blog.bioethics.net

Meet El Presidente

Well this is a banner day for those of us who love and support Paul Root Wolpe who you should know by now is one of the "Editors" named up above - he's Associate Editor of The American Journal of Bioethics and has since the beginning of this enterprise brought the same kind of imagination and entrepreneurship to the launch of the journal that he brings to his other pursuits.

Paul has been elected President of the American Society for Bioethics and the Humanities, the US organization for scholarly bioethics. Paul is a polymath. He helped create the discipline of Jewish bioethics. He's written in the area of genetics, reproduction, end of life, and neuroethics - and helped develop the area of neuroethics in the first place.

He was named National Bioethics Advisor to Planned Parenthood. He is such a good teacher that they sell videotapes of his classes on the Superstar Teacher network. And they love him so much at NASA that they created the position of Chief of Bioethics for him.

Paul writes a lot, both in scholarly journals and as a regular columnist for the Philadelphia Inquirer, and advises numerous students of all levels. He will make an excellent president: he is generous, organized, smart, gentle and - perhaps most important for ASBH - innovative. And anyone who has spent any time with him will also tell you that he is very, very funny. I count Paul among my very best friends, and I could not be more pleased that my peers in bioethics have recognized his record of service to the field and to ASBH, and his vision for building the field. Go Paul.
- gm

Finally a DC Bioethics Think Tank? The Center for American Progress Holds a Bioethics Summit

Our man Jonathan Moreno, who has spent a sabbatical at the Center for American Progress and has some great ideas about the importance of bioethics' participation in new ways in Washington policy debates, is the focus of an event at the Center, where his book will be the touchstone for a conversation about "progressive bioethics" that features Art Caplan, Alta Charo and Vanessa Gamble. Information about the program - which is October 3rd at the Center on H Street - is available via the link. RSVP required.

happy birthday to us

The AJOB Editor's blog is one year old this week, for whatever that's worth. We're putting in two NIH grants on Friday so we're celebrating the occasion by ... not blogging very much.

Bioethics in the Eye of the Storm: The American Journal of Bioethics September/October 2005 is Out

Today, Volume 5 number 5 of The American Journal of Bioethics was released, and it is without question the issue of which we are most proud in recent years. The issue is entitled "Bioethics in the Eye of the Storm," and at its core is an examination of whether bioethics is on the right track - are we holding ourselves to high ethical standards? Are we doing a good job with Hurricane Katrina, and if not, is that because our emphasis is off track? Do we need a new code of ethics?

This special issue is available here and of course in major bookstores and by instant online access and paper subscription at Taylor & Francis Health. American Society for Bioethics and the Humanities members get a special reduced price as part of our partnership with ASBH.

The issue is lead by a special President's Essay from the ASBH, by Arthur Derse, entitled "the Seven Year Itch." Alongside is Robert Baker's target article, "A draft model code of ethics for bioethicists," which is the most tangible product of the special Alden March Bioethics Institute/ASBH/AJOB spring conference here last year on "the ethics of bioethics." Commentaries on Bakers' article by, among others, Tom Beauchamp, John Lantos, Stephen Latham, Ken Kipnis, Frank Miller, Felicia Cohn, and Jeff Spike focus on the whole range of problem about our own ethics that have been brought to the fore: industry involvement, professionalization, careerism, consultation.

In Focus in this issue is another take: Jonathan Moreno's "In the wake of Katrina: has "bioethics" failed?" which asks some contextual questions about how the disaster relates to our role in society.

Also in this issue - which arrives alongside a new issue by our friends down the Hudson at Hastings Center on research ethics - is an excellent Target Article by Ezekiel Emanuel, "Undue inducement: nonsense on stilts?" which makes the most aggressive argument to date that the very notion of "undue inducement" of human subjects in research needs to disappear and be replaced with other ways of protecting human subjects. Commentary on the issue ranges across all the disciplines that work on research ethics, and we expect that this collection will become required reading for those who trouble with the problem of inducements in research. In particular, Norman Fost, Howard Brody and Harold Vanderpool call into question the broad fabric of consent in the first place, and Alex London asks whether or not the whole problem comes from bad science.

Also in this issue is a target article collection on adolescent participation in emergency-department-based research on sensitive issues, and the second installment of our Public Health Bioethics section by new contributing editor Matt Wynia, director of the AMA's Institute for Ethics. And a particularly fascinating exchange concerning cheating on organ transplantation, and an In Focus piece on criminalizing scientific misconduct.

