Yet Another Family in Texas Scrambles to Fight the Bush Law that Ends their Child's Life Support

HoustonChronicle reports that baby Knya Dismuke-Howard is the subject of a decision by Memorial Hermann Hospital that she (Leukemia has spread to her brain, and she is in multi-organ failure and has a major infection...) is not benefitted by the life support she is receiving, and that it is thus no longer good medicine.

Under Texas law (signed by President Bush, while then Governor) eight ten days elapse before the life support is withdrawn, and the family has that long to find another hospital for their child, one that will administer this course of treatment that the hospital says is causing her to suffer greatly while in a hopeless condition.

No word on whether the Texas Legislature or U.S. Congress will intervene is this highly public case in the President's home state.

[thanks L. McCullough for correction on dates]

AP: Evil Part-Human Sheep Lurk in Wait in Nevada

In what might be the silliest "here come the evil mutants" story of the year, Paul Elias, AP biotech writer returning from a field trip to Nevada, tries to extend the half life of the National Academies announcement (which we noted) of a new, proposed stem cell policy. He spins a tale guaranteed to produce at least one media cycle about part-human chimeras thinking hard out in the sheep fields, or wherever it is that sheep hang out:

On a farm about six miles outside this gambling town, Jason Chamberlain looks over a flock of about 50 smelly sheep, many of them possessing partially human livers, hearts, brains and other organs. The University of Nevada-Reno researcher talks matter-of-factly about his plans to euthanize one of the pregnant sheep in a nearby lab. He can't wait to examine the effects of the human cells he had injected into the fetus' brain about two months ago. "It's mice on a large scale," Chamberlain says with a shrug. As strange as his work may sound, it falls firmly within the new ethics guidelines the influential National Academies issued this past week for stem cell research.

The problem with these stories is that they are uncluttered by analysis about what chimeras really are, or about the ubiquity of chimeras in medicine today. Elias does note that "Doctors have transplanted pig valves into human hearts for years, and scientists have injected human cells into lab animals for even longer," but then immediately turns to say that "the biological co-mingling of animal and human is now evolving into even more exotic and unsettling mixes of species, evoking the Greek myth of the monstrous chimera, which was part lion, part goat and part serpent."

[thanks Ken Kuhl]

Four of Them Will be Auctioned on eBay

In the latest installment of Weirdness from the World of Unregulated Assisted Reproduction, young Teresa Anderson, "playing surrogate mother to a childless couple, Luisa Gonzalez and her husband, Enrique Moreno, gave birth to five boys at the Banner Good Samaritan Medical Center..."

Teresa, 25, had met the couple on the Internet and she says she is waiving the $15,000 she had agreed with the couple as fee since she knew the expenses that Luisa, a homemaker, and Enrique, a landscaper, will have to face. She had intended to use the money for a course in nursing so that she can take up a job to support her family. She and her husband have two children.

All of this is roundly celebrated as a miracle, a "gift of a family" and an act of courage. Hard to dispute the last part.

Abortion Plan B

The New Republic Online's Jonathan Cohn discusses a right wing plan to work on abortion politics through the morning after pill controversy:

This time, conservatives are making noise. A year ago, 49 Republican representatives wrote President Bush, urging him to block approval of Barr's FDA application. And, while the FDA's own scientific advisory panel endorsed the application by a vote of 23 to four, the Agency has withheld approval. Early this month, Senators Hillary Clinton and Patty Murray announced they would place an indefinite 'hold' on the nomination of the FDA's acting director, Lester Crawford, to become its permanent director until the Agency issued a ruling. (Unrelated issues have since stalled Crawford's nomination.) Meanwhile, stories of pharmacists refusing to fill Plan B prescriptions are cropping up. Early this month, Illinois Governor Rod Blagojevich issued an emergency rule requiring pharmacies, as publicly licensed health care providers, to dispense the medications, even if employees object. Conservatives there are trying to overturn the order.

National Academies Draft Ethics Guidelines for Stem Cell Research

Nick Wade of New York Times chronicles the announcement of guidelines for embryonic stem cell research from the National Academy of Sciences. The guidelines were promulgated through a group led by Jonathan Moreno and Richard Hynes (of MIT). They are interesting and novel and will spur a lot of good debate. And the NAS does not dodge the bullet by restricting its comments to "left over embryos" - no, this report goes right at the tough stuff like making chimera embryos, cloning based embryos, and egg donation for stem cell research.

Plus let's face it Jon looks sharp.

From the NYT report:

The academy's guidelines would impose limits on three kinds of experiment that involve incorporating human embryonic stem cells into animals. Undesired consequences could follow if human cells were to become incorporated into the sex cells or the brains of animals. In the first case, there is a remote possibility that an animal with eggs made of human cells could mate with an animal bearing human sperm. To avoid human conception in such circumstances, the academy says chimeric animals should not be allowed to mate.

A second possible hazard is that the human embryonic stem cells might generate all or most of an animal's brain, leading to the possibility of a human mind imprisoned in an animal's body. Though neuroscientists consider this unlikely, it cannot be ruled out, particularly with animals closely related to people, like monkeys and apes. The academy advises that human embryonic stem cells not be injected into the embryos of nonhuman primates for the time being.

