If you liked "Farenheit 911" . . .

. . . you just might love Michael Moore's next documentary effort. According to an article today's Chicago Tribune (rquires free registration), he is finalizing financing for a film -- tentatively entitled "Sicko" -- about the American health care system, or at least about two of the country's least favorite players: managed care and the drug companies. Meanwhile, the paper reports, "Some of the nation's biggest drug manufacturers and health insurance plans confirm they have issued warnings to their sales representatives and other employees in recent weeks, telling them to be on the lookout for the shaggy filmmaker in his trademark baseball cap. And, under no circumstances, are they to talk to Moore."

Boundary dispute.

The Miami New Times will publish a piece on Thursday that raises troubling questions of possible boundary violations by a physician. We're not talking about a property dispute over a fence line, but the kind of boundary defined by medical ethics. A physician shouldn't have a romantic or sexual relationship with a patient she or he is treating; that's a boundary violation, crossing over a line that defines the outer limits of the physician-patient relationship. Patients are presumed to be vulnerable and desperate and therefore not in a good position to exercise reasonable judgment or to freely consent or refuse to consent to the conduct in question.

The article focuses on a different type of boundary dispute: money. Specifically, it says that the families of two patients of a physician are contesting their decedents' wills -- which left sizeable portions of their estates to their physician -- on the ground of undue influence. In three cases detailed in the story, the paper reports the following pattern:

All [three women] spent their adult lives in Miami. All of them had been married, but had no children. All lived into their nineties, widows left to grow old in magnificent, rambling houses, beyond whose doors they rarely ventured. All of them left behind estates worth hundreds of thousands of dollars. All of them had employed Dr. Aloysius "Al" Brady as their primary care physician.

When they died, all of them left Brady a significant portion of their estates, or control of the estates.

Sixty-six-years-old, tall with long limbs, and a cadaverous complexion right down to his bone white hair and mustache, Brady has established a pattern of becoming the most important man in the life of women with surprisingly consistent backgrounds: wealthy, childless, frail, nonagenarians.

It appears he accomplished that by making more than just house calls. He bought them groceries and offered to manage their checkbooks, even if there were already people performing these tasks. He also stopped by for cocktails and bought dinner and flowers. In short, say family and friends, who described all of the women as homebound and lonely, he charmed them.

The doctor's lawyer denies the charges. The facts may or may not bear out the accusers' claims, but the cases stand as an illustration of an important ethical principal:

"Another clear rule [says Kenneth Goodman, co-director of the University of Miami's ethics program, and director of its bioethics program] is that you don't borrow money from your patients, and you don't insinuate yourself into their wills. Any time you find yourself in a patient's wallet or checkbook for anything other than a fee, you've gone from practicing medicine to doing something altogether different."

Euthanasia rights for minors.

There are reports (also here) of a coalition of bioethics groups that oppose a recent proposal that would allow patients down to the age of 12 years to obtain euthanasia services without parental consent. Currently, 16-17-year-olds can decide for themselves. I am still looking for independent verification that the Dutch are considering a change in their law.

End of life decision making

Here's long piece in Monday's New York Times about end-of-life decision making. This really resonates with me -- a lot of cases that come to one of the five hospital ethics committees I serve on present just like the cases described here.

Health care costs & technology.

Article worth reading from today's "Week in Review" section of the N.Y. Times: "Health Care Costs Are a Killer, but Maybe That's a Plus," by Steve Lohr. The message: even after we've squeezed out the 10-20% of health care costs attributable to inefficiencies and waste, you can expect health care costs to continue to spiral upward. Electronic medical records, computerized prescriptions, and automated billing systems (all of which will require the investments of billions of dollars in new hardware and software infrastructure), will help reduce the mountains of paper records, lost files, incorrect billing codes, etc., but it will do nothing for our (understandable, even justifiable) taste for high-tech medicine.

"High-tech" doesn't only mean coated coronary artery stents (at $2500 apiece, compared to $1000 for the uncoated variety) and wondrously noninvasive 3-D imaging devices. It also includes the deceptively simple drug delivery devices -- the pill and the capsule -- that get ever more effective pharmaceuticals into our bloodstream. Big Pharm has its critics (including me), but there's little debate over the contribution made by drug companies to the quality and longevity of human existence:

In a working paper for the National Bureau of Economic Research, a nonprofit research group, Frank Lichtenberg, an economist at Columbia University's business school, has concluded that 40 percent of the increased longevity in 52 countries over the last 20 years can be attributed to new drugs. The cost in pharmaceuticals for an extra year of life was on average $5,000 a person, according to his research.

"In general, the benefits of new drugs outweigh the costs by a substantial margin," Mr. Lichtenberg said.

One point not made by the article, but worth considering: Not only do these advances not come cheap. But added years of life mean added years of consuming health care technologies and services. Our successes, in other words, contribute to the ever higher bills we pay as a country.

