Norms, Values, and Science

In 2000 Vioxx promised arthritis sufferers a way to ease pain with less trauma to the stomach than naproxen, an older and cheaper drug in such products as Aleve. Merck, the respected drug giant that created Vioxx, funded the VIGOR study, headed by Claire Bombardier, Director of Rheumatology at the University of Toronto, and this study was published by the prestigious New England Journal of Medicine in November 2000 (Claire Bombardier, et al. “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,” NEJM Volume 343:1520-1528.) The study revealed that Vioxx users had four times the rate of heart attacks as naproxen users. The higher risk came about, the study explained, because naproxen protected the heart, not because Vioxx hurt it. But the authors have been accused of withholding evidence about the drug's heart risks by editors of the New England Journal of Medicine. It was found that three heart attacks out of a total of 20 were omitted from the data just two days before the article was published. Were they included, the study would have revealed an even higher risk of heart attacks among Vioxx users. Merck stopped selling Vioxx last year because another study found that patients taking the drug for more than 18 months doubled their risk of heart attacks and strokes. Since then more than 7,000 people have sued Merck, blaming Vioxx for injuries or deaths. Recently, Dr. Gregory D. Curfman, Executive Editor of the NEJM, said that he should have been more aggressive in challenging the research when it was first submitted for publication. An editorial by Gregory D. Curfman, Stephen Morrissey, and Jeffrey M. Drazen, the editors of NEJM, appears in print in the today's issue of NEJM.

This incident is the latest to raise troubling questions about selective disclosure of data in industry sponsored clinical trials. To be sure, there will always be risks and contraindications with any medication, but health care regulators, providers, and patients can't assess those risks if they aren't given all the information. (See the latest regulatory contibution, note this registry is voluntary.) Important questions that emerge in this case are ones that Jerry Avorn asks us to think of as “pharmacoepistemological”. Epistemological questions are those that involve the nature and the scope of knowledge, truth, and justification of claims. Thus pharmacoepistemological questions have to do with how it is that we-- regulators, patients, and providers-- know that a drug is effective and safe enough to use. How do we --regulators, patients, and providers--get drug information and how can we determine if the information is trustworthy? It is the norm that the most trustworthy sources are scientific articles written in prestigious peer-reviewed journals by experts in the field who work at accredited institutions of higher learning. But in this procedure there is the assumption that people who submit the manuscripts will be telling the truth and not fudging data.

The fraudulent data announcing the creation of human embryonic stem cell lines that were submitted to and published by the world respected journal Science again reminds us that we get to know about empirical data as they are presented to us by trustworthy sources. But all along the chain of transmission of data, from lab investigator to department chair to external funding agency to the editorial board of the journal, we find human beings. And human beings have interests. Bias and interest are not the same thing. Bias can occur because of some interest or other that is contrary to the interest of the truthful and full transmission of data. The problem is not that there are values and interests inherent in the scientific project. This in itself does not make science “subjective." The values of truth telling and full disclosure are essential to good science. Thus, it is the kinds of values and human interests that affect the process that invite scrutiny. We have to ask what values are being advocated and whose interests are being served.

The Bioethics-meets-Jerry-Springer debacle (otherwise known as the Korean Stem Cell Fiasco)

I have been watching in horrified silence and disbelief as the entire story of Hwang Woo Suk and the deceptions surrounding his research and so-called 'findings' has unfolded. The story has all the elements a bad Jerry Springer episode: lies, deceit, betrayal -- the only that is missing is someone ripping off their clothing. And just when you think things can't get much worse, another layer of untruthfulness is revealed; colleague and fellow blogger Glenn McGee is right: it's like peeling an onion -- and it's enough to make you cry. Hundreds of blogs are following the story -- and not surprisingly, opponents of stem cell research are feeling righteous indignation and justification. The consequences of this Hwang's actions will be felt for a long time to come: public faith has been lost and future stem cell research will face heightened scrutiny. The best thing that can come from this fiasco is facing up to what we must learn from this painful lesson -- the importance of teaching and enforcing truthfulness and transparency in research.

The Controversial Virgin Territory

"It's the ultimate gift for the man who has everything." This is what Ms. Yarborough, a 40 year old medical assistant felt about her recent 17th anniversary gift - a surgery to reattach her hymen, making her appear a virgin again - to her husband. This controversial medical procedure, hymenoplasty, originally intended to protect females in the Middle East and Latin America, is gaining popularity in the U.S. for cosmetic reasons. “Last year, 9.2 million cosmetic procedures were performed in the U.S., 24% more than in 2000, according to the American Society of Plastic Surgeons.” The booming popularity of this procedure seems to reflect a wider trend of cosmetic surgery’s increased visibility and society’s increased acceptance of it. Visibility is achieved by various means-hymenoplasty adverts can be seen in magazines, local newspapers, online, and even on billboards. Troy Robbin Hailparn, an obstetrician and gynecologist, advertises vaginal cosmetic surgery on 23 billboards around San Antonio. EdwardJacobson, a Greenwich, Conn., OB-GYN, offers international patients vaginal-makeover “packages” that include airfare, limousine travel and hotel accommodation. "Revirgination" can cost over $5,000, but at Ridgewood Health and Beauty Center, a spa and cosmetic-surgery center in the New York City borough of Queens it costs as little as $1,800. The center's owner, Cuban-born Esmeralda Vanegas, has given away hymenoplasties on a Spanish-language radio station. Ms. Vanegas isn't a doctor and doesn't perform the procedure, but rather leases space to five plastic surgeons.

However, not everyone is excited by such prospects. Many religious groups that value abstinence until marriage say hymen repair is a deception. Devout Roman Catholics consider sex before marriage sinful and equate female virginity with near divinity. Hymen replacement is "misleading and misguided," says Kathleen Raviele, a gynecologist and vice president of the Catholic Medical Association in Needham, Mass. "The best thing is to remain chaste until marriage and then have that genuine experience on your wedding night."

For many Muslims, sexual purity, especially for women, is a way of maintaining the family’s sanctity. But Islamic law also prohibits lying and frivolous cosmetic surgery, says Uzma Mazhar, a St. Louis psychotherapist known for her Web site, CrescentLife.com, which provides Islamic perspectives on Western issues. "What people forget is that Islam teaches us to be honest and fair,"Ms. Mazhar says. "A family should think about this before they present a woman as a virgin when she's not."

Other criticisms of hymenoplasty include questions of the procedures legitimacy and safety. The ethics committee of the American College of Obstetricians and Gynecologists, concerned about the marketing of revirgination, has not taken a formal position on the matter, but has expressed concern over the lack of information in the medical literature regarding the procedure, a fact that may mean performers of the procedure are improperly trained. Marco Pelosi II, an obstetrician and gynecologist in Bayonne, N.J. had this to say about hymenoplasty: "no one used to talk about it, but that's changing," "Really, it's not like a heart transplant-it’s a very simple procedure."On the contrary, Thomas G. Stovall, a recent president of the Society of Gynecologic Surgeons, says "hymen repair is a totally bogus procedure." In general, he says, surgery marketed to improve one's sex life rarely works. As for hymen replacement, "most importantly, it doesn't make you a virgin again."

