Sunday, October 26, 2003
Growth in ER use fueled by insured patients, not uninsured.
U.S. hospital emergency department (ED) visits increased to almost 108 million annually in 2000 and 2001, an increase of about 16 percent from 1996-97. Emergency department visits between 1996-97 and 2000-01 increased 24 percent for privately insured people, 10 percent for Medicare beneficiaries, 10 percent for self-pay or no-charge—typically uninsured—patients but were unchanged for Medicaid beneficiaries, according to the study based on data from the Centers for Disease Control and Prevention's (CDC) National Hospital Ambulatory Medical Care Survey.A news release and a link to the full report are here.
Together, privately insured and Medicare beneficiaries accounted for almost two-thirds of the overall increase in ED visits. In contrast, self-pay or no-charge patients accounted for about 11 percent of the increase in ED visits. People with other sources of coverage—worker's compensation, for example—or unknown coverage accounted for the remaining increase.
For privately insured people, the 24 percent increase in ED visits paralleled an across-the-board increase in ambulatory care use, including a 29 percent increase in physician office visits between 1996-97 and 2000-01, the study found. In contrast, for uninsured people, the 10 percent increase in ED visits was accompanied by a 37 percent decrease in physician office visits, resulting in uninsured people relying on emergency departments for an even greater part of their medical care. One-fourth of all doctor visits by the uninsured now take place in emergency departments, compared with 17 percent in 1996-97.
"Uninsured people clearly are not a major factor in increased crowding at most hospital emergency departments, but uninsured people's growing reliance on emergency care indicates decreased access to other sources of care, including physician's offices. Getting medical care outside of the emergency department is definitely becoming more difficult for uninsured people," said HSC Senior Health Researcher Peter Cunningham, Ph.D., who co-authored the study with HSC Research Assistant Jessica May.
GAO report on specialty hospitals.
From this morning's NY Times: More on Schiavo, PVS, Medicare.
- Schiavo I: article in "The Week in Review" about brain-damage and family decision making by Dudley Clendinen;
- Schiavo II: good piece by Sheila Dewan on the practical aspects of ethics consultations in cases like the Schiavo imbroglio (warning: this link will only last a few days);
- Schiavo III: an informative article about the American Academy of Neurology's guidelines for diagnosing permanent vegetative state (you can read them for yourself here);
- a front-page piece about the dramatic rise of specialty hospitals and the Medicare reimbursement scheme that has contributed to it.
Friday, October 24, 2003
FDA eases stance on importing medicines
Hubbard said the FDA would continue its court battles against "businesses that sell commercial quantities of drugs" from overseas. The agency sent a cease-and-desist letter last month to CanaRx, the company that arranges for Canadian drugs to be shipped to Springfield. The Justice Department is awaiting a ruling after suing in Oklahoma to shut down a chain of stores that provide Canadian drugs under the names Rx Depot and Rx of Canada.Presumably the cities and states are free to negotiate with Canadian pharmacies for discounted prices and employees would then be able to place their orders directly from the Canadian firms.
Slate opinion piece on the Schiavo case
Schiavo case reviewed by Florida's medical ethics community.
Thursday, October 23, 2003
The New York Times editorialized against the legislature's and governor's overruling of the many court decisions that have quite unremarkably upheld Terry Schiavo's husband's right to make the decision he's made.
Wednesday, October 22, 2003
Schiavo: reactions the day after.
Democratic presidential hopeful Joe Lieberman backed the legislature and governor: "I believe that certainly in cases where there is not a living will ... I feel very strongly that we ought to honor life and we ought not to create a system where people are being deprived of nutrition or hydration in a way that ends their lives."
Harvard Law professor Larry Tribe is critical of the intervention, saying that it "violates the core principles" of the Supreme Court's 1990 decision in the Cruzan case. The New York Times ran a piece on their web page today - presumably intended for print on Thursday - laying out some of the constitutional arguments.
Tuesday, October 21, 2003
Senate Passes Ban on Abortion Procedure.
Schiavo update #3
There's nothing on the Governor's web site about this yet, but news announcements are posted here, so stay tuned. The bills are S12-E and H35-E. (The "E" is a reference to the fact that the legislature went into its fifth special session of the year on the 20th of this month.) Here are the key documents:
Schiavo update #2.
