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.

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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."

Cultural alibis, dubious beliefs

Because my culture says it’s ok seems to be the new catch phrase for behaviors all along the questionable behaviors continuum.

For instance, one of the lessons that has emerged from the ongoing rape trial of our ex-Deputy President, Jacob Zuma, is that If you don’t have sex with a woman (and they are wearing a skirt, so clearly wanting it), you are morally wrong and criminally accountable. Heck, you may even be charged with rape. His culture has taught him that leaving a woman in that state (of sexual arousal) was “the worst thing a man could do.” Funny that, I thought rape might have claimed that title. But then, I’m just a woman. And an outsider to the norms dictated by Zuma’s culture.

It seems that culture gives you an alibi for just about anything you feel like doing. In a recent survey of school boys in our KwaZulu-Natal province, beating girls and forcing them to have sex was all justifiable in cultural terms. While one boy said that beating a girl was acceptable practice to keep her in line, another said that hitting a girl meant that you loved her, because if you didn’t (love her), you wouldn’t bother (to hit her). Following this line of argument into marriage, most of the participants believed that forced sex within a marriage was not a problem: “When we are married, I can force you to have sex with me because I know that I pay my money to buy you…” Nor did the youngsters think it was a problem for a man to have sex whenever and with whomever he wanted, even if it was not with his wife.

And what about the risk of AIDS? Well, one can hardly blame young boys for being unconcerned about the possibility of contracting the virus if our former Deputy President, a man who continues to command a strong following and who, ironically, is the former head of the National AIDS Council, has openly admitted to engaging in unprotected sex with an HIV-positive woman. If boys – and girls – want to have unsafe sex, all they need to do is shower afterwards. During his trial, Zuma has testified that he showered after having consensual sex with the alleged rape victim to minimize his risk of contracting HIV from her. A revelation that is sure to set a good example for those who ardently follow and admire their leader: if you have unprotected sex with someone who is HIV-positive, you will be ok so long as you take an anti-HIV shower afterwards, wash all that yucky virus off of you.

Is Researching the Power of Prayer Worth Our Time?

Prayer is constantly being used to help heal the sick, but does it actually work? As the results of the largest study on the subject to date near, both sides of the argument are being addressed. Advocates claim that today’s science fiction, regardless of how outlandish it may seem, is often tomorrow’s science once proven through empirical studies. They offer quantum physics as a possible explanation for the healing effects of “distant prayer”, describing the synonymous relationship between distant particles effecting each other and distant prayers effecting other people. Equally loud are the voices that protest these studies – some feel the power of God cannot be measured by any mortal tests, while others feel that the idea of prayer being able to cure sickness is absolutely absurd. Some studies conducted show no correlation between prayer and healing. However, others do show possible relationships, although some scientists point out numerous flaws in those studies. Many feel a couple positive results among countless negative results is simply chance. However, the larger and better designed a study is, the more truth it can potentially yield, so this upcoming study may shed more conclusive light on this debate. Yet, without doubt, the minds of many will remain unchanged, no matter the results of the study.

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Vive la difference: Men's and Women's Brains Work Differently, even while resting

A key part of the brain involved in processing emotionally influenced memories acts differently in men and women, even in the absence of stimuli, UC Irvine researchers have found.

Larry Cahill, an associate professor of neurobiology and behavior, and Lisa Kilpatrick, a former postdoctoral fellow in his laboratory, have found that the amygdala, an almond-shaped structure found on both sides of the brain, behaves very differently in males and females while the subjects are at rest. In men, the right amygdala is more active and shows more connections with other regions of the brain, even when there is no outside stimulus. Conversely, in women, the left amygdala is more connected with other regions of the brain. In addition, the regions of the brain with which the amygdala communicates while a subject is at rest are different in men and women.

The finding could be key to determining why gender-related differences exist in certain psychiatric disorders and how to treat a variety of illnesses.

The study appears in this week’s issue of NeuroImage.

“These findings are intriguing because they provide the first hint of what could be a fundamental difference in how the brain is wired in men and women,” said Cahill, a fellow at UCI’s Center for the Neurobiology of Learning and Memory. “If, even in a resting state, the brain shows such differences between the sexes, it could have far-reaching implications for our study of certain psychiatric and medical disorders.”

The researchers used Positron Emission Tomography (PET) scans to analyze the brains of 72 healthy, right-handed adults (36 men and 36 women). The subjects were instructed to relax with their eyes closed while being scanned. When the scans were later studied, researchers found that not only was there a difference between the men and women as to which hemisphere's amygdala was more active, but also that the regions of the brain that the amygdala “talked” with were also quite different. In men, the right-hemisphere amygdala showed more connectivity with brain regions such as the visual cortex and the striatum. In contrast, the left amygdala in women was more connected to regions such as the insular cortex and the hypothalamus.

The finding led to an unexpected discovery: Many brain areas communicating with the amygdala in men are engaged with and responding to the external environment. For example, the visual cortex is responsible for vision, while the striatum coordinates motor actions. Conversely, many regions connected to the left-hemisphere amygdala in women control aspects of the environment within the body. Both the insular cortex and the hypothalamus, for example, receive strong input from the sensors inside the body.

“Throughout evolution, women have had to deal with a number of internal stressors, such as childbirth, that men haven’t had to experience,” Cahill said. “What is fascinating about this is the brain seems to have evolved to be in tune with those different stressors.”

Cahill believes this study could be the basis for a fuller understanding and treatment of a number of disorders that affect one gender or the other. For example, in the study, one of the brain areas communicating with the amygdala in women is implicated in disorders such as depression and irritable bowel syndrome, which predominantly affect women.

