The Drama Surrounding “the Juice of Youth”: The FDA Weighs in on “Natural Hormones”

The popularity and perceived value of medications prepared by compounding pharmacies—particularly of hormone medications—is nothing new, and over the last several years has generated a tremendous surge in both interest and controversy fueled by endorsement of bioidentical hormones by celebrities such as actress Suzanne Somers, followed by subsequent complaints ranging from doctors to the Food and Drug Administration (FDA), in which both camps are critical of claims touting the “benefits” of the drugs and manner in which they’re prepared, as unsubstantiated marketing that could endanger the health of women not properly informed.

Somers states she’s only attempted to raise awareness and empower women to analyze and explore alternative HRT therapies available, rather than simply settling for synthetic preparations marketed by big pharma; on the one side, Somers’s supporters praise her courage and conviction, while her detractors are scathingly critical of her endorsement of drugs that they say have not been proven safe—as well as attribution to those they portray as dubious professionals with questionable credentials.

Last week the FDA publicly announced that there was no difference between hormone medications marketed as bioidentical, and prepared by compounding pharmacies, than those marketed as synthetic preparations manufactured by drug companies. The fallout from this stance of course is that compounders are not restricted from claims that their products are better. Many of those who support bioidenticals are convinced that the FDA’s public stance was based more in the drop in sales of commercial prescription HRT medications. Pharma giant Wyeth, no stranger to HRT controversy, has asked the FDA to step in against compounders, who are currently under state regulation, not federal. Again, women are caught in the middle in determining the best course of action.

Details in this blog article from the NY Times

The Bitterly Unfair Truth of Sexuality

Caitlin Flannigan has an op-ed in the New York Times that uses the movie Juno as a starting point to discuss female sexuality. Specifically, she talks about the fairy tale nature of the film (don't read the op-ed if you've not seen the film and don't want the ending completely spoiled), and highlights what she calls

the bitterly unfair truth of sexuality: female desire can bring with it a form of punishment no man can begin to imagine, and so it is one appetite women and girls must always regard with caution.

She goes on to make some very interesting points: that abortion, adoption, or even keeping a child is not an easy decision for a single woman, let alone a single teenage girl, and that very few woman escape from any of these decisions unscathed and able to return to who they were beforehand. (A sentiment I strongly agree with. While I don't buy into the supposed grief and regret that wracks any and every woman who's had an abortion, I do strongly agree that the experience forces significant change in a woman.)

Flannigan continues,

Even the much-discussed pregnancy of 16-year-old Jamie Lynn Spears reveals the rudely unfair toll that a few minutes of pleasure can exact on a girl. The very fact that the gossip magazines are still debating the identity of the father proves again that the burden of sex is the woman’s to bear. He has a chance to maintain his privacy, but if she becomes pregnant by mistake, soon all the world will know.

Pregnancy robs a teenager of her girlhood. This stark fact is one reason girls used to be so carefully guarded and protected — in a system that at once limited their horizons and safeguarded them from devastating consequences. The feminist historian Joan Jacobs Brumberg has written that “however prudish and ‘uptight’ the Victorians were, our ancestors had a deep commitment to girls.”

And again, she makes a good point with a contemporary illustration - Jamie Lynn faces the burden of the pregnancy, the gossip, the everything. A guy can impregnant and run, emotionally distant if he so chooses - a girl doesn't have that option, no matter what choice she makes regarding her pregnancy.

It's hard to argue with the idea that pregnancy robs a teenager of her girlhood. Pregnancy forces a girl to start making decisions that affect her life, short and long term - and also to make decisions that will impact others (or at least potential others). Adolescence is the period of moving from a world revolving around self to a world of interacting with others, and anyone who's spent any amount of time around a teenager can tell you how rapidly they oscillate between the two. Pregnancy forces the hand; wild oscillations have to stop in the face of reality (at least, one hopes).

What then, is the answer, if any? As Flannigan also so rightly notes, it's not as though we have no deep commitment to our teenage girls. Unlike the Victorians, we place our emphasis on commitment elsewhere, not on safeguarding but empowering. We don't look at focusing on their chastity, but instead on empowering girls to believe that they can compete with boys, be better than boys, and don't need to be dependent on anyone but themselves. But to repeat Flannigan's question,

we have to ask ourselves this question: Does the full enfranchisement of girls depend on their being sexually liberated? And if it does, can we somehow change or diminish among the very young the trauma of pregnancy, the occasional result of even safe sex?

I don't know that there is a neat answer to this, at least not when the country itself is divided, in so many ways, about teen pregnancy. And maybe, ultimately, the answer lies not in how we empower or protect the girls themselves, but how we treat those whose values and opinions differ than our own. Maybe the ultimate solution is to move further away from the Victorians, who protected that chastity with shame, and forget the entire concept of shame and sex.

...it's either that or find some way to subject teenage fathers to the same ostracization and stigmatization that pregnant teens are subjected to, and that seems like a much more difficult proposition.
-Kelly

Help your doc help you....

The illustrious Dr. Jerome Groopman (who was recently interviewed on NPR) recently published a new book, How Doctors Think. It's an expanded version of an article he wrote for The New Yorker.

This is a more engaging read than one might think at first blush, in part because of Groopman's liberal use of stories and anecdotes. These illustrate the information he really wants to share with us: the facts that (a) doctors are not perfect, (b) they make predictable errors in diagnosis, often due to cognitive or emotional biases, and (c) we--the general public--can help doctors avoid these pitfalls if we know what they are. By asking, for example, "Is there anything else it could be?" or "Is it possible that I have more than one problem?" we can help the doctor consider options she may have overlooked.

So why is this relevant to you, the WBP reader? Well, two reasons leap to mind. The first is that women continue to play the role of healthcare decision maker for their families, and so we're often in the best position to ask the right question at the right moment. The second is that my own mom, and many other moms of my acquaintance, have shared their stories of "knowing something was wrong" with a loved one, even when the doctors weren't able to find anything at first. Though Groopman doesn't seem to think of it this way, a piece of advice that fits right in with the rest of his argument is "Trust your own intuition--at least far enough to ask the doctor that one more question."

Should Children be Vaccinated against Addiction?

blog.bioethics.net points to an article in Time on the new "cocaine vaccine" and asks whether it should be given preemptively to children.

Basically, the "cocaine vaccine" works by stimulating the body to produce antibodies that bind to cocaine molecules, preventing them from binding to the receptors in the brain that, when activated, produce the "high" from the drug. As a result, the "high" is negated or greatly reduced, which removes the incentive to continue to use the drug.

While I see the potential for this treatment to help addicts overcome cocaine addiction, the talk of giving this preemptively to children worries me. Beyond the issues of informed consent mentioned, I have concerns about using any treatments that could affect brain receptors in children unless it is medically indicated. Psychoactive drugs affect us because our brains have receptors that respond to particular drug molecules; these receptors probably have some other function in normal life. Stimulating the body to produce antibodies that bind to drug molecules to inhibit them from binding to our receptors could have adverse impacts on the natural auto-stimulation and regulation from our bodies. In children whose brains are still developing (and will go into overdrive during puberty), we cannot safely anticipate what the long-term effects on neurotransmitters and brain activity could be.