Third, like many previous committees, the academy says human embryos should not be grown in culture for more than 14 days, the time when the first hints of a nervous system appear.

The academy advises that all institutions conducting human embryonic stem cell research set up local committees, including scientific experts and members of the public, to review all experiments. And it says a national committee should be formed to update regulations and relax the constraints if warranted by new evidence.

The academy also says that donors, including women who donate unfertilized eggs, should not be paid.

Bioethics Deathwatch: "Man Who Advertised for Liver Dies"

A few months ago Houston Chronicle began following a man who got a liver through a billboard asking someone to donate for him. That was news, and an awfully interesting footnote to a broader debate about advertising and solicitation for organs. But in what is becoming an ever popular phenomenon - "bioethics watch" (think about the annual birthday hype over the septuplets, the regular features on what Jack Kevorkian does in jail, and of course the omnipresent search for Clone #1) - the AP has tracked the death of this guy.

Kevin O'Rourke Takes Fire for His Courage

Chicago Trib discusses the fire that Kevin, professor of bioethics at Loyola and a priest, has taken for his words in support of removal of the feeding tube from Terri Schiavo:

Rev. Kevin O'Rourke sat at his computer and started reading hate mail from fellow Catholics infuriated by his stance on end-of-life care.

Many were outraged when the Chicago priest appeared on national TV last month arguing there were moral grounds for removing a profoundly disabled person's feeding tube.

"I was absolutely sickened to hear your commentary," one wrote in an e-mail.

"After listening to you, I now understand why Catholics leave the church," another fumed.

"You were a disgrace. ... What a sad example of a priest!!!!" another said.

For someone considered one of the nation's foremost experts on Catholic medical ethics, they were harsh words, but not unexpected.

O'Rourke, a scholar at Loyola University's Neiswanger Institute for Bioethics and Health Policy, is a leading proponent of letting families withdraw artificial life supports for patients in a vegetative state. As such, he stands at the center of a heated controversy within Catholicism over end-of-life care, one of the most sensitive issues facing the church as Pope Benedict XVI assumes its helm.

And Right Behind the NAS Report... Is a National Stem Cell Bill

BostonHerald discusses the shape of a bipartisan stem cell research funding bill from Kennedy, Feinstein, and Harkin, together with Republicans Hatch and Specter. The bill would ban reproductive cloning, ban the "sale" of eggs, and permit therapeutic nuclear transfer. Finally a bill that has a chance to pass.

And Right Behind That, Fetal Cell Therapy for Lou Gehrig's Disease

Wired News: Fetal Cell Therapy for Humans?.

Drug Industry Funds Politicians: Who Knew?

Jim Drinkard writes in USA Today:

When Sen. Bill Frist needed help in November for a quick tour celebrating the victories of newly elected Republican senators, he didn't have to look far. A Gulfstream corporate jet owned by drugmaker Schering-Plough was ready to zip the Senate majority leader to stops in Florida, Georgia and the Carolinas.

Frist's political committee reimbursed the drugmaker $10,809, the equivalent of a first-class fare for the same trip on a commercial airline, as campaign rules require. The price, a fraction of the cost of a charter flight, was almost a wash for Frist; Schering had donated $10,000 to his committee in 2003-04. What he got was worth far more: the convenience, luxury and efficiency of flying on his own schedule.

The drug company's friendly gesture toward the Senate's most powerful member illustrates the political clout of the pharmaceutical industry. It will be needed in the months ahead as the industry faces the threat of increased federal regulation, brought on by mounting concerns about the safety of the nation's drug supply.

The drug companies' corporate planes have been made available not only to Frist, but also for dozens of trips taken by other powerful lawmakers. House Speaker Dennis Hastert, R-Ill., took at least four trips to GOP fundraising events in the past two years aboard Pfizer's Gulfstream.

Drug companies and their officials contributed at least $17 million to federal candidates in last year's elections, including nearly $1 million to President Bush and more than $500,000 to his opponent, John Kerry. At least 18 members of Congress received more than $100,000 apiece.

The industry also liberally funds think tanks and patient-advocacy groups that don't bear its name but often take its side; the National Patient Advocate Foundation, for instance, receives financial support from at least 10 drug companies. And the industry isn't above playing hardball, according to David Graham, a Food and Drug Administration scientist who got on its bad side.

Since 1998, drug companies have spent $758 million on lobbying — more than any other industry, according to government records analyzed by the Center for Public Integrity, a watchdog group. In Washington, the industry has 1,274 lobbyists — more than two for every member of Congress.