Despite this fact, women are enticed by the ability to tighten their vaginal walls and even redesign the look of their private parts; participating women often indicate that such measures were meant to boost their own confidence levels or please their partners. A 51-year-old patient-a Manhattan attorney and mother of three-had her hymen reattached her hymen and her vaginal walls tightened in 2003. "I thought it would add that extra sparkle to our marriage," says the woman. However, a 26-year-old Latin American woman who lives in New York's Queens who had a hymen repair in 2001 says it took almost two months for her to feel comfortable again. It took even longer for her to enjoy sex. Despite her discomfort, the married mother of two says she’s still glad she had the surgery. She says her husband wanted to experience intercourse with a virgin, explaining that "if a woman isn't a virgin when she gets married, a man can always put her down for that."

Such attitudes irk feminists, who say hymen repair is a manifestation of bigger social pressures that keep women subservient to men. "It comes with a whole set of norms of a macho culture," says Silvana Paternostro, Colombian-born author of "In the Land of God and Man: Confronting Our Sexual Culture." Some feminists liken hymenoplasty to female genital mutilation, a procedure that often forces women to endure genitalia alterations that Western women now pay for.

Read more: “U.S. Women Seek A Second First Time Hymen Surgery Is on the Rise And Drawing Criticism", AMY CHOZICK, THE WALL STREET JOURNAL; December 15, 2005

The Medicare drug "benefit"--benefits whom, again?

So there, I said it. This morning's story on NPR nicely illustrates two important points about the new Medicare drug benefit, which has been touted by its supporters as an improvement for elderly Americans.

Point number one: It's going to be a disaster. The people it's supposedly helping are being asked to choose from a bewildering number of plans, which can differ in cost by thousands of dollars, depending on a given person's (current!!) medications. The NPR story features an interview with a woman who does this for a living--and it takes her about an hour and a half to figure out what is the best choice for a particular person. Oh, and the tools people are supposed to use for this? The Internet. . . and while many of us know tech-savvy elders, it's simply irresponsible for the Internet to be positioned as the primary resource here. There are toll-free numbers set up for assistance, to be sure, but reports indicate that it's hard to get through to a live person. And we're not even talking yet about the actual implementation of this behemoth. Why did we do this, again? Oh, yeah--so that pharmas would have an opportunity to maximize profits. What part of "safety net" don't we understand?

Point number two: Given the inadequate support being provided for elders, guess who is supposed to leap in to fill the gap? The "adult children" of these folks, that's the plan. Let's be honest, folks: that's daughters and daughters-in-law. Just one more example of uabsolutely essential work (unpaid, "caring-centered," time-consuming, and invisible) that ends up on women's plates by fiat and assumption. Externalized costs, anyone?

More controversy on embryonic stem cell research

Embryonic stem cell research might now be more potentially viable for the UK Stem Cell Bank, which learned that samples from 150 random human embryos, far fewer than previously thought, might be able to generate materials beneficial for two thirds of the population. Embryonic stem cells can mature into various types of tissue that can potentially be used to replace “diseased or damaged tissue in conditions such as diabetes and neurodegenerative disorders.” A University of Cambridge team studying such potentialities has explained that the tissues generated from a mere ten samples of specific genetic makeup could theoretically support a UK bank. Researcher Professor Roger Pederson points out that a selective process as described would require “additional regulatory review.”

Displeased opponents say "false hope" is being raised among "desperate patients". Disregarding such criticisms, many scientists welcome stem cell research from spare IVF embryos as offering the possibility of a more cost-effective and practical alternative to therapeutic cloning. The scientific team calculated that cells from 150 random embryos would be enough to provide the best possible match for 13% of recipients, a favourable level of match for 65%, and some use for as many as 85%. Surprisingly, just 10 types of specifically selected genetic material would be enough to provide a favourable level of match for 78% of recipients.

At present the UK bank contains stem cells suitable only for research. Professor Pedersen told the BBC News website that “this research tells us is that the number of lines needed to achieve a significant clinical value is in the practical realm.” Professor Pederson also said that researchers were already working from spare IVF embryos. Dr Glyn Stacey, director of the UK Stem Cell Bank, acknowledged the importance of recent findings, but admitted researchers were still “a long way away in terms of establishing the basic cell culture methods” and do not know “whether all stem cell lines will give the full range of tissues." The charity Life argues that research had shown adult stem cells preferable to embryonic stem cells fro the purposes of treating disease. Spokesman Matthew O'Gorman said: "The UK stem cell debate is obscured by hype which only serves to raise false hope among desperate patients. “Embryonic stem cell research involves destructive experiments on tiny human beings, which is why it has been outlawed in the majority of countries worldwide.” Read more:

A Pill for Alcoholism?

NPR reported this weekend that the University of Virginia is conducting a study on a new drug to help alcoholics who are trying to quit drinking. The drug called topiramate (Topamax®) has shown some remarkable successes, but has not yet been approved by the FDA to treat alcoholics. To date, three medications--disulfiram (Antabuse®), naltrexone (Trexan®), and acamprosate (Campral®)--have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence, but barely 20% of people who need them, use them. Recently, however, there has been research supporting a more central role for medications in the treatment of alcohol-seeking behavior. This behavior appears to be related neurobiologically to dopamine and other neurotransmitters that can alter dopamine function. Topiramate was originally synthesized as a potential anti-diabetic agent and was found to be similar to anticonvulsants. It used for example in the treatment of adult migraine headache. It is a GABA-receptor agonist (GABA is the predominant inhibitory neurotransmitter) and a glutamate antagonist (glutamate is a predominant excitatory neurotransmitter). In a chronic alcoholic state, GABA is decreased while glutamate and dopamine are increased. Work done in 2003 by Dr. Bankole Johnson and his team at the University of Texas at San Antonio have shown that topiramate blocks the glutamate receptors and increases the GABA effect; this combined effect produced a decrease in heavy drinking days and alcohol craving (a person can have one drink and not crave the second third, fourth, fifth, etc.) with an increase in non-drinking days.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) claims that almost 18 million people in the USA abuse or are addicted to alcohol. According to BusinessWeek, this abuse and addiction costs the USA around $185 billion a year in medical services, lost wages, and law enforcement resources. The NIAAA also claims that alcohol affects women differently than men. “Women become more impaired than men do after drinking the same amount of alcohol, even when differences in body weight are taken into account. This is because women's bodies have less water than men's bodies. Because alcohol mixes with body water, a given amount of alcohol becomes more highly concentrated in a woman's body than in a man's. In other words, it would be like dropping the same amount of alcohol into a much smaller pail of water. That is why the recommended drinking limit for women is lower than for men… In addition, chronic alcohol abuse takes a heavier physical toll on women than on men. Alcohol dependence and related medical problems, such as brain, heart, and liver damage, progress more rapidly in women than in men.” For information on alcoholism science go here.

Women's Bioethics Blog Nominated for 2005 Medical Weblog Award

Medgadget is hosting their Second Annual Medical Weblog Awards and this very Women's Bioethics Blog is a nominee. The awards are designed to honor the very best in the medical blogosphere, as decided by the readers. The categories are: Best Medical Weblog; Best New Medical Weblog (established in 2005); Best Literary Medical Weblog; Best Clinical Sciences Weblog; Best Health Policies/Ethics Weblog; and, Best Medical Technologies/Informatics Weblog. Nominations will be accepted until Friday, December 30, 2005. Polls will be open from Tuesday, January 3, 2006 and will close at midnight on Sunday, January 15, 2005 (PST).
Awards will be announced on Wednesday, January 25, 2006. Check it out and vote.
http://www.medgadget.com/archives/2005/11/the_2005_medica.html

Frozen eggs, anyone?

