Saturday, June 18, 2005
This article discusses some interesting research on the differences between the male and female brain and what those differences may mean. It is an interesting read and the Witelson seems to be quite the fascinating researcher with quite a large collection of human brains. According to the article,
Witelson is convinced that gender shapes the anatomy of male and female brains in separate but equal ways beginning at birth.
On average, she said, the brains of women and men are neither better nor worse, but they are measurably different.
Men's brains, for instance, are typically bigger — but on the whole, no smarter.
"What is astonishing to me," Witelson said, "is that it is so obvious that there are sex differences in the brain and these are likely to be translated into some cognitive differences, because the brain helps us think and feel and move and act.
"Yet there is a large segment of the population that wants to pretend this is not true."
No one knows how these neural differences between the sexes translate into thought and behavior — whether they might influence the way men and women perceive reality, process information, form judgments and behave socially.
But even at this relatively early stage in exploration of the brain's microanatomy, battle lines between scientists, equal rights activists and educators have formed.
Some activists fear that research like Witelson's could be used to justify discrimination based on gender differences, just as ill-conceived notions of human genetics once influenced laws codifying racial stereotypes about blacks, Asians and Jews.
Thanks to Heather Lutz for bringing this article to my attention. [bm]
Michael Selgelid of the University of Sydney has published the paper "Ethics and Infectious Disease" in which he claims that "bioethics suffers from a misdistribution of research resources" and that "the general topic of infectious disease has received relatively little attention from the discipline of bioethics in comparison with things like abortion, euthanasia, genetics, cloning, stem cell research, and so on." He argues that infectious diseases deserves more attention due to historical and potential future consequences of infectious diseases such as the Black Death, small pox, AIDS, and SARS. Possible ethical questions having to do with infected person infecting the rest of the population could involve infringing on basic human rights and liberties by surveillance, isolation, and quarantine. Another ethical consideration is balancing the "utilitarian aim of promoting public health" and the "libertarian aims of protecting privacy and freedom of movement." He also points out that the poor face, especially in third-world countires, suffer from infectious disease disproportionately. I appreciate research assistant Lindley Bain's help with this post. [tm]
Friday, June 17, 2005
To speed up IT utilization in healthcare, Senators Bill Frist and Hillary Clinton have introduced a bill (summary) that would establish legal safe harbors allowing hospitals and other organizations to extend their IT systems and allow data to be easily exchanged over a secure network. According to Health Care IT News, the exceptions to federal Stark and anti-kickback laws would allow healthcare providers to share IT tools as long as they are used to exchange health information, as well as create standard quality measures to better assess the value of federal programs. Modernhealthcare.com reports that the bill will provide $625 million over five years for regional and local healthcare information technology projects. Supporters of the bill include AFL-CIO, U.S. Chamber of Commerce, Ford Motor Co., General Motors Corp, American Medical Group Association, the Healthcare Information and Management Systems Society, and the Joint Acreditation of Healthcare Organizations. One aim of the bill is to legislatively codify the Office of the National Coordinator for Health Information Technology in HHS. A permanent IT standards work group made up of representatives from federal agencies and the private sector and chaired by the coordinator would adopt recommendations as standards for the federal government and voluntary data standards for the private sector. See the analysis of the bill. Clinton and Frist have said that IT's use in healthcare will eliminate inefficiency, reduce costs, and improve care. This is one of several healthcare IT bills introduced in the Senate in the past week or so. Thanks to law student research assistant Lindley Bain for her help on this post. [tm]
DHHS' Office of Human Research Protection (OHRP) has concluded that "some AIDS drug experiments [at Columbia University Medical Center/New York Presbyterian Hospital] involving foster children violated federal rules designed to ensure vulnerable youths were protected from the risks of medical research," according to this morning's Washington Post. (Our earlier posts on this subject were on May 4 and May 24.)
The government cited Columbia Presbyterian in a letter dated May 23 with violating rules in at least four AIDS studies involving foster children, including:
Failing to "obtain sufficient information regarding the selection of wards of the state and foster children as research subjects."
- Failing to "obtain sufficient information regarding the process for obtaining permission of parents or guardians for wards of the state or foster children."
- Failing to have enough information to ensure the selection of patients for the studies was "equitable" . . . .
