blog.bioethics.net

Plan B for Plan B

HHS Secretary Mike Leavitt on Monday defended FDA's action of indefinitely deferring a decision on Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, saying that he promised senators that the agency would act by Sept. 1 but never guaranteed a "yes or no" decision, Reuters reports (Heavey, Reuters, 8/29). FDA Commissioner Lester Crawford on Friday said the agency is opening a 60-day public comment period and did not give a timetable for a final decision on Barr's application. The agency in May 2004 issued a "not approvable" letter in response to Barr's original application to allow Plan B -- which can prevent pregnancy if taken within 72 hours of sexual intercourse -- to be sold without a doctor's prescription and in January delayed a ruling on Barr's revised application, which would allow EC to be sold without a doctor's prescription only to women ages 17 and older. As a result of the delay, Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) in June blocked a full Senate vote on Crawford's nomination for commissioner. However, the senators in July agreed to lift their holds after Leavitt in a letter to Sen. Mike Enzi (R-Wyo.), who chairs the Senate Committee on Health, Education, Labor and Pensions, said that FDA would act on Barr's application by Sept. 1. Crawford at a press conference on Friday said that science supported giving nonprescription access to Plan B to women ages 17 and older but added that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to keep girls ages 16 and younger from obtaining the drug (Kaiser Daily Reproductive Health Report, 8/29).

Leavitt Comments, Senators' Reaction

Leavitt on Monday said, "FDA made their commitment to me, and I made my commitment to the senators. The commitment was they would act. They did." He added, "Sometimes action isn't always yes and no. Sometimes it requires additional thought." However, Rodham Clinton and Murray in a joint statement said that Leavitt was playing "word games," adding, "A delay is not a decision, and no amount of semantics can change that" (Heavey, Reuters, 8/29). Leavitt said that in considering Barr's application, FDA found that "the science revealed significant policy questions that needed to be dealt with." He declined to speculate when FDA would issue a final decision on the application, CQ HealthBeat reports (Reichard, CQ HealthBeat, 8/29).

Zeke's Secretary Can Keep Her Stock!

The new rules limit stock ownership in biotech, drug, and other "substantially affected organizations" to $15,000 per company for about 200 senior NIH employees and their families, including institute and center directors and their deputies, as well as scientific and clinical directors. The earlier rule would have applied the holdings cap to about 12,000 NIH employees and would have required about 6,000 intramural scientists, all senior officials, and those having contracting and grant-making authority to divest of all stock in drug and biotech companies ...

"We are extremely satisfied with what we understand the regulations will be," said Ezekiel Emanuel, chief of clinical bioethics at NIH's Warren G. Magnuson Clinical Center and a member of the executive committee of the Assembly of Scientists, an organization representing NIH intramural researchers. "It comes pretty close to what we had suggested five months ago," he told The Scientist.

Just Your Average, Every Day Sterilization

Vera Howse thinks her 26-year-old niece Kirsten Johnson wouldn't be a good mother, so she's asked the Cook County Probate Court for authorization to sterilize her niece against her will. Johnson is cognitively impaired, and her aunt is her legal guardian.

This case has broad significance because Illinois, unlike other states, hasn't established when a court should grant a guardian authority to have a ward permanently sterilized.

Most cases like this are resolved in the doctor's office. Physicians at one Chicago hospital system estimate that it receives one to three guardian requests to sterilize their wards per month, usually from parents of disabled adolescents. After counseling, most eventually opt instead for long-term reversible birth control.

In this precedent-setting case, Riley says he's following a Pennsylvania court that adopted a "discretionary best interest standard." But his application of the specified best interest criteria is misguided and incomplete, because the standard the Pennsylvania court used is intended to focus the court on what's best for the person with a disability, and away from the best interest of the guardian, family, society or potential children.

Persons with disabilities in Illinois deserve better than this. Tubal ligation is a safe, effective form of contraception many women -- including some with cognitive deficits -- freely choose. But allowing guardians to permanently block their ward's reproductive desires with the muscle of the courts and the knife of medicine is a discriminatory step back toward a shameful era to which we should never return.

Just Your Average, Every Day Sterilization

Vera Howse thinks her 26-year-old niece Kirsten Johnson wouldn't be a good mother, so she's asked the Cook County Probate Court for authorization to sterilize her niece against her will. Johnson is cognitively impaired, and her aunt is her legal guardian.

This case has broad significance because Illinois, unlike other states, hasn't established when a court should grant a guardian authority to have a ward permanently sterilized.

Most cases like this are resolved in the doctor's office. Physicians at one Chicago hospital system estimate that it receives one to three guardian requests to sterilize their wards per month, usually from parents of disabled adolescents. After counseling, most eventually opt instead for long-term reversible birth control.

In this precedent-setting case, Riley says he's following a Pennsylvania court that adopted a "discretionary best interest standard." But his application of the specified best interest criteria is misguided and incomplete, because the standard the Pennsylvania court used is intended to focus the court on what's best for the person with a disability, and away from the best interest of the guardian, family, society or potential children.

