In Memoriam: Ronald Cranford

I'm sad to announce that a friend passed away today: Ronald Cranford, Professor of Neurology, University of Minnesota Medical School; Senior Physician and Assistant Chief of Neurology, Hennepin County Medical Center; and Faculty Associate, Center for Bioethics, University of Minnesota, Minneapolis, Minnesota. I had the privilege of meeting Ronnie in Newport shortly after I had done the Gray vs. Romeo case in Rhode Island; we were both lecturing at the Newport Hospital Ethics Conference on Life's Final Days: Rights, Responsibilities, and Resources and we were introduced by our mutual friend, attorney Paul Armstrong, the New Jersey lawyer (now a superior court judge) who represented the families of Karen Ann Quinlan and Nancy Ellen Jobes. Intelligent, passionate in his beliefs, and not one to be intimidated by naysayers, he will be missed. May he rest in peace and in the arms of the angels.

See? We told you sex was bad. . . .

Here is an opinion piece about the new human papillomavirus (HPV) vaccine in yesterday's NYT. The vaccine, Merck's Gardasil, is fully effective against the virus that causes most cases of cervical cancer. Expected to cost between $300 and $500 for a series of three shots, use of the vaccine is expected to draw fire from the right wing as yet another practice that encourages premarital sex. (Some on the right have so far said only that they oppose mandatory vaccination for school entry, but support widespread availability of the vaccine.)

Here's the rub: the vaccine is more effective when it's given between the ages of 10 to 15 than between the ages of 16 and 23; so to maximize its usefulness, experts are recommending vaccination be completed before a person (male or female) becomes sexually active. . . which means vaccinating children against an STD.

If we can prevent cervical cancer by use of this vaccine, is it ethical to decide not to do so--because of concerns about promoting teenage sex? Will Medicaid pay for the vaccine, or will only those who can afford it be protected from cervical cancer? Stay tuned.

Nancy Berlinger has a piece on the Hastings Center's Bioethics Forum here, and Katha Pollitt has a great (year-old) piece on this issue here.

Happy Birthday to the WBP Blog!

It's been a year this month since we launched the Women's Bioethics Project Blog and what a great year it has been! Thank you to Kathryn Hinsch, the East and West Coast Board of Directors, my fellow bloggers, and the academic community for lending their support. We are always looking to build our team, add voices, and expand our knowledge, so if you are interested in blogging for us, please contact Linda MacDonald Glenn [lindaglenn(at)ethicsconsult.com] or Sue Trinidad [sue.trinidad(at)gmail].

Godless Science?

In an article recently published by *The Philadelphia Inquirer* Arthur Caplan discusses the risks of biogenetics. Arthur Caplan reassures the reader that there is no reason for anyone to fear for the advancement of biogenetics. With the many positive outcomes that biogenetics promises, Caplan tells us that "...our society would be foolish and cruel to forbid or ban genetic research given the needs of the sick, starving, impaired and those of future generations for solutions and treatments. Will we really turn away from those who literally are dying before our eyes, or who will die before our children's eyes, simply out of fear of scientist guiding public policy?." Many people who are against biogenetics are people who hold religious beliefs. There is no need, Art Caplan says, to fear that scientists will potentially be leading public policy (with respect to biogenetics), because it is quite foolish for anyone to think that scientists can just create another life being by themselves. If anything, there seems to be a misunderstanding of scientists; that they are mostly not affiliated with religion and that they go about testing extremes every chance that they get. Caplan corrects this stereotype by mentioning that many scientists are actually religious with respect to humankind for the love of other beings, the love of preventing fellow brothers from not becoming sick or becoming sick. Scientists are out to save our society from diseases such as sickle cell, SARS, avian flu, HIV, TB, and many others.