[An AP news story on May 4] prompted a congressional hearing, at which experts testified that the standards for enrolling foster children in medical experiments varied widely across the country. Some lawmakers complained that the foster kids had fewer protections than prisoners.
The OHRP's determination letter is here. [tm]
Thursday's New York Times reports that politics may have been involved in the recent reduction in penalty against the tobacco companies from $130 billion to $10 billion. The article states,
At the close of a major trial that dozens of Justice Department lawyers spent more than five years preparing, the department stunned a federal courtroom last week by reducing the penalties sought against the industry, from $130 billion to $10 billion, over accusations of fraud and racketeering.
The decision generated protests from health advocates and Democratic lawmakers, who accused the Bush administration of political motives, and it prompted an internal departmental inquiry. But details of the behind-the-scenes debate over the issue had remained a mystery.
The department has vigorously defended the decision, denying political motives and saying the $10 billion reflected an effort to arrive at a figure that would comply with an adverse decision from an appellate court this year that some officials said sharply limited the types of sanctions the department could seek. The department did not dispute the authenticity of the memorandum but declined to make Mr. McCallum or other lawyers available to discuss it.
A spokesman for the department, Kevin Madden, said political considerations were never factored into the decision to reduce the penalty.
"This was a decision that was made on the merits of the case and that strictly followed the law," Mr. Madden said.
In light of the appellate court ruling, he said, "a decision was made by the department that the best argument for the government to make was one that would preserve credibility in the government's case with the trial judge, would result in a favorable decision from the trial judge and would result in a trial court decision sustainable upon appeal."
The newly disclosed documents make clear that the decision was made after weeks of tumult in the department and accusations from lawyers on the tobacco team that Mr. McCallum and other political appointees had effectively undermined their case. Mr. McCallum, No. 3 at the department, is a close friend of President Bush from their days as Skull & Bones members at Yale, and he was also a partner at an Atlanta law firm, Alston & Bird, that has done legal work for R.J. Reynolds Tobacco, part of Reynolds American, a defendant in the case.
SCOTUSblog has some further thoughts about the Supreme Court's recent decisions in Spector v. Norwegian Cruise Lines; a case involving the application of Title III of the ADA to foreign cruise ships.
Also, during the January Annual Meeting of the Association of American Law Schools, the maritime law section will be discussing this case in more detail. Here is a brief line-up of the speakers and a brief description of their talks:
Jack Beermann (BU) on problems of civil rights litigation in this context
Looks like a terrific program! [bm]
And those people appear to be not only her parents, but the Governor of Florida, Jeb Bush, who asked for an investigation of some discreptancies that appear in Michael Schiavo's timeline concerning when he called the cops when his wife's heart stopped beating fifteen years ago. Read it and weep:
Refusing to give up on the Terri Schiavo case, Gov. Jeb Bush has asked Pinellas prosecutors to sort out time discrepancies Michael Schiavo has provided regarding the hour he found his wife unconscious 15 years ago.
State Attorney Bernie McCabe has agreed to review the time elements in the case, his chief assistant, Bruce Bartlett, said Thursday.
"We are going to look into the circumstances surrounding the times," said Bartlett, who declined to label the review an investigation. "The governor has expressed concern over that aspect of the case."
Michael Schiavo has said he called 911 immediately after finding his wife collapsed on the floor of their home on Feb. 25, 1990. Though medical records indicate he called 911 about 5:40 a.m. that day, he told the Medical Examiner's Office recently that he found his wife about 4:30 a.m.
The detail fueled suspicions by Terri Schiavo's parents, Bob and Mary Schindler, that Michael Schiavo had some wicked connection to their daughter's collapse and may have delayed his call for help.
"I think this is a very troubling gap in time," Schindler attorney David Gibbs III said Wednesday. "Michael Schiavo needs to step forward and explain."
Michael Schiavo's attorney, George Felos, said if he did give a different time than previously, it was simply a mistake in recalling a detail of an event 15 years ago.
"I think it's preposterous and ludicrous that if Michael did say 4:30 or 5 or something like that, that there's any issue," Felos said. "The opponents of Terri Schiavo's wishes are intent on creating a controversy in this case where none exists."