Because the vaccine has been show to be effective on adults, and because there is usually sufficient time to respond to cocaine addiction, I do not feel that vaccinating children in this case is justified.

And because I still am bitter about the controversy over the HPV vaccine: aren't moralists worried that giving the cocaine vaccine to children will tell them it's okay to start doing drugs?

The Human Side, or the Female Side?

Election years are always interesting in their coverage of candidates - and since I'm something of both a news and politics junkie, it's tailor-made news heaven. This year proves to be an especially interesting one with Hilary Clinton's run for the White House, not necessarily because of her politics or even that she's a Clinton, but because she's a woman, and it really lets us see the double standard the media, and perhaps the public, have towards men and women.

As is being reported in quite a lot of places, Clinton won New Hampshire because she emoted - something, her lack of emotion, she has been criticized heavily for in the past. Now this in and of itself is an interesting thing; when is the last time you can remember a male presidential candidate being skewered for his lack of emotions? Most male candidates don't get choked up, don't cry on camera, keep very firmly in control of their emotions - in fact, to this day many people think that Howard Dean's "famous Iowa scream" is what ultimately cost him the Democratic nomination. A showing of too much raw, uncontrolled emotion.

A negative thing in a man.

But in a woman, not showing emotions seems to be a negative trait. We, as a matter of fact, have some rather unflattering terms for women who're viewed as carefully in control of their emotions, from frigid or ice queen and on.

Yet on the flip side, although apparently her teary exchange with New Hampshire voters did Clinton a world of good, her campaign staff was nervous about how it would play. How would people perceive a woman teary and tired, talking about how exhausting campaigning is? The concern was that it would badly undercut her messages of being experienced, that she is strong, that she can handle the demands of the job.

Do men on the campaign trail face similar damned if you do, damned if you don'ts? At the moment, I'm hard pressed to come up with an example that fits, but that also could be because I'm seeing this very clear example for a woman being damned no matter what she does in front of me. What about you - do you think male politicians face these same issues? Or are we really seeing a nasty side of ourselves that we thought that, as a society, we had passed beyond, where in the same situation women are judged against standards and qualities that men are not?

Perhaps most to the point, I think we have to ask ourselves a simple question: if Obama or Edwards had become teary-eyed in front of voters, talking about the same concerns, would Maureen Dowd of the New York Times have written an article entitled "Can Obama/Edwards Cry His Way To the White House"?
-Kelly

"We" not "She" had an abortion

(This follows nicely from the post on gender.)

blog.bioethics.net reports on a new movement to involve men in outlawing abortion.

According to the article by the L.A. Times:

Abortion is usually portrayed as a woman's issue: her body, her choice, her relief or her regret. This new movement -- both political and deeply personal in nature -- contends that the pronoun is all wrong.

I think that it is great that there is an effort to involve men more in the process of sex and pregnancy. But let's encourage a genuine effort to empower men and give them a voice in this process - let's advocate for men to become more aware of all the processes related to sex, pregnancy, and birth. The archaic "predatory" model of men and sex needs to be fully rejected, and parents need to stop raising their boys to "go get 'em!" while relying on intimidation and threats to foist the burden of chastity only onto their daughters.

It is a good start that men are beginning to realize the emotional impacts of pregnancy termination, but our society ought to come together to share the emotional impacts of all aspects of intimacy and reproduction, aspects that until recently have been shrouded in mystery and shame (and just a bit of possessiveness by women) and withheld from men.

Let's truly forge new respect for life by bringing in both sides of the equation into this effort.

US healthcare: we spend and spend, but....

This week the Department of Health and Human Services released the news that US healthcare spending broke the $2 trillion mark in 2006. Yes, you read that right: TWO TRILLION DOLLARS. This is despite the fact that the annual increase in healthcare costs has actually slowed down a bit in the past few years. (Read more at the NYT here.)

What do we get for this enormous outlay? Well, not so much as you might think, and not as much (in terms of outcomes) as lots of other countries that spend less.

In 2007, the Commonwealth Fund surveyed 12,000 people in 7 countries: Australia, Canada, Germany, the Netherlands, New Zealand, the UK, and the US. (You can find the abstract in Health Affairs, here.) Despite spending nearly double what some of the other countries spend per capita on healthcare, US respondents were more likely to report experiencing medical errors; going without needed care because they can't afford it; and to say that the healthcare system needs to be completely rebuilt. We--along with our neighbors to the north--are also least likely to be able to get a same-day appointment when we're sick, and more likely to show up in the ER because we don't have an alternative.

Consider just this one fact: 32% of Americans surveyed who had two or more chronic conditions said that they'd experienced a medical error in the prior 2 years. Keep in mind that these are just the errors patients know about!

So, it being election time (as if we could forget!), let's see if we can't get the candidates to say more than just "Healthcare is broken, and I'm gonna fix it." Covering more people is an excellent start--but just a start. Among other items on the healthcare to-do list: figure out how to improve quality, how to re-value primary care, and how to help people be more effective self-advocates.

(Lack of) Popularity Linked to Obesity?

A new study from the Archives of Pediatrics and Adolescent Medicine says that how popular a girl perceives herself to be will affect how she gains weight - and how much. The study asked girls aged 12 - 18 a series of questions to rank their own assessment of their popularity, recorded the girls' BMI, and then came back two years later to repeat BMI measurements. The researchers apparently adjusted for a host of variables, including "age, race/ethnicity, baseline BMI, diet, television viewing, depression, global and social self-esteem, menarche, height growth, mother's BMI, and pretax household income" and still found that "adolescent girls who placed themselves on the low end of the school subjective social status scale had a 69% increased odds of having a 2-unit increase in BMI during the next 2 years compared with other girls."

While a part of me wants to react with the "well, yes... of course" reaction of the sort of obvious science that people do where you already know the answer, someone just had to quantify it, another part of me wonders if they're really looking at the right thing at all. If the researchers looked at an earlier age, would they find the same thing, or would they find other causes of weight or social ostricization that lead to either increased weight gain or feeling unpopular? Perhaps the girls who feel they're popular feel like they have to keep up an unhealthy physical image, or partake in disordered eating habits (anorexia, bulimia, etc). I don't know, it just seems a little too neat.

The other thing that seems a little too neat is the suggestion that schools and parents should work on fostering social skills in girls, as if this alone will increase their popularity. I think by very virtue of the concept, some girls will be more and some less popular - improving social skills isn't likely to change that. As far as I recall being a teenager, there's always something to ostracize someone with. Either they're too tall, too short, have developed faster than the rest of the class (or slower), look different, move oddly, aren't coordinated enough for cheerleading, spend too much time with computers or games or any number of things that kids look for as defining differentials. Suggesting that there's a way to eliminate a popularity battle seems to indicate that it's definitely been a while since the researchers were in high school themselves.
-Kelly

One Stop Medical Shopping: Convenience and much more

Would you want to get your pap smear and wrinkles filled in by the same doctor? An article in Health explores how more and more doctors are cashing in on cosmetic procedure boom and quotes our founder and blogger on the potential pitfalls:

"This boon for physicians, then, may be a bust for patients, says Kathryn Hinsch, founder of the Women’s Bioethics Project, a public-policy think tank in Seattle. 'A big problem is that any doctor with very minimal training can perform these procedures, so the potential safety issues are high...Part of the fundamental trust between a patient and doctor is the idea that the doctor has the patient’s best interest at heart, and that there is no financial incentive for the doctor to perform any procedure,' Hinsch says. 'When doctors start adding cosmetic procedures, which they’re adding because they’re big moneymakers, there’s a corruption of that basic trust.'