...A spokesman for drugmaker Novartis, Sheldon Jones, confirmed that company lobbyists were aboard for three trips carrying lawmakers in 2003 and 2004. One, in June 2003, took Reps. Tom Reynolds, R-N.Y.; Mike Oxley, R-Ohio; and Mike Rogers, R-Mich., to a Republican fundraiser in New York City. Rep. Tom Davis, R-Va., and Sen. Chuck Hagel, R-Neb., also took trips on the Novartis Learjet. Of the 1,274 people registered to lobby in Washington for drugmakers in 2003, according to the Center for Public Integrity, 476 are former federal officials — including 40 former members of Congress. “They are one of the strongest, most well-connected and most effective lobbies in Washington,” says Amy Allina of the National Women's Health Network. “Going up against them is more often than not a losing battle.”

- Art Caplan

AJOB Dominates the Universe

Twice in the last couple of months, Thompson ISI, the arbiters of the data about who makes reference to what in all of sciences, have made our day. They let authors from three major AJOB articles know that those articles are among the most cited in all of the sciences. One more time - that's three articles in The American Journal of Bioethics that - just in the past three months - have been selected as among the most cited papers in all of the natural and social sciences and medicine.

So we're feeling a little bit full of ourselves around here. Which shouldn't surprise you since bioethicists as a rule take themselves far too seriously.

Anyway back to us: ISI is the organization that literally counts up the "citations" of all of the articles in all of the major journals, by looking at that same group of journals to see who's referencing whom. Some journals produce articles that are cited a lot. When that starts to happen, you know that the authors and journals who are being cited are (by definition) influencing the field.

Why do we care?

In bioethics, lots of folks have begun to believe that if you want your work to be widely read and influential, you need to publish it in Science, Nature, JAMA or New England Journal - or one of a dozen or so other top tier science and medicine. After all, those journals are top tier precisely because they are the most cited!

Well if you want your bioethics article to be cited - that is, noticed and useful - in the world of the sciences and medicine, it would appear that where you want to be these days is with us. It is an exclusive bunch, too. We have little membership cards. So for a limited time, if you produce an article that gets us kudos like this, we'll send you your choice from:

1) A Tin of AJOB Spam
2) A Selection of only slightly rustyLapel Buttons: GET AJOB; I NEED AJOB; and our favorite I GOT AJOB

Anyway enough about us.

Or, You Could Rent the 9th Season of 'Sex in the City'

Washington Times' DVD pic of the week is Clonus, a 1979 sci-fi movie.The synopsis hints at the movie's greatness:

Secretly financed by government honchos who harvest unwitting victims for organ replacements, Clonus is run like an Olympic training camp, where the brain-washed young-adult clones hone their bodies to athletic perfection, all in the hopes of an eventual graduation to 'America.'

But when smarter-than-your-average-clone Richard (Tim Donnelly) happens upon a stray Old Milwaukee beer can, that random discovery kick-starts a quest that threatens to expose the wide-ranging conspiracy.

"Clonus" (originally "Parts: The Clonus Horror," which is still the on-screen title) works best when focusing on the chilling clone farm and its poignant, doomed residents. The film's third act seems a bit rushed after the brilliant buildup, but "Clonus" recovers in time to reach a disturbing climax.

Pope Benedict on Bioethics

You have no doubt read by now that the new leader of the Catholic Church is very much concerned about cloning, writing that it "is becoming a more dangerous threat than weapons of mass destruction." But the comments of the then Cardinal Ratzinger extend throughout bioethics, as he has long been a theologically active member of the highest eschelon of senior Cardinals in the Vatican. Life News collected some quotes.

The Flog Me Document

Anxious to keep the Schiavo case alive, fundamentalists have begun to beat a new drum: the evils of living wills. You see, a living will is "inherently biased against a pro-life Christian understanding of values." Now, I am not sure what that could possibly mean. But I am quite sure that this anti-living will nonsense is going to amuse confuse caregivers and family members.

Here's a sample from the Florida Baptist Witness:

'I direct my health care provider(s) and health care surrogate(s) to make health care decisions consistent with my general desire for the use of medical treatment that would preserve my life, as well as for the use of medical treatment that can cure, improve, or reduce or prevent deterioration in any physical or mental condition.

'Food and water are not medical treatment, but basic necessities. I direct my health care provider(s) and health care agent to provide me with food and fluids orally, intravenously, by tube, or by other means to the full extent necessary both to preserve my life and to assure me the optimal health possible.

'I direct that medication to alleviate my pain be provided, as long as the medication is not used in order to cause my death.

'I direct that the following be provided:

* the administration of medication;
* cardiopulmonary resuscitation (CPR); and
* the performance of all other medical procedures, techniques, and technologies, including surgery %u2013 all to the full extent necessary to correct, reverse, or alleviate life-threatening or health-impairing conditions, or complications arising from those conditions.

'I also direct that I be provided basic nursing care and procedures to provide comfort care.

'I reject, however, any treatments that use an unborn or newborn child, or any tissue or organ of an unborn or newborn child, who has been subject to an induced abortion. This rejection does not apply to the use of tissues or organs obtained in the course of the removal of an ectopic pregnancy.

'I also reject any treatments that use an organ or tissue of another person obtained in a manner that causes, contributes to, or hastens that person's death.

'The instructions in this document are intended to be followed even if suicide is alleged to be attempted at some point after it is signed.

