Bush Administration v. Big Pharma.

It's a real man-bites-dog story, but the NY Times is reporting that the Bush Administration, over the objections of the pharmaceutical industry, is posting comparative drug prices on the CMS webpage. Having carried some heavy water for Big Pharma for years, the administration appears to have started taking its pro-consumer, pro-market-forces rhetoric seriously.

On the other hand, this is a nearly unverifiable report.

The HHS press release says to find the "Lower Cost Rx Comparison Tool," go to the Medicare home page (www. medicare.gov) and then "simply go to the 'prescription drug and other assistance program' section." I did that. Once there, you have a bunch of tabs and links from which to choose. "Quick Search" is the ticket. Once there, scroll down to the bottom of the page, where there's a search box that allows you to type in a drug name (or search a list of popular drugs or browse an alpha list of drugs). When I typed in "Diovan," my ACE inhibitor of choice, I was told to choose between "Diovan" and "Diovan HCT." After clicking on "Diovan" and the "Add Drug" button, I was taken to a page where I was asked for a dosage. After clicking on "TAB 80 mg" and typing in my current cost ($25), I clicked "Add Dosage." I was then prompted for my ZIP code, which took me to a "user agreement," and after accepting the user agreement, I was asked if I wanted to search for discount cards available at my pharmacy or in my area. Not particularly interested in telling CMS my pharmacy's name, I clicked on the latter. I then (finally) got to a screen with some pricing info, and the option of asking for more detailed info, which includes a fuller list of sources and information about enrollment fees for the various drug plans.

The article quotes "Gail E. Shearer, a health policy expert at Consumers Union: 'This is the kind of information consumers desperately need.' But she added: 'The Web site is challenging to use. You need to be really Web-savvy and good with a computer mouse to get useful information.'" That's right. Heck, you have to be really Web-savvy (which I think I am) even to find the site, and from that point on, there is one counter-intuitive page after another -- 9 mouse clicks, and lots of confusing prompts and choices that could (and did) easily derail even an experienced web surfer like me. My mother is not going to figure this out.

Dementia and the voter.

Here's a sleeper issue, from today's Washington Post ("Dementia and the Voter"):

As swing states with large elderly populations such as Florida gear up for another presidential election, a sleeper issue has been gaining attention on medical, legal and political radar screens: Many people with advanced dementia appear to be voting in elections -- including through absentee ballot. Although there are no national statistics, two studies in Pennsylvania and Rhode Island found that patients at dementia clinics turned out in higher numbers than the general population.

The studies point toward anecdotes like this one:

Florida neurologist Marc Swerdloff was taken aback when one of his patients with advanced dementia voted in the 2000 presidential election. The man thought it was 1942 and Franklin D. Roosevelt was president. The patient's wife revealed that she had escorted her husband into the booth.

"I said 'Did he pick?' and she said 'No, I picked for him,' " Swerdloff said. "I felt bad. She essentially voted twice" in the Florida election, which gave George W. Bush a 537-vote victory and the White House.

This raises fascinating constitutional issues, illustrated by this country's long history of disqualifying voters (e.g., the poor, women, blacks) as a means of reinforcing discrimination. No one is really arguing that a totally demented person should vote, but there are lots of inconsistent laws on the books, and enforcement of the laws requires judgments that are unreliable and that often reinforce political prejudices:

In California, for example, Democrats are suing the Veterans Affairs Medical Center in Menlo Park for preventing activists from talking to residents and homeless veterans. Lawyer Scott Rafferty, a member of presidential candidate John F. Kerry's steering committee, said he was turned away on the grounds that residents have dementia.

Rafferty said that most of the residents were of sound mind -- and that most were Democrats. He charged the Bush administration with suppressing Democratic turnout. The Department of Veterans Affairs said it was protecting patients and was required by law to keep out partisan activity.

About 45 states have laws that address whether people who are unable to look after their own finances or health are allowed to vote, Chemerinsky said. About 25 states automatically terminate the right to vote if a person is under the care of a guardian, Mathis added, but those laws are often arcane -- and unevenly enforced.

The result could hardly be worse: a pastiche of outmoded laws that are out of touch with current science and are being applied inconsistently and arbitrarily. Many competent people in nursing facilities are being prevented from voting, advocates say, even as caregivers of other patients with severe dementia vote on their behalf.

And what does all this have to do with bioethics and law? Read on:

As the baby boomers age, the number of Alzheimer's cases will soar, and experts said it is time for the nation to grapple with the issue -- if only to head off abuse.

Swerdloff said he wondered whether the Florida woman who voted for her demented husband was guilty of fraud. And he worried about activists going into nursing homes, where two-thirds of the residents have Alzheimer's disease.

"If they can go into a nursing home, why not go into an ICU and have a person who is comatose and on a ventilator -- let the caregiver vote," he said. "Then you say if a person is registered to vote, what about the brain-dead person?"

The most interesting line in the story was this one: "Adam Butler of the Disability Rights Center in Little Rock said such talk holds people with disabilities to a higher standard than the rest of the population. No tests of mental competence are required to stand for office, and no law prevents 'competent' voters from choosing candidates for questionable reasons: 'People may vote because they like the way George W. Bush looks or because they like Heinz ketchup.'"

So who does this help: Kerry or Bush? I am reminded of a line from one of my favorite political novels of all time (Roscoe, by William Kennedy), in which a former mayor of Albany defended the practice of registering and voting people based on their names on gravestones: "Just because they are dead doesn't mean they are going to vote Republican."

Single-payer system? Consider Canada.

Steven Lewis has an excellent piece in the Sept. 14 Canadian Medical Association Journal in defense of Canada's single-payer, universal health insurance system. While acknowledging limitations and lessons learned, he insists that the benefits far outweigh the negatives. Here's his list:

• First, it is that rare form of achievement: social justice combined with administrative efficiency. Although somewhat imperfectly (which is inevitable), it allocates service on the basis of need, not ability to pay. It reduces paperwork, lowers transaction costs, and frees personnel and programs to concentrate on delivering care, not fretting over coverage or itemizing the costs of the tissue paper and syringe.
• Second, it signals that health care is a public good, not a market-driven commodity. One crucial element of a public good is the duty to use it prudently, manage it effectively and preserve its accessibility to everyone. To be sure, some aspects of health care have become commodified: heavily marketed drugs, ultrasound "movies" for the prenatal scrapbook, prestige once-overs including whole-body scans. This trend is precisely the problem. More is taken to mean better; utilization mistaken for effectiveness. Keeping health care public is the only way to challenge the more-is-better fallacy that is the real enemy of sustainability.
• Third, it creates a community of interest in, and collective judgements about, access and quality. It places all Canadians in the same health care boat, irrespective of their wealth or station. If the well-off want a better system, it must be better for all. If it requires more tax dollars, governments have a warrant to raise taxes. In a world of hundreds of television channels and isolating technologies, medicare demands a solidarity that transcends class and region.
• Fourth, it liberates businesses and individuals from the wearying, costly and fractious burdens of securing and fine-tuning private health insurance and supplemental programs. It is not simply that the cost of health insurance is higher than the cost of the steel in a US-made car. It is freedom from having to decide where to seek work or whether to stay in a job on the basis of health care coverage, and from spending valuable time worrying about it. It is a wonderful paradox that a state-run, universal health care system lubricates the private economy.
• Fifth, it has the (not fully realized) potential to keep prices down. Drugs are a classic example. A single purchaser has clout with sellers. It could also signal to manufacturers that the state will pay in relation to therapeutic value, not an arbitrarily set price or a multiple of the costs of production. In fragmented, third-party insurance systems, the buck often stops nowhere, while in a single-payer system, accountability is clear. This disciplines both decisions and behaviour.
• Sixth, it is ethically coherent. The system cares for people irrespective of the vagaries of genetics and circumstance, and even the consequences of their own behaviours. Many alternative schemes, notably those proposing to tax the sick, assume that individuals alone choose their health states. This is patently false in many cases — science has not yet uncovered the process for choosing multiple sclerosis or Parkinson's disease or leukemia — and even where behaviour matters, the vast literature on the determinants of health has put paid to the notion that we make our choices on a level playing field.

The inherent message in all this, however, is that a national single-payer system is, at bottom, an expression on political will that is only as strong as its weakest link:

[T]he public sector seems to have forgotten that, since the beginning of universal health insurance, the system has required adjustments, modifications, additions and subtractions of services: a continual process of navigation and renewal. Politicians and health boards cave in to lobbies and narrow interests. For too many of them, medicare is no longer an inspiring metaphor — the social policy equivalent of the Canadian Pacific Railway — but, rather, an unmanageable inheritance with a huge appetite and a will of its own. As for the public, let them eat cake — as much as they want — but levy a premium, and institute a co-payment.