First Amendment: Is there a right to clone?

Brian Alexander has an interesting article in Sunday's N.Y. Times Magazine in which he raises the possibility that scientific research is protected by the First Amendment, just like speech. The gist of the article is in the following paragraphs:

Why legal scholars would defend the right to research is hardly mysterious. The founding fathers passionately defended scientific and academic freedom, and the Supreme Court has traditionally had a high regard for it. In Griswold v. Connecticut, for example, the decision that struck down state prohibitions on the sale of contraceptives, the court stated that the First Amendment protected ''freedom of inquiry.'' But why would the right to read, write and speak as you please extend to the right to experiment in the lab?

Arguments in favor of applying First Amendment scrutiny to antiresearch laws can be complex, but the metaphors lawyers have used are not. One, proposed in separate articles by John Robertson of the University of Texas and James Ferguson, who teaches at Northwestern, compares scientists to reporters. As with journalism, actions that are not strictly speech (research) are so necessary to speech (publishing) that to ban them is to ban the speech.

R. Alta Charo, legal scholar and bioethicist at the University of Wisconsin, says that some experiments are constitutionally protected ''expressive conduct'' in their own right. ''If the questions you ask and the science you do really challenges or explores cultural or religious or political norms . . . that in itself is an act of rebellion, and this is exactly the sort of thing that fits comfortably in the spirit of the First Amendment.''

Just to be clear: this is not an argument that funding -- say, for embryonic stem cell research or cloning -- is constitutionally protected, only that a ban on such research would be constitutionally protected.

Schiavo: Is this the end of the road?

Google News shows 489 stories (and counting) about the Florida Supreme Court's decision yesterday to strike down "Terri's Law," which the state legislature hastily passed last year to authorize Gov. Jeb Bush to circumvent the Florida courts' consistent determinations that Michael Schiavo was the appropriate decision maker on behalf of his wife, lying in a permanent vegetative state in a Florida facility. (For my part, I've probably devoted more space in this blog to the Shiavo case than any other single case or issue: earlier posts can be found here.)

The Supreme Court's unanimous decision concluded that Terri's Law violated the doctrines of separation of powers (by allowing the governor to upset final judgments of the courts) and nondelegation (by effecting a standardless delegation of legislative power to the governor). The court's conclusion is worth reading in full:

We recognize that the tragic circumstances underlying this case make it difficult to put emotions aside and focus solely on the legal issue presented. We are not insensitive to the struggle that all members of Theresa’s family have endured since she fell unconscious in 1990. However, we are a nation of laws and we must govern our decisions by the rule of law and not by our own emotions.

Our hearts can fully comprehend the grief so fully demonstrated by Theresa’s family members on this record. But our hearts are not the law. What is in the Constitution always must prevail over emotion. Our oaths as judges require that this principle is our polestar, and it alone.

As the Second District noted in one of the multiple appeals in this case, we “are called upon to make a collective, objective decision concerning a question of law. Each of us, however, has our own family, our own loved ones, our own children. . . . But in the end, this case is not about the aspirations that loving parents have for their children.” Schiavo IV, 851 So. 2d at 186. Rather, as our decision today makes clear, this case is about maintaining the integrity of a constitutional system of government with three independent and coequal branches, none of which can either encroach upon the powers of another branch or improperly delegate its own responsibilities.

The continuing vitality of our system of separation of powers precludes the other two branches from nullifying the judicial branch’s final orders. If the Legislature with the assent of the Governor can do what was attempted here, the judicial branch would be subordinated to the final directive of the other branches. Also subordinated would be the rights of individuals, including the well established privacy right to self determination. . . . No court judgment could ever be considered truly final and no constitutional right truly secure, because the precedent of this case would hold to the contrary. Vested rights could be stripped away based on popular clamor. The essential core of what the Founding Fathers sought to change from their experience with English rule would be lost, especially their belief that our courts exist precisely to preserve the rights of individuals, even when doing so is contrary to popular will.

The trial court’s decision regarding Theresa Schiavo was made in accordance with the procedures and protections set forth by the judicial branch and in accordance with the statutes passed by the Legislature in effect at that time. That decision is final and the Legislature’s attempt to alter that final adjudication is unconstitutional as applied to Theresa Schiavo. Further, even if there had been no final judgment in this case, the Legislature provided the Governor constitutionally inadequate standards for the application of the legislative authority delegated in chapter 2003-418. Because chapter 2003-418 runs afoul of article II, section 3 of the Florida Constitution in both respects, we affirm the circuit court’s final summary judgment.