They say that all good things must come to an end - what about bad things?? [bm]
There's a good article in today's New York Times about the rising post-Schiavo interest in living wills, both on the part of folks who want to be sure that life-sustaining treatments aren't employed beyond a certain point and on the part of those who want to get the full metal jacket approach, as well as many others in between. The problems inherent in living wills (inability to draft a document that is expansive enough or detailed enough to cover all contingencies) is alluded to in the article's comparison of living wills vs. medical powers of attorney. Angela Fagerlin and Carl Schneider fairly trashed living wills in their article in the Hastings Center Report last year, and -- even though I am not persuaded that livings wills don't do more good than harm for most patients most of the time -- their views are worth considering, too. The Boston Globe had a good article on the Fagerlin/Schneider position earlier this year (Drake Bennett, "Are Living Wills the Answer?, April 3). [tm]
The New England Journal of Medicine has published an article by Alta Charo in which she addresses the issue of physicians, nurses and pharmacists claiming the right not only to refuse to provide services they find objectionable, but also to refuse to refer patients to another provider and to inform them of the existence of legal options for care. She offers the example of a bill introduced in the Wisconsin legislature:
[It] would permit health care professionals to abstain from "participating" in any number of activities, with "participating" defined broadly enough to include counseling patients about their choices. The privilege of abstaining from counseling or referring would extend to such situations as emergency contraception for rape victims, in vitro fertilization for infertile couples, patients' request that painful and futile treatments be withheld or withdrawn, and therapies developed with the use of fetal tissue or embryonic stem cells. This last provisions would mean, for example, that pediatricians without professional penalty or threat of malpractice claims could refuse to tell parents about the availability of varicella vaccine for their children, because it was developed with the use of tissue from aborted fetuses.
She comments on physicians who claim that the right to practice their religion requires that they not be made complicit in any practice to which they have moral or religious objections . She adds that "the professionals involved seek to protect only themselves from the consequences of their actions - not their patients." This "conscience without consequence" trend can be attributed to the emerging norm of patient autonomy and the abortion wars. She says that patient autonomy has eroded the professional stature of medicine, and with that, the notion of extraordinary duty. The article then addresses the necessity of collective obligation and a genuine system for counseling and referring patients so that every patient like their doctor can act according to her own conscience.
The fight leading up to two days of voting on Sunday and Monday mobilized the nation's political and religious establishments like few others, as the leadership of the Roman Catholic Church - including the new pope, Benedict XVI - urged Italians to boycott the referendum.
In the end, the outcome was not even close. Only 26 percent of as many as 50 million eligible Italians voted, meaning that the referendum automatically failed, with the votes uncounted, in its attempt to repeal four crucial sections of a restrictive fertility law passed last year. For the referendum to be valid, 50 percent of eligible voters had to take part.
The results would seem an immediate victory for the church and for the young papacy of Benedict, in a Europe where church influence has declined significantly in recent decades. Similar referendums in Italy on divorce and abortion in the 1970's and 80's passed overwhelmingly despite church opposition, and Italians now seem likely to debate whether apathy or a reverse in secularism in the home of the Roman Catholic Church defeated this referendum.
My favorite quote from the story, "The results of today mean that Italy is maybe more similar to Texas than to Massachusetts," said Rocco Buttiglione, Italy's culture minister and a friend of Pope Benedict. "Italians want a democracy with values - that values human life - and that is why they rejected this referendum." Mmmm - perhaps they don't know about Texas and the death penalty . . . [bm]
Thursday, June 16, 2005
She died from dehydration, Thogmartin said. He said she did not appear to have suffered a heart attack and there was no evidence that she was given harmful drugs or other substances prior to her death.
He said that after her feeding tube was removed, she would not have been able to eat or drink if she had been given food by mouth, as her parents' requested.
"Removal of her feeding tube would have resulted in her death whether she was fed or hydrated by mouth or not," Thogmartin told reporters.
He also said she was blind, because the "vision centers of her brain were dead," and that her brain was about half of its expected size when she died 13 days following the feeding tube's removal.
MSNBC tells us that the battle over Terri may not be over yet as the Schindlerr family are looking into unspecified legal action. [bm]
Last night, the House of Representatives, by a 264-161 vote, rejected an amendment that would have prevented the Department of Justice from prosecuting medical marijuana users in the 10 states where medicinal use of marijuana is legal. According to the Associated Press report,
Opponents of the amendment said it would undercut efforts to combat marijuana abuse. They said Marinol, a government-approved prescription drug that contains the active ingredient in marijuana, offers comparable relief.
