Bill Bennett 's immodest proposal

Remember Bill Bennett? Paragon of virtue (editor, in fact, of the Book of Virtues)? Former Secretary of Education? Former Drug Czar? High-stakes gambler? He's back in the news: apparently he made a remark on a radio show this past Wednesday to the effect that the crime rate could be reduced by selectively aborting "black babies." Mind you, he wasn't recommending this, just . . . . mentioning it.

Everybody with a pulse is condemning his comment. The White House, even, is saying this wasn't, um, "appropriate." This might just be me, but "inappropriate" doesn't seem like the right word for this one. The idea that someone could casually toss off a racist remark about forced abortion is. . . well, kids, what adjective would you use?

Women’s Voices need to be in the Bioethics News

On the FAB listserv yesterday, Joan Callahan drew our attention to the fact that in USA Today’s story introducing the mainstream public to world of bioethics, not one woman is mentioned. She asked for suggestions as to how women bioethicists might be included on whatever list the media have when they need to call an "expert" for ethical insights on news in health care, the life sciences, bioetechnology etc. The mission of the Women’s Bioethics Project to get women’s voices heard in the public debates on bioethical issues. Kathryn Hinsch responded to Joan’s call with the announcement that the Women's Bioethics Project is in the process of compiling a list of women scholars who are willing to talk to the press, conducting press tours to the major media to let them know about this resource, and preparing media training for scholars. She invites scholars to contact Gina Sullivan gsullivan@womensbioethics.org to sign up.

Ed(st) note: For those who aren't familiar with FAB, it's the International Network on Feminist Approaches to Bioethics. More info here.

Generation Rx

Three things came into my e-mail box this morning related to pharma. I teach ethics at a Pharmacy College and I somehow get on pharma news lists. First, Eli Lilly will be putting a “black box” warning on Strattera, a drug used to treat ADHD. This is the loudest possible warning that goes in a drug label. Why the warning? Data show that it causes suicidal thinking in some children and adolescents. This is the same kind of concern there is with Paxil. Second, I get a NYTimes book review for a cleverly named book, Generation Rx by Greg Crister: “baby boomers and their offspring have become the most medicated generation ever, devoted consumers from cradle to grave of every manner of pharmaceutical imaginable - pills that not only cure real diseases, but that also promise, in Mr. Critser's words, to "do everything from guarding us against our excesses of drink, food and tobacco, to increasing our children's performance at school, to jump-starting our own productivity at work, to extending our very time on this mortal coil." Top this off with an invitation to a film called Side Effects, whose www site warns me that before I pop my next pill I should watch their satire about life inside a pharmaceutical company. I think I will go. I need a laugh.

More obstetric horror stories in Africa

Today's NYT carries a story about a heroic Dutch surgeon, Dr. Kees Waaldijk, who is working to help women in Africa recover from obstetric fistulas. With few resources and little help, he estimates he's done 15,000 fistula repair operations over the past 22 years.

An obstetric fistula is what can happen when labor is unsuccessful and there's no doctor standing by to do an emergency C-section: the baby dies, and the woman's urethra and/or bowels are torn, resulting in urinary and fecal incontinence. Given the early age of marriage and pregnancy for some women, combined with the lack of access to medical care, this is a huge problem--and one that has garnered little international attention or funding. (You can also check out the interactive audio/video feature posted with the text story--but do so only if you can handle watching a little bit of the surgery.)

Linda Glenn posted on this same issue here on the blog in June. Wouldn't it be great if the publicity were generating funding for efforts like Dr. Waaldijk?

Connecticut says insurers don't have to pay for infertility treatments in women older than 40

This AP report describes a new law in Connecticut that, while requiring insurance companies to cover the costs of infertility treatment, allows companies to deny this benefit to women older than 40. Similar age-based cutoffs exist in New York (at age 44) and New Jersey (46). There is no federal law requiring insurers to pay for infertility treatments, and only 15 states (including Connecticut) have such laws on the books. Some groups, including RESOLVE: the National Infertility Association, plan to fight the age restriction in Connecticut; they worry that this restriction could be read as a precedent in other states.