Caplan calls for a bridge between the sciences and the humanities and also urges the scientists to reveal themselves to the public and show people that they are also human, "...that they stand shoulder to shoulder with all of us in wanting a better world". Read more here (Link has been added--sorry for the oversight--sbt):

Some Interesting Stories We're Reading Today

Disagreement on abortion pill role

Zeke Emanuel on Priorities on the Avian Flu Vaccine: "Most people have the intuition to say, 'Give it to my 19-year-old. I got to 65; I've lived a good life.'

About 40 percent of the medical malpractice cases filed in the United States are groundless?

FDA Approves Anti-Smoking Pill

5 Bulgarian nurses and a Palestinian doctor accused of infecting more than 400 Libyan children with the HIV virus refused bail.

5 month old conjoined twins in ICU after separation surgery.

Conservative opposition to contraception gaining traction?

Today's New York Times Magazine includes this article by Russell Shorto. Shorto describes efforts by conservative groups in the United States to block information about, and access to, contraception.

The article outlines some of the reasons that contraception is becoming a political battleground (again). It's due in part to technological and pharmacological advances that blur the line between abortion and contraception . . . and in part to the increasing influence of conservative religious beliefs on public policy.

Many people are watching Roe; Shorto's article suggests that we ought to pay attention to Griswold.

Dying Patients right to access experimental drugs

The U.S. Court of Appeals for the District of Columbia Circuit ruled yesterday that terminally ill patients have a constitutional right to obtain experimental drugs before the Food and Drug Administration has decided whether to approve them. The court held that drugs that have passed the first phase of FDA review should be made available if they might save someone's life -- in a reverse application the Supreme Court's holding in Cruzan, Judge Judith W. Rogers wrote "If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded 'life' " .

Are 'Lie-Detectors' a scam?

From the Washington Post today: In the popular mind, fueled by Hollywood representations, polygraphs are lie-detection machines that can peer inside people's heads to determine whether they are telling the truth.

The scientific reality is far different: The machines measure various physiological changes, including in blood pressure and heart rate, to determine when subjects are getting anxious, based on the idea that deception involves an element of anxiety. But because an emotion such as anxiety can be triggered by many factors other than lying, experts worry that the tests can overlook smooth-talking liars while pointing a finger at innocent people who just happen to be rattled.

My question is will the new neuroetechnologies that we posted about earlier be any better?

Too Early to Declare Victory In the War Against Breast Cancer?

Abigail Trafford opines that it might be too early to declare victory in the war against breast cancer.

More States Screening for Post Partum Depression

As we had posted earlier, New Jersey passed a law mandating screening for postpartum depression, but the Washington Post reports that more states are making strides in raising awareness of the disorder and screening more mothers for it. But what about follow-up or feedback mechanisms to see if this legislation is really working?

Less Invasive Glucose Monitoring for Diabetics

For those of us who have diabetes or loved ones with diabetes, great news in the Washington Post today: new devices promise diabetics a new measure of freedom and are expected to be widely available in the United States by late this summer. Instead of needle sticks several times a day and night, a patch worn on the abdomen carries a tiny wire that pokes through the skin to measure glucose in cellular fluid; the patch is worn for several days, wirelessly transmitting information to a receiver the size of a mobile phone, before it is replaced with a new one.

The Juvenile Diabetes Research Foundation is launching a series of independent studies designed to test manufacturer claims about the new devices and provide information on their worth. Among the big questions are how much they can cut rates of hospitalization, car accidents caused by drivers with low blood sugar and the many other problems attributable to diabetes.

India's New Battle Against Imperialism by the Pharmaceutical Companies

Glenn McGee, the director of Alden March Bioethics Institute in Albany, draws a parallel between the outsourcing of clinical trials of Western pharmaceutical companies and the history of British imperialism in India. As the necessity for clinical trials increase with the discovery of new drugs, people willing to enroll in clinical trials from developed countries decreases. Pharmaceutical companies, therefore, are moving clinical trials to the largely illiterate populations of the developing and under-developed countries in exchange for a miniscule amount of US/European currencies. The disparity between the exchange rates reduces the cost of the trials drastically as well as providing a large (in terms of Indian currency) income to the participants in these clinical trials.