'I request and direct that medical treatment and care be provided to me to preserve my life without discrimination based on my age or physical or mental disability or the 'quality' of my life. I reject any action or omission that is intended to cause or hasten death.

'I direct my health care provider(s) and health care agent to follow the above policy, even if I am judged to be incompetent.%u201D"

The truly scary thing is that there is so much conservative money flowing into bioethics right now that this document and many more like it will no doubt be much more widely adopted than 'traditional' living wills. So, maybe we should say, God help the poor clinicians who have to try to figure out how to explain to family members that a feeding tube is in fact medicine and that it is not appropriate to use one in Mr. Jones' case.

1 + 1 = Huge Windfall for Drug Company About to Lose Patent Protection on a Very Important Drug

Newsday does a good job of framing a problem that has become more common as the titans of pharma deal with big ticket drugs that are falling off of patent protection. At issue is Lipitor, the statin that lowers levels of LDL cholesterol. Pfizer will lose patent protection for Lipitor in 2010, which matters just a little bit because the company earned $10.9 billion last year alone in revenue from the drug.

But what if there were a new drug pill that contains two medications - and could produce from the ashes of Lipitor a new "Lipitor-based" product?

That is the hope for Pfizer, who are combining a new drug that elevates levels of HDL (good) cholesterol with Lipitor. It would be a "combination" pill, not unprecedented but certainly never attempted at this scale.

Newsday quotes all sorts of ethics and health service research types about whether it might be a tad disingenuous to make this kind of maneuver with Lipitor.

Pfizer's strategy raises the question of "who's writing the prescription - the drug company or the doctor?" says George Annas, chairman of the health law department at Boston University. "On the surface of it, it looks like they're promoting Lipitor. It looks more like a marketing move than a public health move."

But what's the real harm in combining the two drugs in the form of a new product? In 2010, physicians will be able to choose to prescribe a generic form of Lipitor. But the leverage achieved by combining the two drugs will enable the company to charge a fortune for a 'new kind' of Lipitor, and for access to the other medication - which will be bundled with Lipitor.

The Belmont Report Archive

Bob Baker and Tris Engelhardt have told me over and over again that there is no more important document in bioethics than the Belmont Report, for a whole variety of reasons. There is certainly no question that it prefigures a number of other codes and rules in research in the U.S. and elsewhere. It isn't exactly a thrilling read, but the Belmont Report is as alive as it can be at the new Belmont Report Archive, put together by the U.S. Department of Health and Human Services.

The site includes a video on Belmont and some interesting oral history about research ethics at OHRP, the Office for Human Research Protections, which hosts the archive. Short of inviting Al Jonsen to speak, this site is the ideal way to present the Belmont Report to students.

Pope Benedict, Bioethicist

James Hughes discusses the bioethics implications of a new Pope, including one interesting twist on the Vatican position concerning modifying the genes in human sperm. Tucked away in Hughes' post is a link to a San Diego reporter's claim that the Vatican - in an effort already led by the then Cardinal Ratzinger and his assistant - is about to release a conservative Papal statement on bioethics, which is likely to be aggressive and sweeping. More interesting, it appears that the statement will speak to the individual responsibilities of Catholics rather than (as previous statements on stem cells, e.g., have done) sticking to the broader questions concerning the science. Look for an explicit ban on any Catholic receiving any therapy derived from embryonic stem cells.

The really interesting stem cell question for the Papacy may be adult stem cells - the American Catholic clergy has for some time now argued that "adult cells are better/fine/acceptable" as a hedge against public opinion on embryonic stem cells. But the then Cardinal Ratzinger made the explicit point that if adult cells are de-differentiated so that they behave in such a way as to be essentially embryonic, then they are not different morally from embryonic stem cells. Catch that? Ratzinger's claim was that adult stem cells are not all the same - and some of them may be embryonic even if derived from adults. If elevated to the Papacy, that position would have the effect of taking a lot of the air out of the "first use adult stem cells" hedge.

All He Needs to Do is Pick Up a Few PVS Cases and They'll Leave Him Alone For Sure

Republican Senator Tom Coburn has been struggling for years to continue practice as an obstetrician in his home state of Oklahoma. But

since winning a Senate seat last fall, Coburn has clashed with Senate ethics committee members over whether he could continue to do double duty as a lawmaker and an obstetrician. Now, Coburn says, the ethics committee has ruled that his private practice constitutes a potential conflict of interest with his work in Washington, and it has given him until Sept. 30 to close his office in Muskogee, Okla. An outraged Coburn is vowing to fight the ruling, arguing that the panel's decision contradicts the Founding Fathers' desire for lawmakers to retain ties to their communities."

South Africa Pushes the Envelope on HIV Weirdness

The response to the AIDS crisis in South Africa has long been characterized by its sheer weirdness. In 2000, South African president Thabo Mbeki famously placed himself firmly on the side of ‘AIDS dissidents’, i.e. a group of scientists who question the assumptions that HIV causes AIDS and that anti-retroviral drugs are sufficiently safe and effective. No, the dissidents claimed: HIV is really a harmless antiretrovirus that people who develop AIDS just happen to have (a lot), and AIDS drugs such as AZT are not only toxic but actually cause AIDS.

