afford the prescription drug benefit (estimated at the time to cost $400 billion over ten years), the president was laughing up his sleeve because the true cost was estimated to be 33% higher than the White House was admitting? Interesting way to do policy.

Boston-area father wins case against fertility clinic.

As reported in the Boston Globe on Sunday: "In one of the first legal cases in Massachusetts involving the largely unregulated field of fertility treatment, a Middlesex County jury awarded more than $100,000 yesterday to a Dennis man who said that a Boston fertility clinic impregnated his estranged wife without his permission and should pay his share of child support for his now 7-year-old daughter."

Medicare prescription benefit to cost 1/3 more than originally estimated.

It seems like a pittance, really, just a little rivulet pouring into the ocean of red ink produced by this administration. For what it's worth, however, the White House finally came clean and admitted that the price tag on the prescription benefit for Medicare enrollees won't cost $400 billion over ten years, as originally claimed by the Congressional Budget Office, but $530-540 billion instead, which is what the President's proposed budget will reflect. (The New York Times article by Robert Pear is here.) This would be tolerable if the benefits flowed to seniors who need them, but for the most part they don't. Time to break open the bubbly, Big Pharm? This might have been a better deal for you than even your lobbiests were willing to claim, or admit publicly.

Report Assails Hospital Lapses

The L.A. Times today reported a chilling tale of a hospital run amok. According tothe story, "Nurses at Martin Luther King Jr./Drew Medical Center were ordered to lie about patients' conditions, failed to give crucial medications prescribed by doctors and left seriously ill patients unattended for hours — including three who died — according to a new report by federal health officials." The story continues: "[T]he report [is] by the U.S. Centers for Medicare and Medicaid Services, which oversees federal healthcare funding. The document has not yet been released publicly but was obtained by The Times." I will provide a link as soon as one becomes available.

Florida appeals court strikes down state antikickback statute.

This won't have much impact on Texas' AKB law, which slavishly adheres to federal standards, including federal safe harbors. But, for what it's worth, a Florida court has struck down that state's AKB law because it is inconsistent with the federal version. Here's today's Modern Healthcare story:

A Florida appeals court has overturned the state's Medicaid Provider Fraud Statute, calling its antikickback provision unconstitutional. In doing so, the 3rd District Florida Court of Appeal affirmed a judge's ruling in 2000 that the antikickback provision conflicted with the federal law. The Florida law has a different definition of illegal remuneration and does not include safe harbors, the court said. Thus, the state law "criminalizes certain activity that is protected under the federal antikickback statute and stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," the court said. As awareness of healthcare fraud has grown and whistleblower lawsuits have proliferated, many states have passed their own versions of federal antifraud law. Edgar Bueno, a former attorney with HHS' inspector general's office and now in private practice in Fort Lauderdale, Fla., said there's no binding requirement on other states' courts to follow the Florida decision. "But it does set nonbinding legal precedent," Bueno said. "I suspect we'll hear of more state challenges."

The opinion, State v. Hardin (No. 03-0521, Jan. 28. 2004), is here.

F.D.A. Begins Push to End Drug Imports.

The N.Y. Times has a good piece on the FDA's renewed efforts to stop imports of lower-priced drugs from Canada. (The link is the the paper itself, which requires a free subscription, and which will die in a day or two; you might be able to update the link using Google News.)

UK has its own Peter Singer.

The Sunday papers are all carrying a story about the comments of a bioethicist, John Harris, who is a member of the British Medical Association, that he doesn't see a moral distinction between aborting a full-term fetus and infanticide. Pro-life groups are up in arms, though their reaction is somewhat curious. They don't see a moral distinction between aborting a 4-cell embryo and infanticide, so you'd think they would embrace Harris' comments. Fact is, Harris' point is that infanticide isn't that big a deal, once you embrace the morality of late-term abortions, so the pro-lifers can be excused their contradictory response.

Tort reform and malpractice premiums.

From Health Affairs, a very respected health policy journal:

Malpractice Insurance Premiums Lower In States With Caps
On Damage Awards, According To Health Affairs Analysis

But Sharp Increases In Premiums May Not Be Explained
By Lack Of Tort Reform In Many States, Article Contends


BETHESDA, MD — Medical malpractice insurance premiums are 17.1 percent lower in states that have capped court awards, although the lack of such tort reform measures in other states does not fully explain recent jumps in what physicians pay to cover the cost of malpractice suits, according to a new analysis published on the Health Affairs Web site, www.healthaffairs.org.

Kenneth E. Thorpe, chairman of the health policy and management department at the Emory University Rollins School of Public Health, examines the effects of recent sharp increases in malpractice premiums in many states and states’ efforts to keep malpractice premiums down. Malpractice premiums increased by 23.2 percent in 2002, although the increases varied by state and specialty.

Awards caps exist in 24 states and are the only malpractice reform efforts that have affected physicians’ premiums, reducing them 17.1 percent. While Thorpe says that such measures extended to other states or nationally through a federal law “would ultimately result in lower premiums,” he questions whether taking that step would accomplish the goals of the liability system.

“At issue is whether we should adopt short-term, stopgap solutions to slow the growth in premiums, or use the recent experience to more fundamentally evaluate and perhaps reform the liability system,” Thorpe says. “The results suggest that capping awards may improve the profitability of malpractice carriers and reduce premiums. Whether this is socially desirable or improves the goals of deterrence and compensation remains an open question.”

Three factors have been the principal drivers of malpractice premiums: growing awards and settlements, increased frequency of lawsuits, and declines in investment income. By 2002 every premium dollar collected resulted in $1.29 in total expenses, awards, and settlements, up from 95 cents of total expenses in 1995, Thorpe writes.

Meanwhile, investment earnings have dropped steadily, from 49 percent of premium income 1995 to 18 percent in 2002. Combined, those trends yielded an industrywide net after-tax loss of 11 percent in 2002.

Also disrupting the market has been the bankruptcy of some malpractice insurance carriers and the decisions of others to stop writing policies in some states or withdraw from the business altogether. Thorpe identifies a correlation between the reduction of competition and higher premiums in some states.

Thorpe questions whether the recent increases in malpractice premiums constitute a crisis or simply standard fluctuations in the insurance markets.

“Rising claims costs may reflect a rise in underlying negligence,” Thorpe says. “If true, the system may be functioning as designed, and the spike in premiums may provide stronger incentives to improve the quality of care provided.

“On the other hand, we may be observing a permanent rise in claims payments and costs unrelated to trends in physician negligence,” he says. “At issue is the extent to which the underlying factors generating higher premiums are following a traditional cyclical insurance pattern, or whether a structural change has occurred in severity and frequency.”

To view the article, click here.

Health law and policy

Interesting book review in tomorrow's JAMA:
The Privatization of Health Care Reform: Legal and Regulatory Perspectives
edited by M. Gregg Bloche, 220 pp, $39.95, ISBN 0-19-510868-X, New York, NY, Oxford University Press, 2003.
JAMA. 2004;291:375.

The reviewer is Ronald Andersen, PhD, UCLA School of Public Health. Apparently no fan of the role of health law (or health lawyers?) on the health care system, Andersen concludes his review:

Bloche concludes, "Scholarship that concedes the health sphere's complexities and seeks remedies that fit this country's legal, political and cultural constraints can contribute to reasoned regulatory governance." Again, he may be right. Still, I am left with the troubling suspicion that by narrowly focusing on health law's role in reform of the medical marketplace the book may be seeking to make the proverbial "silk purse out of a sow's ear."

The book itself sounds like it might be a good read:

The failure of President Clinton's health reform plan in 1994 was followed by multiple efforts at market-driven reform in the US health services system. This book is about those efforts. . . .

The authors start from the premise that systematic, state-sponsored overhaul of the US system is unlikely in the foreseeable future. . . .

Much of the market-driven reform over the past 10 years has been the efforts of managed care plans to control costs through preauthorization review of proposed treatments, selective affiliation with frugal providers, bargaining for discounted payment rates, and financial incentives to physicians to limit spending. Challenges to these managed care cost control efforts by consumers and providers and the law's treatment of these challenges is the main focus of the book. The authors provide some in-depth understanding of some of the managed care revolution's failings and the law's relationship to these failings. Some of the authors consider law as a cause of market failure while others examine the law's potential and limitations to correct market failure.