Neither premiums, nor co-payments, nor surtaxes based on use, nor offloading programs will fix health care. They will merely increase citizens' and businesses' costs and erode equity. There is nothing wrong with the concept of single-payer, universal health insurance. It fails only when memory of why we fought for it fades, and the will to sustain it breaks down.

The counterargument is supplied by Janice MacKinnon in "The Arithmetic of Health Care." Her argument is pretty simple:

There is a simple arithmetic to the rising costs of health care, just as there was to the federal deficit in the 1990s. Health care costs are increasing at a faster rate than the revenue of any government in Canada, and the scramble by governments to fund health care means that other critical priorities are being underfunded. In Ontario, for example, because health care costs have increased by an average of 8% a year for the last 5 years, their share of the government spending pie has risen from 32% to 39%; if interest costs are omitted, 46% of all Ontario spending is devoted to health care. These increases have come at the expense of funding for other priorities such as education, social programs and the environment. As Ontario Premier Dalton McGuinty explained, "there will come a time when the Ministry of Health is the only Ministry we can afford to have and we still won't be able to afford the Ministry of Health."

Despite ranking third in health care spending among 24 Organization for Economic Co-operation and Development countries, waiting lists in Canada are among the longest, and the country ranks 13th in health outcomes and status, according to a recent Conference Board of Canada study. Canada's poor ranking is related to the fact that quality of life is twice as important as health services in determining health status. If health spending crowds out investments in education, childhood development, housing, environment and other measures that improve living conditions, then health status suffers.

So, what's a country to do? The editors of the journal reject the two options policy makers have tended to embrace, at different times in the Canadian system's history: either pump it up with an infusion of cash or try to to persuade the populace (especially those with some disposable income) that equity is more important than efficacy. For the editors, a third choice is all but unavoidable: "admit that we have a two-tiered health care system in Canada: the public basket of services that meets predefined efficacy standards (currently about $50 000 per quality-adjusted life year) and a supplementary private basket for those who can afford to purchase other services [either at home or, increasingly, in the US]. Reality health care."

The editors, like Lewis and MacKinnon, understand that the debate will ultimately devolve into a political one: "we need to have a public debate and some frank discussion among our politicians. Not a debate about how much money can be thrown at the problem, but one about the importance of equity and the nuances and limits of efficacy. The continuing development of new diagnostic procedures and therapies (many emerging from the "genomification" of medicine) will test our current resolve to maintain equity. We will have to recognize that some people — those with money — will be able to purchase additional services, and we should make way for this possibility. But we should put equity just slightly ahead of efficacy. To accomplish this other than on the tiresome battlefield of political and economic rhetoric, we will need a continuous flow of information about the benefits and costs, as well as open and continuing discussion about the definition of the public basket."

Child health: a progress report.

The September/October issue of Health Affairs is now on-line, and as you can tell from a quick perusal of its table of contents, it has a lot of good research and writing on the subject of child health, including:

• the usual thoughtful article by editor John Iglehart ("To What Are Children Entitled? Coming Challenges");
• Paul Wise's helpful article, "The Transformation Of Child Health In The United States";
• five articles on coverage issues, most insistently and importantly SCHIP;
• four articles on quality and access, including an interesting piece on "Variations In The Quality Of Care For Very-Low-Birthweight Infants: Implications For Policy" by Rogowski et al.; and
• nearly a dozen more on various aspects of the question of investing in the health of children, including some provocative pieces on pediatric research.

Abstracts of all articles are free; full text requires a subscription and is well worth it for the best health care research and policy analysis published anywhere in the U.S.

Speaking of Big Pharm . . .

Today's N.Y. Times has a review of Marcia Angell's scathing indictment of the pharmaceutical industry, The Truth About the Drug Companies. The reviewer, Janet Maslin, writes that "Dr. Angell's case is tough, persuasive and troubling. Arguing that in 1980 drug manufacturing changed from a good business into 'a stupendous one,' thanks to changes in government regulations. She adds, 'Of the many events that contributed to their sudden great and good fortune, none had to do with the quality of the drugs the companies were selling.'"

Of particular relevance to the reimportation debate is this passage:

"The big drug companies are competing not so much to find new drugs but for the limited number of drugs to license," she argues. The enormous research-and-development budgets that are invoked to justify high drug prices, she claims, also pay for questionable forms of education for doctors and all manner of barely concealed incentives for them to prescribe certain drugs.

It was this passage, however, that caught my eye:

Why, she asks, should new drugs be tested against placebos, and sometimes tested in such high doses that their effectiveness is guaranteed? Why shouldn't they be tested in equivalent doses against drugs that already exist - and already work?

I thought it was unethical for a new drug to be randomized against a placebo if there is already an effective drug available. That is, it's ethical to use a placebo-controlled study only when those receiving the placebo are not denied the possibility of getting the established treatment or one that is possibly equivalent or better (the test drug).

To some degree, I was wrong. It is at least still a somewhat open question whether, and under what circumstances, a three-arm trial (new drug, orthodox treatment, placebo) is ethical. Back in 1994, Kenneth Rothman wrote a "Sounding Board" article for the New England Journal of Medicine ("The Continuing Unethical Use of Placebo Controls," 331:394-398 (Aug. 11, 1994); subscription required) that argued both that placebos are unethical when there's already a orthodox treatment of proved or accepted value and that the FDA hypocritically treats placebo-controlled studies as the gold standard for drug trials, even when an orthodox treatment is already available. Is this still happening?

Apparently so, if an article by two FDA staffers in the 2000 Annals of Internal Medicine is any gauge. (This one requires a subscription, too.) Here's the abstract:

In recent years, several authors have argued that placebo-controlled trials are
invariably unethical when known effective therapy is available for the condition
being studied, regardless of the condition or the consequences of deferring treatment. Some have also disputed the value of placebo-controlled trials in such a setting, asserting that the comparison of new treatment with old treatment is sufficient to establish efficacy and is all that should be of interest. This article considers the ethical concerns about use of placebo controls and describes the limited ability of active-control equivalence (also known as noninferiority) trials to establish efficacy of new therapies in many medical contexts. The authors conclude that placebo-controlled trials are not uniformly unethical when known effective therapies are available; rather, their acceptability is determined by whether the patient will be harmed by deferral of therapy. If patients are not harmed, such trials can ethically be carried out.

Furthermore, active-control trials, although valuable, informative, and appropriate in many circumstances, often cannot provide reliable evidence of the effectiveness of a new therapy.

Temple R & Ellenberg S. Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments, Part 1: Ethical and Scientific Issues. Ann Int. Med. 2000;133:455-63 (Sept. 19). The Letters to the Editor (July 3, 2001) and the authors' reply also makes for interesting reading.

Negative trial results and Big Pharm.

As previously noted here, PhRMA (the pharmaceutical industry association) responded to the rising tide criticism from physicians, consumers, and politicians by proposing guidelines for the release of clinical-trial results when those results are unfavorable.

The NY Attorney General Eliot Spitzer went after Glaxo SmithKline for just such secrecy, resulting in a settlement announced August 26. Pursuant to the settlement, Glaxo will establish a "Clinical Trials Register" containing "all scientifically sound information" -- including both positive and negative results. Although Glaxo denies the allegations, Spitzer accused Glaxo of "[withholding] negative information about Paxil, a drug used to treat depression. Specifically, GSK conducted at least five studies on the use of Paxil in children and adolescents but only released one of these studies, which showed mixed results on efficacy. The lawsuit alleged that the company suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts in certain individuals. The suit further alleged that GSK failed to disclose this information in 'Medical Information Letters' that it sent to physicians."

Now the Sept. 6 N.Y. Times reports that Merck & Co. has announced its intention of posting the same type of information on a government web site, ClinicalTrials.gov. According to the article:

The company has a history of publishing clinical trials even when the results reflected poorly on its drugs. And its announcement that it has already posted its results on ClinicalTrials.gov is, in part, an effort to make that Web site the standard for the rest of the industry.

ClinicalTrials.gov was created to provide patients suffering from deadly diseases a registry of trials of experimental treatments. Merck's move significantly expands the purpose and scope of the Web site's offerings.

Despite Merck's action, some in Congress say there is still a need for legislation that would require such public postings.

The article adds that Sen. Ted Kennedy is expected to introduce such legislation as early as this week.

Meanwhile, a House subcommittee is scheduled to hold hearings on the subject this week and later this month. The Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce has scheduled hearings on September 9 ("Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials") and Sept. 23 ("FDA's Role in Protecting the Public Health: Examining FDA's Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children").

Torture and medicine.