Many, many ethical questions around this one: You've got medicalization questions (Is infertility a disease?), health-care resource allocation questions (Should efforts to help would-be parents conceive be categorized as medical treatment? Is infertility more worthy of insurance coverage than, say, mental health parity?), questions about procreative liberty (Given the costs, likelihood of complications, etc., should women over a certain age do everything possible to conceive?), and questions about the nature of motherhood (Does the kid need to have your DNA for you to be a "real" mother?).

Talk amongst yourselves . . .

Ethical Violations

Most public discourse around medical ethics centers on debates and dilemmas such as stem cell research and the infamous Terry Schiavo case. Another type of ethics problem – ethical violations – makes the news but there is typically little discussion beyond the initial outrage and tsk-tsking. The latest scandal to hit the front page regards fraud within the organ procurement and transplant system. This was blatant, obvious abuse involving faking the identity of a recipient in order to move him from fifty-second on the list up to number one. There is little, if any, room to debate whether or not this was wrong. But there is still plenty to talk about. What incentive could be so great that surgeons were willing to directly harm another person (the one who should have received the organ and was subsequently removed from the list because the procurement agency thought she had received it), jeopardize their own program and careers, and tarnish the public’s trust in a national system that depends on the public’s good will to continue operating? Even after reading the news articles I don’t know the answer to that. But since this isn’t the first scandal, real or imagined, involving this system, it’s time to do more than shake our collective heads. When people hear about these scandals and lose faith that the system is a just one, donations of organs drop. And that hurts everyone. Most people don’t know that transplantation is the only field in medicine in which patients have a formal role in making policies. And any member of the public can raise an issue regarding the policies of the United Network for Organ Sharing (UNOS).

Center for American Progress to address bioethical issues

The DC-based Center for American Progress (CAP) kicks off its program to develop a “progressive bioethics agenda” by hosting a panel discussion on Monday, October 3. The panel will address the question, “What are the cutting-edge issues that confront bioethics?” Featured will be prominent bioethicists Art Caplan (University of Pennsylvania), R. Alta Charo (University of Wisconsin at Madison), and Vanessa Northington Gamble (Tuskegee University), with moderator Jonathan Moreno (University of Virginia). Moreno's book, Is There An Ethicist in the House? has just been published. The accomplished professor is also a senior fellow at CAP and a member of the WBP advisory board. Should be an interesting discussion. If you're in the DC metro area, stop by. It's free. And hey, did we mention there would be refreshments?

"Facing the Future" and other bad puns

Recent announcements that two US medical centers are moving forward to attempt the first face transplant has led to headlines full of puns in newspapers across the country. But the announcement is anything but funny to those involved. People who have faces seriously disfigured by accidents are interviewing to become the first face transplant recipient at Cleveland Clinic. Though the surgery has been perfected on corpses, there are many unknowns facing the first live recipient. So many, in fact, that the consent form itself states that informed consent is not truly possible.

The consent form at Cleveland Clinic states:

• Your face will be removed and replaced with one donated from a cadaver, matched for tissue type, age, sex and skin color. Surgery should last 8 to 10 hours; the hospital stay, 10 to 14 days.
• Complications could include infections that turn your new face black and require a second transplant or reconstruction with skin grafts. Drugs to prevent rejection will be needed lifelong, and they raise the risk of kidney damage and cancer.
• After the transplant you might feel remorse, disappointment, or grief or guilt toward the donor. The clinic will try to shield your identity, but the press likely will discover it.

Since the first surgery is considered research, all expenses will be covered by the medical center. Recipients still have many other hurdles to overcome. The first of which is deciding if the potential benefits outweigh the burdens. A plethora of ethical issues are raised by this proposed transplant, some of which have been eloquently identified by Arthur Caplan. Perhaps the most important question is under what circumstances is it ethical to risk a patient’s life in order to push the envelope on a new scientific procedure? This question holds for any new medical development and the same host of questions were asked at the time of the first heart transplant. Today heart transplants benefit many patients and more patients are waiting for them than there are hearts available. So while the pun is bad, the question is real – what future do these people face?

Well, women aren't so different from livestock, right?

You think I'm joking, dontcha? No such luck.