Bioethics is finding its way through a storm, working to think in new ways to rethink its own identify and its responsibilities to others, and particulary to the vulnerable. We could not be more proud of the work of the many who wrote for this special issue of AJOB, and we look forward to hearing about what you think!

Rick Weiss Wins Prize for Excellence

No reporter has done more to bring academic bioethics into public discourse than Rick Weiss. No one. He doesn't presume to be a bioethicist, unlike some who ply the trade of medical journalism, nor does he play favorites - nobody ever said to me at a meeting, "well Rick Weiss only quotes X, Y, and Z so he doesn't get the real story." He's just, well, Rick. Incisive, careful, innovative, often humble and a good writer. The list of good stories he has produced in health and science is enough to earn him an award, and it did: the 2005 Victor Cohn Prize for Excellence in Medical Science Reporting. As Alta Charo put it, "whooo hoooo" for Rick.
[Thanks Alta Charo]

Dealing with the Image of the Dying in New Orleans Nursing Homes

LA Times takes a glance at the implications of "'the image of people lying in bed with the waters rising, calling for help and no one is there … it could be us,' says Alice Hedt, executive director of the National Citizens' Coalition for Nursing Home Reform. 'We're all just a stroke away from a nursing home.'" - Art Caplan

Commemorating the Kass Chairmanship of the Bush Council on Bioethics

In Christianity Today, Nigel Cameron very generously reviews the work of Leon Kass as Chairman of the PCB.

Schiavo Speaks at the Ronald Cranford Conference

The conference is one of the most important ones in the history of bioethics, because it celebrates the life and work of Ronald Cranford, who has meant as much as anyone to the debate about end-of-life decisionmaking. The Minneapolis-St. Paul Star Tribune covered the guest most in the media were there to here: Michael Schiavo, who for the first time shared his side of the ordeal:

"All I wanted to do was carry out my wife's wishes." Wiping away tears, Schiavo spoke softly. "I'm not a public speaker, as you all know," he said. "You didn't see much of me. All I can do right now is be myself, and tell you how I feel."

Schiavo tried to stay out of the spotlight when the story became front-page news last winter. At the time, he said, he was denounced by the president, Congress, the pope, the Rev. Jesse Jackson "and even Mel Gibson." Eventually, the courts ruled that the feeding tube could be removed, over her parents' objection, and Terri Schiavo, 41, died in a Florida hospice March 31.

"I want everybody to know the day Terri died, she was so peaceful," Schiavo said. "Terri didn't die an awful death." He said he held her in his arms as she slipped away. "I laid a red rose in her hand and said goodbye."

The Power of Profit: Biotechnology After Bayh-Dole

Fortune has this lengthy and excellent piece on the effect of the revolutionary legislation from 25 years ago that opened the doors to what quickly became "transfer of technology" from federally-funded research into private entrepreneurship.

Les Yeux sans visage

Les Yeux sans visage (1959): Here is a French view of what would appear to be the impending arrival of face transplants. Spends more time on the issue of facial surgery than did the more often cited but less pithy 'Face Off' starring Nicholas Cage etc. - Art Caplan

What the World Needs Now: More Bioethics Guidelines

Writes Stuart Rennie, our man in North Carolina:

This June, UNESCO unveiled a a Universal Draft Declaration on Bioethics and Human Rights. The two central objectives of the Declaration are: (1) to state universal principles that lay a foundation for humanity’s response to dilemmas raised by science and technology, and (2) to ground these universal principles in human rights law in order guide states in the formulation of national legislation and policies in bioethics. Despite these lofty aims, the publication of the draft Declaration seemed to go unnoticed in bioethics circles. Perhaps this is to be expected: no one expects universal truths during summer vacation.

But the bioethicists are back from the beach, and some are less than thrilled with what UNESCO has produced. This month’s issue of Developing World Bioethics is devoted, in its entirety, to an examination of the draft Declaration and to speak of a ‘mixed review’ might be a bit charitable. The editorial draws first blood by calling the Declaration an obvious attempt on the part of UNESCO to muscle in on the authority of the World Health Organization on issues pertaining to the ethical regulation of biomedical research. UNESCO, writes the editorial, is an organization with little credibility among in the wider bioethics community and is best known for holding ineffectual (but costly) meetings and producing colorful booklets. Given its weak track record and dubious expertise, the predictable result is a Declaration that fails to state universal principles, redundantly lifts phrases from existing documents, is out of touch with some current bioethics debates, and offers misleading points of ‘guidance’. One thing is sure: Article 10 of the draft Declaration is a truly devastating piece of bioethics parody. “The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.” The deadly serious tone makes it all the more amusing.