I've been remiss in failing to post a comment on the recent article (in the August 21 issue of the British medical journal, The Lancet) by Minnesotan Steven H. Miles, M.D., entitled "Abu Ghraib: its legacy for military medicine" (available for free). It is a stinging indictment of military physicians, PAs, nurses, and medics who persistently and conspicuously violated the Geneva Conventions by tending to the injuries of inmates so that they could be returned to the guards who were mistreating and torturing them. The Defense Department's blanket denial, on closer inspection, appeared to consist of an attack on Miles' sources. Before this is all over, I am willing to bet that the complicity of military medical personnel will be even more extensive, and appalling, than Miles was able to document.

Pediatric ethics & drug studies.

As reported in today's Olympia (Wash.) Olympian, the FDA's Pediatric Ethics subcommittee will meet on Sept. 10 to discuss whether "[i]t is ethical in the name of science to give a healthy child as young as 9 a controlled substance." The story continues:

The research, proposed by the National Institute of Mental Health, includes healthy children among 9- to 18-year-olds who would receive a single 10 mg. dose of dextroamphetamine.

The hoped-for payoff for research: A better understanding of how healthy brains work differently from those of children diagnosed with attention deficit hyperactivity disorder.

The payoff for families: $570.

The study would look at the effects of dextroamphetamine (the active ingredient in Dexedrine and Adderall) . It is similar to a study (by Judith L. Rapoport, chief of child psychology at the National Iinstitute of Mental Health) 20 years ago, which found increases in attention span regardless of whether the child-subject had ADHD. The new study would be similar, but it would add an MRI to map brain responses to the drug. Despite the similarities between the two studies,

review boards that balance risk vs. scientific gain have changed dramatically in 20 years.

Indeed, an NIH review panel met twice and was unable to reach a consensus whether risk to healthy volunteers would be too high in the new study. They kicked the sensitive matter over the FDA's new pediatrics ethics subcommittee.

The scientific merit of the study -- which will include 14 children with ADHD, 14 healthy children, 12 pairs of identical twins, and 12 pairs of fraternal twins -- was confirmed by a NIMH panel last year. But a safety panel was concerned about exposing healthy children to a Class 2 controlled substance, the potential for future drug abuse after the experimental exposures, and the possibly coercive effect of a $570 payment to each participant in the 11-hour study. From past studies, we also know "[t]he most common side effects among healthy children given a single dose of the stimulant in past experiments was temporary insomnia and poor appetite. One brain-damaged child exposed to the medication suffered hallucinations."

So where would your average institutional review board come down on the question if presented with this research protocol?

Many ethicists expect the FDA subcommittee to use a primary litmus test: Does taking the stimulant pose more than a minimal increase to risks that healthy children face in everyday life?

Pearl O'Rourke, who oversees human research affairs, interviewed the heads of six review boards at Massachusetts General and Brigham and Women's Hospital.

"Five said they would not approve this study. And all five said, 'But we wish we could,"' O'Rourke said during a March 3 NIH discussion.

O'Rourke acknowledged that the review boards struggle with murky federal regulations, tightening case law, financing agencies that prefer pediatric studies and the threat of negative media coverage.

"I live in dread fear of what's going to be on the front page of the paper," she told the audience. "So, when I heard this, three things hit my mind: Kids, ohmigod! Psychiatric disease. And a class 2 drug."

The impact of federal regulations and increased numbers of lawsuits is not small thing:

The FDA panel could simply approve the plan if it should find it carried great scientific weight, said Dr. Douglas Diekema, director of medical ethics at Children's Hospital in Seattle.

New Jersey attorney Alan C. Milstein said that would be the wrong call.

Milstein, who represented the family of an 18-year-old whose death in 1999 spurred greater federal oversight of gene therapy trials, pointed to a recent Maryland Supreme Court ruling. The court held that exposing healthy children to higher-than-minimum risk in a medical study is unethical.

"They can't do this study. It doesn't take a genius to figure out why they can't do it," Milstein said. "I can't believe that anybody is going to say it's ethical to do this. It's not even a close call."

Extensive briefing materials for the Pediatric Ethics Subcommittee's Sept. 10 meeting are here. And a recent review article in the August 28 issue of The Lancet (Caldwell et al., "Clinical Trials in Children," Lancet 2004;364:803-11 [subscription required]) takes a good look at the topic from all sides. Here's the abstract:

The imperative to undertake randomised trials in children arises from extraordinary advances in basic biomedical sciences, needing a matching commitment to translational research if child health is to reap the benefits from this new knowledge. Unfortunately, many prescribed treatments for children have not been adequately tested in children, sometimes resulting in harmful treatments being given and beneficial treatments being withheld. Government, industry, funding agencies, and clinicians are responsible for research priorities being adult-focused because of the greater burden of disease in adults, coupled with financial and marketing considerations. This bias has meant that the equal rights of children to participate in trials has not always been recognised. This is changing, however, as the need for clinical trials in children has been increasingly recognised by the scientific community and broader public, leading to new legislation in some countries making trials of interventions mandatory in children as well as adults before drug approval is given. Trials in children are more challenging than those in adults. The pool of eligible children entering trials is often small because many conditions are uncommon in children, and the threshold for gaining consent is often higher and more complex because parents have to make decisions about trial participation on behalf of their child. Uncertain about what is best, despite supporting the notion of trials in principle, parents and paediatricians generally opt for the new intervention or for standard care rather than trial participation. In this review, we explore issues relating to trial participation for children and suggest some strategiesfor improving the conduct of clinical trials involving children.

Class-action suit by 600K docs against 6 insurers.

I don't see anyone else reporting this story, but according to a story in Thursday's N.Y. Times by Milt Freudenheim,"[a]n appeals court upheld class-action status yesterday for a lawsuit brought on behalf of at least 600,000 doctors contending that six of the nation's largest health insurers regularly reduce payments for medical services. . . . A three-judge panel of the United States Court of Appeals for the 11th Circuit, in Atlanta, ruled that the defendants . . . must stand trial on charges of violating the federal Racketeering Influenced and Corrupt Organizations Act, or RICO. [Private civil RICO actions are authorized by 18 U.S.C. § 1964(c).] Health insurance lawyers had said that the appeals panel ruling would be crucial to the case's outcome."

Indeed. The article quotes Stephanie Kanwit, "a lawyer for a health insurance trade association in Washington [America's Health Insurance Plans], [who] said last December that 'class action is absolutely the crucial issue.' She added that the doctors' cases were 'not provable on a case-by-case basis.'"

That's how the 11th Circuit panel saw it, too: "In their suit, the doctors argue that the companies wrongfully underpaid them in various ways, including the use of computer programs that routinely denied parts of their fees. After reviewing the accusations, the appeals panel said, 'It is ridiculous to expect 600,000 doctors across the nation to repeatedly prove these complicated and overwhelming facts.'"

My usual links for free access to the court's opinion (Klay v. Humana, Inc.) -- FindLaw, 11th Cir. homepage -- aren't producing the slip opinion. By the time you are reading this, I hope the links are working. (For WestLaw subscribers, this is the link: 2004 WL 1938845.)

Bioethics council's report card.

The Boston Globe's Raja Mishra wrote an article in Tuesday's paper ("President Bush's bioethics panel has little influence") that assesses the President's Council on Bioethics at the 33-month mark. Mishra's central observations:

The presidential order establishing the council gave the panel two major mandates: To help guide the president in biomedical policy-making and to provide a national forum for discussing these issues. In three years, Bush asked for guidance on a single issue, embryo cloning, then formulated his policy against it months before the council had an opportunity to weigh in. Otherwise, Bush had virtually no interaction with the council, leaving it to explore a set of intriguing issues that lacked clear policy implications.

The council's work led to no federal legislation, a point acknowledged by its chairman, bioethics scholar Dr. Leon R. Kass.

Art Caplan, director of the bioethics program at UPenn, put his finger on the problem pretty well: ''I don't see them as having accomplished much. They issued some reports, most of which turned out to be post facto justifications for the president on stem cells and cloning. . . . They haven't had anything to say about Americans lacking health insurance, research in the Third World, drug pricing. They've been off solely in esoterica."

Of course, part of the reason behind Caplan's observation is that stem cells and cloning have been the major bioethics topics on Congress' plate the past few years, along with late-term abortions. And although the Council's work may have taken on a distinctly academic cast, Kass argues that the Council's scholarly work may pay off down the road. Meanwhile, Mishra's final grade isn't merely a disappointment for those who hoped for more from this Council, but a verdict on a major missed opportunity: "But the council, three years later, has become an afterthought -- with little impact on public debate and virtually no discernable influence on Congress or its creator, President George W. Bush."