But that is not the primary reason why McGee claims that Gandhi would have led a protest march against clinical trials if he had been alive. McGee points out that a majority of the enrollees in these clinical trials have no idea what drugs they are taking. Even though these subjects are giving their consent, they have no idea to what they are consenting. In some cases, the drug has not been proven safe before the trials. McGee mentions the case of the unapproved clinical trial in which 435 women were given a fertility drug that was not cleared for testing on human subjects. Clinical trials too offensive to American research subjects are being proffered to the residents of India. McGee wonders how long until the people of India rise up against this new form of imperialism.

Read more

Jeopardizing the Reproductive Health of Guatemalan Women

In this week’s issue of the Lancet (The Lancet 2006; 367:1227-1228; subscription required but access is free), Hannah Roberts reports on the increasing practice of hymen reconstruction on women in Guatemala to “restore virginity.” I learned of this article and issue reading Stuart Rennie's globalbioethicsblog. This “intimate surgery” as it is called is accounted for because: “Women are expected to be virgins when they marry; in some communities blood evidence from the wedding night is still required for verification by the family. The profound societal significance of bridal virginity is such that women are prepared to compromise their physical health to remain socially acceptable.” Those who perform this expensive surgery (app. $1000US) are not usually licensed health care workers, are found through hand-painted advertisements on walls, provide unsafe operating conditions, and rarely provide follow-up appointments. Women who have undergone this procedure are showing up in hospitals presenting with infections, hemorrhaging, incontinence, fistulas, and extreme pain during sexual intercourse.

Roberts reports that Guatemala has one of the worst records in Central America for reproductive health with high rates of maternal and infant mortality and low levels of knowledge about contraception. (She cites: In some parts of the country, 42·1% of the population had not heard of HIV/AIDS; 2·3% of the women chose condoms as their preferred method of contraception; just over 40% of women had used any form of contraception at all.) This situation is referred to as a crisis.

While activists campaign for stronger legal regulation of reproductive-health information and services, and have support for such in the Guatemala Parliament, the President of the country and the Roman Catholic church are thwarting efforts towards the goal of women’s reproductive health.

Guatemala has a population of approximately 13 million people and is the most populous country in Central America. The population is approximately half indigenous, Mayan. Spanish is the official language but Mayan languages are spoken alongside Spanish. The distribution of income is highly unequal with perhaps 75% of the population below the poverty line. From 1960, the people of Guatemala endured 36 years of bloody civil war between a series of military regimes and anti-government guerrillas which left up to 200,000 people dead and many “disappeared.” According to MADRE, “Behind the smokescreen of "fighting communism," military groups trained and funded by the US killed mostly Indigenous people and destroyed 440 Mayan villages. More than a million people were uprooted from their homes and over a quarter million became refugees in surrounding countries.” In 1992, Rigoberta Menchu, a Mayan rights activist was awarded the Nobel Peace Prize. In 1996, Guatemalans celebrated the signing of Peace Accords, however, the country is still marked by violence and corruption and according to Amnesty International, has witnessed over 1500 brutal killings of women since 2001. There has been a marked lack of thorough and impartial investigation into these and other violent crimes against women. The recent AA report (April 1 2006) concludes that: ”the State of Guatemala is not taking effective action to eliminate gender discrimination in the criminal justice system, ensure proper investigations and bring those responsible for the killing of women to justice. This failure has meant increased suffering on the part of relatives of women killed, which Amnesty International believes amounts to cruel, inhuman and degrading treatment.”

During the civil war, the Roman Church and other religious organizations took a leadership role in giving material, psychological and spiritual aid to victims; sometimes it engaged in political activities and church members were disappeared and murdered. But Church teachings about the morality of reproduction are affecting public health policy in the country to the detriment of women’s reproductive health. Women of the country overwhelming want access to family planning information and services, but it is not being provided. Moreover, international funding for reproductive health programs has been cut off as a consequence of the current US administration's hostility to modern family-planning methods. See: http://www.reproductiverights.org/pdf/guatemala.pdf

Meet Noelle, the Pregnant Robot

Noelle, the first lifelike, birthing simulator is being used in a growing number of medical schools and hospital maternity wards.