Interesting Slate article and blog.bioethics.net post about how a young economist at the University of Virginia found that a woman in her 20s will increase her lifetime earnings by 10 percent if she delays the birth of her first child by a year. Part of that is because she'll earn higher wages—about 3 percent higher—for the rest of her life; the rest is because she'll work longer hours. For college-educated women, the effects are even bigger. For professional women, the effects are bigger yet—for these women, the wage hike is not 3 percent, but 4.7 percent.

Do you throw--make that think--like a girl?

In this story on NPR's Science Friday broadcast yesterday, Ira Flatow and his guests talk about claims regarding gender differences in cognitive abilities. This is a panel held in conjunction with the American Psychological Association's Science Leadership Conference in Washington, DC, in a forum with DC high school students.

Nora Newcombe, a professor of psychology, says that while there is evidence of differences, there's no evidence of one sex being smarter than the other (overall). In general, women are better at writing, at memory tasks, some fine motor tasks, and speech. Men tend to be better at spatial imagery,. In general, women tend to do better with "book learning" type tasks, and men do better with "fluid tasks," meaning extracurricular learning and novel problem-solving.

Stem cell agency in California hassles court to dismiss lawsuits

Eager to progress with its stem cell project, the newly implemented California Institute of Regenerative Medicine pleaded with a judge to dismiss lawsuits that have impeded it from borrowing $3 billion to be used to fund research grants. Newly created by Proposition 71, the stem cell institute has been hindered by two lawsuits that have challenged its constitutionality and intimidated potential leaders. Filed by politically conservative groups, these lawsuits have delayed the agency’s work, according to deputy attorney general Tamar Pachter. For example, rising interest rates since the agency was first prepared to borrow have cost the state an estimated $15 million. The lawsuits question the authority and intentions of the agency’s managers, many of whom, they allege, are not state officials but employees with individual agendas. The agendas of the filers of such lawsuits have been questioned as well. One of the filers, the People's Advocate and the National Tax Limitation Foundation, which opposes abortion and the “right-to-die,” has admitted its disapproval of stem cell research, but claims its motivations are moral, not religious. The group maintains that only state officials should be able to dole out public funds.

The second lawsuit was filed by a newly created nonprofit called the California Family Bioethics Council, self-described as a “stem cell research watchdog group.” Bioethics lawyer David Llewellyn claims that the selection process, whereby elected officials and college administrators select members of the institute's Independent Citizens Oversight Committee, creates a “conflict of interest.” Human embryonic stem cells are created in the first days after conception and give rise to all the organs and tissues in the human body. Scientists hope to someday use stem cells to replacement diseased tissue. Such prospects anger many social conservatives, including President Bush, because embryos are destroyed during research. President Bush’s 2001 restriction on the use of federal money to fund stem cell work has kept the field infantile, according to scientists.

The pending litigation discourages potential leaders, fearful of the potential futility of their investments. The agency has been kept afloat and has opened a permanent headquarters thanks to a $5 million charitable donation from sound pioneer Ray Dolby and a $3 million loan from the state. Even though it has little money, the agency in September awarded 16 grants totaling $39.7 million to universities and nonprofit medical organizations in California. Rulings on the lawsuits are expected at a later date.

IVF-->slight increase in risk of birth defects

According to a new study from the University of Iowa, babies conceived through in vitro fertilization (IVF) have a slightly increased risk of major birth defects (eg, heart or muscle and skeletal defects) compared with babies made the old-fashioned way. The increase is slight--a risk of 6.2% for babies conceived through IVF, versus 4.4% for naturally conceived infants--but may be worth considering. It is not known whether the increase in risk is the result of IVF, or the result of some other factor; other characteristics of women/couples seeking IVF could account for the rise. In addition, the study addresses only congenital defects--not problems that might arise later in life. Here's the link to the abstract in PubMed.

Women's Health and Intimate Partner Violence against Women

While violence against women is recognized as a major health and economic problem, as well as a human rights issue, a lack of comparable and reliable data on root causes and magnitude has hindered public policy makers. In 1997, in order to collect such data, WHO initiated a study, the initial results of which were published last week as the “WHO Multi-country Study on Women's Health and Domestic Violence against Women”. This report is based on interviews with 24, 000 women in Bangladesh, Brazil, Ethiopia, Japan, Namibia, Peru, Samoa, Serbia and Montenegro, Thailand, and Tanzania by carefully trained interviewers. (Countries in North America and Europe were not included as they had been the subject of previous studies.) It says the percentage of women reporting having been physically or sexually assaulted, or both, in their lifetime ranges from 15% in Japan to 71% in rural Ethiopia. Alarm was expressed at this figure in regard to the spread of HIV and Aids. (See also this article.) It was discovered that violence was more prevalent in poorer countries and that women who lived there were more likely to think the violence was justified. Researcher Lori Heise said it was not clear what was behind the differences between richer and poorer countries, but many of the areas with higher rates were more rural, traditional communities where the problem had remained largely hidden: up to half of the women surveyed had never spoken of their situation to anyone. This report shows that research and policy on women’s health, and indeed promotion of women’s health, including psychological and reproductive health, must consider intimate partner sexual and physical violence against women.

Feeling Angry? Good for You!

Contrary to previous studies about anger and the risk of heart disease, new research has found that women with high levels of hostility and anger do not have an increased risk of heart disease compared to women with lower levels of anger. In fact these women were found to have a slightly lower risk, though not enough to be statistically significant. Past studies have shown a link between anger and heart disease and medical models to explain this phenomenon have been proposed. The correlation between angry men and heart disease still holds.

So what is it about women that they may not realize the same health consequences from anger that men do? The study does not answer that question, but a search of the internet reveals some interesting hypotheses. One study from the University of California at San Francisco found that while men and women experience anger differently, both take advantage of their anger in day to day interactions with the same frequency. Women are likely to report anger as feeling akin to frustration or expressing negative feelings about having anger. But they are just as likely as men to act on their anger. The difference seems to be that typically men use their anger directly – to confront people or voice displeasure - whereas women are more likely to channel their anger to create change in a more indirect way. Most people would guess that this difference is one that arises from social expectations and taboos on women expressing strong negative emotions or assertive behavior. Conventional wisdom would tell us that repressing anger is harmful to the body and soul. But apparently repressing it long enough to convert it into another type of action is not only not harmful, it is probably more productive.

A Painful Issue Redux

Art Caplan comments on how abortion politics continue to rip at the social fabric of America in a commentary on proposed fetal pain and abortion laws. It' s hard to imagine that any woman or any physician involved in a such procedure would not discuss this without the mandate of legislation.