Persons with disabilities in Illinois deserve better than this. Tubal ligation is a safe, effective form of contraception many women -- including some with cognitive deficits -- freely choose. But allowing guardians to permanently block their ward's reproductive desires with the muscle of the courts and the knife of medicine is a discriminatory step back toward a shameful era to which we should never return.

Ethics and Superfat NFL Players

A tearful memorial service was held Tuesday in Mountain View, Calif., for Thomas Herrion, 23, an offensive lineman for the San Francisco 49ers football team. The service drew more than 500 people, including the commissioner of the National Football League, Paul Tagliabue, and many other NFL officials and coaches. Their grief for the loss of this young athlete was sincere. But the NFL does not seem to have gotten one message it needs to learn from Herrion's death: Players in the NFL have gotten too fat.

Bioethics Journals Ignore the Developing World

A total of 4029 research articles were retrieved from the nine journals under study (Table 1). Investigators from high-income economies contributed to 3873 of the publications (96.1 percent), and those from developing economies contributed to 156 (3.9 percent).

In addition, the findings suggest that there has been no significant upward trend in the number of publications from developing countries.

Is There an Ethicist in the House?

You Can't Make this Stuff Up

AMSTERDAM, The Netherlands (Reuters) -- Billionaire television producer John de Mol, behind the pioneer show "Big Brother," will test the limits of reality TV with a program in which a woman searches for a potential sperm donor to conceive a child.

His new TV station Talpa, launched earlier this month, confirmed it will air a program called "I want your child ... and nothing else!" but gave no further details about the show due at 1830 GMT on Wednesday.

"The plan is that we visit potential donors and -- of course on camera -- decide which man is most suitable," the 30-year old woman who will feature in the program said in an interview with De Telegraaf newspaper.

"Afterwards there will be artificial insemination," said the woman who was identified only as "Yessica" and who has bought a house with a room for a child.

The show is a one-off competing with four other reality TV programs, one of which follows five former prostitutes starting a cafe. The program receiving most votes from viewers on Saturday, after all the shows have aired, will be turned into a series.

Medical Students Say "Where's the Ethics?"

More

...more than one third said medical ethics was missing from their required curriculum...

than one-third of the nation's medical students responding to a recent survey said medical ethics was missing from their required curricula, and less than half were aware of courses that covered bioterrorism or disaster preparedness, according to a report released on Monday by the American Medical Student Association.

The Association of American Medical Colleges, which represents the nation's 125 accredited medical schools, challenged the findings, pointing out that the responses had come from less than 1 percent of the nation's 67,000 medical students.

The medical-college association's own survey of medical schools found that 124 of the institutions covered ethics in at least one required course in the 2003-4 academic year, the latest year for which data are available, and that required courses at 97 schools covered alternative or complementary medicine.

Ian Wilmut Pushes the Case for Cloning Humans

Job at Princeton

Alden March Bioethics Institute

Teaching Ethics Using Star Trek?
Check Out the Hidden Curriculum

Kids are not the big stars on Star Trek. They are as rare as plants on the deck of the various starships. And in fact they are often portrayed as a nuisance - Jean Luc Picard cannot wait to be rid of Dr. Crusher's young and far-too-inquisitive son Wesley, who remains the most reviled member of the Star Trek cast to this day.

But had Sean Philpott not pointed it out to me, I would never have believed that Star Trek is so highly correlated with pedophilia.

The LA Times recently ran a story about the Child Exploitation Section of the Toronto Sex Crimes Unit, which contained a mind-boggling statistic: of the more than 100 offenders the unit has arrested over the last four years, "all but one" has been "a hard-core Trekkie." Blogger Ernest Miller thought this claim was improbable. "I could go to a science fiction convention," he explained "and be less likely to find that 99+ percent of the attendees were hard-core Trekkies." While there may be quibbling about the exact numbers, the Toronto detectives claim that the connection is undeniable."

Good Thing They Set Aside a Few Billion

Merck has been found negligent in Texas in the first Vioxx decision

Is Your Country Attractive for Clinical Trials

Like any tourist brochure, the fine print lies buried somewhere under the glossy images. In this case, it is a lack of adequately trained staff, a regulatory bureaucracy which is slow and is (though the author delicately avoids the issue) prone to corruption, and a recent history of ethical scandals involving the use of unapproved drugs or the use of approved drugs for unapproved purposes. But nothing, the author suggests, that can't be smoothed over with a few IRB workshops, a few short-term benefits for study participants, and the "check is in the mail" notion of future general access to the tested medications.
-Stuart Rennie

July/August Issue of The American Journal of Bioethics

Are Medical Studies Flawed Because Peer Review Doesn't Work?

almost one-third of the top papers that appeared in top journals over a 13-year period from 1990 to 2003, had been either contradicted or found to have potentially exaggerated results. All the articles had undergone vigorous peer review, leading to questions about whether problems should have been caught by reviewers.

The author of that study, Dr. John Ioannidis, an adjunct professor at the Tufts University School of Medicine, said that flaws in the system were not solely responsible for the problems with the initial studies, but he said that they may be ''part of the puzzle" that should be examined to improve research. Ioannidis couldn't actually study the peer reviews, of course, since they are confidential (and of course anonymous), which in his view and that of many at JAMA and elsewhere is part of the problem.