The legal/regulatory areas that are the book's main focus include "the power of the state vs the federal government in making rules for the medical marketplace; conflicts between insurers and patients and providers regarding what constitutes medical need; how financial rewards to physicians for frugal practice influence their medical decisions; the role of antitrust law in the organization of health care provision and financing; privatization as a solution to bureaucratic and legal rigidities in public hospitals; and the case against tax and regulatory preferences for the nonprofit form over investor ownership in the hospital and health insurance sectors."

Andersen's main beef seems to be his disagreement over the book's focus on private market-driven reforms to the exclusion of top-down reforms: "Nonetheless, I believe that failure of the market-driven mechanisms to provide universal access to care, control costs, or 'empower the consumer' suggests that attention in the book to other approaches to system reform might still have been warranted." But that, as the saying goes, would have been a different book.

Congressional Budget Office doubts economic impact of tort reform on health costs.

As we've, ahem, been saying here all along, tort reform is not the way to get a handle on rising health care costs. Now the bipartisan Congressional Budget Office is saying it, in a report ("Limiting Tort Liability for Medical Malpractice," Jan. 8, 2004) that offers the following key observation:

Evidence from the states indicates that premiums for malpractice insurance are lower when tort liability is restricted than they would be otherwise. But even large savings in premiums can have only a small direct impact on health care spending—private or governmental—because malpractice costs account for less than 2 percent of that spending. Advocates or opponents cite other possible effects of limiting tort liability, such as reducing the extent
to which physicians practice “defensive medicine” by conducting excessive procedures; preventing widespread problems of access to health care; or conversely, increasing medical injuries. However, evidence for those other effects is weak or inconclusive.

The point about the lack of a correlation between tort reform and reduced pressure to practice defensive medicine deserves an additional comment, which appears later in the brief:

Proponents of limiting malpractice liability have argued that much greater savings in health care costs would be possible through reductions in the practice of defensive medicine. However, some so-called defensive medicine may be motivated less by liability concerns than by the income it generates for physicians or by the positive (albeit small) benefits to patients.

The report comes too late to save Texan from Proposition 12, which voters approved last fall, but at least we now have CBO support for the idea that the legislature sold them a pig in a poke.

Institute of Medicine report: US should aim for universal coverage by 2010.

The IOM has added its voice to the steadily rising chorus calling for aggressive steps to cover all Americans (including the 43 million currently uninsured) by 2010. Its report, "Insuring America's Health," can be found on-line, as can summaries of its major findings and statistics. Fact Sheet 4 is an eye-opener: Your chances of being uninsured are higher in Texas than in any other state in the Union (28.4%). As for the impact of this initiative on public budgets, universal coverage would probably save money in the long run. Besides, considering the impact on the health, the lives, and the future of children (who account for half the uninsured), it's the right thing to do!

Emily Dickinson.

Margo Jefferson has a nice end-piece in today's NY Times Book Review ("I Don't Know How She Does It") about Emily Dickinson and the various men who are mostly on display in a recent PBS documentary on the Belle of Amherst. She might as well have named the essay "I Don't Know Why Men Don't Get It." The director/writer Jim Wolpaw takes a couple of direct hits, and Billy Collins gets swiped, too, for his poem, "Taking Off Emily Dickinson's Clothes," which Ms. Jefferson describes as "smarmy." Maybe I like Billy Collins' stuff too much, or perhaps Margo Jefferson likes it too little, but I think his agenda is actually the same as hers: Get past the "blessed virgin" image of the Belle and try to understand that she was a flesh-and-blood creature who did not shrink from the world in all its power and fury and unknowable bleakness and stark beauty. Or something like that.

The Constitution and the war on terrorism (II).

The last time Tony Lewis wrote an op ed for his old employer, The New York Times, before today (see below) it appeared in the paper on February 24, 2003, the 200th anniversary of the Supreme Court's opinion in Marbury v. Madison (click here for full opinion). For purposes of my con law class, at least, it does a very nice job of tying together Marbury (which we will begin discussing on Jan. 21) and the Quirin and Johnson cases (yesterday's class). For a critical view of Lewis' op ed article by a former Supreme Court law clerk (who mysteriously remains nameless), click here (Howard Bashman's "How Appealing" blawg).

The Constitution and the war on terrorism (I).

Anthony Lewis's op ed in today's N.Y. Times is (i) a wonderful reminder of how valuable Lewis' voice has been (and occasionally continues to be) in the national debate over the role of the Constitution in our public and private lives and (ii) a very nice summary of the Supreme Court's terrorism cases. For my con law class, it should help put the Appendix C cases of Ex parte Quirin and Johnson v. Eisentrager in perspective. The University of Chicago Law School has put together a fine web page in connection with a January 17 (2002?) panel discussion there on military tribunals.

Unanimous Supreme Court victory for the children of Texas.

I can't remember the last time the Supreme Court justices all agreed in an Eleventh Amendment case, but it happened yesterday in Frew v. Hawkins (U.S., No. 02-628, Jan. 14, 2004). Bottom line: Texas officials must abide by a consent decree to which they consented in 1996 to increase spending on the Medicaid program's Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program. Legally, the case involves an interesting question whether federal courts can compel a state to adhere to the terms of such a consent decree consistent with the Eleventh Amendment, which in a number of analgous situations has been held to shield states from federal court actions for money damages. I say it's "interesting" because -- despite the Court's unanimous opinion -- it's an arguable point. In this case, the trial judge rejected Texas' Eleventh Amendment argument. On appeal, however, the conservative Fifth Circuit Court of Appeals bought the state's argument. But politically and morally, it's hard to see how Texas' position was anything but crass, cold-hearted, underhanded, and punitive. Here's the syllabus of the Court's opinion:

As a participant in the Medicaid program, Texas must meet certain federal requirements, including that it have an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program for children. The petitioners, mothers of children eligible for EPSDT services in Texas, sought injunctive relief against state agencies and various state officials, claiming that the Texas program did not meet federal requirements. The claims against the state agencies were dismissed on Eleventh Amendment grounds, but the state officials remained in the suit and entered into a consent decree approved by the Federal District Court. In contrast with the federal statute’s brief and general mandate, the decree required state officials to implement many specific proposals. Two years later, when the petitioners filed an enforcement action, the District Court rejected the state officials’ argument that the Eleventh Amendment rendered the decree unenforce-able, found violations of the decree, and directed the parties to submit proposals outlining possible remedies. On interlocutory appeal, the Fifth Circuit reversed, holding that the Eleventh Amend-ment prevented enforcement of the decree because the violations of the decree did not also constitute violations of the Medicaid Act. Held: Enforcement of the consent decree does not violate the Eleventh Amendment.

(a) This case involves the intersection of two areas of federal law: the Eleventh Amendment and the rules governing consent de-crees. The state officials argue that a federal court should not enforce a consent decree arising under Ex parte Young, 209 U. S. 123, unless it first identifies, at the enforcement stage, a violation of federal law such as the EPSDT statute itself. This Court disagrees. The decree here is a federal court order that springs from a federal dispute and furthers the objectives of federal law. Firefighters v. Cleveland, 478 U. S. 501, 525. The petitioners’ enforcement motion sought a remedy consistent with Ex parte Young and Firefighters and accepted by the state officials when they asked the court to approve the consent decree. Pennhurst State School and Hospital v. Halderman, 465 U. S. 89, in which this Court found Ex parte Young’s rationale inapplicable to suits brought against state officials alleging state-law violations, is distinguishable from this case, which involves a federal decree entered to implement a federal statute. Enforcing the decree vindicates an agreement that the state of-ficials reached to comply with federal law. Federal courts are not reduced to approving consent decrees and hoping for compliance. Once entered, that decree may be enforced. See Hutto v. Finney, 437 U. S. 678.