"Marijuana has never been proven as safe and effective for any disease," said Rep. Mark Souder, R-Ind. "Marijuana can increase the risk of serious mental health problems, and in teens, marijuana use can lead to depression, thoughts of suicide, and schizophrenia."
Proponents of medical marijuana had hoped to gain momentum following the high court's ruling. A poll commissioned by the Marijuana Policy Project found that respondents, by a 68-18 percent margin, believe that medical marijuana users should not face federal prosecution.
The poll, conducted June 8-11 by Mason-Dixon Polling & Research, also found that 65 percent of those surveyed favored doctor-prescribed medical marijuana, with 20 percent opposed.
Well, I suppose I am supposed to be happy that my taxpayer money will be going toward the protection of the public from the dangers of seriously ill individuals who are using marijuana to relieve their symptoms. I feel so much safer now. [bm]
Wednesday, June 15, 2005
The pathologists who conducted Terri Schiavo's autopsy held a press conference and discussed the results of their examination today. According to the N.Y. Times, they found "massive" brain damage -- a severely atrophied brain -- that was consistent with the clinical diagnosis of permanent vegetative state. They also found no evidence that she had suffered abuse, which was a frequent allegation by her parents against her husband and guardian. The parents issued their own statement today reiterating their belief that their daughter's brain damage was not that great and that she showed rehabilitative potential. [tm]
According to a story in the latest Business Journal of Wilwaukee, plaintiffs' lawyer Richard Scruggs yesterday filed state-court complaints against three Milwaukee-area nonprofit hospitals or health systems: Milwaukee-based Aurora Health Care, Glendale-based Covenant Healthcare System Inc., and Wauwatosa-based Froedtert & Community Health . As with the dozens of other suits filed in the past year around the country, the complaints allege that uninsured patients were overbilled and that the hospitals in question failed to provide minimum levels of charity care that Scruggs says are a prerequisite for maintaining tax-exempt status. As documented by the American Hospital Association's web site, the claims have met a chilly reception in the federal and state courts that have addressed their merits. [tm]
The Washington Post reports that the new Drug Safety Oversight Board has been strongly criticized by FDA whistle-blower David Graham and Senator Grassley. The FDA created the board to restore confidence in the nation's drug supply but according to Graham and Grassley, it will set back efforts to improve drug safety and will not make it any easier to take dangerous drugs off the market. They conclude that the panel is "severely biased in favor of industry" and that "the FDA cannot be trusted to protect the public or reform itself." The FDA announced the 15-member board last fall, and formally was established last month.
Drug safety has become a hot topic lately, with Congress and many federal agencies addressing the issue. Medicare Administrator Mark McClellan has proposed a plan to use billing and health care information collected from Medicare beneficiaries to create a more effective surveillance system for prescription drugs on the market. According to the Los Angeles Times, he has suggested collecting adverse event information from Medicare beneficiaries who enroll in the new prescription drug benefit. Officials would use billing data from the benefit and combine it with health care information already collected by the Medicare program when beneficiaries submit claims. A computer system would then cross reference the information and detect problems with medications. Sens. Grassley and Baucus are in the process of drafting legislation that would allow CMS to establish an electronic monitoring system. [tm]
Just catching up on a jam-packed week . . .
Last week, the federal government asked U.S. District Judge Gladys Kessler to require tobacco companies to fund a five-year, $10 billion stop-smoking program. This amount is only a fraction of the 25-year, $130 billion program suggested by government witness Michael C. Fiore, a University of Wisconsin medical professor. What happened? If you are suspicious, you are not the only one.
Judge Kessler questioned what was behind the government's decision to reduce the proposed size of a nationwide stop-smoking program. According to a recent article, the Judge hasn't yet received a satisfactory answer:
The Justice Department called the $10 billion program an "initial request" that could be expanded. But Kessler on Wednesday said, "There may be some additional influences being brought to bear" on the government's decision.
Reps. Henry Waxman, D-Calif., and Martin Meehan, D-Mass., sent a letter Wednesday to Justice Department Inspector General Glenn A. Fine, asking him to assess whether "improper political interference" factored in the decision to ask for a smaller program.