The good news is, apparently the FDA is already rethinking--make that "denying," actually--its brilliant idea of appointing a veterinarian to take the place of Susan Wood (who resigned over the agency's non-decision on Plan B) as head of the Office of Women's Health.

Yes, that's right, a veterinarian. Read more--if you think you can stand it--in the Washington Post.

They might not work better, but they sure do make money!

Today's NYT reports that newer drugs for schizophrenia are no better (ok, maybe a teeny weeny bit better) than older, cheaper drugs. Well, for patients anyway. For drug manufacturers, which have been marketing the heck out of these meds, they are a goldmine: the old treatment costs about $60 per month, compared with up to $450 for one of the newer meds, according to the article.

Sound familiar? You could replace "schizophrenia" with "arthritis pain" and be talking about Vioxx; or you could replace "schizophrenia" with "hypertension" and be talking about the legion of anti-hypertensive meds that don't improve on the performance of plain old diuretics ("water pills").

Where to begin with the ethical issues involved here? Let's see, there's patient safety. . . allocation of research dollars toward diseases for which decent treatment exists, while less common or less sexy conditions are research orphans. . . the effects of direct-to-consumer advertising. . . the effects of pharma marketing on physician prescribing patterns. . .

Miracle mitochondria or designer babies?

The United Kingdom’s genetics watchdog agency, the Human Fertilisation and Embryology Authority (HFEA), has granted permission to a team of Newcastle University scientists to create a human embryo that will have genetic material from two mothers.
The BBC reports that “The scientists will transfer the pro-nuclei – the components of a human embryo nucleus - made by one man and woman - into an unfertilized egg from another woman.”

The team and its supporters attribute the value of the research to the potential prevention of the maternal passing of certain genetic diseases to their unborn babies. The relevant genetic diseases, which are known as mitochondrial, arise from DNA found outside the nucleus and are inherited separately from DNA in the nucleus. Although the resulting egg would never be allowed to develop into a baby, if it did, the offspring would still resemble their mother and father because the mitochondrial DNA do not dictate things like hair color.
Mitochondria produce most of the energy that people need to grow and live. Organs such as the heart, brain, liver, kidney are particularly dependent on well functioning mitochondria. One unique feature of mitochondria is that they have their own DNA, which is inherited from the mother only. Faulty maternal DNA puts children at risk of developing a mitochondrial disease that can damage the cells of the brain, heart, liver, kidney and skeletal muscles and confine sufferers to a wheelchair. At present there is no known cure.
Some groups have expressed concern regarding the HFEA approval to proceed with the research. The potential scientific breakthroughs seem to evolve at a rate that surpasses accompanying decisions regarding ethics. Pro-life campaigners fear the decision to approve the research represents an unacceptable step towards the creation of "designer babies".
Professor John Burn, from the Department of Clinical Medical Sciences at Newcastle University, claimed such fears and criticisms to be unfounded. Professor Burn said that technically a baby could be born with two mothers - the DNA from the egg donor and the DNA from the mitochondrial donor. The ethical implications may resemble those regarding a surrogate mother donating an egg or carrying the intended parent's child that was conceived through IVF treatment - a process itself that once generated an abundance of controversy.
[thanks Ana Lita]

Words, War and Emotions...

In early September, 2005, the United Nations co-sponsored a conference entitled “Our Challenge: Voices for Peace, Partnerships and Renewal”. The conference assembled representatives from more than 2,000 Non-Governmental Organizations (NGO’s) from all reaches of the world. As the representative of the IHEU-Appignani Center for Bioethics, I presented at the workshop Words, War and Emotions- Communication Strategies to Bridge Cultural Differences. The presentation focused on the ethical question of genital mutilation - a practice common throughout Africa and parts of the Middle East. In some cultures genital mutilation, the removal of part or all of a woman’s genitalia, is considered a rite of passage to adulthood and a form of purification with a strong religious connotation. While cultural relativists are tempted to accept the practice as a culture-specific rite, human rights campaigners condemn it as a serious breach of the rights of women to self-determination. The situation is clearly alarming as genital mutilation can result in infertility and also death, not to mention excruciating physical pain and suffering. Genital mutilation complements the already dismal picture of a region dominated by disease, poverty, gender inequality, and injustice. Read more about the conference proceedings here.
[thanks Ana Lita!]