PLOS Medicine also encourages peer reviewers to reveal their identity, but it does not demand it.

The journal's senior editor, Barbara Cohen, said some reviewers want anonymity out of concern about retribution, which she described as ''you trashed my paper at Nature, now I'm trashing yours at Science," referring to two leading journals.

Cohen also said she is sympathetic to younger peer reviewers who fear that providing criticism of a senior person in the field will hurt their career. This is a common complaint among reviewers.

But given the high number of studies that end up either wrong or deeply flawed, much of the medical profession is looking for new ways to examine research.

Armstrong, the professor who has read dozens of studies on peer review, cited numerous embarrassing incidents that he said had called the peer review process into question.

In one study, for example, researchers submitted a plagiarized paper to 110 journals, but only two publications recognized the problem. In another study, researchers examined 18 papers that had been published in peer-reviewed journals by a person who later admitted scientific fraud; they found that 16 of the papers had an average of 12 errors each.

1 in 25 Fathers is Raising Someone Else's Child

Inquisition, Anyone?

for perpetuating "a culture of death" by supporting abortion rights or siding against Terry Schiavo's parents in their efforts to keep her feeding tube.

The Cardinal Newman Society also says in a fund-raising appeal that administrators at BC, Georgetown University and elsewhere should be warned their school risks being "stripped of its Catholic identity by the bishop who has authority over that college."

Among those named in the letter are the Rev. John Paris, a bioethics professor at Boston College...Boston College did not have an immediate comment, but Paris dismissed the society as "a self-appointed vigilante committee." He also labeled its planned appeal to the bishops as baseless, since the schools are run independently from the Catholic church. "They neither represent the church nor the academic community," Paris said of the society's leaders, "and yet they want to censor the academic community in the name of the church."

The Cardinal Newman Society also named the Rev. Kevin O'Rourke, a professor at Loyola University's bioethics institute; Tom Beauchamp, a philosophy professor at Georgetown; Maxwell Gregg Bloche, Lawrence Gostin and Peter Rubin, Georgetown law professors; Howard Freed, Lauro Halstead and John Collins Harvey, past or current medical professors at Georgetown; Daniel Maguire, a theology professor at Marquette University; Rev. Richard McBrien, a theology professor at the University of Notre Dame; Curtis Naser, a philosophy professor at Fairfield University; and Kenneth Wing, a professor at the Seattle University School of Law.

The Biggest Ethics Story Ever

Dennis Avner, who goes by his Native American name, Stalking Cat, is known around the world as the Catman. Over the past 25 years, Stalking Cat, 47, has received so many surgical and cosmetic procedures he's lost count. And he says all of them — from full-face tattoos to fanged dentures to steel implants for detachable "whiskers" — have been done to achieve oneness with what he calls his totem, the tiger.

Cha Ching for Stem Cells in New Jersey

Ethical considerations include the assurance of appropriate care for donated stem cells and the unambiguous consent by donors, said Harold Shapiro, the former president of Princeton University who heads the ethics advisory panel overseeing the state-funded research.

The Happiest Bioethicist

Are Christians Losing Bioethics
to Corporate Whores and Athiests?

He says Christians don't get much attention in bioethics anymore. It is hard to disagree with the claim he makes that the dominant views in evidence in bioethics these days are secular. Most bioethics-oriented publications, and those with the most impact in the scientific and medical professions, are undeniably written within the "secular" discourse of bioethics - that is, are written without drawing in a significant way upon theology, or relying on justifications based on God or a Judeo-Christian faith tradition in particular.

Theology and religion both played defining roles in bioethics' origins. "Early" bioethics of the 1970s focused on the "big picture" of environmental and health issues - and there was less focus on esoterica. Theological bioethicists engaged in dialog about big questions like whether or not technology is moving faster than medicine in general, and developed a rich literature about "playing God," to name just two examples. Religious bioethics brought hospital ethics committees into existence. Theologian ethicists and in particular (in the U.S.) scholars of Christian and of Jewish ethics framed bioethics for close to a decade and used it to shape a new and vigorous debate about ethics in society and ethics in technology.

What happened to religious bioethics?

Well, according to Cameron, Caplan happened. Cameron writes:

Arthur Caplan is the quintessential face of contemporary bioethics. Yet he does not in any way represent the American people. How did bioethics get so out of whack with the people? How did it switch from a Hippocratic focus on the sanctity of life to a public relations department for whatever the biotech industry wants to do next? ... [The] central problem, of course, is that we walked out. There is no question that a chief agent of secularization in American culture has been "conservative" Christians.

The problem with Dr. Cameron's argument isn't that he's wrong on the sociology: the best accounts of the changes in bioethics, identified in particular in books by Tina Stevens, Al Jonsen and Jennifer K. Walker, really do show that there was a kind of withdrawal by theology scholars from bioethics, just as bioethics would eventually "move out" in large part from philosophy departments. No question either that bioethics has begun to look "secular" in the sense that most bioethics scholars, like most Americans, do not hold Cameron's view that embryonic stem cell research is murder destroys human life (ed note - revised per Dr. Cameron's comment), that Terri Schiavo should have been kept alive indefinitely, and that human nature is an essential, unchanging thing given by God to be preserved unaltered by human stewards.