For more on what the article and what Kathryn had to say about this, click here.

Gender: Love It or Kill It?

Colleague George Dvorsky sent me a recent blog post of his, thinking that I might be interested -- the title is "Overcoming Gender", and it's a quick summary of a formal paper he and James Hughes are co-authoring on postgenderism. Perhaps it is my feminine nature, but I had to laugh when I read the summary because one of my first thoughts was, "how typically male it is to see gender as something that has to be overcome, rather than something to be embraced or even transcended." (a more tame version of what Ken Wilber said about men and testosterone in A Brief History of Everything) -- so dualistic, rather than integrated.

But then again, I suppose one could argue that that just proves his point?

More on the mind-body connection

This story on NPR reports on a recent study whose authors claim that it shows that the placebo effect can be effective in weight loss and fitness. (You can find the citation and abstract on PubMed here.) Ellen Langer, a psychologist at Harvard Medical School, worked with a sample of hotel maids--whose work is nothing if not physical--to reframe their thinking about their level of exercise. Though these women are on their feet and moving around all day, often hauling heavy carts and vacuums, they didn't consider themselves to be getting much exercise. More to the point, their physical health status didn't reflect the amount of exercise they were getting on the job.

The researchers divided the women into two groups. Women in the experimental group received information about exercise and encouragement/education intended to help them understand that they are already meeting national guidelines for daily activity. Women in the control group received no information. On follow-up, the women who had received the education showed weight loss, lower blood pressures, etc.

The researchers conclude that these changes can be attributed to the educational intervention--that is, that by understanding that they were getting enough exercise for it to improve their health, their health was improved.

Critics comment that because the study was based on self-report and not observation, there's no way of knowing whether the women in the experimental group made other changes--eg, improved their eating habits--perhaps as a result of having their awareness raised through the intervention. Without these missing data, it's impossible to make direct claims for the efficacy of the educational intervention, because other factors could account for the differences that were observed afterward.

This study raises interesting questions about the placebo effect and just how much our thoughts control our physical status. It also brings up some caveats and lessons for all of us who get our medical information from the media. News stories, after all, focus on the interesting finding--not on the validity of the methods employed to reach those findings. As more and more information becomes available to the public through relatively unmediated forums (ha! like this blog!), we all need to take a more critical stance.

Scientists Restore Walking In Mice After Spinal Cord Injury

I wasn't too worried about my computer giving out on me right at the start of the new year, other than the wince that comes along with having bad luck the first week (you know that myth saying your first few days of 2008 reflect how your year will go? Let's really hope myth is the key word there...), since typically not much happens in the news. So if I have to be offline, it's a good time to be offline.

So naturally, science and the news goes and proves me wrong. The first time I sit down with the computer and pull up the news, literally the first thing I see is amazing:

For the first time, a UCLA study shows that the central nervous system can reorganize itself and follow new pathways to restore the cellular communication required for movement. The discovery could lead to new therapies for the estimated 250,000 Americans who suffer from traumatic spinal cord injuries...

"Imagine the long nerve fibers that run between the cells in the brain and lower spinal cord as major freeways," explained Dr. Michael Sofroniew, lead author and professor of neurobiology at the David Geffen School of Medicine at UCLA. "When there's a traffic accident on the freeway, what do drivers do? They take shorter surface streets. These detours aren't as fast or direct, but still allow drivers to reach their destination.

"We saw something similar in our research," he added. "When spinal cord damage blocked direct signals from the brain, under certain conditions the messages were able to make detours around the injury."

It's just a first step; from here, scientists have to actually figure out how to convince nerves to grow around the injured site. So no, tomorrow morning, people with spinal damage won't be able to get up and walk - but, to borrow language from my software days, the proof of concept is there.

I haven't read the Nature article yet, but I also have to wonder what sort of application this might have for other nervous system injuries (especially people who suffer from chronic pain due to problems with their nervous systems).
-Kelly

Amnesty for War Crimes -- even Healthcare Worker War Crimes?

Timothy Murphy of UIC graciously agreed to kick off the discussion in the new year with a provocative post:

Physicist Freeman Dyson has an interesting essay in the current New York Review of Books. In discussing a biography of Wernher von Braun, Dyson says pretty plainly that he considers his own work for the Royal Air Force as collaboration with the people who planned the destruction of Dresden in early 1945. He has called that bombing “a notorious calamity in which many thousands of innocent civilians were burned to death. If we had lost the war, those responsible might have been condemned as war criminals, and I might have been found guilty of collaborating with them.”

Dyson goes on to say: “War is an inherently immoral activity. Even the best of wars involves crimes and atrocities, and every citizen who takes part in war is to some extent collaborating with criminals.” And yet Dyson does not widen the scope of responsibility because he wants to make it possible to bring more ‘collaborators’ to trial. On the contrary, he believes that this widened sense of responsibility for war shows the need for amnesty, not prosecution.

“Without reconciliation there can be no real peace,” he goes on to say. “Reconciliation means amnesty. It is allowable to execute the worst war criminals, with or without a legal trial, provided that this is done quickly, while the passions of war are still raging. After the executions
are done, there should be no more hunting for criminals and collaborators. In order to make a lasting peace, we must learn to live with our enemies and forgive their crimes. Amnesty means that we are all equal before the law. Amnesty is not easy and not fair, but it is a moral necessity,
because the alternative is an unending cycle of hatred and revenge.”

I thought this would interesting because of what this suggests about prosecutions and/or amnesty for healthcare workers who commit offenses during hostilities or who otherwise enable armed conflict. I have lots of reactions to the ideas here, but I will share just one: I am skeptical that opening the door to executions without trials seems to me a terrible mistake. There ought to be trials. Let's refer to the Nazi doctors' trial, for example. Not all were convicted. Not all the convicted were hanged. Whatever else they do, trials introduce a measure of proportion. Maybe you think that more should have been convicted and more hanged, but executions without trials seems to me to open the door to more mistakes, more unmeasured vengeance, more indulgence.

Having Cake is Different From Eating Cake

The National Academy of Sciences has just released a new book, Science, Evolution, and Creationism, to explain the differences between religion and science, and to clarify the currently muddled discussion on matters entangled in the current conflict.

NYT reports:

...it is intended specifically for the lay public and because it devotes much of its space to explaining the differences between science and religion, and asserting that acceptance of evolution does not require abandoning belief in God.

...The 70-page book, “Science, Evolution and Creationism,” says, among other things, that “attempts to pit science and religion against each other create controversy where none needs to exist.” And it offers statements from several eminent biologists and members of the clergy to support the view.

In the past year, there has been a significant push-back by prominent atheists and skeptics against dogma-based attacks on science, but this new publication will be key in defusing the artificially constructed conflict between two completely different human endeavors. Hopefully, this year will mark the emergence of a new movement to continue this effort.

A Modern Day "Handmaid's Tale"?