Human Brain Still Evolving

Studies in a recent edition of Science by Bruce Lahn of the University of Chicago and colleagues claim that the human brain is still evolving. Specifically, two genes involved in determining the size of the human brain have undergone substantial development in the last 60,000 years, though it had generally been accepted that human evolution stopped around 50,000 years ago. It is not clear how these genes enhance brain function, but they are spreading through the human species as though they confer a competitive advantage.

Given that we don’t know what the genes do and that their evolution is ongoing, this may not have much of a practical impact on most of us. What it does do, however, is suggest that we need to think about this finding – that evolution may still be ongoing in humans – in light of some current topics of public discourse. One such topic is the long standing debate about what is and is not within “normal” psychological parameters. If our brain is still developing it lends credence to the argument that it is better to view differences in human makeup merely as differences as opposed to attaching normative value to them. Another topic related to genetic evolution is the still futuristic notion of genetic engineering in humans. While genetic engineering is most widely applied in agriculture, there is much speculation about how this field may benefit or enhance humans. What these studies remind us is that we still need to factor in the influence of evolution.

UK will allow research on three-way embryos

The UK's Human Fertilisation and Embryology Authority (HFEA) has already approved research that would involve human cloning for non-reproductive purposes. Recently, according to The Register, an application that builds on that one was accepted, in which researchers will attempt to create an embryo that contains DNA from not one, not two, but three different people.

Turns out some diseases, such as muscular dystrophy, are triggered by defective genes in the maternal mitochondrial (extra-nuclear) DNA. By transplanting the healthy nucleus into a new, healthy egg, researchers hope they can eliminate these diseases--while still maintaining the "real parenthood" of good old Mom and Dad.

Missing in the dicsussion is the question, where in the world will all these eggs come from?

Read more here.

Deja vu in Kansas

In an effort to prosecute two clinics that provide abortions, Kansas attorney general Phil Kline has subpoenaed the medical records of 90 women and girls. He says these records will help build a case against clinics (and presumably individual physicians) who have broken the state's laws about sexual-abuse reporting and late-term abortion. Seattle Times reports here.

Regardless of one's stance on abortion, the instrumental subpoena of women's (supposedly confidential) medical records -- especially in a time of increased privacy protection and regulation around health care information in general -- ought to raise concerns about privacy and civil rights.

(The very similar efforts of former US Attorney General John Ashcroft, which were intended to bring down Planned Parenthood clinics, were unsuccessful.)

Rapex: The new chastity belt?

Rapex is an anti-rape device that is like a female condom made of latex but with shafts of sharp barbs. If a woman is wearing it and is vaginally penetrated, the barbs are sprung and they hook onto the penetrator’s skin. It can then only be removed by surgery. Such devices have been dreamed up before and even rendered artistically, but Rapex is a reality and is scheduled to go on sale in South Africa next year for a cost of one Rand (20 cents). The device was invented by Sonette Ehlers of South Africa who said she was inspired after meeting a traumatised rape victim who told her, "If only I had teeth down there." She claims that a majority of women surveyed in South Africa said they were willing to use the device but it is not without considerable controversy. There is concern that such a device would escalate violence against women because the entrapped would be enraged and therefore further harm or kill his victim. The response is that by causing the man so much pain, the woman could have the opportunity to flee. There is also a serious worry as to how effective this device would be as a rape deterrent after it was known to exist because women can be raped anally and orally. Further, said a hospital spokesperson at Johannesburg Milpark Hospital, “We would have no idea what it was (if a person sought removal) and a person could spin us a story. There would have to be in-service training. And obviously the patient also has rights.” Lisa Vetten, with the Centre for Violence and Reconciliation is concerned that “once again the responsibility for preventing rape is put on women.” Charlene Smith, one of South Africa's most prominent campaigners against rape charges that Rapex is ”… a medieval instrument, based on male-hating notions and fundamentally misunderstands the nature of rape and violence against women in this society." There are more rapes of women in South Africa than anywhere else in the world.