Of course, Mbeki is not the first president to have dangerously wacky scientific views. It was Ronald Reagan who in 1980 said ‘approximately 80% of our air pollution stems from hydrocarbons released by vegetation’ in order to argue for lax emission standards. But you could see at least what Reagan’s wonky science was doing for him (and the car industry). With Mbeki, you seemed to have weirdness for its own sake. Many could see the dangers of his public stance, but few could see the point, if there was one.

President Mbeki no longer talks like this, at least in public. But his prudence has not made public discourse about AIDS in South Africa any less bizarre. This week finds the South Africa Minister of Health Care, Dr. Manto Tshabalala-Msimang, lending her support to Dr. Matthias Rath, of the Rath Foundation. (http://allafrica.com/stories/200504180835.html) Dr. Rath produces brochures claiming that anti-retrovirals are poisonous, and that they are prescribed to AIDS patients not because they work, but simply to further the sinister interests of a global pharmaceutical cartel. However, effective and safe alternatives to prevent and treat AIDS are at hand: very special vitamins and micronutrients produced by … the Rath Foundation.

Interestingly, Dr. Rath’s supervitamins are more expensive than anti-retrovirals. And why shouldn’t they be? According to the website, they apparently help with cancer too. And diabetes. And cardiovascular disease. And heart failure, irregular heartbeat, high blood pressure, asthma, arthritis, tinnitus and periodontosis. And yes, the doctor has misspelled periodontitis, but I’m sure if periodontosis ever shows up, the vitamins will work for that too.

And it gets better, or worse, depending on your moral and aesthetic tastes. Dr. Rath has set up shop in three impoverished townships of Cape Town, where his clinics dispense vitamins to HIV positive patients, apparently touting them as a replacement of (rather than a supplement to) anti-retroviral treatment. His clinics also allegedly run some interesting impromptu studies on HIV patients too, involving behavioral questionnaires, blood tests without informed consent, and compulsory photography of patients wearing only their panties.

Funny ‘ha ha’ or funny ‘peculiar’? Ultimately neither: the epidemic is bad enough without being aggravated by quacks squeezing money from the poor.
-Stuart Rennie

Cloning Champion Horses -- Um, "Recreating Testicles"? Really?

When the first horse was cloned two years ago, we all knew this was coming. Scientists in Italy have just cloned the first champion racehorse, Pieraz. Pieraz is not a racetrack racehorse, where cloning technology would not be permitted, but is a long-distance racehorse, racing in endurance trials of up to 50 kilometers. But Pietraz was castrated young, so cloning was the only way for him to reproduce. But the company's explanation that cloning was the only way to "recreate his testicles" is just... weird.

MIT Gibberish Machine Writes As Well As You Do

If you were not sure that peer review is a trustworthy mechanism to insure objectivity in science and technology, here is yet another reason to wonder. - Art Caplan

Stem Cells for Defense?

Hmm--why is a Department of Defense contractor sponsoring a conference on the business of stem-cell research?

Cody picks the right man for the job

Acting Governor Richard Codey has picked harold Shapiroto oversee ethical issues into stem cell research in the Garden State. He could not have picked a better person. Harold Shapiro, former President of Princeton, former Chair of President Clinton's National Bioethics Advisory Commission, and all-around mensch (i.e., upstanding, good-hearted person) will oversee New Jersey's stem cell effort with the gravitas and broad mindedness it deserves. Codey pledged $380 million to try and make new Jersey a major player in stem cell research in the United States. Though it is a drop in the bucket compared to California's $3 billion stem cell initiative, if invested wisely and targeting the right start-ups, New Jersey can certainly capture one of the many potential niches for stem cell therapeutics. And with Harold Shapiro running the ethics effort, we can be sure that whichever direction New Jersey goes in, it will go there with proper oversight. maybe New Jerseyans ought to think about giving Acting Governor Codey that job on a more long-term basis?

Of Cabbages and Kings, and Chimeric Creatures...

"The time has come the Walrus said, to think of other things, of shoes and ships and sealing wax, cabbages and kings..." Alice in Wonderland You might think you have fallen down a rabbit hole into an alternate universe when you hear about things like "interspecific chimeric brains", but we have written about this before. The issue of evolving notions of personhood is one that will continue to persist and cause much debate and discussion and, at the risk of repeating myself, if we, in the United States, are not willing to ban chimeric entities in a manner similar to Canada, we should be looking to preserve and expand human rights and human dignity despite that fact our ‘humanness’ and human nature is changing. - Linda Glenn

Bioethicists are a Scream

Who ever said philosophers don't have a sense of humor? An annual dinner by the Center for Bioethics and Humanities at the Univerisity of Colorado, on the theme "Dolly's Dilemma... A Baaad Situation," had them rolling in the aisles in Denver. Who ever said bioethicists are stuffy?