In the latest and, in my opinion, grotesque twist on medical tourism, Judith Warner, author of “"Perfect Madness: Motherhood in the Age of Anxiety" and host of "The Judith Warner Show" on XM Satellite Radio, writes about the commercialization of surrogate motherhood in India. Her report can be found on the New York Times “Domestic Disturbances” blog, located here.

Many of us have talked, debated and written on the topic of surrogate motherhood, but all too often in the academic abstract. For someone like myself, who has thought about surrogacy in terms of commodification and exploitation, it is interesting to read Ms. Warner take on the issue, especially when she states “Our rules of decency seem to differ when the women in question are living in abject poverty, half a world away. Then, selling one’s body for money is not degrading but empowering.”

Generations Ahead

From our colleagues at the Center for Genetics and Society:

With great pleasure we announce the growth of the Gender, Justice and Human Genetics program of the Center for Genetics and Society into a new, independent organization, Generations Ahead. The myriad uses of human reproductive and genetic technologies raise important ethical questions for social justice advocates. As we articulate shared values and develop policies to inform how we use these consequential biotechnologies, it is important that we think not only of how we use them today, but also how they will impact generations ahead.

Generations Ahead will continue working for reproductive and genetic justice through outreach, capacity-building, cross-movement collaborations, and national coalition-building on assisted reproductive and genetic technologies. Sujatha Jesudason will continue to lead this work in her new role as the Executive Director of Generations Ahead.

Congratulations to Sujatha and her new team from the Women's Bioethics Project. You can read more about the efforts of Generations Ahead here.

Big Pharma and Informed Consent

A colleague asked me to post this entry under the nom de plume J. E. Cochran -- a thought provoking post, I thought:

Informed consent, in a clinical trial, requires that a clinical trial subject be fully informed of all the risks and the benefits of taking part in the trial before participation. The goal of informed consent is that the subjects should have all relevant information, and be able to make their own decisions as to whether they should participate in the clinical trial. This approach is complicated not only because of the complicated information that must be presented to the subject,
which can rarely be fully understood, but also the fact that the information must be kept a secret for business reasons.

The requirement of informed consent, was proposed by physicians, ethicists, and even the US Food and Drug Agency (FDA) and the International Committee on Harmonization (ICH). However, while informed consent does invoke a warm fuzzy feeling and is great PR for
the pharmaceutical industry, the practical procedures and implicationsare far from having been completely worked out.

Pharmaceutical companies spend hundreds of thousands of dollars a year protecting their intellectual property by using patents, trade secrets, copyrights, etc. Accordingly, the investigators, subjects, institutions and all other related personnel who would have access to
the drug or its data are subject to strict confidentiality provisions. Practically speaking, however, it is commonly known that researchers talk amongst themselves and patients routinely discuss their treatment protocols with each other. Drug companies hope to curtails this
practice but realize that they have little choice but to "play along." The research industry chooses from only 3-5% of the entire practicing physician population. This population not only does the required research to approve a drug, but consists of key opinion leaders and a
significant portion of the initial prescribing population. In light of the clout of this researcher population, the industry prefers not to antagonize this population by the stringent enforcement of the confidentiality provisions. The practice of stringent enforcement of confidentiality provisions becomes even murkier when we talk about allowing patients to see the Investigator's Brochure (IB).

The IB is a grouping of the significant scientific data, in the original scientific language, which is made available to the investigator so that the investigator knows all the relevant risks
and benefits when enrolling patients. Conversely, the informed consent form is a significantly simplified document that hopes to inform patients, in a language that they can understand, of only the most important risks and benefits. The trade-off, caused by the use of this simplified language, is that a lot of the risks are not completely addressed in the standard informed consent form.

The question therefore arises: Considering the private and proprietary nature of new chemicals entities (NCEs), and the possible lack of complete information in the typical informed consent form, can a potential subject, request to have access to not only the informed consent form (which the subject is usually required to sign or acknowledge), but also the investigator's brochure?

Pro Business and intellectual property (IP) advocates, as advised by their lawyers, err on the side of protection of the data. They believe that the data generated from the drug can save lives, if only given a chance, and provided a profit can be made on the drug. They believe that this profit can only be made if their drug remains unique and the data generated from their studies is not mis characterized. They hence assert that the patient should only have access to the data that is meant for them and provided since that information has been customized for them such that it is easy for them to understand and difficult to mis-characterize. On the other hand, the drug companies believe that the data provided in an IB is difficult for the lay person to understand, and easy to mis characterize. Furthermore, if that data is provided to competitors, it can serve as a source of erosion of profits since the competitors will either mis-characterize
the data or develop me-too products. To avoid all these complications, pro business and intellectual property advocates err on the side of protection of the data.

On the other hand, patient rights advocates believe that despite the confidentiality provisions, the subject must have access to all data. These advocates believe that the understandability of the data is a significant goal, but should not be a barrier to access to this data. They point out that informed consent cannot occur in the absence of complete information. They also assert that the fact that subjects may not understand the data is an inadequate explanation since the
information should be phrased such that it can be easily understood. (IP advocates point to the inherent risks in over warning and the lack of focus present in 40 page informed consent forms.)

Both sides have valid concerns, each of which must be addressed. However, these concerns must not only be addressed in the vacuum of academia but in the bustling streets of commerce with true capitalism testing what the market supports.

For more info on this subject, click here.

Saving the World, One Technology At A Time

In a similar vein to the previous post, I was encouraged to see
7 Technologies that will Save the Earth in 2008:

- Cellulosic Ethanol.

- LEDs

- Electric Cars come back to life.

- MP3s

- The Kindle

- Solar (more specifically Nanosolar)

Cars Running on Water (a misnomer)

Small Cars Rock

For the details and full article, click here.

Botox in Bali

So, greetings from Bali! You might well wonder what there is to blog about regarding bioethics in Bali, but one of the things that slaps you upside the head as you are coming into the country is number of advertisements for Botox, 'vaginal rejuvenation', cosmetic stem cell procedures, IVF, and other elective procedures -- all advertised as half the price as in the US -- encouraging Indonesia as the spot for medical tourism. In fact, you can watch your procedure done in virtual 3D.

Happy New Year: A Celebration of Hope

A very Happy New Year to all of our readers from all of us here at the Women's Bioethics Blog -- I love ringing in the new year, it always hold so much promise. For what can we hope to make it a healthier, more ethical New Year? A few things come to mind:

- Transparency -- I just learned this phrase I had not heard before: "Sunlight is the best disinfectant" and for just about every profession, from academia to health care to the justice system, the metaphor holds true.

- Accountability -- a corollary to the above concept -- as a fellow blogger over at the Healthcare blog notes: "The main value of transparency is not necessarily to enable easier consumer choice or to give a hospital a competitive edge. It is to provide creative tension within hospitals so that they hold themselves accountable. This accountability is what will drive doctors, nurses, and administrators to seek constant improvements in the quality and safety of patient care."

- A step towards healing our broken health care system in the US. (as Art notes in his editorial cited below).

-- Tell us, what do you hope for in 2008?

We Can Always Count on Art

One thing we can always count on is great bioethics commentary from Arthur Caplan, Ph.D., director of the Center for Bioethics at the University of Pennsylvania. Read his New Year's Eve column "2008 - A Year Already Worth Forgetting" here. Thanks Art!