Poverty, Principlism in Bioethics, and Katrina

Most of us in the field of bioethics are familiar with the four principles oft used in bioethics: Autonomy, Beneficence, Nonmaleficence, and Justice (aka known as the "Georgetown Mantra") -- out of those four principles, Justice (some of us prefer to call it Equity) is too often given short shrift because it's not "sexy" or a headline grabber, as Jon Moreno points out in his article in the American Journal of Bioethics. So, it is inspires hope in me when someone like the NY Times' David Brooks points out that the devastation of Hurricane Katrina affords us an opportunity to do something serious about urban poverty -- his suggested rules when rebuilding: Nothing Like Before and Culturally Integrate. It is a chance to bridge the ever-growing gap between the haves and have-nots; to reiterate Brooks, let's not blow it.

Blinding Me with Bad Science

The folks who look out for bad science have a story in the Guardian online on how science usually makes the news. In popular media, science stories tend to belong to one of three families: wacky stories, scare stories and "breakthrough" stories. Wacky stories include the “scientists have found the formula for” variety (love, winning at blackjack, the perfect way to eat ice-cream) and the paradoxical health story (coffee is good for you) According to the author, paradoxical health stories serve one purpose: “they promote the reassuring idea that sensible health advice is outmoded and moralising, and that research on it is paradoxical and unreliable.” Scare stories and the problems they foster are all too familiar. “Breakthrough” stories are worrisome because they foster “the idea that science, and indeed the whole empirical world view, is only about tenuous, new, hotly-contested data.” All three kinds of stories make great headlines and sell lots of papers but they rely on little evidence and poor understanding of the significance of the press release that the story is based, the nature of risk, and the nature of the scientific enterprise, for example, blurring the distinction between empirical evidence and scientific hypothesis. They promote the (false) view that because truth is certainty, and science is never certain, we cannot rely on anything science says. Reporting science in these ways is problematic not just because of the poor understanding of the topics and of what-it-is-that-scientists-do-anyway that it generates and nurtures, but because it is potentially dangerous. For a very important discussion on how bad science enters the courtroom and public policy, esp in the US, visit here. To be sure, scientific research is not value neutral and there are perfectly legitimate criticisms of science to be made by non-scientists. The point is that criticism of science must not be based on bad science or poor understanding of what it is that scientists do.

EPA research on pesticides: To Test or not to Test?

No dilemma in bioethics is a simple one. The issue of pesticide research readily demonstrates that even characterizing a debate as “two-sided” is often an oversimplification. Today the EPA announced that it will bar data from pesticide studies involving children and pregnant women. Protecting a vulnerable population from risk seems like a winning position. However, the impact of such a decision may, in the end, put these populations at even greater risk. As “safe” limits of pesticide exposure are studied and regulated, lack of data regarding the effects on children and pregnant women may mean that the legally acceptable levels are not really safe for them at all. But deciding to accept research using children and pregnant women is also not a simple matter. One recently proposed study that would look at the effect of pesticide exposure on young children had to be shut down when claims were made that it was targeting low-income, less-educated families and that the incentives were so high as to be considered coercive. Another criticism of the study was that the two year research time frame was not sufficient to find negative long term health effects such as developmental delays, cancers and puberty/hormonal disruptions. The history of pesticide testing reveals other thorny issues including problems involved in finding control groups when examining data obtained from observing the health outcomes of children who were exposed to pesticides in their natural environments.

Bioethics and Katrina

A well known bioethicist and supporter of the WBP, Jonathan Moreno writes a provocative essay entitled "In the Wake of Katrina: Has 'Bioethics' Failed?" , taking aim at the failure of bioethics to tackle issues of distributive justice and public health. I have to agree, what has happened with the response (or lack of) to Katrina, has provided a sobering wake-up call; as I had written in a previous article, I find that it is one of the more enobling aspects of being a bioethicist and an attorney to be a nurturing caregiver, protector of life and liberty, guardian of the weak and fragile, and steward of the earth and all its inhabitants. We need to set aside our egos (academic, legal, or otherwise) and ask "How can I serve?"