Schiavo case: report on oral argument

There are a few reports on yesterday's oral argument before the Florida Supreme Court on the constitutionality of "Terri's Law":

A file report from the Associate Press (courtesy of the Winston-Salem Journal) reports (Sept. 1): Justice Charles Wells said he was troubled because he had to conclude that 'Terri's Law,' passed last October, was intended to sidestep a trial-court ruling that found 'clear and convincing evidence' that Schiavo would not want to be kept alive artificially." The Governor's attorneys, on the other hand, argued that "'[t]he legislature gave this power to the governor because the governor ... is the ultimate defender of people's civil rights in the state,' and "that the courts do not have the 'exclusive domain' of protecting the rights of disabled people."

The N.Y. Times' Abby Goodnough reports in today's paper:

The seven justices appeared especially troubled that "Terri's Law" was written to apply only to Mrs. Schiavo. Courts are often skeptical of legislation that applies to only one person, raising questions of denial of equal protection and due process.

The justices also focused on the fact that the law did not require the governor to abide by any standards or procedures, as he is required to do when ordering stays of execution in capital punishment cases.

"The Legislature stepped in here and reversed a decision that was final," Justice Charles Wells said.

And the AP also reports (courtesy of the Sarasota Herald-Tribune) that the appellate judge in the Second Circuit Court whose rulings have consistently favored the legal positions of Michael Schiavo against the claims of his wife's parents coasted to re-election yesterday by a comfortable 64-36 margin (with 30 percent of the precincts reporting).

Keillor on Democrats and Republicans.

Want to know what this election is about? I'd tell you, but Garrison Keillor's done a much better job of it than I can. Amen, Brother Garrison!

Schiavo case to be argued in Fla, Supreme Court today.

As reported in a long, detailed article by Laurie Cunningham in today's Miami Daily Business Review, the Florida Supreme Court will hear oral argument today in Michael Schiavo's challenge to the constitutionality of Terri's Law. A Florida appellate court decided against the state and struck down the statute earlier this year. Earlier discussions on this blog of the litigation and the various opinions can be found here, here, and here.

I never predict outcomes in Supreme Court cases, state or federal, but I will go out on a limb here: Michael Schiavo will win this by a squeaker - perhaps as close as a one-vote margin (with Bush appointees siding with their governor).

Doc wins $366 miilion in peer-review verdict.

It may be the largest verdict in Dallas history: $366 million It has to be the largest plaintiff's verdict in a peer-review case by a physician anywhere, any time. As reported in the Dallas Morning News on Sunday, an interventional cardiologist whose privileges to perform cardiac catheterizations and echocardiograms were temporarily suspended and then reinstated after a panel of national experts defended the quality of the physician's work. Claiming that the temporary suspension harmed his reputation, shrunk his practice, and led to another hospital's decision to deny his application for privileges, the physician sued and won on a variety of claims, including breach of contract, defamation, interference with contractual relations and intentional infliction of emotional distress. (His antitrust claims were dismissed by the judge last fall.) You can view the instructions and verdict form here.

It is impossible to tell, without reviewing the trial record, whether the plaintiff deserved to win this case. His burden was a high one. To get around the immunities provided by the federal Health Care Quality Improvement Act, he had to persuade the jury that the hospital and the physicians who participated in the peer-review action lacked a good-faith belief that its actions were necessary to protect patient health and safety. To win on most of the state-law claims, he had to persuade the jury that the physicians and hospital acted out of malice. The jury form makes it clear that the jury believed his version of the facts with respect to these issues.

It is also impossible to tell, without reviewing the trial record, what could possibly entitle a physician to an award of a third of a billion dollars for the temporary suspension of some of his staff privileges while the hospital looked into the question whether a string of adverse outcomes was nothing more than bad luck or signalled a deeper problem.

But one thing is for sure: This verdict (whether or not it is reduced by the trial judge, and whether or not it is reversed on appeal) will cast a very chilly pall over the peer review activities of hospitals in Dallas County (and elsewhere) and will lead otherwise public-spirited physicians to question whether peer review's gains are worth the personal legal and financial risk.

The Decision of a Lifetime (washingtonpost.com).

Last Saturday The Washington Post published an interesting essay by its long-time chief diplomatic correspondent, Chalmers M. Roberts, whose byline began appearing in the paper in 1949 (the year I was born), who retired in 1971 (the year I graduated from his college and mine), and who in 2004 has appeared for what may well be, at age 93, his last appearance in the pages of the paper he has served so for so long and so well.

The subject wasn't the Iraq war (truth be told, the story there is the lack of diplomacy displayed by the administration of Bush/43) or other international comings and goings, but rather it was Mr. Roberts' heart. Or, more accurately, his aortic valve, which -- like a lot of the rest of his body -- is starting to give out on him. The immediate issue that needed to be addressed this summer was whether to have open-heart surgery, which his cardiologist recommended, to replace the worn-out valve with a porcine one.

Roberts decided against the operation. His reasons display a, well, mature approach to aging and loss and the inevitability of death that strikes me as refreshing and increasingly rare. So much of what I see and deal with on hospital ethics committees arises from the exact opposite instinct: to fight against the inevitable no matter how long the odds are or how remote the chances of "victory." Winning, in Mr. Roberts case, consists in taking satisfaction in a life well lived (interesting career, happy and loving children, a 60-year marriage) and facing the end with equanimity and grace. This essay is a good reminder that "death with dignity" takes its meaning primarily from the goal of "living with dignity," and Mr. Roberts' example is a well-timed and generous one.

Wrongful death claims and the stillborn fetus.

Thanks to Austin friend Louise Joy for alerting me to this case, handed down Thursday by the Texas Supreme Court:

In Fort Worth Osteopathic Hosp., Inc. v. Reese, No. 02-1061, the court held that its ruling in Witty v. Am. Gen. Capital Distrib., Inc., 727 S.W.2d 503 (Tex. 1987) (holding that the statutory wrongful death cause of action does not allow recovery for a stillborn fetus) does not violate the Texas Constitution.

Interestingly, the majority refuses to overrule Witty, primarily because the Legislature codified most of the Witty rule last year. The 78th Legislature amended the definition of "individual" in the wrongful death statute (Tex. Civ. Prac. & Rem. Code § 71.001(4)) to include “an unborn child at every stage of gestation from fertilization until birth,” but as the court notes in Reese, "the statute expressly does not apply to claims 'for the death of an individual who is an unborn child that is brought against . . . a physician or other health care provider licensed in this state, if the death directly or indirectly is caused by, associated with, arises out of, or relates to a lawful medical or health care practice or procedure of the physician or health care provider,'” id. § 71.003(c)(4).

Thus, the court sticks to the Witty rule, which leaves the court with the question whether the exclusion of stillborn fetuses violates the Texas Constitution's equal protection provision (Art. I, § 3). The court concludes that it does not, principally on the ground that, because the U.S. Supreme Court ruled in Roe v. Wade that a fetus is not a "person" for purposes of the 14th Amendment, neither does it enjoy legal protections under the Texas Constitution. The opinion is notable for the utter lack of reasoning in support of its conclusion, other than noting that the law has ever been so. Other states (Maryland, Florida, California) and the Third Circuit agree.

The majority opinion is here. Justice O'Neill's concurring opinion reluctantly agrees with the majority that 17 years of legislative silence (plus 2003's amendments to the wrongful death law) amounts to acquiescence in the Witty rule. Justice Smith's dissenting opinion disagrees with every jot and tittle of the majority's ruling - both the statutory analysis and the equal protection ruling.

Times' obit for Kübler-Ross

Lots more detail than the early AP newswire story: click here. Here's an odd note:

In the later part of her career, she embarked on research to verify the existence of life after death, conducting, with others, thousands of interviews with people who recounted near-death experiences, particularly those declared clinically dead by medical authorities but who were then revived. Her prestige generated widespread interest in such research and attracted followers who considered her a saint.

But this work aroused deep skepticism in medical and scientific circles and damaged her reputation. Her claims that she had evidence of an afterlife saddened many of her colleagues, some of whom believed that she had abandoned rigorous science and had succumbed to her own fears of death.

A great teaching moment:

In 1962, she became a teaching fellow at the University of Colorado School of Medicine in Denver. A small woman, who spoke with a heavy German accent and was shy, despite extraordinary inner self-confidence, she was highly nervous when asked to fill in for a popular professor and master lecturer. She found the medical students rude, paying her scant attention and talking to one another as she spoke.

But the hall became noticeably quieter when she brought out a 16-year-old patient who was dying of leukemia, and asked the students to interview her. Now it was they who seemed nervous. When she prodded them, they would ask the patient about her blood counts, chemotherapy or other clinical matters.

Finally, the teenager exploded in anger, and began posing her own questions: What was it like not to be able to dream about the high-school prom? Or going on a date? Or growing up? "Why," she demanded, "won't people tell you the truth?" When the lecture ended, many students had been moved to tears.