Kudos to Cato Institute

The Cato Institute has produced an outstanding policy analysis of the ethical issues surrounding live kidney donation and the use of incentives. Written by Arthur J. Matas, MD, it makes a compelling case for ethically appropriate ways to compensate kidney donors in order to overcome the dire shortage. He argues that "allowing the sale of kidneys from living donors would greatly increase the supply of kidneys and thereby save lives and minimize the number of patients suffering on dialysis."

Dr. Matas is a professor of surgery and director of the kidney transplant program at the University of Minnesota. Dr. Matas has been a practicing transplant surgeon for more than 25 years and is the immediate past prresident of the American Society of Transplant Surgeons.

You can read the full white paper here.

More Time to be Wise?

The potential to radically extend the human lifespan raises all sorts of bioethical questions from theologically based concerns (Is it moral to seek immortality?) to more practical considerations (Will radical life extension bring increased happiness or despair to the human condition?) "Radical Life Extension and Religious Evolution" by Sonia Arrison, TechNewsWorld, 12/14/07 offers a positive spin:

...not all scholars saw radical life extension as a negative development.

Professor Ron Cole-Turner of the Pittsburgh Theological Seminary discussed how life extension could benefit many religious orders. "Technology will inject competition into religion and force religious authorities to clarify what they mean by immortality." This is important, according to Cole-Turner because "there is currently a lot of evasiveness about what immortality means." This is a good point and, of course, the conversation is not a one-way street.

Religion will also serve to inject ethical competition into technology circles. If the future of evolution is now more in human hands, the religious question is: toward what end? In other words, if humans could live longer, what good should result? Perhaps the Buddhist scholar had the most clear and concise answer.

Professor Derek Maher explained that in Buddhism each person is responsible for their own karma which, taken care of properly, can bring one to a state of nirvana, which is the cessation of suffering. Buddhists, he explained, already embrace the idea of radical life extension because it "gives you more time to attain wisdom and advance spirituality." Essentially, it gives you more time in this life to improve your karma so you can reach nirvana.

Older and wiser? Maybe...

Working out with Wii? Think Again

And finally, I come bearing some bad news. It seems that working out via Wii? Not really that great a work-out after all. While it looks like the Wii does help you burn more calories than a more sedentary game system, we're talking 180 calories an hour for something like tennis - only 20 calories more than the can of soda sitting next to me. In contrast, actual tennis burns around 320 calories an hour.

Now granted, more movement is good - but for all those parents who bought the Wii this Christmas with goals of getting their coach potato kids up and both moving and healthier? This is bound to be disappointing news.
-Kelly

Medical Googlers

Are you a medical Googler? This is the term used by a doctor to describe a difficult patient who used Google to both research her disease and options - and him. Apparently the fact that she used Google contributed to her ill-behaved child and rude manners, who knew?

Tongue less in cheek, of course there's a problem with relying too much on the internet for medical advice - if you're not a doctor (or medical personnel of some sort), chances are pretty good you can't sift out the good advice from the bad advice with 100% accuracy. A doctor has the training to do this; some, like the author of the rather paternalistic Time article, view this as the primary purpose of a doctor - to have the training to separate out good from bad.

But as others note, the problem doesn't appear to be a patient who Googles their condition, so much as it is a patient who doesn't laugh at his jokes, or place full trust and authority in the doctor's hands (like nurses, who are apparently the best patients for just this reason).

The doctor claims this woman tracked down so much information on him, she even knew where he lived. And if this is true, then the patient certainly stepped over a line from researching disease/provider offering treatment to "kinda scary stalker behaviour" - and it's understandable anyone would be creeped out by that. But researching your own disease, and being able to ask "excruciatingly well-informed questions" (a problem, according to the doctor), seems like the precise thing patient-advocacy groups advocate for: a well-informed patient who is making the most informed decisions possible.
-Kelly

Benazir Bhutto

The first woman to lead a Muslim government in modern times, Benazir Bhutto, was assassinated today at a rally in Pakistan.

Regardless of what one thinks of her policies, politics, or even the possibility that the corruption charges repeatedly raised against her were true, Bhutto focused attention on the social, health and human rights of women in a state that routinely treats women as second class citizens.

Critics charge she was all promise and no action, while supporters argue that she was hamstrung by opposing, conservative political parties at every turn. It might be impossible to ever untangle fact from fiction from political manipulation, but what is undeniable is that she was a very visible, female face in Islamic politics, in a region of the world not known for allowing women that type of power.
-Kelly

following up on the Nataline Sarkisyan case

Over the weekend, wreese wrote about the case of Nataline Sarkisyan, a 17 year old leukemia patient denied a liver transplant. Sarkisyan died shortly after her insurance company reversed their decision to not approve payment for the procedure, and now lawsuits and manslaughter charges are being thrown to the media.

At this point, in the slow news days post-Christmas, the media is converging like sharks in bloody water, and someone's finally mentioned "the R-word". Rationing. It's a concept no one likes to hear when medical care is being discussed, but the facts of the matter are simple: there is simply not enough to go around.

What "enough" is varies in cases and circumstances. In this particular case, it's organs for transplant. But in another situation, it might be a vaccine, or drugs to treat a deadly communicable disease.

In Nataline's case, it appears to be, at first glance, a situation where public outcry is being raised against a company being portrayed as evil, greedy, only seeking the bottom line, and not caring about the actual health of the individual. And while this might be the case - for-profit companies are almost always driven by the bottom line - it seems to conveniently overlook a lot of the details of the case. Details like her leukemia, the wildly varying reports of transplant's success in saving her life, her overall medical state. But even if these details weren't overlooked, I think the public outcry would still be there, and for that one simple reason: rationing. And in discussing the case, the Cigna representatives made the mistake of framing the dialogue in terms of limited care that not everyone can receive.

No one likes the idea of medical care being rationed, because everyone wants to believe that they'll be covered if something happens to them or their loved ones. Nataline's case clearly shows otherwise.
-Kelly

Ten Biggest Health Stories of 2007 (from Alternet)

Okay, I promise this is my last 'top ten' post (at least for today and mostly likely for 2007 -- Can you tell I love these lists?). For the next few days, I will be en route to Indonesia and East Timor, so you won't hear much from me, but I do hope to do some blogging in Bali!

From criminal health care to outrageous diet plans, these are AlterNet's most-read health stories of the year:

10. Even Republicans Hate Our Health Care System

9. Are You One of the Shrinking Americans?

8. I'll Have My Cosmetics with a Side of Infertility, Please

7. The Toxic Chemistry of Everyday Products

6. Private Health Insurance Is Not the Answer

5. The Stone Age Diet: Why I Eat Like a Caveman

4. Controversial Michael Moore Flick 'Sicko' Will Compare U.S. Health Care With Cuba's

3. The Frightening New Normalcy of Hating Your Body

2. You Call Yourself a Progressive -- But You Still Eat Meat?

1. Michael Moore Rips Wolf Blitzer on CNN: "Why Don't You Tell the American People the Truth" [VIDEO]

For links to all the above stories, click here.

Wishing you all a happy, joyous, and abundant 2008!