(b) The state officials and amici state attorneys general express le-gitimate concerns that enforcement of consent decrees can undermine sovereign interests and accountability of state governments. How-ever, when a consent decree is entered under Ex parte Young, the response to their concerns has its source not in the Eleventh Amend-ment but in the court’s equitable powers and in the direction given by Federal Rule of Civil Procedure 60(b)(5), which encompasses an equity court’s traditional power to modify its decree in light of changed circumstances. See, e.g., Rufo v. Inmates of Suffolk County Jail, 502 U. S. 367. If a detailed order is required to ensure compliance with a decree for prospective relief that in effect mandates the State to ad-minister a significant federal program, federalism principles require that state officials with front-line responsibility for the program be given latitude and substantial discretion. The federal court must en-sure that when the decree’s objects have been attained, responsibility for discharging the State’s obligations is returned promptly to the State and its officials. The basic obligations of federal law may re-main the same, but the precise manner of their discharge may not. If the State establishes reason to modify the decree, the court should make the necessary changes; otherwise, the decree should be en-forced according to its terms. 300 F. 3d 530, reversed.

This litigation started in 1993, based upon the plaintiffs' claim that Texas has dealt children in desperately poor families a really lousy hand, in violation of their federal-law obligations. If the plaintiffs were right (and I suppose we won't know, technically, since there was no trial and therefore no findings of fact on the underlying claims), it's been over a decade now that these kids have been denied services required by federal law. Perhaps this disgraceful record on children's health is about to come to an end.

Ambiguous Gifts: When Patients Give and Doctors Take

Good article by Denise Grady on VIP patients, gifts from patients, George Harrison's signed guitar, and the morally ambiguous topic of physicians and hospitals who profit from their association with the rich and famous.

Seniority: Two Holes in the Medicare Drug Law/

Finally, somebody is asking the questions that need to be asked about the Medicare reform law signed by
Dubyah last month. In an article in today's NY Times, Fred Brock asks:

What impact will it have on pharmaceutical companies' programs that offer free drugs to low-income people, including those on Medicare? Why does the law prohibit beneficiaries from buying private insurance to cover the considerable gaps in coverage?

As for the first question:

The drug companies themselves are struggling with the first question, as is their trade group in Washington, the Pharmaceutical Research and Manufacturers of America. But one thing is clear: if the companies do not change their requirements by 2006, thousands of older low-income Americans will lose access to free or nearly free drugs. That's because participants in the programs generally must not have any drug coverage or access to it. Of course, they will have access to drug coverage in 2006 - although with coverage gaps that could cost thousands of dollars a year.

The free-drug programs are crucial for many recipients. The income limits are not that strict: in some cases, people earning up to $50,000 a year can qualify. The drugs are commonly dispensed through doctors or via discount cards; patients usually have to requalify regularly and apply separately to each company that makes the drugs they need.

I am particularly interested in that second question:

The prohibition against buying private insurance, meanwhile, will hit middle-income people the hardest. "Many people will be forced to put out their own money, even if they want to buy insurance," Mr. Hayes [president of the nonprofit Medicare Rights Group] said.

A report accompanying the final Medicare bill when it was passed last year said the insurance prohibition was to keep beneficiaries from becoming "insensitive to costs." Well, if your mother needs a prescription, her "sensitivity" is not going to lessen her need, but the cost may lessen her ability to buy it. And why shouldn't she be allowed to buy private insurance to help if she wants to? By that logic, should we prohibit auto insurance to make people sensitive to high repair costs?

Some administration and Congressional officials argue that older Americans would consume less health care if they had to pay more for it, so the government would save money. Maybe, but what are the health consequences?

Deane Beebe, a spokeswoman for the Medicare Rights Center, said: "The whole concept is based on the idea that people will use too much medication if they have coverage. We're really troubled by that."

Mr. Hayes added, "There is something very unrealistic about politicians who think that people will rush off to take prescription medication they don't need."

Hayes believes that the prohibition might be eliminated before 2006, partly because of pressure from insurance companies that want to sell the coverage. "A lot of people who voted for this bill," he said, "had no clue about this provision."

Dallas Morning News: public health comes first.

Thank God the Dallas Morning News has weighed in on the public-health issues facing Dallas County with an editorial that urges the County Commissioners to split the health department from the county's Department of Health and Human Services. The mid-90's merger of public health and welfare functions, says the editorial, was "to cut overhead costs. The budget concerns back then may have been justified. But they have been overtaken by today's more pressing challenges. For one, the county has had to step up its bioterrorism preparedness in this post-9-11 world. And that duty is certain to grow." More importantly:

many physicians have become concerned about the combined department's apparently poor record of controlling diseases. The Dallas County Medical Society cites the county's alarming rates of sexually transmitted diseases, its high incidence of tuberculosis and its low rate of childhood immunizations. A re-energized Health Department would be better able to identify public health problems early on and map out strategies for solving them.

The medical society -- under the leadership (on this issue, as on so many more) of past president Robert Haley -- also deserves our thanks for jaw-boning the county (and the editorial board of the Dallas Morning News, apparently) for adequate public health resources and controls.

2002 shows higher rate of health-care inflation than 2001.

Is anyone in the health care industry really surprised to learn that, "[f]ueled by rising hospital costs and health insurance premiums, U.S. employers, consumers and the government spent 9.3% more on health care in 2002 than they did in 2001"? (USA Today) Not surprised, perhaps, but that doesn't mean everyone took the news in stride. Forbes, for one, opined that "Health Care Costs Rise Beyond Belief":

U.S. health care costs are rising so fast that not only do they outstrip the prior year, they even exceed forecasters' ability to project them.

In mid-2002, the U.S. Department of Health and Human Services projected that national health expenditures would reach $2.8 trillion in 2011--an estimate based on a mean annual growth rate of 7.3%. Since then, the growth rate has increased significantly to 9.3%--to the point where health spending is already at nearly 15% of GDP, according to Centers for Medicare & Medicaid Services (CMS), a unit of HHS.

This increase--and future projections--don't take into account the potential effects of the prescription drug entitlement in the Medicaid bill passed by Congress last year.

The full report from CMS is available in Health Affairs (for a hefty fee; unhelpful article abstract is here); some of the details are on the CMS website here.

Clark: No pro-life appointments to the federal bench if he's elected.

According to a story in today's Manchester Union Leader Gen. Wesley Clark "said yesterday he would never appoint a pro-life judge to the federal bench because the judge’s anti-abortion views would render him unable to follow the established judicial precedent of the 1973 Roe v. Wade decision." I am pro-choice, but I wonder how wise it is to establish an abortion-rights litmus test, any more than a pro-life litmus test should be used by Republican presidents. First, we're not talking about Supreme Court appointments only: Clark's announcement included all federal courts. This ignores the fact that we expect lower-court judges to follow Supreme Court precedent, and their freedom to "vote their conscience" is correspondingly constrained. (This is why I was comfortable supporting the nomination of Mike McConnell, a vociferous critic of Roe, to the US Court of Appeals for the Tenth Circuit.) Second, what's sauce for the goose is sauce for the gander. A single issue litmus test on abortion is decried by liberals when the Republicans invoke it to eliminate pro-choice judicial candidates. Unless that's all bluff and bluster, we should be willing to stand behind that position when it cuts the other way. That, or just shut up when the Republicans exercise their constitutional right to stack the judicial deck against abortion rights.

For-profit Medicare HMOs match, exceed nonprofits' care.

As reported lots of places, including the Boston Herald, a report in today's New England Journal of Medicine (abstract only; full text requires expensive subscription): "The rates of carotid endarterectomy, cardiac catheterization, coronary-artery bypass grafting, and percutaneous transluminal coronary angioplasty were higher in for-profit health plans than they were in not-for-profit health plans; the rates of use of other common costly operative procedures were similar in the two types of plan. After adjustment for enrollee case mix and other characteristics of the plans, the for-profit plans had significantly higher rates than the not-for-profit plans for 2 of the 12 procedures we studied and had lower rates for none." This is definitely one of those glass-half-full or half-empty stories. The Herald story included some follow-up with the authors:

The results were unexpected, but not surprising, said Dr. Eric C. Schneider, a Harvard School of Public Health assistant professor.