The Declaration does not fare much better among some of the contributors to the September issue. David Benatar wonders out loud if the draft Declaration, should it be made official, would itself have a favorable risk/benefit ratio: will it do the world more good than harm? Matti Hayry and Tuija Takala ask why the concept of ‘dignity’ is repeatedly and uncritically used in the draft Declaration, despite recent concerns that the concept has no clear meaning. According to John Williams of the World Medical Association, the draft Declaration fails in both of its major objectives: it neither offers clear or helpful ethical guidance nor does it have the power to place new obligations on states. Commentators elsewhere echo these objections and concerns. See also here.

Other contributors are more positive. Loretta Kopelman is encouraged by elements in the Declaration that can counter ethical relativism and its negative effects on women and vulnerable populations worldwide. Ruth Macklin finds merit in the draft Declaration’s incorporation of considerations such as benefit sharing in research and the requirement that each country conduct ethical review of biomedical research within its own borders. So it looks like there will be a Universal Declaration on Bioethics and Human Rights, like it or not, and whether the world needs it or not.

- Stuart Rennie

Also from AJOB: Face Transplants Back in the News

In the wake of the announcements by surgeons at the University of Louisville (in the pages of The American Journal of Bioethics) that they planned to conduct a face transplant and hold it to be ethical to do so, and subsequent announcements to the effect that Cleveland Clinic was going ahead with the same procedure, there is lots of new coverage of progress on face transplantation and the associated ethical issues. In fact hundreds of papers around the world are playing pun games with face transplantation (Face/off, Facing the Impossible, Faced with Ethical Issues, Faces of Death). An example is the Marilynn Marchione AP story that has run three hundred times at last count, seen here in the Seattle Times:

CLEVELAND — In the next few weeks, five men and seven women will secretly visit the Cleveland Clinic to interview for the chance to have a radical operation that has never been tried anywhere in the world.

They will smile, raise their eyebrows, close their eyes, open their mouths. Dr. Maria Siemionow will study their cheekbones, lips and noses. She will ask what they hope to gain and what they fear.

Then she will ask, "Are you afraid that you will look like another person?"

Because whoever she chooses will endure the ultimate identity crisis.

Siemionow wants to attempt a face transplant...

Matthew Teffeteller, who lives south of Knoxville, Tenn., might seem like an ideal candidate. Three years ago, he was burned in a car crash that killed his pregnant wife. Despite many surgeries, his face still frightens children. Yet he wouldn't try a transplant.

"Having somebody else's face ... that wouldn't be right. I'd be afraid something would go wrong, too. What would you do if you didn't have a face? Could you live?"

Bioethicist Carson Strong at the University of Tennessee wonders, too.

"It would leave the patient with an extensive facial wound with potentially serious physical and psychological consequences," he wrote last summer in the American Journal of Bioethics.

Consequences he just could not face.

25% of the Mentally Ill are Victims of Violence

Archives of General Psychiatry points out that "more than one-fourth of individuals with severe mental illness were victims of violent crime in the past year ... In addition, the annual incidence of violent crime in persons with severe mental illness who live in the community is more than four times higher than that in the general population, said Dr. Teplin, who is director of the Psycho-Legal Studies Program at the Feinberg School."
[Thanks Darby Penny]

Big Money Connections for Transplant

Karen Hill at the Atlanta Journal-Constitution did this piece about the role of cash in transplantation "deals" around the nation, based on the current issue of The American Journal of Bioethics. She writes:

Chris Barr of Richmond Hill is an accountant who likes to play poker. He needs $100,000 for a new kidney. Jeffrey Evans, a Duluth chef who likes to hike, hopes to get $75,000 for a heart. Stanley Harris Jr., a 3-year-old from Decatur with large brown eyes and a shy smile, is looking for $55,000 for a kidney.

So it goes, as national charities turn to cyberspace to connect those needing transplants with people willing to help them pay for their surgery and care afterward.

The money they seek is only what they need to get started. After-surgery care alone can sometimes cost more than $100,000 a year, and often, those expenses are not covered — or are only partially covered — by insurance.

It's common among the 247 transplant centers nationwide — including Emory University Hospital and Piedmont Hospital in Atlanta — to keep people off waiting lists for transplants until those people can devise a plan to pay for a lifetime supply of anti-rejection drugs.