It's Alive! - More on Breast Implants

The FDA Advisory Panel voted yesterday to keep the ban on silicone breast implants, citing insufficient long-term safety data, then turned around today and approved lifting the ban, but with very strict conditions. However, silicone breast implants may be relegated to the back shelves soon, though, in favor of live self-repairing breast tissue. Since posting testimony on the blog, several people have sent links to articles about using stem cells from fat to create new replacement tissue. This month, researchers at the University of Illinois at Chicago are publishing a study in Tissue Engineering showing that stem-cell tissue implants in mice kept their shape longer than traditional implants. Why use silicone when the real thing is available? -- Linda Glenn

Breast Implant Blowout

The FDA subcommittee Panel on General and Plastic Surgery Devices is hearing testimony today and tomorrow on on whether or not to approve new silicone gel filled breast implants. Linda MacDonald Glenn testified on behalf of the Women's Bioethics Project, on ethical issues in long-term safety and informed consent. Here is a copy of her testimony:

My name is Linda MacDonald Glenn, and I am testifying today on behalf of the Women’s Bioethics Project, a non-profit, nonpartisan public policy institute dedicated to ensuring that women’s voices, health, and life experiences are brought to bear on ethical issues in health care and biotechnology.

I am a biomedical ethicist, attorney, educator, and longtime patient advocate. I spent 20 years as an attorney – a prosecutor, government advisor, and general practitioner. During that time, I was called to the field of biomedical ethics both personally and professionally. I then went back to school to switch my career to biomedical ethics. Upon graduating in 2002, I went to the American Medical Association where I was a Senior Fellow at the Institute for Ethics. I hold a faculty appointment at the University Of Vermont. I was recently given the honor of being named a Women’s Bioethics Project Scholar. I have no financial conflict of interest.

“Tell me what you don't like about yourself” - this catch phrase is the opening line to the controversial TV drama "Nip/Tuck” that sums up the plastic surgeon’s attitude towards his patient. The implication is that plastic surgery can fix what “you don’t like about yourself.” And while we’re not here today to talk about plastic surgery, we are here to talk about the approval of new silicone breast implants, which the manufacturers have promoted as “a woman’s choice” – in other words, “let us help you feel better about yourself”. But as I will follow-up and explain, the FDA’s summary of the manufacturers’ own reports indicate that this is a hollow promise.

There are some key ethical issues involved in your decision today: issues of long-term safety and truly informed consent are the primary concerns. In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of Autonomy (the right to control over your own body), Benefit (the good that is accomplished from the treatment or application of technology), No-Harm (the risks and burdens of the treatment), and Justice (a question of fair and equitable access).

The Public Relations firm hired by the breast implant companies came up with a slogan -- "women have a right to choose breast implants" which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA – and there would no protection against claims of charlatans and those peddling magic elixirs.

The slogan – “the right to choose” implies a benefit that a woman will feel better about herself and her appearance, but in fact, the data submitted by Mentor Corporation does not bear out that benefit. Mentor’s own data, and the data that Inamed provided in 2003, both show that on most measures, women feel the same about themselves and their lives 2 years after getting breast implants, compared to before getting breast implants. This is consistent with other research as well, as shown in the FDA summary of Mentor’s reports on pages 66 – 73, indicating that there is no measurable benefit for women who have received breast implants. To quote: In summary, the literature does not provide strong scientific support that breast implants have measurable psychological and psychosocial benefits for women seeking breast augmentation. … Each study had one or more of the following problems…: short duration of follow-up (typically 3 months to 3 years); lack of an appropriate control population or baseline survey; use of different surveys before and after surgery; small study size; low response rate and/or high loss to follow-up; apparent exclusion of participants with adverse outcomes. (page 70 of FDA summary). And this result was not just for women who sought augmentation. The summary, on page 73, explains that Mentor did not provide adequate literature that evaluates the short-term or long-term psychological or psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and the potential risks are substantial: not only the risks of invasive major surgery, but also serious questions about long term safety issues regarding leakage of silicon into the body, silicon migration, and resulting auto-immune disorders. FDA research of women with implants for at least six years found that most women had at least one broken implant and that one in five implant patients had silicone leaking outside the scar capsule, but didn't even know it. Clearly, more studies on long-term safety need to be done.

In terms of ethically sound decision-making, this is what I would call “a slam-dunk” for this committee. Autonomy – “the right to choose” is not a factor where the benefits are not measurable, and the burdens and risks are significant. The path this committee ought to take is clear: these implants should not be approved until clear benefits and long-term safety is established. Thank you for your thoughtful consideration and listening today.

-- A decision is expected from the committee Wednesday.

Neocon Bioethics: The Love-In

At this conference, those who read Leon Kass religiously regularly and who think of Trinity International University as a great place to learn bioethics will be celebrating. Why? Because they will be able to say that they are the biggest, most powerful group in bioethics.