"The Justice Department's approach to tobacco litigation should be based on the facts of the case and not political favors to the tobacco industry," the congressmen wrote. "It is highly unusual for government prosecutors to abandon evidence-based testimony by their key witnesses at the last moment in a major trial."
Associate Attorney General Robert McCallum said the government would address the stop-smoking program again today, when closing arguments are scheduled to conclude. But, speaking to several reporters in the courtroom, he said he would not comment on what factors influenced the decision to ask for a smaller program.
Should be interesting to see how they explain this $120 billion decrease in requested penalty. Indeed, the Department of Justice is now investigating whetherh politics influenced the decision to seek redueced sanctions. [bm]
Margaret Richardson, Research Fellow at the University of California, Berkeley and Todd L Pittinsky, Harvard University, John F. Kennedy School of Government, have written an interesting new article entitled, "The Mistaken Assumption of Intentionality in Equal Protection Law: Psychological Science and the Interpretation of the Fourteenth Amendment." The abstract states:
In this article we explore the intersection of advances in the psychological science of intergroup attitudes and stereotypes and the law. Increasing recognition of the automatic and implicit nature of many attitudes, and their automatic influence on behavior, is making it clearer and clearer that the foundation on which Equal Protection analysis has been based is erroneous. While some legal scholars have attempted to apply the lessons from social psychology to employment discrimination, the same efforts have not been made with respect to Fourteenth Amendment and Equal Protection jurisprudence. Examining this disconnect leads to serious questions about the extent to which the current formulation of Equal Protection jurisprudence achieves its original and continuing aims of securing the equal protection of the laws for all citizens. In this article, we focus on the implications for Equal Protection jurisprudence of recent psychological science findings on prejudice and discrimination. We have chosen this focus because these implications could influence the protection of individual rights throughout society in fundamental ways.
The article is available here. [tm]
The United States District Court in Manhattan recently denied a request by two people with Parkinson's disease to order Amgen to continue to give them a discontinued drug used in a clinical trial. Amgen stopped giving the clinical trial patients the drug (glial cell line-derived neurotrophic factor ("GDNF")) after concluding that it did not produce better results than a placebo and might even be dangerous. Two patients were seeking a preliminary injunction to force Amgen to make the drug available while the suit proceeded. They claim the drug is beneficial to their condition and eased their symptoms. According to the New York Times, the two patients have accused Amgen of treating them as "mere guinea pigs" and argued that the company had a legal and moral obligation to continue the treatment. In his ruling, Judge Castel states that Amgen was under no contractual obligation to continue supplying the drug and that the informed consent forms signed by the patients before participating in the trial explicitly acknowledged Amgen's right to terminate it.
Michael Hutchinson, M.D., Ph.D. of NY University School of Medicine has issued a statement claiming that the majority of GDNF investigators were in "total disagreement with the sponsor Amgen" and that even though early studies of GDNF demonstrated no clear benefits, "the study nevertheless showed definite trends suggesting drug efficacy." See the legal memo and complaint for his additional arguments. [tm]
Tuesday, June 14, 2005
An article in the journal Addiction examines more than 7 million internal tobacco industry documents and discovers that tobacco companies extensively studied gender differences in smoking in order to market specifically to women and design a modified product to lure women smokers. A CBC news article reports that the tobacco companies purposefully designed cigarettes with special appeal to women, such as flavored cigarettes, low in tar and nicotine, and added appetite suppressants in order to enhance smoking among girls and women. Their product-development innovations identified a variety of features aimed at meeting the needs and wants of female smokers. The article was written by researchers at the Harvard School of Public Health and funded by the National Cancer Institute. The documents span from 1969 to 2000. The lead author Carrie Carpenter states that "this goes beyond marketing to actually chemically changing these products so as to exploit women's vulnerabilities to get them addicted to a product that kills 178,000 American women each year."
Despite declining male smoking rates throughout the world, female smoking rates are expected to continue to rise and reach 20 percent by 2025. See also CNN article and Medical News Today. Jack Henningfield, a researcher with the Johns Hopkins University School of Medicine, opines that" the tobacco industry's research conducted on women crossed the line." He says that "when you design a cigarette to make it easier to inhale deeply, you're virtually guaranteeing more smoke will be inhaled more deeply into the lung, causing more damage." Cigarette manufactures adjusted the pressure on the filter design to allow women to inhale more deeply. According to Tow Ewing of MedPage, the resulting products exploited mistaken health notions about the safety of light cigarettes; created false perceptions of social and health effects to be gained from reduced secondhand smoke, improved aroma and taste; and targeted physiological and inhalation differences with greater ease of draw, increased sensory pleasure, and altered tar and nicotine levels. The CDC has a fact sheet on cigarette marketing directed at women.