The phenomenon sheds light on how medicine is outpacing insurance. Transplant patients are living longer, but it's expensive. Raising money online concerns one of the nation's leading bioethicists, who wonders whether the Web sites redirect resources from those who are sickest.

American Academy of Family Physicians: Yes to Free Lunch, No to No Free Lunch

A news update from Carl Elliot to MCW is taken from the No Free Lunch website and available here:

Date: September 14, 2005.

The American Academy of Family Physicians says Yes to McDonald's,
Yes to Free Lunch, No to No Free Lunch.

Contact: Bob Goodman,
bob@nofreelunch.org, tel: 212-305-6263

The American Academy of Family Physicians, one of the nation's
largest medical organizations, has denied No Free Lunch-an
organization of health care providers that encourages physicians
to refuse gifts from industry-the opportunity to exhibit at its
upcoming annual meeting in San Francisco.

In a letter to No Free Lunch's Director Dr. Robert Goodman,
AAFP's
Manager of Sales and Services Sharon Hutinett said that No Free
Lunch's position was "not within the character and purpose of
the
Scientific Assembly" and therefore did not meet the AAFP's
"eligibility requirements." This despite the fact that the
Coca-Cola Company (booths # 2321 & 2323), The McDonald's
Corporation (# 2425 & 2427), and The Distilled Spirits Council of
the U.S. (# 527) will all be present at the meeting, and whose
missions thus presumably are within the character and purpose of
the assembly.

Over 5,000 physicians are expected to attend the meeting, and
exhibitors are told on the AAFP website that "seven dedicated
exhibit hall hours provide you with the opportunity for one-on-one
access to these high-prescribing, qualified buyers!" If this is
not enough, companies are provided with an array of sponsorship
opportunities. For example: $17,500 buys granola bars ("in a
custom designed bag that prominently features your logo") that
are
placed in the "Doctor's Bag" that are distributed to all
registrants' hotel rooms; $150,000 buys 50 custom-made banners
that will adorn the shuttle buses taking attendees to and from San
Francisco's Moscone Center. As the AAFP notes on its website:
"The
supporter of the shuttle bus banners will also receive
complimentary private coach service for its staff from the
supporter's main hotel to and from the convention center." And
of
course, there's free lunch: $60,500 pays for the food vouchers
that physician-attendees will use for lunch each day at the
conference. (see
http://www.aafp.org/x32809.xml)

In April of this year, The American College of Physicians also
denied No Free Lunch the opportunity to exhibit at its Annual
Meeting in San Francisco. The ACP further prevented No Free Lunch
members and medical students from distributing literature-in some
instances using armed San Francisco Police-even when this
literature was the ACP's own guidelines on acceptance of gifts
from industry.

No Free Lunch (http://nofreelunch.org) is
a not for profit organization whose mission is to encourage health
care providers to practice medicine on the basis of scientific
evidence rather than on the basis of pharmaceutical promotion. It
discourages the acceptance of gifts from industry by health care
providers, trainees, and students. Its goal is improved patient
care. It was founded in 1999 by Bob Goodman, a general internist
at Columbia University Medical Center in New York City.

The Zoo is Much Easier to Bear When the Animals Are on Anti-Psychotics

Without an ounce of irony, Toledo Blade reporter Jenni Laidman recounts the drugs used to treat the animals in the Toledo zoo these days.

Johari the gorilla is on antidepressants. It eases her PMS. When the Toledo Zoo needed calm zebras, it used an antipsychotic medication to quiet their jitters. Zoo staffers tried to soothe wildebeests with antipsychotic medication for eight months last year, and even occasionally this year. A swamp monkey was dosed with the antipsychotic, but it didn’t help her get along with her daughter. It wasn’t much good for ostrich aggression either. Yet a little Valium calmed the silverback gorilla when one of the females had a doctor visit. And Prozac helped a female orangutan negotiate life in her group.

The drugs work wonders, according to one very practical zookeeper:

“They’re definitely a wonderful management tool, and that’s how we look at them,” said the Toledo Zoo’s mammal curator, Randi Meyerson. “To be able to just take the edge off puts us a little more at ease.”

The problem is the animals. They just can't adapt normally to their environment (the Swahili word for which is "cage"). So we have to be compassionate. Medicate the animals. Heck, let's pump valium through the water system!