"Now you're acting like human beings, instead of scientists," Dr. Kübler-Ross said.

Her wisdom and tenacity paid off: "Her lectures began to draw standing-room-only audiences of medical and theology students, clergymen and social workers — but few doctors."

The real revolution, the one that occurred among physicians, started to take root in 1965 when

she became an assistant professor in psychiatry at the University of Chicago Medical School, where a group of theology students approached her for help in studying death. She suggested a series of conversations with dying patients, who would be asked their thoughts and feelings; the patients would teach the professionals. At first, staff doctors objected.

The change in professional attitudes came slowly:

To bring public pressure for change in hospitals' treatment of the dying, she agreed to a request by Life magazine in 1965 to interview one of her seminar patients, Eva, who felt her doctors had treated her coldly and arrogantly. The Life article prompted one physician, encountering Dr. Kübler-Ross in a hospital corridor, to remark: "Are you looking for your next patient for publicity."

The hospital said it wanted not to be famous for its dying patients but rather for those it saved, and ordered its doctors not to cooperate further. The lecture hall for her next seminar was empty.

"Although humiliated," she said, "I knew they could not stop everything that had been put in motion by the press." The hospital switchboard was overwhelmed with calls in reaction to the Life article; mail piled up and she was invited to speak at other colleges and universities.

Not that this helped Eva much. Dr. Kübler-Ross said she looked in on her years later and found her lying naked on a hospital bed, unable to speak, with an overhead light glaring in her eyes. "She pressed my hand as a way of saying hello, and pointed her other hand up toward the ceiling. I turned the light off and asked a nurse to cover Eva. Unbelievably, the nurse hesitated, and asked, `Why?' " Dr. Kübler-Ross covered the patient herself. Eva died the next day.

"The way she died, cold and alone, was something I could not tolerate," Dr. Kübler-Ross said. Gradually, the medical profession came to accept her new approaches to treating the terminally ill.

Five Stages of Grief.

The AP story on the death of Elisabeth Kübler-Ross reminds me of a poem that we read in Law, Literature & Medicine, "The Five Stages of Grief" by Linda Pastan:

The night I lost you
someone pointed me towards
the Five Stages of Grief.
Go that way, they said,
it's easy, like learning to climb
stairs after the amputation.
And so I climbed.
Denial was first.
I sat down at breakfast
carefully setting the table
for two. I passed you the toast--
you sat there. I passed
you the paper--you hid
behind it.
Anger seemed more familiar.
I burned the toast, snatched
the paper and read the headlines myself.
But they mentioned your departure,
and so I moved on to
Bargaining. What could I exchange
for you? The silence
after storms? My typing fingers?
Before I could decide, Depression
came puffing up, a poor relation
its suitcase tied together
with string. In the suitcase
were bandages for the eyes
and bottles of sleep. I slid
all the way down the stairs
feeling nothing.
And all the time Hope
flashed on and off
in defective neon.
Hope was a signpost pointing
straight in the air.
Hope was my uncle's middle name,
he died of it.
After a year I am still climbing,
though my feet slip
on your stone face.
The treeline
has long since disappeared;
green is a color
I have forgotten.
But now I see what I am climbing
towards: Acceptance
written in capital letters,
a special headline:
Acceptance,
its name in lights.
I struggle on,
waving and shouting.
Below, my whole life spreads its surf,
all the landscapes I've ever known
or dreamed of. Below
a fish jumps: the pulse
in your neck.
Acceptance. I finally
reach it.
But something is wrong.
Grief is a circular staircase.
I have lost you.

Pastan talks about her work here (20MB sound file; 43:21). Interestingly, she says she wrote the poem when a friend was going through a divorce and it occurred to her that the friend's progress through the divorce resembled Kübler-Ross' five stages of grief.

Kübler-Ross dies.

Elisabeth Kübler-Ross, the path-breaking psychiatrist who wrote On Death and Dying (1969) and whose "fve stages of grief" is taught in every medical school, died Tuesday in Scottsdale at the age of 78. The AP report is here. Kübler-Ross mined a very rich vein of scholarship after her early classic appeared, including such titles as:

• On Life After Death
• Living With Death and Dying
• Life Lessons: Two Experts on Death and Dying Teach Us About the Mysteries of Life and Living
• The Wheel of Life : A Memoir of Living and Dying

In addition to her support for the hospice movement, her writings did more than anyone's to make death and dying a socially acceptable topic for discussion, leading to the advance-directive movement and to the appearance of bestsellers like Sherwin Nuland's How We Die: Reflections on Life's Final Chapter.

Nonprofit hospitals' billing practices examined.

There's a good article by Roger Yu in this morning's Dallas Morning News (requires free subscription) that gets into more of the details of hospitals' billing practices than the USA Today article does. The opening paragraphs tell the story pretty well:

Uninsured and diagnosed with liver cirrhosis, Elaine Sawyer entered the Mayo Clinic in Jacksonville, Fla.

A month later, doctors determined a transplant wouldn't help. She and her husband, Dempsey Sawyer, returned home to McKinney in June with a terminal diagnosis and a hospital bill for $225,000.

Had Mrs. Sawyer, 63, had health coverage, her family might have been responsible for a modest co-payment, and an insurance company would have paid a discounted price – perhaps tens of thousands of dollars less.

"I've talked to some medical people, and they said some of those charges are ridiculous," said Mr. Sawyer, 69, a retired high-tech worker, who borrowed money to pay $190,000 of the bill.

It's not that hard to see how the hospitals got into this situation. First, they have their standard fees - often 3 to 4 times their actual costs. This is the amount that indemnity-type health insurance plans and the uninsured were usually charged. Hardly anyone has an indeminity plan any more: they've been priced beyond the reach of most Americans, for this very reason. Managed care plans exist for basically one reason: to negotiate discounted fees for their insureds. Their rates average about 13 percent above cost (though averages are a bit misleading) and Medicare has legislated itself a sweet deal of 1 percent (on average) above cost.

So who's left paying the full charges? The uninsured. "Paying" may be a misnomer. That's the amount they are billed. Very few pay the full bill and many pay nothing. But that doesn't stop the hospitals from sending bills and trying to collect. As well they should. I believe that, as good stewards of the public's tax subsidy for their operations, nonprofit hospitals have an obligation to take reasonable steps to bill and collect for the services they render.

Is there any relief for the truly indigent? Yes, some. As the article points out:

"It's important to understand that a hospital charges patients the same amount regardless of the type of insurance," said Carmela Coyle, policy analyst with American Hospital Association.

Hospitals in Texas say they can't lower charges for the uninsured because state law prohibits them from knowingly charging more to individuals who have insurance.

The Texas Department of Insurance says this law doesn't apply to Medicare and Medicaid patients or to the "medically indigent."

Patients who qualify for the label "medically indigent" can get a break. All others get the full billed charge, even though a lot of those charges get written off as bad debt after collection efforts have failed.

Nonprofit hospitals in Woe-town (USA Today)

An article in today's USA Today ("Scales tipping against tax-exempt hospitals") provides a laundry-list of legal challenges facing the nonprofit hospital industry. Here's the quick rundown:

•The IRS is looking at salaries paid to executives and officers of 2,000 of the nation's charities and non-profit foundations, which include hospitals. Salaries deemed “excessive” may violate federal law.

•Three congressional committees are investigating non-profit hospitals, looking at how they charge the uninsured, the tactics they use to collect unpaid bills and the amount of charity care they provide. New rules could result. Possibilities include more uniform financial reporting standards and regulations on the size and make-up of hospital boards.

•States and local property tax authorities are renewing their interest in hospital tax exemptions. In Illinois, the Department of Revenue denied the property tax exemption of one hospital, and the status of a second hospital is under review. Similar efforts in the 1990s led some states to require hospitals to report annually on their charitable activities.

•More than 40 class-action lawsuits have been filed since June by a team of high-profile law firms against nearly 400 not-for-profit hospitals. The lawsuits take issue with the way the hospitals treat the bills of the uninsured, saying their tax-exempt status implies that they should be more lenient with the uninsured.

Billing and collections practices are behind a lot of this scrutiny: "'When you start throwing people in jail because they don't show up for a court hearing on their overdue bills, that attracts attention,' says John Colombo, professor of law at the University of Illinois at Urbana-Champaign. 'The question will be: "Why is it we're providing these huge tax subsidies to these organizations?"'"

Bush's health plan doesn't produce claimed results.

And Kerry's will almost undoubtedly cost more -- as much as $300 billion more -- that his campaign's estimate of $653 billion over 10 years. That's what the experts, including those at the nonpartisan Congressional Budget Office, are saying, according to an article in yesterday's Washington Post by Ceci Connelly, whose reporting on the political side of health issues continues to be the best around.