Is this the end of this ghoulish litigation trail? The governor's lawyers can file for reconsideration, of course, and in this election year they might just do that. As The New York Times reports in Friday's edition: "A spokeswoman for Mr. Bush, Jill Bratina, said his lawyers were exploring options like requesting a rehearing or appealing to the United States Supreme Court. Ms. Bratina said Mr. Bush had 10 days to seek a rehearing, during which the woman, Theresa Schiavo, 40, had to continue receiving nourishment."

At the same time, the Times reports, "[t]here were signs that Mr. Bush, who inserted himself in the thorny case last fall, might accept the Supreme Court's ruling":

"The governor was disappointed in the ruling, and his prayers go out to Terri's family," Ms. Bratina said. "At the same time, the governor respects the role of the judicial branch on issues such as this and the rule of law. And he recognizes the Florida Supreme Court is the final arbiter on state laws, and as such recognizes that the options before us may be limited."

Meanwhile, there is still a lower court proceeding that could keep this case in the courts well into 2005:

In the Circuit Court case, Mrs. Schiavo's parents, Robert and Mary Schindler, are seeking to have Mr. Schiavo removed as his wife's guardian. They have also filed a motion to set aside the judge's authorization to remove the feeding tube, pointing to Pope John Paul II's statement in the spring that it was wrong to withhold food and water from people in vegetative states. The Schindlers, like Mr. Bush, are Roman Catholic.

Stay tuned.

The ethics of face transplants

As reported by AP (courtesy of Yahoo!), a team of doctors from the University of Louisville and the Netherlands has joined similar teams from Cleveland, England and France, all waiting for the chance to perform a face transplant. The procedure involves removing a donor's skin and other tissue, putting it over the recipient's bone and cartilage and reconnecting it. The team plans to reserve the procedure for patients whose faces have been severely disfigured as the result of disease or accident. A series of articles not yet posted on the WWW but appearing in the current American Journal of Bioethics tease out the ethical pros and cons of performing the procedure.

An article in yesterday's Louisville Courier-Journal explores some of the ethical considerations:

Nichola Rumsey of the University of the West of England, an expert in psychosocial issues in medicine, expressed [reservations] in one of 14 essays written in reaction to the UofL/Utrecht article and published in the bioethics journal.

"Previous research and current understanding indicate that the psychological risks are more complex and extensive than the Louisville team suggest," she wrote. "I have no wish to minimize the distress experienced by many people with severe disfigurements, but to my mind, the current risk/benefit ratio ... is dubious at best."

But Osborne P. Wiggins, chairman of the UofL philosophy department and one of the authors of today's article, said researchers have gotten as far as they can without actually performing the procedure.

"Do we let the uncertainties and unknowns stop us and decide not to do it at all? Or do we go ahead and perform the procedure and learn the answers? We're willing to take the second option," Wiggins said.

Face transplants differ from other transplants because the face is an integral part of someone's identity, said the researchers, who helped write the article. "What is at stake," the researchers wrote, "is a person's self-image, social acceptability and a sense of normalcy as he or she subjectively experiences them." * * *

Researchers outlined some potential problems, such as misuse of the procedure. Aging rich people, for example, might seek a transplant for cosmetic improvements and criminals might want to conceal their identity, researchers said.

People getting such transplants would also face the same risks as other transplant recipients, such as the increased incidence of infection and cancer associated with immunosuppressive drugs. * * *

But the benefits are many, researchers said in the bioethics article. For example, transplants could restore facial expressions and sensory functions and improve people's psychological outlook. Besides Louisville, such transplants are being considered by teams in Cleveland, England and France.

"In a large number of cases facial disfigurement leads to depression, social isolation and even the risk of suicide," the UofL researchers wrote. "Restoring the abilities
to make facial expressions, enjoy an aesthetically acceptable appearance and
interact comfortably with others lends significant weight to the benefit side of the risk/benefit equation."

But the other side of the equation weighs heavy too, some experts said.

Rumsey, the English researcher, wrote that potential recipients might have to wait a long time for suitable donors and might be tempted to put their lives on hold in the interim. They might also have to endure lots of media coverage, she said. Socially, she wrote, such a procedure might convey the notion that people can't live well with disfiguring conditions. Carson Strong, of the University of Tennessee College of Medicine, wrote that two prominent professional committees — the Royal College of Surgeons of England and the French National Ethics Advisory Committee — have said that a face transplant should not be carried out now.

Strong said recipients would face the risk that their grafts could fail, making things worse. But other experts agreed with UofL researchers that the time for a transplant is now. "Our position is that face transplantation could now be performed," wrote three surgeons from Henri-Mondor Hospital in Paris. "The switch from `could' to `should' depends on the ethical conditions surrounding the procedure."

UofL researchers said they are considering all of the critiques as they move forward. They also have to take several additional steps, such as developing a program with Kentucky's organ procurement agency, developing a funding strategy and finding a full clinical team. The team also needs to find a hospital in which to perform the procedure.

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.)