The same story reports that the federal judge who was assigned the case brought by the Advocacy Center for Persons with Disabilities has dismissed the case, writing that "federal courts - other than the U.S. Supreme Court - are forbidden from interjecting themselves into matters already decided by state courts."
The Schiavo case: legal process run amok.
I've laid out the procedural and clinical details of this case in an earlier post. This latest move by parents, at least one sibling, and various right-to-life and disability-rights groups is either "desperately needed . . . to protect the people of this state" (Rep. Sandy Murman) or a bill that "so oversteps our role . . . it turns democracy on its head" (Rep. Dan Gelber). At the risk of repeating myself, this is apparently all about politics as a contact sport, with Terri Schiavo as the football. According to the AP, the attorney for her husband/guardian "said he thinks the legislation would be unconstitutional. He said it is Terri Schiavo's right under the Florida Constitution to not be kept alive artificially."
A letter to the editor in today's Sarasota Herald Tribune entitled "Some Things Are Worse Than Death" provides some perspective on the struggle of Terri's parents. Still, it's hard to believe that after 10 years and countless expert opinions, the parents insist that a little more rehab will restore their daughter to even a minimum quality of life. With his permission, here is an e-mailed summary of Terri Schiavo's condition from Ron Cranford, a neurologist who has personally examined her:
Terri Schiavo is in a classic permanent vegetative state. I have personally examined her and testified at a 6 day evidentiary hearing in Tampa in October, 2002, where six doctors testified on her neurologic condition, chances of recovery, and any possibility of her responding to treatment. The trial court judge concluded Terri was in a persistent (permanent) vegetative state, there was no possibility of recovery, and no chance of her responding to any treatment, including vasodilator therapy and hyperbaric oxygenation. Terri's most recent CT scans (extensively reviewed during the evidentiary hearing) show massive atrophy of the cerebral hemispheres, and the cerebellar hemispheres and brain stem, findings typical for a patient with severe and irreversible brain damage secondary to hypoxic-ischemic encephalopathy after 13 years in this condition. The trial court judge reviewed the videotaped examinations of the doctors testifying and completely rejected the opinion of the Florida neurologist representing the Schindler family that Terri showed signs of cognitive functioning. The one physician who was most likely persuasive in convincing Judge George Greer of Terri's neurologic condition was the neurologist from Cleveland, Ohio, who was the court appointed medical expert and thus not representing either the Schindler family and Michael Schiavo, the husband. Interestingly, not only did the 3 judge court of appeals agree with the trial court judge, but also reviewed the videotaped examinations of the doctors and agreed that Terri showed no signs of cognition.According to an attorney who appears to be close to this case, a Florida-based nonprofit organization -- The Advocacy Center for Persons With Disabilities -- has filed an action in federal court to block the state court's dehydration order. He says their action is based upon "29 U.S.C. § 794(E) [sic]" (I assume he means 29 U.S.C. § 794e, which is a funding mechanism à la Baby Doe (42 U.S.C. §§ 5106g, 5106i(b)) but without the substantive treatment standards) and 42 U.S.C. § 15043(a)(2)(b) (which confers no legally enforceable rights as far as I can tell). As of 10am (CDT) this morning, there was nothing on their web site about the action.
If you look closely at the short videotapes released by the Schindler family, and know exactly what you're looking for, you'll see that Terri does not have sustained visual pursuit, the classic finding for someone outside a vegetative state. In the close up views of the mother interacting with Terri, you'll notice that it "appears" at times for a few seconds that Terri is "looking" at her mother, but, if you look closely, her eyes are not really tracking her mother most of the time. And she definitely would be tracking her mother the vast majority of the time were she not in a vegetative state.
Sunday, October 19, 2003
To quote Letterman: "Is this something, or is this nothing?"
BIBAC is an expanded, international version of the highly successful former Canadian bioethics council, called the Bayer Advisory Council on Bioethics (BACB). Established in 1997 in response to Canadian public concerns about the safety and availability of blood and plasma, the BACB quickly established itself as a credible authority providing valuable counsel in dealing with the complex blood-related issues of the time. In fact, its inaugural paper, "Creutzfeldt-Jakob Disease, Blood and Blood Products: A Bioethical Framework" contributed to significant policy decisions in both Canada and the United States.BIBAC's first paper can be viewed on the BIBAC Web site at www.BIBAC.org.