Speaking of the CBO, there's a good article about its new director, who is catching some flak from his former bosses at the White House for publishing studies that don't toe the party line, in today's N.Y. Times.

GPO's receive subpoenas from Dallas' U.S. Attorney.

This is going to be huge.

Novation, one of the largest group purchasing organizations (GPO's) in the country ($20 billion a year in sales), has been served with subpoenas signed by the chief of the criminal division of the U.S. Attorney's office in Dallas, according to an article in Saturday's N.Y. Times. It's part of a much larger investigation into the way medical supplies are purchased, sold to hospitals, and billed to federal health programs like Medicare. Novation is owned by, and sells to, some of the largest and most prestigious nonprofit health care centers in the country, who in turn bill Medicare. Ultimately, the investigation will be looking into the hospitals' billing practices.

Medicare reform hits insurers' opposition.

The biggest reform package to amend Medicare since its inception in 1965 (passed last fall) is famously unpopular with seniors (at least the ones who know the details). It also really hacked off Congressional Democrats and Republicans alike, who have objected to being lied to about the true price of the reforms by the White House (through the DHHS/CMS chief actuary, acting under "orders" (literally a threat) from his boss, CMS chief Tom Scully). Now comes the story in the August 22 N.Y. Times that insurers don't much like it either, because it would require them to insure regionally, rather than locally or on a statewide basis, which most if not all insurers claim is not financially feasible. The insurers, of course, like to insure relatively low-cost insureds, and those are found in greater numbers in the cities. Rural patients cost insurance companies more, and the insurers shun them like the . . . well, you know. Of course, the insurers could raise premiums to cover their increased costs, but that would make them less competitive against other insurance companies who aren't in the Medicare market.

This is one more small example of a nearly universal pattern in American health care. Cream-skimming the insurance market, shifting costs to someone else, jimmying your product or your market so that you avoid high costs and thereby help to ensure hefty operating margins -- all of these techniques, which the federal government applies just as skillfully as the private insurance companies, are designed to get "someone else" to pay for the most expensive health care. The result is patchwork affair that will someday have more holes than fabric. The truth is, there is no free ride in health care. Everything gets paid for by someone, whether it's taxpayers, shareholders, other patients' health plans (and therefore other patients and their employers), consumers whose costs are inflated by the cost of health care, citizens who travel further (and at greater risk) for trauma care because of ER closings, the hospital employees who work longer hours for less pay . . . the costs are covered many different ways, some hidden and some more visible. Many of the ways these costs are covered are bad for everyone's health and drive costs up higher than they otherwise would be.

This is nuts. Who is going to bite the political bullet and propose a realistic plan for covering the actual costs of providing health care to all? Neither Kerry nor Bush has really come up with anything close, though Kerry's health plan would do much more for the uninsured than Bush's (and at a much higher cost). Ironically, the Medicare reform law's requirement of regional insurance plans was probably a step in the right direction, but that isn't the way the insurers, who prefer business as usual, want to compete.

First-ever HIPAA conviction.

I'm not sure we needed HIPAA in order to prosecute the conduct described in this press release, but that's the statute that was used by the US Attorney in Seattle to convict Richard Gibson, who admitted that he "obtained a cancer patient's name, date of birth and social security number while [he] was employed at the Seattle Cancer Care Alliance, and that he disclosed that information to get four credit cards in the patient's name. G[ibson] also admitted that he used several of those cards to rack up more than $9,000 in debt in the patient's name. [He] admitted he used the cards to purchase various items, including video games, home improvement supplies, apparel, jewelry, porcelain figurines, groceries and gasoline for his personal use."

DHHS/Health Information Technology: GAO Briefing

The Government Accountability Office (GAO) has published a good summary of the efforts of the Department of Health and Human Services (DHHS) to promote the development and widespread use of electronic health records and the legal environment in which those efforts are being carried out. The briefing document for the staff of the Senate Committee on Health, Education, Labor, and Pensions is entitled, "HHS’s Efforts to Promote Health Information Technology and Legal Barriers to Its Adoption" [GAO-04-991R, August 13, 2004].

Related Recent GAO Reports:
Health Care: National Strategy Needed to Accelerate the Implementation of Information Technology. GAO-04-947T, July 14, 2004 (12 pages).

Medicaid Waivers: HHS Approvals of Pharmacy Plus Demonstrations Continue to Raise Cost and Oversight Concerns. GAO-04-480, June 30, 2004 (74 pages).

Medicare: CMS Needs Additional Authority to Adequately Oversee Patient Safety in Hospitals. GAO-04-850, July 20, 2004 (50 pages).

Illegal immigrants and emergency care.

As previously mentioned here, CMS has announced its plan to implement a provision of the Medicare reform law that is intended to provide some relief for states hit with high costs for providing emergency medical treatment for undocumented immigrants. As reported today's N.Y. Times, one of the quid's that accompanies the government's quo is a requirement that hospitals inquire into and record the immigration status of their patients. Although Congress claims the inquiry is intended to make sure the money provided to the states (including $48 million to Texas) is paid for care to illegal immigrants, it's not at all clear that this will be the effect of the required inquiry: "Hospital executives and immigrant rights groups said the questioning would deter undocumented immigrants from seeking hospital care when they need it, and some hospitals said compliance might cost them more than they would receive in federal aid."

More on stem cells.

If you thought I was too tough on Tommy Thompson's political news release on stem cells earlier this week (see below), here are some excerpts from George Q. Daley's upcoming article, "Missed Opportunities in Stem-Cell Research," slated for publication in the August 12 issue of the New England Journal of Medicine, and released early through the journal's web site today (may require paid subscription):

• "The President’s policy has severely curtailed opportunities for U.S. scientists to study the cell lines that have since been established, many of which have unique attributes or represent invaluable models of human disease."


• "Some 128 new human embryonic stem-cell lines have been produced worldwide since the President’s announcement. . . . Though the federal government is the principal patron of peer-reviewed biomedical research, U.S. scientists studying these cell lines cannot obtain grant support through the National Institutes of Health (NIH); they must find funding from private foundations or philanthropic sources that seldom provide predictable, long-term support."


• "Although the pre-2001 lines facilitate . . . basic studies, they have limited potential for use in clinical therapies. All were cultured in contact with mouse cells and bovine serum, which renders them inferior to newer lines, derived under pristine conditions, for potential therapeutic applications. Moreover, given the limited genetic diversity of the lines, transplantation of their products would face the same immune barrier as organ transplantation. More important questions can be addressed only by means of the lines modeling specific diseases, and therapies may best be pursued with lines genetically matched to specific patients through somatic-cell nuclear transfer. Such approaches are precluded by current policy."


• The science of human embryonic stem cells is in its infancy, and the current policies threaten to starve the field at a critical stage. The explosive growth of research that followed the isolation of mouse embryonic stem cells in 1981 ushered in a revolution in developmental biology. It will be discouraging if studies of human embryonic stem cells, which have such profound implications for human health, are unable to keep pace.

Stem cells.

In an apparent attempt to close the "stem cell gap" between Democrats and Republicans, skillfully highlighted by Ron Reagan at the DNC Convention in Boston, Secretary of Health and Human Services Tommy Thompson released a statement on the subject today. It's not on the HHS Press Office's web page yet, so here it is in full, with my commentary:

Date: August 8, 2004
For Release: Immediately
Contact: HHS Press
Office
(202) 690-6343

STATEMENT BY HHS SECRETARY TOMMY G. THOMPSON ON PRESIDENT'S EMBRYONIC STEM CELL POLICY

Quotable political soundbite/opening paragraph: Three years ago, President Bush opened the nation's laboratory doors for the first time to federal taxpayer funding for human embryonic stem cell research. The President remains committed to this groundbreaking policy that is advancing medical research into some of our most debilitating diseases. As we look forward to further progress on stem cell research, both embryonic and adult, it is important to keep in mind several important points.

President Bush provided - for the first time - federal funding of embryonic stem cell research. [Technically true, but only because Clinton's funding policy came late in his second term and Bush suspended it soon after taking office. Bush's own policy, announced in August 2001, was considerably more restrictive than Clinton's would have been.] The President's unprecedented decision [if you don't count Clinton's] allows for federal funding of research using existing stem cell lines that were derived before Aug. 9, 2001, with no limits on private funding of research. [Limits on private funding would probably have required a change in federal law, and Bush probably understood that he couldn't get such a law passed in 2001, any more than he could get it today.] The President believes that federal funds should not be used to encourage or support further destruction of human embryos, a principle that has been part of federal law since 1996. [And it's a policy that make almost no sense in the context of stem cells. With IVF clinics storing 10's of thousands, if not 100's of thousands, of frozen embryos that have already been designated for donation to research, or which could be legally donated by the clinics, or that have not been designated for any use and will eventually (despite staying frozen) break down and be useless for any purpose, does it make any sense at all to deny federal funds for research on stem cells derived from these embryos?] The impact of the President's decision was to open the flow of federal research dollars for embryonic stem cells and help accelerate work in this field.