“I think it’s unethical to have an animal — for example a dog with separation anxieties, desperately trying to get out of the house, digging until his paws are bloody — it’s unethical not to treat them with drugs if it will make them not as anxious or not as aggressive. You’re making an animal feel more contented,” [Cornell vet] Dr. [Kathy] Houpt said.

What a great analogy: domesticated doggies digging at the door are just like Brazilian monkeys in air conditioned 20 x 40 wire cages in Toledo. Clearly these animals need drugs, not bigger cages and more room to roam. After all, it's a zoo in there.
[thanks Darby Penny]

Abortion and Election

Dom Sisti pointed out this really interesting table that demonstrates the correlation between abortion preferences and election votes in 2004.

60 Minutes on Amgen

Several people have asked me whether we can post a link to the therapeutic misconception / compassionate exemption story that aired on Sunday's 60 Minutes. Here you go.

Biology for Dummies Bioethicists

Scott Gilbert of Swarthmore has produced a book that should have been written a long time ago but wasn't - a guide to embryology written for those who are engaged in debates about stem cell research and cloning. Because they, um, don't, um, always have their facts straight. Scott puts it ever so gingerly: "Missing from most debates about stem cell research is a basic knowledge of human development ... 'Before we can have any informed discussion, people need to understand what an embryo and its cells can and cannot do at various stages.'" Gilbert wrote the book with two of his former students.

U.S. Scientists Seek Ethics Guidance from Israel on Stem Cell Research

Or so it says in the Haaretz.com piece that Andrew Rosenthal sent us. The claim is attributed to Gerald Fischbach, Dean of Columbia's College of Physicians and Surgeons:

"The U.S. is now looking to many laboratories in Israel, to modern innovations both in the science and in the politics dealing with stem cell research," Dr. Gerald Fischbach, who is also executive vice president for health and biomedical sciences at Columbia, said at the conference Tuesday. "I think the ethical debate is on a very high level, that it's not colored by religious dogma the way it is in the United States," he told AngloFile.

It isn't obvious to me that anybody in the U.S. is paying much attention to the incredibly thoughtful scholarship about respect for the embryo that is coming out of Israel these days, but maybe so.

Active Euthanasia in New Orleans

This speaks for itself:

Doctors working in hurricane-ravaged New Orleans killed critically ill patients rather than leave them to die in agony as they evacuated. With gangs of rapists and looters rampaging through wards in the flooded city, senior doctors took the harrowing decision to give massive overdoses of morphine to those they believed could not make it out alive.

One New Orleans doctor told how she "prayed for God to have mercy on her soul" after she ignored every tenet of medical ethics and ended the lives of patients she had earlier fought to save...

Her heart-rending account has been corroborated by a hospital orderly and by local government officials.

One emergency official, William Forest McQueen, said: "Those who had no chance of making it were given a lot of morphine and lain down in a dark place to die."

Euthanasia is illegal in Louisiana and the doctors spoke only on condition on anonymity.

Their families believe their confessions are an indictment of the appalling failure of US authorities to help those in desperate need after Hurricane Katrina flooded the city, claiming thousands of lives and making 500,000 homeless.

"I didn't know if I was doing the right thing," the doctor said.

"But I did not have time. I had to make snap decisions, under the most appalling circumstances, and I did what I thought was right.

"I injected morphine into those patients who were dying and in agony.

"If the first dose was not enough, I gave a double dose.

"And at night I prayed to God to have mercy on my soul."

The doctor, who finally fled her hospital late last week in fear of being murdered by the armed looters, denied her actions were murder.

"This was not murder, this was compassion. They would have been dead within hours, if not days," she said. What we did was give comfort to the end. I had cancer patients who were in agony. In some cases the drugs may have speeded up the death process.

"We divided the hospital's patients into three categories: Those who were traumatised but medically fit enough to survive, those who needed urgent care, and the dying.

"People would find it impossible to understand the situation. I had to make life-or-death decisions in a split second. It came down to giving people the basic human right to die with dignity. There were patients with 'do not resuscitate' signs. Under normal circumstances some could have lasted several days. But when the power went out, we had nothing.

"Some of the very sick became distressed. We tried to make them as comfortable as possible.

"The pharmacy was under lockdown because gangs of armed looters were roaming around looking for their fix.

"You have to understand these people were going to die anyway."

Mr McQueen, a utility manager for the town of Abita Springs, half an hour north of New Orleans, told relatives that patients had been "put down", saying: "They injected them, but nurses stayed with them until they died."

Mr McQueen, who worked closely with emergency teams, added: "They had to make unbearable decisions."