The full-sized mannequin is in demand because medicine is rapidly abandoning the ethically questionable centuries-old tradition of using patients as guinea pigs, turning instead to high-tech simulations.

The Institute of Medicine estimates that as many as 98,000 U.S. patients die annually from preventable medical errors. Obviously, it's better to make a mistake on a $20,000 robot than a live patient -- Other companies make lifelike mannequins to train paramedics in emergencies, but Noelle appears to be the only high-tech, pregnant model available. Noelle models range from a $3,200 basic version to a $20,000 computerized Noelle that best approximates a live birth.


[image from http://ctheory.concordia.ca/hacking/pregnant.html]

Breast Cancer Breakthrough

Good news for women: A large government sponsored study of nearly 20,000 postmenopausal women found that raloxifene (marketed under the name of Evista) reduces their chance of developing breast cancer as effectively as tamoxifen, the only drug previously shown to reduce the risk, but is less likely to cause serious side effects such as uterine cancer and blood clots.

Because an estimated 500,000 women use raloxifene to reduce the risk of osteoporosis, many will be more comfortable using it for breast cancer protection, several experts predicted.

"It's terrific," said Susan Love, a breast cancer expert at the University of California at Los Angeles. "This gives us another drug that we can use to prevent breast cancer that is less risky than the only other drug we had."

Several experts, however, urged caution, saying that the advantage of raloxifene remains unclear and that more research is needed to prove the drug reduced the overall risk over longer periods.

New Jersey New Moms to be screened for depression

New Jersey Governor Jon S. Corzine on Thursday signed into law a measure that aims to provide help to women who become depressed after giving birth. Health care professionals will be required to educate expecting mothers and their families about postpartum depression and to screen new moms for the disorder.

While the intent of the bill is noble, there are some obvious problems with the language of the bill and monitoring mechanisms --
First, postpartum depression can happen anytime within the first year after childbirth -- the language of screening "new mothers for postpartum depression symptoms prior to discharge from the birthing facility and at the first few postnatal check-up visits;" is pretty vague -- the first two, three visits? -- it deosn't create a specific standard of care.

Secondly, there is no follow-up or feedback mechanism --From a research ethics viewpoint, there needs to be put in a formalized report process which protects the anonymity and privacy of the individual, yet collects sufficient to data to indicate that program is being effective -- that the message is getting through to the intended audience -- otherwise, how can it be shown that the legislation will have any effect? Without that, it amounts to more of a 'political' issue than a 'medical' issue.

Finally, the part of the bill that requires "Physicians, nurse midwives and other licensed health care professionals providing prenatal and postnatal care to women shall include fathers and other family members, as appropriate, in both the education and treatment processes" doesn't address issues of medical confidentiality, an important issue with HIPAA (Health Insurance Portability and Accountability Act of 1996 ) these days. This is a particular difficulty with legislatures mandating certain actions -- the legislature is telling the professionals do something that could be contrary to other laws (such as HIPAA) .

Breast implants linked to increased suicide risk

More evidence reported here that suggests that suicide is more common among women who have breast augmentation surgery than those who don't. Their risk of death for most causes, though, is lower than the general population's. . . one wonders how socioeconomic status plays into these stats.

UK team to open "designer baby" clinic

According to this article in the News Telegraph, a UK team plans to open a clinic that will specialize in the creation of "saviour siblings"--that is, children conceived so as to provide a source of genetically matched organs (including blood, etc.) for a sick brother or sister.

Parents doing this isn't new news--it's happened in the US and in the UK. What's new is a clinic designed for this specific purpose.

And while we're on the topic, if you haven't already read Jodi Picoult's book, My Sister's Keeper, this would be a good time . . . . check out the new WBP book club here.