Addendum (posted Sept 6) - And please let's not forget about our companion animals -- the dogs and cats that have been displaced by Hurricane Katrina -- donate now at Humane Society of the United States.

The impact of Katrina

Although at first blush, Hurricane Katrina may not seem like a bioethics issue, the impact of the devastation bleeds over into all areas of our lives, including those of us in the field of bioethics. The hospitals in the affected vicinity are struggling with no electricity or water, evacuation of the critically ill, not to mention unsanitary conditions One of the physicians commented that they are making rounds by flashlight and they have no ability to check laboratory values on patients.

In the face of such an unprecedented natural disaster in the US, how can we, in the field of bioethics, respond? Certainly, this type of situation can bring out the worst of humanity, as witnessed by the looting and rioting reported; but it can also bring out the best of humanity as we gather our resources together and volunteer our time and efforts. We must respond with kindness and love, and all that entails -- I forget who said that "Our acts of kindness warm the coldness of people's lives." And whether it be through donations to the American Red Cross Hurricane Relief or prayers or donating blood, our response will be a reflection of how we choose express our humanity.

Another good reason to ban the barbarism of female circumsion...

A team of Swedish researchers have observed that female circumcision, or genital mutilation, could render affected females infertile. The study, the first of its kind, involved nearly 300 Sudanese women and controlled for potential variables, such as sexually transmitted infections, age, and socio-economic conditions. The researchers concluded that the 2 million females annually affected are five to six times more likely to be infertile than are their unaffected counterparts. Incidence of infertility appears to be greater depending upon the severity of the procedure, which can involve the removal part or all of a female's genitalia. Researchers attribute the increased risk to infection, inflammation, scarring, or resulting physical alterations. Practiced in more than 30 countries, mainly in Africa and sections of the Middle East, female circumcision has been performed on an estimated 135 million females, according to Amnesty International. Though human rights campaigners have called it "an atrocity against womanhood," female circumcision, which is often viewed as a tradition or rite of passage to adulthood, is controversial to address because of cultural relativism. The new research, published in then Lancet medical journal, may strengthen the voices of the opposition.

[Thank you and welcome to Ana Lita, one of our new guest bloggers! Ana, who holds a Ph.D. in Applied Ethics and Social Philosophy and an M.A. in Sociology and speaks five languages, is Director of the IHEU-Appignani Humanist Center for Bioethics at the United Nations in New York City. ]

Now if they'd just get cracking on the "thin and blonde" drug. . .

According to today's NYT, the FDA has approved the new drug Increlex for the treatment of "abnormally short stature." The clinical trials of the new drug were done with kids who had not responded to injections of human growth hormone, the current standard treatment.

The NYT article notes: "An estimated 6,000 children in the United States have the specific condition for which the F.D.A. approved the drug, although some doctors expect Increlex to be more broadly prescribed to children with less severe growth abnormalities."

This is yet another variation on the "treatment vs. enhancement" debate. So at what point--if any--ought short stature be considered a disease? Data suggests that tall folks do, in fact, have social and economic advantages over the vertically challenged: but does that make it a disease or a disability? The larger question--which applies to many other topics, incluindg the fight over whether Ritalin is treating a genuine medical problem or being used to bring the classroom behavior of little boys under control--is whether it's a good idea to medicalize characteristics that are part of the normal range of human variation.

It's also worth asking, who benefits when we decide to label something a disease?

Director of FDA's Office of Women's Health Resigns

In another chapter of the saga of levonorgestrel , Plan B™, Dr. Susan F. Wood, Assistant F.D.A. Commissioner and Director of FDA's Office of Women's Health, has resigned over the FDA’s decision to delay, again, OTC sales of the emergency contraceptive. She says, "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled"… "The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health." Besides allowing greater access, making levonorgestrel available OTC would avoid the problems associated with some pharmacists' claim to a right not to dispense prescriptions for substances that are against their personal and religious values. A new voice in this debate can be heard today in a NYTimes editorial piece called,“Prescription for Injustice.” Florence Ruderman relates the story of a pharmacist who refused to fill a prescription for morphine for her father who was dying of cancer.