But what is really troubling about his argument is that, like Carl Elliot, Cameron claims that secular bioethics is inherently instrumentalist and at the utter disposal of pharmaceutical companies and biotechnology. Like Elliot he presents no substantial evidence of this, and like Elliot his is a claim that turns the goal of Caplan and others of interacting with the public into a sign of (secular) evangelism on behalf of big Pharma.

It is troubling because it is incredibly hypocritical. There is superficial irony in Cameron's clever but incredibly unscholarly bashing "the likes of Caplan" because he and his wannabes aren't "profound Christian thinkers" like Paul Ramsey. Here is Dr. Cameron, after all, writing in some "insiders" website on behalf of "moral seriousness" and careful theology. It's not credible. Nigel Cameron - on behalf of pro-life bioethics scholars in his sway - isn't complaining that the serious theologians have left the bioethics building. He isn't complaining that there isn't enough attention to questions about religion in bioethics. He's complaining that the right-to-life movement doesn't have a Washington think-tank yet, that it doesn't get enough television time, and that it isn't taken seriously because it uses abortion language and gets labeled as the "religious right." If you don't believe me, check out Cameron's web page, which points to his own serious and scholarly engagement with Nightline, Frontline, CNN and the BBC. Nothing wrong with that, obviously, but it does rather put a kink in the whole "naughty secularists chase television" argument.

We do need more energy in theological bioethics. More religion departments hiring Ph.D. trained bioethics scholars with theology backgrounds. More bioethics centers seeking out, hiring and promoting theologians in their midst. More representation of theologians in bioethics societies and panels. But Nigel Cameron is not asking for H. Richard Niebuhr. Real scholars of theology are out there - many have trained a whole generation of smart religionists who write about bioethics - Karen Lebaqz at Pacific School of Religion comes to mind. James Gustafson at Emory. But guess what: many of them aren't conservative. Many of them wouldn't share the view that secularism in bioethics is an evil, or even that it took things "off the religious track." Many of the leading religious bioethicists, for example, took issue with the Catholic establishment of Schiavo, like Prof. John Paris, SJ. I doubt seriously that the Center for Bioethics and Human Dignity will be making a hire like John Paris.

When Nigel Cameron says that Christians are losing bioethics, it is a call to arms. He's smart, and he leads a movement that is on the fast track to allying with the neoconservatives (led by Kass) and the purists (led by Elliot). He'll get his think tank - in fact you could argue that Kass' big booster, the American Enterprise Institute, is well on the way to playing that role. And check out the awfully slick and relatively new right wing bioethics website: bioethics dot com, as well as their journal Ethics & Medicine: A Christian Perspective. At some point the Center for Bioethics and Human Dignity, Trinity International's masters program, the Kass acolytes on the Kass Council, their neocon bioethics journal New Atlantis, and perhaps even the "evil Pharma is buying bioethics" acolytes of Carl Elliot are going to figure out that the enemy of their enemy is their friend. And on that day the pure of soul will take over bioethics in the United States.

But that day won't be a victory for theology. It will be a victory for "old time religion."
- Wannabe [rev 8/13 10:45P]

Fried Chicken, Extra Cheese Pizza but Hold the Cigarette

The Future of the Body

The Gilead Saga Part Three: the Backlash

The tenofovir trials in Cambodia failed to start in August 2004 after the local sex workers union demanded decades of free health care as compensation for participants becoming HIV-positive during the study. The study in Cameroon was suspended in February this year following rumors about deceptive recruitment practices, and despite persistent claims from researchers that no serious wrongdoing took place, last week the site was shut down permanently. The CDC-funded study in Thailand, involving injection drug users, has recently been the target of criticism because there is no provision of sterile injection equipment to be given to the participants. In all cases, the media got involved, AIDS activists got involved, spokepersons for research agencies got involved, local politicians got involved, and it all got ugly.

In the meantime, talk about these problematic trials has filtered through to the commentary sections of learned scientific journals. Interestingly, some seek to shift responsibility for the problems with these studies squarely from researchers to AIDS activists, and the latter are depicted as having a vested interest in creating an atmosphere of sensation and scandal around AIDS clinical trials in the developing world. Joep Lange, former president of the International AIDS Society, can barely contain his outrage against a minority of activists, which he says have ‘taken us hostage’. According to Lange, they will apparently stop at nothing to derail the tenofovir trials:

The methods of these specific activist groups are uninformed demagogy, intimidation, and ‘AIDS exceptionalism’, the last in the sense that they exploit their HIV-positive status to get away with behavior that would not be accepted from others.

According to this perspective, the researchers (and their funders) should have a clear ethical conscience, for they did nothing wrong. It is simply a lunatic fringe of activists, in cahoots with medical journalists who increasingly want hot research ethics [PDF Link] stories, which have undermined studies on a promising new form of HIV prevention and thereby betrayed the struggle against HIV/AIDS.