WBP Launches Book Club Campaign: Stories about cloning and “designer babies” bring bioethical issues to life

The Women’s Bioethics Project (WBP) today announced the launch of a book club program designed to empower women to explore the dramatic ways in which emerging biotechnologies are affecting peoples’ lives. The program provides book club support materials that go beyond asking literary questions to promote discussion of bioethical issues, raising provocative questions such as, “Is it ethical to conceive a child as an organ donor for her sister?”

The format of the WBP book club program is designed to inspire participants to draw their own conclusions about the kind of world they would like to live in. It also encourages readers to consider some of the proposed advantages of new technological advances in biomedicine and genetic engineering, as well as to look at whether it would be possible to minimize the undesirable effects these technologies may have on individuals and society at large.

“Through a series of interviews we’ve learned that women are eager to discuss bioethical issues if they are put in a context that shows how they directly affect their lives,” said Kathryn Hinsch, founder of the Women’s Bioethics Project. “Many women we spoke with said they wanted to participate in discussions about these topics, but only if it didn’t require additional time away from their families and their already loaded schedules. Furthermore, many said they wanted to go beyond merely raising difficult questions to actually taking action on issues that they found personally meaningful.”

The first novels in this book club series chosen by the WBP for this program include the following:

My Sister’s Keeper by Jodi Picoult, which explores the impact of embryo selection and “designer babies” on one family and the heart-wrenching choices that ensue.

Never Let Me Go by Kazuo Ishiguro goes a step further, examining human cloning and organ donation from the perspective of an isolated community of human clones.

Oryx & Crake by Margaret Atwood presents a world so altered by the effects of genetic engineering that both society and the natural environment are profoundly affected.

When read in this order, the selected novels take readers along a continuum from technologically feasible issues surrounding organ transplants and genetic engineering to futuristic scenarios involving advanced applications of these and other biotechnologies that force us to examine many of the implications of what it means to be human.

Public Policy Implications of Bioethical Issues

Beyond the literary analysis and examination of important bioethical issues, another important aspect of the WBP book club program is that it ties the issues raised in these three books to current public policy debates. The book club materials provide women with guidance on how to get involved, share their thoughts with their legislators and help shape legislation.

The most pressing public policy issue the WBP would like to see women take a closer look at after reading these books is human germline genetic modification, which is sometimes referred to as producing “designer babies.” The WBP believes the application of genetic engineering in this area will have profound implications for women and their families. Whether they feel limits should be placed on this technology or believe it should be banned outright, this book club forum offers women a unique opportunity to discuss these issues with one another and explore their feelings about genetic engineering and other biomedical advances on both a personal and policy level.

“We hope that women will come away from this experience feeling informed and motivated to get involved,” said Hinsch. “Although we have included three novels in our campaign, Jodi Picoult’s book My Sister’s Keeper was really our original inspiration. The way she captures the real-life ethical issues around ‘designer babies’ from the perspective of one family really demonstrates the power literature has to let us explore unfamiliar situations and reach our own conclusions.”

Jodi Picoult, author of 12 other novels in addition to My Sister’s Keeper, including the recently published The Tenth Circle, shares this goal. “I was honored when Kathryn asked me to participate in this book club campaign,” Picoult said. “I truly believe the time to address the impact of these emerging technologies is now, and I think this program offers an accessible and relevant way for women to begin engaging with others on these issues. I’m pleased that my novels can play a small
part in that effort.”

All book club program materials are available on our Web site.

Honey, We're Killing the Kids!

No, it's not a sequel to the kids movie, Honey I Shrunk the Kids! -- it's the title of The Learning Channel's latest series to focus on the American diet and the impact on our health care costs and our children -- Last week's issue of the medical journal Pediatrics found that American children are increasingly too big to fit into standard child safety car seats. According to the American Obesity Association, "the percentage of children and adolescents who are overweight and obese is now higher than ever before."