The policy is working. [Sort of, and not nearly as well as it could be.] Under President Bush, federal funding for embryonic stem cell research has grown from zero under previous administrations to $24.8 million in fiscal year 2003 [a drop in the bucket], with no limits on future federal funding of research on eligible lines. [The limits are inherent in the eligible lines themselves, which this statement conveniently fails to acknowledge constitute a fraction of the number of cell lines the president based his policy on.] This investment has supported more than 500 shipments of stem cell lines to researchers around the world who are in the early stages of finding ways stem cells can be used to treat diseases such as neurological disorders, diabetes and heart disease. Additionally, in fiscal year 2003, the National Institutes of Health provided $190.7 million in adult stem cell research, which continues to show exciting promise.

The administration is working to maximize research opportunities within the federal guidelines. The NIH is taking new steps to create a National Embryonic Stem Cell Bank that will provide a ready source of human embryonic stem cells to scientists, ensure consistent quality of the lines and provide other technical support that will make it easier for scientists to use these lines. The NIH is also creating three new Centers of Excellence for Translational Stem Cell Research with the goal of exploiting new discoveries in basic embryonic and stem cell biology.

Let's take advantage of the great opportunity that exists before arguing that more is needed. The President's policy holds tremendous and yet-untapped potential, and there is much work to do. Before anyone can successfully argue that the existing federal stem cell policy needs to be broadened, we must first exhaust the potential of the stem cell lines made available within the policy, as well as the ability of the private sector to go beyond the policy. [Why? We already know the current policy isn't going to get enough stem cell lines into the hands of enough researchers for us to unlock the potential of stem cells anytime soon. Why not unleash that potential now, with a significant increase in the number of cell lines and an increase in the amount of federal funds devoted to this research project?] Keep in mind: More lines are available in the United States than any other country in the world. And while federal funding has paid for more than 500 shipments to researchers to date, more than 3,500 shipments are still available. Unlike many countries, there are no limits in the United States on private stem cell research. One study estimates that 1,000 scientists at more than 30 firms spent $208 million experimenting on embryonic and adult stem cells in 2002 alone.

Quotable political soundbite/closing paragraph: The future is promising. Years of hard work remains to be done before the basic research of today can become viable treatments and cures tomorrow. There is good reason to be optimistic. And this optimism is made possible by the reasoned policy of President Bush. Fair and reasonable people can disagree on this complex and difficult issue. President Bush made a tough decision that invested in the scientific promise of embryonic stem cell research without compromising an important ethical line. Three years later, it is clear that this balanced approach is working. The future is promising with the new research opportunities provided by President Bush's historic decision.

Nonprofit class actions: 1st settlement announced.

Modern Healthcare is reporting that "[s]ix-hospital North Mississippi Health Services, Tupelo, reached an agreement with a Mississippi law firm to provide an estimated $150 million in refunds, debt forgiveness, discounts and free care to about 48,000 eligible uninsured patients. The $150 million would cover the system's obligations under the agreement for the past three years and into the future. The system is the first to address the issue with a group of plaintiffs' attorneys that has filed class-action lawsuits against 40 not-for-profit hospitals and systems covering more than 300 hospitals in 21 states. The lawsuits allege that the hospitals overcharge uninsured patients and are unfair in pursuit of payment."

There may be less here than meets the eye. This system has not yet been sued; it resides in Richard Scruggs' backyard; and it doesn't appear to cost the hospital system any real money that it wasn't already planning to spend:

North Mississippi had not been named in any of the lawsuits. However, the system reached an agreement with attorney Richard Scruggs and the Scruggs Law Firm of Oxford, Miss., because 'there are several community issues we need to be addressing,' North Mississippi's chief executive officer, John Heer, said in a system news release. A lawsuit would be distracting, and the proposed discounts were similar to North Mississippi's current policy, Heer said.

In a national teleconference, Scruggs said the attorneys group has approached several not-for-profit hospitals that have not yet been sued about reaching an agreement. Scruggs praised North Mississippi and called its agreement with the firm 'a very compelling template for the other hospitals and the American Hospital Association.' Under the agreement, which is awaiting approval by a federal judge, North Mississippi will not charge eligible uninsured patients more than 10% of their annual income. It also will provide free care, prospectively and retrospectively, to uninsured patients earning up to 200% of the federal poverty level and for uninsured patients earning more, it will establish a sliding fee scale based on Medicare rates. Scruggs said the system can ask the federal judge in U.S. District Court, Aberdeen, Miss., to revise the agreement if the terms prove too costly.

The teleconference/news conference can be downloaded here (follow links to main litigation page).

Abortion and deceptive trade practices.

It's a somewhat unusual combination, but a federal judge in New Orleans enjoined a local man from a variety of deceptive trade practices all intended to interfere with the abortion rights of women (see AP newswire story, courtesy of the Boston Globe). According to the news story:

US District Judge Stanwood Duval granted a preliminary injunction against William A. Graham, who was accused of listing the business phone of his Causeway Center for Women under ''Abortion Services" and making misleading statements aimed at delaying women until it was too late to get legal abortions. . . .

The lawsuit accused Graham of pretending to refer women to abortion providers at bargain prices, then telling them their appointments had been postponed. Louisiana law allows abortions only during the first 24 weeks of pregnancy.

One plaintiff said Graham told her that if an abortion were ''performed too early, it could be harmful to her health," according to the lawsuit.

Elizabeth Nette of Metairie, La., said Graham deterred her 19-year-old daughter, Mary Schloegel, from getting an abortion.

Nette contacted Graham in January. Graham told her he would set up appointments at a local hospital, but delayed them for six weeks, Nette said.

Schloegel is now eight months pregnant and will have the baby.

As unconscionable as Graham's conduct is (regardless of one's views of abortion), his comment was, ''I still don't see that we've done anything wrong." Clueless.

Indigent care woes.

The Milwaukee Journal-Sentinel has an article in today's paper about cutbacks by Aurora Sinai, a downtown hospital that serves a mostly poor patient population. Bottom line: Sinai isn't making enough money on Medicare and Medicaid patients to offset losses incurred from treating poor patients whose care is paid for by the county's general assistance medical program ("GAMP"). Following back-to-back losses of $24 million last year and $14 million projected for this year -- "[e]ven with staff cutbacks, clinic and ward closures and tougher restrictions on care in Sinai's emergency department" -- the hospital is encouraging its physicians to see fewer GAMP patients, which it hopes will translate into fewer GAMP admissions. A hospital spokesman said, "We are cutting back generally on the population that hurts us the most."

This, of course, is going down like chopped hay in local circles. First, there is the criticism that a tax-exempt hospital darned well ought to be able to provide charity care, which resonates with lawmakers on Capitol Hill, who are holding hearings in the House and the Senate on this topic, and is part and parcel of the 31 class-action lawsuits filed this summer against tax-exempt hospitals all over the country. Logically, however, there is nothing about tax-exempt status that precludes crippling financial losses. Put otherwise, is there any reason to believe that a hospital's tax savings are necessarily sufficient to pay for all the uncompensated care some hospitals are geographically and demographically situated to provide?

Then there's the criticism that at the same time Sinai is cutting back on services to GAMP patients it is seeking governmental approvals to build an $85 million 88-bed suburban hospital 3 miles from an existing facility. Of course, excess net operating revenues from the new hospital could offset operating losses at the downtown hospital and allow Sinai to see more GAMP patients, but critics of tax-exempt hospitals often miss the point that you sometimes have to spend money to make money, even in the nonprofit health sector.

For Dallas County residents, this all sounds dizzyingly familiar, right down to the County Commissioners' criticism of Parkland Hospital's plan to building an out-patient surgery center at the corner of Harry Hines and Motor Street. Aurora Sinai's statement that it want "to reinvent itself as a downtown destination hospital. We want a healthy mix of commercial and neighborhood patients" could have been taken from a page out of Parkland's playbook.

The article concludes with some insightful comments:

"[T]he even bigger issue here is that our health care system is broken, and relying on charity care is a weak patch to put on the system. We need political leadership in Milwaukee County and in this state to overhaul our health care system," said [Darcy Haber, health care campaign director of Wisconsin Citizen Action, a consumer advocacy group].

Aurora Sinai's downtown location is the reason it serves so many poor people, said John Whitcomb, director of Sinai's ER department.

"We are the last ones standing downtown. Someone please help us," he said. "The real villain here is an inadequate health care system."