First Human Clone Maker Resigns Post

After being dogged for months about the source of the women’s eggs he used to create the first human cloned embryo, the South Korean veterinarian Hwang Woo-suk, apologized Thursday and stepped down as director of The World Stem Cell Hub, an international network of fertility clinics recently established by Hwang to create stem cell lines for research. The ethical violation that he admitted to and resigned because of is that he did not tell the truth about the source of his eggs. In 2004 when pressed he told Nature magazine that his own researchers, including graduate students, did not donate their eggs. But they did, even though they did so under false names and apparently without his knowledge. And he said that no woman was paid to donate eggs. But they were. The Washington Post reports that Roh Sung Il, head of Seoul-based MizMedi Women's Hospital, admitted that he had paid about $1,447 each to 20 women to gather human eggs for Hwang's research. Payment for eggs was not illegal in 2003, but it was banned last January by South Korean law. Talking to the BBC, Dr Hwang explained why standards may have slipped, “We needed a lot of ova [eggs] for the research but there were not enough ova around.” Dr. Hwang himself has published research on a method that would allow stem cell lines from human cloned embryos to be created using 17 women’s eggs instead of the 242 it first took.

South Korea treats Dr. Hwang as a national hero and today in the Korean Times an editorial urges that even though his stem cells were procured unethically, this should not diminish the “remarkable achievement” of their native son. In addition to creating the first human embryo clone, last August he unveiled Snuppy, the world's first cloned dog.

Besides lying, ethical issues in this case include the specter of coercion involved in the harvesting of eggs from junior researchers and graduate students thus violating the ethical necessity of donations being given with informed voluntary consent (with coercion the voluntariness condition is breeched). And the problem of the commodification of women emerges in the act of exchanging ova for money.

On this day of Thanksgiving....

For a wonderful spiritual collection of Thanksgiving blessings, meditations, interviews, and thoughts about what Thanksgiving means check out Beliefnet.com. And have a very Happy Thanksgiving from the WBP blogger team!

Women trade health for a paycheck

In September the President’s Commission on Bioethics published Taking Care: Ethical Caregiving in Our Aging Society. It is a broad review and set of recommendations regarding a number of issues facing society and the special medical care needs of the elderly. Of particular interest to women and justice is the following quote:

“Once the typical caregiver was a woman who did not work outside the home; today the typical caregiver, still a woman, is employed outside the home, and often obliged in addition to care for her own young children. At the same time, there are already shortages of professional caregivers—nurses and geriatricians—and caregiving jobs such as nurse’s aides often lack the levels of compensation and benefits that might attract sufficient numbers of workers.” (Chapter 5, section I, paragraph A, point 4)

This point, and its disproportionate impact on women, has been dramatically illustrated by an article in today’s Chicago Tribune. The point of the article isn’t just that women are more often professional caregivers and that they are underpaid, but that by the very act of taking on a paid caregiver position they are, ironically, left without a way to pay for their own healthcare. The personal stories in the article are gripping and tragic. The article quotes the journal Health Affairs as stating that of the 6 million Americans who joined the ranks of the uninsured between 2000 and 2004, nearly two-thirds were working, mostly in low-wage jobs. Nursing home and home-care aides fall in this category, with median annual incomes of $13,287 and $12,265, respectively. Professional caregivers may or may not have access to employer-sponsored health insurance, but even those who do often pass it up because of the high premiums which can easily be 10% of their gross salary for individual coverage and up to half of their salary for family coverage. And since sick days are not covered by home care agencies, women cannot take the time to stand in line for hours at free clinics. Any serious illness requiring hospitalization and resulting bills will force women and their families into a bankruptcy situation. Thus it’s not surprising that the majority of women who work as professional caregivers do not get routine medical exams and screenings and do not seek care early in an illness. Instead, like other working poor without insurance, many of these women resort to using emergency rooms as their primary mode of health care and suffer health outcomes far inferior to those who have general access to health care.

While the typical reaction to such “news” is to bemoan the sad facts, we have to do more than that as a society. As our population ages, the demand for home care givers is on the rise. If people do not respond to this need by becoming home care workers, we, as a society, have a huge problem of figuring out how to care for this population. On the other hand, if people, predominantly women, do respond to this call and we have not reformed the system, then we are complicit in the unjust treatment of women who literally trade their own health to care for the better-off who can afford it.

Malicious modeling?

CNN.com reports on a Catholic school who has fired a preschool teacher for being unmarried and pregnant. The school claims that they are simply "following the personnel handbook," where teachers are "expected to convey the teachings of the Catholic faith by his or her words and actions." Of course, one bit of irony about this situation is that if Ms. McCusker had decided to terminate her pregnancy, she would have violated Church doctrine...and yet saved her job. Exactly what sort of role modeling does the school have in mind? Ms. McCusker is truly caught between a rock and a hard place.

Lawyers for the fired teacher argue that the rules themselves are unjust. After all, how does the school district monitor male teachers' sexual habits? This is another example of inequitable treatment of women in the guise of observance of religious tenets.

Is this what Sister Sledge meant?

I refer, of course, to the 70s disco hit (and frequent wedding reception boogie tune) "We Are Family." Yesterday's NYT ran a front-page article on the phenomenon of "family reunions" between half-sibs "fathered" by the same anonymous sperm donor.

Novel family arrangements aren't unprecedented--certainly, adoption, divorce, remarriage, same-sex parents, and other arrangements have been around for a while now.

But what's interesting to me is this question: to what extent do genes make family?

Harvard Bioethcists Discover Social Justice

The Inaugural Conference on Health and Ethics sponsored by the Harvard University Program in Health and Ethics was held this past Thursday and Friday with a powerful sense of mission. “This conference maps a new departure for bioethics and initiates its exploration” promised the Call for Participation. A host of the conference, Dan Brock, announced to Thursday morning attendees that the conference heralded the birth of a new bioethics, one that was not dedicated to moral issues arising between doctors and patients, for example, end-of-life issues and informed consent for treatment, but rather to a “broader group of ethical issues that come from a population level.” This new bioethics is to be called “Population Bioethics” and will require the collaborative effort of people working in epidemiology, public health, rational decision theory, economics, bioethics, and others. Harvard is advertising for two new positions in bioethics this fall with the development of scholarship in Population Bioethics in mind.

Population Bioethics not only reorganizes bioethics but it also creates new questions for bioethics, said Dan Wikler, in his presentation on what is distinct about Population Bioethics. He, and his colleague Norman Daniels, are leaders in the field of international health and ethics. The audience learned that the new questions for bioethics that emerge from Population Bioethics include: Who has a moral right to health care? How should scarce healthcare resources be distributed? How can and should health care policy at home and abroad be reformed according to the value of justice? What are the ethical and rational justifications of health care measurements, that is, according to which principles may we justify a summary judgment of the health of a population (like women’s health or a nation’s health)? How do we rationally and ethically justify health priorities? What are ethical justifications of government intervention in potential health crises (like Hurricane Katrina and potential epidemics like avian flu)?

Pass the Beano, Please...

Sally Squires of the Washington Post reports on a study that shows that trading about 10 percent of carbohydrates in the diet for beans and healthful fats such as olive oil can help control high blood pressure and raise the level of "good cholesterol." Not too mention it has long been known that addition of legumes to one's diet also is an excellent way to regulate blood sugar levels. Also, the study provides yet another argument that a diet that uses more renewable, sustainable resources (as opposed to concentrating our resources on the production of meat for a relatively small population of the planet) is good for everyone.