"It's very difficult among health plans in general to change the decision-making of physicians and patients,'' he said. "And with liability concerns, health plans may feel that it would be too risky to deny a procedure.'' . . .

In some cases, nonprofits provided fewer procedures, but it's not clear why, Schneider said. It's possible that nonprofit administrators have a better sense of how to care for problems without relying on surgery.

The study clearly shows that "fears about for-profits skimping on high-cost procedures might be unfounded,'' Schneider said. But it doesn't show whether they provide the same level of care when it comes to preventive and other services.

I.M.F. Report Says U.S. Deficits Threaten World Economy

Two cheery reports from the NY Times and Washington Post today raise the question whether the US can continue in its fiscally and environmentally profligate ways.

First, an International Monetary Fund report concluded that the United States is running up a foreign debt of such record-breaking proportions that it threatens the financial stability of the global economy, warning that large budget deficits posed "significant risks" not just for the United States but for the rest of the world. Times article. IMF Occasional Paper 227: "U.S. Fiscal Policies and Priorities for Long-Run Sustainability." A small but important part of the planned deficit, of course, is the recently enacted Medicare prescription drug benefit that we cannot afford.

Second, the Post reports that researchers have published a study (abstract) in the science journal, Nature that concludes that "[m]any plant and animal species are unlikely to survive climate change. New analyses suggest that 15-37% of a sample of 1,103 land plants and animals would eventually become extinct as a result of climate changes expected by 2050." They continue:

For some of these species there will no longer be anywhere suitable to live. Others will be unable to reach places where the climate is suitable. A rapid shift to technologies that do not produce greenhouse gases, combined with carbon sequestration, could save 15-20% of species from extinction. The cover shows a species in the firing line. Boyd's forest dragon, Hypsilurus boydii, is found in Queensland, Australia. About 90% of its distribution would become climatically unsuitable by 2050, on maximum climate warming scenarios.

At some point, industrialized societies have to start getting serious about their ethical obligations to the planet's other inhabitants, as well as to the future. My colleague, Jeff Gaba, has amply demonstrated that arguments about "our obligations to future generations" are fraught with ambiguity, hidden assumptions, and various forms of bad logic, but the rhetorical point somehow seems to survive, at least for me: What gives industrialized nations the right to consume not only a disparate share of the world's natural resources to support their economies anlifestyleses, but also up to a third of the world's species (that's 1.25 million species), as well? This is a bioethics question of transcendent importance.

Maine's Prescription Drug Discount Program on Hold -- Again.

Apparently Maine's star-crossed drug discount program, which survived a Supreme Court challenge in 2003, is again on hold as state officials assess the impact of the recently enacted Medicare reform law. You can read about it in the daily Kaiser health policy report.

Ernst & Young faces civil health fraud charges in Philly.

Kaiser's daily web report collects stories today about the civil case filed on Monday against Ernst & Young in connection with advice it allegedly gave to hospitals that in turn overbilled Medicare:

U.S. Attorney's Office in Philadelphia Files Lawsuit Against Ernst & Young for Allegedly Providing Hospitals Advice That Led to Medicare Overpayments
[Jan 06, 2004]
U.S. Attorney Patrick Meehan in Philadelphia on Monday filed a civil complaint against the accounting firm Ernst & Young for allegedly advising hospitals to overcharge Medicare for common blood tests, leading to excess reimbursements of $900,000 between 1991 and 1995, the New York Times reports (Freudenheim, New York Times, 1/6). The lawsuit claims that because of billing advice given by Ernst & Young, nine hospitals in Connecticut, Indiana, Pennsylvania and Virginia submitted more than 200,000 false claims to the government. The suit contends that the nine hospitals' laboratories used equipment that automatically performed a more thorough level of testing than necessary in some cases, which allowed the hospitals to bill for the complete battery of tests, regardless of whether they were requested by physicians, to maximize Medicare reimbursements. According to Ernst & Young attorney Mark Tuohey, the government permitted such billing until 1996, at which time Ernst & Young advised its clients to stop the practice. If found guilty, Ernst & Young could be ordered to pay three times the amount of damages and millions of dollars in fines. Associate U.S. Attorney James Sheehan said some of the hospitals involved in the dispute have already repaid Medicare (Caruso, AP/Long Island Newsday, 1/5).

Fascinating.

Purdue Pharma spanked by judge for Oxycontin patent claim

As reported in USA Today and elsewhere, a federal judge ruled that Purdue Pharma patents protecting its bestselling painkiller Oxycontin are invalid. The court's opinion states that Purdue's patent application was deceptive and that its patents are unenforceable, clearing the way for drug maker Endo Pharmaceuticals Holdings to sell a generic version of the drug. This is the same judge who held in 2000 (require WestLaw subscription) that Purdue had not obtained its patents through inequitable conduct. It will be interesting to see (when yesterday's opinion becomes available) what changed between 2000 and 2004. Meanwhile, there's lots of interesting background in the N.Y. Times' story on this decision.

New Jersey allows stem cell use in research

New Jersey's governor signed a bill (S. 1909 [passed without amendment - now P.L.2003, c.203]) on Sunday that makes the Garden State the second in this country to legalize embryonic stem cell research, while making human reproductive cloning unlawful. (California's the other state: see Health & Safety Code § 125300 (stem cell research) and § 24185 (cloning).) It's a fine line, and one that bedeviled the President's Council on Bioethics in its 2002 report on cloning, but it's an important line for those who believe that stem cells are the most promising source out there of treatments for a wide variety of diseases and conditions, including traumatic spinal cord injuries.

Reimportation of drugs from Canada.

The Kaiser Family Foundation did its usual excellent job in an article today that pulls together reports from disparate sources concerning the FDA's refusal to accept Canadian assurances that reimported drugs are safe:

FDA Pharmacy Affairs Directory Tom McGinnis on Dec. 24, 2003, said that a safe, legal program to reimport lower-cost, U.S.-manufactured prescription drugs from Canada would likely cost hundreds of millions of dollars, the AP/Richmond Times-Dispatch reports. In addition, McGinnis said that the FDA would never rely on Canadian inspections of prescription drugs to determine their safety. McGinnis said that although the FDA inspects pharmaceutical companies worldwide, Health Canada relies on inspections conducted by the home nations of the companies. McGinnis said, "We've never accepted inspection results from another country." He added that a reimportation program is "just not going to work. There would have to be mechanisms set up, and we would have to get permission from the Canadian government to inspect." Health Canada spokesperson Emmanuel Chabot defended the safety of the Canadian inspection system. He said, "We conduct regulatory reviews of drugs to ensure there is sufficient evidence of safety, efficacy and quality before they receive authorization to be sold in Canada." According to the AP/Times-Dispatch, the FDA position on reimportation "sets the tone" for an HHS study on the safety of the practice required under the new Medicare law (Baldor, AP/Richmond Times-Dispatch, 12/25/03). In recent months, a number of state and local governments have asked the federal government to allow them to import prescription drugs from Canada, the Washington Times reports (Fagan, Washington Times, 1/2). More than 12 states -- such as Iowa, Illinois, Minnesota and New Hampshire -- have considered or plan to implement reimportation programs, USA Today reports. Kevin Concannon, director of the Iowa Department of Human Services, said that the statements FDA officials "make about consumer safety or drug safety are the most bogus words I've seen spoken from a government agency. ... There's more protection of pharmaceutical manufacturers than there is of patients" (Welch, USA Today, 12/31/03). However, HHS spokesperson Bill Pierce said that the agency has twice determined that "we could not guarantee the safety" of reimported prescription drugs, adding, "Nothing has changed since that time" (Washington Times, 1/2).