Don't ask for a lot of diversity (of any kind) at the Center for Bioethics and Human Dignity's 12th Annual International Conference. Pretty much everyone on the speakers list is on the record as being in agreement on pretty much all of the issues at hand. Think of this conference, in fact, as a kind of a revival for the long-ago converted conservatives in bioethics, as well as a workshop on how conservatives can use the media and the church to achieve political power. And - good news - you can trade in your three days of neocon biopower training at Trinity International University, along with a paper on "engaging bioethics ... in contemporary life" with "a biblical-theological mandate," for four hours of graduate credit toward a bioethics degree. And you will never have to read anyone whose view differs from your own!

One wonders: where is William Saletan? Saletan spends so much time bemoaning shallow utilitarianism among liberals in bioethics, in contrast to what he sees as incredibly thoughtful discourse among acolytes of Leon Kass and members of the Italian pro-life community. William, perhaps you should ditch the next undergraduate bioethics conference on your agenda and instead make some time to visit the folks in bioethics who really agree with each other. It will be more fun than ratings day at Fox News Channel.

For a Few Benefits More: Justice in International Research

After long taking a backseat to Beneficence, Non-maleficence and Autonomy, the concept of Justice is experiencing a renaissance in bioethics, particularly in international research ethics. All too often in the past, international biomedical research has placed most of burdens of research on participants and communities in the developing world, while developed world has reaped most of the benefits. There is general agreement that this imbalance of benefits and burdens constitutes exploitation.

But beyond that, there are fundamental disagreements among bioethicists about what the pursuit of justice in international research involves. There currently seem to be two opposing camps forming. Let us call them the minimalist and the aspirational.

According to the minimalist camp, justice in research consists in the avoidance of exploitation, and avoiding exploitation involves a negotiation of a fair benefits/burden ratio between research host communities and research institutions. As long as the research does not make the host community worse off, provides the community with some benefits, and the community judges those benefits of research to compensate for the burdens, then such research is non-exploitative, i.e. just.

It is fair to say that the minimalist view is dominant in international research ethics. After the 2001 Conference on Ethical Aspects of Research in Developing Countries, the delegates – including some big names from big institutions -- formulated a ‘Fair Benefits’ framework of justice in research. The document gives a somewhat quaint view of international research, where creative bargains about all sorts of benefits are cheerfully struck between host communities and research institutions. Imagine the conversations: “No, sorry, we cannot give you this drug if the trial is successful. But how about 5 boreholes for clean water?” As long as the host community comes away from the negotiating table with crumbs whatever benefits are on offer, justice is served. More recent reports, such as the Nuffield Council on Bioethics latest contribution don’t depart from the trend.

Another, more ‘aspirational’ camp is emerging. In this month’s Hasting Center Report, Alex John London takes the minimalist view to task for assuming that the social, political and health care status quo in developing countries is the ‘moral baseline’ from which to evaluate justice in international research. In essence, he asks whether not making impoverished communities worse off is anything (ethically) to write home about, and whether providing the destitute with a bit of borehole benefit meets the obligations of a worthwhile concept of justice. Real justice in international research involves more: to see how much more, well, it won’t be fair to summarize. Read it yourself: (Subscription Required). - Stuart Rennie

Schiavo Again??

From the New York Law Journal:

In a case echoing the fight over Terri Schiavo's fate in Florida, a Queens judge has ordered that artificial nutrition and hydration be provided to a woman with end-stage dementia.

Supreme Court Justice Martin E. Ritholtz's decision in the legal battle over whether to insert a feeding tube through the wall of a woman's stomach centers on Jewish beliefs about the afterlife and an analysis of the history of New York's version of a living will, the health care proxy.

The legal action began in January, shortly after 86-year-old Lee Kahan, suffering from pneumonia, pulmonary edema and advanced Alzheimer's disease, was admitted to St. John's Episcopal Hospital in Far Rockaway. She was awake, but unable to express any preferences.

Ms. Kahan's health care agent — her daughter, Joan Simonson, appointed via a health care proxy executed in 1998 — refused to allow insertion of a percutaneous endoscopic gastrostomy tube (or PEG) into her mother's stomach to facilitate long-term hydrating and feeding, the same procedure reportedly declined by Pope John Paul II.

The hospital discharged Ms. Kahan, returning her to West Lawrence Care Center, where she continued to receive hydration and nutrition via a nasogastric tube. Such tubes are indicated for temporary use only, as prolonged use can lead to aspiration or infections, both potentially fatal.

Three weeks later, on Feb. 19, Ms. Kahan's sister, Rose Borenstein, petitioned the Queens Supreme Court to have a PEG inserted. Ms. Borenstein also sought to have Ms. Kahan's health care proxy voided and to be appointed her guardian. She asked that Ms. Simonson be precluded from "interfering with health care decisions about artificial hydration and nutrition" for Ms. Kahan.

At an emergency hearing three days later, Ms. Borenstein and Ms. Simonson presented their cases.

Ms. Borenstein testified that her sister had become increasingly traditional in her observance of Judaism following her retirement as a legal secretary in 1996. Because of Ms. Kahan's "commitment to traditional or religious judaism," her sister said, "she would, if she could express her wishes, opt for the optimal life-sustaining treatment so she could live as long as possible, even though prolonged life could be a burden."