Wednesday, October 15, 2003
Another interesting grant of certiorari.
Yesterday, SCOTUS granted certiorari in Sabri v. United States, No. 03-44. In the case, a developer was charged with bribing a city council member in Minneapolis. The federal statute under which he was charged makes it a crime to pay a bribe of at least $5,000 to an official whose agency receives at least $10,000 in federal money. There's no requirement that the bribe be related to the federal program for which federal funds are received by the official's agency. Linda Greenhouse's description of the case in today's N.Y. Times includes the suggestion that this case could signal the Court's interest in cutting back on Congress' powers under the Spending Clause, just as it has been doing in connection with the Commerce Clause over the past 5 years. In his blawg, Prof. Eric Muller (passed along to members of the Con Law Prof listserv by Eugene Volokh) wonders why an exercise of Congress' Spending Clause powers should be suspect when a ban on bribes over $5,000 could have been enacted pursuant to Congress' power to regulate interstate commerce. Fair question. (The district court dismissed the charges but the 8th Cir. reinstated them as a constitutional exercise of Congress' powers under the "necessary and proper" clause. The 8th Cir. case -- U.S. v. Basim Omar Sabri -- is available for free here.)
Terri Schiavo's final days.
Tuesday, October 14, 2003
SCOTUS declines review of medical-marijuana gag-rule case.
Genetic discrimination bill passes Senate, 95-0.
Pregnancy Created Using Infertile Woman's Egg Nucleus.
Denise Grady has a piece in today's N.Y. Times that picks up on an AP story that ran on Monday concerning a Chinese procedure for extracting the nucleus of a fertilized egg, inserting the genetic material into a denucleated egg of another woman, and implanting the "new" egg into the uterus of the first woman. The process initiated a pregnancy in a woman who previously could not maintain a pregnancy with a blastocyst beyond the two-cell stage. The new technique resulted in three fetuses, one of which was aborted to give the other two a better chance of survival, and the remaining fetuses died at 24 and 29 weeks. Because this technique involves nuclear transfer, the process has set off alarms among those who are uncomfortable that this is one more step toward human reproductive cloning. It's not exactly cloning, which involves making a genetic copy of oneself, but Jeffrey Kahn of the University of Minnesota worries that it amounts to "'proof of principle' for cloning even if no copying took place."
The technique also adds to biotech's contributions to Family Law exam questions. Consider this headline, from today's Belfast (Ire.) News: "Scientists Create Test Tube Twins with Two 'Mothers'."
It also raises a nice question for a Bioethics exam. As today's Newsday article on the story put it:
But none of her three developing fetuses survived, and some question the ethics of such research.Malcolm Ritter's AP story (from the Ft. Worth Star-Telegram) on the ASRM conference in San Antonio quotes others who aren't so sure about the "roadmap to cloning" argument:
"The gestational outcome was a disaster," said Dr. James Grifo, director of the division of reproductive endocrinology at New York University. Grifo and his NYU colleague, Dr. John Zhang, are listed on the abstract of a paper on the case to be delivered today at the American Society for Reproductive Medicine meeting in Texas. Grifo said they didn't have anything to do with the clinical research "beyond showing them how to do it."
R. Alta Charo, professor of bioethics at the University of Wisconsin at Madison, said the Chinese work is not a direct analogy to cloning. A key difference is that the transferred DNA does not have to be reprogrammed to act properly in an egg as it does in cloning, she said. So the study result doesn't offer a direct indication of the outcome of attempts to clone humans, she said.Finally, for the Administrative Law exam, consider this: Dr. Grifo, the NYU researcher who advised the Chinese team, "said the Food and Drug Administration indicated that work he was doing might be subject to government regulation, and he stopped his experiments in 1998 because of the energy and money required to comply." I wonder what the FDA is thinking this morning about his participation in the Chinese experiment.
[Dr. Joe Massey, a fertility specialist at Reproductive Biology Associates in Atlanta] and [Dr. David Sable, director of the division of reproductive endocrinology at the St. Barnabas Medical Center in Livingston, N.J.,] said the experiment was not cloning, with Massey stressing that it wasn't aimed at copying an individual. "This is not a pathway to cloning. It's not about that," Massey said.