The birth of an idea: iatrogenesis

There's an excellent review in the Sunday N.Y. Times of Sherwin Nuland's "The Doctors' Plague," a history of Ignac Semmelweis' attempt to nail down the etiology of childbed fever. If Semmelweis isn't exactly a household name, it may have to do with the fact that Pasteur, Lister, and Koch would need another 10 years after Semmelweis' research to develop a unified germ theory of disease. Also: Semmelweis' genious as an epidemiologist seems to have been matched by his dismal indifference to bench science --

Semmelweis was a lopsided genius. His singular talent lay in sorting through reams of data and finding subtle patterns squirming beneath -- all the while ignoring the essence of the infection lying within his fingers' reach. In Semmelweis, an insightful epidemiologist seemed to have collided with a blind pathologist. And unfortunately, the more he struggled to make the two prongs of his scientific inquiry meet, the more desperate and unreasonable he seemed to become. His book on childbed fever, written at the end of his life, reads more like a manic manifesto than a treatise. Scientific history never seems to have forgiven him for it.

But what continues to fascinate is Semmelweis' insight -- perhaps a commonplace in this century, but heretical int he 19th -- that puerperile fever was the result of an infection that was passed on from doctor to patient because of a lack of basic sanitation as physicians moved from patient to patient. The review (by Siddartha Mukherjee) concludes:

To the post-Thalidomide generation of doctors -- to doctors inured to the fact that a medicine or procedure can itself be toxic -- Semmelweis's discovery may come as no surprise. But, as Nuland reveals in some of his most reflective paragraphs, for the high-minded physicians of Vienna and Budapest this was a deeply unsettling premise, for it struck directly at the self-image of their profession. Doctoring was supposed to be a do-good business. It wasn't supposed to make young mothers die of preventable illnesses. What Semmelweis had managed to expose was a hidden anxiety within medicine itself, doctors' ''horror at the possibility that they had been killing their patients for years.''

It is this anxiety that still haunts us. In 2003, 150 years after Semmelweis, some of the most disturbing pieces of medical news involved iatrogenic complications -- doctors' plagues, if you will. The first -- SARS -- was an infection that was spread through hospital wards, often carried by doctors, much like the infections that had vexed Semmelweis in the 1850's. The second -- the so-called million-women study, which revealed the toxic side effects of hormone replacement therapy -- marked a moment of deep introspection in women's health, making doctors question their cavalier willingness to push theories and medicines on patients long before the evidence on them had accumulated.

Like Semmelweis himself, Nuland's book is short, intense and single-minded, and these larger themes and implications are left teeming underneath the text, for readers to peer in closely and uncover. ''To receive his due of honor,'' Nuland writes, Semmelweis ''had to be rediscovered.'' ''The Doctors' Plague'' succeeds for exactly that reason: in telling the story of childbed fever, Nuland has managed to rediscover a critical moment in the history of medicine, the anxieties of which, although somewhat attenuated, persist today.

Pharmacy plan in Florida scuttled after one day.

According to the Orlando Sentinel (reported Jan. 3 (requires free registration; AP picked the story up today -- see, e.g., NY Times/AP story),

Amid an outcry from patients and pharmacists, the state of Florida on Friday abruptly pulled the plug on a new system that forces private pharmacists to decide whether to make poor and medically needy patients pay a fee for prescriptions that have been free.

Health advocates and state lawmakers blasted the system, started just two days ago, which they said is illegal and could force thousands of poverty-stricken people to pay fees they can't afford -- or, at worst, deny lifesaving drugs to critically ill patients.

"We've made pharmacists the gatekeepers," said state Rep. Anne Gannon, D-Delray Beach. "They're deciding whether people live or die."

Don't look now, but the same thing is happening in Dallas County's own Parkland Memorial Hospital, where patients who are too poor to afford prescription meds and too "rich" to qualify for Parkland's health plan are being sent home from the ER and from surgery without the drugs they need to stay alive. As the Dallas Morning News editorialized on Saturday, the County Commissioners have a couple of big votes lined up this week, one of them on Parkland's plan to add to its current main hospital/8 clinics. (The other vote concerns a successor to health commissioner Betty Culbreath. What the editorial didn't mention is that Dallas County is currently experiencing a public-health meltdown. We lead the state in any number of infectious diseases and we lack the infrastructure to have a clue -- let alone a plan -- about an outbreak of salmonella that affected more than 650 people in all 50 states until we were warned by the CDC that something fishy was going on in the Anatole's salsa kitchen (story).) Meanwhile, it seems like business as usual on the Commissioner's Court, where public health -- not to mention life-and-death policies affecting Parkland patients -- seems to be a low priority at best. Shame on the Court and (so far) on County Judge Margaret Keliher, whose campaign touted that electing her would be good for Parkland. We're watching . . . .

Medicare and Medicaid - the outlook to 2050

This just in from the AHLA's Health Law Highlights:

CBO Predicts Federal Healthcare Program Spending May Reach Unsustainable Levels Under Current Policies

Total federal spending for Medicare and Medicaid in 2050 could range from 6.4% to more than 21% of gross domestic product (GDP), the Congressional Budget Office (CBO) predicted in its recently released long term budget outlook. In 2003, the programs accounted for 3.9% of GDP. "Unless taxation reaches levels that are unprecedented in the United States, current spending policies will probably be financially unsustainable over the next 50 years," CBO said.

The report is here.

U.S. News: Science calls at the deathbed(1/12/04).

The January 12 issue of U.S. News and World Report has a compelling article about human research conducted on "the nearly dead." The article contrasts research on University of Pittsburgh patients who have already been declared dead according to neurological criteria ("brain dead") but not yet taken off the respirator and research on terminally ill patients at M.D. Anderson who are expected to die soon after life-support is removed. The risk-to-benefit ratio for a dead patient is, of course, extremely low (pretty close to 0/0). The same is almost true of patients as to whom the decision has been made to withdraw life-sustaining treatment and allow the patient to die, but the risk is not zero:

"You can harm living people in ways that you can't harm dead people," says [Pittsburgh ethics panel member Michael] Wicclair. For example, what if the doctors are wrong and the person doesn't die after withdrawal of the machines?

Rebecca Pentz, formerly at M.D. Anderson and now at Emory, is organizing a conference on the topic for Spring 2004. Should be a lively event.

Safire: From politics to books, my 2004 picks

William Safire's New Year's prediction column is always a hoot. This year's outing was no exception. Apart from his prediction of the Academy Award for "Best Picture" ("Mystic River" -- my youngest son concurs), note item 8:

8. The scientific advance of the year will be (a) age retardation enhanced by memory protection; (b) a single pill combining erectile dysfunction treatment with a fast-acting aphrodisiac; (c) neuroscientists' creation of a unified field theory of the brain; (d) the awakening of geneticists to the liberating study of bioethics.

Safire's answer? (d)

British Medical Association's call for review of medical ethics training.

As reported in today's Scotsman, the British Medical Association today (i) published an 800-page 2nd edition of Medical Ethics Today, and (ii) called for a government-funded review of how effectively ethics and basic law are being taught in medical schools and how the system can be improved. A table of contents and a sample chapter are available from the BMA's web site and can be ordered here. It's a pricey paperback (£60) and they charge £18 for shipping to the US - converted to $US the total comes to about $134.42. You can get it for the same £60 but for a lot less in shipping charges through Amazon-UK.

There’s a Blurry Line Between Rx and O.T.C.

Interesting piece by Gina Kolata on the way prescription meds get reclassified for over-the-counter sales. The article accurately states:

At the heart of its decisions, the FDA says, are straightforward scientific and medical questions. Is there a low potential for abuse or misuse? Can consumers use it for self-diagnosed conditions? Can the drug be adequately labeled? Are doctors needed for its safe and effective use?

It also says:

The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.

How can both statements be true? Consider the morning-after pill, which an expert panel has recommended to FDA Commissioner Mark McClellan be made available as an OTC drug, and the competing social agendas at work:

If the morning-after pill were sold over the counter, doctors who opposed the change said at the F.D.A. hearing, teenagers would avoid counseling on responsible sexual behavior. Some also said that making the drug over the counter would interfere with their relationship with their patients. Those favoring the change said that teenagers are going to have unprotected sex in any case and needed a safe way to avoid pregnancy.

And then there's the impact of insurance:

In other cases, straightforward commercial considerations can determine how a company wants a drug classified. For example, drug manufacturers know that patients with drug coverage often prefer prescriptions to paying the full cost of over-the-counter drugs.