[thanks Steve Latham]

Informed Consent Forms Could Use a Little Surgery

Buffalo News ran this great piece by Judy Foreman, sort of a review of how awful things are in the informed consent process these days. A dozen bioethics folks are quoted and the gist of the piece is that routine informed consent is insufficiently geared toward understanding and entirely too focused on shielding practitioners.

Finally, It is Raining Stem Cells Money

California's stem cell research agency, CA Institute for Regenerative Medicine, has unloaded $39.7 million in grants to Stanford, Cal Tech, USC, and eight of the University of California campuses. The money is all still encumbered by pending litigation concerning Prop 71, but they are giving it out nonetheless. Sort of. Well, they are giving out IOUs, essentially. But the money is coming.

A Storm of Issues

Albany Times-Union interviewed Bob Baker and Glenn McGee for this piece about the ethical implications of Hurricane Katrina.

Edmund Pellegrino to Replace Leon Kass as Chair of the President's Council on Bioethics

Dr. Edmund Pellegrino will be nominated to be a new member - and the Chair - of the President's Council on Bioethics, according to this Personnel Announcement from the White House. He will succeed Dr. Leon Kass. Pellegrino is one of the most respected, best published, and most accomplished scholars who has ever worked in bioethics.

It is possible to gush about the White House's decision - a rare opportunity these days - in part because Pellegrino is a good, honest and kind person, but also because Pellegrino is not afraid to engage his academic peers and will not operate like a cheerleader for the administration, nor will he treat the Council like an oversized ethics seminar for neoconservatives. So, for example, I do not expect to hear that the American Enterprise Institute is going to be selling the products of the deliberations by the Council in the future. The sun will never rise on a day where Edmund Pellegrino lobbies Congress as a "private Citizen" for a "second term bioethics agenda," or writes Op Eds defending Presidential stem cell policy while sitting as Chair during a Presidential election year.

Pellegrino's views on a number of issues are well known, since this chair of the PCB has published more than 500 articles in the field and participated in more than 20 books, and while many of them are not my own views, I for one am happy to have those views expressed as the honest result of a well thought-out argument based on his years of peer-reviewed scholarship on clinical ethics. Pellegrino's affiliations with groups of conservatives are of no concern to me because he is, again, no one's stooge. They say as much - see for example the description of his role as Fellow at the Center for Bioethics & Human Dignity here.

A conservative choice, yes, but a solid scholar of bioethics whose entire career has revolved around the virtues and character of physicians. - GM
[thanks Art Caplan and Tony Mazzaschi]

It is Very, Very Good to Be a Medical Student

The Chronicle of Higher Education reports today on a JAMA piece concerning the "bombardment" of medical students with gifts and invitations to activities. In the study,

Eight hundred and twenty-six students responded to the 64-question survey. They answered questions about how often they received gifts or meals from drug companies and about whether they agreed with statements such as "It is sometimes OK for medical students to accept gifts and lunches from drug companies because most students have considerable debts and minimal income."

Not only did most of the students say they accepted weekly gifts or activities from drug-company representatives, but most of them, nearly 70 percent, believed that such gifts would not affect their medical practices. Almost all of the students, 93 percent, said they had been asked or required by a physician to attend a sponsored lunch.

[thanks John Kaplan]

Do You Know Where Your Active Ingredients Are? Global Trade in Fake Drugs

A few years ago, on a market in Cape Town, I bought a knitted hat with ‘Nike’ and the famous swoosh weaved into it with gold thread. The local vendor had made these hats entirely himself. A form of innocent theft: if a man can eke out a living by using the brand of a multinational infamous for its exploitive labor practices, well, so be it.

Hats are one thing, medicines are another. The production and sales of fake medications have been booming for some time in the developing world. In many parts of Francophone Africa, they are routinely sold at pharmacies par terre (roadside drugstores) by self-proclaimed pharmacists or docteurs de rues (street doctors). Much of what they sell are counterfeit medicines made to look convincingly like drug products of major pharmaceutical companies: from the packaging to the hologram to the imprint on the pills themselves. But these fakes may contain a reduced amount of the active ingredient, none of the active ingredient or substances that may be positively toxic. An estimated 120,000 Chinese patients are reported to have died from consuming counterfeit drugs in 2001, and some 500 patients (mostly children) in Haiti, Argentina, Bangladesh, India and Nigeria died when their fake paracetamol syrup turned out to contain diethylene glycol. When you realize there is a powerful underground industry and flourishing market for ersatz drugs ‘treating’ some of the major causes of global mortality -- tuberculosis, malaria and HIV/AIDS – you get a sense for the potential public health consequences of the trade.