This is obviously not going to be the end of the saga. Expect a backlash against the backlash, especially as new trials are being planned for South Africa and Malawi.
-Stuart Rennie

The American Psychological Association Needs to Think Harder About Ethics

The Report of the APA Task Force on psychological ethics and national security has drawn scathing comments in the NY Times and now Lancet. Stephen Behnke is scrambling to do damage control. But there were problems before the report even came out.

An article by Jane Mayer in the July 11/18 2005 New Yorker. "The
experiment: Is the military devising new methods of interrogation
at Guantanamo" raises serious questions about the appropriateness
of one member of the committee and about the complicity of Marty
Seligman in research refining methods of torture as well. I only
recently got a chance to read the New Yorker article but found it
quite troubling. It implicitly raises important questions about
the integrity of the task force and the judgment of Stephen
Behnke. Steve, let's hear from you.

The identifies Colonel Louie (Morgan) Banks as an administrator
of the military's program of systematic research to improve the
efficiency of psychological methods in breaking the will of
prisoners and obtaining confessions, regardless of whether these
confessions are true. The article quotes persons involved in the
mistreatment of prisoners at Guantanamo as indicating that Banks
was a consultant in specific interrogations. Banks himself is
quoted as saying "I do go down to Guantanamo occasionally, PI have
provided assistance" The artice indicates that Banks finds no
problem in helping with interrogations, as long as the law is not
broken.

Dr. Banks was a member of the APA's task force on
psychological ethics and national security! What was he doing on
that committee? Prior to the release of the task force report, I
had written to Stephen Behnke and, noting that the Army would be
represented on the task force, asked that representatives of human
rights organizations be there as well. He did not respond to that
specific request, but said that I would approve of the task force
report. I don't approve of it and I believe that Behnke owes the
membership of APA and the larger community of psychologists an
explanation why someone like Banks, involved in reprehensible
conduct, would be given a key role in how that conduct is judged.

As for Marty Seligman. The article indicates that he has advised
the torture researchers and a spokesperson for them cites learned
helplessness theory as a useful theoretical framework for their
work. I am struggling to figure out the connection between
positive psychology and torture. Is Marty helping these prisoners
get a peak experience?

According to a separate article in the NY Review of Books, Amnesty
International lists 60 alleged incarceration and interrogation
methods employed in US run detention centers, including immersion
in cold water to simulate drowning, forced shaving, being pissed
on, and mock executions. Wow, the technology of learned
helplessness has gone far beyond the insolvable anegrams and 90
decibel noises used in the 70s.

Perhaps Steve Behnke and the APA task force have given us a reason
to show up at the next APA convention: to join others concerned
about human rights in protesting APA's complicity in psychologists
conducting research intended to improve the efficiency of methods
to deprive others of those rights.

Philadelphia Inquirer | 08/10/2005 | When it truly is life or death

Stem Cells: the True Believers

According to Roll Call, the group is "threatening to make the [embryonic stem cell] debate less about the science of the issue and more about the political ramifications" for legislators who oppose broad federal funding for the research. Hli nko says the group will push to form a nationwide grassroots campaign devoted to pressuring wavering lawmakers to support stem cell research using unused embryos created for fertility procedures that otherwise would be destroyed or discarded. StemPAC's strategy differs "significantly" from other groups that promote embryonic stem cell research, such as the Republican Main Street Partnership.

Dead Again

In the aftermath of the death of Terri Schiavo this year (after persistent vegetative state and withdrawal of life supporting artificial nutrition and hydration), there was continued controversy when her husband’s belief that Terri had “left this world” in 1990 was inscribed on her tombstone.

How is the lay person supposed to sort through the semantics and get a handle on what “death” means? Before technology, if someone was dead, it was pretty obvious. Once artificial life support, specifically the mechanical ventilator (breathing machine) became available, the ability to continue life in the context of a person’s body being unable to do so, raised many ethical questions.

In 1981 The President’s Commission for the study of Ethical problems in Medicine and Biomedical and Behavioral Research endorsed adoption of the Harvard Medical School ad hoc group’s recommendation that patients with complete and irreversible brain function be declared dead and removed from ventilators. Public policy has continued to support the concept that whole brain death equals death.

This diagnosis can only be met after the patient meets very strict neurologic criteria. There can be no uncertainty. This allows the willing patient/ family the opportunity to donate organs. In particular, heart donation can occur only when the heart has continued to be perfused, with the assistance of a ventilator. Brain death implies not only the inability of the thinking, interactive portions of the brain to function., but also the brain stem which regulates breathing.

Brain death is not the same as PVS (persistent vegetative state). With this diagnosis, patients meet criteria that predict that they will never be able to interact with their environment again (no eating, talking, walking, watching tv) but they can breathe on their own. Many of us, through advance directives and conversations with family, have spoken of our desire not to live under these circumstances, artificially sustained through medical interventions such as feeding tubes. If these supports are not administered the patient will die of dehydration or electrolyte imbalances usually within ten days. Contrary to some reports in the media, this is not regarded as painful starvation. Not eating and not drinking is a common part of the natural dying process for many totally awake patients. This is what happened to most persons before the advent of our current technologies.