Doctors say they see this insurance effect all the time. Dr. James Osborne, an internist in Greensboro, N.C., says when patients with occasional heartburn ask for a prescription for Nexium, he often suggests they buy Pepsid, which costs 24 cents a day for the four pills needed to equal prescription strength, or about 17 times less than Nexium. "They say, 'It doesn't matter, doc. I have a drug card,' " Dr. Osborne said.

You can stay abreast of developments in the drug field by monitoring the home page of the FDA's Center for Drug Evaluation and Research, which also features a handy daily or weekly e-mail update service. There's also an OTC information page there.

More on medical marijuana.

Angel McClary Raich, one of the successful plaintiffs (on appeal) in yesterday's ruling by the 9th Circuit (see below) has her own website, "Angel's Fight to Stay Alive" with tons of background information.

Medical marijuana use survives US Controlled Substances Act.

The US Court of Appeals for the 9th Circuit yesterday ruled that the federal government lacked the authority under the Commerce Clause of the US Constitution to criminalize the individual use of marijuana for medicinal purposes. The court's opinion is here (FindLaw) and here (court's web site). In most constitutional law cases, the facts are everything. Here is the court's recitation of the facts in this case:

B. Factual Background

Appellants Angel McClary Raich and Diane Monson (the “patient appellants”) are California citizens who currently use marijuana as a medical treatment. Appellant Raich has been diagnosed with more than ten serious medical conditions, including an inoperable brain tumor, life-threatening weight loss, a seizure disorder, nausea, and several chronic pain disorders. Appellant Monson suffers from severe chronic back pain and constant, painful muscle spasms. Her doctor states that these symptoms are caused by a degenerative disease of the spine. Raich has been using marijuana as a medication for over five years, every two waking hours of every day. Her doctor contends that Raich has tried essentially all other legal alternatives and all are either ineffective or result in intolerable side effects; her doctor has provided a list of thirty-five medications that fall into the latter category alone. Raich’s doctor states that foregoing marijuana treatment may be fatal. Monson has been using marijuana as a medication since 1999. Monson’s doctor also contends that alternative medications have been tried and are either ineffective or produce intolerable side effects. As the district court put it: “Traditional medicine has utterly failed these women . . . .”

Appellant Monson cultivates her own marijuana. Raich is unable to cultivate her own. Instead, her two caregivers, appellants John Doe Number One and John Doe Number Two, grow it for her. These caregivers provide Raich with her
marijuana free of charge. They have sued anonymously in order to protect Raich’s supply of medical marijuana. In growing marijuana for Raich, they allegedly use only soil, water, nutrients, growing equipment, supplies and lumber originating from or manufactured within California. Although these caregivers cultivate marijuana for Raich, she processes some of the marijuana into cannabis oils, balm, and foods.

On August 15, 2002, deputies from the Butte County Sheriff’s Department and agents from the Drug Enforcement Agency (“DEA”) came to Monson’s home. The sheriff’s deputies concluded that Monson’s use of marijuana was legal under the Compassionate Use Act. However, after a three-hour standoff involving the Butte County District Attorney and the United States Attorney for the Eastern District of California, the DEA agents seized and destroyed Monson’s six cannabis plants.

The court concluded that this entirely local, entirely intrastate activity of growing and using the pot fell outside the federal government's authority to regulate or criminalize pursuant to its power to regulate interstate commerce. This case will be the talk of Constitutional Law classes all across the country in January. The Commerce Clause has been so expansively interpreted in such a long line of cases over so many decades that any opinion that perceives a limit on Congress' power to regulate commerce will be seen as an outlier, no matter how compelling the facts. Indeed, you can count on the fingers of one hand the number of cases (since 1937) in which the Supreme Court has ruled that Congress exceeded its powers under the Commerce Clause, and all of them have been decided in the last 10 years. The thinking was that a more conservative Supreme Court thought the activist Congress needed to have its wings clipped so that it wouldn't have a blank check to regulate any activity it wanted to touch, no matter how local and no matter how much it was a subject of traditional state concern.

Now the worm has turned, and the liberal 9th Circuit (the most-reversed court of appeals in the federal system) has used this new view of the Commerce Clause to rule against John Ashcroft's Justice Department and uphold individual marijuana use in these cases. Stay tuned . . . I rather suspect the Department of Justice might want to run this one by SCOTUS. Meanwhile, news reports and commentary can be found on Google News.

Not-So-Public Relations - How the drug industry is branding itself with bioethics. By Carl Elliott

Carl Elliott from Univ. of Minnesota's Center for Bioethics - an excellent bioethics think tank - has a great commentary on Eli Lilly's efforts to bolster sales of its new and very expensive antisepsis drug, Xigris, through (among other things) its funding of the "Values, Ethics & Rationing in Critical Care Task Force." The story broke with the Wall Street Journal on September 18 (available here with a subscription). Elliott is predictably and properly critical of the potentially insidious influence of corporate dollars -- especially, it seems, Big Pharm's dollars -- on the research agenda and opinions of bioethicists. He concludes:

Somehow corporate-funded bioethicists have not been touched by the bad publicity. Many bioethicists continue to insist that they are learning from their industry relationships and shaping company policy for the better. A task force commissioned by the two major American professional bioethics bodies—the American Society for Bioethics and Humanities and the American Society of Law, Medicine and Ethics—concluded last year that private corporations should be encouraged to seek out paid bioethics consultants, because "bioethics will have an impact on that (corporate) activity only if bioethicists can be part of the dialogue." The task force went on to endorse the practice of bioethicists advertising their own services as private consultants.

So the next time you meet a bioethicist, pay close attention; he may look like a bioethicist, but when you peel back his mask, you just might see the adman smiling back.

Pattern of Mistakes Found in Zoo Deaths (washingtonpost.com).

HealthLawBlog doesn't often cover developments in the world of veterinary medicine, but a two-part Washington Post series on problems at the National Zoo in Washington, DC, is irresistible. Yesterday's article focused on possible areas of malpractice, as well as shoddy record-keeping and medical records that have been altered after the fact, with many links to the documents themselves on the newspaper's web server. Today's article offers more of the same, with an additional, pointed review of the Zoo's oversight by the Smithsonian. Fascinating reading.

Links to N.Y. Times articles.

Links like the one in the post immediately below are a little iffy. The Times takes articles off its free site after a few days and then limits access based on your ability or willingness to pay. They have relented to some extent, by allowing Dave Winer and USerland to provide stable links to their articles for the benefit of blawgers like me and readers like you. Thus, the Userland link to the article below should be good forever. But I pulled that article up through Google News, and their link, which is the one I used below, uses the same "partner=" format as Userland's link and may be just as stable.

Fortunately, at least with respect to some of their reporting on Medicare, the Times has announced that it will keep their articles in a section of their web site that is free to the public. So -- again, in theory -- the link to the Times' web page for Reed Abelson's piece should be good for a long time, as well. I don't actually believe it and will continue to provide Userland or Google News links until the whole question of stability settles out.

Hospitals Say They’re Penalized by Medicare for Improving Care.

Reed Abelson has an excellent piece in this morning's N.Y. Times about the Medicare prospective payment system (PPS) for reimbursing hospitals for in-patient care. The upshot is that hospitals that creatively and effectively produce the best health outcomes for their patients are often systematically punished by a reimbursement system that pays on the basis of admissions and discharges, rather than outcomes. The lead example in the article is Utah's Intermountain Health Care network, which

says it saves at least 70 lives a year. By giving the right drugs at discharge time to more people with congestive heart failure, Intermountain saves another 300 lives annually and prevents almost 600 additional hospital stays.

But under Medicare, none of these good deeds go unpunished.

Intermountain says its initiatives have cost it millions of dollars in lost hospital admissions and lower Medicare reimbursements. In the mid-90's, for example, it made an average profit of 9 percent treating pneumonia patients; now, delivering better care, it loses an average of several hundred dollars on each case.

"The health care system is perverse," said a frustrated Dr. Brent C. James, who leads Intermountain's efforts to improve quality. "The payments are perverse. It pays us to harm patients, and it punishes us when we don't."