Sunday, October 12, 2003
Stopping a clinical trial before it's complete.
The study was testing the value of administering the drug letrozole to older women who had already taken tamoxifen to ward off a recurrence for about five years, the point at which tamoxifen loses its power. The results exceeded expectations. When compared with a placebo, letrozole cut the recurrence rate nearly in half.As the Times correctly points out, "[t]here seems little doubt that a trial must be terminated if it is harming the participants"; indeed, that is precisely what data safety monitoring boards do. But, as the editorial observes:
By halting the study in midstream, the researchers made the new treatment available to the placebo group and to many thousands of other cancer survivors as well. The downside is that early termination kept them from determining whether the treatment actually saved lives, how long women should keep taking the drug or the likelihood of such adverse effects as osteoporosis and cardiovascular problems.The National Breast Cancer Coalition has criticized the National Cancer Institute's decision to halt the clinical trial, and their paper makes a lot of sense. The National Cancer Institute's explanation for its decision, with a link to a Q&A page on the letrozole study, is here. The researchers' article, which is scheduled to appear in the New England Journal of Medicine on November 6, was posted to the journal's website on October 9 "[b]ecause of its potential therapeutic implications." [Abstract available here without subscription]
Saturday, October 11, 2003
Separation of Egyptian conjoined twins begins in Dallas today.
The surgeons know there are those who will take exception with the decision to operate. One expert who disagrees is Adrienne Asch, a professor of reproduction and bioethics issues at Wellesley College in Massachusetts.I am not so sure that stigmatization is the biggest impairment facing a child with a sibling who is his size and weight attached to the top of his head, or that with these brothers we are dealing with a physical condition that would be considered "normal" in other societies but not here. But I do agree that "normal" is a loaded term that is not particularly helpful in resolving the question whether to separate or leave together conjoined twins.
Dr. Asch is disturbed by the drive to separate conjoined twins because it is usually based on the sense that being conjoined is not a "normal" way to live. But what does normal mean? Does it mean average, or outside statistical boundaries, or desirable? Star athletes and Nobel Prize winners have outstanding qualities that are not considered normal, she pointed out. "We think of some non-normal things as desirable," she said.
People live good lives in a variety of circumstances, and it is not for others to decide whether their circumstances are a burden. To ask whether two conjoined brothers should be separate, she said, is almost akin to asking a black person whether they should be white, or a woman whether she would be better off as a man.
"I don't even like the word normal," she said.
If society considered it acceptable to be conjoined, being attached to your brother or sister would be an unusual but perfectly legitimate way to live, she said. The biggest disability facing these twins, is that society considers it strange. "That's the principal impairment of being conjoined," she said.
Withdrawal of "futile" life-sustaining treatment over family objection.
An elderly woman, whose feeding tube was withdrawn by doctors against the wishes of her family, died in hospital yesterday.It will, of course, be a very difficult case in which to prove causation. There is no doubt, however, that the peremptory action taken by the hospital exacerbated the family's distrust. The ethics rules that govern these types of disputes appear to be about the same in Great Britain as they are in the States:
Olive Nockels, 91, became the focus of a legal battle about treating the elderly after being admitted to the Norfolk and Norwich Hospital more than two weeks ago. She was unconscious and doctors suspected she had suffered a stroke after an operation to pin a broken hip.
They advised her relatives last week that there was no chance of recovery. They said using drips and tubes to feed and hydrate her would unnecessarily prolong her suffering and the tubes were withdrawn on Friday 3 October.
But Mrs Nockels' family objected and obtained an interim court order on Monday compelling the doctors to restart feeding and hydration until a full hearing could be held. Ivy West, 60, Mrs Nockels' daughter, said: "We think she would still be here now if they had not taken her drip away for three days before they were forced to put it back."
The British Medical Association says the "active and intentional" termination of a patient's life is illegal but adds that medical treatment, including artificial feeding and hydration by tube, can be withdrawn when it is "futile, when it would not be in the patient's best interest ... or when the patient has refused further treatment".Experience with the Texas law since its enactment 4 years ago suggests that having legal authority for withdrawals of futile treatment actually helps families accept the ethical principle that there are limits to the duty to treat.