Top Ten Technologies that give you 'superpowers'

From BioSteel that gives you powers like to Spiderman to an invisibility cloak, this is a fun article from the SciFi network.

Editor's Note, added Jan. 31, 2007: Oops, here's the link. Thanks for letting us know!

Top 10 New GMOs for 2007

From Wired Science News, a countdown of the top 10 organisms that didn't exist on Dec. 31, 2006.

1. Ashera GD hypoallergenic cat (although there seems to be some questions as to whether these really have been created -- see this link.)

2. Butanol-producing E. coli

3. Artful fluorescent tadpoles

4. Insulin-producing lettuce

5. Super CO2-absorbing trees

6. Rapid vaccine-making button mushrooms (funded by DARPA)

7. Glow-in-the-dark cats

8. Cancer-fighting Clostridium bacteria

9. Schizophrenic mice

10. Yeast with poison-sensing rat genes

For the full article, click here.

Mandatory HIV testing for pregnant women in New Jersey

AP reports that New Jersey has passed a law that establishes a mandatory, opt-out program for testing pregnant women (and newborns at risk) for HIV.

New Jersey has about 17,600 AIDS cases, according to the Kaiser Foundation. Women represent 32.4 percent of the cases — the third highest rate in the nation. The national average is 23.4 percent.

The state has about 115,000 births per year and had seven infants born with HIV in 2005, according to state health department officials.

Bloomberg also reports:

Health-care providers will test pregnant women for HIV, the virus that causes AIDS, in their first and third trimesters unless they refuse, according to the new law. Newborns whose mother's HIV status is positive or unknown at the time of delivery also will be tested.

The rate of mother-baby HIV transmission has been dramatically reduced due to increased testing and preemptive actions:

The number of children in the U.S. reported with AIDS attributed to HIV transmission during childbirth declined to 48 in 2004 from a peak of 945 in 1992, primarily because of the identification of infected pregnant women and the effectiveness of preventative drugs in reducing mother-to-child transmission, according to the CDC report.

Some questions for consideration:

* Does a woman's right to informational privacy outweigh the state's interest in preventing HIV transmission to newborns?

* Does the incurable nature of HIV lend more weight to the latter?

* Does a woman cede certain personal rights when she decides to carry a pregnancy to term?

* On a finer point - which is more desirable in this circumstance: "opt-in" or "opt-out"?

Questions for Our Leaders

Yesterday, we wrote about our call for a presidential debate on science policy. When pulling together potential questions for the debate, I came across a compelling series titled “American Values and the Next President” in the Los Angeles Times (December 12, 2007, Part A; Pg. 30.) It touches on a few of the incredibly important issues our political leaders need to be prepared to address:

An excerpt from the "Life" essay:
…Last month's news that scientists in Japan and Wisconsin had modified adult skin cells to behave as embryonic stem cells seemed at first to have resolved this issue, but that's only true if you believe that the debate over stem cells, cloning and genetic modification is a subset of the debate over abortion.

It is not. It is, or could become, the central life debate of our time, and depending on your perspective, the questions it raises are either exhilarating or horrifying. If you could ensure that your children would never get melanoma, should you do that? How about nearsightedness? Should we be modifying humans in hopes of making them more fit for survival in a warming climate? How about for handling complicated technology, or space exploration?

If these ideas seem excessively science-fictional, consider that when Leon Kass, the conservative University of Chicago professor who would later serve as head of President Bush's Council on Bioethics, wrote a 1972 screed against the then-novel science of in vitro fertilization, he warned that it could someday make mothers of "single women, widows or lesbians." Yesterday's absurdity is today the mainstay of many lives.

Given the expected level of discourse in a presidential campaign, we may be lucky that the candidates are not keen to explore the frontiers of life. Still, it's a missed opportunity...

I would expand the life debate beyond reproductive technologies. Advances in nanotechnology, neuroscience, and robotics, to name a few, will also play an important part in defining "what is life."

My wish for the New Year is that we get beyond paralyzing partisanship, over the top religious rhetoric and the trivializing sideshow antics of the last year and focus the debate on how we can work together to achieve social justice, equity, human dignity and cultivate a critical optimism towards science in order to shape a better future for all.

News from the Nanoworld

From the UK Telegraph, cool news from the world of nano: The protein linked with Alzheimer's disease has inspired the design of "nanoyarns" that could be put to a vast range of uses, from body armour to parachutes and super strong nets.

Full story here.

Science Debate 2008

The Women's Bioethics Project, as well as bioethicists Thomas H. Murray (Hastings Center), Arthur L. Caplan (University of Pennsylvania), and Harold Shapiro (Princeton University), have joined Science Debate 2008, a coalition of scientists and concerned citizens, to call for a presidential public debate on science and technology policy.

The grassroots initiative states:

Given the many urgent scientific and technological challenges facing America and the rest of the world, the increasing need for accurate scientific information in political decision making, and the vital role scientific innovation plays in spurring economic growth and competitiveness, we call for a public debate in which the U.S. presidential candidates share their views on the issues of The Environment, Health and Medicine, and Science and Technology Policy.

To date, most of the coalition supporters are men. Let’s be sure that women’s voices and concerns don’t get lost in this debate. You can sign the petition yourself here.

Global Warming spreads tropical disease

Chikungunya, a relative of dengue fever, is not something you would expect to contract it Italy, but a recent outbreak in Castiglione di Cervia is the first indication that a disease that had previously been seen only in the tropics is spreading because of global warming and globalization. According to a NY Times article today, Dr. Roberto Bertollini, director of the World Health Organization’s Health and Environment program, “This is the first case of an epidemic of a tropical disease in a developed, European country...Climate change creates conditions that make it easier for this mosquito to survive and it opens the door to diseases that didn’t exist here previously. This is a real issue. Now, today. It is not something a crazy environmentalist is warning about.”

Better cracking on those transgenic mosquitoes we had blogged about earlier.

In the Case of Nataline Sarkisyan

My immediate reaction when first learning of this case, was one of outrage. How dare yet another bean-counting, uncaring, bottom-line thinking insurer, whose job it is to provide health coverage to paying policy-holders, how dare they allow a 17-year old child to die because of petty haggling over approval of a life-saving transplant procedure? How dare they? Particularly given the already tarnished image faced by most of the industry heavy-weights.

Yet, here we are, weighing in on yet another case that at first blush looks like the usual big-guy insurance-giant bullying the little-guy. But is it?
Here is the breakdown:

• Nataline Sarkisyan, 17-year leukemia patient dies after being removed from life support following complications developed after a bone marrow transplant from her brother the day before Thanksgiving. The complications caused Nataline's liver to fail, placing her in a vegetative state.
• Nataline's doctors at the University of California, Los Angeles Medical Center, appealed to the Sarkisyan's insurer, Cigna Corp., to reconsider an initial refusal of a liver transplant, which doctors said was crucial to her survival. Cigna initially refused to authorize the procedure, calling it experimental.
• Cigna later rescinds the earlier decision, agreeing to the transplant in an 11th hour change of heart.
• Nataline dies within an hour of being removed from life support.