“Coma” is another term thrown into the mix that is unrelated to PVS or brain death. It reflects unresponsive behaviors of the patient but is a state from which one can recover.
Death is a natural part of the life cycle.
The use of technology has changed the timing a bit but certainly not the outcome. Mr. Torres is probably quite pleased that his daughter benefited through that technology in spite of the demise of his wife some time ago.

- Guest Blogger Shiela Otto, Clinical Ethics Consulatation Service, Alden March Bioethics Institute

Beyond Palmeiro: Where's the Line?

People who don't tell the truth are very good at lying to your face. Anyone who has watched the truth-shaving of such well-known confabulators as Ken Lay, Bill Clinton, Bernard Ebbers and Charles Keating knows what I mean.

Rafael Palmeiro has apparently joined the ranks of those who will be remembered as being good at delivering the big lie.

...is the point of sport to see what human beings can do without aid of any sort in fair competition...

Raffy, as those "in the know" in the world of sports refer to him, has tested positive for steroid use just five months after sitting in front of a congressional committee and denying unequivocally that he was a "juicer."

This rapid fall from grace of a 3,000-hit and 500-home-run candidate for the Hall of Fame has left sportswriters fuming. He seemed to be a guy you could trust. But, as anyone who has to deal with addicts knows, truth evaporates when it comes to their drug of choice.

Now the airwaves and blogs are bursting with debates about whether Palmeiro has succeeded in lying his way right out of Cooperstown. There is, however, a much bigger and more fundamental ethical question raised by the Palmeiro implosion and the steroid scandal that continues to haunt major league baseball.

It is easy to condemn steroid use. The drugs, while effective, are dangerous. But what if they were not? How are professional and amateur sports going to deal with the impending explosion in performance-enhancing drugs and bioengineering tricks that can boost performance with little or no risk for the user?

For example, at my school, the University of Pennsylvania, physiologist Lee Sweeney is hard at work trying to find ways to tweak genes to make muscles grow bigger and more dense. This research holds out real hope for those with muscular dystrophy and other debilitating muscle diseases.

But the gene transfer technology he is working on will also allow normal muscles to be made bigger and stronger. Figuring out who may or may not have engaged in "gene-doping" will prove next to impossible. And it is likely that there will be little risk associated with genetically altering muscle cells.

Similarly, scientists around the world are busy making pills that enhance our performance a bit by letting us sleep better, fight fatigue, slow the loss of memory, speed up learning, recover more quickly from hard exertion and calm anxieties. Some of us already are benefiting from drugs like these when we use Ambien, Provigil, Ritalin, Prozac or Effexor.

So what are we going to say when the archer, the chess master, the competitive marksman, the Nascar driver or the women's professional golfer says, "If I take these same drugs I just might get enough of an edge to move ahead of my competition"?

Throughout the 1990s when home runs were flying out of baseball stadiums, launched by players who obviously were using steroids, when professional football linemen got huge, when track and field records continued to fall, not much in the way of protest was heard. Americans are in love with those who take risks to break a record, or one another's bones, in the name of sport.

Nor do Americans gripe when we show up at the Olympics with our athletes who have the best training, superb diets, and top-flight equipment and whomp the tar out of athletes from poor nations, some of whom seem to have shown up just to get a decent meal. We are used to employing science to our advantage when it comes to sports, so why should we draw the line at genetic engineering or new miracle pills?

There is nothing about the reaction to Rafael Palmeiro's downfall that indicates we are ready to deal with the fundamental ethical question raised by his use of steroids - how can we draw the line when it comes to enhancement? Is the point of sport to see what human beings can do without aid of any sort in fair competition? If so, we may need to close the training facilities and cut back on what dietitians and trainers are allowed to do.

But if the point of sports is to test the limits of human performance, then we had better get ready to add genetic engineers and a bevy of pharmacologists to the hordes of specialists now working with elite athletes from elementary school to the pros.
There is no right answer to what the point of sport is. But Rafael Palmeiro has made it a question no one who cares about sports can avoid.

Physicians Who Sell Safety Data to Hedge Fund Managers

The practice of selling drug secrets, The Times found, is being driven by hedge funds, the largely unregulated investment pools that cater to the super-rich. Hedge funds can make money with aggressive strategies that exploit quick price swings in stocks, and the volatile biotech industry provides many such opportunities.

A single drug's prospects can determine whether a small biotech company's stock soars or plummets, so any inside information provides a potent investing edge.

Such information is so valuable that elite investors pay up to $1 million a year to firms known as matchmakers, which pair Wall Street firms with doctors involved in ongoing drug research. Gerson Lehrman Group, the largest matchmaker, claims to have 60,000 doctors available to speak to Wall Street, double the number from three years earlier...
Matchmakers typically pay doctors $300 to $500 an hour to talk to elite investors. Some doctors said they can make tens of thousands of dollars a year from such talks.

Drug-company executives say they know about the practice but can't crack down on the doctors they rely upon for conducting patient testing.

One experienced research analyst at a major brokerage firm said he's studied "elicitation techniques" taught to FBI and CIA interrogators.