Ms. Kahan's daughter, Ms. Simonson, said that her "whole concern is that [her mother] not be caused any suffering and that she be able to live out the rest of her natural life . . . as comfortably as possible."

This aspect of the dispute was resolved by an agreement: Later that afternoon, after two doctors testified as to the necessity of the PEG, Ms. Simonson withdrew her objection and consented to allow it.

Two issues, however, remained: whether the court should enjoin Ms. Simonson from serving as her mother's health care agent and whether, in the alternative, the court should preclude her from making decisions regarding her mother's nutrition and hydration.

In deciding to allow Ms. Simonson to remain as health care agent but not to make decisions regarding Ms. Kahan's nutrition and hydration, Justice Ritholtz, in Borenstein v. Simonson, 4120/2005, laid out the origins of New York's health care proxy law.

The decision will be published Tuesday.

The state Legislature passed the Health Care Agents and Proxies Law in July 1990, six days after the U.S. Supreme Court concluded in Cruzan v. Missouri Department of Health, 497 US 261, that failures to honor a patient's desires might be avoided if states considered patients' appointments of health care proxies.

The New York law recognized society's split regarding artificial hydration and nutrition — that some feel it is another form of treatment, comparable to, say, artificial ventilation, while others believe it to be the "act of providing sustenance to a living person." To withdraw nutrition and hydration, the latter group believes, is no different than withdrawing air.

The new law generally favored the former group, by requiring health care proxies to explicitly state a patient's preferences regarding artificial nutrition and hydration. Otherwise, the agent does not have the authority to decide.

Because Ms. Kahan did not clearly state her preferences, Ms. Borenstein argued, Ms. Simonson exceeded the scope of her responsibilities and should be discharged as agent.

Justice Ritholtz agreed that Ms. Simonson overstepped her authority by preventing the insertion of the PEG. However, he added, her attempt to do so did not constitute grounds for her removal as agent.

Split in Jewish Law

To invalidate the health care proxy, the petitioners had to demonstrate that Ms. Simonson's actions constituted "bad faith," as set forth in Public Health Law §2992.

That question required an understanding of the Orthodox Jewish view of the treatment of the critically ill, according to Justice Ritholtz.

The judge cited numerous conflicting interpretations of the Halacha, or Jewish law.

"From a Halachic perspective, a persistent vegetative state and Alzheimer's disease are not terminal conditions, per se. . . . Patients with these illnesses deserve the same full range of treatment that is made available to any other patient," he wrote. "On the other hand, Halacha certainly takes pain and suffering into account." Because of the split in Halachic authority, Justice Ritholtz concluded that Ms. Simonson could not be deemed to have acted in bad faith.

Therefore, "the revocation of the Health Care Proxy held by [Ms.] Simonson is unwarranted," he held. However, Justice Ritholtz added that because the proxy did not specifically grant her such authority, Ms. Simonson's proxy did not extend to issues regarding artificial nutrition and hydration. Therefore, quoting from a different clause of her health care proxy, he ruled, "Lee Kahan, though incompetent, suffering from end-stage dementia, is entitled, in her own words, to 'life-sustaining treatment.'"

Public Courtroom

He concluded the decision by citing In Re Schiavo, 851 So. 2d 182, a decision by the Court of Appeals for the Second District of Florida: "It may be unfortunate that when families cannot agree, the best forum we can offer for this private personal decision is a public courtroom and the best decision-maker we can provide is a judge with no prior knowledge of the ward, but the law currently provides no better solution that adequately protects the interests of promoting the value of life." Since the PEG was inserted six weeks ago, Ms. Kahan's condition has improved, according to her sister's attorney, Samuel A. Abady. "I'm told that she's much more comfortable and has gained weight," he said. "She seems, according to her siblings, to be happier."

- Art Caplan

Saletan Watches the Bioethicists, Take 4

William Saletan, chief political correspondent for the on-line magazine Slate and well-known essayist, contrasts an undergraduate bioethics conference at Penn with a somber bioethics gathering in Rome, and makes various observations about the bankruptcy of "liberal bioethics" he saw in the former gathering, in a two-part [One,Two] commentary. The essays are odd, not particularly rigorous, and hilariously well written. Wayne Shelton points out that they read in fact very much like Hunter S. Thompson. On bioethics.

New Guest Blogger Sean Philpott Ph.D., Ph.D., MSBioethics, from Wadsworth institute in sunny Albany, rants thusly:

I won't say I enjoyed these articles. Saletan describes himself as a biotech liberal, but the tone of the two articles suggests that he is a self-loathing liberal at best. For example, he states that we liberals of bioethics (of which I am unabashedly proud to consider myself a junior member) believe that "[we] are the future". Well, we're not. Nor are we all utilitarians driven by doubt rather than faith.

There are clear distinctions between the two liberal and conservative camps of American bioethics. But for Saletan to suggest that all liberal bioethicists are for unfettered research and biomechanical or pharmacological enhancement is wrong. We're not all industry shills afraid to challenge the research