And it's not just the providers who think the system is perverse:

"Right now, Medicare's payment system is at best neutral and, in some cases, negative, in terms of quality — we think that is an untenable situation," said Glenn M. Hackbarth, the chairman of the Medicare Payment Advisory Commission, an independent panel of economists, health care executives and doctors that advises Congress on such issues as access to care, quality and what to pay health care providers.

In a letter published in the current edition of Health Affairs, a scholarly journal, more than a dozen health care experts, including several former top Medicare officials, urged the program to take the lead in overhauling payment systems so that they reward good care.

Even the departing head of the Medicare program agrees with this assessment: "'It's one of the fundamental problems Medicare faces,' said Thomas A. Scully, who as the administrator of the Centers for Medicare and Medicaid Services has encouraged better care by such steps as publicizing data about the quality of nursing home and home-health care and by experimenting with programs to reward hospitals for their efforts."

Children's Hospital Bans Smoking by Staff.

I am no fan of the tobacco industry, but I wonder about today's news story that all employees of a children's hospital in Columbus, Ohio, will be barred from smoking anywhere on the "sprawling hospital grounds" effective May 2004. Is this about the health of employees? The health of patients and families? A public health statement? A form of public education? Aesthetics? (The CEO is quoted as saying patients should not have to contend with the lingering scent of cigarette smoke on staff members returning from breaks.) Ironically, no one quoted in the article, including the spokesperson for a second-hand smoke organization, claimed that this ban was to improve the healthiness or cleanliness of the hospital environment. As long as this is happening in a private hospital, there would appear to be no constitutional issue involved, so the hospital is well within its rights. But does that make the policy right?

Even the conservative Cato Institute hates this Medicare reform law.

Read their critique (largely based on the fiscal irresponsibility of the thing) here.

Clinton-era policy makers analyze Medicare reform law.

As reported by Reuters this afternoon (click here), liberal health care policy experts are blasting the new Medicare reform package.

Medicare chief to resign.

In the past hour everyone's reporting that Tom Scully has submitted his resignation as CMS chief effective Dec. 16th. Here is the CBS Marketwatch story. As reported in today's Washington Post ("Medicare Chief Scully Says He's 'Checking Out of Dodge'") Scully was extensively involved in the Conference Committee negotiations over the Medicare reform legislation passed last week (which the White House says the President will sign next Monday). Indeed, as possessor of the most detailed and encyclopedic knowledge of the massive new law, he is now in a position to provide highly remunerated value to law firms and investment bankers keen to make a buck in health care over the next few years. As reported not only in the Post article, but in more detail in today's New York Times (Google link; should be stable, but if not try this), the bidding war over Scully's services has been going on for about 6 months. His participation in the Medicare reform negotiations was based upon a waiver he received from CMS's ethics office. In light of Scully's pre-CMS salary as president of the Federation of American Hospitals ($675,000), one might well expect to see his compensation top 7 figures, especially if he works out a combination arrangement with a law firm and an investment banking firm. As the papers are quick to concede, no one is alleging that Scully took any position during negotiations over the future of Medicare with an eye toward his future employment options, and Scully is an honorable man. Also, Scully might have been the perfect choice to spearhead the Administration's efforts to get a passable reform bill out of conference. The ethics clearance, however, was handy, n'est-ce pas?

Church May Penalize Politicians

Great article in Monday's L.A. Times about the rustlings within the Catholic Church to discipline Catholic politicians whose public positions contradict Church orthodoxy. The article is here (requires free registration). According to the article, "Punishments could range from bans on speaking appearances at Catholic institutions to excommunication." It's not just a theoretical possibility, either: "A few of America's 195 dioceses, including Dallas and Philadelphia, bar abortion-rights politicians from speaking at Catholic churches and schools. In April, news leaked that Bishop Robert Carlson of Sioux Falls, S.D., had sent a letter asking the state's Democratic Sen. Tom Daschle to stop calling himself a Catholic."

I have no quarrel with the Catholic Church advocating public policy, nor should the Church -- or any church or religious organization -- feel constrained about identifying politicians with whom it agrees and disagrees. And any faith community has the right to define the content of its core beliefs, as well as to identify those whom it regards as "in" and "out" of the faith's traditions and beliefs. But at least since JFK tried to put this issue to rest, I thought American politicians, and the polity to which they appeal, had a pretty clear idea that politicians don't (and shouldn't) take their lead from church leaders. More to the point: Can't a Catholic politician believe privately that abortion or the death penalty is wrong and yet profess publicly that the country's policies should be open to alternative moral views? That a pro-choice law represents an appropriate balance of competing private moralities, even if -- as a practicing Catholic -- that politician might fervently desire that the law was otherwise?

Texas Doctors’ Group Settles FTC Price-Fixing Charges

Another Texas physicians' group came up short in a price-fixing investigation by the FTC. This must be at least the third (possibly fourth) in the last 18 months or so. The FTC's press release gives some details and a link to the file documents.

Do religious groups have to follow laws they don't believe in?

Texas Health Blog provides a link to this AP story about litigation in NY and Calif. concerning whether the Catholic Church's employee health plan has to include contraceptives in employee health plans. The Catholic Church regards contraceptive use as immoral, but in 20 states failure to provide coverage for contraceptives is deemed (by statute) to discriminate against women. "The 20 states that require private-sector insurance coverage for prescription contraceptives include Arizona, California, Connecticut, Delaware, Iowa, Georgia, Hawaii, Maine, Maryland, Massachusetts, Missouri, Nevada, New Hampshire, New Mexico, New York, North Carolina, Rhode Island, Texas, Vermont and Washington." In both NY and Calif., as well as in other states, "churches are exempt from having to provide contraception coverage for employees who work inside parishes and houses of worship. That is known as the 'religious employer exemption' because the parishes generally serve worshippers and employ those with similar religious views. . . . Several states have no such exemptions for religious entities. Other versions exempt church groups and 'qualified church-controlled organizations.'"

20 Questions for Senior Judge Richard Arnold.

Howard Bashman's "20 Questions" session (on his blog, How Appealing) with Senior Judge Richard Arnold should be required reading for all law students, especially students with an interest in appellate practice or in securing a judicial clerkship after graduation. Or, for that matter, with an interest in a life lived greatly in the law.

Keillor on Twain.

He's been called the Mark Twain of our generation, a born story-teller whose tales from the heartland of America have been embraced by sophisticates on both coasts. So there's a special treat in today's "Writer's Almanac" in the form of Keillor's mini-biography of Twain, whose birthday it is today:

It's the birthday of Mark Twain, born Samuel Langhorne Clemens, in Florida, Missouri (1835). He wrote Life on the Mississippi (1883), The Adventures of Huckleberry Finn (1884), and his own favorite, The Personal Recollections of Joan of Arc (1891). He was cynical and irreverent, but he had a tender spot for cats. There were always kittens in the house, and he gave them names like "Sin" and "Sour Mash." "Mamma has morals," said his daughter Suzy, "and Papa has cats." Twain swore constantly and without shame. His streams of profanity alarmed his wife. One day he cut himself shaving, and she heard a string of oaths from the bathroom. She resolved to move him to repentance, and she repeated back to him all the bad words he had just said. He smiled at her and shook his head. "You have the words, Livy," he said, "but you'll never learn the tune."

After Twain published The Adventures of Huckleberry Finn, he had a great deal of cash on his hands, which he invested in a typesetting machine that was very complicated and demanded more and more investment. In the end, it didn't work. He had to declare bankruptcy, and he decided to go on a worldwide lecture tour, the proceeds of which he would use to pay back all of his creditors. His visits to Africa and Asia convinced him that a God who allowed Christians to believe that they were better than savages was a God he wanted no part of.

Mark Twain said, "It is better to keep your mouth shut and appear stupid than to open it and remove all doubt." And he said, "Good friends, good books and a sleepy conscience: this is the ideal life."

Thanksgiving poem, on the rocks, with a twist.

Today's Book Review section of the N.Y. Times includes a poem by Susan Kinsolving -- "Fill the Cavity with Crumbs" about Thanksgiving at her home the year she was divorcing her "almost-ex". The internal rhymes propel this domestic drama across the page, suggesting the kind of hidden logic by which most families (and family get-togethers) proceed. Very nice.