Cahill has led the way in exploring gender-related differences in the brain. In a 2001 study, he showed that the sexes use different sides of their brains to process and store long-term memories. In another study in 2002, he demonstrated how a particular drug, propranolol, can block memory differently in men and women.

The original press release can be found here.

Hollywood's Conscience, Part Deux: Thank You For Smoking

I love it, too, when Hollywood displays a conscience: Thank You for Smoking, a film now playing in selecting theatres, takes a critical and satirical look at the machinations of the tobacco industry and lobby. As Robert Duvall's character says: "We sell cigarettes... and they're cool, and they're available, and they're addictive... the job is practically done for us!" One of the funnier, albeit politically incorrect, scenes involves the MOD Squad -- that is, Merchants of Death -- lobbyists for the tobacco, alcohol, and gun industry.

One of my favorite actors, William H. Macy found the philosophical, ethical and political questions raised in the film to be among the most engaging elements of the project. "What authority does the government have to protect us from ourselves? I don't know the answer and I think it's constantly changing."

Director Jason Reitman even has his own blog about what it was like tackling these issues and making the movie.

In the meanwhile, one of the lines from the movie, should qualify as the quote of the day:
"99 percent of everything done in the world, good or bad, is done to pay a mortgage...perhaps the world would be a better place if everyone rented."

And Healthcare for All! (nearly)

I love it: Massachusetts is poised to become the first state to provide nearly universal health care coverage with a bill passed overwhelmingly by the legislature Tuesday that Gov. Mitt Romney says he will sign.

The bill does what health experts say no other state has been able to do: provide a mechanism for all of its citizens to obtain health insurance. It accomplishes that in a way that experts say combines methods and proposals from across the political spectrum, apportioning the cost among businesses, individuals and the government.

Bioengineering: Growing Organs on Scaffolding

Tissue Engineering is something that scientists have been dreaming of for years --but just in the last few days an announcement that bladders engineered in the laboratory from patients' own cells and then implanted into the body have succeeded in their first clinical trial.

To create the new bladders, the researchers took a biopsy from patients whose bladders functioned poorly due to an inherited nervous system disorder. The team then placed muscle cells and cells from the bladder lining on a biodegradable bladder-shaped scaffold and allowed them to grow for about two months.

Scientists are also working on growing bio-engineered hearts and pancreases in the lab. In addition, an artificial womb is being tested at Cornell.

Searching For A Progessive BioEthics Agenda: A Jewish Perspective

[A guest post from Rabbi Richard F. Address, D. Min, Director of the Department of Jewish Family Concerns, Union for Reform Judaism] Reflections from a talk at the NYU Conference on Medicine and Morality, March 10, 2006:

The religious approach to issues involved with medical ethics begins by asking, in many ways, a different set of questions. The religious quest asks the "why" questions, not the "how" questions. These questions of "why was I born?", "why must I die?" and "why am I here?" form the basis of religion. They stem from an understanding of Genesis chapter 3 and give rise to what we call a "theology of relationships". This key idea understands that the most powerful aspect of our existence are the relationships we develop; and that we all seek to be in relationship with people, communities etc, as we seek to counter the ultimate alone-ness of death.

An look at the wealth of Jewish texts that speak to issues of medicine yield several facts. One is that Judaism is a holistic medical system. It understands the important linkage between the mind, the body and the soul and important this harmony is to the healing process.

Secondly, a look at the texts suggests a basic "fundamental ethic" which can be expressed as the "dignity and sanctity of human life and the preservation of human life in dignity and sanctity". The application of this ethic to making sacred decisions is impacted by what we call three "wild cards". These "wild cards" impact how people make decisions. These are autonomy, technology and a person's own spirituality. These wild cards impact every person and family and can yield a theory of decision making that has three aspects:

value, context and choice.

What is the value impacting the decisions? What is the context? Judaism is a "case by case" system. It teaches that we are commanded to look at each case on its own merits. Thus, context is key. Also, there are Jewish legal boundaries (especially as life ebbs) that allow for changes in how decisions may be made. Again, this stresses the context of each case.

Applying the value to the context and taking into consideration all the aspects of the case will yield an appropriate choice. Judaism knows that sometimes these choices are not between good and bad, rather they may be between bad and worse.

We recognize the tensions between the community and an individual. This is especially present as Judaism's basic truth that body and life are gifts from God and that we do not have absolute control over either. There is a higher value here and this produced much tension in our world (wild card of autonomy). Quality of life , as a result of technology has become a major issue in decision making across the denominational line.

Texts can continue to be a guide for developing a progressive agenda.

On the issue of health care and health acre reform we can see guidance from some basic Jewish texts. Deuteronomy 22.2 commands us to restore that which has been lost to a neighbor. Illness implies lost health and thus one can make an argument (as some have done) that it is incumbent on society to help restore that which has been lost (health).

Likewise, in Leviticus 19 we are commanded not to stand idly by the blood of one's kinsman. From this many commentators interpret the text to remind us that not to seek healing is to "shed blood". Thus, we should favor a social policy that allows access to health acre for all. Not to allows people to suffer and "shed blood" and thus implicates the entire society.

Another concept that comes into play is that of the "ger" (stranger). We are ethically mandated to welcome the stranger into our midst. We are mandated to not allow people to be seen as or treated as the "stranger" or the "other" within society. Thus, to allow people to exist outside the tent of access to basic health care is to further demean their humanity. Such denial contributes to their status as "stranger" and "other". Such a reality allows for the potential of shedding blood. It reinforces the barriers restore lost health and, it ultimately denies the ability for us to model our fundamental basic relationship that we have with God.