Where do disagreements over end-of-life care come from? Michael Wilks, chairman of the BMA ethics committee, said it well:
"If doctors decide a treatment is not providing benefit, it is unethical to continue to provide it. The commonest reason for a breakdown between a health team and relatives is a failure of communication."
Thursday, October 09, 2003
Med-mal crisis hits Australia.
The amount Michael Kaye is paid by Medicare to see a new patient has not quite doubled to $52 since he started working at Mona Vale Hospital in 1982, while the cost of his medical indemnity insurance has gone up from $100 to $50,000.As here, the plaintiffs' bar has a different take on the med-mal crisis, but so far the rhetoric seems to be outpacing the analysis of causes and effects. Dr. Kaye is hoping for a no-fault compensation scheme, but meanwhile the bad blood between doctors and lawyers bodes poorly for a reasoned dialogue: "I got into this to help people, not try and defend myself to some smart-arse years after the event. Lawyers and judges can take a year to make a decision, we have to do it in half an hour or less."
Dr Kaye has resigned in protest.
"I can't work without insurance and I can't afford the insurance," he said yesterday.
He is one of three obstetricians at the hospital to tender resignations this week, to become effective in three months unless the Government can find a way to stem rocketing insurance costs.
Dr Kaye says the hospital's eight orthopedic surgeons have resigned and about 12 more specialists plan to join them.
Tuesday, October 07, 2003
Medicine and the practice of capital punishment.
1. Yesterday, the Supreme Court of the United States denied certiorari in an 8th Circuit case -- Singleton v. Norris (U.S., 02-10605) [requires subscription to WestLaw] -- in which the court of appeals, sittin en banc, ruled that medicating a mentally ill death row inmate in order to make him competent to be executed does not constitute cruel and unusual punishment. According to The Times' article, this is the first case in the country, state or federal, to so hold. That may be why the Supremes denied review; normally they like to let a few more courts chew on a problem before they tackle it (called "percolation"). The AMA, by the way, is against physicians participating directly in capital punishment (Opinion E-2.06: "When a condemned prisoner has been declared incompetent to be executed, physicians should not treat the prisoner for the purpose of restoring competence unless a commutation order is issued before treatment begins.")
2. In a second article, Adam Liptak reports that in more than 30 states that allow execution by lethal injection, a three-drug "cocktail" is used. One of the drugs -- pancuronium bromide -- is a paralytic. Increasingly, corrections officials and medical experts are questioning the practice of paralyzing prisoners as part of the execution process, particularly given the chance that the other drugs used may have inadequately anesthetized the patient. The result in such a case -- where a prisoner could be conscious, starved for oxgyen, and unable to move -- would be akin to turning the inmate's body into a living tomb. It probably goes without saying that the AMA's Opinion E-2.06 also forbids physicians from administering the cocktail, which may paradoxically increase the chance that just such an unintended effect will be produced.
Monday, October 06, 2003
Minority children: over- or underrepresented in medical research?
Both black and Hispanic children were overrepresented in research on topics that were potentially stigmatizing, such as studies of child abuse, high-risk behaviors or HIV. Fifteen percent of the U.S. population is black but 30 percent of the children in potentially stigmatizing research studies were African American. While 17 percent of the U.S. population is Hispanic, only 10 percent of the children in medical research were Hispanic, and 17 percent of those involved in potentially stigmatizing studies.
"There are possibly benign and not so benign explanations for these findings," Ross said. "Our data could not distinguish. Clearly, black and Hispanic children should be overrepresented in AIDS research as they account for 82 percent of all reported pediatric AIDS cases. On the other hand, there are data to suggest that there is racial and ethnic bias in who is questioned about child abuse."
Why black children were more likely to be involved in clinical research is unclear. One possible explanation may simply be that academic medical centers are disproportionately located in urban centers where minorities live. The authors note that the ongoing shift of clinical research from major medical centers to smaller, suburban, private practices, could reverse this trend.
They conclude on a cautionary note. "Despite the participation of minority children in research, there are data that show that these benefits are not being translated into their clinical care. This should be a top priority." (emphasis added)