God's Bioethics (part deux) and the Church: The Vatican Rejects Intelligent Design

Yahoo reports that the Catholic Church has weighed in on the intelligent design debate. The Rev. George Coyne, the Jesuit director of the Vatican Observatory, said placing intelligent design theory alongside that of evolution in school programs was "wrong" and was akin to mixing apples with oranges. Coyne was quoted as saying that "Intelligent design isn't science even though it pretends to be...If you want to teach it in schools, intelligent design should be taught when religion or cultural history is taught, not science." In a previous article in a British Catholic magazine, Coyne reaffirmed God's role in creation, but said science explains the history of the universe:

"If they respect the results of modern science, and indeed the best of modern biblical research, religious believers must move away from the notion of a dictator God or a designer God, a Newtonian God who made the universe as a watch that ticks along regularly." Rather, he argued, God should be seen more as an encouraging parent.

So, my question is, where does that leave individuals like religious right-wingers like Pat Robertson and those ultra-conservative Catholics who insist on mixing politics and religion? (Let's hope that no one prays that the Vatican is sruck with disaster -- how unChristian would that be?)

Latest installment in Plan B saga

An investigation by the Government Accountability Office, a nonpartisan investigative arm of Congress, has found that Plan B's rejection by FDA was a foregone conclusion. That is, FDA had decided not to approve over-the-counter sale of the "next-day pill" before the manufacturer's application had been through the scientific review process.

According to an article in the New York Times, top FDA officials were "deeply involved in the decision," which is unusual. The GAO's findings have been denied by FDA leadership. There's a lot of he said/she said going on, from the looks of things.

The drug prevents pregnancy if taken within 72 hours of unprotected sex. It has been targeted by anti-abortion activists, citing concerns about use by minors and the use of Plan B (and similar drugs) in place of contraceptives.

Selling Human Eggs Illegally

South Korean police in Seoul reportedly made their first arrest under a law enacted in January 2005. Police captured a man, identified by his family name Kim, who allegedly sold human ova to infertile couples in South Korea and Japan. Kim was accused of luring indebted women to sell their eggs in exchange for monetary compensation. Following his arrest, police raided four Seoul hospitals, resulting in the charging, but not detention, of two university students and a housewife. Police are investigating at least ten other cases in which the Internet may have been a forum for the now illegal selling of one’s ova.

The new law, which forbids reproductive human cloning, was meant to promote stem cell research for therapeutic cloning. The commercial trading of ovum and sperm is now also illegal, with the broker being more penalized than the donor. Kim’s case and others reveal that donors are usually compensated between 3 and 5 million won for ovum that are then sold for approximately 17 million on the Japanese market. While there is no law banning such sales in Japan, the country’s gynecologists have a regulatory ban, which is strictly adhered to. According to the Japanese daily Yomiyuri Shimbun, Japanese women look to South Korean donors because of their proximity and similar racial features.

Click here for more details

Pop Culture: Teen Breast Implants

Occasionally I actually get to watch a TV show and even more occasionally I get to watch one I like. I was pleasantly surprised this fall by a new sitcom on Fox called “The War at Home.” It is a sleeper that I have no doubt will soon be put to sleep if for no other reason than I have enjoyed watching it. In the very first two months of its first season, it has confronted issues such as teen sex, sexual identity, interracial dating and drug use (not necessarily among teens.). More importantly it has done so not in a preachy way, but in a way that shows these issues are a part of everyday life for the average family and that they may not be as black and white as we think. There is no moralizing on this show – there are just ordinary people getting tripped up by the challenges of living and parenting in our culture. I don’t even know if it knows how smart it is. The people who promote it and choose its advertising sure don’t. Had I named this show it might have been called something like “Everyday Ethics” – which means it surely would have been cancelled by now. So imagine my distress when I watched this past week and found myself booing instead of cheering. This week’s conflict was resolved by the parents agreeing to breast implants for their teenage daughter! What?!?! How could this smart, contemporary purveyor of liberal values get derailed so quickly and easily? Since when are teenage breast implants a pressing cultural problem? What parents in their right minds would agree to that?

After hyperventilating, I started an internet search. Sure enough, there are a plethora of reports out there detailing the trend of cosmetic surgery becoming popular in younger and younger age groups. Last year, over 1800 girls under the age of 18 had their breasts augmented. Parents are taking out financing to do it. The mind reels with all the ways in which this is wrong. Teenagers are still forming their identities and values. They want desperately to fit in and be admired. Learning to accept oneself and find one’s strengths is a skill that needs to be modeled and nurtured by parents. By focusing on breast size and not self worth, such parents are encouraging their daughters to accept the shallow societal depiction of women and their value in the world. I could rant on about this, but others have already done so and done so better than I could. Now my interest is more academic. I always tell my ethics students that in order to understand an issue, in order to make a robust argument, one must examine the arguments on all sides. The problem is, I can’t come up with an argument for getting breast implants for one’s teenage daughter.

The Agony and the Ecstasy, Part II

In my previous blogger life, I had written about the use of Ecstasy for treatment of severe anxiety in terminally ill patients; today in New Scientist magazine, a study warns that regular use of Ecstasy could leave the brain vulnerable to inflammation, invasion by viruses or other pathogens. This potential side effect needs to be weighed and balanced against the potential benefits for clinical use in diseases such as schizophrenia, post-traumatic stress disorder and terminal cancer.

God’s Bioethics?

The Women’s Bioethics Project, a non-partisan, public policy think tank, announced today the release of a report detailing a concerted effort by conservative groups to dominate so-called “bioethical issues” surrounding emerging technologies. The report, titled “Bioethics and Public Policy: Conservative Dominance in the Current Landscape,” analyzes the involvement of both progressive and conservative bioethics centers, including traditional think tanks such as the American Enterprise Institute, as well as religious groups such as James Dobson’s Focus on the Family.

To date, the report says that only conservative groups have devoted substantial resources to pushing a broad bioethics agenda. Bioethical issues ranging from stem cell research to the Terri Schiavo case are the battlefield for defining the kind of world we want to create,” said Jonathan Moreno, bioethicist and senior fellow at the Center for American Progress. “The Women’s Bioethics Project analysis is an important wake-up call to people who care about scientific progress and the ability to decide what is right for their own families. The time to engage in these issues is now.”

“The rapid advance of biotechnology is quickly outpacing our ability as a society to absorb the effect it will have on our lives,” said Kathryn Hinsch, founder of the Women’s Bioethics Project and author of the report,” The institutions we have relied on for guidance on difficult moral issues—whether organized religion, government, or the academy – have failed to keep pace with science or societal implications underlying these issues. Because of this confusion, disarray, and public policy flux, the opportunity to influence the direction of public opinion is up for grabs. Essentially, whoever gets there first will frame the debate on these issues and will affect us all for decades to come.”

Full details of the report can be found at www.womensbioethics.org.

First trimester Down syndrome testing now available

Washington Post reports that a study of more than 38,000 U.S. women found a screening method, which combines a blood test with an ultrasound exam, can pinpoint many fetuses with the common genetic disorder 11 weeks after conception. While the testing has drawn criticism from opponents of abortion, researcher Fergal D. Malone of the Royal College of Surgeons in Dublin, who led the study published in today's issue of the New England Journal of Medicine, felt that it would not result in more abortions.