More reactions to the Medicare reform bill.

It's been touted -- by supporters and critics alike -- as the most sweeping set of changes to Medicare since its inception in 1965. It is therefore not surprising, I suppose, that the political reactions to House Bill 4 (at least at this early stage -- months if not years before the full implications of this thing will be known and understood) are confounding the pols and pundits. Two articles in today's N.Y. Times pretty well summarize the situation:

• "But although some economists on the left and right might wring their hands, younger workers don't seem to be complaining. According to polls, members of the post-boomer generation are actually more enthusiastic than their elders about this new legislation. Their feeling is partly due to a desire to see their parents and grandparents save money on drugs, which ultimately redounds to their own benefit. And a lot of these younger adults — like members of Congress who voted for the bill — probably haven't quite focused on who will pay for the program or how." (A $400 Billion Purchase, All on Credit, John Tierney)
• "[Retirees] express disappointment but little surprise because, they say, they never had high hopes. They say they feel they were sold out, by Republicans and AARP, which endorsed a Medicare bill drafted mainly by Republicans. But the Democrats, they say, did not fight hard enough for a better drug benefit." (Florida Elderly Feel Let Down by Drug Benefit, Robert Pear)

US Congress OKs nanotech bill.

According to a report in the on-line version of The Scientist, Congress has passed S. 189, the "21st Century Nanotechnology Research and Development Act." This is a terrific article, with links to a previous piece on the biomedical ethical implications of nanotechnology and various studies and reports on nanotechnology, as well as an easy-to-get overview of the field. For more information, visit the federal government's National Nanotechnology Initiative web site.

Organ retrieval practices tightened up in UK.

As reported in London's Financial Times, "The UK government is to tighten up the rules governing the removal of organs and tissues after death. . . . The legislation, announced in the Queens' speech on Wednesday, will make consent the fundamental principle governing organ removal and set up an an authority with over-arching power to regulate transplantation, anatomical examination, post mortem studies and the use of human tissue in education and research." The article explains that consent has been required since 1994, "but that has not prevented abuses":

As many as 20,000 brains were illegally removed and kept by doctors without the consent of parents in the 1970s 80s and 90s at Alder Hey children's hospital in Liverpool while thymus glands were given to a pharmaceutical company in exchange for cash.

The harrowing events at Alder Hey led to some parents having to conduct up to four funerals as organs from their children were returned at different times.

Ideology and science (II)

The current issue of the eminent journal Science has an editorial by Alan Leshner entitled, "Don't Let Ideology Trump Science" (I don't know for sure, but you may need to be a subscriber to view this article). Here's the gist of it:

The moralizers are trying to muck with U.S. science again. A flurry of activity over the past few weeks has followed the effort of a right-wing religious group to call into question almost 200 National Institutes of Health (NIH) grants focusing on behavioral and social aspects of issues such as sexuality, HIV/AIDS transmission, and drug abuse . . . This incident could have been written off as noise by a fringe group had it not come almost on the heels of the near-passage in the House of Representatives last July of what came to be known as the "Toomey Amendment," after its author Rep. Patrick Toomey (R-PA). By a vote of 212 to 210, the House just missed defunding four NIH research grants on sexual behavior that had already been through rigorous scientific peer review and approval by NIH Institute National Advisory Councils . . . .

We are not concerned that Congress wishes to exert oversight over the U.S. research agenda and research priorities. That is their job, and we want our representatives to do it well. We also believe that the scientific community should be fully accountable to the public, because much science is publicly funded and the public is the ultimate beneficiary of our work. By nature, science is an open enterprise that invites examination and criticism--and more often than not, it is actually strengthened by public scrutiny. Oversight bolsters public confidence in the scientific enterprise and provides incentives for scientists to interact with the public, explain the importance of their research, and spread an ethic of intellectual curiosity and critical thinking that helps make our society more innovative and dynamic.

On occasions like the present one, however, healthy scrutiny gives way to irresponsible attack. The recent assaults on science were not directed at broad research questions or national research priorities. Instead, they were aimed at imposing ideology and religious doctrine on the awarding of individual research grants, intervening in and thereby subverting the scientific peer review system that has served both science and national needs so well.

The moral judges who are doing this don't like the fact that HIV is spread through sexual contact, and they believe that drug addicts have made bad personal choices that have led to addiction. Is their disapproval of these behaviors a justification for stifling research on the diseases that result? Do they suppose that some form of national denial will make these problems go away? Regardless of personal feelings about the etiology of these illnesses, we need to understand their causes and transmission patterns if we are ever to get a handle on some of society's most pervasive public health problems.

WSJ.com - Remaking Medicare

Not sure whether this requires a subscription or not, but for a pretty good roundup of news and analysis of the Medicare reform law, this Wall Street Journal site is good.

Ideology and science (I)

An editorial in today's Palm Beach Post is a reaction to an article I missed from the Nov. 21 Wall Street Journal. Here's a snippet from the Journal article by Antonio Regaldo:

Advocates for infertile couples have raised alarms over draft documents released by President Bush's Council on Bioethics that recommend sweeping changes in the way assisted reproduction is regulated in the U.S.

The draft recommendations, quietly posted to the council's Web site last month, call on the federal government to track and monitor embryos created for fertility purposes. They call for far-reaching legislation that would curtail embryo research and some common business practices. One proposal called for banning the sale of human eggs and sperm, a common practice in the U.S., though transcripts of the council's October meeting indicate that proposal has been withdrawn.

"The recommendations and legislation could change the face of reproductive medicine in this country," said Pamela Madsen, executive director of the American Infertility Association, an advocacy group in New York.

A final report from the ethics panel, formed by President Bush in 2001 following the divisive stem-cell debate, won't be released until next year. Council staff said the drafts are discussion documents and subject to change.

But critics and even some members of the 17-person council said the drafts signaled an ongoing effort by conservative members of the council to create new protections for human embryos created in fertility laboratories.

Here is the Palm Beach paper's reaction in an editorial entitled, "Find a Cure for Ideology":

President Bush's Council on Bioethics is reviving attempts to ban therapeutic cloning for research -- and this time, patients suffering from debilitating diseases and scientists seeking cures for them wouldn't be the only potential victims. In its latest inappropriate invocation of ideology, the president is using his panel to urge Congress to assign legal rights to human embryos. Not only would such unnecessary legislation disrupt research toward cures for Parkinson's, diabetes and other widespread diseases, the action would make it harder for infertile couples to conceive.

Referring to the embryos as "children-to-be," the panel's draft recommendations -- reported in The Wall Street Journal -- call for the federal government to track the creation, use and disposition of embryos. The panel suggests a ban on using an 11-day-old or older embryo for research, restrictions on surrogate mothers and limits on the reason a woman could get pregnant by in vitro fertilization. Would enforcement require parents to declare that they plan to "produce a live-born child"? How does such a requirement fit the panel's claim that it wants to protect women "against certain exploitative and degrading practices"?

According to a study by the Rand Corp. and the Society of Assisted Reproductive Technology, nearly 90 percent of the 396,526 embryos in storage throughout the United States as of April 2002 were designated for future family-building by the patients who created them. Fewer than 3 percent -- 11,000 -- are available for donation for research. Those that are were designated, correctly, by the parents, not the government.

Two years ago, President Bush approved spending federal money on embryonic stem-cell research but set limits on the study. The cell lines he approved for federally financed research were initially grown on mouse cells -- which, a medical ethics panel formed by Johns Hopkins University said this month, could expose humans to an animal virus their immune systems could not fight. Safer stem-cell lines, the panel said, now exist but aren't eligible for federal financing. The president would rather allow ideological debates to halt progress.

Twenty-five years after the birth of the first "test-tube baby," Congress should not let the president and his advisers distract from the quest for life-saving discoveries.

The draft recommendations come in a staff working paper entitled "Biotechnology and Public Policy: Biotechnologies Touching the Beginnings of Human Life/Defending the Dignity of Human Procreation."