Nataline's family has promptly filed suit against Cigna, retaining the legal services of Mark Geragos (remember him from the Michael Jackson and Scott Peterson trials?), who promptly blamed the insurer for Nataline's death. Geragos has asked the California District Attorney's office to press murder or manslaughter charges against Cigna, claiming, the insurer "maliciously killed" her because it didn't want to pay for her transplant and aftercare.

At issue is whether the procedure would indeed have saved her life. Doctors in the case stated the survival rate for patients in similar situations is six months at 65 percent. A complicated case.
Access the article here

Worth Noting

Stumbled across this gem of an article about 7 Medical Myths Even Doctors Believe from LiveScience. The British Medical Journal found out that when it comes to urban myths, doctors aren't immune. For example:

"Myth: We use only 10 percent of our brains.

Fact: Physicians and comedians alike, including Jerry Seinfeld, love to cite this one. It's sometimes erroneously credited to Albert Einstein. But MRI scans, PET scans and other imaging studies show no dormant areas of the brain, and even viewing individual neurons or cells reveals no inactive areas, the new paper points out. Metabolic studies of how brain cells process chemicals show no nonfunctioning areas. The myth probably originated with self-improvement hucksters in the early 1900s who wanted to convince people that they had yet not reached their full potential, Carroll figures. It also doesn't jibe with the fact that our other organs run at full tilt."

For the other six myths and the rest of article, click here.

Sea Cucumbers -- they're not just for dinner anymore

Far from being a mere oriental delicacy, Sea Cucumbers are turning out to be the hottest new miracle organism -- not only are they being investigated to help regenerate our organs and bring eyesight to the blind, they may be able to stop the spread of malaria with transgenic mosquitoes, which could save millions of lives. Genetic engineering at its best.

How cool is that?

EPA vs. States: Round 2

A followup to yesterday's post on the EPA:

Pennsylvania, New Jersey, Washington, and other states have announced that they will join California in the lawsuit against the EPA.

Maryland Gov. Martin O'Malley and Attorney General Doug Gansler, in a joint statement, said the Bush administration's decision is "thwarting the will" of more than a dozen states.

Vermont Gov. Jim Douglas, a Republican, said the EPA "is out of touch with the reality of climate change." New Jersey Gov. Jon Corzine, a Democrat, called the decision "horrendous," while Maine Democratic Gov. John Baldacci called the administration "obstructionist." Officials in New York, Connecticut, Arizona and Pennsylvania made similar comments.

The current investigation by the House Oversight and Government Reform Committee indicates that EPA Administrator Stephen Johnson disregarded staff recommendations that the EPA would lose a lawsuit should California file one.

Excerpt:

Environmental Protection Agency Administrator Stephen Johnson overruled the unanimous opinion of his legal and technical staff in blocking California's effort to cut greenhouse gases from cars and trucks - a new revelation that California officials say shows his decision was based on politics, not the law.

House Oversight and Government Reform Committee Chairman Henry Waxman, D-Los Angeles, launched a probe Thursday into why Johnson made his decision even though EPA staffers reportedly warned him he would lose in court if he denied California's request.

…The EPA's legal staff reportedly prepared a PowerPoint presentation advising Johnson that if he denied California's waiver request and the state sued, the EPA was likely to lose, agency staffers told the Washington Post. If he granted the waiver and automakers sued, the staff wrote, "EPA is almost certain to win."

This issue has clearly left the environmental sector to stake out a spot in Constitutional Law. Stand by for a big rumble.

‘Twas the countdown to Christmas

Our health -- in fact, our survival -- is inextricably connected to the health of our environment: it's not just an issue, like poverty or world peace, it is the overarching issue. Which is why I decided to do things a bit differently this Holiday season. But instead of simply explaining what, I inflicted some derivative seasonal doggerel on my long-suffering fiends and relations...and now on you, dear reader of this blog:

‘Twas the countdown to Christmas and all through my brain

Danced visions of giving to loved ones again.

With credit cards handy and Christmas cards too,

‘Twas Xmas like always -- what else could I do?

But then, from my Mac there arose such a clatter

I sprang to the keyboard to check out the chatter.

And right there on U-Tube was Al Gore himself

With flipcharts behind him -- a right angry old elf!

He’d gained a few pounds and was long in the tooth

But none of that mattered, ‘cause he’d seen the Truth.

His points were all listed -- a litany of shame,

And he highlighted each as he called them by name:

“On climate, on flooding, on habitat loss!

On the things that we purchase, and play with, and toss!

On warming, and melting, and drowned Polar Bears,

On species extinction! (I covered my ears…)

Al’s finger was wagging, it pointed at me.

I looked left and right and got ready to flee…

But what to my wondering eyes should appear

But a handy “Escape Clause” that said “sign right here.”

“Will you change,” asks the Gorester?

Er, sure thing, you bet…

I won’t give this year and (gulp!) I guess I won’t get.

You'll give," says St. Albert, "and here's what you'll do.

You’ll give to your Mother (that’s Gaia to you).

And so, my dear people, tho’ I love you a lot

This Xmas I’ll put all my bucks in one pot

And send a fat check off to where there’s most need.*

MERRY CHRISTMAS TO ALL AND TO ALL A GOOD DEED!

And with peace and goodwill towards all women and men, Santa “Cause”

(A.K.A. Mary)

*Specifically: Conservation International, Amazon Conservation Team, and the Institute for Transportation and Development Policy

FDA to require contraceptives to contain new warnings

According to a press release issued today, the FDA is requiring a new warning on all over the counter stand-alone vaginal contraceptive and spermicidal products. This warning is to inform the public that the spermicide nonoxynol 9 doesn't prevent the spread of sexually transmitted diseases, including HIV.

While this, on the one hand, makes sense - the clinical studies in Africa and Thailand that the press release refers to did show that nonoxynol 9 can irritate mucus membranes, actually increasing the risk for a variety of infections. But on the other hand, do people actually commonly believe, again as the press release suggests, that nonoxynol 9 is an effective barrier against STDs? They very clearly are a contraception, but doesn't our STD education - or even separate HIV education - explain the concept of bodily fluids transmitting infection?

So I admit that while I am neutral on the new packaging (I don't have a lot of faith that people read the directions and warnings in any great detail), I'm sort of baffled with its justification.
-Kelly

A simple Constitutional issue made murky by EPA

NYT reports that the EPA is now denying the right of states to set more stringent automobile emissions standards now that the new federal emissions standards were passed.

Excerpt:

The Environmental Protection Agency on Wednesday denied California and 16 other states the right to set their own standards for carbon dioxide emissions from automobiles.

The E.P.A. administrator, Stephen L. Johnson, said the proposed California rules were pre-empted by federal authority and made moot by the energy bill signed into law by President Bush on Wednesday. Mr. Johnson said California had failed to make a compelling case that it needed authority to write its own standards for greenhouse gas emissions from cars and trucks to help curb global warming.

The decision immediately provoked a heated debate over its scientific basis and whether political pressure was applied by the automobile industry to help it escape the proposed California regulations. Officials from the states and numerous environmental groups vowed to sue to overturn the edict.

In an evening conference call with reporters, Mr. Johnson defended his agency’s decision.

“The Bush administration is moving forward with a clear national solution, not a confusing patchwork of state rules,” he said. “I believe this is a better approach than if individual states were to act alone.”