Many hospital admissions are the result of poor patients not receiving primary care, said Bevan Baker, Milwaukee health commissioner. As they get sicker with conditions that could be managed in a primary care setting, they require expensive hospitalization, he said.

"The solutions are not wrapped around Aurora but around an understanding that care should be assessed through the primary care route," Baker said.

Reproductive rights update.

There are two items of note in today's news roundup:

• The Department of Justice has appealed their trial-court loss in San Francisco in which the district court declared the 2003 federal ban on late-term abortions unconstitutional; you can read the San Francisco Chronicle story here. Considering the unbroken string of losses they have suffered on this statute, which blatantly and baldly fails to include an exception to protect the health of the mother (as required by the Supreme Court in Stenberg), you have to wonder: Is this issue about anything other than staying in touch with the Republicans' conservative base and giving the president a debating point between now and November?
• Planned Parenthood (which is a plaintiff in the San Francisco litigation) has joined with the ACLU in a suit to take a parental-notification provision off the November 2 ballot; you can read the Tallahassee Democrat article here. The plaintiffs claim that the wording of the ballot item deceptively claims that it increases privacy protections: "'What it fails to tell voters is that it will reverse Florida Supreme Court decisions and take away the privacy rights guaranteed by the Florida constitution,' said ACLU attorney Randall Marshall." The ACLU's press release on the suit is here.

Uncompensated care and undocumented immigrants.

Two developments in the past couple of weeks provide enduring lessons in the politics of health care for undocumented immigrants.

On July 22 the Texas Attorney General issued Opinion No. GA-0219 to answer the question whether section 285.201 of the Health and Safety Code requires a hospital district to provide nonemergency public health services to undocumented persons who are otherwise ineligible for those benefits under federal law.

Background: In 2001, the Texas Attorney General told the Harris County Hospital District that federal law prohibited the district from providing free or discounted nonemergency health care to undocumented persons. Tex. Att'y Gen. Op. No. JC-0394 (2001). The Attorney General relied on the Federal Personal Responsibility and Work Opportunity Reconciliation Act ("PRWORA"), 8 U.S.C. §§ 1601-41 (2002), which provided that "undocumented or illegal aliens are ineligible for state and local public assistance, subject to specific exceptions." The Attorney General further observed that federal statute "preempts contrary state laws and renders illegal the state and local programs that provide public benefits to aliens contrary to its terms." The opinion concluded that, under the present state of Texas law, the federal statute prohibited the Harris County Hospital District. The opinion also noted, however, that the PRWORA contains an exception authorizing states to provide additional public benefits to undocumented persons. 8 U.S.C. § 1621(d) (2002).

That is precisely what the 78th Legislature did in 2003 when it added Tex. Health & Safety Code Ann. § 285.201 (Vernon Supp. 2004):

As authorized by 8 U.S.C. Section 1621(d), this chapter affirmatively establishes eligibility for a person who would otherwise be ineligible under 8 U.S.C. Section 1621(a), provided that only local funds are utilized for the provision of nonemergency public health benefits. A person is not considered a resident of a governmental entity or hospital district if the person attempted to establish residence solely to obtain health care assistance.

(emphasis added)

The question posed to the AG focused on the word "eligibility" and asked whether this provision requires a hospital district to furnish nonemergency public health benefits to undocumented persons, or, on the other hand, whether it merely permits a hospital district to do so.

Based upon the AG's reading of various dictionary definitions of "eligibility," as well as Texas caselaw, see Foreman v. Security Insurance Co. of Hartford, 15 S.W.3d 214 (Tex. App.-Texarkana 2000, no pet.) (requires WestLaw subscription), and legislative history, the AG concluded that "eligible," as used in this statute, means something less than "entitled," and therefore hospital districts are permitted but not required to provide nonemergency public health benefits to undocumented persons. This is bad news for undocumented immigrants, who can be turned away from hospitals with impunity unless they have an emergency condition, and it's bad news for the hospitals, which are faced with the Hobson's choice of admitting patients for treatment before their condition becomes life-threatening or waiting until the patients come to the hospitals' emergency departments hours, days, or weeks later with emergency medical conditions and the legal right to receive (more expensive) medical treatment. Of course, Texas (like most states) has never suggested how the care for these patients should be paid for.

Also on July 22, CMS announced a plan to implement a plan for hospitals and other providers to recoup $250 million a year for the next 4 years against the cost of providing unreimbursed health care services to undocument immigrants in emergency rooms. The plan can be read here. The plan would implement a provision in the Medicare reform act sets aside $1 billion over 4 years and requires CMS to have a plan in place by September 1. Comment: The amount that's been appropriated is a drop in the bucket, and it ignores the even more substantial costs of in-patient care for those emergency-department patients who have to be admitted in order to be stabilized as required by the Emergency Medical Treatment and Labor Act (EMTALA). But it's a start, and more of a start than we are seeing from the Lone Star State.

Maternal-fetal conflict, Texas style.

As reported in an article by Mary Alice Robbins in the Aug. 2 issue of Texas Lawyer, the Potter County DA is prosecuting a woman whose newborn tested positive for cocaine. The woman is charges with a violation of the Controlled Substances Act, Health & Safety Code § 481.122, which provides:

(a) A person commits an offense if the person knowingly delivers a controlled substance listed in Penalty Group 1, 1-A, 2, or 3 or knowingly delivers marihuana and the person delivers the controlled substance or marihuana to a person:
(1) who is a child . . . .
(c) An offense under this section is a felony of the second degree.
(d) In this section, "child" means a person younger than 18 years of age. . . .

It would be a stretch to apply this section to a pregnant woman who ingests cocaine and thereby "delivers" the controlled substance to her fetus, except for the fact that the 78th Texas Legislature passed S.B. 319 in 2003, which amended the definition of "person" in the Texas wrongful death statute and the Penal Code to include "an unborn child at every stage of gestation from fertilization until birth." The Legislature was careful, in amending both statutes, to make it clear that the new definition does not apply if the harm to the fetus is the result of conduct by the mother.

What am I missing here? First, the Legislature did not amend the Controlled Substances Act's definition of "child" to include an unborn child. So the amendments to the Wrongful Death Statute and Penal Code should be beside the point.

Second, with respect to the only Penal Code provisions that could conceivably apply to the alleged conduct (in addition to the Controlled Substances Act in the Health & Safety Code) -- which would include assault, endangering a child, and deadly conduct -- the Legislature made it clear that the new definition does not apply when the dangerous or harmful conduct is the mother's.

So if the 2003 change to the definition of "individual" doesn't apply, and the Legislature did nothing that would expand upon the class of protected persons in H&S Code § 481.122, this prosecution comes down to the now widely rejected theory that a woman can unlawfully "deliver" a controlled substance to a fetus prenatally. As terrible as it is for a woman to take cocaine while pregnant, there are plenty of good policy arguments against prosecuting a woman who does.

For health care providers, however, the Potter County DA's interpretation of the Controlled Substances Act is an ominous one. Reportable child abuse under chapter 261 of the Texas Family Code includes the following:

(I) the current use by a person of a controlled substance as defined by Chapter 481, Health and Safety Code, in a manner or to the extent that the use results in physical, mental, or emotional injury to a child; [or]
(J) causing, expressly permitting, or encouraging a child to use a controlled substance as defined by Chapter 481, Health and Safety Code.

It also includes

(B) causing or permitting the child to be in a situation in which the child sustains a mental or emotional injury that results in an observable and material impairment in the child's growth, development, or psychological functioning; [or]
(C) physical injury that results in substantial harm to the child, or the genuine threat of substantial harm from physical injury to the child, including an injury that is at variance with the history or explanation given and excluding an accident or reasonable discipline by a parent, guardian, or managing or possessory conservator that does not expose the child to a substantial risk of harm.

If any of these forms of abuse can be directed at an "unborn child," then physicians, nurses, and others who know the child tested positive for cocaine at birth have an obligation to inform Child Protective Services or local or state law enforcement authorities (Family Code § 103). This is a drastic expansion of current legal duties and would appear to fly in the face of the Supreme Court's 2001 decision in Ferguson v. City of Charleston.

I repeat: What am I missing?

Medical error: does it kill 195,000 annually?

When the IOM study, To Err Is Human (report brief), came out in 1999, it caused an uproar with its estimate that as many as 95,000 Americans a year die as the result of preventable medical error. According to HealthGrades, that estimate would have been twice as large if the IOM had included (1) failure to diagnose and treat a serious medical problem in time and (2) unexpected death in a low-risk hospitalization. HealthGrades bases its estimate on a review of 37 million Medicare records. Their report is HealthGrades Quality Study: Patient Safety in American Hospitals (July 2004).