Good News for Java Lovers

This is really great news for women, like me, who are addicted to their coffee --turns out coffee may be good for you (if you are a woman)...a government sponsored study showed evidence that women who drank four or more daily cups of regular or decaffeinated coffee had a slightly lower risk of developing high blood pressure than those who drank little or none. The same did not hold true for those who drank cola or other sodas containing caffeine. The theory is that coffee has lots of antioxidants, substances that are thought to help protect the heart and reduce risks of cancer.
Same news has been reported at WebMD -- hmmm, I think I'll celebrate with a cup of coffee!

Ha-ha

This might give you a chuckle: Turns out women enjoy a joke more than men. Brain scans indicate that women's brains react more intensely when the punchline is delivered.

Caught in the Schiavo echo chamber

In yesterday's NYT Book Review, William Saletan (Slate's bioethics guy) criticizes Jon B. Eisenberg's new book, Using Terri for, well. . . using Terri.

Clinical Trials in India

While Europeans interested in medical research have, ventured into India before, modern-day globalization has washed a wave of researchers and multinational drug companies onto India’s shores. According to Sean Philpott, managing editor of The American Journal of Bioethics, this wave recalls the gold rush frontier. Not only are research costs low, but there is a skilled workforce to conduct the trials. Though drug companies are undoubtedly enticed by the prospects such as bringing down the price of testing by 60% - their work arguably takes advantage of both India’s educated workforce and individuals mired in poverty, who act as guinea pigs under informed consent after lures of 100 US dollars.

While it may not be for outsiders to judge the significance of such sums to South Asia’s impoverished, many, including Philpott, who cautions that individuals may not even realize they are being coerced, worry that the testing borders on exploitation. Pharmaceutical companies conducting research have come under criticism before. In 2004, before the anti-generic drug rules were enacted, two India-based drug companies, Shantha Biotech and Biocon came under scrutiny for conducting illegal clinical trials without proper consent, actions that led to eight deaths.

Although South Asia’s poor are somewhat used to being enticed by the medical community (particularly when it comes to the sale of vital organs), such testing was not always as prevalent in the region. In the past scientists used foreign produced reverse-engineered drugs, a practice halted after March, when India submitted to pressure by the World Trade Organisation to prohibit local companies from creating generic versions of patented drugs. Considering both relatively lax government oversight and the removed threat of domestic competition, many drug companies are now taking advantage of cost-effective testing ground. By 2010 total spending on outsourcing clinical trials to India could top $2 billion, according to Ashish Singh, vice president of Bain & Co., a consulting firm that reports on the health care industry.

To read more, click here.

Good for the Goose, Good for the Gander?

Interesting commentary in the NY Times.com on how changing technologies will likely change the focus of the debate regards the rights of fathers in reproductive cases. Some of these developments include advancing techniques of the neo-natal intensive care unit, where the threshold of extra-uterine viability has been possibly pushed back to 20 weeks (or five months) gestation, the theoretical possibility of male pregnancy, and perhaps most importantly, the artificial womb. While these developments may not directly answer the debate of the moral status of the fetus or embryo, they will remove the maternal-fetal conflict inherent in the present discussions and disentangle the issue from the rights of a woman over her own body.

What does UNESCO have to say about bioethics?

The governing body of UNESCO has approved a controversial bioethics declaration concerned with the social, legal, and environmental ramifications of medical and technological advancements and procedures, as they affect human beings. Supporters of the doctrine promote it as an ethical framework for the potential standardization of international practices.

While much of the declaration reemphasizes commonly accepted values, such as informed consent, the new emphasis on social responsibility is inciting much more heated debate. Also contentious are the often implicit references to the use of human embryos. Such advisements are particularly pertinent to developing countries that are advancing the sophistication of their scientific capabilities, such as China, India, and South Korea.

Much of the support for UNESCO’s doctrine comes from thinkers on the religious right, who tend to oppose both abortion and the use of human embryos. Conservatives especially value the doctrine’s focus on the concept of ‘human dignity’ and the importance of the individual’s dignity over the sole interest of the state. An advisor to the US delegation at the Paris meeting wrote on the website Christianity Today, "These resonant assertions of the centrality of human dignity and the limitations of science give us hope and ammunition." The Vatican has also promoted the declaration, which essentially backs an anti-abortion position. In an earlier debate, Vatican representative Francesco Follo said that a bioethical system should respect "man and his intrinsic dignity", warning that medical researchers were being tempted "to treat the human person as simple laboratory material".

While conservatives welcome the seemingly ‘moral’ nature of the declaration, academicians are far less enchanted. Arguing that the language used is dangerously vague, they envision a ‘progressive’ view of science, uninhibited by agenda-backed restrictions. Richard Ashcroft, reader in biomedical ethics at Imperial College London, expressed his concern by calling it strange that the document was adopted without being amended after near-universal criticism of the draft declaration by academics.

This declaration is the third document on the topic of bioethics which has been proposed and approved by UNESCO. The first two were the 1997 Universal Declaration on the Human Genome and Human Rights, adopted in 1998, and the International Declaration on Human Genetic Data, approved in 2003, which sought to set ethical standards for collecting, processing, storing and using human genetic data contained in biological samples. This is also unlikely to be the last time that religion and science will clash in the conception of an ethical future.

[Thanks, Ana Lita]

Hubris replaces paternalism as 21st century medical vice

Concern about whether or not childhood immunizations can trigger developmental delays in some children has been a growing question on the minds of parents in a world in which environmental toxins and their health consequences are regularly being exposed. The medical establishment swears up and down that the mercury once used in vaccines is not the type that can cause damage – the same medical establishment that took thirty years to decide if eggs were part of a healthful diet and changed their position several times due to new research findings. The government assures us there is no correlation between autism and childhood immunizations - the same government that allowed civilian exposure to radiation from nuclear testing.

Many parents are now asking to skip certain vaccines or to give the vaccines on a slower schedule to reduce the number of vaccines entering the system at one time. And, yes, some parents are skipping them altogether. Since immunizations are at the heart of pediatric medicine, this has raised an outcry among pediatricians. Many are willing to kick patients out of their practice either for not wanting to vaccinate or for simply asking to slow down the immunization schedule. In a recent study, 39% of pediatricians surveyed indicated that they would be willing to dismiss a family for refusing all vaccinations and 28% would dismiss for refusing select vaccines. The study’s authors urged pediatricians not to dismiss families but instead continue to see the patients so that they would have additional opportunities to educate the family. In fact, the authors recommend that this issue be raised every time the family comes to the office. Ironically, the authors argue that if the pediatrician dismisses the family that the children may have limited access to health care. There is no mention of what effect raising a contentious issue every time they come into the office might have on the family.

The American Academy of Pediatrics (AAP) notes that four percent of pediatricians have refused an immunization for their own children. They also recommend that pediatricians listen carefully and respectfully to parents’ concerns, recognizing that some parents may not use the same decision criteria as the physician and may weigh evidence very differently than the physician does. The main goal of medical ethics is to find the most humane and encompassing solution to a dilemma. A humane and encompassing solution to this conflict would support real listening on the part of both parties and encourage some sort of compromise that could foster mutual respect.