The scale of the problem is staggering: in a recent article, it is estimated that 15% of all medicinal drugs sold worldwide are fake, and in parts of Africa the figure exceeds 50%. And this is a truly global issue: in a recent book (Dangerous Doses: How Counterfeiters are Contaminating America’s Drug Supply), Katherine Eban describes in detail the increasing difficulties US authorities have in keeping phony drugs out of American medicine cabinets.

As far as evaluating the trade in fake drugs goes, this is an ethical no-brainer: those who produce and knowingly distribute them to unwitting patients are simply immoral and criminal. The real ethical questions concern who is responsible for the enabling conditions of the trade, and who is responsible for doing something about it. Pharmaceutical companies are not just victims here. When the price of legitimate medications essential to health lies outside the financial means of a good percentage of the world’s sick, it is hardly surprising that a market exists for cheap substitutes. Pharmaceutical companies also have typically not taken an active, public role in the investigation of counterfeits of their own products. Fearing loss of consumer confidence in their brand, loss of commercial advantage and falling stock prices, they tend to conduct secretive internal inquiries instead of notifying the public about potential dangers. The companies also are reluctant to cooperate with bodies such as the World Health Organization. Unsurprisingly, governments have historically taken the side of the pharmaceutical firms on this matter. But the only ones to profit from this atmosphere of secrecy, mutual suspicion and narrow self-interest may be the manufacturers and distributors of counterfeit medications themselves.

- Stuart Rennie

British Bioethics Scholar in the National Portrait Gallery

From the Independent Online Edition:

"Born in Northern Ireland in 1941, Onora O'Neill is one of Britain's leading philosophers. She studied at Oxford and Harvard and has written widely on political philosophy and ethics, international justice, bioethics and the philosophy of Immanuel Kant. A former philosophy professor, she is now principal of Newnham College, Cambridge. She was created a life peer in 1999 and was a member of the Select Committee on Stem Cell Research. She also chairs the Nuffield Foundation."

Bioethics in the Wake of Hurricane Katrina

Jonathan Moreno has penned an excellent essay on the lessons of the aftermath of hurricane Katrina for bioethics, written in the spirit of regret, horror and concern that, it is safe to say, all those in bioethics now share with the rest of the nation and the world. He writes, for example, that:

If the Katrina disaster partly resulted from a failure of institutions, then bioethics must shoulder its share of the blame. Many commentators have observed that the field has wrapped itself in the embrace of the privileged and their problems. What contribution have we made to the debate about access to health care since the President's Commission in the early 1980s? The failure to create and execute an escape plan for New Orleans' impoverished is part of a continuum of inadequate services that even in ordinary circumstances often proves deadly.

Still more transparent is the sorely limited contact between bioethics and environmental ethics, both in the literature and in institutions. Although we shouldn't exaggerate the influence of bioethicists' voices, the media does provide many of us a soapbox that could be exploited for purposes other than simply to comment on the ethics crisis de jour. The American environmental movement is in its own period of self-examination, following a series of regulatory setbacks and an essay by two influential leaders that roiled the field last year when it proclaimed "the death of environmentalism." (Shellenberger and Nordhaus, 2004) Bioethicists could help reinvigorate the movement by providing new voices and fresh ideas and also enrich our understanding of the reach and significance of our own work.

In the short run, the reconsideration of the scope of bioethics that is proposed could even unite opposing voices in the bioethics culture wars. While conservative and liberal thinkers might continue to disagree about familiar ethical issues like suitable limits on enhancement technologies, they should find common cause in the need to care for a fragile and increasingly ailing planet. Such a discourse would in some ways return us to the insight that gave rise to both fields, that human well-being is dependent upon a complex ecological system in which we are all inextricably linked, one in which we are both actors and patients, doers and sufferers. These brute facts we ignore at our peril.

[thanks to Sean Philpott and John Kwon]

American Journal of Bioethics Article Prompts Re-examination of Advertising for Transplant Donors

From the Seattle Times, and syndicated from the Post-Dispatch:

Last month, a group working on behalf of a New York City public-relations executive was accused of using questionable tactics in their search for a deceased-donor liver. The tactics included posting fliers in hospitals, allegedly tracking trauma patients in emergency rooms and urging police and emergency-medical workers to identify accident victims who might serve as donors.