What we have here is, at the minimum, a desire for federal uniformity of a technological standard affecting local economies and health, placed against the right of states to democratically decide on stricter, more applicable standards for themselves. At the worst, we have a government that has corrupted a federal agency to pander to the interests of an industry. Believe what you will, but at the very least, this is a red flag for undermining the relationship between states and the federal government.

And science is not a factor in this decision:

Mr. Johnson, the E.P.A. administrator, cited federal law, not science, as the underpinning of his decision. “Climate change affects everyone regardless of where greenhouse gases occur, so California is not exclusive,” he said.

The Governator isn't going to take this abuse of federal power sitting down:

Gov. Arnold Schwarzenegger of California said the states would go to federal court to reverse the E.P.A. decision.

“It is disappointing that the federal government is standing in our way and ignoring the will of tens of millions of people across the nation,” Mr. Schwarzenegger said. “We will continue to fight this battle.”

He added, “California sued to compel the agency to act on our waiver, and now we will sue to overturn today’s decision and allow Californians to protect our environment.”

Twelve other states — New York, New Jersey, Connecticut, Maine, Maryland, Massachusetts, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington — had proposed standards like California’s, and the governors of Arizona, Colorado, Florida and Utah said they would do the same.

Cars do not have rights. Car manufacturers do not have an inherent right to economic protectionism. No fundamental human rights are being violated. This is a capitalist society: consumer demand spurs the market. And in California, Washington, and other states, the consumers have spoken; they want cars with higher emission standards, and it is not the place of car manufacturers, the EPA, or George Bush to question their democratic voices when they wish to exceed the (embarrassingly) bare minimum standards established by the federal government.

While more related to environmental policy than to bioethics, this breach of Constitutionally established precedent allowing states to choose more specific and strict regulation than that presented by the federal government will have direct impacts on bioethical policy. We have already seen the federal government overriding democratically established legalization of physician-assisted dying in Oregon state, and I am certain that more issues will be affected as bioethical issues become more and more visible in society. Some will be overridden on moral claims and are therefore potentially open to discussion. But as ethicists, we cannot stand for a breach of Constitutionality based on industry concerns with absolutely no breach of rights.

Stand by for a clash at the Supreme Court, on an issue that a high school civics student should be able to answer:

AMENDMENT X The powers not delegated to the United States by the Constitution, nor prohibited to it by the States, are reserved to the States respectively, or to the people.

New Technology in Tracing Cancer Cells

This came as welcome news to me--albeit too late for a loved one--that a new form of technology has now hit the forefront in medical research that may provide a much-needed breakthrough in stopping cancer from doing what it does so well: kill.

The technology comes in the form of a device that researchers say can detect, isolate and analyze the tiniest fragments of tumor cells still circulating in the blood. The cells, called CTC's are crucial in the occurrence of metastatic disease, because they have been extremely difficult to detect and trap, until it was too late for the patient. According to the research team responsible for developing the device, "Nine out of 10 deaths in cancer are due to the metastatic process...These are really the cells that end up killing people."

The technology will be significant in helping to arrest the disease, because the ability to monitor the existence and rate of growth of these cells would give doctors a significant advantage in detecting remaining disease following surgery or drug treatment.

Too late for my niece who waged...and lost...an eleven-year war against breast cancer--but possibly a ray of hope for those currently fighting the fight.

Access the complete Reuters article here.

Running for the shelter of the Mother's Professor's little helper

In this week's issue of Nature, Cambridge University neuroscientists Barbara Sahakian and Sharon Morein-Zamir have penned a commentary entitled "Professor's little helper," which explores, how cognitive-enhancing drugs (like Nootropics and Provigil) are starting to find their way not only the pharmacopoeia that students have relied on at university campuses, but into the lifestyles of medical professionals and academics, which raises some ethical eyebrows.

Has academia become that much of rat race? -- one phrase sums it up: Impact Factor Scores,
Read it and weep. As one modern day philosopher said, "What drag it is getting old."
Rest of the commentary here.

the adverts are right - Guinness IS good for you!

From Wil Wheaton's blog (yes, that Wil Wheaton) comes the fabulous news that Guinness? Is good for you!

According to a new study out of the University of Wisconsin, drinking a pint of Guinness a day gives the same healthy-heart benefits as an aspirin a day (keeps the heart attack away). Apparently something in Guinness - but no lagers - reduces the clotting activity... at least, in the dogs that were in the study. Something tells me recruiting human research subjects won't be difficult!

No one is really sure what in the Guinness causes this anti-clotting activity; maybe it's added anti-oxidants, maybe it's just the effect of alcohol (leading speculation as to why the lager wasn't as beneficial). I do know that many asthmatics are recommended they drink a glass of wine or pint of beer a day, to alleviate inflammation and constriction, and there are of course numerous studies on the benefits of red wine. So, this would not be the first time alcohol has shown to have potential medicinal benefits.


I don't know about the rest of you, but I think this deserves a drink.
-Kelly

[cross-posted to the AJOBlog]

Top Ten Holiday Gifts for Bioethicists

In the spirit of the season, the Women's Bioethics Blog team has some recommendations to bring some bioethics cheer to your Holiday Gift-Giving:

1.) A Copy of The Omnivore's Dilemma, for anyone who has given any thought to the phrase 'you are what you eat'.

2.) A DVD of Michael Moore's Sicko, for whatever ails you.

3.) Energy-saving light bulbs (How many bioethicists does it take to screw in light bulb?)

4.) Donate to Heifer International (seriously)

5.) Spray-on condoms (not-so-seriously-gag gift)

6.) Biotech blooms - in vitro orchids -a sort of whimsically sweet gift for anyone interested in gardening/plants, or just novel things.

7.) A Grow-Your-Own-Skin Kit (just what I always wanted!)

8.) Med school in a box [game]

9.) Your very own pocket-sized version of the AMA Principles of Medical Ethics.

10.) anything from the Bodyworlds store! The book, however, is always a hit, and you couldn't pry mine out of my cold, dead hands. ;-)


Happy Holidays and Happy New Year to all of our readers!

[Editor's note, added Dec 19 2007 at 7:40pm -- I had to add a personal favorite to my wishlist --for sci-fi lovers, the darkly fascinating Blade Runner, The Final Cut.]

Quote of the Day: Being both pro-life and pro-choice

Anna Clark over at RH Reality Check wins the spot for "Quote of the Day" for the moving essay she has written about how she considers herself both pro-life and pro-choice -- She starts out:

"What if I told you that I used to call myself pro-life?

What if I said that I once believed abortion was murder, or that I suspected women used the procedure to bypass the consequences of sex?

If I told you, would I lose your respect? Would you be suspicious when I say that today I'm committed to the right to reproductive health, access, and choice?"

She then details her ambivalence, her journey and the realization of the complexity of the issue -- the quote that got me, though was this one:

"Pro-choice society, like democractic society, is predicated on space for those who disagree. When we play sides, we forget there are no enemies in the vision we pursue. Our inclusiveness of those who choose not to have abortions, and even those who judge abortion to be morally wrong, is our movement's power. When we approach anti-choicers as friends, not only do we act on the heart of our beliefs, but we create space for anti-choicers to become our allies."

What a poignant reminder -- Life -- it's a beautiful choice.