Private correspondence with the study’s main author revealed deeper insight into the study’s recommendation. When asked about a compromise such as delaying the immunization schedule so that vaccines could be given one at a time instead of in batches, the response was twofold: first, that that would delay coverage of children for a few extra months, and secondly, that doing so would encourage parents to think that there was some validity in their beliefs and that wasn’t an acceptable message to send.

How does one foster mutual respect when one party believes that there is no validity to the other party’s stance? Is it possible to agree to disagree? What harm does it do to accept that people may weigh evidence and benefit differently, as the AAP suggests? Flip the question around and ask what good it does to accept that people may weigh evidence and benefits differently. The good is fundamental – it is respect for individual autonomy. Autonomy, rightly or wrongly, is the cornerstone of western medical ethics.

Not so long ago physicians as a group were accused of being generally paternalistic toward patients. Thirty years ago it was common practice not to disclose grave diagnoses to patients when there was little curative treatment that medicine could offer. The rationale was that is would be too distressing for patients to be given a death sentence. That sort of attitude has changed, as well as the state of medicine, and today a physician would be found to have committed malpractice if he or she withheld a diagnosis from a patient. The change was gradual and there has been some meeting of the minds. The intention behind paternalism in most cases was a beneficent one – wanting to spare the patient and family distress. Medical ethics recognizes that beneficent intent and holds that there are limited, justified uses of paternalism even today. But what ethical stance is behind the insistence that immunizations are not harmful? Beneficence? Not likely. Wanting all children to be vaccinated is a form of beneficence because it refers to a desire to spare children and adults from serious illnesses. But the current debate isn’t about whether or not it is a general public good or even a specific individual good to be vaccinated. The fight is not about an ethical principle at all. It is about who is right.

That pediatricians are willing to take the stance that they know vaccines are safe and they are so certain of this that they are willing to dismiss families from their practices is a sure sign to me that hubris is now the biggest threat to individual autonomy.

International Consensus Statement of Women’s Health

Donna E. Stewart, MD, President of International Association for Women's Mental Health, has recently announced that a final version of the International Consensus Statement of Women’s Health is ready (this older version is all I can find on the net). This document was accepted, to her surprise and delight, at the XIII World Congress of Psychiatry in Cairo. Donna E. Stewart is Professor and Chair of Women's Health at University Health Network and University of Toronto. She and her international team are now in the process of getting the statement endorsed by various organizations. The following are the recommendations .

"We recommend that professional mental health and health organizations and providers, governments, the United Nations system, the World Health Organization, other international health and social organizations and appropriate nongovernmental organizations integrate girls’ and women’s mental health as a priority in policy and program development and… Support psychological health promotion programs that encompass the life context of girls and women to include equal access to basic human rights, education and employment, the elimination of violence and discrimination and the reduction of poverty. Support women’s marital, sexual and reproductive choices and ensure access to safe motherhood. Support public education and awareness campaigns that increase recognition and reduce the stigma of mental illness in girls and women Support safe, respectful, appropriate, gender sensitive comprehensive mental health and physical health services for girls and women across the life cycle irrespective of their economic and social status, race, nationality or ethnocultural background. Support timely access to adequately skilled mental health professionals who provide quality of care consistent with best current knowledge and availability of appropriate therapy, technology or drugs and who take women’s special needs into consideration. Support the development and use of culturally appropriate diagnostic systems that consider the sociocultural context of women’s lives, and biological differences when they are salient. Support the provision of accurate information and respect choices in treatment decision making by girls and women whenever possible Support the provision of mental health care for girls and women that is free from breaches in fiduciary responsibility Support increased attention to research on girls’ and women’s mental health including those factors which enhance or inhibit the development of resiliency. Support the provision of core training and education about gender issues for health, and mental health, professionals. Support gender equality in practice and promotion within mental health services and organizations including equal opportunities for advancement and eradication of gender harassment, intimidation or unjustified discrimination on the basis of sex."

Scientists as Creators (Shades of Frankenstein?)

Should scientists be acting as creators? A group of scientists is trying to form a living being from non-living chemicals reports a New Scientist blog by Bob Holmes. Though this opposes the religious beliefs of some, scientists believe that it will eventually provide immeasurable benefits including organisms that could clean fuel spills and heal injuries. Proto Life, a company based in Venice, is one of the few companies that has ventured to take on this controversial task in hopes of the next Nobel Prize. The company is run by CEO Norman Packard and his partner Rasmussen, a physicist at the Los Alamos National Laboratory in New Mexico. They have nicknamed this creature in creation the “Los Alamos Bug.”

To approach such a monumental task, Rasmussen and his co-workers questioned what base essentials were necessary for an organism to be considered alive. In simplified terms, containment, hereditary and metabolism was what was needed. These are the aspects that they are experimenting with to impart on the Los Alamos Bug.

[Thanks, Ana Lita]

Sex selection trial in China USA has been approved

This just in, a story in the Guardian referring to an article in the most recent issue of Nature:

A clinical trial into the effects of allowing couples to choose the sex of their babies has been given the go-ahead at a US fertility clinic. The controversial study was given the green light by an ethics committee after nine years of consultation. The purpose of the study is to find out how cultural notions, family values and gender issues feed into a couple's desire to choose the gender of their child.

Yes, you are reading that right, folks. A team of fertility specialists at Baylor College of Medicine in Texas will be conducting a trial that involves pre-implanation genetic diagnosis (which has only been used, until now, to identify serious disabilities and potentially life-threatening conditions) to find out why people might select one sex over another. And people are clamoring to get in: there have already been 50 inquiries from would-be parents asking to participate. Can it really be that this is a worthwhile research question? And are we really including selective termination of "wrong-sex" embryos as part of an empirical research protocol? Read more here.

Rumors have been floating around for some time (see Linda Glenn's earlier blog post re the "GenderMentor" test) that existing direct-to-consumer, mail-order prenatal tests, purportedly designed to help future parents plan for the arrival of their wanted child of either sex (Hmm, shall I buy the pink sleeper or the blue one?), have in fact been used as the basis for sex-based terminations.

Just in case you thought the no-girl-babies problem was something that only happened in other countries. . . .

Quote of the day....

"Old bioethicists never die, they just lose autonomy." - Karama Neal, bioethicist and writer. I had the pleasure of meeting Karama at this past weekend ASBH meeting; what a hoot! Along with colleague/bloggers Sue Trinidad, Toby Schonfeld, Glenn McGee, and David Magnus, Hilary Bok, (I think I'm missing someone -- if I am let me know!) it's tempting to propose a blogger affinity group.