United Network for Organ Sharing issued a statement assuring the public that the executive did not get preferential treatment when she got a transplant Aug. 6.

In the current American Journal of Bioethics, Sheldon Zink and colleagues at the University of Pennsylvania Center for Bioethics said recent appeals highlight the potential for exploitation.

State and federal laws permit families to name a specific person to receive their loved one's organs, a process known as "directed donation." Typically those organs go to relatives. Most transplant professionals say designating organs to immediate family members is acceptable.

Another Full Frontal Attack on the HFEA from Britain's Most Prominent IVF Clinician

The IVF meddlers must go, writes Lord Winston, upon his retirement. We discussed his new effort to reveal as illusion the claim that HFEA is the model for regulating reproductive technology. But this is much more direct, and although written as an op ed in a British paper, it is the most accessible for an American audience. He writes:

My retirement from clinical medicine eases a burden. I no longer look over my shoulder at the regulatory body, the Human Fertilisation and Embryology Authority (HFEA), whose workings the government is to review. I can speak plainly because I no longer have a conflict of interests. I believe there is a strong case for abolishing this body.

The authority regulates medical teams and IVF procedures. But why should this one treatment area be singled out? No other medical field is similarly regulated and patients do not suffer in consequence. Is the reason for regulating IVF so strictly because it deals with the beginnings of life, and with small babies? Yet we do not have a regulatory body for obstetrics or midwifery. Neonatal paediatrics is not regulated like this, neither is abortion. All these clinical areas involve just as weighty ethical and medical implications.

Some say special regulations are needed to prevent "evil practices" like human cloning. But cloning is a criminal offence. And it is unthinkable that it could be conducted in the UK without discovery, so there is little need for any authority to prevent it.

Other fertility medicine is unregulated. Tubal surgery, drugs and artificial insemination without donor sperm do not require the meddlesome activities of people who feel they know what is in the best interest of patients. Yet there is little evidence to suggest that clinical practice in these areas is deficient. There are already adequate mechanisms to control doctors, nurses and laboratory workers in all branches of medicine.

The 1990 Act emphasises that clinicians must regard the welfare of any child that might be born after treatment. This is unique to IVF; it doesn't apply to other fertility practice. It is undesirable in principle because it risks injustice, and unworkable in practice because nobody can forecast the future. Of course, a serious history of child abuse might be a good reason for refusing treatment. But only in a tiny minority of cases could we ascertain that a baby might be born into a really adverse environment.

Caroline Flint, the minister responsible for the government review, asserts that the presence of a regulatory body has "instilled public confidence in the safe and ethical use" of IVF. But where is her evidence? Regulatory bodies may well increase public anxieties by focusing on controversial issues which are seen to be more threatening than they really are. One reason why Dr Zavos came to Britain to announce his work on "human cloning" was because he felt he was likely to get maximum publicity. He wanted the controversy that would be stimulated by the presence of the HFEA.

Some authority members boast that the British system is a model of regulation that other countries envy. This boast seems flatly untrue. Over 15 years, many countries peered hesitantly at the British system and then rejected it. There is not a single member country of the European Union with a precisely similar body. There is no evidence that practice in France, Singapore or Australia is more flawed without an equivalent body. As far as I am aware, only Canada has recently established a body along the lines of the HFEA.

So if clinical practice does not need special regulation, surely research, and particularly research on embryos, does? I remain unconvinced. Research in different areas of medicine and on human tissues is so tightly regulated now that the HFEA is superfluous. It is extraordinary that, after having gained institutional committee and local or national ethical committee approval for any research, my colleagues still have to seek HFEA approval. These different committees have been known to disagree with points raised by the authority. This degree of bureaucracy inhibits UK research.

Flint claims that Britain continues "to lead the world in developing new treatments to alleviate infertility". Try saying that to Australian scientists or American, Chinese, Israeli, Singaporean or Swedish experts. IVF success rates have not improved much in the UK over years. And a main reason is that few British clinics are conducting internationally competitive research.

Let me be clear. I am not opposed to regulation. But in the modern UK healthcare system there are now quite enough safeguards without the HFEA. The authority is not a great British success. And it is a costly body: the HFEA charges Hammersmith about £130,000 annually for its licence. These costs inevitably are passed to the patients who already pay large sums for their treatment. What do they get in return?

Christian Science Pharmacist Refuses To Fill Any Prescription

Ok, ok it is from the Onion. [thanks Mike Freeman]