"We get them to talk about the weather, or the Mariners, then you pop in your one innocent question you want to know about," said the analyst, who spoke on the condition that his name not be used. "Then you switch back to whatever it was you were talking about before. When the doctor hangs up, he thinks he's had a nice conversation about the weather or the Mariners."

Writes Art Caplan: This story has been brewing for some time now and it is an ethical doozy! The Seattle Times has found that some members of data safety and monitoring committees are leaking information to investment companies and Wall Street firms. Finding out what is going on in a clinical trial prematurely smacks of insider trading. It should draw the attention of Attorneys General in many parts of the United States. And it is clearly, inarguably and obviously unethical.

Finally an Appropriate Response to Michael Schiavo

He's been rebuked by the Vatican, castigated by Congress and slandered on the Internet, but Michael Schiavo was welcomed as a hero Friday by a state organization whose members make end-of-life decisions for people unable to make them for themselves.

The Florida State Guardianship Association bestowed its Guardian of the Year Award on Schiavo for carrying out his wife's wishes not to be kept alive artificially despite a drumbeat of withering criticism.

In a rare public appearance, Schiavo, 42, modestly accepted the award at the association's 18th annual conference at the Doral Golf Resort & Spa west of Miami.

"As you know," he said, "I'm not much of a speechmaker. I don't talk much. But on behalf of my wife, Theresa, I thank you."

Association members, most of whom are appointed by judges to represent people who have been declared incapacitated, acknowledged Schiavo was a controversial choice and they anticipate a backlash. After all, Gov. Jeb Bush joined world leaders from the president to the pope in aligning themselves with Bob and Mary Schindler, the Pinellas County couple who fought their son-in-law's effort to remove the feeding tube that kept their severely brain-damaged daughter alive for 15 years.

But, group members said, Michael Schiavo's unwavering commitment to honoring his wife's wishes in the face of public scrutiny and enmity embodied the professionalism and compassion with which court-appointed guardians quietly carry out their duties every day.

R.I.P., Canadian Socialized Medicine

He said a top priority was to reduce long waiting times for Canadians to see primary and specialist physicians. The country is plagued by numerous accounts of patients dying while they wait for care, or being forced to travel to the United States and other countries for specialized services.

Those opposed to privatizing the public health system worry it would lead to a two-tier approach in which wealthier patients would jump to the front of waiting lists and eventually lure physicians into private practice.

The Right Wing's Stealth Attempt to Kill Stem Cell Research

But what is clear here is that there is a political strategy in play - while the money for expanded stem cell research that is implicit in any Senate or House proposal thus far is small, the effect on state-based stem cell research under Castle-DeGette would be huge. In effect the Frist effort could clamp down on new state-based initiatives, restricting the amount and kind of research that states (read: California) could do with their own money. Hmm.

And Eric Meslin writes today on MCW:

Amazing how the dominoes start to fall, isn't it? Yesterday George Will made a similar argument, without the call for criminalization. Incidentally, we're still having to deal with this issue at the state level -- here in Indiana Mitch Daniels recently signed into law a bill that we (i.e., our medical school) had a hand in shaping, that linked permissibility of research on stem cells to "applicable federal law" -- a bit of a risky strategy I grant you, that in the worst case would at least set the floor of permissible stem cell research at Bush's 2001 policy and, in the best case would become more permissive if something like Castle-DeGette was passed. (Of course the state would be free to amend the law the maintain the more conservative limit). In this red state that was seen as a major victory, given that the bill as introduced (S.268) would have banned everything -- all cloning, all stem cell research. What remains in the Indiana law is a criminalization provision for violations. Does anyone know of research (legal or otherwise) that shows what the impact is of including criminal penalties in areas of regulated medical research?

Why Don't More Scientists Blog

Speaking of the Nazi Metaphor...

Where Scientists Are Ethical

Major Health Breakthrough - Doggie Cloning

Penn's Autumn Fiester is on the case. And Rick Weiss' treatment of the issue is perilously close to succeeding in making the matter look important or interesting. But at the end of the day, really, who cares? I've been besieged with emails all day asking why we weren't all over this story at bioethics.net and the blog. Hmm. Perhaps because it doesn't matter. Except to animal lovers ... after all it took more than a thousand embryos to produce God knows how many miscarriages before one doggie was successfully birthed. But hey, if you really loved that last pet - and are totally delusional about what cloning cannot reproduce - this is the technological breakthrough for you.

PhRMA Agrees to New Guidelines on Advertising; 23 Companies Sign On

Women's Bioethics Blog

German Ethicists Under Fire

Physician Screw Up Directory

The legislation, which passed the Senate on July 21 and the House on Wednesday, seeks to encourage health care providers to report medical errors voluntarily to patient safety organizations, which will compile and analyze the data. The patient safety organizations will contract with the providers to identify trends and develop proposals to prevent future medical errors. The data will not identify specific patients, providers or individuals who report medical errors. In addition, patients could not use the data as evidence in medical malpractice lawsuits or other litigation, and accrediting bodies or regulators could not use the data to take action against providers (Kaiser Daily Health Policy Report, 7/29). Bush said that "by providing doctors with information about what treatments work and what treatments cause problems, we will reduce medical errors that injure and cause the deaths of thousands of Americans each year."