(image borrowed from http://www.biologycorner.com/quests/bioethics.html)

Have It Your Way - as long as it's not healthy

The “obesity crisis” in the US has fingers of blame wagging at everything from working moms who rely on processed food to the popularity of sedentary activities such as internet surfing. McDonalds, the world’s largest restaurant chain, has spent much time in the center of these discussions due in part to lawsuits filed by angry, obese customers and a movie documenting the disastrous health consequences of living on a McDonalds' diet. McDonalds has made a variety of responses in the last fifteen years including displaying nutritional information posters in their restaurants, hosting a website with nutritional analysis of its food and adding some lower calorie menu items. Their latest endeavor involves changing all the packaging on their food so that consumers will have a basic nutritional breakdown of their lunch literally at their fingertips. While some other fast food chains, notably Wendy’s, have also responded to consumer preferences for more healthful food there is an interesting trend developing among some of the other fast food chains. Since McDonalds has taken much of the heat for the obesity epidemic, other fast food restaurants have been able to stay under the radar. While it would be stretching the truth to claim that McDonalds has moved toward a more healthful menu in any significant way (apple slices with caramel dip merely shifts the problem from fat to sugar), Burger King and Hardees aren’t even pretending to cater to health interests. Hoping to lure away some of McDonalds’ breakfast business, Burger King has introduced a new 730 calorie breakfast sandwich. At least they honor truth in advertising, naming it the Enormous Breakfast Sandwich. Hardees has responded by trouncing the whopper with the Monster Thickburger – a monster indeed at 1420 calories even before you get to the fries and soda. Congress, feeling the need to legislate something, is in the process of passing the “Cheeseburger Bill” – a bill prohibiting individuals from suing restaurants for contributing to their obesity problems. Clearly, responsibility for a healthful diet is left right where it always has been – squarely in the lap of the consumer. If you ever had any doubt about where the loyalty of the food industry lies, in the health of the consumer or in their pocketbooks, consider this: Ruby Tuesday’s recently reversed their new, groundbreaking practice of printing nutritional information on their menus next to each food item. They claim that it is too expensive to print new menus every time there is a recipe change. Coincidentally, during the time the nutritional information was disclosed on the menu there was a dramatic drop in the number of orders of the Colossal Burger, a 1677 calorie hamburger that is a Ruby Tuesday's signature dish.

Can I Pick Your Brain?

ScienceDaily reports that neurobiologists at the Salk Institute for Biological Studies have carried out experiments that prove for the first time that the brain remembers, even if we don't. Lead investigator Thomas D. Albright explains that "For the first time, we can look at the brain activity of a rhesus monkey and infer what the animal knows."

In contrast, the NY Times reports that brain scans are promising, but not yet practical.

The other interesting news about neuroethics is that over the weekend at the annual ASBH meeting in Washington, D. C. , neuroscientist and bioethicist Judy Illes of Stanford led the launch of the Neuroethics Affinity group. Kudos to Judy for being a pioneer!

The Other Problem with IVF...

The findings of three US studies have caused some to believe that all eggs used for IVF should be screened for defects. Because the increase of chromosomal abnormalities and miscarriage increases with age, the UK currently recommends screening only for women over 35 or women who have undergone repeated miscarriages or IVF attempts.

The screening called pre-implantation genetic screening (PGS) for aneuploidy involves the testing of a single cell from a three-day old embryo. It is similar to PGD, a test that looks for specific genes known to cause inherited diseases. Preimplantation-screening of IVF embryos is expensive-the technique virtually doubles the procedure’s overall cost. Until now, eggs from younger women were generally considered to be more frequently defect-free. This concept has been challenged.

Dr. Jeffrey Nelson of the Huntingdon Reproductive Center in California used PGD to screen 289 embryos from 22 healthy egg donors under the age of 30. “Overall, 42% of the embryos had aneuploidy or abnormal chromosomes.” Two other studies, one in Maryland and one in Atlanta, conducted similar studies and also detected unexpectedly high incidences of embryos with chromosomal abnormalities in women once considered at reduced risk for such. Doctors are unclear as to whether the drugs used for IVF are responsible for such inflated risk or if defective eggs are common among the genetic population but are rejected early on by the body.

While most agree that the results have challenged traditional thinking, the ensuing recommendations vary from the radical to the cautious. Dr. Nelson believes the UK Human Fertilisation and Embryology Authority should relax its guidelines and recommend wider IVF screenings. A spokesman from the HFEA answers, “we are concerned that women are properly aware of the potential risks before they choose to have this test and that women and embryos are not tested unnecessarily. Mr. Stuart Lavery, a consultant gynecologist at Hammersmith Hospital and a spokesman for the British Fertility Society, said “it’s very interesting, but it is quite preliminary.” He recommended that caution still be exercised when considering wider screening, as the procedure is relatively new and can be invasive. “He said the benefits would have to outweigh any harms.”

[Thanks, Ana Lita]

Supplement Your Mind . . . and Body?

It is

It is said that there is no such thing as bad publicity, but Dr. Phil might not agree right now. The TV psychologist is in danger of being named in a class action law suit regarding diet products that he has endorsed. The plaintiffs charge that the diet products do not meet the claims that Dr. Phil and the product literature tout, nor were there ever any clinical trials to validate those claims. What most people don’t realize is that dietary supplements, those claiming to aid in weight loss or otherwise, do not need clinical trials before going to market. Dietary supplements are regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA) which allows manufacturers to market dietary supplements without the sort of rigorous testing required for drugs or food additives. The FDA still has the power to control supplements that it can prove are dangerous, but that onus falls on the FDA instead of on the manufacturers to prove that their supplements are safe. What this means is that consumers need to be cautious about what supplements they take as they are not protected from harmful supplements, even though they may think they are. As an example, it took the FDA close to a decade to ban the sale of ephedra – a supplement often used in weight loss efforts which had dire side effects, including many deaths.

The flip side of dietary supplement regulation is that there are many dietary supplements that people have used for thousands of years that are generally regarded as helpful and safe. To require manufacturers of vitamin C, for instance, to produce clinical trials proving its efficacy and safety would effectively mean that no one would be able to produce this supplement because the costs and time associated with testing are beyond what a vitamin manufacturer could afford to invest in product development. Many common herbs and other plants, such as garlic and cilantro, are used as dietary supplements. Dietary supplementation is one way that health conscious people can be proactive about their health. Wide scale regulation and barriers to dietary supplements would be intrusive and even harmful to many people who depend on vitamin and mineral supplementation to support their health. And yet there are serious plans to do just that at both the state and federal levels.

While the regulation of dietary supplements isn’t a particularly sexy issue, it is the sort of meat-and–potatoes issue (or meat-and-veggies for the low-carb dieters) that deserves a lot more public interest than it is currently getting because it promises to affect just about everyone in one way or another. So whether you want to treat your cold with echinacea or are worried that your spouse shouldn’t take gingko biloba with her Coumadin, you might want to follow this issue.

Miers nomination "sexist"?

In an article on CNN.com about President Bush's nomination of Harriet Miers to the U.S. Supreme Court, Senator Dianne Feinstein of California alleged that the conservative criticism of Miers is "sexist." Feinstein comments that individuals instead should "...hold their fire and give people an opportunity to come before a hearing."

While I agree that there is much good to be learned from the hearing process and I applaud Senator Feinstein's call for more information, I take issue with her allegation of sexism. Gender is always a factor, both in the political arena and in career advancement. After all, it is not coincidental that Miers has been nominated to replace Sandra Day O'Connor, one of only two women on the Court. However, it is difficult to see how the far right's criticism of Miers is particularly gender related. Conservatives are concerned that Miers will not be sufficiently respectful of human life or tough enough on crime, but these are religious and/or ideological concerns, not gender concerns.

Why does it matter? It's a bit like the boy who cried wolf. To call these criticisms "sexist" when, in fact, they are not both diverts the public from the real issues and makes it more difficult for them to respond when there are, in fact, sexist claims being supported. Let's call a spade a spade, and reserve the term "sexist" for occasions when there really is something to worry about.