The WHO reported that more women are suffering from tobacco-related diseases. The report "Women and the Tobacco Epidemic- Challenges for the 21st Century" states that young women are lured by the promise of staying slim and slick marketing. WHO has accused the tobacco industry of covering up the harmful effects of tobacco and its addictive nature. A press release by the WHO encourages adoption of a public smoking ban and a ban on tobacco marketing and promotion. [tm]
Jennifer Arlen, the Norma Z. Paige Professor of Law of the New York University School of Law, has written a book chapter entitled, "Private Contractual Alternatives to Malpractice Liability" which appears in MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM: NEW CENTURY, DIFFERENT ISSUES, Rogan Kersh, William Sage, eds., Cambridge University Press (Forthcoming). The abstract follows: Leading law and economics scholars claim that the best way to reform medical malpractice liability is to permit patients and medical providers to determine the scope of malpractice liability by contract. Contractual liability is superior to any form of tort liability for malpractice, it is argued, because contractual liability benefits those patients not well served by existing tort law, but does not hurt patients who benefit from malpractice liability because these patients can, and will, impose liability by contract. This chapter shows that contractual liability is not necessarily better than tort liability because it can make patients worse off. Proponents of contractual liability asserts that contractual liability cannot make patients worse off because they assume that liability obtained by contract affords patients the same benefits as liability imposed by tort. This is not the case. Medical providers often will be unable to design contracts that enable patients to obtain the same benefits from contracted-for liability as they can from tort liability because tort liability benefits patients through the incentives to invest in care (to benefit all patients) provided by the threat of liability for injuries to other patients, now and in the future. Providers may not be able to replicate this collective, multi-period liability by contract. Patients unable to replicate the benefits of tort liability by contract may rationally reject contractual liability, even when they would have benefited from (and voted for) tort liability for malpractice. If so, contractual liability makes these patients worse off. Patients also are worse off if they are not sufficiently informed to contract in their own best interests. Accordingly, while malpractice liability reform is essential, policymakers cannot assume that it would be better accomplished by private contracting because contractual liability and tort liability are quite different products. [bm]
Jennifer Arlen, the Norma Z. Paige Professor of Law of the New York University School of Law, has written a book chapter entitled, "Private Contractual Alternatives to Malpractice Liability" which appears in MEDICAL MALPRACTICE AND THE U.S. HEALTH CARE SYSTEM: NEW CENTURY, DIFFERENT ISSUES, Rogan Kersh, William Sage, eds., Cambridge University Press (Forthcoming). The abstract follows:
Leading law and economics scholars claim that the best way to reform medical malpractice liability is to permit patients and medical providers to determine the scope of malpractice liability by contract. Contractual liability is superior to any form of tort liability for malpractice, it is argued, because contractual liability benefits those patients not well served by existing tort law, but does not hurt patients who benefit from malpractice liability because these patients can, and will, impose liability by contract.
This chapter shows that contractual liability is not necessarily better than tort liability because it can make patients worse off. Proponents of contractual liability asserts that contractual liability cannot make patients worse off because they assume that liability obtained by contract affords patients the same benefits as liability imposed by tort. This is not the case. Medical providers often will be unable to design contracts that enable patients to obtain the same benefits from contracted-for liability as they can from tort liability because tort liability benefits patients through the incentives to invest in care (to benefit all patients) provided by the threat of liability for injuries to other patients, now and in the future. Providers may not be able to replicate this collective, multi-period liability by contract. Patients unable to replicate the benefits of tort liability by contract may rationally reject contractual liability, even when they would have benefited from (and voted for) tort liability for malpractice. If so, contractual liability makes these patients worse off. Patients also are worse off if they are not sufficiently informed to contract in their own best interests. Accordingly, while malpractice liability reform is essential, policymakers cannot assume that it would be better accomplished by private contracting because contractual liability and tort liability are quite different products.