J. Edward Hill, president of the American Medical Association, said the law is "the catalyst we need to transform the current culture of blame and punishment into one of open communication and prevention." He added, "Future errors can be avoided as we learn from past mistakes. This law strikes the proper balance between confidentiality and the need to ensure responsibility throughout the health care system." However, some observers said the law does not guarantee providers will report mistakes and others criticized the legislation for failing to include federal penalties for medical errors, according to the Tribune. Margaret Van Amringe, vice president for public policy and government relations for the Joint Commission on Accreditation of Healthcare Organizations, said, "There's no incentive to report useful information if you know it is going to be used against you. If you don't have the information then you are not going to solve the problem." JCAHO said it might be one of the groups charged with creating a subsidiary "patient safety organization" (Chicago Tribune, 7/30).

New Jersey Might, Um, Not Exactly Be Spending Money on Stem Cells After All

Lies Cure

Just as Atkins seems to be imploding, leaving a vacuum that some new diet must surely fill, we are introduced to the diet of lies.

It Really Was a Flip Flop

News Flash: People Build Studies Around their Politics!
Who Knew?

David Reardon wears two hats when it comes to abortion. He runs the Elliot Foundation, which wants Congress to impose strict barriers to abortion. But he is also a researcher whose studies on abortion have been in peer-reviewed journals. His latest, in a British journal, says that women who have had abortions are ''three times more likely to use illegal drugs during a subsequent pregnancy."

Reardon's findings support his proposal that abortion be defined as an act of ''medical negligence" if a physician does not warn patients about risk factors such as psychological problems.

Meanwhile, The Center for Bioethics and Human Dignity, which cites medical evidence to oppose right-to-die cases, says it was founded after ''more than a dozen leading Christian bioethicists gathered to assess the noticeable lack of explicit Christian engagement in the crucial bioethics arena." This year, the center's director of biotech ethics, Dr. William Cheshire, disputed court-appointed doctors who diagnosed Terri Schiavo as being in a vegetative state. Cheshire said Schiavo had responded to some stimuli, a view quoted by Governor Jeb Bush.

An autopsy found that the court-appointed doctors had been correct. Before Schiavo's death, some critics questioned whether Cheshire was basing his appraisal of her condition on his religious beliefs. The center said last week that Cheshire would not comment. The center's director, John Kilner, said, ''People shouldn't be disqualified from entering public discussions just because they have certain beliefs."

Ethics and Foreskin

One of the highlights of last week’s International AIDS Society conference in Brazil was the presentation of new data suggesting that circumcision significantly reduces a man’s chance of becoming infected by HIV through sexual intercourse. A study sponsored by the French National Agency for AIDS research (ANRS) and conducted with over three thousand HIV-negative young (18-24 yrs.) South African men found that circumcision reduced female-to-male HIV transmission by approximately 65%. The ANRS 1265 study is the first randomized controlled trial demonstrating a strong protective effect of male circumcision on HIV transmission. Data from two similarly designed studies in Uganda and Kenya will be available in 2007. (And no, none of these trials are double-blinded.)

The suspicion that circumcision could reduce the risk of men acquiring HIV through heterosexual intercourse has been around since 1986. Since then, around thirty studies have indicated a positive association between circumcision and lowered HIV transmission, but these studies (and their policy implications) have long been controversial. Skeptics have questioned their scientific validity, while others have deep reservations about the ethics of circumcision as a public health intervention, even if the causal relationship between circumcision and transmission is confirmed.

According to skeptics, previous studies have proven incapable of demonstrating that lower transmission rates among circumcised men are due to the removal of foreskin itself rather than confounding variables. For example, much has been made of the lowered HIV acquisition rates among circumcised Muslim males, but this could be due to differences in sexual ethics and other cultural factors, such as prohibitions against alcohol. Especially in Africa, the rite of circumcision is closely tied to ethnicity, making it difficult to disentangle the effects of circumcision from behaviors rooted in local tradition. If a website passionately devoted to the virtues of males remaining ‘intact’ is anything to go by, the new ANRS study may leave skeptics cold. It is worth pointing out that during medical history circumcision has also been said to prevent insanity, paralysis, bedwetting, excessive masturbation, impotence, tuberculosis, prostate cancer, syphilis, cervical and penile cancer. Foreskins have been unpopular in medical circles.

But there are ethical worries about implementation even if the conclusions of the study seem solid. The ‘good news’ may cause a sharp demand for circumcisions in sub-Saharan Africa, but at present they are most likely to be performed by traditional healers in less-than-hygienic circumstances. Circumcision may also increase unsafe sex practices in so far as men and women come to regard it as a ‘natural condom’: a tragic outcome, since a policy of circumcision does nothing to reduce the risks of male-to-female transmission of HIV. And if circumcision is encouraged but the long-term protectiveness of circumcision turns out to be much less than supposed, the damage to public confidence in the medical establishment and the impact on the fight against HIV/AIDS could be enormous.
- Stuart Rennie
Check out Stuart's new Global Bioethics Blog, where this piece also appears.